Figure 2. Primary and secondary composite endpoints.
A) Primary composite endpoint of all-cause mortality and/or non-disabling/disabling stroke at 30 days. B) VARC-3 early safety composite endpoint of freedom from all-cause mortality and/or all stroke and/or VARC type 2-4 bleeding and/or acute kidney injury >stage 2 and/or major access site complication and/or coronary artery obstruction requiring coronary intervention and/or valvular reintervention and/or need for permanent pacemaker implantation at 30 days. C) VARC-3 device success endpoint defined as “technical success” at exit from procedure room (freedom from procedural mortality and single device without malpositioning and freedom from conversion to surgery and freedom from major access-site complication) and freedom from 30-day mortality and p mean <20 mmHg and PVL <moderate. Values are percentage of the propensity matched cohort of patients without (≤10 mm3, n=358) versus with (>10 mm3, n=358) LVOT calcification. LVOT: left ventricular outflow tract