Table 2.
Bleeding, hospitalization, and right ventricular failure at 12 months after implantation
| Overall (n = 109) | PDE5I (n = 75) | No PDE5I (n = 34) | P value | |
|---|---|---|---|---|
| Bleeding, n (%) | 19 (17) | 17 (23) | 2 (6) | 0.03 |
| No. of bleeding events per patient a | 0.24 (0–3) | 0.32 (0–3) | 0.06 (0–1) | 0.03 |
| RBC transfusion, n (%) | 4 (4) | 4 (5) | 0 (0) | 0.31 |
| RBC units per patient a | 0.36 (0–10) | 0.36 (0–10) | 0 (0–0) | 0.22 |
| Major bleeding | 16 (15) | 14 (19) | 2 (6) | 0.08 |
| Gastrointestinal bleeding | 9 (8) | 8 (11) | 1 (3) | 0.18 |
| BARC type, n (%) | ||||
| 1 | 0 (0) | 0 (0) | 0 (0) | — |
| 2 | 15 (14) | 14 (19) | 1 (3) | 0.03 |
| 3 | 4 (4) | 3 (4) | 1 (3) | 0.79 |
| 4 | — | — | — | — |
| 5 | 1 (1) | 1 (1) | 0 (0) | 0.50 |
| ASS, 100 mg daily | 83 (76) | 58 (77) | 25 (74) | 0.67 |
| Clopidogrel, 75 mg daily | 19 (17) | 13 (17) | 6 (18) | 0.97 |
| Prasugrel, 10 mg daily | 2 (2) | 0 (0) | 2 (6) | 0.10 |
| Over‐therapeutic INR, n (%) b | 4 (4) | 3 (4) | 1 (3) | 0.79 |
| INR value | 2.10 ± 0.77 | 2.09 ± 0.78 | 2.21 ± 0.91 | 0.84 |
| Haemoglobin drop (g/dL) a | 0.9 (0–2.8) | 0.7 (0–2.8) | 2.3 (2.2–2.4) | 0.09 |
| No. of hospitalizations/patient, n (%) a | 0.20 (0–7) | 0.28 (0–7) | 0.03 (0–1) | 0.07 |
| Cumulative hospital stay (days) a | 1.7 (0–34) | 2.4 (0–34) | 0.2 (0–7) | 0.07 |
| Late RVF, n (%) | 10 (9) | 6 (8) | 4 (12) | 0.26 |
ASS, acetylsalicylic acid; BARC, Bleeding Academic Research Consortium; INR, international normalized ratio; PDE5I, phosphodiesterase‐5 inhibitor; RBC, red blood cell; RVF, right ventricular failure.
a
Values in brackets refer to median (range: min–max).
b
Over‐therapeutic INR refers to INR > 2.8.