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).
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. However, serious hemorrhagic complications associated with a 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 therefore planned 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. 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. At first, 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3,045
1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists
12-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists
Division of Cardiology, Kyoto University Hospital
Kyoto, Japan
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding
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-month
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke
Time frame: 12-month
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke
Time frame: 60-month
Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
Time frame: 12-month
Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group
Time frame: 60-month
Upper gastrointestinal endoscopic examination or treatment
Time frame: 60-month
Composite event of all-cause death/myocardial infarction
Time frame: 12-month
Composite event of all-cause death/myocardial infarction
Time frame: 60-month
All-cause death
Time frame: 12-month
All-cause death
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Time frame: 60-month
Composite event of cardiovascular death/myocardial infarction
Time frame: 12-month
Composite event of cardiovascular death/myocardial infarction
Time frame: 60-month
Cardiovascular death
Time frame: 12-month
Cardiovascular death
Time frame: 60-month
Myocardial infarction
Time frame: 12-month
Myocardial infarction
Time frame: 60-month
Stroke
a neurological deficit with acute onset that persists for at least 24 hours caused by a disturbance of the cerebral circulation due to ischemia or hemorrhage
Time frame: 12-month
Stroke
a neurological deficit with acute onset that persists for at least 24 hours caused by a disturbance of the cerebral circulation due to ischemia or hemorrhage
Time frame: 60-month
MACE (Major Adverse Cardiac Events)
Composite event of cardiac death, myocardial infarction and clinically-indicated target vesion revascularization
Time frame: 12-month
MACE (Major Adverse Cardiac Events)
Composite event of cardiac death, myocardial infarction and clinically-indicated target vesion revascularization
Time frame: 60-month
Definite stent thrombosis
Time frame: 12-month
Definite stent thrombosis
Time frame: 60-month
Target lesion failure
Composite event of cardiac death, myocardial infarction (MI) of target vessels, and Clinically-indicated TLR
Time frame: 12-month
Target lesion failure
Composite event of cardiac death, myocardial infarction (MI) of target vessels, and Clinically-indicated TLR
Time frame: 60-month
Target vessel failure
Time frame: 12-month
Target vessel failure
Time frame: 60-month
Target lesion revasucularization
PCI performed in the target lesion (within 5 mm of the stent edges), or CABG performed for restenosis of the target lesion or for treatment of other complications
Time frame: 12-month
Target lesion revasucularization
PCI performed in the target lesion (within 5 mm of the stent edges), or CABG performed for restenosis of the target lesion or for treatment of other complications
Time frame: 60-month
Clinically-driven target lesion revascularization
the revascularization that meets the following criteria; (1) recurrence of angina pectoris, presumably related to the target vessel, (2) objective signs of ischemia at rest or during exercise test (or equivalent), presumably related to the target vessel, (3) Signs of functional ischemia revealed by any invasive diagnostic test (e.g., Doppler flow velocity reserve \[FVR\], fractional flow reserve \[FFR\]), and (4) revascularization for ≥ 70% diameter stenosis even in the absence of the above-mentioned ischemic signs or symptoms. Presence/absence of clinical findings is judged by the operator of the procedure before the revascularization.
Time frame: 12-month
Clinically-driven target lesion revascularization
the revascularization that meets the following criteria; (1) recurrence of angina pectoris, presumably related to the target vessel, (2) objective signs of ischemia at rest or during exercise test (or equivalent), presumably related to the target vessel, (3) Signs of functional ischemia revealed by any invasive diagnostic test (e.g., Doppler flow velocity reserve \[FVR\], fractional flow reserve \[FFR\]), and (4) revascularization for ≥ 70% diameter stenosis even in the absence of the above-mentioned ischemic signs or symptoms. Presence/absence of clinical findings is judged by the operator of the procedure before the revascularization.
Time frame: 60-month
Non target lesion revascularization
Time frame: 12-month
Non target lesion revascularization
Time frame: 60-month
Coronary artery bypass graft
Time frame: 12-month
Coronary artery bypass graft
Time frame: 60-month
Target vessel revascularization
Time frame: 12-month
Target vessel revascularization
Time frame: 60-month
Any coronary reascluarization
Time frame: 12-month
Any coronary reascluarization
Time frame: 60-month
Bleeding complications
Evaluated with TIMI (major/minor/minimal), GUSTO (severe/moderate) and BARC (Type 1, 2, 3a, 3b, 3c, 4, 5a, 5b)
Time frame: 12-month
Bleeding complications
Evaluated with TIMI (major/minor/minimal), GUSTO (severe/moderate) and BARC (Type 1, 2, 3a, 3b, 3c, 4, 5a, 5b)
Time frame: 60-month
Gastrointestinal bleeding
Bleeding events requiring upper gastrointestinal endoscopic study or treatment.
Time frame: 12-month
Gastrointestinal bleeding
Bleeding events requiring upper gastrointestinal endoscopic study or treatment.
Time frame: 60-month
Gastrointestinal complaints
Symptoms requiring upper gastrointestinal endoscopic study or treatment
Time frame: 12-month
Gastrointestinal complaints
Symptoms requiring upper gastrointestinal endoscopic study or treatment
Time frame: 60-month
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-month