Localized intracoronary gamma-radiation therapy to inhibit the recurrence of restenosis after stenting

Martin B. Leon, Paul S. Teirstein, Jeffrey W. Moses, Prabhakar Tripuraneni, Alexandra J. Lansky, Shirish Jani, S. Chiu Wong, David Fish, Stephen Ellis, David Holmes, Dean Kerieakes, Richard E. Kuntz

Research output: Contribution to journalArticle

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Abstract

Background: Although the frequency of restenosis after coronary angioplasty is reduced by stenting, when restenosis develops within a stent, the risk of subsequent restenosis is greater than 50 percent. We report on a multicenter, double-blind, randomized trial of intracoronary radiation therapy for the treatment of in-stent restenosis. Methods: Of 252 eligible patients in whom in-stent restenosis had developed, 131 were randomly assigned to receive an indwelling intracoronary ribbon containing a sealed source of iridium-192, and 121 were assigned to receive a similar-appearing nonradioactive ribbon (placebo). Results: The primary end point, a composite of death, myocardial infarction, and the need for repeated revascularization of the target lesion during nine months of follow-up, occurred in 53 patients assigned to placebo (43.8 percent) and 37 patients assigned to iridium-192 (28.2 percent, P=0.02). However, the reduction in the incidence of major adverse cardiac events was determined solely by a diminished need for revascularization of the target lesion, not by reductions in the incidence of death or myocardial infarction. Late thrombosis occurred in 5.3 percent of the iridium-192 group, as compared with 0.8 percent of the placebo group (P=0.07), resulting in more late myocardial infarctions in the iridium-192 group (9.9 percent vs. 4.1 percent, P=0.09). Late thrombosis occurred in irradiated patients only after the discontinuation of oral anti-platelet therapy (with ticlopidine or clopidogrel) and only in patients who had received new stents at the time of radiation treatment. Conclusions: Intracoronary irradiation with iridium-192 resulted in lower rates of clinical and angiographic restenosis, although it was also associated with a higher rate of late thrombosis, resulting in an increased risk of myocardial infarction. If the problem of late thrombosis within the stent can be overcome, intracoronary irradiation with iridium-192 may become a useful approach to the treatment of in-stent restenosis.

Original languageEnglish (US)
Pages (from-to)250-256
Number of pages7
JournalNew England Journal of Medicine
Volume344
Issue number4
DOIs
StatePublished - Jan 25 2001

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Iridium
Gamma Rays
Stents
Radiotherapy
Recurrence
Thrombosis
Myocardial Infarction
clopidogrel
Placebos
Coronary Restenosis
Ticlopidine
Incidence
Therapeutics
Angioplasty
Blood Platelets
Radiation

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Leon, M. B., Teirstein, P. S., Moses, J. W., Tripuraneni, P., Lansky, A. J., Jani, S., ... Kuntz, R. E. (2001). Localized intracoronary gamma-radiation therapy to inhibit the recurrence of restenosis after stenting. New England Journal of Medicine, 344(4), 250-256. https://doi.org/10.1056/NEJM200101253440402

Localized intracoronary gamma-radiation therapy to inhibit the recurrence of restenosis after stenting. / Leon, Martin B.; Teirstein, Paul S.; Moses, Jeffrey W.; Tripuraneni, Prabhakar; Lansky, Alexandra J.; Jani, Shirish; Wong, S. Chiu; Fish, David; Ellis, Stephen; Holmes, David; Kerieakes, Dean; Kuntz, Richard E.

In: New England Journal of Medicine, Vol. 344, No. 4, 25.01.2001, p. 250-256.

Research output: Contribution to journalArticle

Leon, MB, Teirstein, PS, Moses, JW, Tripuraneni, P, Lansky, AJ, Jani, S, Wong, SC, Fish, D, Ellis, S, Holmes, D, Kerieakes, D & Kuntz, RE 2001, 'Localized intracoronary gamma-radiation therapy to inhibit the recurrence of restenosis after stenting', New England Journal of Medicine, vol. 344, no. 4, pp. 250-256. https://doi.org/10.1056/NEJM200101253440402
Leon, Martin B. ; Teirstein, Paul S. ; Moses, Jeffrey W. ; Tripuraneni, Prabhakar ; Lansky, Alexandra J. ; Jani, Shirish ; Wong, S. Chiu ; Fish, David ; Ellis, Stephen ; Holmes, David ; Kerieakes, Dean ; Kuntz, Richard E. / Localized intracoronary gamma-radiation therapy to inhibit the recurrence of restenosis after stenting. In: New England Journal of Medicine. 2001 ; Vol. 344, No. 4. pp. 250-256.
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abstract = "Background: Although the frequency of restenosis after coronary angioplasty is reduced by stenting, when restenosis develops within a stent, the risk of subsequent restenosis is greater than 50 percent. We report on a multicenter, double-blind, randomized trial of intracoronary radiation therapy for the treatment of in-stent restenosis. Methods: Of 252 eligible patients in whom in-stent restenosis had developed, 131 were randomly assigned to receive an indwelling intracoronary ribbon containing a sealed source of iridium-192, and 121 were assigned to receive a similar-appearing nonradioactive ribbon (placebo). Results: The primary end point, a composite of death, myocardial infarction, and the need for repeated revascularization of the target lesion during nine months of follow-up, occurred in 53 patients assigned to placebo (43.8 percent) and 37 patients assigned to iridium-192 (28.2 percent, P=0.02). However, the reduction in the incidence of major adverse cardiac events was determined solely by a diminished need for revascularization of the target lesion, not by reductions in the incidence of death or myocardial infarction. Late thrombosis occurred in 5.3 percent of the iridium-192 group, as compared with 0.8 percent of the placebo group (P=0.07), resulting in more late myocardial infarctions in the iridium-192 group (9.9 percent vs. 4.1 percent, P=0.09). Late thrombosis occurred in irradiated patients only after the discontinuation of oral anti-platelet therapy (with ticlopidine or clopidogrel) and only in patients who had received new stents at the time of radiation treatment. Conclusions: Intracoronary irradiation with iridium-192 resulted in lower rates of clinical and angiographic restenosis, although it was also associated with a higher rate of late thrombosis, resulting in an increased risk of myocardial infarction. If the problem of late thrombosis within the stent can be overcome, intracoronary irradiation with iridium-192 may become a useful approach to the treatment of in-stent restenosis.",
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AU - Leon, Martin B.

