From:  Antithrombotic therapy after transcatheter mitral valve repair and replacement: a systematic review of outcomes and safety

 Aggregated primary and secondary outcomes across included studies.

StudyPrimary outcome(s)Secondary outcome(s)
El Bèze et al. [15]Bleeding complications (9% DOAC vs. 40% VKA)Stroke, mortality, major vascular complications, and length of hospital stay.
Guerrero et al. [16]1 year mortality (22.4%)Stroke (1.5%), device thrombosis (1.7%), mitral valve reintervention (9.1%), and major vascular complications (2.3%).
Giustino et al. [17]Incidence of CVE (7.8% at 4 years)Impact of anticoagulation on CVE risk (HR: 0.24 with anticoagulation, HR: 2.27 without).
Körber et al. [18]MVARC-defined bleeding complications (21.6%)Major bleeding (7.4%), transfusion requirement (4.9%), and mortality.
Paukovitsch et al. [19]MVARC-defined bleeding complications (13.3%)Major bleeding (1.7%), transfusion requirement (4.9%), and mortality.
Nathan et al. [20]Trends in anticoagulant use (DOAC use increased from 12.4% in 2014 to 37.2% in 2018)Stroke prevention, thromboembolic risk, and anticoagulant adherence.
Li et al. [21]Survival and procedural success (97%)Stroke (6.1%), mortality (6.1%), NYHA class improvement, and quality of life (KCCQ-12).
Geis et al. [22]Reduction in VA and implantable cardioverter defibrillator therapies (VA reduced from 2.24 to 1.26 events/patient/month)Mortality (21.2% at 1 year), heart failure hospitalization, and NYHA class improvement.
Malaisrie et al. [23]Composite outcome of 1 year mortality and stroke (0% mortality, 0% stroke)Quality of life (NYHA, KCCQ), valve thrombosis (6%), and valve performance.
Mentias et al. [14]All-cause mortality (DOACs: HR 0.67 vs. warfarin)Stroke (DOACs: HR 0.72 vs. warfarin), major bleeding (DOACs: HR 0.79 vs. warfarin).
Ludwig et al. [24]Procedural success and mortality (100% procedural success, 6 month mortality: 22.2%)NYHA class improvement, mitral regurgitation elimination, and major bleeding (18.2%).
Hohmann et al. [25]All-cause mortality (HR: 3.84 for no anticoagulation vs. single antiplatelet therapy)Major bleeding, ischemic stroke, and thromboembolic events.
Tichelbäcker et al. [26]Left ventricular thrombus formation (1.1% overall, 4.4% in LVEF < 30%)Stroke, mortality, and the effectiveness of the anticoagulation strategy.
Schipper et al. [27]Composite of ischemic CVEs and major bleedingOverall survival, no difference in the composite primary endpoint between DOAC and VKA; mortality was significantly lower with DOACs.
Composite of ischemic events and major bleeding*.
Alaour et al. [28]Net clinical benefit composite and primary safety composite (life-threatening or major bleeding)VKAs vs. DOACs showed higher long-term mortality and lower disabling stroke with VKAs, whereas rates of major bleeding were similar.
Net clinical benefit composite** and primary safety composite.

*: Composite endpoint in Schipper et al. [27]: ischemic CVE or major bleeding (Bleeding Academic Research Consortium ≥ 3); **: net clinical benefit in Alaour et al. [28]: composite of all-cause mortality, myocardial infarction, stroke, or life-threatening/major bleeding. CVE: cerebrovascular event; DOAC: direct oral anticoagulant; HR: hazard ratio; KCCQ: Kansas City Cardiomyopathy Questionnaire; MVARC: Mitral Valve Academic Research Consortium; NYHA: New York Heart Association; VA: ventricular arrhythmias; VKA: vitamin K antagonist.