Table 4.
Core laboratory-assessed angiographic outcomes.
| Outcome | Women, n = 144 | Men, n = 484 | P value |
|---|---|---|---|
| Post-IVL angiographic outcomesa | n = 126 | n = 429 | |
| Acute gain, mm | 0.78 ± 0.40 | 0.84 ± 0.50 | .21 |
| Minimum lumen diameter, mm | 1.80 ± 0.39 | 1.92 ± 0.50 | .004 |
| Residual diameter stenosis, % | 34.1 ± 11.6 | 35.8 ± 13.4 | .18 |
| Post-IVL serious angiographic complications | 2/128 (1.6) | 10/435 (2.3) | .75 |
| Severe dissection (type D-F) | 2/126 (1.6) | 8/434 (1.8) | .53 |
| Perforation | 0/126 (0.0) | 0/435 (0.0) | — |
| Abrupt closure | 0/126 (0.0) | 0/435 (0.0) | — |
| Slow flow | 0/126 (0.0) | 2/435 (0.5) | 1.00 |
| No reflow | 0/126 (0.0) | 0/435 (0.0) | — |
| Final in-segment angiographic outcomes | |||
| Acute gain, mm | 1.37 ± 0.45 | 1.51 ± 0.49 | .004 |
| Minimum lumen diameter, mm | 2.39 ± 0.40 | 2.59 ± 0.48 | <.001 |
| Residual diameter stenosis, % | 16.3 ± 8.0 | 16.5 ± 8.4 | .85 |
| <50% | 143 (100.0) | 481 (99.4) | .59 |
| ≤30% | 136 (95.1) | 465 (96.1) | .61 |
| Final in-stent angiographic outcomes | |||
| Acute gain, mm | 1.59 ± 0.40 | 1.71 ± 0.48 | .002 |
| Minimum lumen diameter, mm | 2.60 ± 0.37 | 2.79 ± 0.45 | <.001 |
| Residual diameter stenosis, % | 11.4 ± 6.6 | 12.3 ± 6.9 | .18 |
| <50% | 143/143 (100.0) | 482/482 (100.0) | 1.00 |
| ≤30% | 143/143 (100.0) | 475/482 (98.5) | .21 |
| Final serious angiographic complications | 0 (0.0) | 2 (0.4) | 1.00 |
| Severe dissection (type D-F) | 0 (0.0) | 1 (0.2) | .51 |
| Perforation | 0 (0.0) | 1 (0.2) | 1.00 |
| Abrupt closure | 0 (0.0) | 1 (0.2) | 1.00 |
| Slow flow | 0 (0.0) | 0 (0.0) | — |
| No reflow | 0 (0.0) | 0 (0.0) | — |
Values are mean ± standard deviation or n/N (%).
IVL, intravascular lithotripsy.
a
Post-IVL angiographic data capture was not required per protocol in the Disrupt CAD studies.