Safety and efficacy of double vs. triple antithrombotic therapy in patients with atrial fibrillation with or without acute  coronary syndrome undergoing percutaneous  coronary intervention： a systematic review  and meta-analysis of vitamin k antagonist  a

Objective: To compare the safety and efficacy of double therapy (DT) (no aspirin) versus triple therapy (TT) (with aspirin) antithrombotic drugs in patients with atrial fibrillation and acute coronary syndrome or underwent percutaneous coronary intervention (PCI).Methods: We searched PubMed, Cochrane, Scopus, and Web of Science for relevant articles from inception to December 2020. We conducted the analysis of dichotomous outcomes using risk ratio (RR) and relative 95% confidence interval (CI), while the continuous outcomes were analyzed using mean difference (MD) and relative 95% CI. Heterogeneous outcomes were analyzed with random-effects model, and homogeneous data were analyzed with fixed-effects model. We assessed the risk of bias among the included studies by using Cochrane’s risk of bias tool.Results: A total of five studies were included. Regarding Major or Minor Bleeding, the overall risk ratio was significantly lower with DT group compared with TT group (RR=0.60 [0.45, 0.81], (P = 0.07)). For the safety endpoint (TIMI major or minor bleeding, TIMI major bleeding) favored DT group over TT group, respectively (RR=0.60 [0.45, 0.81], (P = 0.07)); (RR= 0.55 [0.43, 0.70], (P < 0.01)). Intracranial hemorrhage did not differ between both groups (RR=0.62 [0.37, 1.05], (P = 0.07)). The efficacy endpoint, all-cause death showed no significant difference between both groups (RR=1.08 [0.89, 1.31], (P = 0.42)). There were no significant differences between two groups in cardiovascular death, stent thrombosis, myocardial infarction and stroke, respectively (RR=1.10 [0.86, 1.41], (P = 0.43); (RR=1.40 [0.92, 2.12], (P = 0.11); (RR=1.20 [0.98, 1.49], (P = 0.08); (RR=0.95 [0.66, 1.37], (P = 0.79).; respectively).Conclusion: Compared with triple antithrombotic therapy, double antithrombotic therapy is associated with lower bleeding risks, including minor and major bleeding, but the incidence of efficacy endpoints was similar between both groups.

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Safety and efficacy of double vs. triple antithrombotic therapy in patients with atrial fibrillation with or without acute coronary syndrome undergoing percutaneous coronary intervention: a collaborative meta-analysis of non-vitamin K antagonist oral anticoagulant-based randomized clinical trials

European Heart Journal - Cardiovascular Pharmacotherapy ◽

10.1093/ehjcvp/pvaa116 ◽

2020 ◽

Cited By ~ 2

Author(s):

Giuseppe Gargiulo ◽

Christopher P Cannon ◽

Charles Michael Gibson ◽

Andreas Goette ◽

Renato D Lopes ◽

...

Keyword(s):

Atrial Fibrillation ◽

Percutaneous Coronary Intervention ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Coronary Intervention ◽

