Обзор американских кардиологических журналов за неделю (ссылки)

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Trial Summary
COMPARE
Title: Second-Generation Everolimus-Eluting and Paclitaxel-Eluting Stents in Real-Life Practice
Trial Sponsor: Abbott Vascular and Boston Scientific
Year Presented: 2009, 2010
Year Published: 2010
Topic(s): Interventional Cardiology
Summary Posted: 09/23/2010
Writer: Dharam J. Kumbhani, M.D., S.M.
Author Disclosure: NOTHING TO DISCLOSE
Reviewer: Deepak L. Bhatt, M.D., M.P.H., F.A.C.C.
Reviewer Disclosure: RESEARCH/RESEARCH GRANTS: Astra Zeneca, Heartscape, Eisai, Sanofi Aventis, The Medicines Company, Ethicon, Bristol Myers Squibb Cogentus, PLx Pharma, Takeda

Description:

The current trial sought to compare outcomes between the everolimus-eluting stent (EES) (Xience V) and paclitaxel-eluting stent (PES) (Taxus Liberte) in a real-world situation.
Hypothesis:
EES would be superior to PES in the treatment of coronary artery disease in unselected patients.
Drugs/Procedures Used:
Patients meeting enrollment criteria were randomized to receive either EES or PES in a 1:1 fashion.
Concomitant Medications:

Glycoprotein IIb/IIIa inhibitors (32%); aspirin 300 mg once, then 100 mg daily for life; clopidogrel 300 or 600 mg once, then 75 mg daily for 12 months
Principal Findings:

A total of 1,800 patients were randomized, 903 to PES and 897 to EES. Baseline characteristics were fairly similar between the two arms. About 25% of patients presented with acute myocardial infarction (MI), and 23% with non-ST-elevation MI. Multivessel disease was noted in 27% of the patients, and 18% were diabetic. Left main stenting was conducted in 2% of the patients. The mean stent length per lesion was 28 mm, and the mean number of lesions was 1.65 per patient.

The primary endpoint of major adverse cardiac events (MACE) at 1 year (all-cause mortality, nonfatal MI, and target vessel revascularization [TVR]) was significantly lower in the EES arm compared with PES (6.2% vs. 9.1%, hazard ratio [HR] 0.69, 95% confidence interval [CI] 0.50-0.95, p = 0.023). Similarly, the incidence of death, MI, and target lesion revascularization (TLR) at 1 year was significantly lower in the EES arm compared with PES (4.9% vs. 8.2%, HR 0.60, 95% CI 0.42-0.86, p = 0.005).

In addition, the incidence of nonfatal MI (2.8% vs. 5.4%, p = 0.007) and TVR (2.4% vs. 6.0%, p = 0.0001) was significantly lower in the EES arm. The incidence of stent thrombosis at 1 year was also significantly lower in the EES arm (0.7% vs. 2.6%, HR 0.26, 95% CI 0.11-0.64, p = 0.002). This was mainly due to a reduction in early stent thrombosis (p = 0.002), rather than late stent thrombosis (p = 0.25).

Two-year follow-up was available for 1,795 patients. Only 15.2% and 11.4% of patients were on dual antiplatelet therapy beyond 1 year of index procedure, respectively (p = 0.02). The primary endpoint of MACE at 2 years was still significantly lower in the EES arm compared with PES (9.0% vs. 13.7%, HR 0.66, 95% CI 0.50-0.86, p = 0.0016). The incidences of MI (3.9% vs. 7.6%, p = 0.0009) and stent thrombosis (0.9% vs. 3.9%, p < 0.0001) at 2 years were significantly lower in the EES arm (0.3% vs. 1.5%, p = 0.013), although only about 13% of the patients were on dual antiplatelet therapy beyond 1 year.
Interpretation:

The results of this trial indicate that EES is superior to PES (Taxus Liberte) in the reduction in clinical endpoints including MACE, nonfatal MI, and stent thrombosis at 1 year, when utilized in a real-world situation. These results are similar to those of the recently presented SPIRIT IV trial. Earlier studies had demonstrated a greater reduction in late lumen loss with EES. The current trial demonstrates that low late lumen loss can be achieved with EES without a concomitant increase in stent thrombosis, as compared with PES.

Two-year results show persistently better outcomes with EES compared with PES, including MACE, MI, and stent thrombosis. Beyond 1 year, when most patients were not on dual antiplatelet therapy, there was still a significant reduction in stent thrombosis with EES, as compared with PES. These findings are very important, and suggest that second-generation drug-eluting stents (DES) seem to have been successful in at least partially overcoming one of the biggest bete noire's of the first-generation stents: late stent thrombosis. Further long-term follow-up, and the performance of these second-generation DES, as compared with third-generation/bioabsorbable stents, is eagerly awaited.
Conditions:
Coronary heart disease
Therapies:
Stent/drug-eluting
Study Design:

Patients Enrolled: 1,800
Mean Follow Up: 1 year, then 2 years
Female: 30
Primary Endpoints:
All-cause mortality, nonfatal MI, and TVR at 1 year
Secondary Endpoints:
Cardiac death, nonfatal MI, and ischemia-driven TLR at 1 year, and then annually up to 5 years
All-cause mortality, nonfatal MI, and TVR at 2-5 years
Incidence of stent thrombosis annually during 5 years
Patient Population:
Patient is suitable candidate for PCI
Life expectancy >5 years
Exclusions:
No dual antiplatelet therapy for 1 year
Cardiogenic shock at presentation
Planned major surgery within 1 month
Participation in another trial

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Title: LEVANT I: A Prospective Randomized Trial of a Paclitaxel-Eluting Balloon Compared to a Non-Drug-Eluting Balloon With and Without Stenting in Patients with Diseased Femoropopliteal Arteries
Event: TCT 2010
Topic(s): Interventional Cardiology
Presenter: Dierk Scheinert
Writer(s): Xiushui Ren
Date Posted: 09/23/2010

Treatment of peripheral artery stenoses with paclitaxel-eluting balloon catheter (with or without a bare-metal stent) in patients with de novo femoropopliteal arterial disease appears to be safe and reduced late lumen loss compared with use of a non-coated balloon for the procedure.
Background

The success of percutaneous intervention in peripheral arterial disease is limited by restenosis. Paclitaxel-eluting balloon has been shown to be superior to uncoated balloon in patients undergoing angioplasty for femoropopliteal arterial disease.

The current study compared a new paclitaxel-eluting balloon catheter with a noncoated balloon catheter in patients with femoropopliteal arterial disease undergoing percutaneous intervention with or without stents. The new paclitaxel-eluting balloon catheter has a proprietary 2 μg/mm2 paclitaxel coating with hydrophilic non-polymeric carrier that delivers the drug during a single 30-second inflation.
Study Design

This is a prospective, single-blind, randomized, multicenter study of 101 patients with de novo femoropopliteal arterial disease. Patients were stratified prior to randomization into stent or non-stent group. After initial balloon pre-dilatation, patients were randomized to receive paclitaxel-eluting balloon catheter or noncoated balloon catheter treatment.

The primary endpoint was angiographic late lumen loss at 6 months. Secondary endpoints included target-lesion revascularization (TLR), target-vessel revascularization (TVR), primary patency, and safety.
Results and Conclusions

Baseline characteristics were similar between groups. The mean lesion length was 8.7±3.7 cm.

