BIOSOLVE-IV: Drug-eluting magnesium scaffold confers improved outcomes at 12 months
WASHINGTON — Patients with de novo coronary artery stenosis who were treated with a sirolimus-eluting magnesium scaffold had low rates of target lesion failure at 12 months and excellent procedure and device success, according to data from the BIOSOLVE-IV registry presented at Cardiovascular Research Technologies.
Results from this study confirmed results from previous trials with this device (Magmaris, Biotronik), according to the presentation.
“[It has] higher bending flexibility and higher acute radial force with complete reabsorption at 12 months,” Stefano Galli, MD, of Centro Cardiologico Monzino in Milan, said during the presentation. “It’s completely different from [poly-L-lactic acid] resorbable scaffolds.”
Researchers assessed data from 583 patients (mean age, 62 years; 75% men) with de novo coronary artery stenosis who were treated with this device in this prospective, multicenter, real-world setting registry. These patients had completed 12 months of follow-up.
The primary endpoint was TLF at 12 months, which was defined as a composite of target vessel MI, cardiac death, clinically driven target lesion revascularization and CABG. Secondary endpoints at 6 months and between 1 and 5 years included clinically driven TLR and target vessel revascularization, TLF, target vessel MI, cardiac death, procedure and device success, and scaffold thrombosis.
Of the patients assessed in this registry, 20.8% had diabetes, 16.8% had non-STEMI and 5.9% had bifurcation lesions.
TLF occurred in 5.1% of patients at 12 months (95% CI, 3.6-7.2). When broken down into individual components of the primary endpoint, cardiac death occurred in 0.2% of patients (95% CI, 0-1.2), 1.3% had target vessel MI (95% CI, 0.7-2.7), 4.6% had clinically driven TLR (95% CI, 3.2-6.6) and 0.5% had scaffold thrombosis (95% CI, 0.2-1.6).
The rate of device success was 97.1%, and the procedural success rate was 98.7%.
“Another interesting point is if you consider an evaluation that the physician gives to the Magmaris, some of the characteristics of global Magmaris performance is very high, similar to the second-generation DES with a high trackability, pushability and crossability,” Galli said. – by Darlene Dobkowski
Galli S, et al. Late Breaking Trials: Session III. Presented at: Cardiovascular Research Technologies; March 2-5, 2019; Washington, D.C.
Disclosure: The study was sponsored by Biotronik AG. Galli reports he received research support from Biotronik AG.