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Research In Brief

This article was originally published in The Gray Sheet

Executive Summary

Boston Scientific optimistic for MADIT-CRT: Boston Scientific CEO Jim Tobin says the results of the Medtronic-sponsored REVERSE trial of cardiac resynchronization therapy in patients with mild heart failure raise hopes that his company's much larger MADIT-CRT trial will show that CRT therapy can prevent early-stage heart failure patients from getting worse. REVERSE missed its primary endpoint "by not a lot" despite enrolling fewer than half as many patients as MADIT-CRT. Further, on a secondary endpoint that is the primary endpoint for MADIT-CRT, REVERSE showed a big benefit for CRT, Tobin observed. "If you connect all those dots, there is a reasonable expectation [that] we should make it. There is no guarantee - that is why you run the trial - but I am pretty optimistic," he said during a Cowen and Company Healthcare Conference March 17. REVERSE missed the primary endpoint of difference in the percentage of patients whose heart failure status score worsened (1"The Gray Sheet" April 7, 2008, p. 4). However, data from the 262 patients in the European cohort of REVERSE shows that CRT plus medical therapy reduced the risk of death and heart failure hospitalization by 62% compared to medical therapy alone. The 1,820-patient MADIT-CRT trial is comparing CRT plus implantable cardioverter defibrillator therapy (CRT-D) to ICD therapy alone. The endpoint is reduction in combined all-cause mortality and heart failure events. Because the endpoint is "events-driven," Boston Scientific does not know when the trial will be complete, but says there is a chance it could be ready for presentation at the Heart Rhythm Society conference in Boston in May
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