Key result
Dual antithrombotic treatments without aspirin reduced ISTH major bleeding compared to VKA-based triple therapy.
Why the study?
To analyze pooled data from three recent trials evaluating dual antithrombotic therapies with NOACs and a P2Y12 inhibitor without aspirin versus VKA-based triple therapy in patients with AF and ACS or undergoing PCI.
Does dual antithrombotic therapy with a NOAC and P2Y12 inhibitor without aspirin reduce bleeding compared to VKA-based triple therapy in AF patients with ACS or undergoing PCI?
Meta-Analysis (n=9,463)
Yes
Does dual antithrombotic therapy with a NOAC and P2Y12 inhibitor without aspirin reduce bleeding compared to VKA-based triple therapy in AF patients with ACS or undergoing PCI?
In AF patients with ACS or undergoing PCI, NOAC-based dual antithrombotic therapy without aspirin significantly reduces bleeding compared to VKA-based triple therapy, though it may increase the risk of stent thrombosis.
Answers are grounded in this paper and cite their sources.
Supports omitting aspirin from NOAC-based dual therapy to cut major bleeding in AF with ACS/PCI; reinforces this approach over VKA triple therapy.
AIMS: Recently, three randomized trials reported that dual antithrombotic treatments (DATs) including non-vitamin K antagonist oral anticoagulants (NOACs) and a P2Y12 inhibitor without aspirin were associated with significantly less bleeding than vitamin K antagonist (VKA)-based triple antithrombotic therapy (TAT) in atrial fibrillation (AF) patients with acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI). We conducted an analysis of pooled data from these trials. METHODS AND RESULTS: A meta-analysis of the PIONEER AF-PCI, RE-DUAL PCI, and AUGUSTUS trials considering major bleeding [International Society on Thrombosis and Haemostasis (ISTH) and Thrombolysis in Myocardial Infarction], clinically relevant non-major bleeding, all-cause/cardiovascular death, stroke, myocardial infarction (MI), and stent thrombosis. Treatment effect is reported as odds ratio (OR) and 95% confidence interval. Among 9463 patients (53% with ACS), DAT regimens were associated with significantly less bleeding than TAT (OR 0.598, 0.491 -0.727; P < 0.001 for ISTH major bleeding), as were NOAC-based vs. VKA-based regimens (OR 0.577, 0.477 -0.698; P < 0.001). Stroke and mortality rates were similar, but there was statistically non-significant trend towards greater risk of MI (OR 1.211, 0.955 -1.535; P = 0.115) and significantly higher risk for stent thrombosis (OR 1.672, 1.022 -2.733, P = 0.041) with DAT vs. TAT (but not NOAC- vs. VKA-based regimens). This was mainly driven by Dabigatran 110 mg; the trends were lower with full-dose NOAC or Rivaroxaban 15 mg-based DATs. CONCLUSION: Our findings support the use of full-dose NOAC (Apixaban 5 mg, Dabigatran 150 mg) or Rivaroxaban 15 mg-based treatments in most AF patients with ACS or undergoing PCI. Notwithstanding the better safety of DAT, an initial course of NOAC-based TAT may be desirable in most AF patients.
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Potpara et al. (2019) conducted a meta-analysis in Atrial fibrillation with acute coronary syndrome or undergoing percutaneous coronary intervention (n=9,463). Dual antithrombotic treatments (DATs) without aspirin vs. Vitamin K antagonist (VKA)-based triple antithrombotic therapy (TAT) was evaluated on ISTH major bleeding (OR 0.598, 95% CI 0.491-0.727, p=< 0.001). Dual antithrombotic treatments without aspirin reduced ISTH major bleeding compared to VKA-based triple therapy.
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