This article is more than 5 years old. Information may no longer be current.
DESolve Nx: 6-month results strong for bioresorbable scaffold
Click Here to Manage Email Alerts
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.
Alexandre Abizaid
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.
Perspective
Back to Top
Andreas Baumbach, MD
DESolve is a well constructed stent. It appears to have very good mechanical parameters, radial strength and acute results. Compared with what we have seen so far with the one system that has been widely used (Absorb), the DESolve stent erodes within a year, much faster than Absorb, which takes 3 years. However, 1 year is still after the time a scaffold is absolutely needed, so it will likely do the job. This is exciting because you can then start to assess the benefits of the disappeared stent much earlier. So, this is very exciting first clinical data and I look forward to seeing larger cohorts testing this device.
Perspective
Back to Top
Ashok Seth, MD
This study adds to our present knowledge in that it was a roughly 130-patient study looking at late loss and showed that the late loss with the DESolve scaffold was low. The other important aspect was that there was a low incidence of complications. That in a sense provides us with important data, as it was a good enough study to get a CE mark for the DESolve scaffold. As a clinician, it's nice to have another absorbable scaffold despite the data being preliminary. However, for Absorb Bioresorbable Vascular Scaffold (Abbott Vascular) we have angiographic data on 110 patients and it is still the most studied absorbable stent with optical coherence tomography, IVUS and CTA at multiple time frames, providing tremendous insights into performance, safety and efficacy. The 800-patient, single-arm, multicenter ABSORB EXTEND trial has enrolled close to 700 patients and will be finishing soon, which will give us robust safety and efficacy data in more “real-world” patients and the ABSORB FIRST post-marketing registry is on way.
Additionally, having another bioabsorbable scaffold available brings down the cost of the device as a result of competition. So if we have another device, however preliminary the data may be, and it shows that there is low late loss, it provides us with another very valuable option. So this is a device that may become part of my armamentarium. We should look forward to larger pivotal studies with the device in the future.
Click Here to Manage Email Alerts