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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.

Authors :
Jin U
Seo KW
Yang HM
Lim HS
Choi BJ
Choi SY
Shin JH
Tahk SJ
Yoo SY
Rha SW
Chung WY
Kim CH
Won KB
Pyun WB
Jang JS
Lee SY
Hong YJ
Kim MH
Hong SJ
Choi YS
Kim HY
Choi RK
Kang WC
Cho EJ
Yoon MH
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.

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