At the end of 6 months, patients treated with paclitaxel-eluting balloon catheter had less late lumen loss as compared with patients treated with noncoated balloon catheter (0.46 mm vs. 1.09 mm, p=0.016). TLR was also numerically less common in the paclitaxel-eluting balloon group (13% vs. 22%, p=Not significant)). The benefit was seen in both balloon and stent groups, although number of patients was smaller in the subgroup analysis.

These data suggest that paclitaxel-eluting balloon treatment in patients is safe and reduces late lumen loss. Larger studies are needed to confirm these results.
References

1. Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008 Sep 23;118(13):1358-65.

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Title: PERfECT STENT: A Prospective, Randomized Trial Evaluating a Paclitaxel-Eluting Balloon in Patients Treated with Endothelial Progenitor Cell Capturing Stents for De Novo Coronary Artery Disease
Event: TCT 2010
Topic(s): Interventional Cardiology
Presenter: Jochen Wöhrle
Writer(s): Xiushui Ren
Date Posted: 09/23/2010

Summary

In patients with de novo coronary lesions, treatment with Endothelial Progenitor Cell (EPC) Capturing stent plus paclitaxel-eluting balloon catheter was superior to EPC stent alone in preventing late lumen loss.
Background

The endothelial progenitor cell capturing stent (EPC stent) has been shown to promote late regression of neointimal hyperplasia and may be comparable to paclitaxel-eluting stent (Taxus) in selected patients.

The current study compared EPC stent plus paclitaxel-eluting balloon catheter to EPC stent alone.
Study Design

This was a prospective, randomized, multicenter, single blinded trial of 120 patients with a de-novo lesion in native coronary artery between 2.5 mm and 4 mm. Exclusion criteria included graft lesion, chronic total occlusion, bifurcation lesion, left main lesion, restenosis and in-stent restenosis, and contraindication to aspirin or clopidogrel.

The primary end-point was in-stent late loss at 6-month angiographic follow-up. Secondary end-points included both angiographic and clinical components.
Results and Conclusions

At 6-month follow-up, patients treated with EPC stent plus paclitaxel-eluting balloon catheter had less in-stent late loss (0.34 mm vs. 0.88 mm, p<0.001). In addition, treatment with EPC stent plus paclitaxel-eluting balloon catheter resulted in decreased proximal late loss (0.04 mm vs. 0.21 mm, p=0.01), binary angiographic in-stent restenosis (5.1% vs. 21.4%, p=0.009), and major adverse cardiac events (4.8% vs. 17.2%, p=0.03). The rates of MI and death were low and not significantly different. There was no incidence of stent thrombosis in either group.

Thus in this small prospective, randomized, multicenter study of patients with de novo coronary lesions, EPC stent plus paclitaxel-eluting balloon catheter resulted in significant lower rates of late-loss, anigiographic restenosis, and combined clinical endpoints.
References

1. Duckers HJ, Soullié T, den Heijer P, Rensing B, de Winter RJ, Rau M, Mudra H, Silber S, Benit E, Verheye S, Wijns W, Serruys PW. Accelerated vascular repair following percutaneous coronary intervention by capture of endothelial progenitor cells promotes regression of neointimal growth at long term follow-up: final results of the Healing II trial using an endothelial progenitor cell capturing stent (Genous R stent). EuroIntervention. 2007 Nov;3(3):350-8.

2. Beijk MA, Klomp M, Verouden NJ, van Geloven N, Koch KT, Henriques JP, Baan J, Vis MM, Scheunhage E, Piek JJ, Tijssen JG, de Winter RJ. Genous endothelial progenitor cell capturing stent vs. the Taxus Liberte stent in patients with de novo coronary lesions with a high-risk of coronary restenosis: a randomized, single-centre, pilot study. Eur Heart J. 2010 May;31(9):1055-64.

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Nature Reviews Cardiology 7, 539 (October 2010) | doi:10.1038/nrcardio.2010.128

Antiplatelet therapy: Eptifibatide is noninferior to abciximab: implications for clinical practice

Alexandra King
Abstract

The glycoprotein IIb/IIIa (GPIIb/IIIa) inhibitors eptifibatide and abciximab have comparable efficacy and safety in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). These findings, from a randomized trial and a registry study, are reported in two papers published in the Journal of the American College of Cardiology (JACC).

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Title: BIOFREEDOM: A Prospective Randomized Trial of Polymer-Free Biolimus A9-Eluting Stents and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease
Event: TCT 2010
Topic(s): Interventional Cardiology
Presenter: Eberhard Grube
Writer(s): Xiushui Ren
Date Posted: 09/25/2010

Summary

A new-generation polymer-free drug-eluting stents appears to be safe and efficacious as compared with standard drug-eluting stent.
Background

Due to concerns for stent thrombosis, newer generation coronary stents have been developed. A previous study showed noninferiority of a stent (Nobori) coated with bioresorbable polymer, polylactic acid, and Biolimus A9 as compared to the Taxus Liberté stent.

The BioFreedom Biolimus A9 (BA9) coated stent is the first polymer-free drug-eluting stent (DES) using a stainless steel platform that holds the antiproliferative agent Biolimus A9 on the abluminal surface. Thus this design may potentially reduce the risk of late stent thrombosis and the duration of dual antiplatelet therapy.

The current study compared the BioFreedom polymer-free stent with paclitaxel-eluting stent (PES) in patients with de novo coronary lesions.
Study Design

This was a prospective, randomized, noninferiority trial of 182 patients: 75 patients in the first cohort (enrolled between September 2008 and January 2009), and 107 patients in the second cohort (enrolled between January 2009 and June 2009.

Patients with single de novo coronary lesions (2.25-3 mm vessel size and ≤14 mm lesion length) were randomized (in a 1:1:1 ratio) to BA9 standard dose stent (15.6µg/mm), BA9 low-dose stent (7.8µg/mm), or PES. Dual antiplatelet therapy was recommended for a minimum of 6 months.

The primary end point was angiographic in-stent late lumen loss at 12 months (second cohort). Secondary end points included angiographic in-stent late lumen loss at 4 months (first cohort) and various clinical end points.
Results and Conclusions

At 12-month follow-up, the BA9 standard dose stent met the prespecified noninferiority criteria as compared with the Taxus Liberté stent (late loss 0.17 mm vs. 0.35 mm, p=0.001), whereas the BA9 low-dose stent did not. The BA9 stent had a numeric trend toward superiority as compared to the Taxus Liberté stent (p=0.11).

The rates of major adverse cardiac events (including all-cause death, MI, emergent bypass surgery, or target-lesion revascularization) were low in all groups and definitive conclusions cannot be drawn.

