Meta-analysis of antithrombotic therapy with new oral anticoagulants in patients with atrial fibrillation after percutaneous coronary intervention.
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ABSTRACT:
SUBMITTER: Siddiqi R
PROVIDER: S-EPMC7203637 | biostudies-literature |
REPOSITORIES: biostudies-literature
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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.
| S-EPMC8545975 | biostudies-literature
Project description:Background The optimal antithrombotic therapy for patients with atrial fibrillation undergoing percutaneous coronary intervention is a topic of debate. We aimed at defining the efficacy and safety of double antithrombotic therapy with single antiplatelet therapy (SAPT) plus a non-vitamin K antagonist oral anticoagulant (NOAC) against triple antithrombotic therapy with dual antiplatelet therapy (DAPT) added to a vitamin K antagonist (VKA), illustrating the pooled cumulative distribution of events, the ranking of different NOACs tested in NOAC+SAPT combination strategies, and the state of the current evidence in the field. Methods and Results Randomized controlled trials meeting the inclusion criteria were identified. The primary efficacy end point was the composite of trial-defined major adverse cardiac events. The primary safety end point was clinically significant bleeding. Secondary end points were the components of primary end points. Trial-level pairwise and Bayesian network meta-analyses, reconstructed Kaplan-Meier analyses, and trial sequential analysis were performed. Four randomized controlled trials (10 969 patients) were included. No differences were found in terms of major adverse cardiac events (hazard ratio [HR], 1.07; 95% CI, 0.94-1.22), and the NOAC+SAPT strategy showed a lower rate of clinically significant bleeding compared with VKA + DAPT (HR, 0.56; 95% CI, 0.39-0.80). These results were consistent in reconstructed Kaplan-Meier analyses. In the Bayesian network meta-analysis, different NOACs displayed diverse risk-benefit profiles. Trial sequential analyses suggest that the evidence for the similarity in major adverse cardiac events compared with VKA + DAPT and the bleeding risk reduction observed with NOAC+SAPT is likely to be conclusive. Conclusions NOAC+SAPT does not increase the risk of major adverse cardiac events and reduces the risk of bleeding compared with VKA + DAPT in AF patients undergoing percutaneous coronary intervention. Various NOACs may have different risk-benefit profiles in combination strategies. Registration URL: https://www.crd.york.ac.uk/prospero/; Unique identifier: CRD42020151089.
| S-EPMC7660808 | biostudies-literature
Project description:ObjectiveThe aim of this systematic review and network meta-analysis was to evaluate the comparative efficacy and safety of antiplatelet agents, vitamin K antagonist (VKA) and non-VKA oral anticoagulants (NOACs) in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI).MethodsPubMed, EMBASE, and the Cochrane Central Register of Controlled Trials were searched to identify clinical trials comparing antiplatelet drugs with VKA and NOACs or their combination in AF patients undergoing PCI with a mean/median follow-up of at least 12 months. A network meta-analysis was conducted to directly and indirectly compare the efficacy and safety of competitive antithrombotic regimens with a Bayesian random-effects model. Results were presented as relative risks (RRs) and 95% confidence intervals (CIs).ResultsA total of 15 studies enrolling 13,104 patients were included. Among 5 regimens, rivaroxaban 15 mg daily plus P2Y12 inhibitor treatment demonstrated significant superiority over dual- and triple-antiplatelet therapies (DAPT, TT) in reducing thromboembolic events (0.64 [0.38, 0.95] and 0.68 [0.43, 0.98], respectively) but showed the maximum possibility of major bleeding risk, while VKA plus single antiplatelet therapy (SAPT) seemed the safest. Significantly less risk of major bleeding was seen in DAPT group than that in TT group (0.63 [0.39, 0.99]).ConclusionsThe present study suggests that combination of VKA and SAPT is the best choice for AF patients undergoing PCI considering both efficacy and safety. Rivaroxaban 2.5 mg twice daily plus DAPT treatment owns the highest probability to be the optimal alternative to VKA plus SAPT for these patients.
