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P2Y12 inhibitors with oral anticoagulation for percutaneous coronary intervention with atrial fibrillation: a systematic review and meta-analysis.

ABSTRACT: OBJECTIVE:This study aimed to compare the safety and efficacy of third-generation P2Y12 inhibitors versus clopidogrel in combination with oral anticoagulation (OAC) with or without aspirin in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI). METHODS:We performed a systematic review including both prospective and retrospective studies that compared dual and triple antithrombotic regimens for bleeding and major adverse cardiac events (MACE) in patients with AF undergoing PCI. We analysed rates of bleeding and MACE by P2Y12 inhibitor choice. Risk ratio (RR) 95% CIs were measured using the Mantel-Haenszel method. Where study heterogeneity was low (I2 <25%), we used the fixed effects model, otherwise the random effects model was used. RESULTS:A total of 22?014 patients were analysed from the seven studies included. Among patients treated with both OAC and P2Y12 inhibitor with or without aspirin, 90% (n=9708) were treated with clopidogrel, 8% (n=830) with ticagrelor, and 2% (n=191) with prasugrel. When compared with clopidogrel, use of ticagrelor (RR 1.36; 95%?CI 1.18 to 1.57) and prasugrel (RR 2.11; 95%?CI 1.34 to 3.30) were associated with increased rates of bleeding. Compared with clopidogrel, there were no significant differences in rates of MACE with ticagrelor (RR 1.03; 95%?CI 0.65 to 1.62) or prasugrel (RR 1.49; 95%?CI 0.69 to 3.24). CONCLUSION:Based on this meta-analysis, the use of clopidogrel is associated with a lower rate of bleeding compared with ticagrelor or prasugrel in patients with AF on OAC undergoing PCI.

SUBMITTER: Lupercio F

PROVIDER: S-EPMC7265981 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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P2Y<sub>12</sub> inhibitors with oral anticoagulation for percutaneous coronary intervention with atrial fibrillation: a systematic review and meta-analysis.

Lupercio Florentino F Giancaterino Shaun S Villablanca Pedro Arturo PA Han Frederick F Hoffmayer Kurt K Ho Gordon G Raissi Farshad F Krummen David D Birgersdotter-Green Ulrika U Feld Gregory G Reeves Ryan R Mahmud Ehtisham E Hsu Jonathan C JC

Heart (British Cardiac Society) 20200207 8

<h4>Objective</h4>This study aimed to compare the safety and efficacy of third-generation P2Y<sub>12</sub> inhibitors versus clopidogrel in combination with oral anticoagulation (OAC) with or without aspirin in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI).<h4>Methods</h4>We performed a systematic review including both prospective and retrospective studies that compared dual and triple antithrombotic regimens for bleeding and major adverse cardiac eve ...[more]

PMID: 32034008

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Project description:Background: Warfarin, along with aspirin and clopidogrel, has long been recommended for patients with atrial fibrillation (AF) who are undergoing percutaneous coronary intervention with a drug-eluting stent (PCI-DES). However, this triple therapy has been known to increase the risk of bleeding complications. Meanwhile, there is no evidence from prospective trials on the use of ticagrelor in a dual therapy. We here aimed to compare the antiplatelet drug ticagrelor as a dual antithrombotic agent to aspirin and clopidogrel in bleeding events. Methods: In this multicenter, active-controlled, open-label, randomized trial, patients with AF taking warfarin who had undergone PCI-DES were randomly assigned to the ticagrelor therapy group (Dual group) or the clopidogrel plus aspirin therapy group (Triple group). The primary and secondary endpoints were overall bleeding events and major bleeding events, respectively, according to the Thrombolysis in Myocardial Infarction (TIMI) criteria at 6 months. Cardiovascular events [re-PCI, surgical bypass, myocardial infarction (MI), heart failure, rehospitalization due to angina pectoris, stent thrombosis and death due to cardiovascular causes] at 6 months were also recorded. Results: A total of 296 patients from 12 medical centers in China were randomized after PCI-DES to either the Dual therapy group (n = 148) or the Triple group (n = 146) for 6 months. The overall incidence of bleeding events at 6 months was 36.49% in the Dual therapy group and 35.62% in the Triple group [hazard ratio, 0.930; 95% confidence interval (CI), 0.635 to 1.361; P = 0.7088]. The incidence of the secondary endpoint over 6 months was 4.73% in the Dual therapy group and 1.37% in the Triple group (hazard ratio, 0.273; 95% CI, 0.057 to 1.315; P = 0.1056). Cardiovascular event occurrence was also comparable in both groups at 6 months (18.24 vs. 16.44%; hazard ratio, 0.845; 95% CI, 0.488 to 1.465; P = 0.5484). Conclusions: The incidence of total bleeding events in AF patients treated with ticagrelor was comparable to that in patients treated with clopidogrel plus aspirin at 6 month; Meanwhile, the incidence of cardiovascular events were also comparable between the groups. Clinical Trial Registration: MANJUSRI, ClinicalTrials.gov# NCT02206815, 2014, August 1st.

