OPTIMIZE and ARCTIC-INTERRUPTION Trials Look at Dual Antiplatelet Therapy Use After PCI
Shorter-term dual antiplatelet therapy (DAPT) was noninferior to long-term among patients with stable coronary artery disease or history of low-risk acute coronary syndrome (ACS) undergoing PCI with zotarolimus-eluting stents, according to results from the OPTIMIZE Trial presented on Oct. 31 as part of TCT 2013 and simultaneously published in the Journal of the American Medical Association.
The OPTIMIZE trial, an open-label, active-controlled,1:1 randomized noninferiority study, included 3,119 patients in 33 sites in Brazil between April 2010 and March 2012. Patients were prescribed aspirin (100-200mg daily) and then clopidogrel (75mg daily) for three months (n = 1,563) or 12 months (n = 1,556) following PCI, unless contraindicated.
The primary end point was net adverse clinical and cerebral events (NACCE), with secondary end points being major adverse cardiac events (MACE) and Academic Research Consortium definite or probable stent thrombosis. Overall, NACCE occurred in 93 patients (6.0 percent) receiving short-term DAPT and 90 patients (5.8 percent) receiving long-term DAPT. Kaplan-Meier estimates demonstrated MACE rates at one year of 8.3 percent in the short-term group and 7.4 percent in the long-term group. (Download the slides .)
The results were similar in several key subgroups, including patients with diabetes, history of low-risk ACS, multivessel disease, or bifurcation lesions. "These findings build on those from other randomized noninferiority trials with relatively smaller sample sizes, which suggested safety and efficacy of short-term dual antiplatelet therapy in patients treated with second-generation drug-eluting stents," the authors said.
Moving forward, the authors suggest that their findings may be "especially relevant" for patients at high risk of bleeding complications following PCI, such as the elderly or those with a history of hemorrhagic events. "In our study, no significant differences were observed in the occurrence of major bleeding according to the primary outcome definition," they said. "Even when considering any bleeding events, there was no statistically significant association between duration of dual antiplatelet therapy and bleeding occurring after 90 days."
Meanwhile, a second study presented at TCT, also looked at DAPT after drug-eluting stent implantation. The ARCTIC- Interruption Trial assessed the impacts of two-year vs. one-year duration of DAPT and found no ischemic benefit of prolongation of DAPT up to 2 years after drug-eluting stent implantation. These findings were also consistent irrespective of prespecified subgroups, the investigators said. (Download the slides .)
Keywords: Coronary Artery Disease, Acute Coronary Syndrome, Kaplan-Meier Estimate, Brazil, Thrombosis, Drug-Eluting Stents, Ticlopidine, Sirolimus, Diabetes Mellitus, Stents
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