DCB Compared to BMS in Femoropopliteal Lesions in 3-Year Data From Four Studies

November 3, 2022—Mehdi Shishehbor, DO, presented 3-year results from a patient-level, propensity-adjusted comparison of drug-coated balloons (DCBs) versus bare metal stents (BMSs) in femoropopliteal lesions in prospective, multicenter studies.

Using advanced statistical methods for patient-level evaluation of prospectively collected, core laboratory–adjudicated data, this analysis demonstrated superior 12-month patency and 36-month freedom from clinically driven target lesion revascularization (CD-TLR) for DCBs compared to BMSs.

Dr. Shishehbor presented the findings in the first of three Late-Breaking Clinical Trials sessions at the VIVA22 conference held by the VIVA Foundation on October 31 to November 3 in Las Vegas, Nevada. The study was simultaneously published by Dr. Shishehbor et al online in Journal of the American College of Cardiology.

As summarized in the VIVA Foundation press release, the patient-level data were pooled from the DCB arms of the IN.PACT SFA I/II and IN.PACT SFA Japan randomized controlled trials and the prospective, multicenter, single-arm Complete SE and DURABILITY II BMS studies.

DCBs and BMSs were compared using the inverse probability of treatment weight (IPTW) method with weighted log-rank P values.

A total of 771 patients (288, DCB vs 483, BMS) were included in the primary analysis. Demographic, baseline lesion, and procedural characteristics were matched between treatment groups after the IPTW adjustment.

Dr. Shishehbor reported that based on IPTW-adjusted Kaplan-Meier estimates, the 12-month primary patency (90.4% vs 80.9%; P = .007), freedom from 36-month CD-TLR (85.6% vs 73.7%; P = .001), and cumulative 36-month major adverse events (25.3% vs 38.8%; P < .001) differed significantly, all favoring the DCB group versus the BMS group.

There were no statistically significant differences observed in the cumulative incidence of IPTW-adjusted all-cause mortality (9.5% vs 13.0%; P = .23), major target limb amputation (0.0% vs 0.8%; P = .29), or thrombosis at the target lesion site (1.0% vs 2.1%; P = .41) through 36 months, although rates were numerically lower in the DCB group versus the BMS group.

The investigators concluded that the analysis results support the primary use of DCB versus BMS in moderately complex femoropopliteal lesions, with superior effectiveness and no differences in mortality, amputation, or thrombosis.

DCBs may provide a durable benefit over BMSs in femoropopliteal lesions amenable to both treatments, supporting DCBs as a first-line treatment strategy when both treatment options are at equipoise, stated the VIVA Foundation press release.