Study | Country | Sample size | Mean age (years) | Men (%) | Smoker (%) | DM (%) | Hyperlipidemia (%) | Hypertension (%) | ABI | Mean lesion (cm) | Intervention and control | Follow-up duration | Study quality |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
AcoArt I 2016 [17] | China | 200 | 65.8 | 73.5 | 31.0 | 55.5 | 28.0 | 67.0 | 0.46 | 14.9 | Paclitaxel-coated (3.0 μg/mm2) and standard uncoated balloon catheters | 6 and 12 months | 4 |
BIOLUX P-I 2015 [18] | Germany | 60 | 70.8 | 56.7 | 68.8 | 33.4 | 61.7 | 73.4 | 0.70 | 6.0 | Paclitaxel-coated (3.0 μg/mm2) balloon or the uncoated balloon | 6 and 12 months | 3 |
BIOLUX P-II 2015 [19] | Germany | 72 | 71.3 | 79.2 | 55.6 | 66.7 | 68.1 | 86.1 | NA | NA | Passeo-18 Lux paclitaxel-coated (3.0 μg/mm2) drug-eluting balloon or Passeo-18 percutaneous transluminal angioplasty | 6 and 12 months | 3 |
CONSEQUENT 2017 [20] | Germany | 153 | 68.1 | 68.0 | 47.7 | 36.6 | 54.4 | 78.4 | NA | 13.2 | Paclitaxel-coated (3.0 μg/mm2) balloons or plain old balloon angioplasty | 6, 12, and 24 months | 4 |
DEBATE-SFA 2013 [21] | Italy | 104 | 75.0 | 69.2 | 51.0 | 74.0 | 57.7 | 88.5 | 0.32 | 9.5 | Paclitaxel-eluting (3.0 μg/mm2) balloon plus bare-metal stent or percutaneous transluminal angioplasty plus bare-metal stent | 12 months | 4 |
DEBELLUM 2012 [22] | Italy | 50 | 67.0 | 74.0 | 62.0 | 44.0 | 58.0 | 68.0 | 0.56 | 7.5 | Paclitaxel-eluting (3.5 μg/mm2) balloon or angioplasty balloon | 6 and 12 months | 4 |
ILLUMENATE Pivotal 2017 [23] | US, Austria | 300 | 68.8 | 58.7 | 81.0 | 50.3 | 88.7 | 93.7 | 0.75 | 8.3 | Stellarex Drug-Coated (2.0 μg/mm2) Balloon or percutaneous transluminal angioplasty | 12 months | 3 |
ILLUMENATE European 2017 [24] | Germany, Austria | 299 | 66.4 | 69.9 | 86.3 | 36.5 | 62.2 | 77.9 | 0.71 | 7.2 | Low-dose paclitaxel coated (2.0 μg/mm2) balloon or percutaneous transluminal angioplasty | 12 months | 3 |
IN.PACT SFA 2015 [25] | US, Europe | 331 | 67.7 | 65.9 | 37.8 | 43.2 | 83.7 | 90.3 | 0.76 | 8.9 | Paclitaxel-coated (3.5 μg/mm2) balloons or percutaneous transluminal angioplasty | 12 and 24 months | 4 |
IN.PACT 2017 [26] | Belgium | 106 | 70.5 | 65.1 | 57.5 | 100.0 | 73.6 | 88.7 | NA | 7.6 | Paclitaxel-coated (3.5 μg/mm2) balloons or plain old balloon angioplasty | 6 months | 3 |
ISAR-STATH 2017 [27] | Germany | 100 | 69.4 | 70.0 | 70.0 | 25.0 | 90.0 | 80.0 | 0.75 | 7.1 | Paclitaxel-coated (3.5 μg/mm2) balloons or plain balloon angioplasty | 6 and 24 months | 3 |
LEVANT I2014 [28] | Germany | 101 | 68.5 | 67.3 | 34.7 | 47.5 | 64.4 | 91.1 | 0.64 | 8.0 | Lutonix paclitaxel-coated (2.0 μg/mm2) balloons or uncoated balloons | 6, 12, and 24 months | 4 |
LEVANT 22015 [29] | US, Europe | 476 | 68.2 | 63.0 | 34.7 | 42.9 | 88.4 | 88.7 | 0.74 | NA | Paclitaxel-coated (2.0 μg/mm2) balloon or standard angioplasty | 12 months | 4 |
PACIFIER 2012 [30] | Germany | 91 | 71.0 | 61.5 | 53.8 | 35.2 | 48.4 | 65.9 | 0.69 | 6.8 | Paclitaxel-coated (3.5 μg/mm2) IN.PACT Pacific or uncoated Pacific balloons | 6 and 12 months | 4 |
PACUBA 2016 [31] | Austria | 74 | 68.2 | 58.1 | 47.3 | 40.5 | 58.1 | 71.6 | 0.65 | 17.9 | Paclitaxel-based drug-eluting (3.0 μg/mm2) balloon angioplasty or standard percutaneous transluminal angioplasty | 6 and 12 months | 4 |
THUNDER 2008 [32] | Germany | 102 | 68.5 | 63.7 | 22.5 | 48.0 | 65.7 | 81.4 | 0.50 | 7.4 | Paclitaxel-coated (3.0 μg/mm2) balloons or uncoated balloons | 6, 12, and 24 months | 3 |
FemPac 2008 [33] | Germany | 87 | 68.7 | 59.8 | 41.4 | 47.1 | 57.5 | 79.3 | 0.70 | 4.3 | Paclitaxel-coated (3.0 μg/mm2) balloons or uncoated balloons | 6 and 24 months | 3 |