MASTER Trial: Novel Stent With Mesh Covering Improves ST-Segment Resolution Post-PCI
A novel bare-metal stent with a mesh covering significantly improved complete ST-segment resolution compared with conventional bare-metal stents post-percutaneous coronary intervention (PCI) in patients with acute ST-segment elevation myocardial infarction (STEMI), according to results of the MASTER trial.
The prospective, randomized, multicenter MASTER (Safety and Efficacy of MGuard Stent After a Heart Attack) trial was presented on Oct. 24 at the TCT 2012 in Miami, Fl., and published simultaneously in the Journal of the American College of Cardiology. The trial evaluated the safety and efficacy of the MGuard commercial bare-metal stent, a thin-strut metal stent with a polyethylene terephthalate micronet sleeve covering designed to trap and exclude thrombi and friable atheromatous debris to prevent distal embolization during PCI.
Thirty-day results of the trial had a cohort of 433 patients with acute STEMI presenting to a medical center within 12 hours of symptom onset and treated with emergent PCI. The patients randomized to receive the new stent had superior rates of complete ST-segment resolution. This was defined as ≥70 percent reduction in ST-segment elevation post-procedure from baseline, compared with patients treated with standard bare-metal stents (57.8 percent vs. 44.7 percent, p = 0.008).
Treatment with the MGuard stent also resulted in superior rates of thrombolysis in myocardial infarction grade 3 (TIMI-3) epicardial coronary flow compared with the control stents (91.7 percent vs. 82.9 percent, p = 0.006) and comparable rates of myocardial blush grade 2 or 3 (83.9 percent versus 84.7 percent, p + 0.81). Mortality rates and rates of major adverse events were comparable between the two groups.
Patients were age 18 years and older (median age 59), with symptoms consistent with STEMI and ≤2mm of ST-segment elevation in ≤2 contiguous electrocardiogram leads. They were enrolled and randomized at 50 sites in nine countries. Post-procedure follow-up was performed at 30 days, six months and 12 months.
The authors note that a larger randomized trial is needed to determine whether these favorable results lead to reduced infarct size or improved clinical outcomes, or both.
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