One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients
Circ., cariovasc. interv. (Print)
; 13(11): 222-232, Nov. 2020. tab, graf
Article
en En
| CONASS, SES-SP, SESSP-IDPCPROD, SES-SP
| ID: biblio-1150552
Biblioteca responsable:
BR79.1
Ubicación: BR79.1
ABSTRACT
BACKGROUND:
Despite treatment guidance endorsing shortened dual antiplatelet therapy (DAPT) duration in high bleeding risk (HBR) patients after drug-eluting stents, limited evidence exists to support these recommendations. The present study was designed to examine the safety and effectiveness of 1-month DAPT duration following percutaneous coronary intervention with zotarolimus-eluting stents in HBR patients.METHODS:
Onyx ONE Clear was a prospective, multicenter, nonrandomized study evaluating the safety and effectiveness of 1-month DAPT followed by single antiplatelet therapy in HBR patients undergoing percutaneous coronary intervention with Resolute Onyx drug-eluting stents. The primary analysis of cardiac death or myocardial infarction between 1 month and 1 year was performed in the prespecified one-month clear population of patients pooled from the Onyx ONE US/Japan study and Onyx ONE randomized controlled trial. One-month clear was defined as DAPT adherence and without major adverse events during the first month following percutaneous coronary intervention.RESULTS:
Among patients enrolled in Onyx ONE US/Japan (n=752) and Onyx ONE randomized controlled trial (n=1018), 1506 patients fulfilled one-month clear criteria. Mean HBR characteristics per patient was 1.6 with 44.7% having multiple risks. By 2 months and 1 year, respectively, 96.9% and 89.3% of patients were taking single antiplatelet therapy. Between 1 month and 1 year, the rate of the primary end point was 7.0%. The 1-sided upper 97.5% CI was 8.4%, less than the performance goal of 9.7% (P<0.001).CONCLUSIONS:
Among HBR patients who were event free before DAPT discontinuation at 1 month, favorable safety and effectiveness through 1 year support treatment with Resolute Onyx drug-eluting stents as part of an individualized strategy for shortened DAPT duration following percutaneous coronary intervention.
Texto completo:
1
Banco de datos:
CONASS
/
SES-SP
/
SESSP-IDPCPROD
Asunto principal:
Stents Liberadores de Fármacos
Tipo de estudio:
Clinical_trials
/
Etiology_studies
/
Guideline
/
Risk_factors_studies
Idioma:
En
Revista:
Circ Cardiovasc Interv
/
Circ., cariovasc. interv. (Print)
/
Circulation. cardiovascular interventions (Online)
/
Circulation. cardiovascular interventions (Print)
Año:
2020
Tipo del documento:
Article