5 results on '"Watanabe, Hirotoshi"'
Search Results
2. 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
- Author
-
Watanabe, Hirotoshi, Morimoto, Takeshi, Natsuaki, Masahiro, Yamamoto, Ko, Obayashi, Yuki, Ogita, Manabu, Suwa, Satoru, Isawa, Tsuyoshi, Domei, Takenori, Yamaji, Kyohei, Tatsushima, Shojiro, Watanabe, Hiroki, Ohya, Masanobu, Tokuyama, Hideo, Tada, Tomohisa, Sakamoto, Hiroki, Mori, Hiroyoshi, Suzuki, Hiroshi, Nishikura, Tenjin, Wakabayashi, Kohei, Hibi, Kiyoshi, Abe, Mitsuru, Kawai, Kazuya, Nakao, Koichi, Ando, Kenji, Tanabe, Kengo, Ikari, Yuji, Morino, Yoshihiro, Kadota, Kazushige, Furukawa, Yutaka, Nakagawa, Yoshihisa, and Kimura, Takeshi
- Subjects
Male ,Myocardial Infarction ,Drug-Eluting Stents ,Hemorrhage ,Clopidogrel ,Percutaneous Coronary Intervention ,Humans ,Drug Therapy, Combination ,Female ,Acute Coronary Syndrome ,Cardiology and Cardiovascular Medicine ,Platelet Aggregation Inhibitors ,Original Investigation ,Aged - Abstract
IMPORTANCE: Clopidogrel monotherapy after short dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) has not yet been fully investigated in patients with acute coronary syndrome (ACS). OBJECTIVE: To test the hypothesis of noninferiority of 1 to 2 months of DAPT compared with 12 months of DAPT for a composite end point of cardiovascular and bleeding events in patients with ACS. DESIGN, SETTING, AND PARTICIPANTS: This multicenter, open-label, randomized clinical trial enrolled 4169 patients with ACS who underwent successful PCI using cobalt-chromium everolimus-eluting stents at 96 centers in Japan from December 2015 through June 2020. These data were analyzed from June to July 2021. INTERVENTIONS: Patients were randomized either to 1 to 2 months of DAPT followed by clopidogrel monotherapy (n = 2078) or to 12 months of DAPT with aspirin and clopidogrel (n = 2091). MAIN OUTCOMES AND MEASURES: The primary end point was a composite of cardiovascular (cardiovascular death, myocardial infarction [MI], any stroke, or definite stent thrombosis) or bleeding (Thrombolysis in MI major or minor bleeding) events at 12 months, with a noninferiority margin of 50% on the hazard ratio (HR) scale. The major secondary end points were cardiovascular and bleeding components of the primary end point. RESULTS: Among 4169 randomized patients, 33 withdrew consent. Of the 4136 included patients, the mean (SD) age was 66.8 (11.9) years, and 856 (21%) were women, 2324 (56%) had ST-segment elevation MI, and 826 (20%) had non–ST-segment elevation MI. A total of 4107 patients (99.3%) completed the 1-year follow-up in June 2021. One to 2 months of DAPT was not noninferior to 12 months of DAPT for the primary end point, which occurred in 65 of 2058 patients (3.2%) in the 1- to 2-month DAPT group and in 58 of 2057 patients (2.8%) in the 12-month DAPT group (absolute difference, 0.37% [95% CI, −0.68% to 1.42%]; HR, 1.14 [95% CI, 0.80-1.62]; P for noninferiority = .06). The major secondary cardiovascular end point occurred in 56 patients (2.8%) in the 1- to 2-month DAPT group and in 38 patients (1.9%) in the 12-month DAPT group (absolute difference, 0.90% [95% CI, −0.02% to 1.82%]; HR, 1.50 [95% CI, 0.99-2.26]). The major secondary bleeding end point occurred in 11 patients (0.5%) in the 1- to 2-month DAPT group and 24 patients (1.2%) in the 12-month DAPT group (absolute difference, −0.63% [95% CI, −1.20% to −0.06%]; HR, 0.46 [95% CI, 0.23-0.94]). CONCLUSIONS AND RELEVANCE: In patients with ACS with successful PCI, clopidogrel monotherapy after 1 to 2 months of DAPT failed to attest noninferiority to standard 12 months of DAPT for the net clinical benefit with a numerical increase in cardiovascular events despite reduction in bleeding events. The directionally different efficacy and safety outcomes indicate the need for further clinical trials. TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: NCT02619760 and NCT03462498
- Published
- 2022
3. 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: The STOPDAPT-2 Randomized Clinical Trial.
