Editor's Choice – Drug Coated Balloon Angioplasty vs. Standard Percutaneous Transluminal Angioplasty in Below the Knee Peripheral Arterial Disease: A Systematic Review and Meta-Analysis

Abstract

WHAT THIS PAPER ADDS This systematic review and meta-analysis is an update on the role of drug coated balloons in the endovascular treatment of infrapopliteal arterial disease. Based on the results of this paper no statistically significant differences were found between drug coated balloon angioplasty and standard percutaneous transluminal angioplasty. Objective: The aim was to review and analyse the literature on clinical outcomes of drug coated balloon (DCB) vs. standard percutaneous transluminal angioplasty (PTA) for the treatment of infrapopliteal arterial disease. Methods: This is a systematic review and meta-analysis. The MEDLINE, EMBASE and Cochrane Database of Systematic Reviews were searched for studies published between January 2008 and November 2018. Two authors independently performed the search, study selection, assessment of methodological quality and data extraction. Studies were eligible when reporting PTA and DCB outcomes in infrapopliteal arteries, published in English, human studies, and full text was available. Methodological quality was determined by MINORS and Cochrane risk of bias tool. GRADE methodology was used to rate the evidence for observed outcomes. The primary outcome was the 12 month limb salvage rate. Secondary outcomes were 12 month survival, amputation free survival (AFS), restenosis, and target lesion revascularisation (TLR) rates. Inclusion criteria for pooling data were randomised controlled trials and comparative studies with 12 month outcomes. Results: Ten studies representing 1593 patients met the inclusion criteria. The quality was assessed as moderate or low. Data from five studies were pooled, and 12 month outcomes for DCB vs. PTA were limb salvage rate, 94.0% vs. 95.7% (odds ratio (OR), 0.92; 95% confidence interval (CI), 0.39e2.21); and survival rate, 89.8% vs. 92.9% (OR 0.69; 95% CI 0.39e1.21). Data from four studies were pooled, and 12 month outcomes for PTA vs. DCB were restenosis rate, 62.0% vs. 32.9% (OR 2.87; 95% CI 0.83e9.92); and TLR rate, 27.8% vs. 14.0% (OR 2.76; 95% CI 0.90e8.48). Pooled data from two studies showed 12 month AFS rate for DCB vs. PTA; 82.5% vs. 88.7% (OR 0.79; 95% CI 0.23e2.75). No statistically significant differences were found. Conclusion: Based on this systematic review and meta-analysis no significant differences in limb salvage, survival, restenosis, TLR, and AFS rates were found when DCB angioplasty was compared with standard PTA.

Progress on developing an effective below-the-knee drug-coated balloon

“…The lack of clear benefit of PCB has since then been confirmed by Ipema et al [67] in their review of 10 studies including 1593 patients. The authors did not reveal a significant difference in their primary outcomes of 12-month limb salvage or secondary endpoints (survival, restenosis, TLR, amputation-free survival).…”

World’s First Experience Treating TASC II C and D Tibial Occlusive Disease Using the Selution SLR Sirolimus-Eluting Balloon: Six-Month Results From the PRESTIGE Study

“… 29 However, there are other meta-analyses that did not show superiority of PCB over CBA in terms of binary restenosis, TLR, and major amputation rates. 30 – 32 Furthermore, Katsanos et al 15 have recently showed a worse 1-year AFS rate following infrapopliteal arteries treated with PCBs, although this meta-analysis has been heavily criticized for use of nonpublished data at the time. AFS was worse in those studies using a higher dose (3.0–3.5 µg/mm 2 ) balloon drug coating and paclitaxel distal embolization was postulated to be the underlying mechanism by the authors.…”

“…Another reason why there may have been a discrepancy in different meta-analysis findings in the efficacy of PCBs in the tibial vessels may be related to adequacy of lesion preparation between the studies included. 32 Literature describes favorable outcomes for prolonged inflation time especially for more calcified and long total occlusive lesions. 34 , 35 In PRESTIGE, both primary investigators used a 180-second preparatory CBA inflation time and judicial use of longer length balloons to minimize the risk of dissection.…”

Utility of a novel high pressure non-compliant balloon for tibial atherosclerotic lesions in Asian patients with chronic limb threatening ischaemia

“…Would this have improved the primary patency of 73% at 6 months? Data using paclitaxel coated balloons (PCB) in tibial lesions are currently conflictory with a recent metaanalysis showing no advantage in terms of limb salvage, survival, restenosis and TLR over POBA [10]. Furthermore safety concerns have been raised recently using PCB below the knee by Katsanos et al who showed a worse one-year AFS rate (a composite endpoint of death and major LEA) following treatment of infra-popliteal arteries with PCBs [11], although this was not borne out from a subsequent meta-analysis by Dinh et al [29].…”

“…Devices coated with paclitaxel have been used successfully in the clinical arena to limit restenosis by inhibiting the biologic pathway that leads to NIH [9]. However, recent systematic reviews and study-level meta-analyses of randomized controlled trials investigating treatment of the infra-popliteal arteries with paclitaxel-coated balloons (PCB) compared with conventional POBA for CLTI either showed no significant differences in limb salvage, survival, restenosis, TLR, and amputation-free survival (AFS) between the two groups [10] or was significantly worse in those who had PCB [11]. Current poor patency seen in tibial angioplasty is also likely contributed in part by small vessel size, especially pertinent to Asian tibial arteries, and poor luminal gain after standard semi-compliant POBA.…”