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BMS with or without DCB effective for treatment of PAD

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A bare-metal stent yielded favorable outcomes in patients with peripheral artery disease as a stand-alone therapy or combined with a drug-coated balloon, according to the 12-month results of two trials presented at the Charing Cross Symposium in London.

Researchers reported results from two studies of patients treated with the BMS (Pulsar-18, Biotronik).

BIOFLEX PEACE

The prospective, multicenter, nonrandomized BIOFLEX PEACE all-comers registry was the first report of performance of the 4F BMS in femoropopliteal lesions in a real-world setting, according to a press release issued by the company.

A total of 164 patients (mean age, 70 years; 61% men) were followed for 12 months.

Freedom from clinically driven target lesion revascularization was 96.2% at 12 months in the overall cohort, whereas in an imaging cohort, primary patency was 73.6% at 12 months, Michael K.W. Lichtenberg, MD, from Vascular Center Clinic in Arnsberg, Germany, said during a presentation.

During the study period, he said, 80.8% of patients improved at least one Rutherford class, and mean ankle-brachial index improved from 0.66 to 0.91.

“These results are in line with already published data for the Pulsar stent from controlled trials, thus confirming the stent’s efficacy for a broader range of patients and lesions,” Lichtenberg said in the release.

BIOLUX 4EVER

In the physician-initiated, prospective, multicenter, controlled BIOLUX 4EVER trial, researchers studied the efficacy of the BMS plus a DCB (Passeo-18 Lux, Biotronik) for treatment of femoropopliteal arterial stenotic disease.

A total of 120 patients (mean age, 71 years; 66% men) with a target lesion less than 19 cm were included in the study, whose primary endpoint was primary patency rate at 12 months.

The BMS-DCB combination was associated with a primary patency rate of 89.9% and a rate of freedom from TLR of 93.6% at 12 months.

“The 12-month outcomes of the BIOLUX 4EVER trial indicate the value of a combined approach that provides physicians with more options and versatility when treating [superficial femoral artery] lesions while achieving [drug-eluting stent]-like results,” Koen Deloose, MD, from AZ Sint-Blasius in Dendermonde, Belgium, said in the release. “While DES is limited by the need to fully cover the lesion with a stent and fully treat the lesions with paclitaxel, the new combination approach of a DCB and BMS means that there is now the freedom to determine how much support is necessary based on each vessel’s unique anatomy and lesion characteristics for a more tailored approach.” – by Dave Quaile

References:

Deloose K, et al. The contribution of drug elution to a stent.

Lichtenberg MK, et al. Stent use consensus update. Both presented at: Charing Cross Symposium; April 25-28, 2017; London.

Disclosure: Deloose reports receiving consultant fees from Abbott, Bard, Bentley, Biotronik, Cook, GE Healthcare, iVascular, Medtronic and Spectranetics. Lichtenberg reports financial ties with AB Medica, Biotronik, Boston Scientific, C.R. Bard, LimFlow, Optimed, Straub Medical, Terumo, TVA Medical, Veniti, Veryan and Volcano.