Lee CJ, et al. Int J Heart Fail. 2024 Apr;6(2):56-69. https://doi.org/10.36628/ijhf.2024.0010

Objective: To assess the long term comparative effectiveness of P2Y ₁₂ inhibitor monotherapy compared with aspirin monotherapy in patients after percutaneous coronary intervention (PCI) and discontinuation of dual antiplatelet therapy (DAPT). Design: Individual participant data (IPD) meta-analysis of randomised clinical trials. Data sources: PubMed/Medline, Scopus, Web of Science, and Ovid/Embase. Eligibility criteria for selecting studies: Randomised trials investigating monotherapy with a P2Y ₁₂ inhibitor or aspirin for secondary prevention of ischaemic events in patients with coronary artery disease who underwent PCI. Data extraction and synthesis: Anonymised IPD were extracted and transferred to the coordinating centre by dedicated electronic spreadsheets. Data were primarily combined by mixed effects models (one stage analysis) and complemented with multivariable mixed effects models and two stage analyses based on random effects models. The primary and co-primary outcomes were a composite of major adverse cardiac and cerebrovascular events (MACCE) and major bleeding, respectively. The secondary outcomes included a net composite of adverse cardiac and cerebrovascular events (NACCE), derived from the combination of the primary and co-primary outcomes, and individual ischaemic and bleeding events. Results: A total of 16 117 patients assigned to P2Y ₁₂ inhibitor or aspirin monotherapy after PCI and completion of the recommended DAPT regimen (median duration of 12 months) in five randomised trials were included. At a median follow-up of 1351 days (interquartile range 373-1791 days), P2Y ₁₂ inhibitor monotherapy was associated with a lower risk of MACCE compared with aspirin monotherapy (one stage analysis: hazard ratio 0.77 (95% confidence interval (CI) 0.67 to 0.89), P<0.001; multivariable one stage analysis: adjusted hazard ratio 0.77 (0.67 to 0.89), P<0.001; two stage analysis: hazard ratio 0.77 (0.67 to 0.89), P<0.001), yielding a number needed to treat to benefit of 45.5 (95% CI 31.4 to 93.6). No significant difference in major bleeding (one stage analysis: hazard ratio 1.26 (0.78 to 2.04), P=0.35; multivariable one stage analysis: 1.12 (0.74 to 1.70), P=0.60; two stage analysis: 1.15 (0.69 to 1.92), P=0.59) was observed. NACCE, myocardial infarction, and stroke were lower in patients assigned to a P2Y ₁₂ inhibitor compared with those assigned to aspirin. These findings were confirmed across multiple sensitivity and subgroup analyses. Conclusions: In patients who had undergone PCI and discontinued DAPT, at a follow-up of about 5.5 years, P2Y ₁₂ inhibitor monotherapy with ticagrelor or clopidogrel was associated with lower MACCE, owing to reduced rates of myocardial infarction and stroke compared with aspirin monotherapy, without a concurrent increased risk of major bleeding. Review registration: PROSPERO CRD42024517983.

Kang J, et al. Korean Circ J. 2016 Sep;48:e101. https://doi.org/10.4070/kcj.2018.0166

Dual-antiplatelet therapy (DAPT) with aspirin and a potent P2Y12 inhibitor is the standard treatment for patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). De-escalation of the potent P2Y12 inhibtor is an appealing concept to balance the ischaemic and bleeding risks after PCI. An individual patient data meta-analysis was performed to compare de-escalation versus standard DAPT in patients with ACS. Electronic databases, including PubMed, Embase, and the Cochrane database, were searched to identify randomised clinical trials (RCTs) comparing the de-escalation strategy with the standard DAPT after PCI in patients with ACS. Individual patient-level data were collected from the relevant trials. The co-primary endpoints of interest were the ischaemic composite endpoint (a composite of cardiac death, myocardial infarction, and cerebrovascular events) and bleeding endpoint (any bleeding) at 1-year post-PCI. Four RCTs (the TROPICAL-ACS, POPular Genetics, HOST-REDUCE-POLYTECH-ACS, and TALOS-AMI trials) including 10 133 patients were analysed. The ischaemic endpoint was significantly lower in the patients assigned to the de-escalation strategy than in those assigned to the standard strategy (2.3% vs. 3.0%, hazard ratio [HR] 0.761, 95% confidence interval [CI] 0.597-0.972, log rank P = 0.029). Bleeding was also significantly lower in the de-escalation strategy group (6.5% vs. 9.1%, HR 0.701, 95% CI 0.606-0.811, log rank P < 0.001). No significant intergroup differences were observed in terms of all-cause death and major bleeding events. Subgroup analyses revealed that compared to guided de-escalation, unguided de-escalation had a significantly larger impact on bleeding endpoint reduction (P for interaction = 0.007); no intergroup differences were observed for the ischaemic endpoints. In this individual patient data meta-analysis, DAPT-based de-escalation was associated with both decreased ischaemic and bleeding endpoints. Reduction in bleeding endpoints was more prominent for the unguided than the guided de-escalation strategy. This study was registered in the PROSPERO (ID: CRD42021245477). A total of 10 133 patients from four randomized clinical trials were analysed. During the first year after percutaneous coronary intervention, the de-escalation strategy was associated with a lower risk of the ischaemic and bleeding endpoints. The absolute risk difference of endpoints between the two astrategies was 0.69% for the ischaemic endpoint and 2.48% for the bleeding endpoint. CI, confidence interval; DAPT, dual antiplatelet therapy; HR, hazard ratio.

Kim KJ, et al. Int J Heart Fail. 2019 Oct;1:e1. https://doi.org/10.36628/ijhf.2019.0002

To demonstrate the association of the serum creatinine/serum cystatin C ratio (sarcopenia index, SI) with clinical outcomes including cardiovascular and bleeding risk in older patients who underwent percutaneous coronary intervention (PCI), we analyzed a multicenter nation-wide pooled registry. A total of 1086 older patients (65 years or older) who underwent PCI with second-generation drug-eluting stents (DES) were enrolled. The total population was divided into quartiles according to the SI, stratified by sex. The primary clinical outcomes were major adverse cardiovascular events (MACE, all-cause death, myocardial infarction and target lesion revascularization) and thrombolysis in myocardial infarction major and minor bleeding during a 3-year follow-up period. In the total population, MACE occurred within 3 years in 154 (14.2%) patients. The lowest SI quartile group (Q1) had a significantly higher 3-year MACE rate (Q1 vs. Q2–4; 23.1% vs. 11.2%, p < 0.001), while bleeding event rates were similar between the groups (Q1 vs. Q2–4; 2.6% vs. 2.2%, p = 0.656). The Cox proportional hazard model showed that lower SI is an independent predictor for MACE events (HR 2.23, 95% CI 1.62–3.07, p < 0.001). The SI, a surrogate for the degree of muscle mass, is associated with cardiovascular and non-cardiovascular death, but not with bleeding in older patients who underwent PCI.