The MGuard net protective stent did not significantly decrease median troponin I release at 24 hours (0.67 vs 1.06 ng/mL, p=0.807) compared to conventional stents in acute coronary syndromes.
RCT (n=46)
1:1
No
Does the MGuard net protective stent reduce periprocedural troponin I release compared to conventional stents in patients with acute coronary syndromes undergoing PCI?
The use of a net protective stent (MGuard) during PCI for acute coronary syndromes did not significantly reduce periprocedural myocardial injury as measured by troponin I release compared to conventional stents.
Absolute Event Rate: 0.67% vs 1.06%
p-value: p=0.807
This study was designed to determine whether the treatment of patients with unstable angina pectoris or non-Q-wave myocardial infarction with a stent containing a protection net to prevent coronary microembolization affects the severity of biomarker release.The MGuard stent (InspireMD, Tel Aviv, Israel) was designed as a plaque/thrombus-trapping device, using a conventional bare metal stent covered with an ultrathin, flexible mesh net. We hypothesized that this stent would partly eliminate distal embolization and decrease subsequent troponin I (TnI) release.Forty-six acute coronary syndrome patients referred for percutaneous coronary intervention (PCI) were included and randomized in this study. Serum concentrations of TnI were measured prior to, as well as 24 and 48 hours after, the PCI procedure.Technical success was 95% and 100% in the MGuard group and non-MGuard group, respectively. A transient no-reflow phenomenon was observed in one interventional procedure in each group of patients (5% versus 4%; NS). Two patients (one in each group) died during the hospital stay. There was no statistically significant difference in median postprocedural TnI levels in either group.The results suggest that coronary stenting with a stent system containing a protection net to prevent coronary microembolization (eg the MGuard stent) in patients with acute coronary syndromes does not decrease procedural myocardial injury, as measured by TnI release. It seems likely that stenting with the MGuard stent is feasible, however, its safety should be verified in larger studies.
Veselka et al. (Sat,) conducted a rct in Acute coronary syndromes (unstable angina pectoris or non-Q-wave myocardial infarction) (n=46). MGuard stent vs. Conventional bare metal or drug-eluting stents was evaluated on In-hospital level of troponin I at 24 hours post-PCI (p=0.807). The MGuard net protective stent did not significantly decrease median troponin I release at 24 hours (0.67 vs 1.06 ng/mL, p=0.807) compared to conventional stents in acute coronary syndromes.