SAN FRANCISCO, CA – OCTOBER 31, 2013 - A new study demonstrates that some patients may not need to receive prolonged anti-clotting therapy after drug-eluting stent (DES) implantation with the Endeavor zotarolimus-eluting stent, and that shortening the duration could reduce bleeding risks and treatment costs. The OPTIMIZE clinical trial findings were presented today at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.
Current guidelines recommend long-term (12 month) dual antiplatelet therapy (DAPT) after DES implantation, but the clinical benefits of this regimen remain unclear, especially with newer generation DES. The OPTIMIZE trial enrolled 3,120 patients with largely stable coronary artery disease in a prospective, randomized (1:1) multicenter clinical evaluation that compared short-term (3 month) and long-term (12 month) dual antiplatelet therapy. All patients underwent PCI with Endeavor zotarolimus-eluting stents, a second-generation DES.
The primary endpoint was a composite of Net Adverse Clinical and Cerebral Events (NACCE), which included death from any cause, myocardial infarction, stroke or major bleeding at one year follow-up.
After one year, NACCE rates for patients receiving short-term DAPT were similar to those who received the longer, standard DAPT (6.1 percent vs. 5.9 percent respectively), establishing non-inferiority of the shorter-term therapy (non-inferiority p-value = 0.002).
After 90 days, both groups showed comparable rates of NACCE, stent thrombosis and revascularization. Patients in the long-term DAPT group also showed a trend towards increased bleeding events.
"To date, OPTIMIZE is the only DAPT duration study using a single second-generation DES, and these promising findings could help shorten antiplatelet therapy time and reduce related complication risks for patients receiving select drug-eluting stents," said lead investigator Fausto Feres, MD of the Instituto Dante Pazzanese de Cardiologia in São Paulo, Brazil.
"These outcomes may be especially relevant for patients who are at a high risk of bleeding complications following PCI, such as the elderly and patients with a history of hemorrhagic events."
The OPTIMIZE trial was funded by Medtronic Comercial Ltda in São Paulo, Brazil. Dr. Feres reported consulting fees/honoraria from Biosensors, Eli Lilly, and Medtronic.
About CRF and TCT
The Cardiovascular Research Foundation (CRF) is an independent, academically focused nonprofit organization dedicated to improving the survival and quality of life for people with cardiovascular disease through research and education. Since its inception in 1991, CRF has played a major role in realizing dramatic improvements in the lives of countless numbers of patients by establishing the safe use of new technologies and therapies in interventional cardiovascular medicine. CRF is the sponsor of the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Celebrating its 25th anniversary this year, TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine. For more information, visit http://www.crf.org and http://www.tctconference.com.
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