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Publications

Journal Article Ahead of print

PubMed: 42555546 DOI: 10.1093/ehjacc/zuag089

Biodegradable polymer sirolimus-eluting or durable polymer zotarolimus-eluting stents in high bleeding-risk patients with acute coronary syndrome: the BIOFLOW-DAPT randomized trial.

Eur Heart J Acute Cardiovasc Care

Authors: Nader Mankerious, Rayyan Hemetsberger, Adrian Wlodarczak, Béla Merkely, Henning Kelbæk, Guillaume Cayla, Jacek Legutko, Stefano Galli, Matthieu Godin, Gabor G Toth, Thibault Lhermusier, Mohammed Saad, Benjamin Honton, Francesca Sanguineti, Peter Laurenz Dietrich, Derk Frank, Francis Stammen, Bert Ferdinande, Johanne Silvain, Davide Capodanno, Holger Nef, Gert Richardt, Ralph Toelg, Marco Valgimigli

Affiliations

  • Heart Center Bad Segeberg, Segeberger Kliniken GmbH, Bad Segeberg, Germany.
  • Cardiology Department, Zagazig University, Sharkia, Egypt.
  • Department of Cardiology, Internal Medicine II, Medical University of Vienna, Vienna, Austria.
  • Division of Cardiology, Copper Health Centre Inc. Lubin 59-301, Poland.
  • Faculty of Medicine, Wroclaw University of Science and Technology, Wroclaw 50-981, Poland.
  • Heart and Vascular Center, Semmelweis University, Budapest, Hungary.
  • Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.
  • Department of Cardiology, University of Montpellier, Hospital of Nimes, Nîmes, France.
  • Department of Interventional Cardiology, Jagiellonian University Medical College, Institute of Cardiology, John Paul II Hospital, Krakow, Poland.
  • Department of Interventional Cardiology, Centro Cardiologico Monzino IRCCS, Milan, Italy.
  • Department of Cardiology, Clinique Saint Hilaire, Rouen, France.
  • University Heart Center Graz, Medical University Graz, Graz, Austria.
  • Department of Cardiology, Hôpital Universitaire de Toulouse, Toulouse, France.
  • Medical Faculty, Christian-Albrechts-University of Kiel, Kiel, Germany.
  • Cardiology Department, Clinique Pasteur, Toulouse 31300, France.
  • Institut Cardiovasculaire Paris Sud, Ramsay Générale de Santé, Massy, France.
  • Division of Cardiology, Stadtspital Triemli, Zurich, Switzerland.
  • Department of Cardiology, AZ Delta, Roeselare, Belgium.
  • Department of Cardiology, Hospital Oost-Limburg, Genk, Belgium.
  • ACTION Group, Sorbonne Université, INSERM UMRS 1166, Hôpital Pitié-Salpêtrière (AP-HP), Institut de Cardiologie, Paris, France.
  • Division of Cardiology, Azienda Ospedaliero Universitaria Policlinico 'G. Rodolico-San Marco,', University of Catania, Catania, Italy.
  • Center for Cardiovascular and Diabetes Medicine, Asklepios Clinic Bad Oldesloe, Bad Oldesloe, Germany.
  • Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale (EOC), Università della Svizzera Italiana, Via Tesserete 48, Lugano CH-6900, Switzerland.

Abstract

AIMS

Patients at high bleeding risk (HBR) and acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) are at high risk of adverse outcomes. We investigated the clinical outcomes and their consistency after biodegradable polymer sirolimus-eluting (BP-SES) or durable polymer zotarolimus-eluting stent (DP-ZES) implantation in HBR patients with or without ACS.

METHODS AND RESULTS

The per-protocol population of the BIOFLOW-DAPT randomized control trial (RCT) consisted of HBR patients with (n = 541) or without ACS (n = 1245) who were randomized to BP-SES or DP-ZES and underwent 1 month dual antiplatelet therapy (DAPT). The primary efficacy and safety endpoints were target lesion failure (TLF), defined as the composite endpoint of cardiac death, target vessel myocardial infarction (TV-MI), or clinically driven target lesion revascularization (cd-TLR) as well as major bleeding defined as BARC 3 or 5 (according to Bleeding Academic Research Consortium classification) and definite/probable stent thrombosis (ST). At 1 year, patients with ACS suffered from higher cardiac death rates (3.4 vs. 1.3%, log-rank P = 0.004) but similar TLF (6.8 vs. 6.7%, P = 0.992), TV-MI (2.8 vs. 4.5%, P = 0.100), cd-TLR (1.4 vs. 2.1%, P = 0.300), major bleeding (4.2 vs. 3.1%, P = 0.266), and ST (0.2 vs. 0.9%, P = 0.098) compared with no ACS patients. The rate of TLF and of all secondary endpoints was consistent with BP-SES or DP-ZES across ACS strata.

CONCLUSION

HBR patients with ACS are at higher risk of cardiac death than those without ACS and experience a consistent outcome with BP-SES or DP-ZES followed by 1 month DAPT at 1 year follow-up.

CLINICAL TRIAL REGISTRATION

NCT04137510.

MeSH

Stents, Hemorrhage, Polymers, Cardiovascular Diseases, Sirolimus, Acute Coronary Syndrome