DESolve Nx: 6-month results strong for bioresorbable scaffold
PARIS — The DESolve NX pivotal trial has indicated positive results for the DESolve Bioresorbable Coronary Scaffold at 6 months, including low rates of late lumen loss and MACE.
The results were presented today by Alexandre Abizaid, MD, PhD, trial investigator with the Instituto Dante Pazzanese de Cardiology, São Paulo, Brazil.
According to Abizaid, who is also an Editorial Board member of Cardiology Today’s Intervention, serial quantitative coronary angiography at 6 months showed a late lumen loss of 0.21 ± 0.34 for patients implanted with the DESolve Bioresorbable Coronary Scaffold (Elixir Medical), while serial IVUS at 6 months indicated increases in mean vessel area (12.23 mm2 vs. 10.44 mm2), mean scaffold area (6.78 mm2 vs. 5.86 mm2) and mean lumen area (6.43 mm2 vs.5.9mm2; P for all<.001). The rate of MACE at 6 months was 3.25%, which was a composite of cardiac death (0.8%), target vessel MI (0.8%) and clinically indicated target lesion revascularization PCI (1.6%). There were no reports of definite stent thrombosis.
“Based on these data, it’s fair to conclude that the DESolve Nx pivotal trial was successful in demonstrating the safety and efficacy of the DESolve Scaffold,” Abizaid said during a presentation. “Serial imaging assessment demonstrated an increase in scaffold and lumen areas indicating early vessel restoration at 6 months with the DESolve scaffold.”
The DESolve Nx involved 126 patients at 13 international sites in Europe, New Zealand and Brazil. All patients had a single de novo coronary artery lesion, a reference vessel diameter of 2.75 mm to 3.0 mm, and were on dual antiplatelet therapy for 12 months. Patients were a mean age of 62 years and 22% were diabetic. The primary endpoint was 6-month in-scaffold late lumen loss and secondary clinical endpoints included MACE and scaffold thrombosis. – by Brian Ellis
For more information:
Abizaid A. LBCT 3. Presented at: EuroPCR; May 21-24, 2013; Paris.
Disclosure: Abizaid has received research grants from Abbott Vascular, Boston Scientific, Elixir and Medtronic.