One-year outcome of a prospective trial stopping dual antiplatelet therapy at 3 months after everolimus-eluting cobalt-chromium stent implantation: ShortT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent (STOPDAPT) trial

Natsuaki, Masahiro; Morimoto, Takeshi; Yamamoto, Etsuhide; Shiomi, Hiroki; Furukawa, Yutaka; Abe, Mitsuru; Nakao, Kōichi; Ishikawa, Takahiro; Kawai, Kensuke; Yunoki, Kei; Shimizu, Shogo; Akao, Masaharu; Sato, Miki; Yamamoto, Masashi; Okada, Hisayuki; Hoshino, Kozo; Kadota, Kazushige; Morino, Yoshihiro; Igarashi, Keiichi; Tanabe, Kengo; Kozuma, Ken; Kimura, Takeshi

doi:10.1007/s12928-015-0366-9

Cited by 65 publications

(38 citation statements)

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“…12 Furthermore, prolonged dual-antiplatelet therapy was reported to be associated with increasing risk for bleeding and noncardiac death. 11,[13][14][15][16][17][18] The risk of bleeding is particularly pertinent in the present study enrolling a large proportion of patients with advanced age. Therefore, appropriate management of medical treatment including duration and case selection for intensive antithrombotic therapy in patients with STEMI would be required to improve long-term mortality of patients with STEMI because preventing adverse effects of antithrombotic therapy may improve noncardiac mortality associated with bleeding and surgical procedure in late phase of STEMI.…”

Section: Discussionmentioning

confidence: 99%

Cardiac and Noncardiac Causes of Long-Term Mortality in ST-Segment–Elevation Acute Myocardial Infarction Patients Who Underwent Primary Percutaneous Coronary Intervention

Yamashita

Shiomi

Morimoto

et al. 2017

Circ: Cardiovascular Quality and Outcomes

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A cute myocardial infarction (AMI) remains one of the leading causes of mortality worldwide. 1 In recent decades, in-hospital mortality after ST-segment-elevation AMI (STEMI) has dramatically decreased to ≈5% because of the establishment of coronary care units, improvements in medical therapy, and widespread use of early reperfusion therapy by primary percutaneous coronary intervention (PCI). 2 However, the long-term risks and causes of deaths beyond the acute phase of STEMI have not been adequately evaluated yet although the majority of patients having STEMI survive to discharge from hospital in the current clinical practice.3 A study reported that noncardiac causes were responsible for the majority of late deaths in STEMI patients. 4 It is not known whether the observed predominance of noncardiac death is true in different geographic area and age groups.Therefore, we sought to evaluate short-term (within 6-month) and long-term (beyond 6-month) incidences and causes of deaths in STEMI patients who underwent primary PCI in a large-scale observational database of AMI in Japan.Background-In patients with ST-segment-elevation acute myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention, long-term risks for cardiac and noncardiac death beyond acute phase of STEMI have not been thoroughly evaluated yet. Methods and Results-We identified 3942 STEMI patients who had primary percutaneous coronary intervention within 24 hours after onset between January 2005 and December 2007 in the CREDO-Kyoto AMI registry (Coronary Revascularization Demonstrating Outcome study in Kyoto Acute Myocardial Infarction) and evaluated their short-term (within 6-month) and long-term (beyond 6-month) incidences and causes of deaths. The cumulative 5-year incidence of all-cause death in the current study population was 20.4% (cardiac death, 12.2% and noncardiac death, 9.4%, respectively). The vast majority of deaths were cardiac in origin within 6-month (cardiac death, 8.0% and noncardiac death, 0.9%), whereas noncardiac death accounted for nearly two thirds of all-cause death beyond 6-month (cardiac death, 4.6% and noncardiac death, 8.5%). In the stratified analysis according to age, the proportion of noncardiac death was similar regardless of age although the absolute mortality rate was higher with increasing age. By the multivariable Cox regression models, the independent risk factors of all-cause death were advanced age, cardiogenic shock, renal dysfunction, large infarct size, and anterior wall infarction within 6 months after STEMI, and advanced age, previous heart failure, renal dysfunction, and liver cirrhosis beyond 6 months after STEMI, respectively. Conclusions-In STEMI patients who underwent primary percutaneous coronary intervention, the long-term risk for cardiac death was relatively low compared with that for noncardiac death, which accounted for nearly two thirds of all-cause death beyond 6 months. Methods Study PopulationThe CREDO-Kyoto AMI registry (Coronary Revascularization Demonstrating Outc...

