Efficacy and Safety of 3 Versus 6 Months of Dual-Antiplatelet Therapy in Patients Implanted With a Coroflex ISAR Stents: A Prospective, Multicenter, Randomized Clinical Trial.
J Invasive Cardiol
; 34(9): E653-E659, 2022 09.
Article
de En
| MEDLINE
| ID: mdl-35863061
ABSTRACT
BACKGROUND:
The optimal duration of dual-antiplatelet therapy (DAPT) after implantation of a drug-eluting stent (DES), especially recently developed polymer-free DESs, is unknown. This study examined the efficacy and safety of 3- versus 6-month DAPT in patients implanted with Coroflex ISAR polymer-free DESs.METHODS:
Between May 2015 and August 2020, 488 patients who underwent Coroflex ISAR stent implantation were enrolled in the study and randomly assigned to the 3-month (n=244) or 6-month (n=244) DAPT group.RESULTS:
At 1 year, the primary endpoint (composite of cardiovascular death, myocardial infarction, target vessel revascularization, and Bleeding Academic Research Consortium [BARC] type 2-5 bleeding) occurred in 9 (3.7%) patients in the 3-month DAPT group and in 7 (2.9%) patients in the 6-month DAPT group (hazard ratio 1.31; P=.60). There was no difference between the 3- and 6-month DAPT groups in either BARC type 2-5 bleeding (1.6% vs 0.8%; hazard ratio 2.00; P=.42) or any bleeding (2.9% vs 3.3%; hazard ratio 0.87; P=.80).CONCLUSION:
Compared with 6 months of DAPT, 3 months of DAPT did not increase the risk of primary endpoint 1 year after Coroflex ISAR stent implantation, although it should be noted that the trial has limited power to see differences due to low event rate and low recruitment rate.Mots clés
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Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Endoprothèses à élution de substances
/
Intervention coronarienne percutanée
/
Infarctus du myocarde
Type d'étude:
Clinical_trials
/
Observational_studies
/
Risk_factors_studies
Limites:
Humans
Langue:
En
Journal:
J Invasive Cardiol
Sujet du journal:
CARDIOLOGIA
Année:
2022
Type de document:
Article