Comparative Effectiveness of Plain Balloon Angioplasty, Bare Metal Stents, Drug-Coated Balloons, and Drug-Eluting Stents for the Treatment of Infrapopliteal Artery Disease: Systematic Review and Bayesian Network Meta-analysis of Randomized Controlled Trials.
PURPOSE
To report a Bayesian network meta-analysis of randomized controlled trials (RCTs) comparing bare metal stents (BMS), paclitaxel-coated balloons (PCBs), and drug-eluting stents (DES) with balloon angioplasty (BA) or with each other in the infrapopliteal arteries.


METHODS
Sixteen RCTs comprising 1805 patients with 1-year median follow-up were analyzed. Bayesian random effects binomial models were employed (WinBUGS). Relative treatment effects were expressed as odds ratios (ORs) with 95% credible intervals (CrI), and the cumulative rank probabilities were calculated to provide hierarchies of competing treatments. Quality of evidence (QoE) was assessed with the GRADE (grading of recommendations assessment, development, and evaluation) system. Sensitivity, heterogeneity, and consistency analyses were performed.


RESULTS
There was high QoE that infrapopliteal DES significantly reduced restenosis compared with BMS (OR 0.26, 95% CrI 0.12 to 0.51) and BA (OR 0.22, 95% CrI 0.11 to 0.45). Likewise, DES significantly reduced target lesion revascularization (TLR) compared with BA (OR 0.41, 95% CrI 0.22 to 0.75) and BMS (OR 0.26, 95% CrI 0.15 to 0.45). Paclitaxel-coated balloons also reduced TLR compared with BA (OR 0.55, 95% CrI 0.34 to 0.90) and BMS (OR 0.35, 95% CrI 0.18 to 0.67), but QoE was low to moderate. BA had lower TLR than BMS (OR 0.63, 95% CrI 0.40 to 0.99) with high QoE. DES was the only treatment that significantly reduced limb amputations compared with BA (OR 0.58, 95% CrI 0.35 to 0.96), PCB (OR 0.51, 95% CrI 0.26 to 0.98), or BMS (OR 0.38, 95% CrI 0.19 to 0.72) with moderate to high QoE. DES also significantly improved wound healing compared with BA (OR 2.02, 95% CrI 1.01 to 4.07) or BMS (OR 3.45, 95% CrI 1.41 to 8.73) with high QoE. Results were stable on sensitivity and meta-regression analyses without any significant publication bias or inconsistency.


CONCLUSION
Infrapopliteal DES were associated with significantly lower rates of restenosis, TLR, and amputations and improved wound healing compared to BA and BMS. DES also significantly reduced amputations compared with PCB.
['Katsanos|Konstantinos|K|', 'Kitrou|Panagiotis|P|', 'Spiliopoulos|Stavros|S|', 'Diamantopoulos|Athanasios|A|', 'Karnabatidis|Dimitris|D|']
D000671:Amputation D000800:Angioplasty, Balloon D001499:Bayes Theorem D002317:Cardiovascular Agents D020099:Coated Materials, Biocompatible D057186:Comparative Effectiveness Research D003251:Constriction, Pathologic D054855:Drug-Eluting Stents D006801:Humans D023821:Limb Salvage D008390:Markov Chains D008670:Metals D000071076:Network Meta-Analysis D016017:Odds Ratio D058729:Peripheral Arterial Disease D011150:Popliteal Artery D011474:Prosthesis Design D016032:Randomized Controlled Trials as Topic D012008:Recurrence D012307:Risk Factors D015607:Stents D013997:Time Factors D016896:Treatment Outcome D062666:Vascular Access Devices D014654:Vascular Patency D014945:Wound Healing
balloon angioplasty bare metal stents drug-eluting stents infrapopliteal arteries network meta-analysis randomized controlled trial paclitaxel-coated balloons restenosis target lesion revascularization amputation wound healing critical limb ischemia