EuroPCR 2019: New Data Confirms Future of Resorbable Magnesium Scaffolds

New data from the BIOSOLVE-IV registry strengthen the clinical evidence for the Magmaris^®1 resorbable scaffold device and procedure success and safety profile at one year. Dr. Stefan Verheye, Senior Interventional Cardiologist at Antwerp Cardiovascular Institute, Antwerp, Belgium presented results on the first 800 patients from the BIOSOLVE-IV registry cohort at the 12-month follow-up during the EuroPCR congress in Paris.²

The target lesion failure³ (TLF) rate at 12 months was 4.7%. Moreover, the Magmaris Resorbable Magnesium Scaffold (RMS) showed a very good safety profile with cardiac death occurring in 0.1% of the patients and scaffold thrombosis in 0.6%. An additional analysis of the data showed a device success rate⁴ of 97.1% and procedure success⁵ in 98.8% of the cases.

“Overall BIOSOLVE-IV confirmed low TLF rates from previous trials in a real world setting, including 17.8% NSTEMI patients and 5.6% patients with bifurcation lesions,” explained principal investigator Dr. Stefan Verheye. “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.” This aspect was also addressed by Prof. Michael Joner, Interventional Cardiologist at the German Heart Center, Munich, Germany. He pointed out, that dual antiplatelet therapy duration should be given according to the 12-month resorption time of the Magnesium backbone.⁶

Regional registries from Spain⁷ and Poland⁸ supported the positive clinical experience with the magnesium-based scaffold at EuroPCR. Based on one-year data of 78 patients in the Spanish registry and of 50 patients with acute coronary syndrome (ACS) in the Polish registry, the use of Magmaris was associated with procedural safety and promising clinical outcomes. The Spanish study is in the early enrollment stage, while the Polish study is of particular interest showing low rates of TLR (4.3%) and zero scaffold thrombosis in 70 out of 150 ACS patients (NSTEMI) enrolled at 12 months.

During EuroPCR, Prof. Michael Haude, Lukas Hospital, Neuss, Germany, revealed first insights into BIOTRONIK’s next generation scaffold DREAMS 3G, which will provide improved mechanical properties and reduced strut thickness.⁹ “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,” said Prof. Michael Haude.

“With additional data from three studies presented at this year’s EuroPCR, our magnesium scaffold technology has built an impressive body of clinical evidence,” commented Dr. Alexander Uhl, Senior Vice President Corporate Marketing at BIOTRONIK. “We believe in the resorbable magnesium scaffold technology today and tomorrow. We also believe that this innovation should be available to selected patients now and will become a viable option for a broader range of indications in the future.”

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 800 subjects at 12-month follow-up of the BIOSOLVE-IV registry. Presented at: EuroPCR, May 22, 2019; Paris, France.}

^{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. Device success is defined as final residual diameter stenosis of <30% by quantitative coronary analysis or visual assessment, using the assigned device only.}

^{5. Procedure success is defined as achievement of a final diameter stenosis of <30% by quantitative coronary analysis (using any percutaneous method) or by visual estimation without the occurrence of death, Q-wave or non-Q-wave myocardial infarction, or repeat revascularization of the target lesion during the hospital stay.}

^{6. Joner M. What is Magmaris. Presented at: EuroPCR, May 21, 2019; Paris, France.}

^{7. Iñiguez A. Safety and Performance of the Magnesium-based Resorbable Scaffold in Patients with De Novo Coronary Lesions: a Prospective, Observational, Real World Setting Spanish Registry – MAGMARIS-ES. Presented at: EuroPCR, May 2019; Paris, France.}

^{8. Lanocha M. Twelve-month outcome of magnesium BRS implantation in ACS. Presented at: EuroPCR, May 21, 2019; Paris, France.}

^{9. Haude M. Future developments: next gen Magmaris. Presented at: EuroPCR, May 21, 2019; Paris, France.}