Evolving Landscapes in Coronary Stents for Patients at High Bleeding Risk

HomeCirculation: Cardiovascular InterventionsVol. 14, No. 3Evolving Landscapes in Coronary Stents for Patients at High Bleeding Risk Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyRedditDiggEmail Jump toFree AccessEditorialPDF/EPUBEvolving Davide CapodannoMD, PhD CapodannoDavide Capodanno Correspondence to: Capodanno, MD, PhD, Division of Cardiology, Azienda Ospedaliero-Universitaria Policlinico “G. Rodolico-San Marco,” Via S. Sofia, 78-95123 Catania, Italy. Email E-mail Address: [email protected] https://orcid.org/0000-0002-5156-7723 University Search more papers by this author Originally published1 Mar 2021https://doi.org/10.1161/CIRCINTERVENTIONS.121.010591Circulation: Interventions. 2021;14:e010591This article is a commentary on the followingPrimary Results EVOLVE Short DAPT StudySee Article Mangieri et alAbout 40% patients undergoing percutaneous coronary intervention (PCI) present with high bleeding risk (HBR) according combination major and minor criteria standardized 2019 Academic Research Consortium HBR (ARC-HBR).1 Based subsequent validation studies ARC-HBR definition, these are exposed serious or life-threatening events ≥4% 1 year from PCI.2–4 For HBR, dual antiplatelet therapy (DAPT) currently indicated 6 months after PCI depending their clinical presentation other circumstances.5For decades, key focus trials has been development stents that minimize restenosis stent thrombosis. reduces burden thrombotic complications, but its trade-off uncertain especially where weighing efficacy safety considerations recommended.6 The paradigm contemporary field now shifting testing strategies reduction combine modern shortened effort improve while preserving (Figure).7Download figureDownload PowerPointFigure. Trials devices short risk. BMS indicates bare metal stent; DCB, drug-coated balloon; DCS, DES, drug-eluting OPG, objective performance goal.In issue Circulation: Interventions, Kirtane al8 results DAPT—a global, regulatory, single-arm study 1487 (mostly elderly stable artery disease noncomplex lesions) treated thin-strut, biodegradable-polymer Synergy everolimus-eluting stent, who were free ischemic between 0 3 left only aspirin discontinuation P2Y12 inhibitor months. At 12 (ie, 15 PCI), incidence death myocardial infarction subjects was noninferior propensity-matched historical cohort limus-eluting received (5.6% versus 5.7%; P noninferiority, 0.0016). rate definite probable thrombosis low (0.2%) well below prespecified goal 1.0% (P=0.0005). In analysis restricted not oral anticoagulation (n=1032), no differences noted secondary end point types 2, 3, 5 as compared controls 12-month (6.3% 4.2%; P=0.98). Notably, because timing some control group unknown, latter comparison based worst-case scenario such assumed occur were, therefore, censored clear period months.The should be interpreted light considerations. randomized, comparisons given against mixing different an goal. Similar designs lack randomization increasingly admitted regulatory authorities adopted recent intended use (Figure).9–11 Although authors correct randomizing (eg, like former LEADERS-FREE SENIOR trials)12,13 would have challenging era, analytic limitations approach apparent unknown confounders). addition, one most unspoken benefits randomized controlled inclusion simultaneous cohorts ascertainment bias minimized. potential introducing evident study, where—counterintuitively likely due differential underreporting—the numerically higher shorter DAPT. standards, ONYX-ONE trial)14 preferable.7 If anything, scope investigate 3-month duration receiving current standard months) rather than longer informative. Yet, enrollment initiated 2016, before default elective set international guidelines.5 Strategies represent moving target, selecting right essential avoid hypothesis becoming obsolescent during course trial.7These notwithstanding, rates ischemic/thrombotic particularly observed DAPT-free notable reassuring. Importantly, findings apply low-risk infarction, relatively straightforward angiographic presentation, occurring first PCI. Two-thirds enrolled criterion age >75 years (a definition) coupled judgment. Unfortunately, we told which proportion population fulfill available time design. This information helpful sake comparability across patients.The supports evolving discontinuing does imply negative selected HBR. An obvious practical implication stemming design decision durations device taken downstream) upstream). Another perspective corroborated data can long enough when circumstances require duration. similar considerations, Food Drug Administration issued indication August 2020.While options those 1-month early accumulate, same indications ongoing. COMPARE 60/80 trial (https://www.clinicaltrials.gov; unique identifier: NCT04500912) will contrast Supraflex Ultimaster stents, BIOFLOW NCT04137510) compare Orsiro durable-polymer Resolute Onyx stents. Remaining questions include how handle individual patients’ risks events. fact, comparing do address efficacy, safety, net benefit using question hopefully addressed ongoing MASTER-DAPT TARGET-SAFE identifiers: NCT03023020 NCT03287167).Disclosures Dr reports speaker’s honoraria AstraZeneca, Biotronik, Boston Scientific, Medtronic, Sanofi Aventis.FootnotesThe opinions expressed necessarily editors American Heart Association.For Disclosures, see page 313.This manuscript sent Frederick G. 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ONYX Polymer-based 382:1208–1218. 10.1056/NEJMoa1910021CrossrefMedlineGoogle Scholar Previous Back top Next FiguresReferencesRelatedDetailsRelated articlesPrimary StudyAjay Kirtane, al. 2021;14 March 2021Vol Issue 3Article InformationMetrics Download: 210 © 2021 Association, Inc.https://doi.org/10.1161/CIRCINTERVENTIONS.121.010591PMID: 33641373 publishedMarch 1, Keywordsplatelet aggregation inhibitorsstentsEditorialspercutaneous interventionPDF download SubjectsCompliance/AdherencePercutaneous InterventionPharmacology