Adding antiplatelet therapy to oral anticoagulation in atrial fibrillation patients after TAVI increased net adverse clinical events (HR 2.29) and major bleeding (HR 3.33).
Does adding antiplatelet therapy to oral anticoagulation reduce net adverse clinical events and major bleeding in patients with atrial fibrillation after successful TAVI?
In patients with atrial fibrillation undergoing TAVI, adding antiplatelet therapy to oral anticoagulation significantly increases the risk of net adverse clinical events, major bleeding, and stroke without improving mortality.
Absolute Event Rate: 0% vs 0%
Abstract Background/Introduction Few studies have compared dual versus single anti-thrombotic therapy, consisting of oral anticoagulation (OAC) with or without single (SAPT) or dual (DAPT) concomitant antiplatelet therapy (APT) in patients with atrial fibrillation (AF) before transcatheter aortic valve implantation (TAVI), but no study did so after successful intervention. Purpose To investigate the effect of OAC with APT on net adverse clinical events (NACE), bleeding, and stroke in patients with AF after successful TAVI. Methods This analysis compared annualised clinical event rates in patients with or without concomitant APT in ENVISAGE-TAVI AF (NCT02943785), a prospective, randomised, open-label, adjudicator-masked trial comparing edoxaban and vitamin K antagonists (VKA) in patients with AF after TAVI. The primary efficacy and safety outcomes were NACE and major bleeding. Results Of 1377 patients who received at least one dose of the study drug, 658 (47.8%) had pre-declared APT at randomisation and 821 (59.6%) were exposed to APT therapy during follow-up. Patients with APT were more likely to have a history of stroke or transient ischaemic attack, myocardial infarction, and prior percutaneous coronary intervention. At inverse probability weighted analysis with a marginal structural model, APT exposure was associated with higher risk of NACE (hazard ratio (HR) 95% confidence interval (CI): 2.29 1.67, 3.15; P0.0001), major bleeding (HR 95%CI: 3.33 2.13, 5.20; P0.0001), major gastrointestinal bleeding, (HR 95%CI: 4.10 2.16, 7.76; P0.0001), any stroke (HR 95%CI: 3.49 1.69, 7.21; P=0.0008) and ischaemic stroke (HR 95%CI: 3.84 1.62, 9.10; P=0.002; Figure 1). All-cause death did not differ between patients with or without APT. Stratified analyses of SAPT or DAPT compared with no APT or type of OAC yielded consistent results (Figure 2). Conclusions Among patients with AF who underwent successful TAVI, dual anti-thrombotic therapy with OAC and APT was associated with similar mortality but greater risk of NACE, major bleeding, and stroke compared with OAC alone, irrespective of the random allocation to edoxaban or VKA.For image description, please refer to the figure legend and surrounding text. For image description, please refer to the figure legend and surrounding text.
Valgimigli et al. (Sun,) reported a other. Adding antiplatelet therapy to oral anticoagulation in atrial fibrillation patients after TAVI increased net adverse clinical events (HR 2.29) and major bleeding (HR 3.33).