TWENTE: Second-Generation DES Show Good Long-term Outcomes in Bifurcation Lesions

Three years after implantation with a second-generation drug-eluting stent (DES), patients with and without coronary bifurcation lesions have similar overall clinical outcomes, with no obvious between-stent differences, according to a substudy of the TWENTE trial published online October 25, 2014, ahead of print in the American Heart Journal.

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

The substudy compared long-term outcomes in patients treated for bifurcation lesions (n = 362) and nonbifurcation lesions (n = 1,029). Among those with bifurcations, 49.4% received ZES and 50.6% received EES. Prior to PCI, side-branch lumens in bifurcated lesions measured 2.27 ± 0.41 mm with a lesion length of 10.1 ± 6.8 mm and side-branch stenosis of 62.5 ± 13.6%.

 

Few Differences Seen

At 3 years, rates of target-vessel failure (TVF; cardiac death, target-vessel MI, or clinically driven TVR) and cardiac death were similar between patients with and without bifurcation lesions. There was a higher incidence of target-vessel MI in the bifurcation group, but rates of definite or probable stent thrombosis were low and similar in both groups (table 1).

Outcomes at 3 Years

Among patients with bifurcation lesions, TVF did not differ between those with side branches ≥ 2.0 mm vs < 2.0 mm (P = .80). Additionally, the incidence of TVF was similar between the ZES and EES groups (13.6% vs 12.6%; P = .78), as was the prevalence of definite or probable stent thrombosis (1.1% vs 0.5%; P = .62). Neither the stent technique (single or a 2-stent approach) nor the use or omission of a final kissing balloon inflation was associated with differences in outcome.

Although the periprocedural MI rate was higher in patients with bifurcations than in those without (6.9% vs 3.1%; P < .01), in a landmark analysis, no differences were seen beyond 48 hours (P = .37). Cox regression analysis suggested that bifurcation treatment was associated with increased risk of target-vessel MI, but after adjustment for potential confounders it was no longer significant (P = .30).

Reassurance Tempered With Caution

According to the study authors, these long-term results from TWENTE, which enrolled a broad population of patients with advanced CAD and complex lesions, “are relevant, as in most patients with bifurcation lesions a simple approach with provisional T-stenting was applied, which is currently the recommended approach.”

They add that their findings are in line with those of other studies comparing Resolute and Xience V in cohorts that included bifurcation lesions but acknowledge that bifurcation angles were not measured in the trial and there was no routine angiographic follow-up.

In an email with TCTMD, Gregg W. Stone, MD, of Columbia University Medical Center (New York, NY), cautioned against overinterpreting low-frequency endpoints in this subgroup analysis given the relatively small number of bifurcation lesions in the study.

Nonetheless, he said, “Perhaps the most reassuring message here is that the outcomes with Xience and Resolute in bifurcation lesions were roughly comparable.”

 


Source:
Lam MK, Sen H, van Houwelingen KG, et al. Three-year clinical outcome of patients with bifurcation treatment with second-generation Resolute and Xience V stents in the randomized TWENTE trial. Am Heart J. 2014;Epub ahead of print.

Disclosures:

  • The TWENTE trial was supported by equal unrestricted grants from Abbott Vascular and Medtronic.
  • Dr. von Birgelen reports serving as a consultant to and receiving lecture fees or travel expenses from Abbott Vascular, Boston Scientific, and Medtronic. He also reports having received travel expenses from Biotronik and lecture fees from MSD and that his institution has received research grants from Abbott Vascular, Biotronik, Boston Scientific, and Medtronic.
  • Dr. Stone reports serving as a consultant to Boston Scientific.

 

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