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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