- Author
-
Watanabe, Hirotoshi, Domei, Takenori, Morimoto, Takeshi, Natsuaki, Masahiro, Shiomi, Hiroki, Toyota, Toshiaki, Ohya, Masanobu, Suwa, Satoru, Takagi, Kensuke, Nanasato, Mamoru, Hata, Yoshiki, Yagi, Masahiro, Suematsu, Nobuhiro, Yokomatsu, Takafumi, Takamisawa, Itaru, Doi, Masayuki, Noda, Toshiyuki, Okayama, Hideki, Seino, Yoshitane, and Tada, Tomohisa
- Subjects
- *
PERCUTANEOUS coronary intervention , *CLOPIDOGREL , *ASPIRIN , *HEMORRHAGE , *MYOCARDIAL infarction , *ISCHEMIA , *PLATELET aggregation inhibitors , *RANDOMIZED controlled trials , *RESEARCH , *COMBINATION drug therapy , *DRUG-eluting stents , *RESEARCH methodology , *MEDICAL care , *NEUROTRANSMITTERS , *EVALUATION research , *MEDICAL cooperation , *CARDIOVASCULAR system , *DRUG administration , *COMPARATIVE studies , *DRUGS - Abstract
Importance: Very short mandatory dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with a drug-eluting stent may be an attractive option.Objective: To test the hypothesis of noninferiority of 1 month of DAPT compared with standard 12 months of DAPT for a composite end point of cardiovascular and bleeding events.Design, Setting, and Participants: Multicenter, open-label, randomized clinical trial enrolling 3045 patients who underwent PCI at 90 hospitals in Japan from December 2015 through December 2017. Final 1-year clinical follow-up was completed in January 2019.Interventions: Patients were randomized either to 1 month of DAPT followed by clopidogrel monotherapy (n=1523) or to 12 months of DAPT with aspirin and clopidogrel (n=1522).Main Outcomes and Measures: The primary end point was a composite of cardiovascular death, myocardial infarction (MI), ischemic or hemorrhagic stroke, definite stent thrombosis, or major or minor bleeding at 12 months, with a relative noninferiority margin of 50%. The major secondary cardiovascular end point was a composite of cardiovascular death, MI, ischemic or hemorrhagic stroke, or definite stent thrombosis and the major secondary bleeding end point was major or minor bleeding.Results: Among 3045 patients randomized, 36 withdrew consent; of 3009 remaining, 2974 (99%) completed the trial. One-month DAPT was both noninferior and superior to 12-month DAPT for the primary end point, occurring in 2.36% with 1-month DAPT and 3.70% with 12-month DAPT (absolute difference, -1.34% [95% CI, -2.57% to -0.11%]; hazard ratio [HR], 0.64 [95% CI, 0.42-0.98]), meeting criteria for noninferiority (P < .001) and for superiority (P = .04). The major secondary cardiovascular end point occurred in 1.96% with 1-month DAPT and 2.51% with 12-month DAPT (absolute difference, -0.55% [95% CI, -1.62% to 0.52%]; HR, 0.79 [95% CI, 0.49-1.29]), meeting criteria for noninferiority (P = .005) but not for superiority (P = .34). The major secondary bleeding end point occurred in 0.41% with 1-month DAPT and 1.54% with 12-month DAPT (absolute difference, -1.13% [95% CI, -1.84% to -0.42%]; HR, 0.26 [95% CI, 0.11-0.64]; P = .004 for superiority).Conclusions and Relevance: Among patients undergoing PCI, 1 month of DAPT followed by clopidogrel monotherapy, compared with 12 months of DAPT with aspirin and clopidogrel, resulted in a significantly lower rate of a composite of cardiovascular and bleeding events, meeting criteria for both noninferiority and superiority. These findings suggest that a shorter duration of DAPT may provide benefit, although given study limitations, additional research is needed in other populations.Trial Registration: ClinicalTrials.gov Identifier: NCT02619760. [ABSTRACT FROM AUTHOR]- Published
- 2019
- Full Text
- View/download PDF
4. 1 vs 12 Months of Dual Antiplatelet Therapy for Patients After Percutaneous Coronary Intervention-Reply.