There was no incidence of stent thrombosis at 12 months among the entire 182 patients.
References

1. Chevalier B, Silber S, Park SJ, et al. Randomized comparison of the Nobori Biolimus A9-eluting coronary stent with the Taxus Liberté paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: the NOBORI 1 trial--Phase 2. Circ Cardiovasc Interv 2009 Jun;2(3):188-95.
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Title: AVIO: A Prospective Randomized Trial of Intravascular Ultrasound-Guided Compared to Angiography-Guided Stent Implantation in Complex Coronary Lesions
Event: TCT 2010
Topic(s): Interventional Cardiology
Presenter: Antonio Colombo
Writer(s): Xiushui Ren
Date Posted: 09/25/2010

Summary

IVUS-guided stent implantation results in larger final minimal lumen diameter, but in a small group,no difference was seen in clinical endpoints, as compared to angiography-guided stent implantation in patients with complex coronary lesions.
Background

Angiographic assessment of coronary disease frequently results in inaccurate estimation of vessel size and disease severity. Thus angiography-guided stent implantation can lead to suboptimal stent sizing, expansion, and apposition, all of which can contribute to in-stent restenosis and stent thrombosis.
Study Design

The current study is a multicenter, randomized, open label, investigator-driven study comparing intravascular ultrasound (IVUS)-guided stent implantation to angiography-guided stent implantation in patients with complex coronary lesions.

Patients with complex coronary lesions (defined as bifurcations, long lesions (> 28 mm), chronic total occlusion, small vessels, and patients requiring 4 or more stents) were randomized to IVUS-guided or angiography-guided stent implantation. After stent implantation and post-dilatation, 49 patients from the angiography-guided group were randomized to final IVUS. An independent core-lab analyzed all data, including quantitative coronary angiography and IVUS data.

The primary end point was post-procedure in-lesion minimal lumen diameter (MLD). Secondary end points were target vessel revascularization (TVR) at 9 months and of major adverse cardiac events (MACE) at 1, 6, and 9 months.
Results and Conclusions

A total of 284 patients (142 patients in each group) were randomized. Baseline characteristics were similar in the 2 groups. The mean age was 64 years, and about 20% were women. About 25% of patients had diabetes, and 30% had unstable angina. About 15% of lesions were chronic total occlusions, 25% were bifurcations, 60% were long, and 20% involved small vessels.

The final MLD (primary endpoint) was larger in IVUS-guided patients (2.7±0.46 mm versus 2.51±0.46 mm, p=0.0002). There was no difference in 30-day or 9-month MACE.

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FDA restricts rosiglitazone use
European Medicines Agency suspends marketing authorization.

The FDA has announced that it will restrict use of the diabetes drug rosiglitazone to patients with type 2 diabetes who cannot control their diabetes with other medications, according to a press release.

In a separate announcement, the European Medicines Agency (EMA) has recommended suspending the marketing authorization of all rosiglitazone-containing antidiabetes medicines, including Avandia, Avandamet and Avaglim. Plans to phase out the drug’s availability in Europe within the next few months are in place.
“Both the FDA and the EMA have evaluated the same evidence and reached similar conclusions. Our different approaches in part reflect differences in the tools we have available to manage [the] risk and benefits of [the] medication,” Margaret A. Hamburg, MD, FDA commissioner, said during a conference call.

Rosiglitazone (Avandia, GlaxoSmithKline) will still be available in the United States, but the FDA will require GlaxoSmithKline to develop a restricted access program for the drug under a Risk Evaluation and Mitigation Strategy. Under the strategy, current rosiglitazone users who are benefiting from the drug will be able to continue taking it. Only patients who could not achieve glucose control with other medications and are unable to take pioglitazone (Actos, Takeda) will be able to take rosiglitazone. As previously reported by Cardiology Today, the FDA announced it would be evaluating preliminary results from a long-term, observational study suggesting patients who were taking pioglitazone may be at increased risk for bladder cancer. As of press time, no association had been confirmed.

“However, because of concerns of cardiovascular ischemia, physicians and health care professionals may want to consider switching patients to a different medication,” Joshua Sharfstein, MD, FDA principal deputy commissioner, said during the call.

In all cases, physicians must attest to and document their patients’ eligibility for taking the drug, and patients must review statements regarding the CV safety of rosiglitazone and acknowledge they understand the risks.

Both agencies’ decisions come in light of reviews that linked the medicines with an elevated risk for adverse CV events. Previous clinical trials, observational studies and meta-analyses of existing research from the past 3 years denoted a potential association between the medications and increased risk for ischemic heart disease, HF and fluid retention. Consequently, restrictions for the medications’ use in people with HF or a history of HF were implemented after market approval.

The FDA also ordered GlaxoSmithKline to convene an independent group of scientists to review key aspects of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, which compared the CV safety of rosiglitazone to other diabetes drugs. An earlier review noted a potential bias in the identification of CV events. In July, the U.S. Senate Committee on Finance accused GlaxoSmithKline of withholding scientific data pertaining to the drug.

Further, the FDA halted the company’s Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) trial, which compared rosiglitazone with pioglitazone and other diabetes drugs, and rescinded all regulatory deadlines for the completion of the trial.

In Europe, the EMA said it could not pinpoint further measures that would reduce CV risk. Unless GlaxoSmithKline can offer solid evidence that identifies a patient population in whom the drugs’ benefits would outweigh the risks, the suspension will hold.

The European Commission has also been notified of the committee’s recommendation for the adoption of a legally binding decision.

The EMA also advises patients who are currently taking these medications to consult their physicians to find alternative treatments. They should not, however, discontinue treatment before speaking with their doctors.
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PARTNER: TAVI in high-risk surgical patients linked with reduced mortality rates
Although an association between transcatheter aortic valve implantation and improved mortality was reported, it came at the price of increased stroke incidence

Transcatheter aortic valve implantation was associated with reduced mortality in patients who were at heightened risk for conventional valve replacement surgery, newly published results from the PARTNER trial suggested.

Researchers enrolled 358 patients who had aortic stenosis, cardiac symptoms and who were deemed unsuitable for conventional valve replacement surgery, which included balloon aortic valvuloplasty. Patients were randomly assigned to two cohorts: those who were at high risk for surgery but who received standard therapy (n=179) and those at high risk for surgery and underwent transcatheter aortic valve implantation (TAVI; n=179). The primary study endpoint was the rate of death from any cause during the study period
According to the results, a Kaplan-Meier analysis showed that 1-year rate of death from any cause was 30.7% in the TAVI group vs. 50.7% with standard therapy (HR with TAVI=0.55; 95% CI, 0.40-0.70). The composite endpoint of death from any cause or repeat hospitalization was also lower in the TAVI group vs. the standard therapy group (42.5% vs. 71.6%; HR=0.46; 95% CI, 0.35-0.59). The rate of cardiac symptoms was lower at 1 year in patients who underwent TAVI vs. those who received standard therapy (25.2% vs. 58%; P<.001).

Despite improvements in death from any cause and other endpoints, TAVI was also associated with an elevated incidence of major strokes vs. standard therapy (5% vs. 1.1%; P=.06), as well as an increase in the incidence of vascular complications (16.2% vs. 1.1%; P<.001).

“Although we were optimistic about the results of the trial, it ended up exceeding our expectations,” Michael Mack, MD, a study co-author and vice president of the Society of Thoracic Surgeons, told Cardiology Today. “Although this trial was unprecedented because we have randomized data available for the first time, just about as important will be the data from cohort A, which will be available in the spring, because that will compare the results with those of conventional surgery.”

Mack said the results will likely have a positive effect on the incorporation of the procedure into practice.

