Multicenter research of bleeding risk between prasugrel and clopidogrel in Japanese patients with coronary artery disease undergoing percutaneous coronary intervention

Tokimasa, Satoshi; Kitahara, Hideki; Nakayama, Takashi; Fujimoto, Yoshihide; Shiba, Taiki; Shikama, Nobuaki; Nameki, Mizuo; Himi, Toshiharu; Fukushima, K; Kobayashi, Yoshio

doi:10.1007/s00380-019-01395-0

Cited by 3 publications

(8 citation statements)

References 18 publications

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“…According to a study by Akita et al that investigated 62,737 Japanese ACS patients, 68.1% of patients received prasugrel, while 31.9% received clopidogrel [ 18 ]. The dose of prasugrel was basically reduced (LD/MD: 20/3.75 mg) in contrast to the standard dose of clopidogrel (LD/MD: 300/75 mg) in these Japanese real-world practice settings [ 18 , 19 , 20 , 21 , 22 , 23 ]. The findings of such clinical studies comparing a Japanese dose of prasugrel and a standard dose of clopidogrel in CAD patients are inconsistent among Japanese registry studies [ 18 , 19 , 20 , 21 , 22 , 23 ].…”

Section: Discussionmentioning

confidence: 99%

A Japanese Dose of Prasugrel versus a Standard Dose of Clopidogrel in Patients with Acute Myocardial Infarction from the K-ACTIVE Registry

Mori

Mizukami

Maeda

et al. 2022

JCM

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Background: Dual antiplatelet therapy (DAPT) with aspirin plus P2Y12 inhibitor is used as a standard therapy for patients with acute myocardial infarction (AMI) treated with drug-eluting stents (DESs). In Japan, clopidogrel was the major P2Y12 inhibitor used for a decade until the new P2Y12 inhibitor, prasugrel, was introduced. Based on clinical studies considering Japanese features, the set dose for prasugrel was reduced to 20 mg as a loading dose (LD) and 3.75 mg as a maintenance dose (MD); these values are 60 and 10 mg, respectively, globally. Despite this dose discrepancy, little real-world clinical data regarding its efficacy and safety exist. Methods: From the K-ACTIVE registry, based on the DAPT regimen, patients were divided into a prasugrel group and a clopidogrel group. The ischemic event was a composite of cardiovascular death, non-fatal MI, and non-fatal stroke. The bleeding event was type 3 or 5 bleeding based on the Bleeding Academic Research Consortium (BARC) criteria. Results: Substantially more patients were prescribed prasugrel (n = 2786) than clopidogrel (n = 890). Clopidogrel tended to be selected over prasugrel in older patients with numerous comorbidities. Before adjustments were made, the cumulative incidence of ischemic events at 1 year was significantly greater in the clopidogrel group than in the prasugrel group (p = 0.007), while the cumulative incidence of bleeding events at 1 year was comparable between the groups (p = 0.131). After adjustments were made for the age, sex, body weight, creatine level, type of AMI, history of MI, approach site, oral anticoagulation therapy, presence of multivessel disease, Killip classification, and presence of intra-aortic balloon pumping, both ischemic and bleeding events became comparable between the groups. Conclusion: A Japanese dose of prasugrel was commonly used in AMI patients in the real-world database. Both the prasugrel and clopidogrel groups showed comparable rates of 1 year ischemic and bleeding events.

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Section: Discussionmentioning

confidence: 99%

A Japanese Dose of Prasugrel versus a Standard Dose of Clopidogrel in Patients with Acute Myocardial Infarction from the K-ACTIVE Registry

Mori

Mizukami

Maeda

et al. 2022

JCM

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“…Major bleeding was reported in ve RCT (n = 5,919) [10,11,28,29,31] and six observational studies (n = 31,113) [12,13,[32][33][34][35]. Overall, patients receiving low-dose prasugrel exhibited an increased risk of major bleeding relative to patients receiving clopidogrel (RR 1.35, 95%CI 1.10 to 1.67; I 2 = 61.4%; n = 37,110; Fig.…”

