Background
Methods
Data sources, search strategy, and selection criteria
Data collection and quality assessment
Statistical analysis
Results
Literature search
Study characteristics
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 |
MLD
Outcomes | Subgroup | WMD or RR and 95% CI | P value | Heterogeneity (%) | P value for Meta-regression |
---|---|---|---|---|---|
MLD at 6 months | Mean age (years) | ||||
≥ 70.0 | 0.37 (− 0.26 to 1.01) | 0.247 | 90.4 (0.001) | < 0.001 | |
< 70.0 | 0.94 (0.64 to 1.24) | < 0.001 | 70.0 (0.005) | ||
Smoker (%) | |||||
≥ 50.0 | 0.63 (0.21 to 1.05) | 0.003 | 76.9 (0.005) | < 0.001 | |
< 50.0 | 0.91 (0.53 to 1.29) | < 0.001 | 81.7 (0.001) | ||
DM (%) | |||||
≥ 50.0 | 0.63 (−0.55 to 1.81) | 0.294 | 96.0 (< 0.001) | 0.140 | |
< 50.0 | 0.78 (0.57 to 1.00) | < 0.001 | 66.1 (0.011) | ||
Hyperlipidemia (%) | |||||
≥ 60.0 | 0.74 (−0.14 to 1.61) | 0.099 | 85.0 (0.001) | 0.127 | |
< 60.0 | 0.82 (0.56 to 1.09) | < 0.001 | 84.9 (< 0.001) | ||
Hypertension (%) | |||||
≥ 80.0 | 0.74 (−0.14 to 1.61) | 0.099 | 85.0 (0.001) | 0.127 | |
< 80.0 | 0.82 (0.56 to 1.09) | < 0.001 | 84.9 (< 0.001) | ||
Dose of paclitaxel | |||||
3.0 μg/mm2 | 0.73 (0.30 to 1.17) | 0.001 | 88.6 (< 0.001) | 0.032 | |
3.5 μg/mm2 | 0.74 (0.52 to 0.95) | < 0.001 | 17.9 (0.296) | ||
LLL at 6 months | Mean age (years) | ||||
≥ 70.0 | 0.08 (−0.61 to 0.78) | 0.815 | 94.8 (< 0.001) | < 0.001 | |
< 70.0 | −0.83 (−1.14 to − 0.52) | < 0001 | 90.3 (< 0.001) | ||
Smoker (%) | |||||
≥ 50.0 | −0.37 (− 1.10 to 0.36) | 0.320 | 95.4 (< 0.001) | < 0.001 | |
< 50.0 | −0.75 (−1.08 to − 0.41) | < 0.001 | 93.2 (< 0.001) | ||
DM percent (%) | |||||
≥ 50.0 | −0.55 (−1.64 to 0.55) | 0.329 | 96.7 (< 0.001) | < 0.001 | |
< 50.0 | −0.57 (−1.14 to − 0.00) | 0.049 | 99.0 (< 0.001) | ||
Hyperlipidemia (%) | |||||
≥ 60.0 | −0.72 (−1.37 to − 0.07) | 0.031 | 86.1 (< 0.001) | < 0.001 | |
< 60.0 | −0.44 (−1.12 to 0.24) | 0.201 | 99.4 (< 0.001) | ||
Hypertension (%) | |||||
≥ 80.0 | −0.80 (−1.76 to 016) | 0.102 | 90.7 (< 0.001) | < 0.001 | |
< 80.0 | −0.46 (−1.08 to 0.16) | 0.148 | 99.3 (< 0.001) | ||
Dose of paclitaxel | |||||
3.0 μg/mm2 | −0.59 (−0.87 to − 0.31) | < 0.001 | 90.5 (< 0.001) | < 0.001 | |
3.5 μg/mm2 | − 0.51 (−1.99 to 0.97) | 0.500 | 96.0 (< 0.001) | ||
Primary patency at 12 months | Mean age (years) | ||||
≥ 70.0 | – | – | – | – | |
< 70.0 | 1.51 (1.25–1.83) | < 0.001 | 67.8 (0.008) | ||
Smoker (%) | |||||
≥ 50.0 | 1.37 (1.15–1.63) | < 0.001 | – | 0.445 | |
< 50.0 | 1.58 (1.22–2.03) | < 0.001 | 73.3 (0.005) | ||
DM (%) | |||||
≥ 50.0 | 2.26 (1.65–3.09) | < 0.001 | – | 0.003 | |