“This trial being positive will positively influence and catalyze the adoption of the procedure, but what it won’t do is change the regulatory process, and that will have to play out,” he said. “What it will do, though, is increase the enthusiasm for the procedure. If this trial was negative, it would have significantly negatively impacted the whole field.” – by Eric Raible

Leon M. N Engl J Med. 2010;doi:10.1056/NEJMoa1008232.

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MADIT II follow-up: Survival benefit sustained out to 8 years
Goldenberg I. Circulation. 2010;122:1265-1271.

Patients with ischemic left ventricular dysfunction who received an implantable cardioverter defibrillator as first-line therapy showed sustained mortality benefits out to 8 years and across all patient subsets, results from an analysis of the MADIT-II trial suggested.

Researchers evaluated the 1,232 patients enrolled in the MADIT-II study, who were randomly assigned to either ICD therapy or non-ICD medical therapy and were followed through November 2001. A total of 1,020 patients (630 with an ICD and 390 without an ICD) survived until study closure. The primary endpoint of the MADIT-II trial was the occurrence of all-cause mortality during the 8 years of enrollment in the study.

According to results, the cumulative probability of all-cause mortality was lower in patients treated with primary ICD therapy vs. non-ICD medical therapy (49% vs. 62%, P<.001). Multivariate analysis suggested that ICD therapy was associated with a long-term mortality benefit (HR from 0 to 8 years=0.66; 95% CI, 0.56-0.78). Primary treatment with an ICD was also associated with a reduction in the risk for death during the early portion (years 0 through 4) of the extended follow-up period (HR=0.61; 95% CI, 0.50-0.76), as well as the late portion (years 5 through 8) of the follow-up period (HR=0.74; 95% CI, 0.57-0.96).

Multivariate analysis also suggested that the long-term mortality benefit was consistent across all patient subsets, including for young and old patients; male and female patients; patients with stable or advanced baseline NYHA HF functional class; and for patients with a prolonged QRS duration.

“Our data on the continued life-prolonging benefit of the ICD during long-term follow-up provide support for a more widespread use of ICD in a primary prevention setting,” the researchers concluded. “However, our findings also suggest that more measures should be taken to improve long-term device efficacy in the low-ejection fraction population.”

Preliminary results of the long-term follow up were reported by Cardiology Today from the Heart Rhythm Society’s 2009 Scientific Sessions in Boston.
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Meta-analysis: Statins yield post-procedural MI benefit when administrated prior to invasive procedures

Winchester D. J Am Coll Cardiol. 2010;56:1099-1109.
Eagle K. J Am Coll Cardiol. 2010;56:1110-1112.

The administration of statins prior to procedures like percutaneous coronary intervention and CABG was linked with reductions in the risk for post-procedural MI, results from a meta-analysis suggested.

The researchers conducted a computerized search of literature in both MEDLINE and Cochrane databases, and included 21 studies in which statins had been administered prior to invasive procedures. The meta-analysis study population totaled 4,805 patients in whom PCI was typically performed as an elective procedure, although four of the studies included patients with acute coronary. The primary endpoints of interest were post-procedural nonfatal MI; secondary outcomes included all-cause mortality, revascularization and atrial fibrillation.
According to the study results, post-procedural MI was reduced with pre-procedural statin therapy vs. patients in control groups (RR=0.57; 95% CI, 0.46-0.70). Specifically, the incidence of post-procedural MI was 7.5% with statin therapy vs. 13.3% for the controls (P<.0001). In trials where periprocedural MI was defined as creatine kinase-myocardial band (CK-MB) >3 times the upper limit of normal, the MI reduction remained (P=.003). Reductions in all-cause mortality in patients receiving pre-procedural statin therapy were reported, but did not approach statistical significance (RR=0.66; 95% CI, 0.37-1.17). Repeat revascularization in the PCI studies trended in favor of the statin treatment arms (P=.09). In addition, post-operative AF was lower in the statin arms of the CABG studies vs. controls (19% vs. 37%, P<.0001).

“Pre-procedural statin therapy should become an increasingly important strategy to improve the safety of invasive procedures,” the researchers concluded.

In an accompanying editorial, Kim A. Eagle, MD, and Vineet Chopra, MD, both of the University of Michigan Health System in Ann Arbor, asserted that the answer to whether or not patients undergoing invasive coronary procedures should routinely be treated with statin therapy (which they colloquially referred to as “an old friend”) has been answered in the affirmative.

“The available evidence creates a convincing argument for statin treatment before coronary procedures,” they wrote. “Given the strong biological rationale and the sum of individual clinical data, no patient should undergo coronary procedures without statin therapy unless clear contraindications exist. Indeed, it is time to consider a new indication for an old friend.”

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Atrial Fibrillation Termination as a Procedural Endpoint During Ablation in Long-Standing Persistent Atrial Fibrillation
Elayi CS, Di Biase L, Barrett C, et al.
Heart Rhythm 2010;7:1216-1223.
Study Question: Is termination of long-standing persistent atrial fibrillation (AF) by ablation predictive of a successful outcome after radiofrequency catheter ablation (RFCA)?

The Relation Between Hospital Procedure Volume and Complications of Cardioverter-Defibrillator Implantation From the Implantable Cardioverter-Defibrillator Registry
Freeman JV, Wang Y, Curtis JP, et al.
J Am Coll Cardiol 2010;56:1133-1139.
Study Question: Is there a lower risk of complications from implantation of an implantable cardioverter-defibrillator (ICD) at high-volume centers than at low-volume centers?

Spectrum and Outcome of Reoperations After the Ross Procedure
Stulak JM, Burkhart HM, Sundt TM 3rd, et al.
Circulation 2010;122:1153-1158.
Study Question: What is the frequency and spectrum of pathology and complexity of reoperations following the Ross procedure?

Transcatheter Device Closure of Perimembranous Ventricular Septal Defects: Mid-Term Outcomes
Yang J, Yang L, Wan Y, et al.
Eur Heart J 2010;31:2238-2245.
Study Question: What are the safety, efficacy, and outcomes of transcatheter device closure of perimembranous ventricular septal defects (pmVSD)

J-Curve Revisited: An Analysis of Blood Pressure and Cardiovascular Events in the Treating to New Targets (TNT) Trial
Bangalore S, Messerli FH, Wun CC, et al., on behalf of the Treating to New Targets Steering Committee and Investigators.
Eur Heart J 2010;Sep 16:[Epub ahead of print].
Study Question: In patients with coronary artery disease (CAD), a J-curve relationship has been reported between blood pressure (BP) and future cardiovascular events. What is the relationship between BP and cardiovascular outcomes in patients with CAD participating in a non-BP clinical trial?

Intensive Blood-Pressure Control in Hypertensive Chronic Kidney Disease
Appel LJ, Wright JT Jr, Greene T, et al.
N Engl J Med 2010;363:918-929.
Study Question: What is the effect of intensive blood pressure control on the progression of chronic kidney disease among black patients?

Genetic Counselling and Testing in Cardiomyopathies: A Position Statement of the European Society of Cardiology Working Group and Myocardial and Pericardial Diseases
Charron P, Arad M, Arbustini E, et al.
Eur Heart J 2010;Sep 7:[Epub ahead of print].
Perspective: This position statement, from the European Society of Cardiology Working Group on Myocardial and Pericardial Disease, provides a summary of research on the genetics behind heritable cardiomyopathies and recommendations for screening and family counseling. The following are 10 points to remember.

