Table 1.
Baseline clinical and angiographic measures for femoropopliteal studies
| Trial | Enrollment period | Patients randomized (n) | DCB | Inclusion criteria | Exclusion criteria | Follow-up period | Outcomes measured | Baseline RC | Total occlusions | Lesion length | Stent placement |
|---|---|---|---|---|---|---|---|---|---|---|---|
| THUNDER24 | 2004–2005 | 102 (48 DCB vs 54 PTA) | Standard balloons coated with paclitaxel (PACCOCATH coating) (3 mg/mm2 balloon surface) | One vessel with >70% stenosis, >2 cm length in SFA/Pop | Poor inflow. No outflow, acute presentation, pregnancy, life expectancy <1 year | 6-month angiogram follow-up 6, 12, and 24 months clinical follow-up | LLL and MAE at 6 months | DCB 3.4; PTA 3.1 | DCB 27%; PTA 26% | DCB 7.5 cm; PTA 7.4 cm | DCB 17%; PTA 11% |
| THUNDER25 5 year | 2004–2005 | 102 (48 DCB and 54 PTA) of which 30 patients had 5-year follow-up data | Standard balloons coated with paclitaxel (PACCOCATH coating) (3 mg/mm2 balloon surface) | One vessel with >70% stenosis, >2 cm length in SFA/Pop | Poor inflow. No outflow, acute presentation, pregnancy, life expectancy <1 year | 2–5 years postoperative clinical follow-up | TLR | DCB 3.4; PTA 3.1 | DCB 27%; PTA 26% | DCB 7.5 cm; PTA 7.4 cm | DCB 17%; PTA 11% |
| LEVANT127 | 2009–2009 | 75 randomized to DCB vs PTA after standard angioplasty | Lutonix (2 mg/mm2 balloon surface polysorbate/sorbitol) | Symptomatic with one lesion >70% stenosis, 4–15 cm in length, vessel diameter 4–6 cm | Severe calcification, inflow disease, or absence of ≥1 runoff vessel | 1, 6, 12, and 24-month clinical follow-up. Angiogram at 6 months | LLL at 6 months, CD-TLR at 1, 6, 12, and 24 months | RC 2/3/4/5; DCB 22%/72%/2%/4%; PTA 21%/71%/4%/4% | DCB 41%; PTA 42% | DCB 80.8±37.0 mm; PTA 80.2±37.8 mm | DCB 27%; PTA 38% |
| LEVANT228 | 2011–2012 | 476 randomized 2:1 to DCB vs PTA | Lutonix (2 mg/mm2 balloon surface polysorbate/sorbitol) | Symptomatic claudication, RC 2–4 with >70% stenosis in SFA or Pop length <15 cm and diameter 4–6 cm | Need for stent post predilation angioplasty | 1, 6, and 12-month clinical follow-up | Primary patency, death, amputation | RC 2/3/4; DCB 29%/63%/8%; PTA 34%/58%/8% | DCB 21%; PTA 21.9% | DCB 62.7±41 mm; PTA 63.2±40.4 mm | DCB 2.5%; PTA 6.9% |
| DEBATE- SFA31 | 2010–2011 | 104 randomized to DCB + BMS or PTA + BMS | IN.PACT Admiral (3 mg/mm2 balloon surface) and urea as hydrophilic natural spacer | Claudication with >70% stenosis, >4 cm length in SFA/Pop with at least one patent infrapopliteal vessel | Life expectancy <1 year, preprocedure need for amputation | 12-month angiogram | Binary restenosis by angiogram or US PSV ratio>2.4 (primary) and TLR (secondary) | RC 3/4/5/6; DCB 21/21/55/496; PTA 31/22/41/696 | DCB 55%; PTA 69% | DCB 94 mm; PTA 96 mm | DCB 100%; PTA 100% |
| PACIFIER29 | 2010–2012 | 85; 44 DCB vs 41 Pacific Xtreme (PTA) | IN.PACT Pacific (3 mg/mm2 balloon surface) and urea as hydrophilic natural spacer | Claudication with >70% stenosis of SFA/Pop, length 3–30 cm | Inflow disease, significant three-vessel infrapopliteal disease | 6-month angiogram. 6 and 12-month clinical follow-up | LLL at 6 months, CD-TLR at 6 and 12 months | RC 2/3/4/5; DCB 9%/86%/0%/4.5%; PTA 13%/83%/43%/0% | DCB 22.7%; PTA 38.3% | DCB 7 cm; PTA 6.3 cm | DCB 20.5%; PTA 34% |
| IN.PACT SFA33 | 2010–2013 | 331 randomized 2:1 DCB vs PTA | IN.PACT Admiral (3.5 mg/mm2 balloon surface) and urea as hydrophilic natural spacer | RC 2–4, >70% stenosis of SFA/Pop, 4-18 cm if no occlusion, < 10 cm If total occlusion | Inflow disease, significant three-vessel infrapopliteal disease | 1, 6, and 12-month clinical follow-up | Primary patency at 12 months | RC 2/3/4/5; DCB 38%/57%/5%/0%; PTA 38%/56%/5%/1% | DCB 25.8%; PTA 19.5%; P=0.22 | DCB 8.94±4.89 cm; PTA 8.81±5.12 cm | DCB 7.3%; PTA 12.6% |
| IN.PACT SFA 2 year32 | 2010–2013 | 331 randomized 2:1 DCB vs PTA (evaluation complete for DCB 170 and PTA 94) | IN.PACT Admiral (3.5 mg/mm2 balloon surface) and urea as hydrophilic natural spacer | RC 2-4, >70% stenosis of SFA/Pop, 4–18 cm if no occlusion, <10 cm if total occlusion | Inflow disease, significant three-vessel infrapopliteal disease | 12- to 24-month clinical follow-up | Primary patency, freedom from CD-TLR | RC 2/3/4/5; DCB 38%/57%/5%/0%; PTA 38%/56%/5%/1% | DCB 25.8%; PTA 19.5%; P=0.22 | DCB 8.94±4.89 cm; PTA 8.81±5.12 cm | DCB 7.3%; PTA 12.6% |
| BIOLUX-P134 | 2010–2011 | 60 patients randomized 1:1 DCB vs PTA | Passeo 18- Lux Balloon (3 mg/mm2 balloon surface) with BTHC excipient | RC 2–5, >70% stenosis of SFA/Pop, 3–20 cm lesion length | Thrombus present, <1 patent infrapopliteal vessel, prior stent at target lesion, prior bypass graft, severe calcification | 6-month angiogram. 6 and 12-month clinical follow-up | Primary – LLL at 6 months Secondary –BR and CD-TLR at 6 and 12 months | RC 2/3/4/5; DCB 23/57/13/7; PTA 30/57/7/7 | 38.2% of entire cohort | DCB 51.4±47.2 mm; PTA 68.5±57.0 mm; P=0.31 | DCB 6.7%; PTA 26.7%; P=0.038 |
Note: Primary patency, freedom from binary restenosis by US or TLR.
Abbreviations: BMS, bare metal stent; BR, binary restenosis; BTHC, n-butyryl-tri-n-hexyl citrate; CD-TLR, clinically driven target lesion revascularization; DCB, drug-coated balloon; LLL, late lumen loss; MAE, major adverse event; Pop, popliteal artery; PSV, peak systolic velocity; PTA, percutaneous transluminal angioplasty; RC, Rutherford classification; SFA, superficial femoral artery; TLR, target lesion revascularization; US, ultrasound.