Format

Send to

Choose Destination
J Am Coll Cardiol. 2017 Jan 17;69(2):162-171. doi: 10.1016/j.jacc.2016.10.009. Epub 2016 Oct 30.

2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents.

Author information

1
Hôpital Claude Galien, Institut Cardiovasculaire Paris-sud Ramsay-Générale de Santé, Quincy Sous-Sénart, France; Hôpital Privé Jacques Cartier, Institut Cardiovasculaire Paris-sud Ramsay-Générale de Santé, Massy, France.
2
Hôpital Privé Jacques Cartier, Institut Cardiovasculaire Paris-sud Ramsay-Générale de Santé, Massy, France.
3
Siriraj Hospital, Bangkok, Thailand.
4
London School of Hygiene and Tropical Medicine, London, United Kingdom.
5
MonashHeart and Monash University, Melbourne, Australia.
6
Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil, and Hospital Albert Einstein, São Paulo, Brazil.
7
Cardiology Department, Toulouse Rangueil Hospital, Toulouse, France.
8
Department of Medical Statistics, Contilia Heart and Vascular Centre, Elisabeth Krankenhaus, Essen, Germany.
9
Cardiology Department, Complejo Hospitalario Universitario de Vigo, Hospital Meixoeiro, Meixoeiro, Spain.
10
Dorset Heart Centre, Royal Bournemouth Hospital, Bournemouth, United Kingdom.
11
Department of Cardiology, Craigavon Cardiac Center, Portadown, United Kingdom.
12
Department of Cardiology, Aarhus University Hospital, Skejby, Denmark.
13
Biosensors Europe, Morges, Switzerland.
14
Department of Internal Medicine/Cardiology, Universität Leipzig-Herzzentrum, Leipzig, Germany.
15
Service de Cardiologie, Groupement de Coopération Sanitaire Etablissements de Santé, Axium-Rambot, City, France.
16
Department of Cardiology, Charité Campus Virchow Klinikum, Berlin, Germany.
17
Tan Tock Seng Hospital, Singapore.
18
Department of Cardiology, King's College Hospital, London, United Kingdom.
19
St. Thomas Hospital, London, United Kingdom.
20
Cardiovascular European Research Center, Massy, France.
21
Cardiovascular Department, Hôpital de la Tour, Geneva, Switzerland. Electronic address: philip.urban@latour.ch.

Abstract

BACKGROUND:

A 1-year follow-up, polymer-free metallic stent coated with biolimus-A9 followed by 1-month dual antiplatelet therapy is safer and more effective than a bare-metal stent (BMS) for patients with high risk of bleeding.

OBJECTIVES:

This study analyzed 2-year outcomes to determine whether these benefits are maintained.

METHODS:

In a prospective, multicenter, double-blind trial, we randomized 2,466 high bleeding risk patients to receive a drug-coated stent (DCS) or a BMS followed by 1-month dual antiplatelet therapy. The primary safety endpoint was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy endpoint was clinically driven target lesion revascularization.

RESULTS:

At 2 years, the primary safety endpoint had occurred in 147 DCS and 180 BMS patients (15.3%) (hazard ratio: 0.80; 95% confidence interval: 0.64 to 0.99; p = 0.039). Clinically driven target lesion revascularization occurred for 77 DCS and 136 BMS patients (12.0%) (hazard ratio: 0.54; 95% confidence interval: 0.41 to 0.72; p < 0.0001). Major bleeding occurred in 8.9% of DCS and 9.2% of BMS patients (p = 0.95), and a coronary thrombotic event (myocardial infarction and/or stent thrombosis) occurred in 8.2% of DCS and 10.6% of BMS patients (p = 0.045). One-year mortality was 27.1% for a major bleed and 26.3% for a thrombotic event. At 2 years, multivariate correlates of major bleeding were age >75 years, anemia, raised plasma creatinine, and planned long-term anticoagulation. Correlates of the primary safety endpoint were age, anemia, congestive heart failure, multivessel disease, number of stents implanted, and use of a BMS rather than a DCS.

CONCLUSIONS:

Safety and efficacy benefits of DCS over BMS were maintained for 2 years in high bleeding risk patients. Rates of major bleeding and coronary thrombotic events were no different and were associated with a substantial and comparable mortality risk. (A Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug Coated Stent Versus the Gazelle Bare Metal Stent in Patients With High Risk of Bleeding [LEADERS FREE]; NCT01623180).

KEYWORDS:

bare-metal stent; bleeding; drug-coated stent; dual antiplatelet therapy; thrombosis

PMID:
27806919
DOI:
10.1016/j.jacc.2016.10.009
[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center