Safety and efficacy of 6-month versus 12-month dual antiplatelet therapy in patients after implantation of multiple biodegradable polymer-coated sirolimus-eluting coronary stents: Insight from the I-LOVE-IT 2 trial.
OBJECTIVE
This study sought to compare the clinical outcomes of 6-month versus 12-month dual antiplatelet therapy (DAPT) in patients receiving multiple biodegradable polymer-coated sirolimus-eluting stents (BP-SES) implants.


BACKGROUND
The clinical outcomes for patients who undergo multiple BP-SES implantation with different DAPT durations are uncertain.


METHODS
In the I-LOVE-IT 2 trial, 907 patients treated with multiple BP-SES (total stent number ≥2) were assigned to receive 6-month (n = 440) or 12-month (n = 467) DAPT. The primary endpoint was 12-month target lesion failure (TLF), which is a composite of cardiac death, target vessel myocardial infarction (MI) or clinically indicated target lesion revascularization. The major secondary endpoints were 12-month net adverse clinical events, a composite of all causes of death, MI, stroke, any revascularization and bleeding.


RESULTS
The number of stents per patient between the 6-month and 12-month DAPT group was similar (2.4 ± 0.7 vs. 2.4 ± 0.7, P = 0.47). The incidence of 12-month TLF was comparable in the 6-month and 12-month DAPT groups (9.3% vs.7.5%, Log-rank P = 0.33). However, landmark analysis showed that 12-month DAPT, compared to 6-month DAPT, was associated with a significantly lower risk of TLF (4.8% vs. 2.4%, Log-rank P = 0.049) at a cost of a slightly increased risk of all bleeding events (0.5% vs. 1.7%, Log-rank P = 0.07) between 6 and 12 months.


CONCLUSIONS
In patients treated with multiple BP-SES, 6- and 12-month DAPT had similar impacts on 12-month clinical outcomes. Additionally, 12-month DAPT might reduce TLF between 6 and 12 months at the cost of a slightly increased risk of all bleeding events. © 2017 Wiley Periodicals, Inc.
The Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China.|The Department of Cardiology, The First Clinical College, Liaoning University of Traditional Chinese Medicine, Shenyang, China.
Jing
J
Qi
The Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China.
Yi
Y
Li
The Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China.
Jing
J
Li
The Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China.
Quanmin
Q
Jing
The Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China.
Kai
K
Xu
The Department of Cardiology, Henan Provincial People's Hospital, Zhengzhou, China.
Chuanyu
C
Gao
The Department of Cardiology, Anhui Provincial Hospital, Hefei, China.
Likun
L
Ma
The Department of Cardiology, Third Affiliated Hospital of Liaoning Medical College, Jinzhou, China.
Zhi
Z
Zhang
Catheterization Laboratory, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Bo
B
Xu
The Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, China.
Yaling
Y
Han
D020341:Absorbable Implants; D054058:Acute Coronary Syndrome / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002681:China; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D011108:Polymers; D011446:Prospective Studies; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage* / Q000009:adverse effects; D020521:Stroke / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D010975:Platelet Aggregation Inhibitors; D011108:Polymers; D020123:Sirolimus
biodegradable polymer; dual antiplatelet therapy; multiple stent implantation