Section: Major Bleedingmentioning

confidence: 99%

“…Eight studies (66.7%) were performed with ACS patients [10-13, 31, 30, 33, 35], and four studies (33.3%) were performed with CAD patients [28,29,32,34]. Nine studies (75.0%) examined the effects of a 3.75 mg dose of prasugrel [10,12,13,28,[31][32][33][34][35], two studies (16.7%) examined 5 mg dose [11,30] and one (8.3%) compared these two doses [29]. Most studies were conducted in Japan (10 studies) [11-13, 28-30, 32-35], while the other 2 studies included one conducted in Italy [31] and one that gathered data from 52 countries around the world [10].…”

Section: Study Characteristicsmentioning

confidence: 99%

“…We judged the risk of bias as high in one RCT (16.7%) due to inadequate information about allocation concealment in the randomization process [30]. The risk of bias in three observational studies (50.0%) was considered moderate [12,13,35], and the other three studies (50.0%) were considered to have serious risk of bias due to the existence of possible confounds ( Figure S1) [32][33][34], MACE MACE was reported in six RCTs (n = 6020) [10,11,[28][29][30][31], and ve observational studies (n = 7081) [13,[32][33][34][35]. There was no difference in the risk of MACE between patients receiving low-dose prasugrel and patients receiving clopidogrel (RR 1.02, 95%CI 0.91 to 1.14; Fig.…”

Section: Risk Of Biasmentioning

confidence: 99%

“…Of these, 40 were included for full-text review. Twelve studies were included in the nal analysis consisting of six RCTs [10,11,[28][29][30][31] and six observational studies [12,13,[32][33][34][35]. The study selection is illustrated in Fig.…”

Section: Study Selectionmentioning

confidence: 99%

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Efficacy and Safety of Low-Dose Prasugrel Versus Clopidogrel in Patients With Acute Coronary Syndrome or Patients Undergoing Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis

Wonngsalap

Ungsriwong

Kumtepm

et al. 2021

Preprint

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Purpose To assess the efficacy and safety of prasugrel at low doses compared to clopidogrel by looking at the occurrence of major adverse cardiac events (MACE) and major bleeding in patients with acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI). Methods We searched PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov for eligible randomized controlled trials (RCTs) and observational studies assessing efficacy and safety of low-dose prasugrel versus clopidogrel in patients with ACS or undergoing PCI up to May 22, 2020. We did a meta-analysis using a random-effects model to estimate relative risks (RRs). The primary efficacy and safety endpoints were MACE and major bleeding, respectively. Results Six RCTs (n = 6,131) and six observational studies (n = 31,426) were included. There was no MACE reduction in patients receiving low-dose prasugrel compared with those receiving clopidogrel (RR 1.02, 95%CI 0.91 to 1.14), but there was an increased risk of major bleeding (RR 1.35, 95%CI 1.10 to 1.67). Conclusions Low-dose prasugrel yields no increase in efficacy when compared with clopidogrel, but it does expose patients to an increased risk of bleeding. Most studies considered here were conducted in Japan. Studies conducted with non-Asian patients may find that low-dose prasugrel offers a more favorable efficacy and risk profile. Considering the results of this analysis we believe low-dose prasugrel should be prescribed with extreme caution as it may result in bleeding events without any additional benefit over clopidogrel.

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Efficacy and Safety of Low-Dose Prasugrel Versus Clopidogrel in Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: a Systematic Review and Meta-analysis

Wongsalap

Ungsriwong

Kumtep

et al. 2021

Cardiovasc Drugs Ther

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Multicenter research of bleeding risk between prasugrel and clopidogrel in Japanese patients with coronary artery disease undergoing percutaneous coronary intervention

Cited by 3 publications

References 18 publications

A Japanese Dose of Prasugrel versus a Standard Dose of Clopidogrel in Patients with Acute Myocardial Infarction from the K-ACTIVE Registry

A Japanese Dose of Prasugrel versus a Standard Dose of Clopidogrel in Patients with Acute Myocardial Infarction from the K-ACTIVE Registry

Efficacy and Safety of Low-Dose Prasugrel Versus Clopidogrel in Patients With Acute Coronary Syndrome or Patients Undergoing Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis

Efficacy and Safety of Low-Dose Prasugrel Versus Clopidogrel in Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: a Systematic Review and Meta-analysis

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