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Three-year clinical outcome of patients with bifurcation treatment with second-generation Resolute and Xience V stents in the randomized TWENTE trial - 10/12/14

Doi : 10.1016/j.ahj.2014.10.011 
Ming Kai Lam, MD a, Hanim Sen, MD a, K. Gert van Houwelingen, MD a, Marije M. Löwik, PhD a, Liefke C. van der Heijden, MD a, Marlies M. Kok, MD a, Frits H.A.F. de Man, MD, PhD a, Gerard C.M. Linssen, MD, PhD b, c, Kenneth Tandjung, MD, PhD a, Carine J.M. Doggen, PhD d, Clemens von Birgelen, MD, PhD a, d,
a Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands 
b Department of Cardiology, Ziekenhuisgroep Twente, Almelo, the Netherlands 
c Department of Cardiology, Ziekenhuisgroep Twente, Hengelo, the Netherlands 
d Health Technology and Services Research, MIRA–Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, the Netherlands 

Reprint requests: Prof C von Birgelen, MD, PhD, Thoraxcentrum Twente, Department of Cardiology, Haaksbergerstraat 55, 7513 ER Enschede, the Netherlands.

Riassunto

Background

Only limited data from large randomized clinical trials have been published on the long-term performance of second-generation drug-eluting stents in bifurcation lesions.

Methods

We investigated in patients in the randomized TWENTE trial the long-term safety and efficacy of treating bifurcation lesions with 2 widely applied second-generation drug-eluting stents, the zotarolimus-eluting Resolute stent (Medtronic Inc, Santa Rosa, CA) and the everolimus-eluting Xience V stent (Abbott Vascular, Santa Clara, CA). Three-year follow-up was available in 99.3%. Patients were categorized into treatment for ≥1 bifurcation lesion versus treatment for nonbifurcation lesions only.

Results

Among the 1,391 patients of the TWENTE trial, 362 (26%) were treated for bifurcation lesions. At 3-year follow-up, target-vessel failure did not differ between patients treated for bifurcation versus nonbifurcation lesions (13.1% vs 12.6%; P = .84), whereas the periprocedural myocardial infarction rate was higher in patients with bifurcation lesions (6.9% vs 3.1%; P < .01). Of the 362 patients with bifurcation lesion treatment, 179 (49.4%) were treated with Resolute and 183 (50.6%) with Xience V. There was no significant difference in target-vessel failure between the Resolute and Xience V groups with bifurcation treatment (13.6% vs 12.6%; P = .78), and their incidence of definite-or-probable stent thrombosis was low and similar (1.1% vs 0.5%, respectively; P = .62).

Conclusion

Despite a significant difference in periprocedural myocardial infarction, 3-year clinical outcome after implantation of second-generation stents was favorable and similar for patients with and without bifurcation lesions. In addition, we observed no difference in long-term clinical outcome after bifurcation lesion treatment with Resolute and Xience V stents.

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 Conflict of interest: Clemens von Birgelen is or has been consultant to and has received lecture fees or travel expenses from Abbott Vascular, Boston Scientific, and Medtronic; he received travel expenses from Biotronik and lecture fees from MSD; the institution has received research grants from Abbott Vascular, Biotronik, Boston Scientific, and Medtronic. All other authors declare that they have no conflict of interest. The TWENTE trial is an investigator-initiated study, supported by equal unrestricted grants from Abbott Vascular and Medtronic. There is no financial or other conflict of interest other than stated; there were no other sponsors than indicated.


© 2014  Elsevier Inc. Tutti i diritti riservati.
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