Background: Although a 1-year duration of dual antiplatelet therapy (DAPT) is used in many patients after drug-eluting stent (DES) implantation, the evidence supporting this duration is uncertain. Objectives: The authors investigated the risk-benefit profile of 1-year vs ≤6-month DAPT after DES using 2 novel scores to risk stratify bleeding and ischemic events. Methods: Ischemic and bleeding risk scores were generated from ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents), a multicenter, international, “all-comers” registry that enrolled 8,665 patients treated with DES. The risk-benefit profile of 1-year vs ≤6-month DAPT was then investigated across risk strata from an individual patient data pooled dataset of 7 randomized trials that enrolled 15,083 patients treated with DES. Results: In the derivation cohort, the ischemic score and the bleeding score had c-indexes of 0.76 and 0.66, respectively, and both were well calibrated. In the pooled dataset, no significant difference was apparent in any ischemic endpoint between 1-year and ≤6-month DAPT, regardless of the risk strata. In the overall dataset, there was no significant difference in the risk of clinically relevant bleeding between 1-year and ≤6-month DAPT; however, among 2,508 patients at increased risk of bleeding, 1-year compared with ≤6-month DAPT was associated with greater bleeding (HR: 2.80; 95% CI: 1.12-7.13) without a reduced risk of ischemic events in any risk strata, including those with acute coronary syndromes. These results were consistent in a network meta-analysis. Conclusions: In the present large-scale study, compared with ≤6-month DAPT, a 1-year duration of DAPT was not associated with reduced adverse ischemic events in any risk strata (including acute coronary syndromes) but was associated with greater bleeding in patients at increased risk of bleeding.
|Number of pages||19|
|Journal||Journal of the American College of Cardiology|
|Publication status||Published - 2021 Nov 16|
Bibliographical noteFunding Information:
Dr Palmerini has received speaker fees from Abbott Vascular, Biotronik, and Edwards Lifesciences; and has received a research grant from Eli Lilly. Dr Abizaid is proctor for transcatheter aortic valve replacement for Boston Scientific (Acurate Neo). Dr Valgimigli has received personal fees from AstraZeneca, Alvimedica/CID, Abbott Vascular, Daiichi-Sankyo, Opsens, Bayer, CoreFLOW, Idorsia Pharmaceuticals LTD, Universität Basel Department Klinische Forschung, Vifor, Bristol Myers Squibb SA, iVascular, Medscape, and Biotronik; and has received grants and personal fees from Terumo outside of the submitted work. Dr Morice is a shareholder and CEO of CERC, a CRO not involved in this analysis; and is a minor shareholder of Electroducer, not involved in the study either. Dr Park has received speaker’s fees from Daiichi- Sankyo, AstraZeneca, Sanofi, Bristol Myers Squibb, Bayer, and Pfizer outside of the submitted work. Dr Chieffo has received speaker/consultant fees from Abbott, Abiomed, Biosensor, Cardinal Health, GADA, and Magenta. Dr Nakamura has received grants from Daiichi-Sankyo Co, Ltd, Sanofi K.K., and Bayer K.K.; and has received fees from Daiichi-Sankyo Co, Ltd, Sanofi K.K., Terumo Corporation, Bristol Myers Squibb K.K, and Japan life line Co LTD. Dr Saia has received lecture fees from AstraZeneca, Daiichi-Sankyo, Bayer, and Boehringer Ingelheim. Dr Weisz has received consultation fees from Filterlex, Intratech, and Magenta; and has stock options in Filterlex, Intratech, Magenta, Medivizer, Trisol, and Vectorious. Dr Kirtane has received institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, and ReCor Medical; in addition to research grants, institutional funding includes fees paid to Columbia University and/or Cardiovascular Research Foundation for speaking engagements and/or consulting; has received personal consulting fees from Neurotronic; and has received travel expenses/meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Dr Mehran has received institutional research grants from Abbott Laboratories, Abiomed, Applied Therapeutics, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Medtronic, Novartis Pharmaceuticals, OrbusNeich, and Zoll; has received consultant fees from Boston Scientific, Cine-Med Research, Janssen Scientific Affairs, and Medscape/WebMD; has received consultant fees paid to the institution from Abbott Laboratories, Abiomed (spouse), Bayer (spouse), Beth Israel Deaconess, Bristol Myers Squibb, CardiaWave, Chiesi, Concept Medical, DSI, Duke University, Idorsia Pharmaceuticals, Medtronic, Novartis, and Spectranetics/Philips/Volcano Corp; has equity <1% from Applied Therapeutics, Elixir Medical, STEL, and CONTROLRAD (spouse); has served as a consultant (no fee) for Regeneron Pharmaceuticals; and has served as Associate Editor for the ACC and AMA. Dr Stone has received speaker or other honoraria from Terumo, Cook, and Infraredx; has served as a consultant to Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Reva, MAIA Pharmaceuticals, Vascular Dynamics, Shockwave, V-Wave, Cardiomech, and Gore; and has equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and MedFocus family of funds. No sponsor of any of the individual trials had any role in the study design, data collection, data interpretation, or drafting the manuscript. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
© 2021 American College of Cardiology Foundation
All Science Journal Classification (ASJC) codes
- Cardiology and Cardiovascular Medicine