The VaSecure Paclitaxel Drug Coated Balloon Clinical Trial: One Year Outcomes.

OBJECTIVE

Previous randomised controlled trials (RCTs) have shown comparable short term outcomes of drug coated balloon (DCB) angioplasty vs. standard percutaneous transluminal angioplasty (PTA) in patients with chronic limb threatening ischaemia (CLTI) with femoropopliteal lesions. The study aimed to evaluate the one year follow up data of a multicentre RCT to verify the safety and efficacy of the VaSecure paclitaxel DCB vs. PTA for the treatment of femoropopliteal CLTI.

METHODS

This prospective, multicentre RCT enrolled 199 subjects with CLTI from 16 centres. Subjects were randomised 1:1 to DCB angioplasty or PTA. Assessments through one year included freedom from clinically driven target lesion revascularisation (CD-TLR), amputation, and all cause death. Other outcomes assessed included risk factors for death and major amputation.

RESULTS

The full analysis set included data for 199 subjects. Due to the absence of key data for 40 subjects, the per protocol set data included 159 subjects (DCB group, n = 80 vs. control group, n = 79). The intervention technical success and device success rates for both groups were 100%. There was no statistically significant difference between the two groups in rates of all cause death (2.5% vs. 1.3%; p = 1.0), major or minor amputation (0.0% vs. 0.0%; p = 1.0), target vessel thrombosis (1.3% vs. 0.0%; p = 1.0), and change in ankle brachial index (0.63 ± 0.22 vs. 0.51 ± 0.25; p = .008) at 12 month follow up. Late lumen loss at six months was 0.38 ± 0.58 in the DCB group and 1.25 ± 1.13 in the PTA group, with a difference of -0.88 (95% confidence interval [CI] -1.16 - -0.59). The upper limit of the 95% CI was below the threshold for superior efficacy. The minimum lumen diameter at six months was 3.15 ± 1.14 and 2.30 ± 1.29 in the two groups, respectively, with a statistically significant difference (p < .001). Rates of major adverse events (MAEs) (7.5% vs. 19.0%; p = .032), primary patency (72.7% vs. 50.0%; p = .007), re-stenosis (8.1% vs. 19.0%; p = .025), CD-TLR, and clinically driven target vessel re-intervention (CD-TVR) (5.1% vs. 15.0%; p = .025) at 12 months all showed statistically significantly better efficacy in the VaSecure paclitaxel DCB group compared with the control group.

CONCLUSION

The results of this multicentre RCT showed comparable safety outcomes in all cause death and major or minor amputation rates for the VaSecure paclitaxel DCB and control groups. For the safety evaluation, the DCB angioplasty group had statistically significantly lower rates of severe adverse events and MAEs compared with the control group. Drug coated balloon angioplasty demonstrated superior effectiveness compared with PTA in primary patency, re-stenosis rate, CD-TLR, and CD-TVR at 12 months. Further results from this trial, including two and five year outcomes, will be reported in the future.