Real‐world reasons and outcomes for 1‐month versus longer dual antiplatelet therapy strategies with a polymer‐free BIOLIMUS A9‐coated stent

• Published in: Catheterization and cardiovascular interventions 2020-09, Vol.96 (3), p.E248-E256
• Main Authors: Gallone, Guglielmo, D'Ascenzo, Fabrizio, Boccuzzi, Giacomo, Cortese, Bernardo, Di Biasi, Maurizio, Omedè, Pierluigi, Capodanno, Davide, Cerrato, Enrico, Vicinelli, Paolo, Infantino, Vincenzo, Poli, Arnaldo, Ugo, Fabrizio, Conrotto, Federico, Grigis, Giulietta, Varbella, Ferdinando, Latini, Roberto A., D'Urbano, Maurizio, Montabone, Andrea, Senatore, Gaetano, Ferrara, Erika, D'Amico, Maurizio, De Ferrari, Gaetano M., Ielasi, Alfonso
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Antiplatelet therapy; bleeding; Cardiovascular Agents - administration & dosage; Cardiovascular Agents - adverse effects; Coronary Artery Disease - diagnostic imaging; Coronary Artery Disease - mortality; Coronary Artery Disease - therapy; Drug Administration Schedule; drug eluting stent; Drug-Eluting Stents; Dual Anti-Platelet Therapy - adverse effects; Dual Anti-Platelet Therapy - mortality; dual antiplatelet therapy; Female; Humans; Implants; Ischemia; Italy; Male; Middle Aged; Myocardial infarction; Percutaneous Coronary Intervention - adverse effects; Percutaneous Coronary Intervention - instrumentation; Percutaneous Coronary Intervention - mortality; Platelet Aggregation Inhibitors - administration & dosage; Platelet Aggregation Inhibitors - adverse effects; Polymers; polymer‐free biolimus‐eluting stent; Prosthesis Design; Registries; Sirolimus - administration & dosage; Sirolimus - adverse effects; Sirolimus - analogs & derivatives; Stents; Time Factors; Treatment Outcome
• ISSN: 1522-1946; 1522-726X
• DOI: 10.1002/ccd.28757

Background A large trial established the favorable profile of a new polymer‐free biolimus A9‐eluting stent (PF‐BES) with a 1‐month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients. This is the first study comparing outcomes for a 1‐month versus longer DAPT strategies following PF‐BES‐percutaneous coronary intervention (PCI). Methods All patients undergoing PF‐BES‐PCI (January 2016 to July 2018) were included in the multicenter CHANCE registry. Patients were stratified according to DAPT strategy at discharge (planned 1‐month vs. planned >1‐month). Primary outcomes were the 390‐day estimates of a patient‐oriented and of a device‐oriented composite endpoints (POCE: death, myocardial infarction [MI] or target vessel revascularization; DOCE: cardiac death, target vessel‐MI or ischemia‐driven target lesion revascularization). Landmark analyses from 1‐month post‐PCI were carried. Results Following PF‐BES‐PCI, 328(40.3%) and 485(59.6%) patients were discharged with 1‐month and longer DAPT (12 months [6–12]), respectively. Patients with a previous or index MI were less likely to be discharged on 1‐month DAPT. Patients prescribed with 1‐month DAPT were more likely to be at HBR than those with longer DAPT (90.2% vs. 69.9%, p = .001). No between‐groups differences in the primary outcomes (planned 1‐month vs. planned >1‐month DAPT: POCE 11.9% vs. 13.2%, p = .747; DOCE: 4.8% vs. 8.1%, p = .500) were observed, also after adjusting for confoundings (POCE: adjusted‐hazard ratio [adj‐HR] 1.26, 95%CI 0.74–2.13; DOCE: adj‐HR 1.00, 95%CI 0.49–1.99). Landmark analyses showed similar results. Conclusions In a large all‐comers registry of PF‐BES PCI, no interaction of planned DAPT strategy (1‐month vs. >1‐month) with outcomes was found. This observation warrants investigation in adequately powered randomized studies (ClinicalTrials.gov NCT03622203).