1-Year Data Published for B. Braun’s SeQuent Please OTW DCB

April 22, 2021—One-year findings from the CONSEQUENT ALL COMERS observational study demonstrating low target lesion revascularization (TLR) and mortality rates for the SeQuent Please over-the-wire (OTW) drug-coated balloon (DCB; B. Braun Melsungen AG) in an unselected patient population were published by Principal Investigator Ralf Langhoff, MD, et al online in Angiology. Earlier this year, the data were presented at LINC 2021, the Leipzig Interventional Course, which was held virtually.

The prospective, single-arm, multicenter observational study evaluated the safety and efficacy of Sequent Please OTW, a resveratrol-paclitaxel-coated peripheral DCB, in an all-comer patient cohort undergoing endovascular treatment of above- and below-the-knee peripheral artery disease. The primary endpoint was the 12-month TLR rate. Secondary endpoints included vessel patency, target vessel revascularization, and all-cause mortality.

As summarized in Angiology, the investigators analyzed a total of 879 lesions in 784 consecutive patients (age, 71.3 ± 10.4 years; 57.7% male). Of these patients, 53.3% had claudication, and the remaining 46.7% exhibited critical limb ischemia (CLI). Substantial comorbidities were present, including diabetes mellitus (41.2%), smoking (66.1%), and coronary artery disease (33.9%). Lesion length (879 lesions) was 12 ± 9.3 cm, and 31.8% were TransAtlantic Inter-Society Consensus II C/D lesions.

The investigators reported an overall technical success rate of 99.6% (1.6 ± 0.79 devices/patient) with the 1,269 DCBs used in the study. At 12 months, TLR rates were 6.3% in patients with CLI and 9.6% in claudicants, with a primary patency rate of 89.9% and 87.1%, respectively. All-cause mortality was 4.3% (28/658). Predictors for TLR were in-stent restenosis at baseline, vessel diameters ≤ 4.5 mm, lesion length, and post-DCB bailout stenting, reported the investigators in Angiology.