One-Year CONSEQUENT Data Published for B. Braun's SeQuent Please Over-the-Wire DCB
June 28, 2017—The 6- and 12-month angiographic and clinical outcomes from the CONSEQUENT trial were published by Gunnar Tepe, MD, et al online in CardioVascular and Interventional Radiology. The trial evaluated B. Braun's SeQuent Please over-the-wire (OTW) drug-coated balloon (DCB) in femoropopliteal lesions.
In early 2017, the 1-year CONSEQUENT clinical trial data were presented by Principal Investigator Prof. Thomas Albrecht, MD, at LINC 2017, the Leipzig Interventional Course, which was held January 24–27 in Leipzig, Germany. The SeQuent Please OTW DCB is a paclitaxel-coated balloon with a nominal dose of 3 µg/mm2 that is integrated into a matrix with resveratrol. According to the company, preclinical testing of the DCB revealed a favorable coating integrity and stability, which does not appear to require lesion predilatation in nonocclusive stenoses.
As summarized in CardioVascular and Interventional Radiology, the investigators sought to study the safety and efficacy of the device to inhibit intimal hyperplasia in symptomatic claudicants with morphologically challenging lesions.
The randomized controlled trial was composed of 153 patients with symptomatic peripheral artery disease in femoropopliteal lesions who were randomized to either the DCB or to plain old balloon angioplasty (POBA). The mean lesion length was 13.2 ± 10.4 cm, with target lesion total occlusions in 26.1% of all patients (40/153).
The investigators reported that the primary endpoint of in-lesion late lumen loss (LLL) at 6 months was significantly reduced in the DCB group as compared to the POBA group: 0.35 mm (confidence interval [CI], 0.19–0.79 mm) vs 0.72 mm (CI, 0.68–1.22 mm; P = .006).
At 12 months, the target lesions revascularization (TLR) rate in the DCB group was significantly lower as compared to the POBA group (17.8% vs 37.7%; P = .008). The censored walking distance increase at 12 months suggests a benefit for patients who underwent DCB angioplasty as compared to the standard POBA treatment (165 ± 105 m vs 94 ± 136 m: P = .012).
Use of SeQuent Please DCB angioplasty as compared to POBA was associated with significantly reduced in-lesion LLL and reduced TLR rates, concluded the investigators in CardioVascular and Interventional Radiology.