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

IVUS-XPL Investigators

Research output: Contribution to journalArticle

52 Citations (Scopus)

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)

Original languageEnglish
Pages (from-to)1438-1446
Number of pages9
JournalJACC: Cardiovascular Interventions
Volume9
Issue number14
DOIs
Publication statusPublished - 2016 Jul 1

Fingerprint

Randomized Controlled Trials
Stents
Group Psychotherapy
Myocardial Infarction
Therapeutics
Stroke
Hemorrhage
Acute Coronary Syndrome
Korea
Diabetes Mellitus
Thrombosis
Everolimus

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

@article{955d4bdcd32f415cb2dd12a222b3e091,
title = "6-Month Versus 12-Month Dual-Antiplatelet Therapy Following Long Everolimus-Eluting Stent Implantation: The IVUS-XPL Randomized Clinical Trial",
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)",
author = "{IVUS-XPL Investigators} and Hong, {Sung Jin} and Shin, {Dong Ho} and Kim, {Jung Sun} and Kim, {Byeong Keuk} and Ko, {Young Guk} and Donghoon Choi and Her, {Ae Young} and Kim, {Yong Hoon} and Yangsoo Jang and Hong, {Myeong Ki}",
year = "2016",
month = "7",
day = "1",
doi = "10.1016/j.jcin.2016.04.036",
language = "English",
volume = "9",
pages = "1438--1446",
journal = "JACC: Cardiovascular Interventions",
issn = "1936-8798",
publisher = "Elsevier Inc.",
number = "14",

}

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

In: JACC: Cardiovascular Interventions, Vol. 9, No. 14, 01.07.2016, p. 1438-1446.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 6-Month Versus 12-Month Dual-Antiplatelet Therapy Following Long Everolimus-Eluting Stent Implantation

T2 - The IVUS-XPL Randomized Clinical Trial

AU - IVUS-XPL Investigators

AU - Hong, Sung Jin

AU - Shin, Dong Ho

AU - Kim, Jung Sun

AU - Kim, Byeong Keuk

AU - Ko, Young Guk

AU - Choi, Donghoon

AU - Her, Ae Young

AU - Kim, Yong Hoon

AU - Jang, Yangsoo

AU - Hong, Myeong Ki

PY - 2016/7/1

Y1 - 2016/7/1

N2 - 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)

AB - 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)

UR - http://www.scopus.com/inward/record.url?scp=84971222740&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84971222740&partnerID=8YFLogxK

U2 - 10.1016/j.jcin.2016.04.036

DO - 10.1016/j.jcin.2016.04.036

M3 - Article

C2 - 27212028

AN - SCOPUS:84971222740

VL - 9

SP - 1438

EP - 1446

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

SN - 1936-8798

IS - 14

ER -