EES Compared Favorably with SES In Two Pivotal Trials

SAN FRANCISCO, CALIF.—PRECOMBAT-2, SORT OUT IV linked EES to strong composite endpoint results.

The everolimus-eluting stent yielded comparable outcomes to the sirolimus-eluting stent in terms of both MACCE and MACE in the PRECOMBAT-2 and SORT OUT IV trials, respectively, even comparing well with CABG, according to results presented at TCT 2011.

Seung-Jung Park, MD, PhD, of Asan Medical Center in Seoul, South Korea, presented results of the PRECOMBAT-2 trial, and Lisette Okkels Jensen, MD, PhD, of Odense University Hospital, in Denmark, presented 2-year follow-up data from SORT OUT IV.

PRECOMBAT-2 results

Park said that the aim of PRECOMBAT-2 was to evaluate the safety and efficacy of PCI using EES (Xience V; Abbott Vascular) in 334 patients with unprotected left main coronary artery stenosis. These outcomes were compared with those of patients receiving PCI with the sirolimus-eluting stent (Cypher, Cordis) or CABG in the PRECOMBAT trial.

Patients returned for follow-up angiography at 8 to10 months after PCI or at onset of symptoms.

The primary endpoint of MACCE, which was a composite of death, MI, stroke or ischemia-driven target vessel revascularization, was not statistically different between the three groups (see Figure).

“There were also no statistical differences for late lumen loss” between SES and EES, Park said; in-stent left main late loss was 0.19 mm with SES vs. 0.18 mm with EES; P=.83. Late loss results were similar for the LAD and left circumflex.

Restenosis rates were also similar between the SES (13.8%) and EES arms (9.2%; P=.16). 

“The use of EES for [unprotected left main coronary artery] stenosis was comparably safe and effective with regard to the incidence of 18-month MACCE, as compared with SES or CABG,” Park concluded. “Although the need of repeat revascularization is higher than CABG, the second-generation EES had comparable risk of angiographic and clinical restenosis [compared] with the first-generation SES.” Ischemia-driven TVR was 8.2% for SES, 6.5% for EES, and 2.6% for CABG (P=.005 and P=.019 for SES and PES vs. CABG, respectively).

SORT OUT IV results

The SORT OUT IV trial included 1,390 patients with chronic stable CAD or ACS who were treated with EES and 1,384 patients treated with SES. The primary endpoint was defined as MACE, a composite of cardiac death, MI, definite stent thrombosis and TVR, at 9 months.

According to Jensen, the primary endpoint rate was 8.9% in the SES arm and 8.4% in the EES arm (P=.66). The rate of definite stent thrombosis was 0.9% for SES vs. 0.2% for EES (P=.02). The combined rate of definite or probable stent thrombosis was 1.2% for the SES and 1.1% for EES (P=.72).

“Both stents were associated with relatively low MACE in this all-comers patient population,” Jensen said. “The EES was found to be as effective and safe as the SES.”