Two-year outcomes of high bleeding risk patients after polymer-free drug-coated stents
J. Am. Coll. Cardiol
; 69(2): 162-171, 2017. graf, tab
Article
in English
| Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP
| ID: biblio-1063749
Responsible library:
BR79.1
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)...
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Collection:
National databases
/
Brazil
Database:
Sec. Est. Saúde SP
/
SESSP-IDPCPROD
Main subject:
Thrombosis
/
Stents
/
Drug-Eluting Stents
Type of study:
Controlled clinical trial
/
Etiology study
/
Risk factors
Language:
English
Journal:
J. Am. Coll. Cardiol
Year:
2017
Document type:
Article
Institution/Affiliation country:
Biosensors Europe/CH
/
Cardiology Department, Toulouse Rangueil Hospital/FR
/
Cardiovascular Department, Hôpital de la Tour/CH
/
Cardiovascular European Research Center/FR
/
Complejo Hospitalario Universitario de Vigo, Hospital Meixoeiro/ES
/
Contilia Heart and Vascular Centre, Elisabeth Krankenhaus/DE
/
Department of Cardiology, Aarhus University Hospital/DK
/
Department of Cardiology, Charité Campus Virchow Klinikum/DE
/
Department of Cardiology, Craigavon Cardiac Center/GB
/
Department of Cardiology, King's College Hospital/GB