The DESolve bioresorbable coronary scaffold system achieves good efficacy and safety with low rates of late lumen loss and major coronary adverse events at six months, show first results from the pivotal DESolve Nx trial reported at EuroPCR 2013 in Paris, France (21–24 May).
DESolve (Elixir Medical) is the first bioresorbable PLLA-based polymer scaffold that releases novolimus, a major metabolite of sirolimus. “The degradation time is about one year,” explained the lead study author Alexandre Abizaid, director of Interventional Cardiology at Institute Dante Pazzanese de Cardiologia, São Paulo, Brazil. He added, “One of the most attractive features, which we do not see with most bioresorbable scaffolds, is that this device shows significant increase in vessel scaffold and luminal area at six months.”
The DESolve Nx trial treated target lesions in 126 patients with single de novo coronary artery lesions with the DESolve device. Results showed the primary endpoint of in-stent late lumen loss was 0.21mm (+0.34) at six months. Major adverse cardiac events occurred in 3.25% of patients, including one cardiac death. Acute recoil occurred in 6.6% of patients at six months.
Stents and vessels were assessed by intravascular ultrasound in a subset of 40 patients. “There was a clearly significant increase in vessel area,” Abizaid reported. Mean vessel area increased by 16.8% at six months (p<0.001), while mean scaffold area increased by 15.7% (p<0.001) and mean lumen area by 9.0% (p<0.001). “We do not usually see this improvement until two years,” he noted. Serial optical coherence tomography (OCT) analysis in 38 patients demonstrated a 16.9% increase in mean scaffold area (p<0.001) after six months. Nearly 99% of struts were covered by this time point.
Abizaid concluded, “The DESolve Nx trial was successful in demonstrating the safety and efficacy of the DESolve Scaffold. In terms of acute performance, there was a high rate of device deliverability and acute recoil was low. Efficacy results showed low late lumen loss at six months and safety was also good, with a low 6-month MACE rate and high strut coverage.” He added, “What really impressed me was to see an increase in scaffold and lumen areas indicating early vessel restoration at six months. We saw results at six months that we see with most scaffolds at two to three years.”
Commenting on the study findings, Adnan Kastrati, deputy director of Cardiovascular Diseases at the German Heart Centre of the State of Bavaria, Munich, Germany, said: “Bioresorbable drug-eluting scaffolds are emerging as the dominant device of the future for percutaneous coronary interventions. The results shown today with the DESolve scaffold eluting novolimus make interventional cardiologists richer in treatment options. Different biopolymer resorption kinetics and antiproliferative drugs may better serve individualisation of PCI treatment to patients’ needs.” But he cautioned, “The promising results shown with bioresorbable drug-eluting scaffolds so far need corroboration in larger patient cohorts followed for a longer period. Last, but not at least, available devices still need design improvement before offering their advantages to the majority of complex lesions we are currently treating.”