Real-World CONSEQUENT Data Presented for B. Braun’s SeQuent Please OTW DCB

February 12, 2021—B. Braun Melsungen AG announced that the 1-year findings of the CONSEQUENT all-comers observational study of the company’s SeQuent Please over-the-wire (OTW) paclitaxel drug-coated balloon (DCB) demonstrated low target lesion revascularization (TLR) and mortality rates.

The data were reported by Principal Investigator Ralf Langhoff, MD, at LINC 2021, the Leipzig Interventional Course held virtually on January 25-29.

According to B. Braun, the prospective, multicenter study is evaluating the safety and efficacy of the SeQuent Please OTW in the treatment of de novo and restenotic lesions in peripheral arteries above the knee (ATK) and below the knee (BTK). The study is composed of 784 patients and 879 lesions (approximately one-third are TASC II C/D lesions, 78.8% calcified and 44.6% occluded).

“We have represented real-world data in this all-comers registry,” said Dr. Langhoff. “Many registries are including mostly claudicants. But here, we had a really large group of critical limb ischemia (CLI) patients—almost 50% had CLI. Lesion length is also more challenging—13.3 ± 9.3 cm in the CLI group and 10.8 ± 9.1 cm in the claudicant group. That is fairly realistic in terms of what we treat every day.”

B. Braun stated that the 12-month findings included the following:

• TLR of 8.1% (CLI patients, 6.3%; non-CLI patients, 9.6%)
• Patency rate of 88.3% (CLI, 89.9%; non-CLI, 87.1%)
• All-cause mortality of 4.3% (CLI, 7.0%; non-CLI, 2.0%)

Predictors for TLR included in-stent restenosis at baseline, lesion length, and female gender.

In the company’s press release, Dr. Langhoff noted that TLR rates were similar ATK and BTK. He commented, “Restenosis rates are generally much higher in BTK arteries, but this was just not the case in the CONSEQUENT registry. This is another hint that the SeQuent Please OTW DCB seems to work in BTK arteries.”

Addressing the investigators’ additional analysis with respect to mortality in response to the findings of the 2018 meta-analysis by Katsanos et al, he stated, “We did not see any difference—as predicted—in all-cause mortality in terms of paclitaxel dose. This is only 1-year data, but we didn’t see any correlation so far. Three- and 5-year data will be collected and presented later.”