- Author
-
Watanabe, Hirotoshi and Kimura, Takeshi
- Abstract
The authors respond to comments on their Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent 2 (STOPDAPT-2) research which showed noninferiority and superiority of 1 month against 12 months dual platelet therapy (DAPT) on cardiovascular and bleeding events among patients with everolimus-eluting stents. Topics discussed include the appropriateness of the noninferiority margin and actual timing of aspirin discontinuation.
- Published
- 2019
- Full Text
- View/download PDF
5. 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.
- Author
-
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, and Kimura T
- Subjects
- Aged, Clopidogrel therapeutic use, Drug Therapy, Combination, Female, Hemorrhage chemically induced, Hemorrhage epidemiology, Humans, Male, Platelet Aggregation Inhibitors therapeutic use, Acute Coronary Syndrome drug therapy, Acute Coronary Syndrome etiology, Acute Coronary Syndrome surgery, Drug-Eluting Stents, Myocardial Infarction drug therapy, Percutaneous Coronary Intervention adverse effects
- Abstract
Importance: Clopidogrel monotherapy after short dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) has not yet been fully investigated in patients with acute coronary syndrome (ACS)., Objective: To test the hypothesis of noninferiority of 1 to 2 months of DAPT compared with 12 months of DAPT for a composite end point of cardiovascular and bleeding events in patients with ACS., Design, Setting, and Participants: This multicenter, open-label, randomized clinical trial enrolled 4169 patients with ACS who underwent successful PCI using cobalt-chromium everolimus-eluting stents at 96 centers in Japan from December 2015 through June 2020. These data were analyzed from June to July 2021., Interventions: Patients were randomized either to 1 to 2 months of DAPT followed by clopidogrel monotherapy (n = 2078) or to 12 months of DAPT with aspirin and clopidogrel (n = 2091)., Main Outcomes and Measures: The primary end point was a composite of cardiovascular (cardiovascular death, myocardial infarction [MI], any stroke, or definite stent thrombosis) or bleeding (Thrombolysis in MI major or minor bleeding) events at 12 months, with a noninferiority margin of 50% on the hazard ratio (HR) scale. The major secondary end points were cardiovascular and bleeding components of the primary end point., Results: Among 4169 randomized patients, 33 withdrew consent. Of the 4136 included patients, the mean (SD) age was 66.8 (11.9) years, and 856 (21%) were women, 2324 (56%) had ST-segment elevation MI, and 826 (20%) had non-ST-segment elevation MI. A total of 4107 patients (99.3%) completed the 1-year follow-up in June 2021. One to 2 months of DAPT was not noninferior to 12 months of DAPT for the primary end point, which occurred in 65 of 2058 patients (3.2%) in the 1- to 2-month DAPT group and in 58 of 2057 patients (2.8%) in the 12-month DAPT group (absolute difference, 0.37% [95% CI, -0.68% to 1.42%]; HR, 1.14 [95% CI, 0.80-1.62]; P for noninferiority = .06). The major secondary cardiovascular end point occurred in 56 patients (2.8%) in the 1- to 2-month DAPT group and in 38 patients (1.9%) in the 12-month DAPT group (absolute difference, 0.90% [95% CI, -0.02% to 1.82%]; HR, 1.50 [95% CI, 0.99-2.26]). The major secondary bleeding end point occurred in 11 patients (0.5%) in the 1- to 2-month DAPT group and 24 patients (1.2%) in the 12-month DAPT group (absolute difference, -0.63% [95% CI, -1.20% to -0.06%]; HR, 0.46 [95% CI, 0.23-0.94])., Conclusions and Relevance: In patients with ACS with successful PCI, clopidogrel monotherapy after 1 to 2 months of DAPT failed to attest noninferiority to standard 12 months of DAPT for the net clinical benefit with a numerical increase in cardiovascular events despite reduction in bleeding events. The directionally different efficacy and safety outcomes indicate the need for further clinical trials., Trial Registration: ClinicalTrials.gov Identifiers: NCT02619760 and NCT03462498.
- Published
- 2022
- Full Text
- View/download PDF
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.