| S-EPMC5638551 | biostudies-literature
Project description:BackgroundsWe investigated the prognostic impact of antithrombotic regimens at 1-year after percutaneous coronary intervention (PCI) among patients with atrial fibrillation (AF).Method and resultsA total of 13,278 AF patients who underwent PCI from 2009 to 2013 were selected from Korean National Health Insurance Service database. Patients were categorized by antithrombotic regimens at 1-year after PCI: (1) OAC with or without single antiplatelet (OAC±SAPT); (2) triple therapy (TT) and (3) antiplatelets (APT) only. After propensity score matching, composite ischaemia (death, myocardial infarction, and stroke), composite bleeding (intracranial hemorrhage and gastrointestinal bleeding), and a composite clinical outcome (composite ischaemia and bleeding) were compared. Of total population, 1,100 (8.3%), 746 (5.6%), and 11,432 (86.1%) were treated with OAC±SAPT, TT, and APT only, respectively. Compared to OAC±SAPT group, the TT group had significantly higher risk of the composite clinical outcome (hazard ratio [HR] 1.46, 95% confidence interval [CI] 1.00-2.13) attributed to a higher trend in both ischaemia (HR 1.63, 95% CI 0.99-2.67) and bleeding (HR 1.22, 95% CI 0.69-2.13). The APT only group showed a higher risk of ischaemia (HR 1.85, 95% CI 1.25-2.74), despite a lower risk of bleeding (HR 0.55, 95% CI 0.32-0.94) compared to OAC±SAPT group.ConclusionsOAC±SAPT was associated with better clinical outcomes compared to TT or APT only treatments, beyond 1-year after PCI among Asians with AF.
| S-EPMC7561121 | biostudies-literature
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.
| S-EPMC7240352 | biostudies-literature
Project description:BackgroundPatients with atrial fibrillation undergoing percutaneous coronary intervention have indications for oral anticoagulation and dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor. The concurrent use of all three agents, termed triple oral antithrombotic therapy (TAT), increases the risk of bleeding. A number of prospective trials showed that the omission of aspirin mitigates the risk of bleeding without affecting major adverse cardiovascular event (MACE).Materials and methodsThe databases of PubMed, Embase, and Cochrane Central databases were searched from inception to October 2019. Relevant randomized control trials comparing dual antithrombotic therapy (DAT) versus TAT were identified and a metanalysis was performed using random-effect model. The safety endpoints of interest were thrombolysis in myocardial infarction criteria (TIMI) major and minor bleeding, TIMI major bleeding, and intracranial bleeding. The efficacy endpoints of interest were MACE and individual components of MACE.ResultsSix trials with 11,722 patients were included. For safety endpoint, DAT was associated with significantly lower incidence of TIMI major and minor bleeding [RR: 0.58, 95% CI 0.44-0.77, P = 0.0001], TIMI major bleeding [RR: 0.55, 95% CI 0.42-0.73, P < 0.0001] as well as intracranial bleeding [RR: 0.35, 95% CI 0.16-0.73, P = 0.006] compared with TAT. No significant difference was observed for MACE [RR: 0.96 (0.79-1.17) P = 0.71] or any of the individual components of MACE between the two groups.ConclusionOmission of aspirin from TAT in patients with Atrial Fibrillation (AF) after percutaneous coronary intervention is associated with lower risk of bleeding without compromising the efficacy in terms of mortality and cardiovascular thrombotic events.
| S-EPMC7791287 | biostudies-literature
Project description:Patients with atrial fibrillation affected by an acute coronary syndrome have indications for oral anticoagulation and dual antiplatelet therapy with aspirin and a P2Y12 adenosine diphosphate receptor inhibitor after coronary artery stenting. The concurrent use of all 3 agents, termed triple oral antithrombotic therapy, significantly increases the risk of bleeding. To date, there is a lack of evidence on the proper combination and duration of anticoagulant and antiplatelet agents in patients with indications for both therapies. As such, care has been guided by expert opinion, and there is wide variation in clinician practice. In this review, the latest evidence on the risks and benefits of triple oral antithrombotic therapy in patients with atrial fibrillation after coronary artery stenting is summarized. We discuss the clinical risk scores useful in guiding the prediction of stroke, bleeding, and stent thrombosis. Additionally, we highlight where additional evidence is needed to determine the proper balance of anticoagulant and antiplatelet agents in this patient population.
| S-EPMC6649565 | biostudies-literature
Project description:BACKGROUND:The combination of vitamin K antagonists (VKA) for atrial fibrillation (AF) and antiplatelet agents following percutaneous coronary intervention (PCI) is associated with an increased bleeding risk. HYPOTHESIS:Direct oral anticoagulants (DOAC) are associated with a greater safety profile but the optimal antithrombotic treatment strategy, especially when considering ischemic events, is unclear. METHODS:We performed a meta-analysis of randomized controlled trials comparing outcomes in AF patients following PCI and/or acute coronary syndrome (ACS) when treated with DOAC vs VKA, both in combination with one (dual) or two (triple) antiplatelet regimens. A systematic review was performed by searches of electronic databases MEDLINE (source PubMed) and the Cochrane Controlled Clinical Trials Register Database as well as Cardiology annual meetings. Three studies were finally included. RESULTS:Compared to VKA triple therapy, the use of DOAC was associated with a decreased risk of any bleeding (relative risk [RR] 0.68 [0.62; 0.74]), major bleeding (RR 0.61 [0.51; 0.75]) and intracranial bleeding (RR 0.33 [0.17; 0.66]) and similar rates of the composite efficacy endpoint (RR 1.0 [0.87; 1.14]) and its components. Similar and consistent results were observed with both dual and triple therapy including a DOAC compared to VKA. CONCLUSION:Our meta-analysis supports the use of dual therapy combining a DOAC and clopidogrel as the default regimen in most AF patients after PCI and/or ACS.