< 50.0 | 1.38 (1.20–1.59) | < 0.001 | 39.5 (0.158) | ||
Hyperlipidemia (%) | |||||
≥ 60.0 | 1.36 (1.22–1.52) | < 0.001 | 12.7 (0.329) | 0.001 | |
< 60.0 | 2.34 (1.74–3.15) | < 0.001 | 0.0 (0.506) | ||
Hypertension (%) | |||||
≥ 80.0 | 1.35 (1.14–1.61) | 0.001 | 41.8 (0.180) | 0.254 | |
< 80.0 | 1.92 (1.18–3.11) | 0.008 | 81.5 (0.004) | ||
Dose of paclitaxel | |||||
2.0 μg/mm2 | 1.29 (1.15–1.46) | < 0.001 | 0.0 (0.696) | 0.001 | |
3.0 μg/mm2 | 2.34 (1.74–3.15) | < 0.001 | 0.0 (0.506) | ||
3.5 μg/mm2 | 1.57 (1.29–1.91) | < 0.001 | – | ||
Restenosis at 6 months | Mean age (years) | ||||
≥ 70.0 | 0.58 (0.28–1.19) | 0.137 | 71.4 (0.015) | 0.005 | |
< 70.0 | 0.38 (0.29–0.49) | < 0.001 | 0.0 (0.850) | ||
Smoker percent (%) | |||||
≥ 50.0 | 0.56 (0.31–0.99) | 0.047 | 66.1 (0.019) | 0.009 | |
< 50.0 | 0.37 (0.28–0.49) | < 0.001 | 0.0 (0.770) | ||
DM (%) | |||||
≥ 50.0 | 0.61 (0.27–1.40) | 0.242 | 88.4 (< 0.001) | 0.200 | |
< 50.0 | 0.41 (0.29–0.56) | < 0.001 | 0.0 (0.973) | ||
Hyperlipidemia (%) | |||||
≥ 60.0 | 0.58 (0.34–0.97) | 0.038 | 64.5 (0.024) | 0.008 | |
< 60.0 | 0.36 (0.26–0.48) | < 0.001 | 0.0 (0.715) | ||
Hypertension (%) | |||||
≥ 80.0 | 0.62 (0.35–1.09) | 0.098 | 70.0 (0.019) | 0.004 | |
< 80.0 | 0.36 (0.27–0.48) | < 0.001 | 0.0 (0.849) | ||
Dose of paclitaxel | |||||
3.0 μg/mm2 | 0.48 (0.29–0.81) | 0.005 | 72.7 (0.003) | 1.000 | |
3.5 μg/mm2 | 0.48 (0.32–0.71) | < 0.001 | 0.0 (0.506) | ||
TLR at 6 months | Mean age (years) | ||||
≥ 70.0 | 0.56 (0.31–1.00) | 0.051 | 0.0 (0.522) | 0.075 | |
< 70.0 | 0.31 (0.18–0.52) | < 0.001 | 42.9 (0.105) | ||
Smoker (%) | |||||
≥ 50.0 | 0.57 (0.33–0.98) | 0.041 | 0.0 (0.720) | 0.035 | |
< 50.0 | 0.28 (0.16–0.50) | < 0.001 | 45.5 (0.102) | ||
DM (%) | |||||
≥ 50.0 | 0.32 (0.08–1.36) | 0.124 | 86.2 (0.007) | 1.000 | |
< 50.0 | 0.37 (0.24–0.56) | < 0.001 | 10.0 (0.353) | ||
Hyperlipidemia (%) | |||||
≥ 60.0 | 0.49 (0.26–0.92) | 0026 | 31.2 (0.213) | 0.041 | |
< 60.0 | 0.27 (0.17–0.45) | < 0.001 | 19.8 (0.289) | ||
Hypertension (%) | |||||
≥ 80.0 | 0.46 (0.23–0.94) | 0.033 | 46.5 (0.133) | 0.062 | |
< 80.0 | 0.28 (0.17–0.46) | < 0.001 | 14.9 (0.319) | ||
Dose of paclitaxel | |||||
2.0 μg/mm2 | 0.57 (0.23–1.45) | 0.241 | – | 0.039 | |
3.0 μg/mm2 | 0.26 (0.15–0.45) | < 0.001 | 31.5 (0.199) | ||
3.5 μg/mm2 | 0.56 (0.32–0.97) | 0.037 | 0.0 (0.558) | ||
TLR at 12 months | Mean age (years) | ||||
≥ 70.0 | 0.53 (0.21–1.35) | 0.183 | 63.7 (0.064) | 0.421 | |
< 70.0 | 0.42 (0.29–1.60) | < 0.001 | 69.9 (< 0.001) | ||
Smoker (%) | |||||
≥ 50.0 | 0.47 (0.31–0.72) | < 0.001 | 36.6 (0.163) | 1.000 | |
