Angiographical Follow-Up After Radioactive “Cold Ends” Stent Implantation

Wardeh, Alexander J.; Albiero, Remo; Kay, Ian; Knook, A.H.M.; Wijns, William; Kozuma, Ken; Nishida, Toshihiko; Ferrero, Valeria; Levendag, Peter C.; Giessen, Willem J. van der; Colombo, Antonio; Serruys, Patrick W.

doi:10.1161/hc0502.104539

Cited by 15 publications

(4 citation statements)

References 15 publications

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“…18 In patients treated with radioactive stents, edge stenosis has proved to be an important clinical problem, occurring in 30% of patients. 8,19 TAXUS II confirmed that no edge effect greater than that found with a BMS occurs with either MR or SR paclitaxel-eluting stents. As reported previously, the term "edge effect" is used to connote an effect greater than would be seen with BMS.…”

Section: Edge Effects and Restenosismentioning

confidence: 71%

“…As reported previously, the term "edge effect" is used to connote an effect greater than would be seen with BMS. 8,19 In fact, there was a slight but nonsignificant decrease in edge stenosis compared with BMS. Edge stenosis (diameter stenosis Ͼ50%) rates for BMS were 3.4% (proximal) and 3.1% (distal), whereas for the SR and MR groups, the rates were 1.6% and 2.3% at the proximal and distal edges, respectively.…”

Section: Edge Effects and Restenosismentioning

confidence: 93%

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Vascular Responses at Proximal and Distal Edges of Paclitaxel-Eluting Stents

et al. 2004

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MD; for the TAXUS II Study GroupBackground-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, Pϭ0.194) for patients in the SR (Ϫ0.54Ϯ2.1 mm 2 ) and MR (Ϫ0.88Ϯ1.9 mm 2 ) groups compared with the BMS (Ϫ1.02Ϯ1.9 mm 2 ) group. For the distal edge, a significant decrease in lumen area was only observed with BMS (Ϫ0.91Ϯ2.0 mm 2 , PϽ0.0001); this decrease was significantly attenuated with SR (0.08Ϯ2.0 mm 2 ) and MR (Ϫ0.19Ϯ1.7 mm 2 ) stents (PϽ0.0001 by ANOVA). Negative vessel remodeling was observed at the proximal (Ϫ0.48Ϯ2.2 mm 2 , Pϭ0.011) 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.

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Section: Edge Effects and Restenosismentioning

confidence: 71%

Section: Edge Effects and Restenosismentioning

confidence: 93%

Vascular Responses at Proximal and Distal Edges of Paclitaxel-Eluting Stents

et al. 2004

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“…The cold-ends study failed to improve upon the uniformly radioisotope stents [15]. In the hot-ends study, the distance from the edge of the deployed stent to the area of balloon injury was reduced from 2 mm to 1 mm.…”

Section: P Radioisotope Stents -Human Studiesmentioning

confidence: 98%

Radioisotope stents

Fischell¹,

Fischell²,

Fischell³

et al. 2002

Minimally Invasive Therapy & Allied Technologies

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Intracoronary stent placement following PTCA improves the long-term outcome of the treated patient, but in-stent restenosis remains problematic, especially in smaller vessels and longer lesions. Intravascular brachytherapy is a rapidly evolving field of research and clinical treatment, with a number of different irradiation techniques being used clinically. Many clinical data are now available that indicate clearly that either n or g radiation can reduce, and hopefully cure restenosis. The combination of radiation with stents has several distinct advantages over radiation with balloon angioplasty. It should be possible to use the stent as the radioactive source, as the radioactivity levels required by a permanent implant are extremely safe (< 1/1000 of the radioactivity of the least radioactive brachytherapy catheters). Once the stent has been implanted, the procedure is complete; catheter-based brachytherapy requires a second procedure after stent implantation. Unfortunately, in many human studies of the efficacy of radioisotope stents, although an excellent result in terms of a dramatically reduced neointima was seen in the stent, the incidence of an 'edge effect', with a reduced lumen just beyond the stent-edge occurred at an unacceptable rate. The encouraging results of the 'hot ends' study, where the stent ends were made more radioactive to reduce the edge effect, coincided with even more encouraging results from sirolimus drug-eluting stents. As a result, most work on radioisotope stents for the treatment of restenosis has been abandoned. There may, however, be applications for radioisotope stents in the treatment of malignant ducts, such as the esophagus and bronchia, which could justify further study of the devices.

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“…In the past, edge restenosis was the major limitation of endovascular brachyterapy, representing 30% of its failures [3,16,17].…”

Section: Edge Effectmentioning

confidence: 99%