Drug-Coated Balloon Angioplasty Compared with Uncoated Balloons in the Treatment of Infrapopliteal Artery Lesions: 6-Month Results of a Randomized, Multi-Centers, Single-Blind, and Superiority Trial

Abstract

Background: Drug-coated balloons (DCBs) have shown promising results in treating femoropopliteal artery lesions while data on infrapopliteal lesions are controversial. We undertook this clinical trial to compare the safety and efficacy of DCBs versus uncoated balloon percutaneous transluminal angioplasty (control) of de novo or recurrent steno-occlusive lesions of the infrapopliteal arteries in patients with critical limb ischemia. Methods: In this prospective multicenter single-blind randomized study, 120 patients were randomized to the DCB group (Litos/Tulip, Acotec Scientific; n=61) or control group treated with uncoated balloons (n=59) in 11 centers in China from May 22, 2014, to June 13, 2018. Follow-up was scheduled at one and six months and included angiographic assessment at six months. Adverse events were assessed by an independent clinical events committee, angiographic parameters by an independent core laboratory. The study is registered at ClinicalTrials.gov, number NCT02137577. Findings: Regarding the primary safety endpoint (composite of all-cause mortality, target extremity major amputation, and target lesion revascularization at 30 days), there was one event (1·6%) in the DCB group and none in the control group (p=0·33). The primary efficacy endpoint-primary patency (defined as absence of target vessel occlusion, major amputation, or target lesion revascularization) at six months was accomplished in 77·1% [95% Cl 65·2%-89%] of the DCB group and 28·3% [95% Cl 15·3%-41·3%] of control group (p<0·001). Freedom from clinically driven target lesion revascularization was 95·1% [95% Cl 89·5%-100%] versus 79·7% [95% Cl 69·7%-90·1%] (p < 0·01) and late lumen loss 0·35±0·74mm [95% Cl 0·14-0·56mm] versus 1·08±0·62mm [95% Cl 0·90-1·26mm] (p<0·001). Interpretation: The Litos/Tulip DCBs are safe and effective in treating infrapopliteal artery lesions, resulting in improved angiographic and clinical outcomes compared with uncoated balloon PTA. Trial Registration Number: The study is registered at ClinicalTrials.gov, number NCT02137577. Funding: Acotec. Declaration of Interest: We declare no competing interests. Ethical Approval: The trial was conducted in conformity with the Declaration of Helsinki and the provisions for the conduct of clinical trials of medical devices issued by the China Food and Drug Administration. It was approved by the Chinese PLA General Hospital Ethics Committee and other ten local ethics committees of participating hospitals in China. All patients gave written informed consent prior to any study procedure.