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TWENTE: Still Few Differences between ZES and EES at 2 Years

By L.A. McKeown

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At 2-year follow-up, a zotorolimus-eluting stent (ZES) and an everolimus-eluting stent (EES) demonstrated similar safety and efficacy in a real-world patient population characterized by complex lesions and off-label indications for drug-eluting stents (DES). The results, from a large randomized, single-center trial, were published online April 24, 2013, ahead of print in the Journal of the American College of Cardiology.

For the TWENTE (The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente) trial, investigators led by Clemens von Birgelen, MD, PhD, of Thoraxcentrum Twente (Enschede, The Netherlands), randomized 1,391 patients undergoing PCI to the Resolute ZES (Medtronic CardioVascular, Santa Rosa, CA; n = 697) or the Xience V EES (Abbott Vascular, Abbott Park, IL; n = 694) between June 2008 and August 2010.

The study population included a wide range of patients and lesion complexities, including off-label indications. There also were no limits on lesion length or reference vessel size. In accordance with European guidelines, the recommended duration of dual-antiplatelet therapy (DAPT) was 1 year following PCI.

Similar Safety, Efficacy at 2 Years

The rates of target vessel failure (TVF; composite of cardiac death, target vessel MI, and clinically driven TVR), the primary endpoint, did not differ between ZES and EES at 2 years despite less TLR with EES. The rates of the patient-oriented composite endpoint (all-cause mortality, any MI, any repeat revascularization) also were similar between the 2 groups, as were the individual components of the primary endpoint (table 1).

Table 1. Two-year Outcomes

 

ZES
(n = 695)

EES
(n = 692)

P Value

TVF

10.8%

11.6%

0.65

TLR

4.9%

2.6%

0.03

Patient-oriented Composite Endpoint

16.4%

17.1%

0.75

Cardiac Death

1.6%

2.7%

0.14

Target Vessel MI

5.3%

5.6%

0.80

Clinically Driven TVR

5.6%

5.1%

0.65

 

Additionally, in an exploratory subgroup analysis, EES were associated with less clinically indicated TLR compared with ZES (4.9% vs. 2.6%; P = 0.03), but this did not result in a difference in the primary endpoint (10.5% vs. 9.8%; P = 0.68).

While the great majority of patients in both groups discontinued dual antiplatelet therapy after 1 year or earlier, 7.7% of ZES patients and 6.2% of EES patients were still on the therapy at 2-year follow-up.

At 2 years, rates of Academic Research Consortium-defined definite or probable stent thrombosis were low and similar between the ZES and EES groups (1.2% vs. 1.4%; P = 0.63). Very late stent thrombosis occurred at a rate of 0.3% in each arm (P = 1.00).

Comparisons to RESOLUTE and Others

According to the study authors, the 2-year data from TWENTE “generally support the findings of RESOLUTE All Comers and show that Resolute ZES has a long-term safety profile that is similar to Xience V EES, which was previously shown to be superior to the Taxus stent in SPIRIT IV and COMPARE.” In RESOLUTE All Comers, ZES were equivalent to EES with regard to both TVF and the patient-oriented composite endpoint.

The authors point to 1 difference between RESOLUTE All Comers and the current study. While in the former study, the TLR rates were similar for ZES and EES, in TWENTE, TLR was lower with EES. Although the difference did not affect TLF, the investigators say their data “suggest that assessment of this parameter beyond the present 2-year follow-up may be of interest.

“The low rates of very late stent thrombosis in TWENTE are particularly noteworthy, considering the low rate of DAPT continuation beyond 12 months,” Dr. von Birgelen and colleagues write. “In fact, the rate of DAPT use at 2-year follow-up … was much lower than that of several European DES trials in all-comer populations … and some US DES trials in patients with somewhat less complex coronary disease.” In this regard, TWENTE “provides interesting safety information on stringent discontinuation of DAPT at 1 year following PCI in a study population with many complex patients and lesions,” they conclude.

 

Source:
Tandjung K, Sen H, Lam MK, et al. Clinical outcome following stringent discontinuation of dual antiplatelet therapy after 12 months in real-world patients treated with second-generation zotarolimus-eluting Resolute and everolimus-eluting Xience V stents: Two-year follow-up of the randomized TWENTE trial. J Am Coll Cardiol. 2013;Epub ahead of print.

 

 

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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.

Comments

DES/BRS/DCB