Personalized, CT-guided antithrombotic therapy versus lifelong single antiplatelet therapy to reduce thromboembolic and bleeding events in non-atrial fibrillation patients after transcatheter aortic valve implantation: a pragmatic, international, multicentre, randomized clinical trial (POPular ATLANTIS trial)

aortic valve stenosis

The primary endpoints are thromboembolic and bleeding events: Thromboembolic events, defined as the composite of cardiovascular mortality, ischaemic stroke, transient ischaemic attack, myocardial infarction, systemic embolism and clinically significant valve thrombosis according to the VARC-3 criteria. All bleeding, defined as the composite of type 1-4 bleeding, according to the VARC-3 criteria.

Net clinical benefit, defined as the composite of cardiovascular mortality, stroke, transient ischaemic attack, systemic embolism, clinically significant valve thrombosis and type 1-4 bleeding according to the VARC-3 criteria., Major bleeding (VARC-3 type 2-4), Cerebrovascular events (All stroke and TIA according to VARC-3), Cardiovascular mortality, All-cause mortality, Aortic bio-prosthetic valve dysfunction assessed by echocardiography yearly after TAVI (standard care)., Quality of life as assessed by EuroQol- 5 Dimension 5 Level (EQ-5D-5L), Kansas City Cardiomyopathy Questionnaire (KCCQ) and Short Form Health Survey (SF-12) at baseline, 3 and 12 months, and then yearly after TAVI procedure., Medication adherence as assessed by the Medication Adherence Report Scale (MARS-5) yearly after randomization., To evaluate the cost-effectiveness of a CT-guided antithrombotic strategy after TAVI.

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