Updated 1-Year BIOSOLVE-IV Data Presented for Biotronik's Magmaris Resorbable Scaffold
June 7, 2019–Biotronik announced that updated 12-month follow-up cohort results from the first 800 patients in the BIOSOLVE-IV registry were presented by the study's Principal Investigator Stefan Verheye, MD, at EuroPCR held May 21–24 in Paris, France.
According to the company, the 1-year data for the magnesium-based Magmaris resorbable scaffold support the procedural success and safety profile with a 1-year target lesion failure (TLF) rate of 4.7%, incidence of cardiac death of 0.1%, and scaffold thrombosis in 0.6% of patients. An additional analysis of the data showed a device success rate of 97.1% and procedure success in 98.8% of the cases.
In Biotronik's announcement, Dr. Verheye commented, “Overall BIOSOLVE-IV confirmed low TLF rates from previous trials in a real-world setting, including 17.8% non–ST-segment elevation myocardial infarction (NSTEMI) patients and 5.6% patients with bifurcation lesions."
Dr. Verheye noted, "When looking closer at the five scaffold thrombosis cases, we noticed that in four of them antiplatelet or anticoagulant therapy was interrupted early after scaffold implantation.” Prof. Michael Joner, MD, addressed this finding, pointing out that dual antiplatelet therapy duration should be given according to the 12-month resorption time of the Magnesium backbone.
Additionally, Biotronik reported that data from regional registries in Spain and Poland supporting the positive clinical experience with the Magmaris scaffold were presented at EuroPCR. One-year data from the Spanish registry and those with acute coronary syndrome (ACS) in the Polish registry demonstrated that the use of Magmaris was associated with procedural safety and promising clinical outcomes. Notably, the Polish study showed low rates of TLR (4.3%) and zero scaffold thrombosis in 70 out of 150 ACS NSTEMI patients enrolled at 12 months, stated the company.
Also at EuroPCR, Prof. Michael Haude, MD, presented first insights into Biotronik's next-generation scaffold, Dreams 3G, which will provide improved mechanical properties and reduced strut thickness. "Next-generation resorbable magnesium scaffolds should meet a number of requirements including an increased scaffolding time. From what we have seen so far, Dreams 3G is on a good way to achieve these goals,” commented Prof. Haude in Biotronik's press release.
The preliminary 12-month results of the BIOSOLVE-IV study were first presented by Clinical Investigator Stefano Galli, MD, as late-breaking clinical data at CRT 2019, the Cardiovascular Research Technologies annual meeting held March 2–5 in Washington, DC.