Patients’ and Cardiologists’ Perceptions of the Benefits of Percutaneous Coronary Intervention for Stable Coronary Disease
Rothberg MB, Sivalingam SK, Ashraf J, et al.
Ann Intern Med 2010;153:307-313.
Study Question: Do cardiologists and patients have similar beliefs about the benefit of percutaneous coronary intervention (PCI)?

Application of Appropriateness Criteria to Stress Single Photon Emission Computed Tomography Sestamibi Studies: A Comparison of the 2009 Revised Appropriateness Criteria to the 2005 Original Criteria
Carryer DJ, Hodge DO, Miller TD, Askew JW, Gibbons RJ.
Am Heart J 2010;160:244-249.
Study Question: The purpose of this study was to compare the 2005 to 2009 appropriate use criteria (AUC) in 281 patients who underwent single-photon emission computed tomography (SPECT) in May 2005. What is the impact of the new revised criteria on appropriateness of this study?

A Randomized Trial of a Telephone-Care Management Strategy
Wennberg DE, Marr A, Lang L, O’Malley S, Bennett G.
N Engl J Med 2010;363:1245-55.
Study Question: Can patient telephone care-management improve medical costs and resource utilization?

Acceptance, Panic, and Partial Recovery: The Pattern of Usage of Drug-Eluting Stents After Introduction in the U.S. (A Report From the American College of Cardiology/National Cardiovascular Data Registry)
Krone RJ, Rao SV, Dai D, et al., on behalf of the ACC/NCDR Investigators.
J Am Coll Cardiol Intv 2010;3:902-910.
Study Question: What are the trends in the use of drug-eluting stents (DES) in the United States?

Comparison of Zotarolimus-Eluting Stents With Sirolimus-Eluting and Paclitaxel-Eluting Stents for Coronary Revascularization: The ZEST (Comparison of the Efficacy and Safety of Zotarolimus-Eluting Stent with Sirolimus-Eluting and PacliTaxel-Eluting Stent for Coronary Lesions) Randomized Trial
Park DW, Kim YH, Yun SC, et al.
J Am Coll Cardiol 2010;56:1187-1195.
Study Question: What is the relative safety and efficacy of the zotarolimus-eluting stents (ZES) compared with the sirolimus- (SES) and paclitaxel-eluting stents (PES) in routine clinical practice?

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Title: Flavanols and Cardiovascular Disease Prevention
Date Posted: September 28, 2010
Authors: Heiss C, Keen CL, Kelm M.
Citation: Eur Heart J 2010;Sep 18:[Epub ahead of print].

Perspective:
Diet plays a major role in the primary and secondary prevention of numerous chronic diseases, including cardiovascular conditions and diabetes. Epidemiological studies suggest that the beneficial cardiovascular health effects of diets rich in fruits and vegetables are in part mediated by their flavonoid content, with particular benefits provided by one member of this family, the flavanols. This concept is supported by findings from small-scale intervention studies with surrogate endpoints including endothelium-dependent vasodilation, blood pressure, platelet function, and glucose tolerance. Mechanistically, effects on endothelium-dependent vasodilation following the consumption of flavanol-rich foods, as well as purified flavanols, have been linked to an increased nitric oxide bioactivity in healthy humans, and those with increased cardiovascular risk.

While flavanols represent a promising class of food components that are associated with lower cardiovascular risk and may positively affect cardiovascular surrogate parameters in the short term, epidemiological studies are prone to confounding, and no long-term randomized controlled dietary intervention trials with hard clinical endpoints are available to date. More clinical and experimental studies are needed before flavanols can be considered as a feasible and effective therapeutic option for the prevention or treatment of cardiovascular diseases.
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Title: Long-Term Effects of a Lifestyle Intervention on Weight and Cardiovascular Risk Factors in Individuals With Type 2 Diabetes Mellitus: Four-Year Results of the Look AHEAD Trial
Date Posted: September 30, 2010
Authors: The Look AHEAD Research Group.
Citation: Arch Intern Med 2010;170:1566-1575.

Study Question:
Does a lifestyle modification intervention result in long-term changes in weight and cardiovascular disease risk factors among patients with type 2 diabetes?
Methods:
The Look Ahead Study is a multicenter randomized clinical trial comparing the effects of an intensive lifestyle intervention versus diabetes support and education. Patients all had type 2 diabetes and were between the ages of 45 and 76 years. Additional inclusion criteria included a body mass index (BMI) of 25 or greater. The intensive intervention included diet modification for a goal weight loss of 7% over the first year, with weight loss maintenance over the following years. Participants met with study members weekly in the first 6 months, then three times per month for the next 6 months, followed by once per month for the following study follow-up period. The control group had three group sessions each year.
Results:
A total of 5,145 overweight or obese patients with diabetes (mean age 58.7 years, 59.5% female) were included in the study. Over the 4-year follow-up, patients in the intensive lifestyle modification group had greater weight loss compared to the control group (-6.15% vs. -0.88%, p < 0.001) and greater improvement in treadmill fitness (12.74% vs. 1.96%, p < 0.001). The intensive intervention also resulted in lower glycated hemoglobin levels, and lower systolic and diastolic blood pressure compared to the control group. Lipid profiles among those in the intensive group also improved with great increases in high-density lipoprotein (HDL) cholesterol (3.67 vs. 1.97, p < 0.001) and reductions in triglyceride levels (-25.56 vs. 19.75 mg/dl, p < 0.001). Reductions in low-density lipoprotein cholesterol were greater in the control group, as compared to the intensive lifestyle group (-11.27 vs. 12.84 mg/dl, p = 0.009); however, lipid-lowering medication use was higher in the control group, which may explain this finding. At 4 years, those patients in the intensive intervention group had greater improvements in weight, fitness, glycated hemoglobin, systolic blood pressure, and HDL cholesterol compared to those in the control group.
Conclusions:
The investigators concluded that an intensive lifestyle modification program can result in reductions in weight and improvements in cardiovascular disease risk factors and fitness over several years.
Perspective:
Lifestyle modification can result in significant improvements of risk factors, including blood pressure and lipids. These findings are encouraging in that the intervention resulted in long-term improvements, which have the potential to result in reductions in cardiovascular disease events. However, the ability to implement such intensive programs in the community remains unclear.

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Title: Short-Term Outcome After Stenting Versus Endarterectomy for Symptomatic Carotid Stenosis: A Preplanned Meta-Analysis of Individual Patient Data
Date Posted: September 30, 2010
Authors: Carotid Stenting Trialists’ Collaboration.
Citation: Lancet 2010;376:1062-1073.