| S-EPMC6727878 | biostudies-other
Project description:BackgroundIn patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), selecting an antithrombotic regimen requires balancing risks of ischemic cardiac events, stroke, and bleeding.MethodsWe studied 467 patients with AF undergoing PCI in the time period from December 2015 to July 2018 identified via a chart audit by 47 Canadian cardiologists in the CONNECT AF+PCI (the Coordinated National Network to Engage Interventional Cardiologists in the Antithrombotic Treatment of Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention) study, to determine patterns of initial antithrombotic therapy selection.ResultsThe median (25th, 75th percentile) CHADS2 score was 2 (1, 3), and PCI was performed in the setting of acute coronary syndrome in 62.1%. Triple antithrombotic therapy (TAT) was the initial treatment in 62.7%, dual-pathway therapy in 25.7%, and dual antiplatelet therapy in 11.6%, with a temporal increase in use of dual-pathway therapy during the course of the study; median intended TAT duration was 1 (1, 3) month. Compared with patients selected for TAT, patients selected for dual-pathway therapy were less likely to have prior myocardial infarction (35.8% vs 25.8%, P = 0.045) and prior PCI (33.8% vs 23.3%, P = 0.03), and they received shorter total length of stents (38 [23, 56] vs 30 [20, 46] mm, P = 0.03). Patients selected for dual-pathway therapy had a higher prevalence of prior stroke/transient ischemic attack (13.0% vs 23.3%, P = 0.01). There was no difference in prevalence of anemia (21.5% vs 25.8%, P = 0.30). Use of dual-pathway therapy was similar among patients with acute coronary syndrome and those with stable disease (24.1% vs 28.2%, P = 0.32).ConclusionsApproximately one-quarter of AF patients undergoing PCI are treated with dual-pathway therapy in Canadian practice, with its use increasing during the studied period. Patients selected for dual-pathway therapy have less-complex coronary disease history and intervention.
| S-EPMC8712598 | biostudies-literature
Project description:BackgroundPatients on oral anticoagulants (OACs) undergoing percutaneous coronary intervention (PCI) also require aspirin and a P2Y12 inhibitor (triple therapy). However, triple therapy increases bleeding. The use of non-vitamin K antagonist oral anticoagulants (NOACs) and stronger P2Y12 inhibitors has increased. The aim of our study was to gain insight into antithrombotic management over time.MethodsA prospective cohort study of patients on OACs for atrial fibrillation or a mechanical heart valve undergoing PCI was performed. Thrombotic outcomes were myocardial infarction, stroke, target-vessel revascularisation and all-cause mortality. Bleeding outcome was any bleeding. We report the 30-day outcome.ResultsThe mean age of the 758 patients was 73.5 ± 8.2 years. The CHA2DS2-VASc score was ≥ 3 in 82% and the HAS-BLED score ≥ 3 in 44%. At discharge, 47% were on vitamin K antagonists (VKAs), 52% on NOACs, 43% on triple therapy and 54% on dual therapy. Treatment with a NOAC plus clopidogrel increased from 14% in 2014 to 67% in 2019. The rate of thrombotic (4.5% vs 2.0%, p = 0.06) and bleeding (17% vs. 14%, p = 0.42) events was not significantly different in patients on VKAs versus NOACs. Also, the rate of thrombotic (2.9% vs 3.4%, p = 0.83) and bleeding (18% vs 14%, p = 0.26) events did not differ significantly between patients on triple versus dual therapy.ConclusionsPatients on combined oral anticoagulation and antiplatelet therapy undergoing PCI are elderly and have both a high bleeding and ischaemic risk. Over time, a NOAC plus clopidogrel became the preferred treatment. The rate of thrombotic and bleeding events was not significantly different between patients on triple or dual therapy or between those on VKAs versus NOACs.
| S-EPMC9123099 | biostudies-literature