1. Primary Results of the EVOLVE Short DAPT Study
- Author
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Robert W. Yeh, James W. Choi, Ian T. Meredith, Dean J. Kereiakes, Franz-Josef Neumann, Stephan Windecker, Robert C. Stoler, Ralph Toelg, Robert L. Feldman, Ajay J. Kirtane, Loukas Boutis, Harold L. Dauerman, Matthew J. Price, Islam Othman, Paul Underwood, Naeem Tahirkheli, Dominic J. Allocco, and Bernardo Stein
- Subjects
medicine.medical_specialty ,Polymers ,medicine.medical_treatment ,Population ,Coronary Artery Disease ,Percutaneous Coronary Intervention ,Absorbable Implants ,medicine ,Humans ,Everolimus ,Myocardial infarction ,610 Medicine & health ,education ,Stroke ,ComputingMilieux_MISCELLANEOUS ,education.field_of_study ,Aspirin ,business.industry ,Stent ,Percutaneous coronary intervention ,Drug-Eluting Stents ,medicine.disease ,Thrombosis ,Surgery ,Treatment Outcome ,ComputingMethodologies_DOCUMENTANDTEXTPROCESSING ,Drug Therapy, Combination ,Cardiology and Cardiovascular Medicine ,business ,Platelet Aggregation Inhibitors ,medicine.drug - Abstract
Background: Prolonged dual antiplatelet therapy (DAPT) after percutaneous coronary intervention is associated with increased bleeding, despite a reduced incidence of ischemic events. The SYNERGY everolimus-eluting stent is a thin-strut platinum-chromium stent that elutes everolimus from a thin abluminal layer of bioabsorbable polymer. These design elements may facilitate rapid endothelialization and enable shorter-duration DAPT. Methods: EVOLVE Short DAPT prospectively evaluated the safety of 3-month DAPT in high bleeding risk patients treated with the SYNERGY everolimus-eluting stent, enrolling 2009 patients at 110 global sites. Patients with acute myocardial infarction or complex lesions were excluded. After percutaneous coronary intervention, patients were required to take DAPT (aspirin+P2Y 12 inhibitor) for 3 months, except those on chronic anticoagulation in whom aspirin was optional. Patients free of events (stroke, myocardial infarction, revascularization, and stent thrombosis) who discontinued P2Y 12 inhibitor at 3 months, but continued aspirin, and had at least 1 year of follow-up or an end point event were included in the primary analysis. Two powered coprimary end points were (1) death/myocardial infarction compared with a historical control and (2) study stent-related definite/probable stent thrombosis compared to a performance goal. Results: The analysis population consisted of 1487 patients. The adjusted rate of death/myocardial infarction between 3 and 15 months was 5.6% among patients receiving 3-month DAPT versus 5.7% patients in the 12-month DAPT control (propensity adjusted difference=−0.12%; 97.5% upper bound=1.63% which was less than the prespecified margin of 2.52; P non-inferiority =0.0016). The rate of study stent-related stent thrombosis between 3-15 months was 0.2% in the 3-month DAPT group (97.5% upper bound=0.63%; P =0.0005 for comparison to 1% performance goal). Conclusions: Favorable rates of ischemic outcomes were observed among selected high bleeding risk patients undergoing percutaneous coronary intervention with the SYNERGY everolimus-eluting stent who tolerated 3 months of P2Y 12 inhibitor and then discontinued it, supporting the safety of abbreviated DAPT with this stent platform. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02605447.
- Published
- 2021