- Background:
Bioresorbable scaffolds aim to mitigate long-term complications of drug-eluting stents (DES). The bioresorbable magnesium scaffold Magmaris is an alternative, but its role in acute coronary syndrome (ACS) remains insufficiently studied. Therefore, we aimed to evaluate safety and efficacy of Magmaris in ACS and compare outcomes with DES.
Methods:
We systematically searched PubMed, Embase and Cochrane Central Register of Controlled Trials for randomized and observational studies reporting outcomes of Magmaris in ACS. Primary outcome was target-lesion failure (TLF) defined as composite of cardiac death (CD), target-vessel myocardial infarction (TV-MI) and target-lesion revascularization (TLR) at one year. Secondary outcomes included scaffold/stent thrombosis (ST) and procedural success. Single-arm pooled event rates and pairwise comparisons were estimated using generalized linear mixed-effects models (GLMM).
Results:
We included four studies (n = 622 patients;Background:
Bioresorbable scaffolds aim to mitigate long-term complications of drug-eluting stents (DES). The bioresorbable magnesium scaffold Magmaris is an alternative, but its role in acute coronary syndrome (ACS) remains insufficiently studied. Therefore, we aimed to evaluate safety and efficacy of Magmaris in ACS and compare outcomes with DES.
Methods:
We systematically searched PubMed, Embase and Cochrane Central Register of Controlled Trials for randomized and observational studies reporting outcomes of Magmaris in ACS. Primary outcome was target-lesion failure (TLF) defined as composite of cardiac death (CD), target-vessel myocardial infarction (TV-MI) and target-lesion revascularization (TLR) at one year. Secondary outcomes included scaffold/stent thrombosis (ST) and procedural success. Single-arm pooled event rates and pairwise comparisons were estimated using generalized linear mixed-effects models (GLMM).
Results:
We included four studies (n = 622 patients; 322 Magmaris, 300 DES) for pairwise analysis. At one year, no statistically significant difference in TLF was observed between Magmaris and DES (7.5% vs. 5.3%, OR 1.53, 95% CI 0.79–2.97; p = 0.21; I2 = 54.7%), although confidence intervals were wide. TLR was significantly higher with Magmaris (6.8% vs. 3.0%, OR 2.63, 95% CI 1.17–5.90; p = 0.019; I2 = 10.7%), while TV-MI, CD and ST did not differ significantly between groups. Twelve studies (n = 1,391 patients) contributed single-arm analyses showing pooled 1-year incidence of TLF 4.97%, TLR 4.16% and ST 0.83%. Procedural success was 98.49% (95% CI 97.21–99.18; I2 = 35.4%).
Conclusion:
In ACS, Magmaris was associated with low observed ST rates, nevertheless, comparative safety and efficacy vs. DES remain uncertain due to limited and heterogeneous evidence. Higher TLR rates with Magmaris suggest that further technical improvements in next-generation magnesium scaffolds are needed before this strategy can be considered a robust alternative in ACS.…
