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.