Study Question:
What is the relative safety of carotid artery stenting (CAS) versus carotid endarterectomy (CEA) in symptomatic patients?
Methods:
The authors performed a patient-level meta-analysis of 3,433 patients who were enrolled in the Endarterectomy versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis (EVA-3S) trial, the Stent-Protected Angioplasty Versus Carotid Endarterectomy (SPACE) trial, and the International Carotid Stenting Study (ICSS) trials. The primary outcome event was any stroke or death.
Results:
Patients randomized to CAS were more likely to have a stroke or die within the first 120 days after randomization (8.9% vs. 5.8%; relative risk [RR], 1.53; 95% confidence interval [CI], 1.20-1.95; p = 0.006). There was significant interaction with age, with no difference in outcome of patients younger than 70 years (5.8% vs. 5.7%; RR, 1.00; 95% CI, 0.68-1.47), whereas in patients older than 70 years, the outcome was worse with carotid stenting (12% vs. 5.9%; RR, 2.04; 95% CI, 1.48-2.82).
Conclusions:
CEA is safer than CAS for symptomatic disease in patients older than 70 years, whereas there was no difference in outcome in younger patients.
Perspective:
The findings of this meta-analysis corroborate those of the CREST trial, which demonstrated no difference in outcome between CAS and CEA overall, and relatively better outcome with CAS in younger patients and with CEA in older patients. The three trials that were included in the meta-analysis were limited by variability in operator training (in the stenting arm), and the results in the stenting arm were inferior to those seen in the recent US series (Gray WA, et al., Circ Cardiovasc Interv 2009;2:159-66) or in the CREST trial. However, the totality of the data would suggest that older patients should preferentially be treated with CEA while either strategy may be chosen in younger patients based on patient and physician choice and local expertise.

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Where are we with revascularization procedures medical therapy in 2010?
by Carl J. Pepine, MD

After several decades associated with an evolving landscape for coronary revascularization and medical therapy, some clarity is beginning to emerge relative to appropriate expectations for patient management.

The short- and intermediate-term morbidity and mortality benefits of adding prompt revascularization by percutaneous coronary intervention to contemporary medical therapy have been established in high-risk patients with acute ischemic syndromes (eg, STEMI). Although some debate remains relative to early PCI use in lower risk acute ischemic syndrome patients, an early invasive approach is still favored by many, including myself, for these patients also.

Among patients with chronic ischemic syndromes, the results of the BARI 2D trial and a meta-analysis of 17 other trials document similar efficacy of PCI and optimal medical therapy in regard to short and intermediate-term mortality and MI risks. However, in high-risk diabetic patients, prompt CABG improves survival vs. optimal medical therapy alone, particularly when diabetes is treated with insulin sensitizing agents.

Perhaps overshadowed by the similarity in mortality and MI outcomes comparing PCI and optimal medical therapy is the fact that revascularization, by either PCI or CABG, generally results in greater symptom control and ischemia reduction than drug therapy alone. A meta-analysis of 14 trials from 1992 to 2007 has further confirmed that PCI is associated with greater freedom from angina compared with medical therapy, but interestingly, this benefit appears to be attenuated in the more contemporary studies. Such attenuation among patients treated by PCI may be related to greater use of evidence-based medications in the more contemporary trials, changing characteristics of the disease, and/or changing characteristics of the patients referred for PCI (eg, more severe or extensive disease). Thus, in patients with chronic ischemic syndromes, it seems that deferring PCI does not result in excess MI or mortality but will likely be at the expense of less symptom reduction and reduced quality of life. However, among those with more advanced disease, deferring CABG is likely to result in an increase in adverse outcomes, particularly when the patient has diabetes.

New clinical trial results also raise important questions about other medical management questions among diabetics and nondiabetics. The benefits of additional drugs to reach lower BP goals, glycohemoglobin <7%, specific glucose-lowering drugs, and/or raising HDL cholesterol, while becoming clearer, are still not completely resolved.

Based on the randomized ACCORD trial, and supported by findings from the observational extended follow-up of the INVEST diabetes cohort, among diabetes patients at high risk for CV events, targeting a systolic BP <120 mm Hg (as compared with <140 mm Hg) does not reduce fatal and nonfatal CV events. While there was a small reduction in stroke risk, it was at the expense of an increase in drug and/or low BP-related adverse experiences. Intensive therapy targeting normal glycated hemoglobin levels was associated with increased mortality and did not significantly reduce major CV events. Intensive drug therapy did not reduce risks of advanced microvascular outcomes, but delayed onset of albuminuria, some measures of eye complications, and neuropathy, but these benefits must be weighed against the increase in total and CV-related mortality, increased weight gain, and high risk for severe hypoglycemia. Intensive glycemic control and intensive dyslipidemia treatment, but not intensive BP control, were associated with reduced progression of retinopathy.

The BARI 2D trial focused on advanced CAD in established diabetic patients, but whether newly incident diabetics should be screened for subclinical atherosclerosis and treated aggressively with drug therapy as in BARI 2D is unclear. There is still uncertainty whether these strategies will provide further benefit in reducing long-term morbidity and mortality.
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Guideline changes for CPR led to higher neurologically-intact hospital discharge rates
Aufderheide TP. Heart Rhythm. 2010;7:1357–1362.

American Heart Association guideline changes for CPR resulted in significantly higher neurologically-intact hospital discharge rates in patients with out-of-hospital cardiac arrest, suggested data from Heart Rhythm.

“In 2005, AHA recommended multiple ways to improve circulation during CPR. Little is known about the impact of this new approach on survival rates for patients with out-of-hospital cardiac arrest,” the researchers wrote.

They tested this hypothesis that the new changes — including a renewed emphasis on more hard and fast compressions, fewer ventilations and complete chest wall recoil – could improve outcome by analyzing conglomerate quality assurance data during prospective implementation of the 2005 AHA Guidelines in five emergency medical services (EMS) systems. The EMS personnel were all trained in the new aspects of the guidelines and the primary outcome was defined as survival to hospital discharge.

According to study results, demographics, rate of bystander CPR, and time from the 911 call for help to arrival of EMS personnel were similar between the intervention (n=1,605) and historical control (n=1,641) groups. Researchers recorded a survival to hospital discharge rate of 10.1% in the control group vs. 13.1% in the intervention group (P=.007).

Additional study data indicated that the survival to discharge in patients presenting with a rhythm of ventricular fibrillation/ventricular tachycardia was 20% in controls vs. 32.3% the intervention group (P<.001), while the intervention group also had an advantage in survival to discharge with a CPC classification or 1 or 2 (intervention, 59.6% vs. control, 33.3%; P=.038).

“These findings support the importance of implementing an optimized sequence of therapeutic interventions during the performance of CPR for patients in cardiac arrest,” the researchers concluded. – by Brian Ellis

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Occupational, leisure-time physical activity reduced risk for HF
Wang Y. J Am Coll Cardiol. 2010;56:1140-1148.

New data from a study featuring more than 55,000 Finnish men and women suggested that moderate and high levels of occupational or leisure-time physical activity may reduce the risk for HF.

The study cohorts included 28,334 men and 29,874 women from Finland, who were free of HF at baseline and between the ages of 25 and 74 years. Researchers utilized baseline measurement of different types of physical activity to predict incident HF and followed patients for a mean of 18.4 years.

During follow-up, HF developed in 1,868 (6.6%) men and 1,640 (5.5%) women. After adjusting for multivariates, including age, smoking, BMI and systolic BP, the HRs for HF were as follows for the three occupational activity levels in men: light, 1.00; moderate, 0.90; and active 0.83 (P=.005 for trend). For women, the HRs for the occupational activity levels were 1.00 for light, 0.80 for moderate and 0.92 for active (P=.007).

