Table. VARC-2 End Points at 2 Years Postrandomizationa.
| Characteristic | No. (%) | Hazard Ratio (95% CI) | |
|---|---|---|---|
| CoreValve (n = 305) | Lotus (n = 607) | ||
| All-cause mortality or disabling stroke | 79 (27.0) | 132 (22.8) | 0.81 (0.61-1.07) |
| All-cause mortality | 65 (22.5) | 123 (21.3) | 0.94 (0.69-1.26) |
| Cardiovascular mortality | 45 (15.9) | 79 (14.2) | 0.87 (0.60-1.25) |
| Stroke | 32 (11.4) | 48 (8.4) | 0.75 (0.48-1.17) |
| Disabling | 24 (8.6) | 26 (4.7) | 0.53 (0.31-0.93) |
| Nondisabling | 8 (2.8) | 23 (4.0) | 1.46 (0.65-3.27) |
| Major vascular complications | 19 (6.4) | 45 (7.5) | 1.21 (0.71-2.06) |
| Permanent pacemaker implantation | |||
| All patients | 61 (21.1) | 202 (34.2) | 1.85 (1.39-2.46) |
| Pacemaker-naive patients | 61 (26.1) | 202 (41.7) | 1.87 (1.41-2.49) |
| Bleeding | 60 (20.5) | 125 (21.7) | 1.07 (0.79-1.45) |
| Life-threatening or disabling | 35 (12.3) | 71 (12.4) | 1.03 (0.69-1.55) |
| Myocardial infarction | 17 (6.3) | 32 (6.1) | 0.93 (0.52-1.68) |
| Repeated procedure for valve-related dysfunction | 8 (2.9) | 3 (0.6) | 0.19 (0.05-0.70) |
| TAVR | 6 (2.2) | 0 (0.0) | Undefined |
| Surgical AVR | 1 (0.5) | 3 (0.6) | 1.48 (0.15-14.18) |
| Hospitalizationb | 52 (18.9) | 98 (18.4) | 0.92 (0.66-1.29) |
| New onset of atrial fibrillation/flutter | 14 (4.7) | 39 (6.6) | 1.42 (0.77-2.62) |
| Prosthetic aortic valve thrombosis | 0 (0.0) | 16 (3.0) | Undefined |
Abbreviations: NYHA, New York Heart Association; TAVR, transcatheter aortic valve replacement; VARC, Valve Academic Research Consortium.
a
Time-to-event rates in the intention-to-treat patient population.
b
Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV).