Table 4.
Procedure and Lesion Success Outcome Measures.a
| Baseline RC |
p |
|||||
|---|---|---|---|---|---|---|
| RC2,3; 486 subjects, 605 lesionsb | RC4,5; 571 subjects, 775 lesionsb | RC6; 98 subjects, 148 lesionsb | RC2,3 vs RC4,5 | RC2,3 vs RC6 | RC4,5 vs RC6 | |
| Procedure success | 392/469 (83.6) [79.9 to 86.8] | 413/545 (75.8) [72.0 to 79.3] | 63/92 (68.5) [58.0 to 77.8] | 0.002 | 0.001 | 0.15 |
| Final residual stenosis <50% in all lesions | 425/469 (90.6) [87.6 to 93.1] | 456/546 (83.5) [80.1 to 86.5] | 72/94 (76.6) [66.7 to 84.7] | 0.001 | <0.001 | 0.11 |
| Significant angiographic complications | 41/483 (8.5) [6.2 to 11.3] | 66/566 (11.7) [9.1 to 14.6] | 14/95 (14.7) [8.3 to 23.5] | 0.10 | 0.08 | 0.40 |
| Severe dissection (C-F) | 13/485 (2.7) [1.4 to 4.5] | 17/569 (3.0) [1.7 to 4.7] | 6/98 (6.1) [2.3 to 12.9] | 0.85 | 0.11 | 0.13 |
| Perforation | 6/485 (1.2) [0.5 to 2.7] | 4/569 (2.5) [1.4 to 4.1] | 2/98 (2.0) [0.2 to 7.2] | 0.18 | 0.63 | >0.99 |
| Abrupt closure | 4/485 (0.8) [0.2 to 2.1] | 13/569 (2.3) [1.2 to 3.9] | 3/98 (3.1) [0.6 to 8.7] | 0.08 | 0.10 | 0.72 |
| Distal embolization | 21/482 (4.4) [2.7 to 6.6] | 31/566 (5.5) [3.8 to 7.7] | 5/95 (5.3) [1.7 to 11.9] | 0.48 | 0.60 | >0.99 |
| Lesion success | 491/578 (84.9) [81.8 to 87.8] | 580/733 (79.1) [76.0 to 82.0] | 106/141 (75.2) [67.2 to 82.1] | 0.007 | 0.01 | 0.36 |
| Final residual stenosis <50% | 533/580 (91.9) [89.4 to 94.0] | 636/733 (86.8) [84.1 to 89.1] | 119/143 (83.2) [76.1 to 88.9] | 0.003 | 0.003 | 0.32 |
| Significant angiographic complications | 47/600 (7.8) [5.8 to 10.3] | 78/771 (10.1) [8.1 to 12.5] | 18/144 (12.5) [7.6 to 19.0] | 0.15 | 0.07 | 0.33 |
| Severe dissection (C-F) | 13/604 (2.2) [1.2 to 3.7] | 18/773 (2.3) [1.4 to 3.7] | 7/148 (4.7) [1.9 to 9.5] | 0.78 | 0.11 | 0.14 |
| Perforation | 6/604 (1.0) [0.4 to 2.1] | 14/773 (1.8) [1.0 to 3.0] | 2/148 (1.4) [0.2 to 4.8] | 0.21 | 0.71 | 0.69 |
| Abrupt closure | 4/604 (0.7) [0.2 to 1.7] | 13/773 (1.7) [0.9 to 2.9] | 3/148 (2.0) [0.4 to 5.8] | 0.10 | 0.14 | 0.77 |
| Distal embolization | 27/599 (4.5) [3.0 to 6.5] | 41/775 (5.3) [3.8 to 7.1] | 8/144 (5.6) [2.4 to 10.7] | 0.60 | 0.72 | 0.96 |
Abbreviation: RC, Rutherford category.
a
Data are presented as the number/sample (percentage) [95% confidence interval].
b
Number of subjects/lesions with data available for core laboratory analysis, unless otherwise noted.