Use of localised intracoronary β radiation in treatment of in-stent restenosis: the INHIBIT randomised controlled trial

Waksman, Ron; Raizner, Albert E.; Yeung, Alan C.; Lansky, Alexandra J.; Vandertie, Lynn

doi:10.1016/s1062-1458(02)00730-4

Cited by 64 publications

(109 citation statements)

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“…[3][4][5] Only intracoronary radiation therapy has emerged as a promising modality to attenuate the neointimal hyperplasia after stent placement. 6,7 However, initial enthusiasm in the use of radioactive stents has been limited by the occurrence of stenosis in the segments adjacent to the proximal and distal edge of the stent (so-called edge stenosis). 8,9 Recently, stent-based local drug delivery with a number of pharmacological agents has been demonstrated to reduce in-stent neointimal hyperplasia.…”

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confidence: 99%

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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confidence: 99%

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

et al. 2004

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“…These rates are slightly higher than those reported at 6 months with the initial radiation trials but are significantly lower than the TLR rates after conventional PCI without IRT for patients who failed radiation therapy (33.3% to 55.0%). 5,6 They are also lower in comparison with the patients from the control group of the radiation trials for ISR, who have been reported to have TLR rates of 41% to 63%. [1][2][3][4][5]8 It is possible that the main cause for failure of the first IRT is related to an inadequate dose because most of the patients in the early phase of the IRT trials received a dose of 14 to 15 Gy.…”

Section: Waksman Et Al Repeat Radiation Therapy For In-stent Restenosmentioning

confidence: 89%

“…[1][2][3][4][5] However, 20% to 25% of patients treated with IRT require repeat revascularization to the irradiated site because of stenosis recurrence. 6,7 The optimal treatment strategy for these patients remains unclear.…”

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confidence: 99%

Repeat Intracoronary Radiation for Recurrent In-Stent Restenosis in Patients Who Failed Intracoronary Radiation

et al. 2003

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Background-Intracoronary radiation therapy (IRT) is the only proven treatment for in-stent restenosis (ISR). It is,however, associated with a significant failure rate. The present study evaluated the outcomes of patients who underwent repeat intracoronary radiation for recurrent ISR. Methods and Results-Fifty-one consecutive patients who failed a previous radiation treatment, presented with angina and angiographic evidence of ISR, and were treated with percutaneous coronary intervention (PCI) and repeat radiation to the same segment were studied. Twenty-five patients were treated with gamma radiation in a dose of 15 Gy, and 26 were treated with beta radiation doses of 18.3 to 23 Gy. The mean cumulative dose for this cohort was 39.5Ϯ11.9 Gy (range, 29 to 75.6 Gy). The outcomes of those patients were compared with outcomes of 299 patients who also failed initial radiation but were treated with repeat conventional PCI to a previously irradiated segment without repeat radiation. At 9 months after treatment, the repeat-IRT group had lower rates of target lesion revascularization (23.5% versus 54.6%; PϽ0.001) and major adverse cardiac events, including target vessel revascularization (29.4% versus 61.3%; PϽ0.001).At 9 months, patients with repeat IRT were free of angiographic and clinical events related to the radiation therapy. Conclusions-Repeat gamma or beta radiation to treat failed IRT for ISR after conventional PCI is safe and effective at 9 months and should be considered as a therapeutic option for this difficult patient subset.

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“…After the risks and benefits were discussed with the patients, those who signed informed consent forms were enrolled either in the irradiation or the control group according to the availability of 188 Re. The patients were enrolled in the study if they met the following criteria: (1) 40 years of age or older; (2) should have undergone CBA for diffuse in-stent restenosis lesions (≥10 mm in length) in a native coronary artery; and (3) should have a target lesion with a reference vessel of ≥2.5 cm in diameter. Patients were excluded from the study if: (1) they exhibited a final angiographic residual stenosis of greater than 30% following on-line quantitative coronary analysis (QCA); (2) there was angiographic evidence of thrombus in the target lesion; (3) they were pre-menopausal; (4) they had previously received thoracic therapeutic irradiation; (5) they had advanced renal failure (serum creatinine concentrations greater than 3.0), left ventricular ejection fraction <25%, evolving myocardial infarction (MI) or within 72 h; (6) they had used thrombolytic or GpIIb/IIIa inhibitors within 48 h before the study; or (7) they had irradiation delivery failure.…”

Section: Methodsmentioning

confidence: 99%

Six-Year Clinical Follow-up After Treatment of Diffuse In-Stent Restenosis With Cutting Balloon Angioplasty Followed by Intracoronary Brachytherapy With Liquid Rhenium-188-Filled Balloon via Transradial Approach

Hang

Hsieh

et al. 2011

Circ J

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Background: Long-term follow-up studies revealed a significant decline in the benefits of intracoronary radiation for in-stent restenosis. Methods and Results:A total of 25 study and 25 contemporaneous control patients with diffuse in-stent restenosis who underwent cutting balloon angioplasty (CBA) transradially, followed by subsequent intracoronary irradiation with a liquid β-emitter Rhenium-188 ( 188 Re)-filled balloon were enrolled in the study. The mean clinical follow-up durations were 64.9±13.0 and 66.3±13.8 months for the irradiated and control patients, respectively. Six-month angiographic restenosis was observed in 16% (4 of 25) of the patients in the irradiated group and 48% (12 of 25) of the patients in the control groups (P=0.03). The 6-month major adverse cardiac events (MACE) rate was 12% and 44%, respectively (P=0.025). The 3-year follow-up angiography was performed in 16 of 21 (76%) irradiated patients and in 4 of 13 (31%) control patients who had no significant restenosis at the 6-month angiographic follow-up. Restenosis occurred in 1 of 16 (7%) irradiated patients and 2 of 4 (50%) control patients. Late target lesion revascularization was performed in 1 irradiated and 2 control patients. The MACE rate within 6 years was significantly reduced in the irradiated group (20% vs. 56%, P=0.019). Conclusions:Brachytherapy using 188 Re-filled balloon following CBA for diffuse in-stent restenotic native coronary arteries is effective in reducing target lesion restenosis and improving long-term outcomes. (Circ J 2011; 75: 113 - 120)

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Use of localised intracoronary β radiation in treatment of in-stent restenosis: the INHIBIT randomised controlled trial

Cited by 64 publications

References 0 publications

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

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

Repeat Intracoronary Radiation for Recurrent In-Stent Restenosis in Patients Who Failed Intracoronary Radiation

Six-Year Clinical Follow-up After Treatment of Diffuse In-Stent Restenosis With Cutting Balloon Angioplasty Followed by Intracoronary Brachytherapy With Liquid Rhenium-188-Filled Balloon via Transradial Approach

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