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Comprehensive comparative efficacy and safety of potent P2Y₁₂ inhibitors in patients undergoing coronary intervention: A systematic review and meta-analysis.

ABSTRACT: Potent P2Y₁₂ receptor antagonists have been used widely for patients undergoing percutaneous coronary intervention with different results. Benefits from different regimens various between trials. Randomized controlled trials (RCTs) have restrictive inclusion and exclusion criteria; thus, they may limit the generalizability of the findings to a broader population. This study was aimed to comprehensively investigate the outcomes of potent P2Y₁₂ inhibitors in patients undergoing PCI, including RCTs and real-world evidence (RWE) studies. Multiple electronic databases were systemically reviewed and searched on compared potent P2Y₁₂ inhibitors with clopidogrel. The primary efficacy end point was composite ischemic cardiovascular event and primary safety endpoint was major bleeding. Overall estimates of proportions and incidence rates with 95 % confidence intervals (CI) were calculated using fixed-effects models. Total 24 studies (140,986 patients) underwent coronary intervention were included in this meta-analysis, including 18 RCTs and 6 large cohort studies with propensity score matching. The potent P2Y₁₂ inhibitors including cangrelor, prasugrel, and ticagrelor, significantly decreased the risk of composite adverse cardiovascular ischemic events (95 % CI 0.89-0.96, p < 0.001), but increased major bleeding (95 % CI 1.15-1.33, p < 0.001) or any bleeding (95 % CI 1.21-1.33, p < 0.001) compared with Clopidogrel. This meta-analysis merges RCTs and RWE studies and comprehensively evidences newer potent P2Y₁₂ inhibitors are significantly more effective than clopidogrel in reduction of composite adverse thrombotic events, but the incidence of major or any bleeding was higher compared with clopidogrel.

SUBMITTER: Huang CL

PROVIDER: S-EPMC10869917 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature

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Comprehensive comparative efficacy and safety of potent P2Y12 inhibitors in patients undergoing coronary intervention: A systematic review and meta-analysis.

Huang Chien-Lung CL Tsao Tien-Ping TP Yin Wei-Hsian WH Huang Wen-Bin WB Jen Hsu-Lung HL Lin Chang-Chyi CC Chang Chung-Yi CY Hsu Ching-Hwa CH

International journal of cardiology. Heart & vasculature 20240210

Potent P2Y12 receptor antagonists have been used widely for patients undergoing percutaneous coronary intervention with different results. Benefits from different regimens various between trials. Randomized controlled trials (RCTs) have restrictive inclusion and exclusion criteria; thus, they may limit the generalizability of the findings to a broader population. This study was aimed to comprehensively investigate the outcomes of potent P2Y12 inhibitors in patients undergoi ...[more]

PMID: 38371311

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Project description:BackgroundAmong patients receiving percutaneous coronary intervention (PCI), the role of a genotype-guided approach for antiplatelet therapy compared with usual care is unclear. We conducted a Bayesian analysis of the entire TAILOR-PCI (Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response After Percutaneous Coronary Intervention) randomized clinical trial population to evaluate the effect of the genotype-guided antiplatelet therapy post-PCI compared with the usual care on the risk of major adverse cardiovascular events (MACE).MethodsThe primary outcome for our study was the composite of MACE (myocardial infarction, stroke, and cardiovascular death). Secondary outcomes included cardiovascular death, stroke, myocardial infarction, stent thrombosis, and major/minor bleeding. Bayesian modeling was used to estimate the probability of clinical benefit of genotype-guided therapy using (1) noninformative priors (ie, analyzing the TAILOR-PCI trial) and (2) informative priors derived from the ADAPT, POPular Genetics, IAC-PCI, and PHARMCLO trials (ie, analyzing TAILOR-PCI trial in the context of prior evidence). Risk ratio (RR: ratio of cumulative outcome incidence between genotype-guided and conventional therapy group) and 95% credible interval (CrI) were estimated for the study outcomes, and probability estimates for RR <1 were computed.ResultsUsing noninformative priors, in TAILOR-PCI the RR for MACE was 0.78 (95% CrI, 0.55-1.07) in genotype-guided therapy after PCI, and the probability of RR <1 was 94%. Using noninformative priors, the probability of RR <1 for cardiovascular death (RR, 0.95 [95% CrI, 0.52-1.74]), stroke (RR, 0.68 [95% CrI, 0.44-1.06]), myocardial infarction (RR, 0.84 [95% CrI, 0.37-1.89]), stent thrombosis (RR, 0.75 [95% CrI, 0.37-1.45]), and major or minor bleeding (RR, 1.22 [95% CrI, 0.84-1.77]) were 57%, 96%, 67%, 81%, and 15%, respectively. Using informative priors, the posterior probability of RR <1 for MACE, from genotype-guided therapy, was 99% (RR, 0.69 [95% CrI, 0.57-0.84]). Using informative priors, the posterior probability of RR <1 for cardiovascular death (RR, 0.86 [95% CrI, 0.61-1.19]), stroke (RR, 0.69 [95% CrI, 0.48-0.99]), myocardial infarction (RR:0.56 [95% CrI, 0.40-0.78]), stent thrombosis (RR, 0.59 [95% CrI, 0.38-0.94]), and major or minor bleeding (RR, 0.84 [95% CrI, 0.70-0.99]) were 81%, 99%, 99%, 99%, and 99%, respectively.ConclusionsBayesian analysis of the TAILOR-PCI trial provides clinically meaningful data on the posterior probability of reducing MACE using genotype-guided P2Y12 inhibitor therapy after PCI.

