TCT 2018: Magmaris Resorbable Magnesium Scaffold Demonstrates Early Endothelialization and Reduced Rates of Late Scaffold Thrombosis

Preliminary data from BIOSOLVE-IV registry shows low target lesion failure (TLF) rates of 4.3% with Magmaris^a and only one case of scaffold thrombosis (after DAPT interruption before the event).¹

The data presented at the TCT congress as late-breaking news reported 12-month data of the first 400 patients of its recently extended, full cohort of now 2,054 patients. The BIOSOLVE-IV study included 15.8% of NSTEMI patients – a challenging patient group.¹

“Resorbable scaffolds remain of great interest to interventional cardiologists,” commented Dr. Michael Kang-Yin Lee as Coordinating Clinical Investigator of the BIOSOLVE-IV registry. “The preliminary data from the BIOSOLVE-IV registry adds to the growing body of evidence, particularly relating to scaffold thrombosis that suggests Magnesium-based technology has a role to play in modern PCI.”

In addition to the BIOSOLVE-IV data, Professor Michael Haude presented the pooled patient level analysis of BIOSOLVE-II and BIOSOLVE-III data out to 24 months (n=184). Reported TLF (5.5%) and clinically-driven target lesion revascularization (TLR; 2.8%) were shown to be comparable to second-generation drug-eluting stents (DES).²

New Insights into Magnesium Scaffolds’ Healing Profile
Dr. Pasi Karjalainen, Helsinki University Hospital, Helsinki, Finland, presented data on the short-term healing properties following Magmaris implantation. Results showed early and adequate neointimal coverage of struts with a neointimal hyperplasia thickness comparable to modern DES.³

Endothelial integrity is associated with a reduced risk of neoatherosclerosis.^b,4 New optical coherence tomography data at three years from the BIOSOLVE-II study support earlier pre-clinical findings that Magmaris demonstrates signs of reduced neoatherosclerosis.

“Neoatherosclerosis is a known risk factor for very late scaffold thrombosis, which can cause device-related mortality,” explained Professor Michael Joner, German Heart Center Munich, Germany. “Even though procedure-related mortality is thankfully rare with modern DES, 40% of patients who passed away nine months after a DES implantation showed signs of neoatherosclerosis⁵.”

This new Magmaris data was released shortly after the ESC/EACTS Guidelines on myocardial revascularization⁶ rated bioresorbable scaffolds as class III products. In contrast to the trial data available for the Absorb^c bioresorbable vascular scaffold (BVS), the guidelines recognized that “initial results” on the Magnesium scaffold “appear encouraging, but further evaluation is needed.”⁶

“The convincing clinical data presented at TCT 2018 continue to support the safety and efficacy of the Magmaris scaffold,” commented Dr. Alexander Uhl, Senior Vice President Corporate Marketing at BIOTRONIK. “Based on these results, we believe that the class of recommendation for Magmaris needs to be differentiated from the Absorb BVS.”

References:

^{1 Kang-Yin Lee M. BIOSOLVE-IV: Twelve-Month Outcomes With a Resorbable Magnesium Scaffold in a Real-world Setting. Presented at TCT; September 23, 2018; San Diego, USA.}

^{2 Haude M. Safety and Clinical Performance of the Drug Eluting Absorbable Metal Scaffold in the Treatment of Subjects with de Novo Lesions in Native Coronary Arteries at 24-month follow-up - BIOSOLVE-II and BIOSOLVE-III, Presented at TCT; September 21, 2018; San Diego, USA.}

^{3 Karjalainen P. Neointimal Healing Evaluated by Optical Coherence Tomography after Drug-Eluting Resorbable Magnesium Scaffold Implantation in de novo Native Coronary Lesions, Presented at TCT, September 2018, San Diego, USA.}

^{4 Andreou I, Stone P. In-Stent Atherosclerosis at a Crossroads. Neoatherosclerosis … or Paleoatherosclerosis? Circulation. 2016;134:1413–1415.}

^{5 Nakazawa G, Vorpahl M, Finn M, et al. One Step Forward and Two Steps Back With Drug-Eluting-Stents. JACC: Cardiovascular Imaging. 2009; 2(5): 625-628.}

^{6 Neumann FJ, Sousa-Uva M, Ahlsson A, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. European Heart Journal. 2018; 00: 1-96.}

^{a Not currently available in the United States}

^{b As demonstrated in pre-clinical studies}

^{c Absorb is a registered trademark of Abbott Laboratories}