Similarly, HRs for HF during leisure time activity also decreased with the progression from low (men, 1.00; women, 1.00) to moderate (men, 0.83; women, 0.84) to high (men, 0.65; women, 0.75) activity levels (P<.001 for both men and women trends).

Study limitations included the self-report of physical activity, and that physical activity was recorded only once at baseline.

“This study confirms that moderate or high levels of occupational or leisure-time physical activity have a negative association with the risk of HF among men and women,” the researchers concluded.
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Single CRP threshold may lead to inequalities in statin eligibility
Shah T. Circ Cardiovasc Genet. 2010;doi:10.1161/CIRCGENETICS.110.957431.

A single C-reactive protein threshold of 2 mg/L for CV risk prediction could result in inequality for statin eligibility due to differences in C-reactive protein concentrations in populations of diverse ancestry, according to new data appearing in Circulation: Cardiovascular Genetics.

“Eligibility for rosuvastatin (Crestor, AstraZeneca) treatment for CVD prevention includes a CRP concentration greater than 2 mg/L,” researchers wrote. “Most observational studies of CRP and CVD have been in Europeans. We evaluated the influence of ancestry on population CRP concentration to assess the implications for statin targeting in non-Europeans.”

The systematic review and meta-analysis featured 221,287 people from 89 studies. The geometric mean CRP was 2.6 mg/L in blacks (n=18,585), 2.51 mg/L in Hispanics (n=5,049), 2.34 mg/L in South Asians (n=1,053), 2.03 mg/L in whites (n=104,949) and 1.01 mg/L in East Asians (n=39,521).

According to researchers, differences in CRP levels were not explained by study design or CRP assay and remained even after adjustment for age and BMI. Furthermore, by age 60 years, 39% of East Asians, 55% of whites, 57% of South Asians, 62.5% of blacks and 63% of Hispanics were estimated to have CRP values exceeding 2 mg/L.

“We found substantial differences in CRP concentration across diverse ancestral groups that could have major impact on eligibility for rosuvastatin treatment based on CRP cut-point value of 2 mg/L,” researchers concluded. “A one-size-fits-all threshold value of CRP for risk prediction or statin targeting could diminish the opportunity to receive a statin in individuals from certain ethnic backgrounds while increasing this opportunity among others. This policy could lead to inequalities in statin eligibility that do not closely relate to underlying levels of risk.”

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HORIZONS-AMI: Bivalirudin vs. unfractionated heparin plus GPIIb/IIIa reduced 1-year mortality, recurrent MI in high-risk patients

Alfonso F. J Am Coll Cardiol Intv. 2010;3:803-805.
Parodi G. J Am Coll Cardiol Intv. 2010;3:796-802.

Bivalirudin reduced 1-year mortality and recurrent MI vs. unfractionated heparin plus glycoprotein IIb/IIIa inhibitors in high-risk patients undergoing primary percutaneous coronary intervention for acute MI, study data indicated.

The HORIZONS-AMI trial featured patients classified as low, intermediate and high risk according to the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) risk score.

Of the patients (n=3,602) enrolled in the trial, 2,530 could be classified by the CADILLAC risk score, with 1,522 (60%) classified as low risk, 531 (21%) as intermediate risk and 477 (19%) as high risk. The mortality rates in the low-risk group were 0.4% in the bivalirudin arm, 1.2% in the unfractionated heparin (UFH) plus GPIIb/IIIa arm (P=.09); in the intermediate-risk group, rates were 4.2% for bivalirudin and 4.1% for UFH plus GPIIb/IIIa arm (P=.99); and in the high-risk group, rates were 8.4% in the bivalirudin arm and 15.9% in the UFH plus GPIIb/IIIa arm (P=.01).

“The reduction in mortality in patients randomized to bivalirudin as compared with UFH plus [GPIIb/IIIa] was mainly driven by a difference in mortality in the high-risk patient group, whereas no difference could be revealed in the intermediate-risk group, and only a trend favoring bivalirudin was revealed in the low-risk group,” researchers wrote in their study. Although not certain of the mechanisms involved in the benefit of bivalirudin in high-risk patients, they added, “The results of the present analysis support bivalirudin treatment as a standard of care for high-risk patients undergoing primary PCI for acute MI.”

Fernando Alfonso, MD, PhD, and Manuel Paulo, MD, both with the Cardiovascular Institute at San Carlos University Hospital in Madrid, said in an accompanying editorial that HORIZONS-AMI provided adequate guidance to optimize interventions in patients with a high risk for STEMI.

“For these patients, bivalirudin appears to be not only safer but also more effective than standard antithrombotic strategies and, therefore, should be considered the preferred option,” they concluded. “Further investigation is now warranted to assess the value of bivalirudin for patients receiving novel, more predictable and potent antiplatelet agents.”
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Title: Quality of Life and Cost-Effectiveness of a 3-Year Trial of Lifestyle Intervention in Primary Health Care
Date Posted: September 13, 2010
Authors: Eriksson MK, Hagberg L, Lindholm L, Malmgren-Olsson EB, Österlind J, Eliasson M, et al.
Citation: Arch Intern Med 2010;170:1470-1479.

Study Question:
Does a primary care-based lifestyle intervention program improve quality of life, while being cost-effective?
Methods:
Men and women at high risk for cardiovascular disease were enrolled in the Swedish Björknäs Study and randomized to a primary health care-based lifestyle intervention program with standard care, or to standard care alone. The lifestyle intervention was comprised of supervised exercise sessions and diet counseling for 3 months, followed by regular group meetings over a 3-year follow-up period. Quality of life was measured with the EuroQol (EQ-5D) and the EuroQol-Vas (EQ-VAS), the 36-Item Short Form Health Survey (SF-36), and the 6-dimensional Short-Form 6D (SF-6D). Cost-effectiveness was assessed with a cost-utility analysis with a societal perspective. Cost-effective ratios were based on gained quality-adjusted life-years (QALYs), and net costs for the intervention group were compared with the control group.
Results:
A total of 151 adults, ages 18-65 years, were included in this study. The mean age of the participants was 54.4 years, 57% were female, and the majority had one or more cardiovascular risk factors. Over 86% were overweight or obese and over 50% were sedentary or minimally active. Compared to those randomized to usual care, patients who received the lifestyle intervention were more likely to report improvement in quality of life. Over a 3-year period, differences between the two groups were observed for measures of quality of life including EQ-VAS (p = 0.002), SF-6D (p = 0.01) and SF-36 (p = 0.04), and physical summary. No differences between the two groups were observed for EQ-5D or SF-36 mental component summary. The mean number of family physician visits decreased by 0.28 per 6 months compared to baseline in the intervention group, and increased by 0.10 in the control group. Savings in office visits was $493 for the 3-year period. The net savings were $47 per participant. Costs per gained QALY, savings not counted, were $1,668-$4,813. Probabilities of cost-effectiveness were 89-100% when the amount of $50,000 was used as stakeholder’s threshold of willingness to pay for a gained QALY.
Conclusions:
The investigators concluded that lifestyle intervention in primary care can improve quality of life and is cost-effective in comparison to standard care.
Perspective:
These findings suggest that lifestyle modification programs based in the primary care setting can be cost-effective. Given the prevalence of overweight or obese Americans, adoption of such wellness programs may prove cost-effective in the United States as well.

