A new resorbable magnesium scaffold for de novo coronary lesions (DREAMS 3): one-year results of the BIOMAG-1 first-in-human study

Reviewer: Dr. Melehat Hicran Aksu

Fulltext: https://api.eurointervention.com/v1/articles/17353/download/pdf

Introduction

Absorbable scaffolds have been developed to reduce the long-term negative consequences after implantation of a permanent metallic drug-eluting stent (DES). Absorbable scaffolds disappear after the initial healing phase of the vessel and can have a positive effect on vessel tension by preventing long-term flattening. Magnesium is therefore an attractive resorbable material with mechanical properties similar to conventional DESs.

Although there is ample evidence confirming that implantation of DREAMS 2G, the predecessor of DREAMS 3G, resulted in low (long-term) clinical event rates, angiographic parameters such as late lumen loss through the scaffold (LLL) could not compete with contemporary DESs. DREAMS 3G was developed with the aim to maintain the overall resorption time, but increase radial strength and prolong the scaffold time to prevent constrictive remodeling and achieve LLL values similar to contemporary DESs. Furthermore, DREAMS 3G exhibited more homogeneous strut degeneration with less variability. Therefore, qualitative and quantitative aspects of degradation were improved by using a new magnesium alloy and more homogeneous resorption resulted in long-term stability.

Objective

The aim of the study was to evaluate the safety and clinical performance of DREAMS 3G with angiographic and intracoronary imaging results.

Method

BIOMAG-1 is a prospective, multicenter, single-arm, first-in-human study. The study included 116 of 117 patients with 117 lesions between April 2020 and February 2022. Clinical follow-up was planned at 1, 6, 12, 24, 36, 48 and 60 months after DREAMS 3G implantation, with imaging follow-up including angiographic, OCT and IVUS evaluations at 6 and 12 months.

Results

Device success, defined as <30% final residual diameter stenosis by QCA or visual assessment, was achieved in 97.7% (126/129) of devices with successful delivery of the scaffold to the target lesion, proper placement of the scaffold, and successful removal of the delivery system. Procedural success with QCA, defined as < 30% final diameter stenosis, using any percutaneous method, with no death, Q-wave or non-Q-wave myocardial infarction or TLR occurring during hospitalization, was achieved in 99.1% (115/116) of patients. Serial QCA data were available in 100 patients. Paired intra-scaffold LLL was 0.19±0.25 mm at 6 months and 0.24±0.36 mm at 12 months. Serial IVUS data were available in 75 patients and OCT data in 89 patients. When evaluated by IVUS, the minimum lumen areas decreased from 4.98±1.99 mm² at 6 months to 4.95±2.24 mm² at 12 months, device areas decreased from 5.01±1.97 mm² to 5.01±2.29 mm², and the mean plaque area decreased from 7.90±2.77 mm² at 6 months to 7.46±2.65 mm² at 12 months. No intraluminal mass was observed by OCT at any time and struts were not visible at 12 months. At the end of the resorption period, the intra-instrument LLL at 12 months was 0.24±0.36 mm, 38% lower than the 0.39±0.27 mm reported in the BIOSOLVE-II study.

Conclusion

In conclusion, with the caveat that very complex lesions are excluded, the preliminary results of the BIOMAG-I first-in-human trial demonstrated that the third generation drug-eluting resorbable magnesium scaffold DREAMS 3G met its design objectives. It has an improved LLL compared to its predecessor DREAMS 2G, making DREAMS 3G a potential alternative to permanent DESs, avoiding lifelong metallic implants associated with adverse long-term outcomes. These results will need to be confirmed in large randomized clinical trials comparing DREAMS 3G with contemporary DES.