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Study Summary

The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention remains a debated topic. The risk of bleeding needs to be weighed against the risk of stent thrombosis. Given that the second-generation of drug-eluting stents are associated with lower risk of stent thrombosis, strategies to investigate whether shorter duration of DAPT will have similar safety and efficacy profiles were explored in the STOPDAPT2 trial. This was a prospective, multicenter, open-label, single-arm trial comparing 1-month DAPT followed by clopidogrel monotherapy with the standard 12-month DAPT with aspirin and clopidogrel after implantation of cobalt-chromium everolimus-eluting stents in 2974 enrollees (38% with acute coronary syndromes) who were followed for 1 year (see accompanying Hurst's Central Illustration). Exclusion criteria included the need of oral anticoagulants and history of intracranial bleeding. The primary end point was a composite of net adverse cardiovascular events: cardiovascular death, myocardial infarction, stroke, definite stent thrombosis, and bleeding (defined by the TIMI bleeding criteria). The primary end point was observed in 2.4% versus 3.7% in groups receiving 1 month versus 12 months of DAPT (HR 0.64, 95% CI 0.42-0.98; P for non-inferiority <0.001; P for superiority = 0.04). The benefit was driven by significant reduction in bleeding events without increase in ischemic events. The signal for benefit was noted in most subgroup analyses, except for those with severe chronic kidney disease.

Commentary

Study Strengths: The major strengths of the trial include a large study population, a randomized design, and the use of second-generation drug-eluting stents. Second-generation drug-eluting stents have mostly replaced bare-metal and first-generation drug-eluting stents, and outcomes with use of the newer stent platforms has filled a gap in the literature.

Study Limitations: The major limitations of the trial included lack of blinding or placebo control and limited enrollment of high-risk patients, as the median SYNTAX score was <10 in both groups, just 7% had multivessel disease, and only 6% had severe chronic kidney disease.

Next Steps/Clinical Perspective: Based on this large trial, shorter duration of DAPT appears to be non-inferior (and may be superior in reducing bleeding) to longer duration DAPT when using second-generation drug-eluting stents. However, caution must be used when generalizing the results to higher risk groups (such as those with complex lesions and higher risks of thrombosis and bleeding) or other stent types. These results are similar to the SMART-CHOICE study, also presented at the 2019 American College of Cardiology congress. The SMART-CHOICE study compared short-duration DAPT (3 months) followed by P2Y12 inhibitor monotherapy versus longer-duration DAPT (12 months) among patients undergoing drug-eluting stent implantation. The authors showed that short duration DAPT was noninferior to longer-duration DAPT for the primary outcome of major adverse cardiovascular events (2.9% versus 2.5%; P for noninferiority = 0.007, P for superiority = 0.46).

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