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Bioabsorbable scaffold yielded promising 3-year results
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DALLAS — A paclitaxel-eluting bioabsorbable magnesium scaffold was associated with an excellent safety profile at 3 years and significantly improved efficacy at 12 months, and did not lead to death or scaffold thrombosis at follow-up, according to a researcher from the BIOSOLVE-I trial.
For the first-in-man study, Michael Haude, MD, with the Städtische Kliniken-Neuss, Lukaskrankenhaus GmbH in Neuss, Germany, and investigators treated 46 patients with a paclitaxel-eluting bioabsorbable magnesium scaffold (DREAMS, Biotronik). The scaffold features an alloy refined from a previous iteration (bare absorbable magnesium scaffold [AMS]), 120 mcm strut thickness, 6-crown design and PLGA-polymer carrier.
The prospective, multicenter study featured two cohorts: cohort one included angiographic and IVUS follow-up at 6 months and cohort two included angiographic and IVUS follow-up at 12 months. Haude and colleagues tested the scaffold on single de novo coronary artery lesions that were between 3 mm and 3.5 mm and no more than 12 mm long.
The primary endpoint was target lesion failure at 6 months for cohort one and TLF at 12 months for cohort two. Patients were followed for 1 month and 6, 12, 24 and 36 months.
Haude and colleagues reported device and procedural success in all cases. At 6 and 12 months, there were two reported cases of TLF in cohort one vs. none in cohort two.
Three-year results for cohort one indicated two cases of TLF, and no cases of cardiac death, MI and scaffold thrombosis.
At the time of presentation, results from cohort two were still ongoing.
Overall, Haude said, “DREAMS demonstrates an excellent safety profile at up to 36 months ... and significantly improved efficacy at 12 months compared to the bare AMS. TLF rate remains stable at up to 36-month follow-up, at least in cohort one, which is available at present.”
Additionally, Haude said serial IVUS, IVUS-derived virtual histology, echogenicity analysis and optical coherence tomography documented the scaffold’s absorption with time, and vasomotion within the scaffolded segment was achieved at 6-month follow-up with no further change at 12 months.
Haude said there is a prospective, multicenter BIOSOLVE-II study planned, which will assess the paclitaxel-eluting bioabsorbable magnesium scaffold in 121 patients with single de novo coronary artery lesions in up to two coronary arteries. The primary endpoint will be in-segment late lumen loss at 6 months. Patients will be followed for 1 month, and 6, 12, 24 and 36 months. – by Brian Ellis
For more information:
Haude M. Abstract #11264. Presented at: the American Heart Association Scientific Sessions; Nov. 16-20, 2013; Dallas.
Disclosure: Haude reports receiving research grant support from Biotronik, and serving as a consultant on the advisory board of Biotronik.