This article is more than 5 years old. Information may no longer be current.
Mesh-covered embolic protection stent implantation linked to trend toward reduced mortality
Click Here to Manage Email Alerts
Use of a polymer mesh-covered bare-metal stent designed to reduce distal embolization during primary PCI was associated with a trend toward reduced mortality at 1 year in patients with STEMI, according to new data from the MASTER trial.
Researchers reported data on 217 patients with STEMI up to 12 hours who were undergoing primary PCI of a single de novo native lesion who were randomly assigned to the mesh-covered BMS (MGuard, InspireMD) and 216 randomly assigned to PCI with any commercially available stent (drug-eluting stents used in 39.8%). Patients were followed for clinical outcomes through 1 year. Angiography at 13 months was scheduled in 50 patients assigned the mesh-covered BMS.
At 30 days, all-cause and cardiac mortality had occurred in 0% of patients in the mesh-covered BMS group vs. 1.9% in the control group (P = .04). At 1 year, the rate of all-cause mortality was 1% in the mesh-covered BMS group vs. 3.3% in the control group (HR = 2.3%; 95% CI, 0.06-1.36) and the rate of cardiac mortality was 0.5% vs. 2.3%, respectively (HR = 0.2; 95% CI, 0.02-1.69).
“However, as the study was not powered for mortality, these findings should be interpreted with caution,” the researchers wrote.
At 30 days, rate of MACE was 1.8% in the mesh-covered BMS group vs. 2.3% in the control group. By 1 year, the MACE rate was 8.6% vs. 0.9%, respectively (P = .0003). This difference at 1 year was mainly driven by greater ischemia-driven target lesion revascularization, according to the researchers.
In other results, definite stent thrombosis at 1 year was reported in 2.3% of the mesh-covered BMS group vs. 0.5% of the control group (P = .1). The two groups did not differ in definite/probable stent thrombosis or reinfarction.
Angiographic data at 13 months demonstrated that late lumen loss was 0.99 ± 0.8 mm and the rate of binary stenosis was 31.6% in the mesh-covered BMS group.
Researchers also performed a post-hoc, nonrandomized analysis of the mesh-covered BMS results compared with DES or BMS considered separately. At 1 year, all-cause mortality was 1% with the mesh-covered BMS vs. 4.7% with DES (P = .04) and 1% vs. 2.4% with BMS (P = .29). The mesh-covered BMS was associated with higher rates of ischemia-driven TLR and MACE when compared with DES or BMS. Stent thrombosis was not different between the two groups.
The researchers noted that two large, randomized, multicenter trials assessing use of this mesh-covered BMS during primary PCI for STEMI are ongoing: MASTER-II and GUARDIAN.
Disclosure: The study was sponsored by InspireMD. Some researchers report financial ties with Boston Scientific, Daiichi Sankyo, Eli Lilly and InspireMD.
Click Here to Manage Email Alerts