Table 2.
Safety outcomes at 5 yearsa
| Luminor 35 DCB (N = 85) | POBA (N = 86) | P Value | |
|---|---|---|---|
| All-cause death | 9/80 (11) | 14/86 (16) | 0.38 |
| Within 30 days | 0/9 | 0/14 | |
| Undetermined causeb | 2/9 (22) | 3/14 (21) | > 0.99 |
| Cardiovascular-relatedb | 2/7 (29) | 5/11 (45) | 0.64 |
| Cardiac-related | 1/7 (14) | 4/11 (36) | 0.60 |
| Stroke | 1/7(14) | 1/11 (9) | > 0.99 |
| Non-cardiovascular-relatedb | 5/7 (71) | 6/11 (55) | 0.64 |
| Neoplasms | 2/7 (29) | 1/11 (9) | 0.53 |
| Respiratory failure | 0/7 | 2/11 (18) | 0.50 |
| Multiorgan failure | 1/7 (14) | 1/11 (9) | > 0.99 |
| Infection/sepsis | 1/7 (14) | 1/11(9) | > 0.99 |
| Diabetic coma | 1/7 (14) | 0/11 | 0.39 |
| Suicide | 0/7 | 1/11 (9) | > 0.99 |
| Major target limb amputation | 0/49 | 1/51 (2) | > 0.99 |
| Minor target limb amputation | 0/49 | 1/51 (2) | > 0.99 |
| Binary restenosis | 23/45 (51) | 35/54 (65) | 0.22 |
| CD-TLR | 10/49 (20) | 18/51 (35) | 0.12 |
| Any TVRc | 19/53 (36) | 21/51 (41) | 0.69 |
Data are counts (percentage)
aSixty-five months were set as cutoff for analysis
bCauses of death were adjudicated by an independent data safety monitoring board. None of the deaths were assessed as device- or procedure-related
cTVR included TLR and non-TLR TVR
DCB drug-coated balloon, POBA plain old balloon angioplasty, CD-TLR, clinically driven target lesion revascularization, TVR target vessel revascularization