Six-Month Versus 12-Month Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents: The Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting (EXCELLENT) Randomized,…
By H. Gwon, J. Hahn, Kyung-Woo Park, Y. Song, I. Chae, D. Lim, K. Han, Jin‐Ho Choi, Seung‐Hyuk Choi, Hyun-Jae Kang and 16 more. Circulation, 2012
596 citations recorded by the source corpus.
Background— The optimal duration of dual antiplatelet therapy (DAPT) after implantation of drug-eluting coronary stents remains undetermined. We aimed to test whether 6-month DAPT would be noninferior to 12-month DAPT after implantation of drug-eluting stents. Methods and Results— We randomly assigned 1443 patients undergoing implantation of drug-eluting stents to receive 6- or 12-month DAPT (in a 1:1 ratio). The primary end point was a target vessel failure, defined as the composite of cardiac death, myocardial infarction, or ischemia-driven target vessel revascularization at 12 months. Rates of target vessel failure at 12 months were 4.8% in the 6-month DAPT group and 4.3% in the 12-month DAPT group (the upper limit of 1-sided 95% confidence interval, 2.4%; P=0.001 for noninferiority with a predefined noninferiority margin of 4.0%). Although stent thrombosis tended to occur more frequently in the 6-month DAPT group than in the 12-month group (0.9% versus 0.1%; hazard ratio, 6.02; 95% confidence interval, 0.72–49.96; P=0.10), the risk of death or myocardial infarction did not differ in the 2 groups (2.4% versus 1.9%; hazard ratio, 1.21; 95% confidence interval, 0.60–2.47; P=0.58). In the prespecified subgroup analysis, target vessel failure occurred more frequently in the 6-month DAPT group than in the 12-month group (hazard ratio, 3.16; 95% confidence interval, 1.42–7.03; P=0.005) among diabetic patients. Conclusions— Six-month DAPT did not increase the risk of target vessel failure at 12 months after implantation of drug-eluting stents compared with 12-month DAPT. However, the noninferiority margin was wide, and the study was underpowered for death or myocardial infarction. Our results need to be confirmed in larger trials. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00698607.
Subfields: Cardiology and Cardiovascular Medicine, Surgery
View Paper: https://www.semanticscholar.org/paper/0aff7773e9bf16da30d840708c2cb9f3bcaf7aa5
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In Cardiology and Cardiovascular Medicine
Citations in the corpus
- 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. (2016, methodology): “Compared with first-generation DES, currently used newer-generation DES are associated with a lower risk of stent thrombosis and appear to require a shorter minimum duration of DAPT (17,18,21,38,96,97) Several studies of DAPT duration in patients treated with newer-generation DES did not detect any ”
- [2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS.] (2018, methodology): “at least 12-month DAPT duration: The Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting (EXCELLENT) trial compared a 6-month DAPT [acetylsalicylic acid (ASA) + clopidogrel] duration with 1-year DAPT after DES [100].”