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Multiple Studies Show Effectiveness of DCB for Treatment of SFA Disease
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Several studies presented at the Leipzig Interventional Conference showed that a novel drug-coated balloon is effective at treating superficial femoral artery disease.
Researchers presented data from the BIOLUX P-III all-comers registry of the DCB (Passeo-18 Lux, Biotronik), the BIOFLEX PEACE all-comers registry of the DCB in combination with a self-expanding stent (Pulsar-18, Biotronik) and the BIOLUX 4EVER clinical trial of the combination therapy.
BIOLUX P-III
Gunnar Tepe, MD, from RodMed Klinikum, Rosenheim, Germany, presented interim 6-month data from the prospective, multicenter BIOLUX P-III registry. Researchers plan to enroll at least 700 patients; the presentation covered the first 200.
The primary outcome was freedom from major adverse events, defined as freedom from mortality, major target limb amputation and target lesion revascularization, at 6 months.
Tepe reported that the rate of freedom from major adverse events was 94.4% and the rate of freedom from TLR was 96.8%.
“Passeo-18 Lux proved its safety in earlier randomized, controlled trials for both superficial femoral artery (SFA) and below-the-knee indications,” Tepe said in a press release issued by Biotronik. “As these trials served as proof of concept for the technology, the next step was to extend those results in a population reflecting real-world clinical practice. ... The results seen in the small cohort of patients from the earlier trials are now strengthened by an interim analysis of 200 patients, offering further support for DCB as a potential standard approach for treating lower limb disease.”
BIOFLE X PEACE and BIOLUX 4EVER
Michael K.W. Lichtenberg, MD, from Arnsberg Clinic, Arnsberg, Germany, presented early results of the BIOFLEX PEACE registry of 126 patients, in which 55 patients received the self-expanding stent after the DCB.
At 6 months, the primary patency rate was 89.1% and the rate of freedom from TLR was 90.9%, according to Lichtenberg.
He also presented 6-month data from the BIOLUX 4EVER clinical trial of 85 patients who received the self-expanding stent after the DCB. There, primary patency was 96.1% and freedom from TLF was 98.8%.
The two studies “confirm the trend in the earlier DEBAS trial. All of them show the high potential of combination therapy with Passeo-18 Lux and Pulsar-18 in the SFA,” Marianne Brodmann, MD, from Medical University of Graz, Austria, and chair of the symposium that included the presentation, said in the release. “These preliminary results indicate that combination therapy ... may improve the treatment outcomes of the two individual technologies in challenging vessel morphologies and patient populations.”
The DCB and the self-expanding stent are not currently available in the United States. – by Erik Swain
References:
Lichtenberg MKW. SFA Combination Therapy: The Next Vascular Horizon?
Tepe G. Clinical Trial Update – Peripheral Clinical Trials and Selected Abstracts. Both presented at: Leipzig Interventional Conference; Jan. 26-29, 2016; Leipzig, Germany.
Disclosure: The studies were funded by Biotronik. Tepe reports receiving research grants and speaking honoraria from Bard Peripheral Vascular, B. Braun, Biotronik, Covidien, Medrad, and Medtronic, consulting for Abbott, Cardiovascular Systems Inc., Covidien, Medrad and Medtronic and serving on and advisory board for Medtronic. Lichtenberg reports no relevant financial disclosures. Brodmann reports receiving honoraria from AstraZeneca, Bard Peripheral Vascular, Bayer, Biotronik, Boehringer Ingelheim, Bristol-Myers Squibb/Sanofi, Daiichi Sankyo, Medtronic, Novartis, Pfizer, Sanofi Aventis, Takeda and Terumo and consulting for Bard Peripheral Vascular and Covidien.