PROTamine Application in patients underGOing tRAnScatheter aortic valve replacement (PROTAGORAS)

Adult patients with severe aortic stenosis scheduled for transfemoral TAVR

Primary and key secondary endpoints (hierarchical testing) are: Primary: Bleeding grade ≥type 2 (VARC) until 60h post TAVR procedure (superiority); Key secondary: Major ischemic events until 60h post procedure (non-inferiority) defined as the composite of Cardiovascular mortality, Myocardial infarction, Ischemic stroke, Major ischemic vascular complications

• Index-hospital mortality, • All-cause mortality at 30 days post TAVR procedure, • Bleeding grade type 1 (VARC) until 60h post TAVR procedure, • Unplanned cardiac or vascular surgery at 30 days post TAVR procedure, • Minor vascular complications until 60h post TAVR procedure, • Mean aortic valve gradient measured by transthoracic echocardiography (TTE) until 60h post TAVR procedure, • Delta mean aortic valve gradient (before TAVR vs. post TAVR procedure) measured by TTE until 60h post TAVR procedure, • Evidence of subclinical TAVR valve thrombosis until 60h post TAVR procedure, • Analysis of patients with and without oral anticoagulation with respect to the primary endpoint, • Analysis of patients with single vs. dual antiplatelet therapy with respect to the primary endpoint, • Analysis of different vascular closure devices with respect to the primary endpoint, • Analysis of different sheath sizes with respect to the primary endpoint, • Maximal drop of hemoglobin level from admission until follow-up until 60h post TAVR procedure, • Amount of red blood cell transfusions until 60h post TAVR procedure, • Performance of percutaneous transluminal angioplasty of access site until 60h post TAVR procedure, • Sex-specific analysis of the primary composite endpoint as well as its components, • Sex-specific analysis of all secondary endpoints, • Change of baseline NYHA class at 30 days post TAVR procedure, • Length of hospital stay after TAVR procedure

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