ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study

Conditions

Coronary Artery Disease

Keywords

Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors

Brief summary

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).

Detailed description

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.

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.

2026-03-18

10.1161/circinterventions.125.016280

Clopidogrel Monotherapy After 1-Month DAPT in Patients With High Bleeding Risk or Complex PCI

Ko Yamamoto, Hirotoshi Watanabe, Takeshi Morimoto, Yuki Obayashi, Masahiro Natsuaki et al. (34 authors)

JACC Asia2023-01-1015 citations

10.1016/j.jacasi.2022.09.011

Clopidogrel Monotherapy After 1-Month Dual Antiplatelet Therapy in Patients With Diabetes Undergoing Percutaneous Coronary Intervention.

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.

2022-12-1411 citations

10.1016/j.jcin.2022.09.053

Clopidogrel Monotherapy After 1-Month Dual Antiplatelet Therapy in Percutaneous Coronary Intervention: From the STOPDAPT-2 Total Cohort

Yuki Obayashi, Hirotoshi Watanabe, Takeshi Morimoto, Ko Yamamoto, Masahiro Natsuaki et al. (35 authors)

Circulation Cardiovascular Interventions2022-08-0128 citations

10.1161/circinterventions.122.012004

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

Hirotoshi Watanabe, Takeshi Morimoto, Masahiro Natsuaki, Ko Yamamoto, Yuki Obayashi et al. (100 authors)

JAMA Cardiology2022-03-02274 citations

10.1001/jamacardio.2021.5244

Very Short Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Patients Who Underwent Complex Percutaneous Coronary Intervention: Insight From the STOPDAPT-2 Trial

Ko Yamamoto, Hirotoshi Watanabe, Takeshi Morimoto, Takenori Domei, Masanobu Ohya et al. (30 authors)

Circulation Cardiovascular Interventions2021-05-0130 citations

10.1161/circinterventions.120.010384

Influence of CYP2C19 genotypes for the effect of 1-month dual antiplatelet therapy followed by clopidogrel monotherapy relative to 12-month dual antiplatelet therapy on clinical outcomes after percutaneous coronary intervention: a genetic substudy from the STOPDAPT-2.

Watanabe H, Morimoto T, Ogita M, Suwa S, Natsuaki M, Suematsu N, Koeda Y, Morino Y, Nikaido A, Hata Y, Doi M, Hibi K, Kimura K, Yoda S, Kaneko T, Nishida K, Kawai K, Yamaguchi K, Wakatsuki T, Tonoike N, Yamamoto M, Shimizu S, Shimohama T, Ako J, Kimura T, STOPDAPT-2 Investigators.

2020-11-128 citations

10.1007/s12928-020-00719-6

Details on the effect of very short dual antiplatelet therapy after drug-eluting stent implantation in patients with high bleeding risk: insight from the STOPDAPT-2 trial.

Watanabe H, Domei T, Morimoto T, Natsuaki M, Shiomi H, Toyota T, Ohya M, Suwa S, Takagi K, Nanasato M, Hata Y, Yagi M, Suematsu N, Yokomatsu T, Takamisawa I, Doi M, Noda T, Okayama H, Seino Y, Tada T, Sakamoto H, Hibi K, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Hanaoka KI, Morino Y, Kozuma K, Kadota K, Furukawa Y, Nakagawa Y, Kimura T, STOPDAPT-2 investigators.

2020-02-2141 citations

10.1007/s12928-020-00651-9

Effect of 1-Month Dual Antiplatelet Therapy Followed by Clopidogrel vs 12-Month Dual Antiplatelet Therapy on Cardiovascular and Bleeding Events in Patients Receiving PCI

Hirotoshi Watanabe, Takenori Domei, Takeshi Morimoto, Masahiro Natsuaki, Hiroki Shiomi et al. (36 authors)

JAMA2019-06-25800 citations

10.1001/jama.2019.8145

Interventions

DRUG1-month DAPT

1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists

DRUG12-month DAPT

12-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

Inclusion criteria

* Patients received percutaneous coronary intervention with cobalt-chromium everolimus-eluting stent * Patients who are capable of oral dual antiplatelet therapy consisting of asprin and P2Y12 receptor antagonist

Exclusion criteria

* Patients requiring oral anticoagulants * Patients with medical history of intracranial hemorrhage * Patients who have experienced serious complications (myocardial infarction, stroke, and major bleeding) during hospital stay after percutaneous coronary intervention * Patients with drug eluting stents other than Cobalt chromium everolimus eluting stents (Xience) implanted at the time of enrollment * Patients comfirmed to have no tolerability to clopidgorel before enrollment * Patients requiring continuous administration of antiplaelet drugs other than aspirin and P2Y12 receptor antagonists at the time of enrollment * Patients with coronary bioabsorbable vascular scaffolds (BVS) implanted prior to or at the time of enrollment

Design outcomes

Primary

Measure	Time frame	Description
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding	12-month	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

Secondary

Measure	Time frame	Description
Stroke	12-month	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
All-cause death	12-month	—
Composite event of cardiovascular death/myocardial infarction	12-month	—
Cardiovascular death	12-month	—
Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke	12-month	—
Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group	12-month	—
Upper gastrointestinal endoscopic examination or treatment	60-month	—
Composite event of all-cause death/myocardial infarction	12-month	—
MACE (Major Adverse Cardiac Events)	12-month	Composite event of cardiac death, myocardial infarction and clinically-indicated target vesion revascularization
Definite stent thrombosis	12-month	—
Target lesion failure	12-month	Composite event of cardiac death, myocardial infarction (MI) of target vessels, and Clinically-indicated TLR
Myocardial infarction	12-month	—
Target lesion revasucularization	12-month	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
Clinically-driven target lesion revascularization	12-month	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.
Non target lesion revascularization	12-month	—
Coronary artery bypass graft	12-month	—
Target vessel revascularization	12-month	—
Any coronary reascluarization	12-month	—
Bleeding complications	12-month	Evaluated with TIMI (major/minor/minimal), GUSTO (severe/moderate) and BARC (Type 1, 2, 3a, 3b, 3c, 4, 5a, 5b)
Gastrointestinal bleeding	12-month	Bleeding events requiring upper gastrointestinal endoscopic study or treatment.
Gastrointestinal complaints	12-month	Symptoms requiring upper gastrointestinal endoscopic study or treatment
Newly diagnosed cancer	60-month	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.
Target vessel failure	12-month	—

Countries

Japan

Outcome results

None listed