Data gathered by a multicenter, prospective, observational registry further confirm the efficacy and safety of a resorbable magnesium-based scaffold in more complex lesion settings. Presenting Tuesday at the EuroPCR 2024 conference in Paris, IT-Masters Registry principal investigator Stefano Galli, MD, revealed that the magnesium bioresorbable scaffold (BRS) Magmaris (Biotronik) achieved a target lesion failure (TLF) of 4.3% and scaffold thrombosis rate of 0.7% noted in the follow up of 303 patients at 12 months. According to Galli, an interventional cardiologist at the Centro Cardiologico Monzino IRCCS in Milan, the findings are comparable with second-generation drug eluting stents (DES), despite selected lesion and population issues. “Regarding this point, 276 patients (89%) in this population were on dual antiplatelet therapy (DAPT) therapy after 12 months,” he said in a recent interview with CRTonline.org, discussing the study’s findings. “So 0.7% of subocclusive thrombosis in a multicenter registry with different sites, I’m very happy because it is similar to results from the BIOSOLVE (study),” he said. “I believe that the TLF rate of 4.3% is comparable in this population to the new-generation DES,” he added. “If we use this technology for selected lesions, the result will most likely be very good.” Scaffold thrombosis Notably, two incidences of scaffold thrombosis (ST) occurred as another major adverse cardiovascular event at 12 months. Here, an anterior ST elevation myocardial infarction occurred at 2 months after Magmaris treatment, where the patient was on DAPT. “IVUS [intravascular ultrasound] showed scaffold recoil with thrombus, which was successfully treated with DES in scaffold,” said Galli during the Late-Breaking Trials session. “Follow up at 30 months was event-free.” The other incidence was an inferior non-ST elevation myocardial infarction, which occurred at 4 months after Magmaris treatment on the proximal right coronary artery due to subocclusive ST. Galli explained that the patient was on DAPT and was successfully treated with DES in scaffold with a subsequent event-free follow-up. Other findings from the national registry noted a target lesion revascularization (TLR) rate of 4.0% in the same patient population. Approval of Freesolve The study findings come as a new resorbable magnesium scaffold received regulatory approval in February. Freesolve (Biotronik), which received official European CE approval, was the subject of the BIOMAG-I trial, the results of which were presented at European Society of Cardiology 2023 congress in Amsterdam. Here, the research team noted a 99.3% magnesium strut degradation 12 months after implantation. An additional investigation also highlighted the scaffold’s consistent performance, regardless of lesion characteristics, and restoration of vasomotion. “I’m very happy to try this platform for 1 month,” said Galli. “Obviously, we have no clinical data from the BIOMAG trial in terms of late lumen loss. “In practical terms, I believe the change in alloy (magnesium and aluminum), the maintenance of resorbable time (12 months) is important as is the avoidance of recoil.” Future of bioresorbable magnesium On the future of bioresorbable magnesium on a current day-to-day practice and its potential to take market share from current DES and drug-coated balloon (DCB) devices, Galli said the technology was important to address a “panorama of different plaques.” “There are patients with calcific plaques, bifurcation, and so on. In this situation I believe the current generation of devices are perfect in treating these plaques. “In the case of vulnerable plaques, without any calcification, where we prepare the lesion very well in a relatively young patient, I believe that this is a very important segment, where this technology will apply.” Galli also spoke of the possibilities for hybrid solutions, for example in combination with a DCB, where he thought a full metal jacket was not the correct approach in certain cases. “In my mind and in interventional cardiology, there is going to be a lot of options, opening up on the basis of experience and evidence from intravascular imaging to offer the best to patients.” Study setup The IT-Masters Registry enrolled 359 patients at 21 clinical sites in Italy, where 409 lesions were treated with the resorbable magnesium metallic scaffold Magmaris. Baseline characteristics of this population were 296 male (82%), 63 female (18%), with a mean age of 60±10 years. Clinical follow-up occurred at 30 days in 100% (n=359) of patients, with another clinical follow-up scheduled at 6 months. Another clinical follow-up at 12 months was completed in 84% (n=303) of the patient population, with a final follow-up at 24 months. The primary endpoint was defined as the TLF, a composite of cardiac death, non-fatal myocardial infarction, urgent coronary artery bypass grafting, and clinically driven TLR at 12 months. Photo Credit: Screenshot by Jason Wermers/CRTonline.org Photo Caption: Stefano Galli, MD, discusses results of an analysis of the IT-Masters Registry during late-breaking trials session Tuesday at EuroPCR 2024.