November 4, 2013 — A new study demonstrated 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 at the 25th annual Transcatheter Cardiovascular Therapeutics scientific symposium (TCT 2013).
Current guidelines recommend long-term (12 months) 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 (CAD) in a prospective, randomized (one-to-one) multicenter clinical evaluation that compared short-term (three-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 versus 5.9 percent, respectively), establishing non-inferiority of the shorter-term therapy (non-inferiority p = 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 Fausto Feres, M.D., Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil, and lead investigator.
“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.”
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