< 50.0 | 0.41 (0.25–0.67) | < 0.001 | 79.0 (< 0.001) | ||
DM (%) | |||||
≥ 50.0 | 0.48 (0.18–1.30) | 0.149 | 83.5 (0.002) | 0.778 | |
< 50.0 | 0.43 (0.30–0.61) | < 0.001 | 62.3 (0.005) | ||
Hyperlipidemia (%) | |||||
≥ 60.0 | 0.47 (0.30–0.75) | 0.001 | 69.5 (0.002) | 1.000 | |
< 60.0 | 0.38 (0.22–0.65) | < 0.001 | 70.1 (0.010) | ||
Hypertension (%) | |||||
≥ 80.0 | 0.50 (0.28–0.89) | 0.018 | 76.5 (0.001) | 0.297 | |
< 80.0 | 0.39 (0.26–0.58) | < 0.001 | 56.1 (0.034) | ||
Dose of paclitaxel | |||||
2.0 μg/mm2 | 0.62 (0.43–0.88) | 0.007 | 26.1 (0.255) | 0.007 | |
3.0 μg/mm2 | 0.44 (0.26–0.76) | 0.003 | 74.7 (0.001) | ||
3.5 μg/mm2 | 0.24 (0.13–0.42) | < 0.001 | 14.2 (0.312) | ||
TLR at 24 months | Mean age (years) | ||||
≥ 70.0 | – | – | – | – | |
< 70.0 | 0.42 (0.30–0.58) | < 0.001 | 35.6 (0.169) | ||
Smoker (%) | |||||
≥ 50.0 | 0.45 (0.20–0.98) | 0.045 | – | 1.000 | |
< 50.0 | 0.41 (0.28–0.60) | < 0.001 | 48.6 (0100) | ||
DM (%) | |||||
≥ 50.0 | – | – | – | – | |
< 50.0 | 0.42 (0.30–0.58) | < 0.001 | 35.6 (0.169) | ||
Hyperlipidemia (%) | |||||
≥ 60.0 | 0.43 (0.28–0.68) | < 0.001 | 51.9 (0.100) | 0.624 | |
< 60.0 | 0.38 (0.22–0.65) | < 0.001 | 22.2 (0.257) | ||
Hypertension (%) | |||||
≥ 80.0 | 0.43 (0.28–0.68) | < 0.001 | 51.9 (0.100) | 0.624 | |
< 80.0 | 0.38 (0.22–0.65) | < 0.001 | 22.2 (0.257) | ||
Dose of paclitaxel | |||||
2.0 μg/mm2 | 0.73 (0.44–1.22) | 0.233 | – | 0.059 | |
3.0 μg/mm2 | 0.35 (0.24–0.52) | < 0.001 | 0.0 (0.401) | ||
3.5 μg/mm2 | 0.37 (0.24–0.57) | < 0.001 | 0.0 (0.593) | ||
All-cause mortality at 6 months | Mean age (years) | ||||
≥ 70.0 | 0.65 (0.18–2.29) | 0.499 | 0.0 (0.567) | 0.481 | |
< 70.0 | 1.26 (0.34–4.69) | 0.732 | 0.0 (0.517) | ||
Smoker (%) | |||||
≥ 50.0 | 0.81 (0.25–2.61) | 0.719 | 0.0 (0.577) | 0.797 | |
< 50.0 | 1.03 (0.24–4.39) | 0.963 | 0.0 (0.393) | ||
DM percent (%) | |||||
≥ 50.0 | 1.04 (0.22–4.91) | 0.962 | – | 0.803 | |
< 50.0 | 0.82 (0.27–2.53) | 0.732 | 0.0 (0.571) | ||
Hyperlipidemia (%) | |||||
≥ 60.0 | 0.94 (0.34–2.56) | 0.900 | 0.0 (0.655) | 0.804 | |
< 60.0 | 0.71 (0.05–9.49) | 0.797 | 28.9 (0.236) | ||
Hypertension (%) | |||||
≥ 80.0 | 1.05 (0.37–3.03) | 0.924 | 0.0 (0.576) | 0.536 | |
< 80.0 | 0.05 (0.09–3.31) | 0.513 | 0.0 (0.462) | ||
Dose of paclitaxel | |||||
2.0 μg/mm2 | 0.32 (0.03–2.96) | 0.315 | – | 0.564 | |
3.0 μg/mm2 | 1.44 (0.28–7.30) | 0.663 | 0.0 (0.567) | ||
3.5 μg/mm2 | 0.93 (0.26–3.30) | 0.910 | 0.0 (0.443) | ||
All-cause mortality at 12 months | Mean age (years) | ||||
≥ 70.0 | 0.54 (0.10–2.93) | 0.474 | 30.4 (0.238) | 0.815 | |
