Table 1.

Details and timing of items evaluated during the study

Item	Time point during study
	Registration	Baselinea	Every 6 months (± 3 months)
Confirmation of inclusion and exclusion criteria	○
Consent, visit status, and health check		○	○
Patient characteristicsb		○
Antithrombotic drug status		○	○
Administration status of medications other than antithrombotic drugsc		○	○
Status of implementation of invasive procedures			○
Blood-clotting test (PT-INR)d,e		○	○
Clinical course and laboratory teste		○	○
Echocardiographyf		○	○f
Adverse eventsg		Throughout

PT-INR, prothrombin time-international normalized ratio

^aBaseline was defined as the date of eligibility confirmation and enrollment in the study. If no data were available on the day of baseline, the most recent data were used, with the exception of echocardiogram, which used data immediately after the baseline (i.e., stabilized post-surgery)

^bIncluded information on bioprosthetic valve replacement, atrial fibrillation, medical history, and complications/comorbidities

^cIncluded antiarrhythmics, antihypertensives, lipid-lowering drugs, antidiabetic agents, treatments for peptic ulcer (proton pump inhibitor, histamine H2 receptor antagonist), and P-glycoprotein inhibitors

^dOnly patients receiving warfarin. The PT-INR data collected included up to the three most recent measurements at baseline and one measurement every 6 months

^eData were collected only if implemented under routine clinical practice

^fEchocardiography was performed every 1 year ± 6 months

^gIncluded incidence of stroke, systemic embolism, hemorrhagic event, heart failure requiring hospitalization, and revision of bioprosthesis