Two-Year Outcomes Published From Elixir Medical's DESolve Nx Trial

March 24, 2016—Two-year outcomes from the DESolve Nx trial were published by Alexandre Abizaid, MD, et al in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2016;9:565–574). The study is evaluating the late multimodality imaging and clinical outcomes of Elixir Medical’s poly-l-lactic-acid–based Desolve novolimus-eluting bioresorbable coronary scaffold system for the treatment of de novo coronary lesions.

According to the investigators, the results showed favorable performance of the Desolve scaffold, effective inhibition of neointimal hyperplasia, and for the first time, early luminal and scaffold growth at 6 months with sustained efficacy and safety through 2 years. Overall, 126 patients were enrolled at 13 international sites between November 2011 and June 2012. 

The primary endpoint was in-scaffold late lumen loss at 6 months. Major adverse cardiac events, the main safety endpoint, were defined as the composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. All patients underwent angiography at 6 months. Serial intravascular ultrasound and optical coherence tomography were performed in a subset of patients.

As summarized in JACC: Cardiovascular Interventions, the scaffold device success rate was 97% (n = 122 of 126), and procedural success was 100% (n = 122 of 122). The major adverse cardiac event rate was 3.3% (n = 4 of 122) at 6 months and 7.4% (n = 9 of 122) at 24 months, including one probable stent thrombosis within the first month. At 6-month angiographic follow-up, in-scaffold late lumen loss was 0.20 ± 0.32 mm. Paired intravascular ultrasound analysis demonstrated a significant increase in vessel, lumen, and scaffold dimensions between postprocedure and 6-month follow-up, and strut-level optical coherence tomography analysis showed full strut coverage in 99 ± 1.7%, reported the investigators.

In October, Elixir Medical announced that Prof. Abizaid, who is Coprincipal Investigator of the DESolve Nx trial, presented these clinical and imaging results at TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific symposium held in San Francisco, California. 

DESolve NX trial Coprincipal Investigator Stefan Verheye, MD, commented in the company’s announcement, “I am delighted to see the sustained and excellent long-term vascular response and patent vessels in patients with the Desolve scaffold after it has been completely resorbed. The golden tube continuation from 18 through 36 months, with plaque regression and the restoration of the vessels to their normal physiologic condition, clearly reinforces the advantage of Desolve over other modes of treatment, and expands its potential for evaluation in new clinical indications.” 

Prof. Abizaid is from The Instituto Dante Pazzanese de Cardiologia in Vila Mariana, São Paulo, Brazil. Dr. Verheye is from Antwerp Cardiovascular Center, ZNA Middelheim in Antwerp, Belgium.