TCT 2019: Real-World Registry Data Confirm Safety of Resorbable Scaffold Technology

Full cohort data from the BIOSOLVE-IV registry strengthen the clinical evidence for BIOTRONIK’s Magmaris^®1 Resorbable Magnesium Scaffold (RMS) as a therapy option for patients with coronary artery disease. Dr. Stefan Verheye, Senior Interventional Cardiologist at Antwerp Cardiovascular Institute, Antwerp, Belgium presented primary endpoint results of the BIOSOLVE-IV registry at the TCT congress in San Francisco.²

The BIOSOLVE-IV registry investigates the clinical performance and long-term safety of the Magmaris RMS in a real world setting. In a cohort of 1,075 patients, at 12 months the target lesion failure³ (TLF) rate was 4.3%. With cardiac death occurring in 0.2% and scaffold thrombosis in 0.5% of the patients⁴, the device demonstrated a very good safety profile.

“Our results confirm the low TLF rate of the Magmaris scaffold, as we have seen in previous studies,” commented principal investigator Dr. Stefan Verheye. “This is remarkable as the patient cohort included a relatively high proportion of challenging cases⁴, with 19.2% NSTEMI patients, 5.1% patients with bifurcation lesions and 21.2% patients with diabetes. Even in these subgroups, consistent safety has been proven.”

Bioresorbable scaffolds aim to provide comparable performance to existing metallic drug-eluting stents, while delivering complete scaffold resorption within a certain time period to facilitate complete vessel healing with the restoration of normal vascular function.⁵ Magmaris RMS dissolves in the body approximately 95% at one year after implantation,⁶ which lowers the risk of late scaffold thrombosis⁶ – a potentially dangerous complication.

During the TCT congress, Prof. Michael Haude, Lukaskrankenhaus, Neuss, Germany also presented pooled results of the BIOSOLVE-II and BIOSOLVE-III trials, demonstrating an excellent safety profile with Magmaris RMS at the 36-month follow-up, with a TLF rate of 6.4% and scaffold thrombosis in 0.0% of 174 patients.

“We developed Magmaris RMS as the first drug-eluting magnesium resorbable scaffold to overcome the limitations of permanent metallic stents,” commented Dr. Alexander Uhl, Senior Vice President Corporate Marketing at BIOTRONIK. “With its growing evidence base, Magmaris RMS has once again shown low event rates and efficacious outcomes. These new data support that resorbable magnesium scaffolds will play a significant role in coronary interventions.”^​

References:

^{1 Magmaris is a trademark or registered trademark of the BIOTRONIK Group of Companies. The Magmaris Resorbable Magnesium Scaffold is not currently commercially available in the United States..}

^{2 Verheye S. Safety and Performance of the Resorbable Magnesium Scaffold Magmaris in a Real World Setting First Cohort Subjects at 12 month Follow up of the BIOSOLVE IV Registry. Presented at: TCT, September 25, 2019; San Francisco.}

^{3 Target lesion failure is defined as composite of cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization and emergent coronary artery bypass grafting.}

^{4 Four out of five subjects had an early DAPT interruption prior to 6-month.}

^{5 Bennett J et al. Magmaris resorbable magnesium scaffold for the treatment of coronary heart disease: overview of its safety and efficacy, Expert Review of Medical Devices, DOI: 10.1080/17434440.2019.1649133.}

^{6 Joner M, Ruppelt P, Zumstein P, et al. Preclinical Evaluation of Degradation Kinetics and Elemental Mapping of First and Second Generation Bioresorbable Magnesium Scaffolds. EuroIntervention. 2018. pii: EIJ-D-17-00708. DOI: 10.4244/EIJ-D-17-00708.}