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MADIT II follow-up: Survival benefit sustained out to 8 years

Goldenberg I. Circulation. 2010;122:1265-1271.

Issue: November 2010

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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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