• Cardiology Clinical Trials
• Thrombotic Disorders
• Interventional Techniques & Devices

• Cardiology Clinical Trials
• Thrombotic Disorders
• Cardiology & Cardiovascular Medicine
• Interventional Techniques & Devices

Fausto Feres, MD, PhD, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil, presented the final results from the Optimized Duration of Clopidogrel Therapy Following Treatment With the Zotarolimus-Eluting Stent in Real-World Clinical Practice trial [OPTIMIZE; Feres F et al. JAMA 2013], demonstrating that in patients with coronary heart disease who received a drug-eluting stent (DES), cessation of dual antiplatelet therapy (DAPT) 3 or 12 months after implantation did not increase their risk of the composite endpoint of death, MI, stroke or major bleeding, or stent thrombosis at 1-year follow-up.

Although the optimal duration of DAPT following DES implantation remains uncertain, early discontinuation of DAPT is considered one of the most important predictors of thrombotic events after first-generation DES implantation [Bhatt DL et al. N Engl J Med 2006]. Current guidelines therefore recommend that patients receive long-term DAPT, for ≥12 months [Levine GN et al. Circulation 2011; Wijns W et al. Eur Heart J 2010].

OPTIMIZE, the largest prospective, multicenter, randomized controlled trial on this subject to date, was designed as a noninferiority trial to evaluate the safety and clinical impact of short-term DAPT in patients following DES implantation.

Patients were eligible to be included if they had symptoms of stable angina, silent ischemia, or a history of low-risk acute coronary syndrome (characterized by unstable angina or recent, but not acute, myocardial infarction [MI]). Exclusion criteria included primary or rescue percutaneous coronary intervention (PCI) for ST-segment elevation MI, previous treatment with any DES, and lesion located in a saphenous vein graft.

The primary endpoint of the study was net adverse clinical and cerebral events (NACCE) defined as a composite of all-cause death, MI, stroke, or major bleeding at 1 year. Secondary endpoints were major adverse cardiac events (MACE) defined as a composite of all-cause death, MI, emergent coronary artery bypass graft surgery, or target lesion revascularization and Academic Research Consortium (ARC) definite or probable stent thrombosis.

A total of 3119 patients were randomized 1:1 to either short-term (3 months; n=1563) or long-term (12 months; n=1556) DAPT following zotarolimus-eluting stent placement.

At 1-year follow-up, there was no significant difference between patients receiving 3 months and 12 months of DAPT following DES implantation in NACCE rates (6.0% vs 5.8%; risk difference, 0.17; 95% CI, −1.52 to 1.86; p=0.002 for noninferiority), MACE rates (8.3% vs 7.4%; p=0.36), or the occurrence of ARC definite or probable stent thrombosis (0.8% vs 0.8%; p=0.86).

Between 3 months and 1 year, there was no significant difference between short- and long-term DAPT groups in the occurrence of NACCE (2.6% vs 2.6%; risk difference 0.05; 95% CI, −1.06 to 1.17; p=0.91) or stent thrombosis (ARC definite or probable; 0.3% vs 0.1%; risk difference, 0.20; 95% CI, −0.09 to 0.48; p=0.18), for the short- versus long-term groups, respectively.

“Any bleeding” complications were reported in 80 patients up to 1 year, but only 23 cases (29%) were categorized as major bleeding events. Between 3 months and 1 year, although not statistically significant, there was a trend toward increased bleeding with prolonged DAPT, with a 2-fold higher rate in the long-term treatment group (major bleeding 0.4% vs 0.2%; p=0.31; any bleeding 1.0% vs 0.4%; p=0.07).

Prof. Feres concluded that, despite current guideline recommendations, data from the OPTIMIZE study demonstrate noninferiority of shorter-term DAPT in patients after DES implantation for the occurrence of death, MI, stroke, or major bleeding events, and without a significantly elevated risk of stent thrombosis. Long-term DAPT may therefore not always be necessary following second generation DES placement, and this may be particularly important for patients at high risk of bleeding following PCI.

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