Comparison of a Bioresorbable, Magnesium-Based Sirolimus-Eluting Stent with a Permanent, Everolimus-Eluting Metallic Stent for Treating Patients with Acute Coronary Syndrome: the PRAGUE-22 Study
Abstract
Background: Magnesium-based bioresorbable Magmaris stents are rapidly resorbed. Few randomized studies have evaluated the efficacy of such stents in patients with acute coronary syndrome.
Aim: To investigate late lumen loss as assessed via quantitative coronary angiography (QCA) and optical coherence tomography (OCT) in patients with acute coronary syndrome treated with Magmaris stents or permanent, everolimus-eluting metallic Xience stents. Methods and Results: This PRAGUE-22 study was a two-centre, investigator-initiated, randomized study.
Fifty patients were randomized based on the inclusion criteria for acute coronary syndrome and the anatomical suitability to receive Magmaris or Xience stents. The patient characteristics did not differ between the Magmaris group (n = 25) and Xience group (n = 25).
The mean ages were 57.0 +- 10.5 vs. 55.5 +- 9.2 years (p = 0.541) and the total implanted stent length was 24.6 +- 10.7 mm vs. 27.6 +- 11.1 mm (p = 0.368), respectively. Four clinical events occurred in the Magmaris group and one in the Xience group during 12 months of follow-up.
The extent of late lumen loss (assessed via QCA) at 12 months was greater in the Magmaris group than in the Xience group (0.54 +- 0.70 vs. 0.11 +- 0.37 mm; p = 0.029). The late lumen loss diameter (measured via OCT) in the Magmaris group was also significantly larger than that in the Xience group (0.59 +- 0.37 vs. 0.22 +- 0.20 mm; p = 0.01).
Conclusion: Implantation of a magnesium-based bioresorbable stent in patients with acute coronary syndrome is associated with a greater extent of late lumen loss at the 12-month follow-up compared with implantation of a permanent, everolimus-eluting metallic stent. Trial Registration: ISRCTN89434356