A shortened course of dual antiplatelet therapy (DAPT) after angioplasty was associated with reduced bleeding, with no significant uptick in ischemic events, over longer follow-up of the SMART-CHOICE trial.
Patients undergoing percutaneous coronary intervention (PCI) had similar rates of major adverse cardiac and cerebrovascular events at 3 years whether they had been randomized to long-term P2Y12 inhibitor monotherapy or extended DAPT (6.3% vs 6.1%, HR 1.06, 95% CI 0.79-1.44), according to Joo-Yong Hahn, MD, PhD, of Korea’s Samsung Medical Center and Sungkyunkwan University School of Medicine, and colleagues.
Notably, the strategy of ditching aspirin but keeping the other antiplatelet after an initial 3-month period of DAPT did produce less bleeding (Bleeding Academic Research Consortium [BARC] types 2-5: 3.2% vs 8.2%, HR 0.39, 95% CI 0.28-0.55) and major bleeding (BARC types 3-5: 1.2% vs 2.4%, HR 0.56, 95% CI 0.31-0.99) in the long run, Hahn’s group reported in JAMA Cardiology.
Landmark analyses from 3 months to 3 years and per-protocol analyses showed consistent results.
Based on the available evidence, “long-term P2Y12 inhibitor monotherapy after a minimum period of DAPT might be the most reliable option from among aspirin monotherapy, P2Y12 monotherapy, and extended DAPT for maintenance therapy after stabilizing patients who have undergone PCI with a current-generation DES [drug-eluting stent],” Hahn’s team concluded.
They had previously reported that P2Y12 inhibitor monotherapy was noninferior to prolonged DAPT at 12 months’ follow-up.
American guidelines have since issued a class IIa recommendation for the discontinuation of aspirin after 1-3 months and a transition to P2Y12 inhibitor monotherapy after coronary artery revascularization.
Nevertheless, the standard antiplatelet strategy after PCI remains at least 6-12 months of standard DAPT, or aspirin plus a P2Y12 inhibitor, a class I recommendation.
Another alternative under investigation is the concept of DAPT de-escalation, in which the P2Y12 inhibitor component is downgraded from prasugrel (Effient) or ticagrelor (Brilinta) to either clopidogrel (Plavix) or a lower dose.
“For patients at greatest risk for recurrent ischemic events, the role of continued DAPT is always an option, but these data (and other consistent trials) give clinicians more options to pursue individualized treatment decisions,” two JAMA Cardiology editors wrote in an accompanying note.
“To some, the continually moving field of [post-PCI] antiplatelet therapy has provided too many choices, which can at times be dizzying. To us, every patient is different, and thoughtful evidence-based consideration is increasingly possible for many of our treatment decisions,” said Ajay Kirtane, MD, SM, of Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, and Roxana Mehran, MD, of the Icahn School of Medicine at Mount Sinai, both in New York City.
SMART-CHOICE was an open-label trial conducted at 33 Korean hospitals, and included 2,993 PCI patients randomized to short DAPT or extended DAPT, with the choice of P2Y12 inhibitor left to the discretion of each physician — who usually picked clopidogrel.
The two study arms shared similar baseline characteristics. Mean age was 64.6 years, and about 73% of the cohort were men.
Investigators defined major adverse cardiac and cerebrovascular events as a composite of all-cause death, myocardial infarction, or stroke.
Consistent with this endpoint, there were no between-group differences in any individual ischemic outcomes at 3 years, according to Hahn and colleagues.
They acknowledged, however, that follow-up data were available for only 92.5% of participants by then, and that fewer than two-thirds of the extended DAPT arm still adhered to their assigned treatment.
“Although the 3-year risk of ischemic cardiovascular events was comparable between the 2 groups, this result should be interpreted with caution owing to the limited number of events and sample size,” the study authors cautioned.
Kirtane and Mehran maintained that the concept of P2Y12 monotherapy remains attractive “because it may optimize antiplatelet effects through a single agent that can avoid the gastrointestinal toxicity of aspirin, as well as the increased bleeding that comes with stacking multiple antithrombotics.”
The strategy awaits further confirmation through ongoing trials such as A-CLOSE and SMART-CHOICE III.
The study was supported by the Korean Society of Interventional Cardiology, Abbott Vascular, Biotronik, and Boston Scientific.
Hahn reported receiving grants from Medtronic outside the submitted work and personal fees from AstraZeneca, Daiichi Sankyo, and Sanofi-Aventis.
Kirtane reported institutional funding from Medtronic, Boston Scientific, Abbott Vascular, Amgen, Cardiovascular Systems, Philips, ReCor Medical, Neurotronics, Biotronik, Chiesi, Bolt Medical, Magenta Medical, Canon, SoniVie, Shockwave Medical, and Merck; and personal fees from Interventional Medical Device Solutions, Medtronic, Boston Scientific, Abbott Vascular, Cardiovascular Systems, Siemens, Philips, ReCor Medical, Chiesi, Opsens, Zoll, and Regeneron.
Mehran reported grants from Abbott, Abiomed, Alleviant Medical, AM-Pharma, Amgen, Applied Therapeutics, Arena, AstraZeneca, AtriCure, Bayer, Biosensors, Biotronik, Boston Scientific, Bristol Myers Squibb, Cardiawave, CeloNova, Chiesi, Concept Medical, CSL Behring, CytoSorbents, Daiichi Sankyo, Element Science, Faraday, Humacyte, Idorsia, Janssen, Magenta, Medtronic, Novartis, OrbusNeich, PhaseBio, Philips, Pi-Cardia, RenalPro, RM Global, Shockwave, Vivasure, and Zoll; personal fees from Cine-Med Research and WebMD; and equity in Applied Therapeutics, Elixir Medical, Stel, and ControlRad (spouse).