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A novel cobalt-chromium-based zotarolimus-eluting stent (ZES) is noninferior to a platinum-chromium-based everolimus-eluting stent (EES), according to a paper comparing the 2 third-generation devices published online February 2, 2014, ahead of print in The Lancet.

Results from the all-comer DUTCH PEERS (Durable polymer-based stent Challenge of Promus ElemEnt versus ReSolute integrity) trial were previously presented at the annual Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco, CA, in October 2013.

Researchers led by Clemens von Birgelen, MD, PhD, of Thoraxcentrum Twente (Enschede, the Netherlands), randomized 1,811 patients (n = 2,371 target lesions) to third-generation Resolute Integrity ZES (n = 906; Medtronic, Santa Rosa, CA) or Promus Element EES (n = 905; Boston Scientific, Natick, MA) in the single-blind trial at 4 study sites in the Netherlands from November 2010-May 2012.

Resolute Integrity “uses a novel, open-cell stent design for increased flexibility and deliverability,” the paper reports, while the Promus Element “is designed for improved deliverability and visibility (ie, radiopacitiy).”

Noninferiority was determined 1 year postprocedure with a primary endpoint of target-vessel failure (TVF; defined as: cardiac death, target vessel-related MI, or clinically indicated TVR).

ZES Noninferior, More Structurally Sound?

ZES met the noninferiority criteria compared with EES at 1 year with an absolute risk difference in TVF of 0.88% (95% CI -1.24 to 3.01; P for noninferiority = 0.006). Each of the component endpoints also was similar (table 1). Stent thrombosis, whether definite or definite/probable, occurred at a rate of 1% or less in both groups (P = 0.51 and 0.40, respectively)

Table 1. Outcomes at 1 Year

The stents differed, however, in structural durability. Longitudinal stent deformation was noted in 9 patients receiving EES (0.6%), though there were no clinical sequelae, whereas ZES showed no such deformities. According to the researchers, “[t]he excellent radiographic visibility of the Promus Element stent might have contributed to the more frequent recognition of longitudinal stent deformation and the slightly higher frequency of stent post-dilation compared with the Resolute Integrity stent.”

Challenging Population, Unexpectedly Promising Outcomes

This is the first randomized comparison of the third-generation ZES and EES, and the first trial to ever investigate the Resolute Integrity ZES, the authors report.

Within the all-comers population, many patients presented with:

• ACS: 59% (including 20% STEMI and 25% NSTEMI)
• Complex ACC/AHA class B2 or C lesions: 66%
• At least 1 lesion in a small vessel: 59%
• Bifurcated lesions: nearly 26%

The researchers had expected to see an adverse event rate comparable to that of RESOLUTE All Comers, a similar trial conducted with corresponding second-generation stents.

“However, although we succeeded in enrolling more patients with [STEMI] than did the RESOLUTE All Comers trial, event frequencies were lower,” they write, noting that underreporting of events in the current trial is unlikely. Moreover, the authors add, HOST-ASSURE and COMPARE II “also had low event frequencies, suggesting that our findings are actually more representative of the present outcomes of [PCI] than of those from when the trial was designed.”

von Birgelen C, Sen H, Lam MK, et al. Third-generation zotarolimus-eluting and everolimus-eluting stents in all-comer patients requiring a percutaneous coronary intervention (DUTCH PEERS): a randomized, single-blind, multicentre, non-inferiority trial. The Lancet. 2014;Epub ahead of print.

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