< 70.0 | 0.94 (0.47–1.89) | 0.860 | 0.0 (0.771) | ||
Smoker (%) | |||||
≥ 50.0 | 0.83 (0.28–2.46) | 0.741 | 7.1 (0.357) | 1.000 | |
< 50.0 | 0.88 (0.41–1.91) | 0.746 | 0.0 (0.663) | ||
DM (%) | |||||
≥ 50.0 | 1.13 (0.42–3.02) | 0.806 | 0.0 (0.749) | 0503 | |
< 50.0 | 0.74 (0.33–1.63) | 0.450 | 0.0 (0.488) | ||
Hyperlipidemia (%) | |||||
≥ 60.0 | 0.94 (0.47–1.92) | 0.873 | 0.0 (0.627) | 0.686 | |
< 60.0 | 0.67 (0.19–2.42) | 0.546 | 0.0 (0.401) | ||
Hypertension (%) | |||||
≥ 80.0 | 1.04 (0.50–2.14) | 0.926 | 0.0 (0.663) | 0.403 | |
< 80.0 | 0.56 (0.17–1.81) | 0.332 | 0.0 (0.500) | ||
Dose of paclitaxel | |||||
2.0 μg/mm2 | 0.82 (0.35–1.88) | 0.632 | 0.0 (0.698) | 0.973 | |
3.0 μg/mm2 | 0.98 (0.35–2.73) | 0.965 | 0.0 (0.575) | ||
3.5 μg/mm2 | 0.83 (0.03–24.78) | 0.915 | 63.0 (0.100) | ||
Major adverse events at 12 months | Mean age (years) | ||||
≥ 70.0 | 0.52 (0.20–1.36) | 0.183 | 71.9 (0.029) | 0.196 | |
< 70.0 | 0.44 (0.29–0.66) | < 0.001 | 0.0 (0.694) | ||
Smoker (%) | |||||
≥ 50.0 | 0.49 (0.32–0.76) | 0.001 | 47.5 (0.090) | – | |
< 50.0 | – | – | – | ||
DM (%) | |||||
≥ 50.0 | 0.75 (0.38–1.46) | 0.400 | 59.6 (0.116) | 0.018 | |
< 50.0 | 0.37 (0.24–0.57) | < 0.001 | 0.0 (0.685) | ||
Hyperlipidemia (%) | |||||
≥ 60.0 | 0.59 (0.36–0.95) | 0.031 | 46.2 (0.134) | 0.083 | |
< 60.0 | 0.33 (0.17–0.62) | 0.001 | 0.0 (0.333) | ||
Hypertension (%) | |||||
≥ 80.0 | 0.75 (0.38–1.46) | 0.400 | 59.6 (0.116) | 0.018 | |
< 80.0 | 0.37 (0.24–0.57) | < 0.001 | 0.0 (0.685) | ||
Dose of paclitaxel | |||||
2.0 μg/mm2 | 0.45 (0.28–0.74) | 0.001 | 0.0 (0.418) | 0.046 | |
3.0 μg/mm2 | 0.79 (0.39–1.60) | 0.514 | 43.5 (0.184) | ||
3.5 μg/mm2 | 0.33 (0.17–0.62) | 0.001 | 0.0 (0.333) | ||
Amputation at 12 months | Mean age (years) | ||||
≥ 70.0 | 0.56 (0.05–5.91) | 0.632 | – | 0.857 | |
< 70.0 | 0.72 (0.20–2.61) | 0.616 | 0.0 (0.802) | ||
Smoker (%) | |||||
≥ 50.0 | 0.50 (0.12–2.11) | 0.348 | 0.0 (0.855) | 0.506 | |
< 50.0 | 1.11 (0.18–6.99) | 0.910 | 0.0 (0.633) | ||
DM (%) | |||||
≥ 50.0 | 0.47 (0.07–3.09) | 0.429 | 0.0 (0.792) | 0.627 | |
< 50.0 | 0.84 (0.20–3.43) | 0.805 | 0.0 (0.714) | ||
Hyperlipidemia (%) | |||||
≥ 60.0 | 1.08 (0.25–4.58) | 0.922 | 0.0 (0.877) | 0.321 | |
< 60.0 | 0.33 (0.05–2.03) | 0.232 | 0.0 (0.996) | ||
Hypertension (%) | |||||
≥ 80.0 | 1.10 (0.22–5.60) | 0.907 | 0.0 (0.712) | 0.419 | |
< 80.0 | 0.43 (0.09–2.08) | 0.296 | 0.0 (0.845) | ||
Dose of paclitaxel | |||||
2.0 μg/mm2 | 1.60 (0.25–10.06) | 0.617 | 0.0 (0.899) | 0.500 | |
3.0 μg/mm2 | 0.47 (0.07–3.09) | 0.429 | 0.0 (0.792) | ||
3.5 μg/mm2 | 0.33 (0.04–2.99) | 0.326 | – |