Author + information
- Received February 6, 2017
- Revision received April 27, 2017
- Accepted May 18, 2017
- Published online August 21, 2017.
- Didier Carrié, MDa,∗ (, )
- Ian Menown, MDb,
- Keith Oldroyd, MDc,
- Samuel Copt, MDd,
- Suneel Talwar, MDe,
- Luc Maillard, MDf,
- Marie-Claude Morice, MDg,
- Lim Soo Teik, MDh,
- Irene Lang, MDi and
- Philip Urban, MDj
- aCentre Hospitalier Universitaire, Toulouse, France
- bCraigavon Cardiac Centre, Craigavon, United Kingdom
- cWest of Scotland Regional Heart and Lung Centre, Glasgow, United Kingdom
- dBiosensors Europe, Morges, Switzerland
- eDorset Heart Centre, Royal Bournemouth Hospital, Bournemouth, United Kingdom
- fCentre de Cardiologie Interventionnelle Axium-Rambot, Aix-en-Provence, France
- gHôpital Privé Jacques Cartier, Massy, France
- hNational Heart Centre, Singapore, Singapore
- iMedical University of Vienna, Vienna, Austria
- jHôpital La Tour, Meyrin, Switzerland
- ↵∗Address for correspondence:
Dr. Didier Carrié, Service de Cardiologie B, University Medical Center Rangueil, 1, Avenue Jean Poulhès, 31059 Toulouse cedex 9, France.
Objectives The aim of this study was to compare the performance of drug-coated stents (DCS) versus bare-metal stents (BMS) in patients who are candidates for long-term oral anticoagulation (OAC) after percutaneous coronary interventions.
Background The randomized controlled LEADERS FREE (A Randomized Clinical Evaluation of the BioFreedom™ Stent) trial demonstrated the superior safety and efficacy of a polymer-free biolimus A9 DCS compared with a similar BMS used with 1 month of dual antiplatelet therapy in 2,466 patients at high bleeding risk.
Methods The 2 stents were compared in a pre-specified analysis of the 879 LEADERS FREE patients (35.6%) scheduled to remain on OAC after percutaneous coronary intervention. The primary safety endpoint was a composite of cardiac death, myocardial infarction, and stent thrombosis. The primary efficacy endpoint was the incidence of clinically driven target lesion revascularization.
Results Baseline characteristics of 448 DCS and 431 BMS recipients were similar, 78.8% had histories of atrial fibrillation, and 21% presented with acute coronary syndromes. Four hundred patients in the DCS group and 376 in the BMS group were discharged on OAC after percutaneous coronary intervention. At 2 years, for the DCS and BMS recipients, respectively, the incidence of clinically driven target lesion revascularization was 7.5% versus 11.2% (hazard ratio: 0.63; 95% confidence interval: 0.40 to 1.01; p = 0.0514), the safety endpoint was reached by 14.4% and 15.0% (p = NS), and the rates of major bleeding events (Bleeding Academic Research Consortium 3 to 5) were 10.7% and 12.9% (p = NS).
Conclusions The efficacy advantage of DCS over BMS up to 2 years appears confirmed in patients on long-term OAC. Despite the very short course of dual antiplatelet therapy, both the DCS and BMS groups experienced similarly high rates of major bleeding. (A Randomized Clinical Evaluation of the BioFreedom™ Stent [Leaders Free]; NCT01623180)
- antiplatelet therapy
- antithrombotic therapy
- bare-metal coronary stent(s)
- chronic anticoagulation
- drug-coated coronary stent(s)
- percutaneous coronary intervention
The LEADERS FREE trial was funded by Biosensors Europe. Dr. Copt is a full-time employee of Biosensors. Dr. Urban is a paid consultant to Biosensors. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received February 6, 2017.
- Revision received April 27, 2017.
- Accepted May 18, 2017.
- 2017 American College of Cardiology Foundation