Dual antiplatelet therapy strategies and clinical outcomes in patients treated with polymer-free biolimus A9-coated stents
Fabrizio D'Ascenzo, Guglielmo Gallone, Giacomo Boccuzzi, Bernardo Cortese, Maurizio Di Biasi, Davide Capodanno, Paolo Vicinelli, Vincenzo Infantino, Arnaldo Poli, Giulietta Grigis, Ferdinando Varbella, Gaetano Maria De Ferrari, Alfonso Ielasi, Collaborators, Enrico Cerrato, Mauro Pennone, Fabrizio Ugo, Pierluigi Omedè, Roberto Adriano Latini, Maurizio D’Urbano, Antonio Montefusco, Andrea Montabone, Gaetano Senatore, Erika Ferrara, Mauro Rinaldi, Maurizio D’Amico, Fabrizio D'Ascenzo, Guglielmo Gallone, Giacomo Boccuzzi, Bernardo Cortese, Maurizio Di Biasi, Davide Capodanno, Paolo Vicinelli, Vincenzo Infantino, Arnaldo Poli, Giulietta Grigis, Ferdinando Varbella, Gaetano Maria De Ferrari, Alfonso Ielasi, Collaborators, Enrico Cerrato, Mauro Pennone, Fabrizio Ugo, Pierluigi Omedè, Roberto Adriano Latini, Maurizio D’Urbano, Antonio Montefusco, Andrea Montabone, Gaetano Senatore, Erika Ferrara, Mauro Rinaldi, Maurizio D’Amico
Abstract
Aims: A large trial established the favourable clinical profile of a new polymer-free biolimus A9-eluting stent (PF-BES) with a one-month dual antiplatelet therapy (DAPT) regimen in patients at high bleeding risk (HBR). We aimed to evaluate the real-world patterns of indications, DAPT strategies and outcomes for the PF-BES following this evidence.
Methods and results: CHANCE is a multicentre registry including all patients who underwent percutaneous coronary intervention (PCI) with at least one PF-BES. The reasons for the PF-BES PCI and planned antithrombotic regimens were collected. Primary outcomes were the 390-day Kaplan-Meier estimates of patient-oriented and device-oriented composite endpoints (POCE: death, myocardial infarction [MI] or target vessel revascularisation [TVR]; DOCE: cardiac death, target vessel MI or ischaemia-driven target lesion revascularisation [ID-TLR]). Between January 2016 and July 2018, 858 patients (age 74±10 years, 64.6% male, 58.7% acute coronary syndrome presentation) underwent PF-BES PCI. The main reasons for the physicians' choice of PF-BES reflected a perceived HBR in 77.7% of patients. One-month DAPT was planned in 40.3% of patients. At 390-day follow-up (median 340 days, interquartile range: 187-390 days), the estimated incidence of POCE was 13.1% (any MI 3.7%, any TVR 3.4%) and of DOCE was 7.1% (TV-MI 3.6%, ID-TLR 1.4%), while the 390-day estimate of any bleeding event was 11.1% (BARC 3-5 bleeding 3.0%).
Conclusions: In a large all-comers registry, PF-BES was used mostly in HBR patients, frequently followed by a very short DAPT regimen. The reported outcomes suggest a favourable safety and efficacy profile for the PF-BES in a real-world clinical setting. ClinicalTrials.gov identifier: NCT03622203.
Source: PubMed