Vitamin K Antagonist ◽

Safety And Efficacy ◽

Coronary Syndrome ◽

Percutaneous Coronary ◽

Triple Antithrombotic Therapy

Abstract Aims Safety and efficacy of antithrombotic regimens in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) may differ based on clinical presentation. We sought to compare double vs. triple antithrombotic therapy (DAT vs. TAT) in AF patients with or without acute coronary syndrome (ACS) undergoing PCI. Methods and results A systematic review and meta-analysis was performed using PubMed to search for non-vitamin K antagonist oral anticoagulant (NOAC)-based randomized clinical trials. Data on subgroups of ACS or elective PCI were obtained by published reports or trial investigators. A total of 10 193 patients from four NOAC trials were analysed, of whom 5675 presenting with ACS (DAT = 3063 vs. TAT = 2612) and 4518 with stable coronary artery disease (SCAD; DAT = 2421 vs. TAT = 2097). The primary safety endpoint of ISTH major bleeding or clinically relevant non-major bleeding was reduced with DAT compared with TAT in both ACS (12.2% vs. 19.4%; RR 0.63, 95% CI 0.56–0.71; P < 0.0001; I2 = 0%) and SCAD (14.6% vs. 22.0%; RR 0.68, 95% CI 0.55–0.85; P = 0.0008; I2 = 66%), without interaction (P-int = 0.54). Findings were consistent for secondary bleeding endpoints, including intra-cranial haemorrhage. In both subgroups, there was no difference between DAT and TAT for all-cause death, major adverse cardiovascular events, or stroke. Myocardial infarction and stent thrombosis were numerically higher with DAT vs. TAT consistently in ACS and SCAD (P-int = 0.60 and 0.86, respectively). Findings were confirmed by multiple sensitivity analyses, including a separate analysis on dabigatran regimens and a restriction to PCI population. Conclusions DAT, compared with TAT, is associated with lower bleeding risks, including intra-cranial haemorrhage, and a small non-significant excess of cardiac ischaemic events in both patients with or without ACS.

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Intracranial haemorrhages vs. stent thromboses with direct oral anticoagulant plus single antiplatelet agent or triple antithrombotic therapy: a meta-analysis of randomized trials in atrial fibrillation and percutaneous coronary intervention/acute coronary syndrome patients

EP Europace ◽

10.1093/europace/euz345 ◽

2020 ◽

Vol 22 (4) ◽

pp. 538-546 ◽

Cited By ~ 7

Author(s):

Mattia Galli ◽

Felicita Andreotti ◽

Italo Porto ◽

Filippo Crea

Keyword(s):

Atrial Fibrillation ◽

Percutaneous Coronary Intervention ◽

Antithrombotic Therapy ◽

Randomized Trials ◽

Coronary Intervention ◽

Direct Oral Anticoagulant ◽

Coronary Syndrome ◽

Thrombosis Risk ◽

Percutaneous Coronary ◽

Triple Antithrombotic Therapy

Abstract Aims To assess the efficacy-safety profile of dual antithrombotic therapy (DAT) including direct oral anticoagulant (DOAC) vs. triple antithrombotic therapy (TAT) in patients with atrial fibrillation (AF) and acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI). Methods and results Randomized trials of AF patients with ACS/PCI, comparing DAT using DOACs against TAT, were selected. Overall, 11 161 studies were screened, 458 trials assessed, and four included, comprising 10 234 patients followed for a mean of 11 months. DAT compared to TAT resulted in significant reductions of trial-defined primary safety outcome [odds ratio (OR) 0.63, 95% confidence interval (CI) 0.50–0.79, number needed to treat (NNT) 17] and of thrombolysis in myocardial infarction (TIMI) major bleeding (OR 0.54, 95% CI 0.41–0.70, NNT 76) and in a numerical reduction of intracranial haemorrhage (OR 0.50, 95% CI 0.21–1.19, NNT 314), which became significant after exclusion of DOACs from TAT and vitamin K antagonist from DAT arms (OR 0.31, 95% CI 0.15–0.64). There were no significant differences in the risks of cardiovascular or any deaths or stroke, but with DAT, there was a numerical increase in myocardial infarctions (MIs) (OR 1.23, 95% CI 0.99–1.54, estimated NNT for an additional harmful outcome (NNTH) 151), which became significant in the ACS/PCI subgroup (OR 1.43, 95% CI 1.02–2.00), and a 60% significant increase in stent thrombosis risk (OR 1.60, 95% CI 1.02–2.52; NNTH 274). Conclusion Dual antithrombotic therapy, compared to TAT, conferred a significantly reduced risk of overall bleeding but with a significant increase of stent thrombosis risk in the overall population and a significant 43% increase of MI in the ACS/PCI subgroup.

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