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Title: PERfECT STENT: A Prospective, Randomized Trial Evaluating a Paclitaxel-Eluting Balloon in Patients Treated with Endothelial Progenitor Cell Capturing Stents for De Novo Coronary Artery Disease
Event: TCT 2010
Topic(s): Interventional Cardiology
Presenter: Jochen Wöhrle
Writer(s): Xiushui Ren
Date Posted: 09/23/2010

Summary

In patients with de novo coronary lesions, treatment with Endothelial Progenitor Cell (EPC) Capturing stent plus paclitaxel-eluting balloon catheter was superior to EPC stent alone in preventing late lumen loss.
Background

The endothelial progenitor cell capturing stent (EPC stent) has been shown to promote late regression of neointimal hyperplasia and may be comparable to paclitaxel-eluting stent (Taxus) in selected patients.

The current study compared EPC stent plus paclitaxel-eluting balloon catheter to EPC stent alone.
Study Design

This was a prospective, randomized, multicenter, single blinded trial of 120 patients with a de-novo lesion in native coronary artery between 2.5 mm and 4 mm. Exclusion criteria included graft lesion, chronic total occlusion, bifurcation lesion, left main lesion, restenosis and in-stent restenosis, and contraindication to aspirin or clopidogrel.

The primary end-point was in-stent late loss at 6-month angiographic follow-up. Secondary end-points included both angiographic and clinical components.
Results and Conclusions

At 6-month follow-up, patients treated with EPC stent plus paclitaxel-eluting balloon catheter had less in-stent late loss (0.34 mm vs. 0.88 mm, p<0.001). In addition, treatment with EPC stent plus paclitaxel-eluting balloon catheter resulted in decreased proximal late loss (0.04 mm vs. 0.21 mm, p=0.01), binary angiographic in-stent restenosis (5.1% vs. 21.4%, p=0.009), and major adverse cardiac events (4.8% vs. 17.2%, p=0.03). The rates of MI and death were low and not significantly different. There was no incidence of stent thrombosis in either group.

Thus in this small prospective, randomized, multicenter study of patients with de novo coronary lesions, EPC stent plus paclitaxel-eluting balloon catheter resulted in significant lower rates of late-loss, anigiographic restenosis, and combined clinical endpoints.
References

1. Duckers HJ, Soullié T, den Heijer P, Rensing B, de Winter RJ, Rau M, Mudra H, Silber S, Benit E, Verheye S, Wijns W, Serruys PW. Accelerated vascular repair following percutaneous coronary intervention by capture of endothelial progenitor cells promotes regression of neointimal growth at long term follow-up: final results of the Healing II trial using an endothelial progenitor cell capturing stent (Genous R stent). EuroIntervention. 2007 Nov;3(3):350-8.

2. Beijk MA, Klomp M, Verouden NJ, van Geloven N, Koch KT, Henriques JP, Baan J, Vis MM, Scheunhage E, Piek JJ, Tijssen JG, de Winter RJ. Genous endothelial progenitor cell capturing stent vs. the Taxus Liberte stent in patients with de novo coronary lesions with a high-risk of coronary restenosis: a randomized, single-centre, pilot study. Eur Heart J. 2010 May;31(9):1055-64.
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