Abstract
Backgrounds and ObjectivesDrug-coated balloons (DCBs) have shown promising benefits in improving the outcomes for patients with peripheral artery disease. Several randomized clinical trials have reported that paclitaxel-coated balloon significantly reduce the rates of restenosis and the need for reintervention in comparison with regular balloon angioplasty. Due to the differences in excipients, paclitaxel dose, and coating techniques, variable clinical outcomes have been observed with different DCBs. In this study, we aimed to evaluate the safety and efficacy of a novel ZENFlow carrier-free DCB in the treatment of femoropopliteal artery occlusive disease.MethodsIn this randomized controlled trial conducted at 15 sites, 192 patients with Rutherford class 3–5 were randomly assigned into two groups: drug-coated balloon group and percutaneous transluminal angioplasty group. The primary endpoint was a late lumen loss at 6 months based on blinded angiographic core laboratory evaluations, and the secondary endpoints included primary patency rate, binary restenosis, clinically driven target lesion revascularization, ankle-brachial index, Rutherford class change, and major adverse events.ResultsIn this multicenter trial, 93 patients received DCB angioplasty, whereas 99 patients underwent regular balloon angioplasty. The late lumen loss at 6-month follow-up was 0.50 ± 0.82 and 1.69 ± 0.87 mm in the drug-coated balloon and percutaneous transluminal angioplasty groups, respectively (p < 0.001). During the 12-month follow-up period, the drug-coated balloon group showed a significantly higher primary patency rate (54 vs. 31.3%, p = 0.009) and markedly lower rates of target vessel restenosis (22.1 vs. 64.3%, p < 0.001) and clinically driven target lesion revascularization rate (5.4 vs. 19.2%, p = 0.006) than the percutaneous transluminal angioplasty group. Compared with the percutaneous transluminal angioplasty group, the drug-coated balloon group had significant improvements in the ankle-brachial index and Rutherford class. The all-cause mortality rate was comparable, and no device-related deaths occurred in either groups.ConclusionsBalloon angioplasty using a ZENFlow carrier-free drug-coated balloon is a safe and effective treatment method for femoropopliteal artery lesions. This novel drug-coated balloon catheter achieved satisfactory early and 1-year outcomes in this trial.Clinical Trial Registrationhttps://clinicaltrials.gov, identifier: NCT03844724.
Highlights
Superficial femoral and popliteal arteries are the frequently involved arteries in lower extremity ischemia due to atherosclerosis, which is characterized by long and severe calcified lesions with a high incidence of restenosis after percutaneous transluminal angioplasty (PTA) with standard plain balloon catheter
Most current drug-coated balloon (DCB) are coated with paclitaxel, which can be delivered into the vessel intima during balloon inflation
Larger prospective multicenter randomized controlled trials have demonstrated that DCBs have a superior mid-term primary patency rate and are associated with reduced rates of clinically driven target lesion revascularization (CD-TLR) compared with regular PTA [7, 8]
Summary
Superficial femoral and popliteal arteries are the frequently involved arteries in lower extremity ischemia due to atherosclerosis, which is characterized by long and severe calcified lesions with a high incidence of restenosis after percutaneous transluminal angioplasty (PTA) with standard plain balloon catheter. In case of flow-limited dissection after PTA, bare metal stent (BMS) implantation can prevent elastic recoil of the injured vessel walls. The mid- and long-term outcomes after BMS implantation are not satisfactory because of in-stent restenosis (ISR), stent fractures, and other stent-related complications. 1-year patency rates after stenting range from 63 to 83% and longer-term patency rates from 60 to 75% [1–5]. Drug-coated balloons (DCBs) have shown benefits in improving long-term patency rate, without the drawbacks of BMS implantations. Most current DCBs are coated with paclitaxel, which can be delivered into the vessel intima during balloon inflation. Larger prospective multicenter randomized controlled trials have demonstrated that DCBs have a superior mid-term primary patency rate and are associated with reduced rates of clinically driven target lesion revascularization (CD-TLR) compared with regular PTA [7, 8]
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