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SPIRIT IV: Everolimus-eluting stent trumped paclitaxel-eluting stent, but not in patients with diabetes

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TCT 2009

Gregg W. Stone, MD, of Columbia University Medical Center, New York, presented results showing that Xience V significantly reduced target lesion failure at one-year follow-up compared with Taxus Express (Xience V 4.2% vs. Taxus 6.8%) in the SPIRIT IV trial.

Although overall results favored Xience V, results in patients with diabetes did not.

Stone said there were significant reductions in target lesion failure, target vessel failure and major adverse cardiac events for patients who received Xience V (n=2,458) vs. Taxus (n=1,229) through one year.

Xience V also outperformed Taxus for a secondary endpoint of ischemia-driven target lesion revascularization reduction, with an RR reduction of 45% (RR=0.55; 95% CI, 0.38-0.78). In another secondary endpoint, a composite of cardiac death or myocardial infarction at one year, there was no difference between the two stents (RR=0.69; 95% CI, 0.46-1.04).

SPIRIT IV also included a large number of patients with diabetes (32.2%, n=1,185) compared with SPIRIT III (29%, n=290), but results were not as desirable as some hoped, according to comments during the discussant portion of the presentation.

“This clearly demonstrates that we have a novel, effective … stent platform out to a year and within that, we have greater precision and understanding of all the components,” said Mitchell Krucoff, MD, professor of medicine and cardiology at Duke University Medical Center. “Which of those could be tweaked to have a greater impact in diabetes? It’s important that we continue to wrestle with the science of revascularization in diabetics.”

Stone said there was a comparable rate of target lesion failure for Xience V and Taxus (6.4% Xience V vs. 6.9% Taxus; P=0.80). He said that outcomes in patients with diabetes should be improved through future development of novel drugs and stent design. – by Judith Rusk

For more information:

• Stone GW. Plenary Session IV, Late Breaking Clinical Trials I. Presented at: Transcatheter Cardiovascular Therapeutics 2009; Sept. 21-25, 2009; San Francisco.