AU - Teirstein, Paul S.

AU - Moses, Jeffrey W.

AU - Tripuraneni, Prabhakar

AU - Lansky, Alexandra J.

AU - Jani, Shirish

AU - Wong, S. Chiu

AU - Fish, David

AU - Ellis, Stephen

AU - Holmes, David

AU - Kerieakes, Dean

AU - Kuntz, Richard E.

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Y1 - 2001/1/25

N2 - Background: Although the frequency of restenosis after coronary angioplasty is reduced by stenting, when restenosis develops within a stent, the risk of subsequent restenosis is greater than 50 percent. We report on a multicenter, double-blind, randomized trial of intracoronary radiation therapy for the treatment of in-stent restenosis. Methods: Of 252 eligible patients in whom in-stent restenosis had developed, 131 were randomly assigned to receive an indwelling intracoronary ribbon containing a sealed source of iridium-192, and 121 were assigned to receive a similar-appearing nonradioactive ribbon (placebo). Results: The primary end point, a composite of death, myocardial infarction, and the need for repeated revascularization of the target lesion during nine months of follow-up, occurred in 53 patients assigned to placebo (43.8 percent) and 37 patients assigned to iridium-192 (28.2 percent, P=0.02). However, the reduction in the incidence of major adverse cardiac events was determined solely by a diminished need for revascularization of the target lesion, not by reductions in the incidence of death or myocardial infarction. Late thrombosis occurred in 5.3 percent of the iridium-192 group, as compared with 0.8 percent of the placebo group (P=0.07), resulting in more late myocardial infarctions in the iridium-192 group (9.9 percent vs. 4.1 percent, P=0.09). Late thrombosis occurred in irradiated patients only after the discontinuation of oral anti-platelet therapy (with ticlopidine or clopidogrel) and only in patients who had received new stents at the time of radiation treatment. Conclusions: Intracoronary irradiation with iridium-192 resulted in lower rates of clinical and angiographic restenosis, although it was also associated with a higher rate of late thrombosis, resulting in an increased risk of myocardial infarction. If the problem of late thrombosis within the stent can be overcome, intracoronary irradiation with iridium-192 may become a useful approach to the treatment of in-stent restenosis.

AB - Background: Although the frequency of restenosis after coronary angioplasty is reduced by stenting, when restenosis develops within a stent, the risk of subsequent restenosis is greater than 50 percent. We report on a multicenter, double-blind, randomized trial of intracoronary radiation therapy for the treatment of in-stent restenosis. Methods: Of 252 eligible patients in whom in-stent restenosis had developed, 131 were randomly assigned to receive an indwelling intracoronary ribbon containing a sealed source of iridium-192, and 121 were assigned to receive a similar-appearing nonradioactive ribbon (placebo). Results: The primary end point, a composite of death, myocardial infarction, and the need for repeated revascularization of the target lesion during nine months of follow-up, occurred in 53 patients assigned to placebo (43.8 percent) and 37 patients assigned to iridium-192 (28.2 percent, P=0.02). However, the reduction in the incidence of major adverse cardiac events was determined solely by a diminished need for revascularization of the target lesion, not by reductions in the incidence of death or myocardial infarction. Late thrombosis occurred in 5.3 percent of the iridium-192 group, as compared with 0.8 percent of the placebo group (P=0.07), resulting in more late myocardial infarctions in the iridium-192 group (9.9 percent vs. 4.1 percent, P=0.09). Late thrombosis occurred in irradiated patients only after the discontinuation of oral anti-platelet therapy (with ticlopidine or clopidogrel) and only in patients who had received new stents at the time of radiation treatment. Conclusions: Intracoronary irradiation with iridium-192 resulted in lower rates of clinical and angiographic restenosis, although it was also associated with a higher rate of late thrombosis, resulting in an increased risk of myocardial infarction. If the problem of late thrombosis within the stent can be overcome, intracoronary irradiation with iridium-192 may become a useful approach to the treatment of in-stent restenosis.

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