Prasugrel Monotherapy After Percutaneous Coronary Intervention With Biodegradable-Polymer Platinum-Chromium Everolimus Eluting Stent for Japanese Patients With Chronic Coronary Syndrome (ASET-JAPAN).

BACKGROUND: P2Y12 inhibitor monotherapy without aspirin immediately after percutaneous coronary intervention (PCI) has not been tested in East Asian patients, so in this study we aimed to assess the safety and feasibility of reduced dose (3.75 mg/day) prasugrel monotherapy in Japanese patients presenting with chronic coronary syndrome (CCS).Methods and Results: ASET-JAPAN is a prospective, multicenter, single-arm pilot study that completed enrolment of 206 patients from 12 Japanese centers in September 2022. Patients with native de-novo coronary lesions and a SYNTAX score <23 were treated exclusively with biodegradable-polymer platinum-chromium everolimus-eluting stent(s). Patients were loaded with standard dual antiplatelet therapy (DAPT) and following successful PCI and optimal stent deployment, they received low-dose prasugrel (3.75 mg/day) monotherapy for 3 months. The primary ischemic endpoint was a composite of cardiac death, spontaneous target-vessel myocardial infarction, or definite stent thrombosis. The primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5. At 3-month follow-up, there were no primary bleeding or ischemic events, or any stent thrombosis. CONCLUSIONS: This pilot study showed the safety and feasibility of prasugrel monotherapy in selected low-risk Japanese patients with CCS. This "aspirin-free" strategy may be a safe alternative to traditional DAPT following PCI.

Safety and efficacy of short-term (1 to 3 months) dual antiplatelet therapy in patients undergoing percutaneous coronary interventions: a meta-analysis of randomized controlled trials.

Among patients who have undergone percutaneous coronary intervention (PCI), the use of dual antiplatelet therapy (DAPT) is associated with increased risk of bleeding, but decreased stent thrombosis and myocardial infarction unrelated to the stent. As PCI techniques and devices have progressed, the optimal duration of DAPT has come into question. We identified all randomized controlled trials (RCTs) of patients undergoing PCI, who received one or more drug eluting stents (DES) for stable coronary artery disease (CAD) or acute coronary syndrome (ACS), and randomized to short (1-3 months) versus standard duration DAPT. The prespecified primary outcome was major adverse cardiovascular events (MACE). Important secondary outcomes were net adverse clinical events (NACE) defined as MACE and major bleeding; any bleeding; major bleeding; all-cause death; cardiovascular death. We calculated hazard ratios (HR) and 95% confidence intervals (CI) using random-effects model. Analysis included 7 RCTs, comprising 35,857 patients and 53,321 patient-years of follow-up. The mean (SD) age of patients was 64.4 (10.6) years, 49.6% of patients presented with ACS, and 25.5% were female. There was no difference between short and standard-length DAPT in regards to MACE (HR = 0.93; 95% CI 0.84-1.03; p = 0.19), NACE (HR = 0.93; 95% CI 0.85-1.02; p = 0.12), all-cause death (HR = 0.92; 95% CI 0.80-1.05; p = 0.21), or cardiovascular death (HR = 0.85; 95% CI 0.64-1.13; p = 0.26). However, short-term DAPT was associated with significantly reduced major bleeding events (HR = 0.67; 95% CI 0.47-0.95; p = 0.03) and any bleeding event (HR = 0.63; 95% CI 0.44-0.90; p = 0.01) compared with standard-length DAPT. Among patients undergoing PCI for CAD, the use of short-term DAPT (1-3 months) followed by single antiplatelet therapy was associated with a lower incidence of clinically relevant bleeding events, but with similar risk of MACE, all-cause death, and cardiovascular death compared with standard duration DAPT.

Sex differences among patients receiving ticagrelor monotherapy or aspirin after coronary bypass surgery: A prespecified subgroup analysis of the TiCAB trial.

BACKGROUND: There is limited evidence on the association of sex with outcomes among patients undergoing coronary bypass surgery (CABG) and treated with ticagrelor monotherapy or aspirin. METHODS: This was a pre-specified sub-analysis of TiCAB, an investigator-initiated placebo-controlled randomized trial. Primary efficacy endpoint was the composite of cardiovascular death, myocardial infarction, stroke, or repeat revascularization 1 year after CABG. Safety endpoint was BARC type 2, 3 or 5 bleeding. RESULTS: A total of 280 (15.0%) women and 1579 (85.0%) men were included. Compared with men, women were older (66.1 ± 10.2 vs. 70.1 ± 9.3 years) with more acute presentation (17.0% vs 21.1%). The incidence of the primary endpoint was similar between women and men (9.2% vs. 8.9%, HR 1.08, 95%CI 0.71-1.66, P = 0.71). Cardiovascular death occurred more often in women (2.9% vs 1.0%, adjusted HR 2.87, 95%CI 1.23-6.70, P = 0.02). The incidence of bleeding was similar between the sexes (2.2% vs. 2.5%, HR 0.91, 95% CI 0.51-1.65, P = 0.77). Ticagrelor vs aspirin was associated with a similar risk of the primary endpoint in women (10.6% vs. 7.9%, HR 1.39, 95%CI 0.63-3.05, P = 0.42) and men (9.5% vs. 8.2%, HR 1.15, 95%CI 0.82-1.62, P = 0.41;pinteraction = 0.69), and a similar risk of bleeding in women (2.9% vs. 1.4%, HR 2.09, 95%CI 0.38-11.41, P = 0.40) and men (2.2% vs. 2.8%, HR 0.80, 95%CI 0.42-1.52, P = 0.49;pinteraction = 0.35). CONCLUSIONS: Among women and men undergoing CABG, ticagrelor monotherapy was associated with a similar risk of the primary efficacy endpoint and bleeding compared with aspirin. The risk of cardiovascular death was increased in women irrespective of antiplatelet therapy.

Efficacy and safety of clopidogrel versus aspirin monotherapy for secondary prevention in patients with coronary artery disease: a meta-analysis.

Background: The benefits and risks of aspirin verse clopidogrel monotherapy in patients with coronary artery disease (CAD) remain controversial. This meta-analysis evaluated the efficacy and safety of aspirin verse clopidogrel monotherapy for long-term treatment in patients with CAD. Methods: Literature was searched in the Pubmed, the Cochrane Library, and the Embase databases until March 2023. The Cochrane Risk of Bias Tool was used to assess the risk of bias in included studies. Data were extracted from the included studies, heterogeneity analysis, and pooled analysis conducted by RevMan 5.3 software. Results: A total of five trials were included, involving 11, 766 patients with CAD. Compared with the aspirin group, the clopidogrel group was associated with reduced risk of major adverse cardiac and cerebrovascular events (MACCE) [risk ratio (RR) = 0.68, P = 0.0007], myocardial infarction (MI, RR = 0.66, P = 0.01), stroke (RR = 0.58, P = 0.003), and BARC major bleeding (RR = 0.63, P = 0.02). There were no significant differences in death from any cause (RR = 1.06, P = 0.59) and vascular death (RR = 0.92, P = 0.62) between the two groups. Conclusions: Patients with CAD use clopidogrel could further reduce the risk of MACCE, MI, stroke, and BARC major bleeding, compared with the use of aspirin. This finding supported the use of clopidogrel rather than aspirin in patients with CAD who required long-term antiplatelet monotherapy for preventing ischemic events.