MAGICAL

Objective

The objective of the MAGICAL Trial was to evaluate the feasibility and safety of the MGuard stent in the setting of PCI for STEMI.

Study design

The MAGICAL study was conducted in Poland by primary investigator Dariusz Dudek, and was a multicenter, prospective, single arm study in which 60 patients with STEMI <12 hours were enrolled (2). The primary endpoints of the study were the frequency of TIMI grade 3 flow after PCI and the incidence of complete ST-segment resolution after PCI.

Results

Baseline characteristics showed that 8.3% of patients were diabetic, and 5% suffered a prior MI. Predilatation was performed in 61.7% of the cases and thrombus aspiration in 18.3%. In one (1.7%) patient the stent could not cross the lesion. Final TIMI grade 3 flow was observed in 90.0% of patients, with myocardial blush grade 3 in 73.3% of patients and complete (>70%) ST-segment resolution 60 minutes after PCI was achieved in 61.4% of patients. In 5.0% of cases, distal embolization occurred. The total major adverse cardiac events rate at 30 days and 6 months was 1.7%.

Extended follow-up

1 year MACE was 1.7% which increased to 8.8% after 3 years. Out of the 57 patients available for follow-up, there was 7% cardiac death, 1.8% TLR, 3.5% TVR, and 0% re-MI. There were no cases of stent thrombosis (1).

Conclusion

MGuard stent implantation in STEMI patients was safe and highly effective, and the results of the extended follow-up allude to a preserved safety and efficacy of MGuard over a 3 year period.

References

1. Dudek D, Dziewierz A, Kleczynski P, Giszterowicz D, Rakowski T, et al. 2013. Long-term follow-up of mesh-covered stent implantation in patients with ST-segment elevation myocardial infarction. Kardiol Pol

2. Dudek D, Dziewierz A, Rzeszutko L, Legutko J, Dobrowolski W, et al. 2010. Mesh covered stent in ST-segment elevation myocardial infarction. EuroIntervention 6:582-9