Shelley Wood

November 11, 2011

November 11, 2011 (San Francisco, California) — Another randomized controlled "real-world" trial has demonstrated noninferiority of the Resolute zotarolimus-eluting stent (Medtronic) against the market-leading Xience everolimus-eluting stent (Abbott) at one year.

Dr Clemens von Birgelen (Thoraxcentrum Twente, Enschede, the Netherlands) presented the TWENTE results here on the last day of the TCT 2011 meeting.

"Zotarolimus-eluting Resolute stents were noninferior to everolimus [Xience V stents] in terms of safety and efficacy for treating real-world patients with a vast majority of complex lesions and off-label indications for [drug-eluting stents] DES," von Birgelen said.


TWENTE was designed with no limit to the number of lesions or vessels treated and no limit to lesion length or vessel size, in a cohort of patients with stable angina or non-ST-elevation ACS.

In all, 1391 patients were randomized to receive the Xience V stent or the Resolute stent.

At one year, rates of the primary end point of target vessel failure--a composite of cardiac death, target vessel–related MI, and clinically driven target vessel revascularization (TVR)--were nearly identical in the two groups. Rates of each end point within the composite were also very similar.

Stent-thrombosis rates, both definite/probable and definite, were very low, and there was no different between groups.

One-Year Outcomes in Xience V vs Resolute

End point Xience V (%) Resolute, % Log-rank p
Primary end point 8.1 8.2 0.94
Cardiac death 1.4 1.0 0.46
Target vessel MI 4.6 4.6 0.98
TVR 2.7 3.3 0.53
Definite/probable stent thrombosis 1.16 0.86 0.59
Definite stent thrombosis 0.58 0 0.12

To heartwire , von Birgelen noted that TWENTE is now the second randomized controlled trial to directly compare Resolute with the market-leading Xience; TWENTE, however, was an investigator-initiated trial with funding split equally between the manufacturers of the two stents studied.

Resolute uses the same drug coating and Driver cobalt-alloy platform as its predecessor, the Endeavor, but boasts a new biocompatible polymer. In the RESOLUTE All-Comers trial, Resolute was noninferior to Xience for a primary end point of target lesion failure.

"This confirms the noninferiority of the Resolute stent compared with the Xience V in a real-word patient population with many acutely diseased and complex patients and many patients treated for off-label indications," von Birgelen told heartwire . Indeed, the curves for the primary end point out to one year are "superimposable," he added. "You cannot come to any other conclusion but that the devices are noninferior to each other."

He also highlighted the strengths of the study: 100% patient follow-up, a clinically driven primary end point, and the use of the same independent core lab as that used for RESOLUTE All-Comers, making comparisons between the two studies easier.

In practice, von Birgelen says, he has continued to use both stents (at least until starting a new study using the newer Resolute Integrity stent). Speaking of Xience and Resolute, he said, "We are convinced that both are excellent devices as workhorses in busy cath labs."

Dr Ron Waksman (Washington Hospital, DC) said that it is very hard to differentiate between the Resolute and Xience V stents right now in terms of performance and that decisions to choose one stent over another are likely to be based on stent sizes, lengths, and pricing. Dr John Hodgson (Geisinger Heart Institute, Danville, PA) agreed, saying that any debate over the superiority of one stent over the other is splitting hairs, adding that both stent platforms were excellent and decisions to use one over the other will likely to come down to hospital contracts and price.

Von Birgelen disclosed being a consultant and receiving speaker's bureau honoraria and/or traveling expenses from Abbott Vascular, Medtronic, and Boston Scientific.