Table 4.
Primary and secondary outcomes for BTK studies
| Trial | Primary patency | LLL (mm) | BR | Clinical improvement or RC at follow-up | ABI | TLR | MAEs |
|---|---|---|---|---|---|---|---|
| Schmidt et al46 (Single Center Leipzig Registry) | 3 months: 72.6% | NA | 27.4%: 19.1% restenosis and 8.3% target vessel occlusion | Clinical improvement 91.2%, complete wound healing 74.2% of RC 5 patients | NA | 17.3% | Four amputations (two major, two minor) |
| Debate BTK47 | NA | NA | DCB: 27.0%; PTA: 74.3% (P<0.001) | DCB: 0.90±1.8; PTA: 2.0±2.3 (P<0.004) | DCB: 0.78±0.22; PTA: 0.47±0.28 | DCB: 18%; PTA: 43% (P=0.002); TVO–DCB: 17%; PTA: 55% (P<0.001) | DCB: 31%; PTA: 51% (P=0.02) – driven by TLR and wound healing, amputation–DCB: 0%; PTA: 1.5% (P=0.0005) |
| IN.PACT DEEP48 | NA | DCB: 0.61±0.78 mm; PTA: 0.62±0.78 mm (P=0.950) | DCB: 41.0%; PTA: 35.5% (P=0.609) | NA | NA | CD-TLR; DCB: 9.2%; PTA: 13.1% (P=0.291) | 6-month primary safety composite – DCB: 17.7%; PTA: 15.8%; 12-month major amputation – DCB: 8.8%; PTA: 3.6% |
| BIOLUX P-II50 | DCB 65.2%; POBA 52.6%; P=0.02 | DCB: 0.56±0.65 mm; PTA: 0.54±0.66 mm (P=0.913) | DCB: 53.1%; PTA: 41.4% (P=0.359) | DCB: 2.3±2.3; PTA: 2.7±2.4 (P>0.05) | 12-month DCB: 1.0±0.2; PTA: 0.9±0.2 (P=0.327) | CD-TLR; DCB: 31.3%; PTA: 26.9% (P=0.805) | 12-month MAE composite; DCB: 41.1%; PTA: 39.1% (P=0.957) |
Abbreviations: ABI, ankle–brachial index; BR, binary restenosis; BTK, below-the-knee; CD-TLR, clinically driven target lesion revascularization; DCB, drug-coated balloon; LLL, late lumen loss; MAE, major adverse event; NA, not available; POBA, plain old balloon angioplasty; PTA, percutaneous transluminal angioplasty; RC, Rutherford classification; TLR, target lesion revascularization; TVO, target vessel occlusion.