SAN FRANCISCO, CA — A rare, large-scale, randomized, investigator-initiated trial of two "third-generation" drug-eluting stents (DES) suggests that two of the market-leading DES are equally safe and effective in an "all-comers" population[1].
Dr Clemens von Birgelen (Thoraxcentrum Twente, Enschede, the Netherlands) presented the DUTCH PEERS trial here at TCT 2013 , a meeting where eager interventionalists tend to pay close attention to flashy, up-and-coming devices. Drug-eluting stents, which nabbed the spotlight in the late 2000s, are not the news generators they once were.
But von Birgelen, asked if his trial "matters" during a morning press conference, gave a sobering response. While earlier-generation devices were subjected to rigorous comparisons, the newer, more deliverable devices never saw large head-to-head studies. The key advantage of the third-generation, permanent-polymer stents, he explained, is their deliverability. But with this enhanced deliverability has come concerns that the price of improved flexibility has been reduced longitudinal strength.
And while clinical outcomes were reported for the everolimus-eluting Promus Element (Boston Scientific), von Birgelen and his coinvestigators point out that no such data were reported for the zotarolimus-loaded Resolute Integrity (Medtronic).
So yes, von Birgelen said, "for me and for my patients, it matters. The third-generation DES take a lot of pressure from us. I'm a clinician. . . . I got this stent design in my hands and it was much more flexible than the stents we were used to using, and when you are standing there in the middle of the night, fighting with a right coronary artery that is tortuous and calcified, it matters."
DUTCH PEERS is also published simultaneously in the Lancet.
No Clinical Differences; Few Stent Malformations
von Birgelen and colleagues randomized 1811 "all-comers" patients, including approximately 20% STEMI patients and 25% non-STEMI, to either the zotarolimus-eluting stent or the everolimus-eluting stent.
At 12 months, the primary end point (target vessel failure, combining cardiac death, target-vessel–related MI, and target vessel revascularization) was 6% in the zotarolimus group and 5% in the everolimus group. The zotarolimus stent met the definition of noninferiority to the everolimus-eluting stent, according to the study design. Individual end points were no different between groups. A total of three and six definite stent thromboses occurred in the zotarolimus-eluting and everolimus-eluting stent groups, respectively. Longitudinal stent deformation, by contrast, was seen in the everolimus-eluting stent group only, but in just 1% of stents used, and no adverse events were associated with this finding.
"In this all-comer patient population, no significant difference was seen between stent groups in the primary end point of target vessel failure at 12-month follow-up," the authors concluded.
Commenting on the study at the TCT meeting, Dr Cindy Grines (Detroit Medical Center) said she finds all of the new-generation stents "very flexible and deliverable" and that these two, on the basis of this study, "seem reasonably equivalent."
An accompanying editorial in the Lancet by Drs Robert A Byrne and Adnan Kastrati (Deutsches Herzzentrum, Technische Universität, Munich, Germany) notes that the higher finding of longitudinal stent deformation with the Promus Element may in part reflect the fact that its platinum-base stent is more easily picked up on angiography[2].
They also make a strong case for trials to aim higher than "noninferiority," noting that this makes sense for a product that is aiming to show it measures up to the standard of care because it offers some other additional advantage. "Otherwise," they argue, "a model based on superiority testing should attract more [research] resources, so that findings can provide a rationale for adoption of new devices. As a community, perhaps it is time that we reassessed the focus of clinical trials of drug-eluting stents to promote progress."
von Birgelen disclosed being a consultant to Abbott Vascular, Boston Scientific, and Medtronic and having received a travel grant from Biotronik and lecture fees from Biotronik and MSD; the coauthors have no disclosures. Kastrati disclosed receiving speaker's fees from Abbott, Biosensors, and Biotronik. Byrne had no conflicts of interest.
Heartwire from Medscape © 2013 Medscape, LLC
Cite this: 'It Matters': Two Third-Gen DES Equivalent in DUTCH PEERS - Medscape - Nov 01, 2013.
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