The purpose of this study is to evaluate the safety of reducing dual antiplatelet therapy (DAPT) duration to 1 month after implantation of the everolimus-eluting cobalt-chromium stent (CoCr-EES) under the setting of acute coronary syndrome (ACS).
The drug-eluting stents (DESs) are currently used in the majority of percutaneous coronary intervention (PCI) procedures. On the other hand, the problems of the first-generation DES (late adverse events, such as very late stent thrombosis) have been pointed out. Dual antiplatelet therapy (DAPT) has become a standard regimen after DES implantation and for fear of very late stent thrombosis, DAPT is frequently performed for 1 year or longer in clinical practice. Especially guidelines recommend 1-year DAPT for patients with acute coronary syndrome (ACS), though its rational is based on the study more than 15 years old. However, serious hemorrhagic complications associated with prolonged DAPT duration can bring disadvantages to patients, and it is extremely important to clarify an optimal DAPT duration after DES procedure. Currently, 1-month DAPT regimen after bare metal stent (BMS) implantation is commonly used in clinical practice, producing no major problems. Based on a meta-analysis of recent clinical studies, it has also been reported that the use of Cobalt-Chromium Everolimus-Eluting Stent (CoCr-EES) reduces the risk of early stent thrombosis by half compared to the use of BMS. There is no necessity to extend antiplatelet therapy after CoCr-EES implantation longer than after BMS implantation, and it is considered possible to use the same 1-month DAPT duration as after BMS implantation. The investigators already planned and started a multicenter, randomized, open-label, controlled study, in which the subjects who have undergone CoCr-EES procedure will be divided into the 1-month DAPT and clopidogrel monotherapy group and the 12-month DAPT and aspirin monotherapy group (STOPDAPT-2; NCT02619760), where primary endpoint is the incidence of composite events including cardiovascular death, myocardial infarction, stent thrombosis, stroke, and bleeding defined by TIMI major or minor bleeding. In STOPDAPT-2, the non-inferiority about primary endpoint of 1-month DAPT group will be evaluated at 12 months after index procedure and secondarily, the superiority about primary endpoint of 1-month DAPT group will be evaluated at 5 years after index procedure. The proportion of patients with ACS is about 30-40% in STOPDAPT-2 and the power is insufficient to evaluate the safety and efficacy of 1-month DAPT regimen specifically for patients with ACS. Therefore the investigators planned the current study to enroll patients of ACS with the same protocol as STOPDAPT-2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
3,008
1-month DAPT followed by 59-month monotherapy
12-month DAPT followed by 48-month monotherapy
Kyoto University Graduate School of Medicine
Kyoto, Japan
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
Time frame: 12 months
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
Time frame: 60 months
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke
Time frame: 12 months
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke
Time frame: 60 months
Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
Time frame: 12 months
Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
Time frame: 60 months
Upper gastrointestinal endoscopic examination or treatment
Time frame: 60 months
Composite event of all-cause death/myocardial infarction
Time frame: 12 months
Composite event of all-cause death/myocardial infarction
Time frame: 60 months
All-cause death
Time frame: 12 months
All-cause death
Time frame: 60 months
Composite event of cardiovascular death/myocardial infarction
Time frame: 12 months
Composite event of cardiovascular death/myocardial infarction
Time frame: 60 months
Cardiovascular death
Time frame: 12 months
Cardiovascular death
Time frame: 60 months
Myocardial infarction
Time frame: 12 months
Myocardial infarction
Time frame: 60 months
Stroke
Time frame: 12 months
Stroke
Time frame: 60 months
Definite stent thrombosis
Academic Research Consortium definition
Time frame: 12 months
Definite stent thrombosis
Academic Research Consortium definition
Time frame: 60 months
Target lesion failure
Time frame: 12 months
Target lesion failure
Time frame: 60 months
Target vessel failure
Time frame: 12 months
Target vessel failure
Time frame: 60 months
Major adverse cardiac event
Composite of cardiac death, myocardial infarction, and clinically-driven TLR
Time frame: 12 months
Major adverse cardiac event
Composite of cardiac death, myocardial infarction, and clinically-driven TLR
Time frame: 60 months
Target lesion revascularization
Time frame: 12 months
Target lesion revascularization
Time frame: 60 months
Clinically-driven target lesion revascularization
Time frame: 12 months
Clinically-driven target lesion revascularization
Time frame: 60 months
Non target lesion revascularization
Time frame: 12 months
Non target lesion revascularization
Time frame: 60 months
Coronary artery bypass graft
Time frame: 12 months
Coronary artery bypass graft
Time frame: 60 months
Target vessel revascularization
Time frame: 12 months
Target vessel revascularization
Time frame: 60 months
Any coronary revascularization
Time frame: 12 months
Any coronary revascularization
Time frame: 60 months
Bleeding complications
Time frame: 12 months
Bleeding complications
Time frame: 60 months
Gastrointestinal bleeding
Time frame: 12 months
Gastrointestinal bleeding
Time frame: 60 months
Gastrointestinal complaints requiring upper gastrointestinal endoscopy
Time frame: 12 months
Gastrointestinal complaints requiring upper gastrointestinal endoscopy
Time frame: 60 months
Newly diagnosed cancer
The endpoint is a newly diagnosed malignancy during the follow-up period that has not been previously diagnosed before enrollment. This does not include recurrent tumor after remission, includes early-stage cancer eligible for endoscopic treatment, and includes the tumors which are not diagnosed by tissue biopsy but are judged to be clinically malignant on imaging.
Time frame: 60 months
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