Table 2.
Primary and secondary outcomes for femoropopliteal studies
| Trial | Primary patency | LLL | RC improvement at follow-up | ABI change | BR | TLR | MAE |
|---|---|---|---|---|---|---|---|
| THUNDER24 | NA | DCB 0.4±1.2 mm; PTA 1.7±1.8 mm; P<0.001 | DCB 1.2; PTA 1.6; P=0.92 | DCB 0.9; PTA 0.8; P=0.79 | DCB 17%; PTA 44%; P=0.01 | 12/24 months; DCB 10%/15%; PTA 48%/52%; P<0.001/0.001 | None |
| THUNDER 5 years25 | NA | DCB 0.7+1.5 mm; PTA 1.5±1.3 mm; P=0.54 | NA | NA | DCB 17%; PTA 54%; P=0.04 | DCB 21%; PTA 56%; P<0.0005 | None |
| LEVANT127 | NA | DCB 0.46 mm; PTA 1.09 mm; P=0.016 | 6/12/24 months; DCB 1.7/1.6/2.1; PTA 1.6/2.1/1.8 | 6/12/24 months; DCB 0.2/0.18/0.2; PTA 0.22/0.2/0.18 | NA | 6/12/24 months; DCB 13%/29%/36%; PTA 24%/37%/51%; P=0.23 | No difference between groups |
| LEVANT228 | DCB 65.2%; PTA 52.6%; P=0.02 | NA | 12 months; DCB 1.9; PTA 1.7; P=NS | 12 months; DCB 0.17; PTA 0.18; P=NS | DCB 62%; PTA 65%; P=NS | 12 months; DCB 38%; PTA 37.5%; P=NS | DCB 16%; PTA 21%; P=NS |
| DEBATE- SFA31 | NA | DCB 0.86 mm; PTA 1.68 mm; P<0.001 | RC delta ≥2; DCB 81.8%; PTA 54.5%; P=0.02 | NA | DCB 17%; PTA 47.3%; P=0.008 | 12 months; DCB 17%; PTA 33.3%; P=0.07 | None |
| PACIFIER29 | NA | DCB −0.01 mm; PTA 0.65 mm; P=0.001 | Improvement in RC >1; DCB 80%; PTA 68% | NA | DCB 8.6%; PTA 32.4%; P=0.01 | 6/12 months; DCB 7.1%/7.1%; PTA 26.2%/34.9%; P=0.01/0.01 | Death, amputation, TLR; DCB 7.1%; PTA 34.9%; P=0.003 |
| IN.PACT SFA33 | DCB 82.2%; PTA 52.4%; P<0.001 | NA | Sustained clinical improvement; DCB 85%; PTA 67%; P<0.001 | DCB 0.95; PTA 0.89; P=0.002 | NA | DCB 2.4%; PTA 20.6%; P<0.001 | No difference |
| IN.PACT SFA 2 years32 | DCB 78.9%; PTA 50.1%; P<0.001 | NA | Sustained clinical improvement; DCB 77%; PTA 59%; P=0.003 | DCB 0.92; PTA 0.94; P=0.611 | DCB 19.8%; PTA 46.9%; P<0.01 | DCB 9.1%; PTA 28.3%; P<0.001 | Safety composite: DCB 87.4%; PTA 69.4%; P<0.001; MAE: DCB 19.2%; PTA 31.1%; P=0.02 |
| BIOLUX-P134 | NA | DCB 0.51±0.72 mm; PTA 1.04±1.00 mm; P=0.033 | RC improvement >1; DCB 72%; PTA 65.2%; P=NS | DCB 0.9±0.2; PTA 1.0±0.2 | DCB 11.5%; PTA 34.6%; P=0.048 | DCB 15.4%; PTA 41.7%; P=0.06 | DCB 19.2%; PTA 41.2%; P=0.14 |
Note: Primary patency, freedom from binary restenosis by US or TLR.
Abbreviations: ABI, ankle–brachial index; BR, binary restenosis; DCB, drug-coated balloon; LLL, late lumen loss; MAE, major adverse event; NA, not available; NS, not significant; PTA, percutaneous transluminal angioplasty; RC, Rutherford classification; SFA, superficial femoral artery; TLR, target lesion revascularization; US, ultrasound.