Table 3.
Baseline clinical and angiographic measures for BTK studies
| Trial | Enrollment period | No of patients randomized | DCB | Inclusion criteria (all CLI) | Exclusion criteria | Follow-up period | Outcomes measured | Baseline RC | Total occlusions | Lesion length (mm) |
|---|---|---|---|---|---|---|---|---|---|---|
| Schmidt et al46 | 2009–2010 | Nonrandomized, 104 patients | IN.PACT Amphirion (FreePac coating) (3 mg/mm2 balloon surface, urea excipient) | Tibial vessel(s) with >70% stenosis, >8 cm length | NA, not listed | 3-month angiographic; 3- and 12-month clinical | BR and clinical improvement (≥50% ulcer reduction or increase of at least one RC | 4.5 | 61.90% | 173±87 |
| Debate BTK47 | 2010–2011 | 132 randomized l:l to DCB vs PTA | IN.PACT Amphirion (FreePac coating) (3 mg/mm2 balloon surface, urea excipient) | Diabetes, tibial vessel(s) with >70% stenosis, >4 cm length, with distal runoffa | Allergy to paclitaxel, planned major amputation, life expectancy <1 year | 12-month clinical and angiographic (or DUS) | BR, CD-TLR, amputation, and TVO | DCB 5.15; PTA 5.09 | DCB 77.5%; PTA 82.1% | DCB 129±83; PTA 131±79 |
| IN. PACT DEEP48 | 2009–2012 | 358 randomized 2:1 to DCB vs PTA (all clinical cohort, 167 angiographic cohort) | IN.PACT Amphirion (FreePac coating) (3 mg/mm2 balloon surface, urea excipient) | Tibial vessel(s) >70% stenosis any length, with distal runoff.a Angiogram cohort lesion <10 cm. |
Inflow lesion >15 cm length, failure to cross TL with 0.014′ wire, planned major amputation, failure to obtain <30% postprocedure residual stenosis | 1, 6, and 12-month clinical follow-up; ±12-month angiography | CD-TLR, LLL, primary safety composite | DCB 4.87; PTA 4.85 | DCB 38.6%; PTA 45.9% | DCB 102±91; PTA 129±95; angiogram cohort: DCB 59.1±41.7; PTA 79.7±74.6 |
| BIOLUX P-II50 | 2012–2014 | 72 randomized 1:1 to DCB vs PTA | Passeo-18 Lux DEB (3 mg/mm2 balloon surface, BTHC excipient) | Tibial vessel(s) with >70% stenosis, >3 cm, with distal runoffa | Need for stent postprediction angioplasty | 1, 6, and 12-month clinical follow-up; 6-month angiography | Primary safety composite and 6-month target lesion primary patency | DCB 4.5; PTA 4.4 | Not reported | DCB 113.1±88.1; PTA 115.0±86.9 |
Notes:
a
Distal runoff: at least one tibial vessel with runoff to the foot. Target vessel may have direct or collateral runoff.
Abbreviations: BR, binary restenosis; BTHC, n-butyryl tri-n-hexyl citrate; BTK, below the knee; CLI, critical limb ischemia; CD-TLR, clinically driven target lesion revascularization; DCB, drug-coated balloon; LLL, late lumen loss; NA, not available; PTA, percutaneous transluminal angioplasty; RC, Rutherford classification; TL, target lesion; TVO, target vessel occlusion; DUS, Doppler ultrasound.