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Medtronic releases four-year data for ENDEAVOR II clinical trial

Medtronic : 13 May, 2008  (Company News)
Medtronic has released four-year data from the ENDEAVOR II clinical trial that reinforces the long-term safety and durable efficacy of the company’s Endeavor Zotarolimus-Eluting Coronary Stent System for the treatment of coronary artery disease.
“As the duration of follow-up in ENDEAVOR II grows, so too does our confidence in the enduring safety and effectiveness of the Endeavor stent,” said Dr Jean Fajadet of the Clinique Pasteur Unite de Cardiologie Interventionnelle in Tolouse, France, who presented the data. “The durability of this device’s performance is remarkable based on these four-year results, which show low rates of late adverse events.”

The newly released data indicate that the Endeavor Stent offers durable efficacy out to four years of follow-up, with no new events requiring target lesion revascularization (TLR) between years three and four. They also reinforce the long-term safety record of the Endeavor stent, which was associated with no new episodes of Stent thrombosis over the same period.

Compared with Medtronic’s Driver bare-metal Stent (the control in ENDEAVOR II), these trial results show a lower rate of target vessel failure (TVF) for patients treated with the Endeavor Stent due largely to a diminished rate of target vessel revascularization (TVR). TVF is a composite of TVR, myocardial infarction and cardiac death.

Through four years of clinical follow-up with more than 97 percent of patients in each arm of ENDEAVOR II, the rate of: TLR was 7.2 percent for the Endeavor group compared to 15.8 percent for the Driver group, representing a 54 percent reduction (p less than 0.001) in the need for repeat procedures. TVR was 9.8 percent for Endeavor patients and 18.8 percent for Driver patients, a 48 percent reduction (p less than 0.001) TVF, the trial’s primary endpoint (assessed at nine months), was 13.6 percent for Endeavor and 22.6 percent for Driver, a 40 percent reduction (p<0.001). Major Adverse Cardiac Events (MACE) was 13.4 percent for Endeavor and 22.1 percent for Driver, a 39 percent reduction (p less than 0.001).

These results indicate that treatment with the Endeavor Stent provides a statistically significant and superior reduction compared to Driver in TLR, TVR, TVF and MACE through four years, with no evidence of an erosion of clinical benefit over this time period. In addition, rates of cardiac death, myocardial infarction (MI) and the combination of the two were numerically fewer (although not to a statistically significant degree) in the Endeavor group through four years of follow-up: Cardiac death Endeavor 2.4 percent (14/581); Driver 2.6 percent (15/584) MI Endeavor 3.3 percent (19/581); Driver 4.5 percent (26/584) Cardiac death plus MI Endeavor 5.3 percent (31/581); Driver 7.0 percent (41/584)

“The four-year results of ENDEAVOR II demonstrate the long-term safety and durable efficacy of the Endeavor drug-eluting stent,” said Sean Salmon, vice president and general manager of the Medtronic’s Coronary and Peripheral Vascular business. “This year’s update on our pivotal trial shows the sustainable superiority of the Endeavor Stent over its bare-metal control.”

Part of the comprehensive ENDEAVOR clinical programme, ENDEAVOR II is a double-blind randomised controlled trial designed to compare the Endeavor drug-eluting Stent with the Driver bare-metal on safety and efficacy metrics.

The international trial enrolled 1,197 patients from 72 medical centres in Europe, Asia Pacific, Israel, Australia and New Zealand. With one-to-one randomisation, half of the patients received the Endeavor Stent (n = 598); the other half, the Driver Stent (n = 599).

Published in the August 2006 issue of Circulation, ENDEAVOR II demonstrated the superiority of the Endeavor Stent on the primary endpoint of TVF at nine months: Endeavor 7.9 percent; Driver 15.1 percent a 48 percent reduction (p less than 0.001). The Endeavor Stent was also superior to the Driver Stent on the secondary endpoint of TLR at nine months: Endeavor 4.6 percent; Driver 11.8 percent a 61 percent reduction (p less than 0.001).
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