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Section: Discussionmentioning

confidence: 99%

Cardiac and Noncardiac Causes of Long-Term Mortality in ST-Segment–Elevation Acute Myocardial Infarction Patients Who Underwent Primary Percutaneous Coronary Intervention

Yamashita

Shiomi

Morimoto

et al. 2017

Circ: Cardiovascular Quality and Outcomes

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“…Sample size calculation for the main analysis of this study was previously described. [3] Statistical analyses were conducted by a physician (Natsuaki M) and a statistician (Morimoto T) with the use of JMP 10.0 software. We used 2-sided P values <0.05 as statistically significant.…”

Section: Discussionmentioning

confidence: 99%

“…STOPDAPT trial is a prospective multi-center single-arm trial enrolling patients who agreed to follow the 3-month DAPT protocol (discontinuation of clopidogrel at 2-to 4-month and aspirin monotherapy thereafter) after successful CoCr-EES implantation in all-comer population. [3] Patients who underwent successful percutaneous coronary intervention (PCI) using CoCr-EES were to be enrolled, if the physicians in charge judged the patient to be eligible for the study evaluating 3-month DAPT duration. Patients who had previous history of PCI using DES other than CoCr-EES were excluded.…”

Section: Study Populationmentioning

confidence: 99%

“…A total of 1559 patients were selected as a historical control group. [3] https://doi.org/10.1371/journal.pone.0227612.g001…”

Section: Study Populationmentioning

confidence: 99%

“…We previously reported the favorable outcomes of those patients treated with 3-month DAPT after cobalt-chromium everolimus-eluting stent (CoCr-EES) in the STOPDAPT (ShorT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobaltchromium stent) trial as compared with those enrolled in the historical control of RESET (Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial) study, in which nearly 90% of patients had continued DAPT at 1-year. [3,4] The STOPDAPT trial included a substantial proportion of patients with ACS. Therefore, we sought to evaluate the safety of 3-month DAPT duration after CoCr-EES implantation in those with ACS as compared with those with stable CAD.…”

Section: Introductionmentioning

confidence: 99%

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One-year clinical outcomes of patients with versus without acute coronary syndrome with 3-month duration of dual antiplatelet therapy after everolimus-eluting stent implantation

et al. 2020

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There has been no previous prospective study evaluating 3-month dual antiplatelet therapy (DAPT) after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation in patients with acute coronary syndrome (ACS). The STOPDAPT trial is a prospective multi-center single-arm study evaluating 3-month DAPT duration in all-comer population after CoCr-EES implantation. Among 1525 study patients enrolled from 58 Japanese centers, the present study compared the 1-year clinical outcomes between ACS patients (N = 487) and stable coronary artery disease (CAD) patients (N = 1038). In the ACS group, 228 patients (47%) had unstable angina and 259 patients (53%) had myocardial infarction. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, definite stent thrombosis (ST) and TIMI major/minor bleeding. Thienopyridine was discontinued within 4-month in 455 patients (94.0%) in the ACS group and 977 patients (94.3%) in the stable CAD group. Cumulative 1-year incidence of and the adjusted risk for the primary endpoint were not significantly different between the ACS and stable CAD groups (2.3% vs. 3.0%, P = 0.42, and HR 0.94, 95%CI 0.44-1.87, P = 0.87). In the 3-month landmark analysis,

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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

Watanabe

Domei

Morimoto

et al. 2019

JAMA

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682

507

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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.

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One-year outcome of a prospective trial stopping dual antiplatelet therapy at 3 months after everolimus-eluting cobalt-chromium stent implantation: ShortT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent (STOPDAPT) trial

Cited by 65 publications

References 21 publications

Cardiac and Noncardiac Causes of Long-Term Mortality in ST-Segment–Elevation Acute Myocardial Infarction Patients Who Underwent Primary Percutaneous Coronary Intervention

Cardiac and Noncardiac Causes of Long-Term Mortality in ST-Segment–Elevation Acute Myocardial Infarction Patients Who Underwent Primary Percutaneous Coronary Intervention

One-year clinical outcomes of patients with versus without acute coronary syndrome with 3-month duration of dual antiplatelet therapy after everolimus-eluting stent implantation

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

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