One-year findings of the CONSEQUENT all-comers observational study of the paclitaxel drug-coated balloon (DCB) SeQuent Please OTW (B Braun) were reported at LINC 2021 (The Leipzig Interventional Course; 25–29 January, online). Principal investigator Ralf Langhoff (Sankt Gertrauden Krankenhaus, Berlin, Germany) relayed low target lesion revascularisation (TLR) and mortality rates.
The prospective, multicentre study evaluates the safety and efficacy of the SeQuent Please OTW in the treatment of de novo and restenotic lesions in peripheral arteries above and below the knee. It includes a total of 784 patients and 879 lesions (almost one third TASC II C/ D lesions, 78.8% calcified and 44.6% occluded).
“We have represented real-world data in this all-comers registry,” said Langhoff. “Many registries are including mostly claudicants. But here, we had a really large group of CTLI [chronic limb-threatening ischaemia] patients—almost 50% had CLTI. Lesion length is also more challenging—13.3±9.3cm in the CLTI group and 10.8±9.1cm in the claudicant group. That is fairly realistic in terms of what we treat every day.”
Twelve-month findings include a TLR rate of 8.1% (CLTI patients, 6.3%; non-CLTI, 9.6%), a patency rate of 88.3% (CLTI, 89.9%; non-CLTI, 87.1%), and an all-cause mortality rate of 4.3% (CLTI, 7%; non-CLTI, 2%). Predictors for TLR included in-stent restenosis at baseline, lesion length, and female gender.
TLR rates were similar above and below the knee, commented Langhoff: “Restenosis rates are generally much higher in BTK [below-the-knee] 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”.
The group also carried out additional analysis with respect to mortality in response to the findings of the 2018 meta-analysis by Katsanos et al: “We did not see any difference—as predicted—in all-cause mortality in terms of paclitaxel dose. This is only one-year data, but we didn’t see any correlation so far. Three- and five-year data will be collected and presented later.”