Vascular responses at proximal and distal edges of paclitaxel-eluting stents: serial intravascular ultrasound analysis from the TAXUS II trial.

Abstract

BACKGROUND:

On the basis of brachytherapy experience, edge stenosis has been raised as a potential limitation for drug-eluting stents. We used serial intravascular ultrasound (IVUS) to prospectively analyze vessel responses in adjacent reference segments after implantation of polymer-controlled paclitaxel-eluting stents.

METHODS AND RESULTS:

TAXUS II was a randomized, double-blind trial with 2 consecutive patient cohorts that compared slow-release (SR) and moderate-release (MR) paclitaxel-eluting stents with control bare metal stents (BMS). By protocol, all patients had postprocedure and 6-month follow-up IVUS. Quantitative IVUS analysis was performed by an independent core laboratory, blinded to treatment allocation, in 5-mm vessel segments immediately proximal and distal to the stent. Serial IVUS was available for 106 SR, 107 MR, and 214 BMS patients. For all 3 groups, a significant decrease in proximal-edge lumen area was observed at 6 months. The decrease was comparable (by ANOVA, P=0.194) for patients in the SR (-0.54+/-2.1 mm2) and MR (-0.88+/-1.9 mm2) groups compared with the BMS (-1.02+/-1.9 mm2) group. For the distal edge, a significant decrease in lumen area was only observed with BMS (-0.91+/-2.0 mm2, P<0.0001); this decrease was significantly attenuated with SR (0.08+/-2.0 mm2) and MR (-0.19+/-1.7 mm2) stents (P<0.0001 by ANOVA). Negative vessel remodeling was observed at the proximal (-0.48+/-2.2 mm2, P=0.011) but not the distal edges of BMS and at neither edge of SR or MR stents.

CONCLUSIONS:

The marked reduction in in-stent restenosis with SR or MR stents is not associated with increased edge stenosis at 6-month follow-up IVUS. In fact, compared with BMS, there is instead a significant reduction in late lumen loss at the distal edge with TAXUS stents.

• Authors: Patrick W Serruys, Muzaffer Degertekin, Kengo Tanabe, Mary E Russell, Giulio Guagliumi, John Webb, Jaap Hamburger, Wolfgang Rutsch, Christoph Kaiser, Robert Whitbourn, Edoardo Camenzind, Ian Meredith, François Reeves, Christoph Nienaber, Edouard Benit, Clemens Disco, Jörg Koglin, Antonio Colombo, TAXUS II Study Group
• Journal: Circulation (Circulation) Vol. 109 Issue 5 Pg. 627-33 (Feb 10 2004) ISSN: 1524-4539 [Electronic] United States
• PMID: 14769685 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Paclitaxel

Topics

• Coronary Restenosis (diagnostic imaging, prevention & control)
• Coronary Vessels (diagnostic imaging, drug effects, surgery)
• Double-Blind Method
• Drug Delivery Systems
• Female
• Humans
• Male
• Middle Aged
• Paclitaxel (administration & dosage, therapeutic use)
• Stents
• Treatment Outcome
• Ultrasonography