Original title: Randomised study of a bioabsorbable polymer-coated sirolimus-eluting stent: results of the DESSOLVE II trial. Reference: Wijns W EuroIntervention 2015 Apr 22;10(12):1383-90.
Multicenter, randomized study, which enrolled in 26 centers, a total of 184 patients 2:1 (bioabsorbable polymer-coated sirolimus-eluting stent, (SES) [n = 123] versus zotarolimus-eluting stent (ZES) [n = 61]). All patients were evaluated with quantitative coronary angiography (QCA) immediately after stent implantation and at nine months, while a subgroup of patients in both groups were also subjected to evaluation by optical coherence tomography (OCT).
The primary hypothesis of superiority of the work, is evaluating SES over SLZ in “late lumen loss” (LLL). At nine months hypothesis was fulfilled, showing significant differences in SES in LLL values (0.27 ± 0.46 mm versus 0.58 ± 0.41 mm, p <0.001); the percentage of uncovered stent struts at nine months by OCT was very low in both groups, as well as the number of major events and stent thrombosis, with similar results in both groups.
Conclusion
DESSOLVE II study demonstrated superiority of SES over SLZ regarding the primary objective, demonstrating a significant reduction in late lumen loss (LLL). Also confirms by OCT that the percentage of coverage stent struts is high in both groups at nine months, with a high safety profile of both stents, with low MACE and stent thrombosis.
Editorial comment
There are several limitations of the study: protocol of small dimensions, with a short follow-up so far (planned follow-up to five years), “single-blind” (in this way can create a selection bias towards injuries to treat), with a percentage of patients who underwent OCT without explaining the criteria why some patients were selected, with a “soft” primary endpoint (LLL). Moreover, the treated lesions were simple lesions (A, B1, B2), being complex injuries an exclusion criterion. Despite all this, the goal of superiority was met with SES, and above all, it was possible to show that the safety profile of the device is at least similar to SLZ, with low percentages and acceptable MACE and stent thrombosis (to nine months SES/SLZ 4.3% versus 6.7% and 0.9% versus 1.7%, respectively). Long-term monitoring is pending to draw major conclusions.
Courtesy of Santiago F. Coroleu MD
Interventional Cardiologist
Instituto de Cardiología de Santiago del Estero (Argentina).
Dr. Santiago F. Coroleu
