Table 6.
Safety endpoints in the overall population and patient subgroups.
| Overall | Primary IVL | Secondary IVL | Bailout IVL | ISR IVL | p | |
|---|---|---|---|---|---|---|
| No. of patients | 105 | 24 | 48 | 11 | 22 | |
| Primary safety endpoint | ||||||
| Median follow-up (months) | 12.3 (8.6–19.7) | 9.5 (8.1–15.1) | 16.8 (9.7–21.3) | 8.9 (7.8–11.4) | 12.1 (8.6–19.2) | 0.006 |
| In-hospital MACE | ||||||
| Cardiac death, n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | - |
| Peri-procedural MI (CK-MB >3 × URL), n (%) | 21 (20) | 3 (12.5) | 9 (18.8) | 2 (18.2) | 7 (31.8) | 0.42 |
| Peri-procedural MI (IV UD), n (%) | 7 (6.7) | 2 (8.3) | 2 (4.2) | 2 (18.2) | 1 (4.5) | 0.38 |
| Peri-procedural MI (SCAI definition), n (%) | 7 (6.7) | 1 (4.2) | 3 (6.3) | 1 (9.1) | 2 (9.1) | 0.9 |
| Stent thrombosis,*n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | - |
| Target lesion revascularization,*n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | - |
| Target vessel revascularization,*n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | - |
| Early MACE (<30 days) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | - |
| Cardiac death, n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | - |
| Spontaneous MI | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | - |
| Stent thrombosis,*n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | - |
| Target lesion revascularization,*n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | - |
| Target vessel revascularization,*n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | - |
| Late MACE (>30 days) | 14 (13.3) | 3 (12.5) | 1 (2.1) | 2 (18.2) | 8 (36.4) | 0.0008 |
| Cardiac death, n (%) | 2 (1.9) | 0 (0) | 1 (2.1) | 0 (0) | 1 (4.5) | 0.58 |
| Spontaneous MI (TVMI), n (%) | 5 (4.8) | 0 (0) | 0 (0) | 1 (9.1) | 4 (18.2) | 0.003 |
| Stent thrombosis,*n (%) | 2 (1.8) | 0 (0) | 0 (0) | 0 (0) | 2 (8.7) | 0.051 |
| Probable, n (%) | 1 (0.9) | 0 (0) | 0 (0) | 0 (0) | 1 (4.3) | 0.31 |
| Definite, n (%) | 1 (0.9) | 0 (0) | 0 (0) | 0 (0) | 1 (4.3) | 0.31 |
| Target vessel revascularization,*n (%) | 13 (11.8) | 3 (12) | 0 (0) | 2 (18.2) | 8 (34.8) | <0.0001 |
| Target lesion revascularization,*n (%) | 8 (7.3) | 3 (12) | 0 (0) | 0 (0) | 5 (21.7) | 0.002 |
| Target vessel non-target lesion revascularization,*n (%) | 7 (6.4) | 1 (4) | 0 (0) | 2 (18.2) | 4 (17.4) | 0.004 |
| Secondary safety endpoint | ||||||
| Freedom from procedural complications, n (%) | 97 (92.4) | 20 (83.3) | 45 (93.8) | 10 (90.9) | 22 (100) | 0.15 |
| Serious angiographic complications,*n (%) | 4 (3.6) | 2 (8) | 1 (1.9) | 1 (9.1) | 0 (0) | 0.21 |
| Flow-limiting dissection,*n (%) | 3 (2.7) | 2 (8) | 0 (0) | 1 (9.1) | 0 (0) | 0.07 |
| Perforation,*n (%) | 1 (0.9) | 0 (0) | 1 (1.9) | 0 (0) | 0 (0) | 0.99 |
| Acute stent thrombosis,*n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | - |
| Persistent slow-flow or no-reflow phenomena, *n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | - |
| Serious IVL-related arrhythmias,*n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | - |
| Ventricular tachycardia,*n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | - |
| Ventricular fibrillation,*n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | - |
| Failure of the IVL system,*n (%) | 5 (4.6) | 2 (8) | 3 (5.9) | 0 (0) | 0 (0) | 0.69 |
| Malfunction,*n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | - |
| Balloon burst,*n (%) | 5 (4.6) | 2 (8) | 3 (5.9) | 0 (0) | 0 (0) | 0.69 |
Values are n (%).
CK-MB, creatine kinase muscle and brain; ISR, in-stent restenosis; IVL, intravascular lithotripsy; MI, myocardial infarction; SCAI, Society for Cardiovascular Angiography and Intervention; TLR, target lesion revascularization; TVR, target vessel revascularization; TVMI, target vessel myocardial infarction; URL, upper reference limit; IV UD, Fourth Universal Definition.
*
Calculations were based on a per lesion basis (overall n = 110, primary IVL therapy n = 25, secondary IVL therapy n = 51, bailout IVL therapy n = 11, ISR IVL therapy n = 23).