Key result
Implantation of a magnesium-based bioresorbable stent in patients with acute coronary syndrome resulted in a significantly greater extent of late lumen loss at 12 months (0.54 mm vs 0.11 mm) compared to a permanent metallic stent.
Why the study?
Magnesium-based bioresorbable Magmaris stents are rapidly resorbed, but few randomized studies have evaluated their efficacy in patients with acute coronary syndrome.
Does a magnesium-based bioresorbable sirolimus-eluting stent reduce late lumen loss compared to a permanent everolimus-eluting metallic stent in patients with acute coronary syndrome?
RCT (n=50)
Single-blind
Envelope method
Yes
Does a magnesium-based bioresorbable sirolimus-eluting stent reduce late lumen loss compared to a permanent everolimus-eluting metallic stent in patients with acute coronary syndrome?
Absolute Event Rate: 0.54% vs 0.11%
p-value: p=0.029
In patients with acute coronary syndrome, a magnesium-based bioresorbable sirolimus-eluting stent resulted in significantly greater late lumen loss at 12 months compared to a permanent everolimus-eluting metallic stent.
Warrants caution with magnesium-based bioresorbable stents in ACS; challenges expectations of bioresorbable advantages over metallic stents.
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.
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Toušek et al. (2021) conducted an RCT in Acute Coronary Syndrome (n=50). Magmaris magnesium-based bioresorbable sirolimus-eluting stent vs. Xience permanent everolimus-eluting metallic stent was evaluated on Late lumen loss at 12 months assessed by quantitative coronary angiography (QCA) (p=0.029). Implantation of a magnesium-based bioresorbable stent in patients with acute coronary syndrome resulted in a significantly greater extent of late lumen loss at 12 months (0.54 mm vs 0.11 mm) compared to a permanent metallic stent.
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