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Title: Associations Between Physician Characteristics and Quality of Care
Date Posted: September 15, 2010
Authors: Reid RO, Friedberg MW, Adams JL, McGlynn EA, Mehrotra A.
Citation: Arch Intern Med 2010;170:1442-1449.

Study Question:
Patients are encouraged to select physicians on the basis of characteristics such as education, board certification, and malpractice history. In a large sample of Massachusetts physicians, what is the relationship between physician characteristics and performance on a broad range of quality measures?
Methods:
Overall performance scores were calculated on 124 quality measures from RAND’s Quality Assessment Tools for each of 10,408 Massachusetts physicians using claims generated by 1.13 million adult patients. The patients were continuously enrolled in one of four Massachusetts commercial health plans from 2004 to 2005. Physician characteristics were obtained from the Massachusetts Board of Registration in Medicine. Associations between physician characteristics and overall performance scores were assessed using multivariate linear regression.
Results:
The mean overall performance score was 62.5% (5th to 95th percentile range, 48.2%-74.9%). Three physician characteristics were independently associated with significantly higher overall performance: female sex (1.6 percentage points higher than male sex; p < 0.001), board certification (3.3 percentage points higher than noncertified; p < 0.001), and graduation from a domestic medical school (1.0 percentage point higher than international; p < 0.001). There was no significant association between performance and malpractice claims (p = 0.26). The available physician characteristics explained only 2.8% of overall variation in physician performance.
Conclusions:
Few characteristics of individual physicians were associated with higher performance on measures of quality, and observed associations were small in magnitude. Publicly available characteristics of individual physicians are poor proxies for performance on clinical quality measures.
Perspective:
The data, as presented above in the summary of results, were derived from the entire cohort regardless of specialty. When considered by specialty, the 877 OB/GYN practitioners had higher scores (better care) if they had one or more malpractice claims or attended lower-ranked or unranked medical school compared to a top 10 school, and not significantly better if board certified. There was no relationship between quality measures and years in practice for any specialty. The authors concluded that ‘public reporting of individual physician quality data may provide the consumer with more valuable guidance when seeking providers of high-quality health care.’ I doubt that will be any better than claims-based data. The task of evaluating individual physicians and health care systems will improve with a national health care registry, but only if carefully risk adjusted with criteria established by a national representative group of primary care physicians and specialty groups.

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Pulmonary Venous Isolation by Antral Ablation With a Large Cryoballoon for Treatment of Paroxysmal and Persistent Atrial Fibrillation: Medium-Term Outcomes and Non-Randomized Comparison With Pulmonary Venous Isolation by Radiofrequency Ablation
Kodojojo P, O’Neill MD, Lim PB, et al.
Heart 2010;96:1379-1384.
Study Question: How effective is a cryoablation balloon for pulmonary vein (PV) isolation?

Long-Term Efficacy of Catheter Ablation for Atrial Fibrillation: Impact of Additional Targeting of Fractionated Electrograms
Hunter RJ, Berriman TJ, Diab I, et al.
Heart 2010;96:1372-1378.
Study Question: Does targeting complex fractionated atrial electrograms (CFAEs) enhance the efficacy of radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF)?

Aortic Dissection in Young Adults Who Abuse Amphetamines
Westover AN, Nakonezny PA.
Am Heart J 2010;160:315-321.
Study Question: Utilizing a large national database: 1) What is the relationship between amphetamine use and aortic dissection (AD) in young patients when controlling for known risk factors for AD, and 2) what are the temporal trends in both amphetamine use and AD?

Regression of Myocardial Hypertrophy After Aortic Valve Replacement: Faster in Women?
Petrov G, Regitz-Zagrosek V, Lehmkuhl E, et al.
Circulation 2010;122:S23-S28.
Study Question: Does sex affect left ventricular (LV) mass regression after aortic valve replacement in patients with aortic stenosis (AS)?

Differential Associations Between Specific Depressive Symptoms and Cardiovascular Prognosis in Patients With Stable Coronary Heart Disease
Hoen PW, Whooley MA, Martens EJ, Na B, van Melle JP, de Jonge P.
J Am Coll Cardiol 2010;56:838-844.
Study Question: Depression in stable coronary heart disease (CHD) is associated with a poor cardiac prognosis. Symptoms of depression can be both cognitive (e.g., sad, anhedonia) and somatic (e.g., fatigue, poor appetite). Are certain depressive symptoms more cardiotoxic than others?

Unintended Effects of a Computerized Physician Order Entry Nearly Hard-Stop Alert to Prevent a Drug Interaction: A Randomized Controlled Trial
Strom BL, Schinnar R, Aberra F, et al.
Arch Intern Med 2010;170:1578-1583.
Study Question: How effective is the nearly "hard stop" computerized physician order entry (CPOE) prescribing alert that is intended to reduce concomitant orders for warfarin and trimethoprim-sulfamethoxazole?

Predicting Late Myocardial Recovery and Outcomes in the Early Hours of ST-Segment Elevation Myocardial Infarction: Traditional Measures Compared With Microvascular Obstruction, Salvaged Myocardium, and Necrosis Characteristics by Cardiovascular Magnetic Resonance
Larose E, Rodes-Cabau J, Pibarot P, et al.
J Am Coll Cardiol 2010;55:2459-2469.
Study Question: What is the relationship of myocardial recovery following ST-segment elevation myocardial infarction (STEMI) to findings on contrast-enhanced cardiac magnetic resonance imaging (CMR) techniques including microvascular obstruction and extent of late gadolinium enhancement?

Self-Management Counseling in Patients With Heart Failure: The Heart Failure Adherence and Retention Randomized Behavioral Trial
Powell LH, Calvin JE Jr, Richardson D, et al., on behalf of the HART Investigators.
JAMA 2010;304:1331-1338.
Study Question: Does the addition of self-management counseling to heart failure education lead to improved heart failure outcomes?

Trastuzumab-Induced Cardiotoxicity: Clinical and Prognostic Implications of Troponin I Elevation
Cardinale D, Colombo A, Torrisi R, et al.
J Clin Oncol 2010;28:3910-3916.
Study Question: Can troponin I (Tn-I) identify patients at risk for trastuzumab-induced cardiotoxicity (TIC)?

Cumulative Exposure to Ionizing Radiation From Diagnostic and Therapeutic Cardiac Imaging Procedures: A Population-Based Analysis
Chen J, Einstein AJ, Fazel R, et al.
J Am Coll Cardiol 2010;56:702-711.
Study Question: What is the exposure to ionizing radiation from cardiac diagnostic procedures in a diverse population?

Long-Term Effects of a Lifestyle Intervention on Weight and Cardiovascular Risk Factors in Individuals With Type 2 Diabetes Mellitus: Four-Year Results of the Look AHEAD Trial
The Look AHEAD Research Group.
Arch Intern Med 2010;170:1566-1575.
Study Question: Does a lifestyle modification intervention result in long-term changes in weight and cardiovascular disease risk factors among patients with type 2 diabetes?