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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.
- Source :
-
The Journal of invasive cardiology [J Invasive Cardiol] 2022 Sep; Vol. 34 (9), pp. E653-E659. Date of Electronic Publication: 2022 Jul 22. - Publication Year :
- 2022
-
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.<br />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.<br />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).<br />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.
- Subjects :
- Drug Therapy, Combination
Hemorrhage chemically induced
Hemorrhage epidemiology
Humans
Platelet Aggregation Inhibitors adverse effects
Prospective Studies
Treatment Outcome
Drug-Eluting Stents adverse effects
Myocardial Infarction epidemiology
Percutaneous Coronary Intervention adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1557-2501
- Volume :
- 34
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- The Journal of invasive cardiology
- Publication Type :
- Academic Journal
- Accession number :
- 35863061
- Full Text :
- https://doi.org/10.25270/jic/21.00330