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ZES, EES comparable in treatment of unprotected left main CAD
Zotarolimus-eluting and everolimus-eluting stents displayed similar efficacy in the treatment of unprotected left main coronary artery lesions at 1 year, according to recent results of the ISAR-LEFT MAIN 2 trial published in the Journal of the American College of Cardiology.
The results of the trial were initially presented at Transcatheter Cardiovascular Therapeutics 2012.
In the study, the researchers noted that PCI accounts for only 2% of treatment routes in randomized trials of patients with unprotected left main CAD, with most patients instead undergoing CABG.
Julinda Mehilli, MD, of the Munich University Clinic, Germany, and colleagues randomly assigned patients older than 18 years to the zotarolimus-eluting stent (ZES; Medtronic; n=324) or the everolimus-eluting stent (EES; Abbott; n=326) between 2007 and 2011.
All-cause death, MI and target lesion revascularization after 1 year served as the primary endpoint, with stent thrombosis and binary angiographic restenosis serving as secondary endpoints.
At baseline, the Parsonnet score of more than 15, indicating high risk for surgery, was comparable between the two arms (ZES, 37% vs. EES, 35.3%; P=.70). In the ZES group, 83% of lesions were located in the distal left main coronary artery compared with 76.8% in the EES group (P=.13).
The researchers noted that stent placement was successful in each patient. After the procedure, patients were administered 75 mg/day of clopidogrel (Plavix, Sanofi-Aventis) or 10 mg/day of prasugrel (Effient, Daiichi Sankyo/Eli Lilly; 2.5% of ZES group vs. 3.5% of EES group) for 12 months.
At 1-year follow-up, the primary endpoint occurred in 17.5% (95% CI, 13.7-22.1) of the ZES arm vs. 14.3% (95% CI, 10.9-18.6) of the EES arm (RR=1.26; P=.25).
All-cause mortality was 5.6% in both groups (RR=1.00; 95% CI, 0.52-1.93; P=.98). Diabetes was associated with an increased risk for mortality in the ZES arm (RR=1.26; 95% CI, 0.50-3.20; P=.62).
Definite stent thrombosis occurred in 0.6% of both arms, with one additional occurrence of fatal probable thrombosis in the ZES arm (P>.99).
Binary angiographic restenosis occurred in 21.5% of the ZES arm, which did not differ significantly from 16.8% in the EES arm (RR=1.28; 95% CI, 0.86-1.92).
Compared with the first ISAR-LEFT MAIN trial, the 2% risk for MI was lower in the current trial, although TLR rates were higher (ZES, 11.7% vs. EES, 9.5%; ISAR-LFET MAIN, approximately 7%). Researchers wrote that the MI improvements may be due to the reduced risks with second-generation drug-eluting stents and the more severe disease in the second trial could explain the increased rate of TLR.
“Within the statistical limitations of the present study, both second-generation ZES and EES platforms provide comparable clinical and angiographic outcomes out to 1-year follow-up when used for treatment of [unprotected left main coronary artery lesions] in a relatively unselected population,” the researchers concluded.
Disclosure: See the study for a full list of relevant financial disclosures.
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