Dual therapy with edoxaban as safe as triple therapy in AF regardless of reason for PCI
Among patients with atrial fibrillation who underwent PCI, dual therapy with edoxaban showed similar safety and efficacy as triple therapy with a vitamin K antagonist at 1 year, regardless of whether coronary disease was acute or chronic.
At 1 year, although the strategy of dual antithrombotic therapy with edoxaban (Savaysa, Daiichi Sankyo) trended towards better safety among patients with ACS, in those with stable CAD, major bleeding rates were very similar, according to data from a subanalysis of the ENTRUST-AF PCI trial presented at the European Society of Cardiology Congress.
In those with stable CAD, also known as chronic coronary syndrome (CCS), those assigned dual therapy with edoxaban had elevated risk for bleeding at 2 weeks but reduced risk between 2 weeks and 1 year compared with those assigned triple therapy with a vitamin K antagonist, according to the researchers.
Healio previously reported on the primary findings of the ENTRUST-AF PCI trial at the 2019 ESC Congress.
“In this prespecified subgroup analysis of the ENTRUST-AF PCI trial, we analyzed safety and efficacy endpoints according to clinical presentation over 12 months,” Pascal Vranckx, MD, PhD, from the faculty of medicine and life sciences at the Hasselt University in Hasselt, Belgium, and colleagues wrote in a simultaneous publication in the European Heart Journal. “For the primary composite endpoint of ISTH major and clinically relevant nonmajor bleeding, we did not find a difference in treatment effects between ACS and CCS patients treated with edoxaban and a P2Y12 inhibitor and VKA in combination with a P2Y12 inhibitor plus aspirin for 1 to 12 months.”
The analysis included 1,506 patients with AF who had PCI (median age, 70 years; 26% women) stratified based on presentation with ACS or stable CAD.
“The comparative safety and efficacy of combination regimens of antiplatelets and anticoagulants may differ among patients with AF according to their clinical presentation,” the researchers wrote. “Therefore, we prespecified to assess the consistency of the treatment effects among patients with ACS or CCS who underwent PCI and were included in the ENTRUST-AF PCI trial.”
Bleeding after PCI on dual therapy
At 12 months, in patients with ACS, the primary outcome occurred in 15.2% of those assigned dual therapy compared with 20.3% of those assigned triple therapy (HR = 0.73; 95% CI, 0.59-1.02). In the population with stable CAD, the primary outcome occurred in 19% of patients on dual therapy compared with 19.9% of those on triple therapy (HR = 0.94; 95% CI, 0.68-1.31; P for interaction = .2741).
Prevalence of a secondary composite outcome, which included CV death, MI, stroke, systemic embolic event or stent thrombosis, was similar when investigators compared subgroups (ACS: dual therapy group, 8.5%; triple therapy group, 7.2%; HR = 1.16; 95% CI, 0.7-1.92; stable CAD: dual therapy group, 4.4%; triple therapy group, 4.9%; HR = 0.91; 95% CI, 0.47-1.78; P for interaction = .5573).
‘Early hazard of bleeding’
“There was a favorable HR for VKA relative to edoxaban in the first 2 weeks that converted to an almost similar HR for both subgroups that continuously favored edoxaban throughout the remainder of the study period,” the researchers wrote in the European Heart Journal. “The early hazard of bleeding events with edoxaban over VKA was more pronounced in the CCS patients as compared to the ACS patients. The lower-than-expected bleeding rate on VKA in the first 2 weeks may be explained by the high proportion of patients with an INR < 2, no bridging with low molecular weight heparins was used in VKA patients.”
Reference:
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Vranckx P, et al. Poster 87277. Presented at: European Society of Cardiology Congress; Aug. 29-Sept. 1, 2020 (virtual meeting).
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