Project description:BackgroundNew randomized, controlled trials have become available on oral P2Y12 inhibitors in acute coronary syndrome. We aimed to evaluate current evidence comparing the efficacy and safety profile of prasugrel, ticagrelor, and clopidogrel in acute coronary syndrome by a meta-analysis of randomized controlled trials.MethodsWe performed a network meta-analysis and direct pairwise comparison analysis of efficacy and safety outcomes from 12 randomized controlled trials including a total of 52 816 patients with acute coronary syndrome.ResultsIn comparison with clopidogrel, ticagrelor significantly reduced cardiovascular mortality (hazard ratio [HR], 0.82 [95% CI, 0.72-0.92]) and all-cause mortality (HR, 0.83 [95% CI, 0.75-0.92]), whereas there was no statistically significant mortality reduction with prasugrel (HR, 0.90 [95% CI, 0.80-1.01] and HR, 0.92 [95% CI, 0.84-1.02], respectively). In comparison with each other, there were no significant differences in mortality (HR prasugrel versus ticagrelor, 1.10 [95% CI, 0.94-1.29] and 1.12 [95% CI, 0.98-1.28]). In comparison with clopidogrel, prasugrel reduced myocardial infarction (HR, 0.81 [95% CI, 0.67-0.98]), whereas ticagrelor showed no risk reduction (HR, 0.97 [95% CI, 0.78-1.22]). Differences between prasugrel and ticagrelor were not statistically significant. Stent thrombosis risk was significantly reduced by both ticagrelor and prasugrel versus clopidogrel (28%-50% range of reduction). In comparison with clopidogrel, both prasugrel (HR, 1.26 [95% CI, 1.01-1.56]) and ticagrelor (HR, 1.27 [95% CI, 1.04-1.55]) significantly increased major bleeding. There were no significant differences between prasugrel and ticagrelor for all outcomes explored.ConclusionsPrasugrel and ticagrelor reduced ischemic events and increased bleeding in comparison with clopidogrel. A significant mortality reduction was observed with ticagrelor only. There was no efficacy and safety difference between prasugrel and ticagrelor. Registration: URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD42019155648.

Project description:BackgroundCilostazol combined with P2Y12 receptor inhibitor has been used as a substitute regimen for aspirin-intolerant patients undergoing percutaneous coronary stent implantation on a small scale. Its exact impact on platelet functions and clinical benefits of aspirin-intolerant patients is unknown.HypothesisCilostazol combined with P2Y12 receptor inhibitors could be used as a substitute antiplatelet regimen for aspirin-intolerant patients undergoing percutaneous coronary stent implantation.MethodsIn this multicenter prospective cohort trial, patients undergoing elective percutaneous coronary stent implantation were assigned to the cilostazol group (cilostazol plus P2Y12 receptor inhibitors), based on aspirin intolerance criteria, or the aspirin group (aspirin plus P2Y12 receptor inhibitors). Platelet PAC-1, CD62p, and vasodilator-stimulated phosphoprotein phosphorylation (VASP-P) were detected by flow cytometry. The primary endpoints were major adverse cardiovascular and cerebrovascular events (MACCE) including all-cause death, acute myocardial infarction, emerging arrhythmia, nonfatal stroke, and heart failure. The secondary endpoints were the Bleeding Academic Research Consortium (BARC) bleeding events.ResultsOne hundred and fifty-four aspirin-intolerant percutaneous coronary stent implantation patients and 154 matched aspirin-tolerant patients from a total of 2059 percutaneous coronary stent implantation patients were enrolled. The relative activation level of PAC-1, CD62p, and platelet reaction index reflected by the VASP-P test were similar in the two groups (p > .05). After 12 months of follow-up, the incidence of all-cause death was 1.9% in the cilostazol group and 1.3% in the aspirin group (risk ratio [RR], 1.500; 95% confidence interval [CI], 0.254-8.852; p = 1.000); the incidence of acute myocardial infarction was 0.6% in the cilostazol group and 1.3% in the aspirin group (RR, 0.500; 95% CI, 0.046-5.457; p = 1.000). No significant difference was seen in other MACCE events, or in any types of BARC bleeding events.ConclusionsCilostazol combined with P2Y12 inhibitors was not inferior to aspirin-based standard therapy and could be used as a reasonable substitute antiplatelet regimen for aspirin-intolerant patients undergoing percutaneous coronary stent implantation, but again with limitations, which required a larger sample and longer follow-up to confirm its efficacy.

Dataset Information

Comprehensive comparative efficacy and safety of potent P2Y₁₂ inhibitors in patients undergoing coronary intervention: A systematic review and meta-analysis.

Publications

Comprehensive comparative efficacy and safety of potent P2Y<sub>12</sub> inhibitors in patients undergoing coronary intervention: A systematic review and <i>meta</i>-analysis.

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