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

Abstract

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.

Third Generation P2Y12 Inhibition for East Asian ACS Patients

“… 3 , 4 Conversely, data from Japan suggests that dose-adjusted prasugrel (20-mg loading and 3.75-mg maintenance dose) had lower major adverse cardiac events and comparable bleeding rates compared with clopidogrel. 5 , 6 This data might give dose-adjusted prasugrel the current edge over standard dose ticagrelor as a preferred regimen in the East Asian cohort.…”

What More Can Be Delivered to Future Patients with Coronary Syndromes?

“…Jo et al [ 9 ] performed a multicenter, double-blind, randomized trial and found that a single pill of olmesartan/amlodipine plus rosuvastatin therapy was more effective and safe for the management of both hypertension and dyslipidemia than either olmesartan plus rosuvastatin or olmesartan plus amlodipine therapy. Mori et al [ 10 ] further provided real-world evidence for the use of a modified Japanese dose of prasugrel (loading/maintenance: 20/3.75 mg) with a similar efficacy and safety to the standard dose of clopidogrel in patients with AMI.…”