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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Research In Brief
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Research In Brief
NMT PFO stroke trial comes up short: Preliminary results of the 910-patient CLOSURE I study of NMT Medical's STARFlex patent foramen ovale closure device show it is not superior to best medical therapy for preventing stroke and transient ischemic attack, the trial's primary endpoint, the firm reports June 17. Closure rates for STARFlex were 86.5%. NMT is now in discussions with FDA about the next steps relating to the stroke/TIA indication. The firm had planned to submit a PMA this year (1"The Gray Sheet" April 13, 2009). Although not statistically significant, "The preliminary data did demonstrate that our implant device provided a small benefit over current best medical therapy and maintained an excellent safety profile," NMT CEO Frank Martin notes. The company will discuss full results of the trial in November at the American Heart Association annual meeting. STARFlex is currently approved for ventricular septal defect and atrial level shunt patients. In a same-day research note, Wells Fargo analyst Larry Biegelsen speculates the CLOSURE I results could spell bad news for AGA Medical, which is conducting the RESPECT study of its Amplatzer PFO occluder in stroke. "Although there are significant differences between the CLOSURE I and RESPECT trials, we believe the CLOSURE I results will make it more challenging for physicians to close a PFO," he writes
Research In Brief
Endurant: Medtronic announces May 6 it has completed enrolling patients in a clinical trial of its Endurant endovascular abdominal aortic aneurysm (AAA) stent graft two months ahead of schedule. The single-arm trial is intended to support a PMA for non-surgical AAA repair. The company expects to announce key data from the study in late 2010. The study enrolled about 150 patients at 30 centers. The primary endpoint is one-year treatment success. Medtronic is also sponsoring the Endurant Stent Graft Natural Selection Global Post-market (ENGAGE) registry, evaluating Endurant in about 1,200 patients at 80 centers on six continents (1"The Gray Sheet" April 13, 2009, p. 15)