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.

Department of Cardiology 3rd Medical Faculty Charles University and University Hospital Královské Vinohrady Prague Czech Republic

Department of Cardiology AGEL Pardubice Czech Republic

Medtronic Czechia Partner of INTERCARDIS Project Prague Czech Republic

Zobrazit více v PubMed

Ali ZA, Gao R, Kimura T, et al. Three-year outcomes with the Absorb bioresorbable scaffold: individual-patient-data meta-analysis from the ABSORB randomized trials. Circulation. 2018;137(5):464–479. doi: 10.1161/CIRCULATIONAHA.117.031843. PubMed DOI

Smits PC, Chang CC, Chevalier B, et al. Bioresorbable vascular scaffold versus metallic drug-eluting stent in patients at high risk of restenosis: The COMPARE-ABSORB randomised clinical trial. EuroIntervention. 2020;16(8):645–653. doi: 10.4244/EIJ-D-19-01079. PubMed DOI

Brugaletta S, Gori T, Tousek P, et al. Bioresorbable vascular scaffolds versus everolimus-eluting metallic stents in patients with ST-segment elevation myocardial infarction: 5-year results of the BVS-EXAMINATION study. EuroIntervention. 2020;15(16):1436–1443. doi: 10.4244/EIJ-D-19-00773. PubMed DOI

Tousek P, Kocka V, Maly M, et al. Long-term follow-up after bioresorbable vascular scaffold implantation in STEMI patients: PRAGUE-19 study update. EuroIntervention. 2016;12(1):23–29. doi: 10.4244/EIJV12I1A5. PubMed DOI

Kocka V, Tousek P, Kozel M, et al. Bioresorbable scaffold implantation in STEMI patients: 5 years imaging subanalysis of PRAGUE-19 study. J Transl Med. 2020;18(1):33. doi: 10.1186/s12967-020-02230-1. PubMed DOI PMC

Verheye S, Wlodarczak A, Montorsi P, et al. BIOSOLVE-IV-registry: safety and performance of the Magmaris scaffold: 12-month outcomes of the first cohort of 1,075 patients. Catheter Cardiovasc Interv. 2021;98(1):E1–E8. doi: 10.1002/ccd.29260. PubMed DOI PMC

Haude M, Ince H, Kische S, et al. Sustained safety and performance of the second-generation sirolimus-eluting absorbable metal scaffold: pooled outcomes of the BIOSOLVE-II and -III trials at 3 years. Cardiovasc Revasc Med. 2020;21(9):1150–1154. doi: 10.1016/j.carrev.2020.04.006. PubMed DOI

Sabate M, Alfonso F, Cequier A, et al. Magnesium-based resorbable scaffold versus permanent metallic sirolimus-eluting stent in patients with ST-segment elevation myocardial infarction: the MAGSTEMI Randomized Clinical Trial. Circulation. 2019;140(23):1904–1916. doi: 10.1161/CIRCULATIONAHA.119.043467. PubMed DOI

Gomez-Lara J, Ortega-Paz L, Brugaletta S, et al. Bioresorbable scaffolds versus permanent sirolimus-eluting stents in patients with ST-segment elevation myocardial infarction: vascular healing outcomes from the MAGSTEMI trial. EuroIntervention. 2020;16(11):e913–e921. doi: 10.4244/EIJ-D-20-00198. PubMed DOI

Ortega-Paz L, Brugaletta B, Gomez-Lara J, et al. Target lesion revascularisation of bioresorbable metal scaffolds: a case series study and literature review. EuroIntervention. 2021;16(13):1100–1103. doi: 10.4244/EIJ-D-19-00421. PubMed DOI PMC

Cerrato E, Barbero U, Gil Romero JA, et al. Magmaris resorbable magnesium scaffold: state-of-art review. Future Cardiol. 2019;15(4):267–279. doi: 10.2217/fca-2018-0081. PubMed DOI

Schmidt W, Behrens P, Brandt-Wunderlich C, et al. In vitro performance investigation of bioresorbable scaffolds - standard tests for vascular stents and beyond. Cardiovasc Revasc Med. 2016;17(6):375–383. doi: 10.1016/j.carrev.2016.05.001. PubMed DOI

Neumann F-J, Sousa-Uva M, Ahlsson A, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019;40(2):87–165. doi: 10.1093/eurheartj/ehy394. PubMed DOI

Ielasi A, Cerrato E, Geraci S, et al. Sirolimus-eluting magnesium resorbable scaffold implantation in patients with acute myocardial infarction. Cardiology. 2019;142(2):93–96. doi: 10.1159/000499536. PubMed DOI

Wlodarczak A, Lanocha M, Jastrzebski A, et al. Early outcome of magnesium bioresorbable scaffold implantation in acute coronary syndrome-the initial report from the Magmaris-ACS registry. Catheter Cardiovasc Interv. 2019;93(5):E287–E292. doi: 10.1002/ccd.28036. PubMed DOI