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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-month DAPT | Active Comparator | 1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists and clopidogrel monotherapy for 59 months |
|
| 12-month DAPT | Active Comparator | 1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists; 11-month DAPT composed of aspirin and clopidogrel and aspirin monotherapy for 48 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1-months DAPT | Drug | 1-month DAPT followed by 59-month monotherapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke | 12 months | |
| Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke | 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takeshi Kimura, MD | Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyoto University Graduate School of Medicine | Kyoto | 606-8507 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41847750 | Derived | Watanabe H, Morimoto T, Natsuaki M, Yamamoto K, Obayashi Y, Nishikawa R, Kimura T, Imada K, Suwa S, Isawa T, Ando K, Fujita T, Kadota K, Tokuyama H, Sakamoto H, Suzuki H, Wakabayashi K, Ono K, Hayashi F, Tanabe K, Akao M, Onishi Y, Yoshida R, Kusuyama T, Tamura T, Onoue Y, Yagi M, Kaitani K, Kimura T; STOPDAPT-2 ACS investigators. Clopidogrel Versus Aspirin Monotherapy Beyond 1 Year After PCI: The Final 5-Year Results of the STOPDAPT-2 ACS and STOPDAPT-2 Total Cohort. Circ Cardiovasc Interv. 2026 Jun;19(6):e016280. doi: 10.1161/CIRCINTERVENTIONS.125.016280. Epub 2026 Mar 18. | |
| 36873770 |
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| 12-month DAPT |
| Drug |
12-month DAPT followed by 48-month monotherapy |
|
| Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group | 12 months |
| Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group | 60 months |
| Upper gastrointestinal endoscopic examination or treatment | 60 months |
| Composite event of all-cause death/myocardial infarction | 12 months |
| Composite event of all-cause death/myocardial infarction | 60 months |
| All-cause death | 12 months |
| All-cause death | 60 months |
| Composite event of cardiovascular death/myocardial infarction | 12 months |
| Composite event of cardiovascular death/myocardial infarction | 60 months |
| Cardiovascular death | 12 months |
| Cardiovascular death | 60 months |
| Myocardial infarction | 12 months |
| Myocardial infarction | 60 months |
| Stroke | 12 months |
| Stroke | 60 months |
| Definite stent thrombosis | Academic Research Consortium definition | 12 months |
| Definite stent thrombosis | Academic Research Consortium definition | 60 months |
| Target lesion failure | 12 months |
| Target lesion failure | 60 months |
| Target vessel failure | 12 months |
| Target vessel failure | 60 months |
| Major adverse cardiac event | Composite of cardiac death, myocardial infarction, and clinically-driven TLR | 12 months |
| Major adverse cardiac event | Composite of cardiac death, myocardial infarction, and clinically-driven TLR | 60 months |
| Target lesion revascularization | 12 months |
| Target lesion revascularization | 60 months |
| Clinically-driven target lesion revascularization | 12 months |
| Clinically-driven target lesion revascularization | 60 months |
| Non target lesion revascularization | 12 months |
| Non target lesion revascularization | 60 months |
| Coronary artery bypass graft | 12 months |
| Coronary artery bypass graft | 60 months |
| Target vessel revascularization | 12 months |
| Target vessel revascularization | 60 months |
| Any coronary revascularization | 12 months |
| Any coronary revascularization | 60 months |
| Bleeding complications | 12 months |
| Bleeding complications | 60 months |
| Gastrointestinal bleeding | 12 months |
| Gastrointestinal bleeding | 60 months |
| Gastrointestinal complaints requiring upper gastrointestinal endoscopy | 12 months |
| Gastrointestinal complaints requiring upper gastrointestinal endoscopy | 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. | 60 months |
| Derived |
| Yamamoto K, Watanabe H, Morimoto T, Obayashi Y, Natsuaki M, Domei T, Yamaji K, Suwa S, Isawa T, Watanabe H, Yoshida R, Sakamoto H, Akao M, Hata Y, Morishima I, Tokuyama H, Yagi M, Suzuki H, Wakabayashi K, Suematsu N, Inada T, Tamura T, Okayama H, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Morino Y, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 and STOPDAPT-2 ACS Investigators. Clopidogrel Monotherapy After 1-Month DAPT in Patients With High Bleeding Risk or Complex PCI. JACC Asia. 2023 Jan 10;3(1):31-46. doi: 10.1016/j.jacasi.2022.09.011. eCollection 2023 Feb. |
| 36599584 | Derived | Yamamoto K, Watanabe H, Morimoto T, Obayashi Y, Natsuaki M, Yamaji K, Domei T, Ogita M, Ohya M, Tatsushima S, Suzuki H, Tada T, Ishii M, Nikaido A, Watanabe N, Fujii S, Mori H, Nishikura T, Suematsu N, Hayashi F, Komiyama K, Shigematsu T, Isawa T, Suwa S, Ando K, Kimura T; STOPDAPT-2 and STOPDAPT-2 ACS Investigators. Clopidogrel Monotherapy After 1-Month Dual Antiplatelet Therapy in Patients With Diabetes Undergoing Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2023 Jan 9;16(1):19-31. doi: 10.1016/j.jcin.2022.09.053. Epub 2022 Dec 14. |
| 35912647 | Derived | Obayashi Y, Watanabe H, Morimoto T, Yamamoto K, Natsuaki M, Domei T, Yamaji K, Suwa S, Isawa T, Watanabe H, Yoshida R, Sakamoto H, Akao M, Hata Y, Morishima I, Tokuyama H, Yagi M, Suzuki H, Wakabayashi K, Suematsu N, Inada T, Tamura T, Okayama H, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Morino Y, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 and STOPDAPT-2 ACS Investigators. Clopidogrel Monotherapy After 1-Month Dual Antiplatelet Therapy in Percutaneous Coronary Intervention: From the STOPDAPT-2 Total Cohort. Circ Cardiovasc Interv. 2022 Aug;15(8):e012004. doi: 10.1161/CIRCINTERVENTIONS.122.012004. Epub 2022 Aug 1. |
| 35234821 | Derived | Watanabe H, Morimoto T, Natsuaki M, Yamamoto K, Obayashi Y, Ogita M, Suwa S, Isawa T, Domei T, Yamaji K, Tatsushima S, Watanabe H, Ohya M, Tokuyama H, Tada T, Sakamoto H, Mori H, Suzuki H, Nishikura T, Wakabayashi K, Hibi K, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Morino Y, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 ACS Investigators. Comparison of Clopidogrel Monotherapy After 1 to 2 Months of Dual Antiplatelet Therapy With 12 Months of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome: The STOPDAPT-2 ACS Randomized Clinical Trial. JAMA Cardiol. 2022 Apr 1;7(4):407-417. doi: 10.1001/jamacardio.2021.5244. |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| C028145 | 2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine |
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