ESSENCE-DIABETES Published: Xience, Cypher Equally Equipped to Treat Diabetics

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Second-generation everolimus-eluting stents are noninferior to conventional sirolimus-eluting stents in reducing in-segment late loss in diabetic patients. The results, published online August 1, 2011, ahead of print in Circulation, also show similar clinical outcomes between the 2 devices.

Findings from the randomized ESSENCE-DIABETES trial were previously presented in September 2010 at the annual Transcatheter Cardiovascular Therapeutics symposium in Washington, DC.

For the prospective trial, researchers led by Seung-Jung Park, MD, of Asan Medical Center (Seoul, South Korea), enrolled 300 diabetic patients with stable angina and ACS at 15 cardiac centers in South Korea. Subjects were randomized to receive either Xience V everolimus-eluting stents (EES; n = 149; Abbott Vascular, Santa Clara, CA) or Cypher Select and Cypher Select Plus sirolimus-eluting stents (SES; n = 151; Cordis, Warren, NJ). Baseline characteristics were largely similar in both groups, although SES patients were more often male and were more likely to present with acute MI.

EES were noninferior to SES for the study’s primary endpoint of angiographic in-segment late loss at 8 months, and they produced similar levels of in-stent late loss. In-stent and in-segment restenosis, meanwhile, both were less common in EES patients (table 1).

Table 1. Angiographic Outcomes at 8 Months

^a For noninferiority.

At 12 months, results for ischemia-driven TLR, death, and MI all favored EES, but the differences did not reach statistical significance. Stent thrombosis rates were equivalent between the 2 groups (table 2).

Table 2. Clinical Outcomes at 12 Months

“The major finding of this study is that both EES and SES implantation showed favorable performance in diabetic patients,” Dr. Park and colleagues write. While previous studies in diabetics have found promising results for SES vs. paclitaxel-eluting stents, the relative efficacy of second- to first-generation DES had not been tested previously in this population.

Importantly, the current results demonstrate “that the effectiveness of EES for neointimal suppression is extrapolated to the diabetic population,” they conclude. Also reassuring is the fact that the equivalent safety between EES and SES found by ESSENCE-DIABETES mirrors the results of SORT-OUT IV, which evaluated the 2 stents in more than 2,600 nondiabetic patients across a wide range of lesion and clinical complexity, the investigators note.

 

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Source:
Kim W-J, Lee S-W, Park S-W, et al. Randomized comparison of everolimus-eluting stent versus sirolimus-eluting stent implantation for de novo coronary artery disease in patients with diabetes mellitus (ESSENCE-DIABETES): Results from the ESSENCE-DIABETES trial. Circulation. 2011;Epub ahead of print.

 

 

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