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TWENTE: Zotarolimus DES Noninferior to Everolimus DES at 1 Year

By L.A. McKeown

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SAN FRANCISO, CA—New-generation zotarolimus-eluting stents are noninferior to everolimus-eluting stents at 1 year in patients with stable angina or non-ST-segment elevation acute coronary syndromes (ACS), according to the results of a single-center, randomized trial.

The findings were reported by Clemens von Birgelen, MD, PhD, of Thoraxcentrum Twente (Enschede, The Netherlands), November 11, 2011, at the annual Transcatheter Cardiovascular Therapeutics scientific symposium.

For the TWENTE (The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente) trial, 1,391 patients undergoing PCI were randomized to a zotarolimus-eluting stent (Resolute; Medtronic CardioVascular, Santa Rosa, CA; n = 697) or an everolimus-eluting stent (Xience V; Abbott Vascular, Abbott Park, IL; n = 694).

Similar to the multicenter RESOLUTE All Comers trial, which randomized 2,300 patients with symptomatic CAD to receive Resolute or Xience V, the TWENTE study included a wide range of patients as well as multiple lesions or vessels treated, and all lesion types with few exclusions. There also were no limits on lesion length or reference vessel size.

No Difference in Primary Endpoint

At 1-year follow-up, the zotarolimus-eluting stent met the criteria for noninferiority to the everolimus-eluting stent for the primary endpoint of TVF (composite of cardiac death, target vessel MI, and clinically driven TVR; figure 1).

Similarly, there was no difference between groups in the individual components of the primary endpoint at 1 year (table 1).

Table 1. One-Year Outcomes

 

Resolute
(n = 697)

Xience V
(n = 694)

Log-rank P Value

Cardiac Death

1.0%

1.4%

0.462

Target Vessel MI

4.6%

4.6%

0.983

Clinically Driven TVR

3.3%

2.7%

0.534


In addition, there was no difference between the zotarolimus and everolimus groups in the patient-oriented endpoint of death, any MI, and any revascularization (11.2% vs. 10.5%; P = 0.69). The incidence of ARC-defined definite stent thrombosis was similarly low for both stent groups (0.58% vs. 0%; P = 0.12).

The primary endpoint was consistent across multiple subgroups with the exception of diabetic patients, in whom there was a higher rate of TVF with Resolute compared with Xience V, although the difference did not reach statistical significance (13.9% vs. 7.3%; P = 0.08).

“Zotarolimus-eluting Resolute stents were noninferior to everolimus-eluting 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, which were implanted with liberal use of postdilatation,” Dr. von Birgelen concluded.

 

Source:
Von Birgelen C. TWENTE: A prospective, randomized trial of zotarolimus-eluting stents and everolimus-eluting stents in patients with coronary artery disease. Presented at: Transcatheter Cardiovascular Therapeutics 2011; November 11, 2011; San Francisco, CA.

 

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Disclosures
  • The study was funded by Abbott Vascular and Medtronic.
  • Dr. von Birgelen reports serving as a consultant to and receiving speaker’s honoraria and/or traveling expenses from Abbott Vascular, Boston Scientific and Medtronic.

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