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6-Month Versus 12-Month Dual-Antiplatelet Therapy Following Long Everolimus-Eluting Stent Implantation: The IVUS-XPL Randomized Clinical Trial.

Authors
 Sung-Jin Hong  ;  Dong-Ho Shin  ;  Jung-Sun Kim  ;  Byeong-Keuk Kim  ;  Young-Guk Ko  ;  Donghoon Choi  ;  Ae-Young Her  ;  Yong Hoon Kim  ;  Yangsoo Jang  ;  Myeong-Ki Hong  ;  the IVUS-XPL Investigators 
Citation
 JACC-CARDIOVASCULAR INTERVENTIONS, Vol.9(14) : 1438-1446, 2016 
Journal Title
JACC-CARDIOVASCULAR INTERVENTIONS
ISSN
 1936-8798 
Issue Date
2016
MeSH
Aspirin/administration & dosage* ; Aspirin/adverse effects ; Cardiovascular Agents/administration & dosage* ; Cardiovascular Agents/adverse effects ; Coronary Thrombosis/etiology ; Drug Administration Schedule ; Drug Therapy, Combination ; Drug-Eluting Stents* ; Everolimus/administration & dosage* ; Everolimus/adverse effects ; Hemorrhage/chemically induced ; Humans ; Intention to Treat Analysis ; Myocardial Infarction/etiology ; Percutaneous Coronary Intervention/adverse effects ; Percutaneous Coronary Intervention/instrumentation* ; Percutaneous Coronary Intervention/mortality ; Platelet Aggregation Inhibitors/administration & dosage* ; Platelet Aggregation Inhibitors/adverse effects ; Prosthesis Design ; Republic of Korea ; Risk Factors ; Stroke/etiology ; Ticlopidine/administration & dosage ; Ticlopidine/adverse effects ; Ticlopidine/analogs & derivatives* ; Time Factors ; Treatment Outcome
Keywords
coronary artery disease ; drug-eluting stent(s) ; dual-antiplatelet therapy
Abstract
OBJECTIVES: The aim of this study was to investigate whether a 6-month dual-antiplatelet therapy (DAPT) duration was comparable with a 12-month duration in patients who underwent everolimus-eluting stent implantation.
BACKGROUND: Well-designed studies that determine optimal DAPT strategies after everolimus-eluting stent implantation are limited.
METHODS: A total of 1,400 patients (implanted mean total stent length >45 mm) were randomly assigned to receive 6-month (n = 699) or 12-month (n = 701) DAPT between October 2010 and July 2014 at 20 centers in Korea. The primary endpoint was the composite of cardiac death, myocardial infarction, stroke, or TIMI (Thrombolysis in Myocardial Infarction) major bleeding at 1 year, analyzed using an intention-to-treat approach.
RESULTS: The primary endpoint occurred in 15 patients (2.2%) in the 6-month DAPT group and 14 patients (2.1%) in the 12-month DAPT group (hazard ratio [HR]: 1.07; p = 0.854). Definite or probable stent thrombosis occurred in 2 patients (0.3%) in the 6-month DAPT group and in 2 patients (0.3%) in the 12-month DAPT group (HR: 1.00; p = 0.999). There were no significant between-group differences in the primary endpoint in 686 patients with acute coronary syndrome (2.4% in both groups; HR: 1.00; p = 0.994) and in 506 patients with diabetes mellitus (2.2% [6-month] vs. 3.3% [12-month]; HR: 0.64; p = 0.428).
CONCLUSIONS: Compared with 12-month DAPT, 6-month DAPT did not increase the composite events of cardiac death, myocardial infarction, stroke, or TIMI major bleeding at 1 year in patients who underwent everolimus-eluting stent implantation. (Impact of Intravascular Ultrasound Guidance on Outcomes of XIENCE PRIME Stents in Long Lesions [IVUS-XPL Study]; NCT01308281).
Full Text
http://www.sciencedirect.com/science/article/pii/S1936879816304897
DOI
10.1016/j.jcin.2016.04.036
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Ko, Young Guk(고영국) ORCID logo https://orcid.org/0000-0001-7748-5788
Kim, Byeong Keuk(김병극) ORCID logo https://orcid.org/0000-0003-2493-066X
Kim, Jung Sun(김중선) ORCID logo https://orcid.org/0000-0003-2263-3274
Shin, Dong Ho(신동호) ORCID logo https://orcid.org/0000-0002-7874-5542
Jang, Yang Soo(장양수) ORCID logo https://orcid.org/0000-0002-2169-3112
Choi, Dong Hoon(최동훈) ORCID logo https://orcid.org/0000-0002-2009-9760
Hong, Myeong Ki(홍명기) ORCID logo https://orcid.org/0000-0002-2090-2031
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/147133
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