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


OBJECTIVE
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).
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.
Philippe
P
Garot
Hôpital Privé Jacques Cartier, Institut Cardiovasculaire Paris-sud Ramsay-Générale de Santé, Massy, France.
Marie-Claude
MC
Morice
Siriraj Hospital, Bangkok, Thailand.
Damras
D
Tresukosol
London School of Hygiene and Tropical Medicine, London, United Kingdom.
Stuart J
SJ
Pocock
MonashHeart and Monash University, Melbourne, Australia.
Ian T
IT
Meredith
Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil, and Hospital Albert Einstein, São Paulo, Brazil.
Alexandre
A
Abizaid
Cardiology Department, Toulouse Rangueil Hospital, Toulouse, France.
Didier
D
Carrié
Department of Medical Statistics, Contilia Heart and Vascular Centre, Elisabeth Krankenhaus, Essen, Germany.
Christoph
C
Naber
Cardiology Department, Complejo Hospitalario Universitario de Vigo, Hospital Meixoeiro, Meixoeiro, Spain.
Andres
A
Iñiguez
Dorset Heart Centre, Royal Bournemouth Hospital, Bournemouth, United Kingdom.
Suneel
S
Talwar
Department of Cardiology, Craigavon Cardiac Center, Portadown, United Kingdom.
Ian B A
IBA
Menown
Department of Cardiology, Aarhus University Hospital, Skejby, Denmark.
Evald H
EH
Christiansen
London School of Hygiene and Tropical Medicine, London, United Kingdom.
John
J
Gregson
Biosensors Europe, Morges, Switzerland.
Samuel
S
Copt
Hôpital Privé Jacques Cartier, Institut Cardiovasculaire Paris-sud Ramsay-Générale de Santé, Massy, France.
Thomas
T
Hovasse
Department of Internal Medicine/Cardiology, Universität Leipzig-Herzzentrum, Leipzig, Germany.
Philipp
P
Lurz
Service de Cardiologie, Groupement de Coopération Sanitaire Etablissements de Santé, Axium-Rambot, City, France.
Luc
L
Maillard
Department of Cardiology, Charité Campus Virchow Klinikum, Berlin, Germany.
Florian
F
Krackhardt
Tan Tock Seng Hospital, Singapore.
Paul
P
Ong
Department of Cardiology, King's College Hospital, London, United Kingdom.
Jonathan
J
Byrne
St. Thomas Hospital, London, United Kingdom.
Simon
S
Redwood
Cardiovascular European Research Center, Massy, France.
Ute
U
Windhövel
Biosensors Europe, Morges, Switzerland.
Samantha
S
Greene
Biosensors Europe, Morges, Switzerland.
Hans-Peter
HP
Stoll
Cardiovascular Department, Hôpital de la Tour, Geneva, Switzerland. Electronic address: philip.urban@latour.ch.
Philip
P
Urban
D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D003327:Coronary Disease / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000401:mortality / Q000517:prevention & control; D003643:Death; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality / Q000517:prevention & control; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects*; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012306:Risk; D020123:Sirolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D013223:Statistics as Topic; D015607:Stents / Q000009:adverse effects*; D015996:Survival Rate
D010975:Platelet Aggregation Inhibitors; C518022:umirolimus; D020123:Sirolimus
bare-metal stent; bleeding; drug-coated stent; dual antiplatelet therapy; thrombosis