Project description:ImportanceAntithrombotic treatment in patients with atrial fibrillation (AF) and percutaneous coronary intervention (PCI) presents a balancing act with regard to bleeding and ischemic risks.ObjectivesTo evaluate the safety and efficacy of 4 antithrombotic regimens by conducting an up-to-date network meta-analysis and to identify the optimal treatment for patients with AF undergoing PCI.Data sourcesOnline computerized database (MEDLINE).Study selectionFive randomized studies were included (N?=?11?542; WOEST, PIONEER AF-PCI, RE-DUAL PCI, AUGUSTUS, ENTRUST-AF PCI).Data extraction and synthesisThe Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used in this network meta-analysis, in which bayesian random-effects models were applied. The data were analyzed from September 9 to 29, 2019.Main outcomes and measuresThe primary safety outcome was thrombolysis in myocardial infarction (TIMI) major bleeding and the primary efficacy outcome was trial-defined major adverse cardiovascular events (MACE).ResultsThe total number of participants included in the study was 11 532. The mean age of the participants ranged from 70 to 72 years, 69% to 83% were male, 20% to 26% were female, and the participants were predominantly white (>90%). Compared with vitamin K antagonists (VKA) plus dual antiplatelet therapy (DAPT) (reference), the odds ratios (ORs) (95% credible intervals) for TIMI major bleeding were 0.57 (0.31-1.00) for VKA plus P2Y12 inhibitor, 0.69 (0.40-1.16) for non-VKA oral anticoagulant (NOAC) plus DAPT, and 0.52 (0.35-0.79) for NOAC plus P2Y12 inhibitor. For MACE, using VKA plus DAPT as reference, the ORs (95% credible intervals) were 0.97 (0.64-1.42) for VKA plus P2Y12 inhibitor, 0.95 (0.64-1.39) for NOAC plus DAPT, and 1.03 (0.77-1.38) for NOAC plus P2Y12 inhibitor.Conclusions and relevanceThe findings of this study suggest that an antithrombotic regimen of VKA plus DAPT should generally be avoided, because regimens in which aspirin is discontinued may lead to lower bleeding risk and no difference in antithrombotic effectiveness. The use of a NOAC plus a P2Y12 inhibitor without aspirin may be the most favorable treatment option and the preferred antithrombotic regimen for most patients with AF undergoing PCI.

Project description:BackgroundThe safety and effectiveness of dual therapy (direct oral anticoagulant [DOAC] plus P2Y12 inhibitor) versus triple therapy (vitamin K antagonist plus aspirin and P2Y12 inhibitor) in patients with nonvalvular atrial fibrillation (AF) after percutaneous coronary intervention (PCI) is unclear.PurposeTo examine the effects of dual versus triple therapy on bleeding and ischemic outcomes in adults with AF after PCI.Data sourcesSearches of PubMed, EMBASE, and the Cochrane Library (inception to 31 December 2019) and ClinicalTrials.gov (7 January 2020) without language restrictions; journal Web sites; and reference lists.Study selectionRandomized controlled trials that compared the effects of dual versus triple therapy on bleeding, mortality, and ischemic events in adults with AF after PCI.Data extractionTwo independent investigators abstracted data, assessed the quality of evidence, and rated the certainty of evidence.Data synthesisFour trials encompassing 7953 patients were selected. At the median follow-up of 1 year, high-certainty evidence showed that dual therapy was associated with reduced risk for major bleeding compared with triple therapy (risk difference [RD], -0.013 [95% CI, -0.025 to -0.002]). Low-certainty evidence showed inconclusive effects of dual versus triple therapy on risks for all-cause mortality (RD, 0.004 [CI, -0.010 to 0.017]), cardiovascular mortality (RD, 0.001 [CI, -0.011 to 0.013]), myocardial infarction (RD, 0.003 [CI, -0.010 to 0.017]), stent thrombosis (RD, 0.003 [CI, -0.005 to 0.010]), and stroke (RD, -0.003 [CI, -0.010 to 0.005]). The upper bounds of the CIs for these effects were compatible with possible increased risks with dual therapy.LimitationHeterogeneity of study designs, dosages of DOACs, and types of P2Y12 inhibitors.ConclusionIn adults with AF after PCI, dual therapy reduces risk for bleeding compared with triple therapy, whereas its effects on risks for death and ischemic end points are still unclear.Primary funding sourceNone.

Dataset Information

P2Y12 inhibitors with oral anticoagulation for percutaneous coronary intervention with atrial fibrillation: a systematic review and meta-analysis.

Publications

P2Y<sub>12</sub> inhibitors with oral anticoagulation for percutaneous coronary intervention with atrial fibrillation: a systematic review and meta-analysis.

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