Intracoronary gamma-radiation therapy after angioplasty inhibits recurrence in patients with in-stent restenosis

Treatment of in-stent restenosis presents a critical limitation of intracoronary stent implantation. Ionizing radiation has been shown to decrease neointimal formation within stents in animal models and in initial clinical trials. We studied the effects of intracoronary gamma-radiation therapy versu...

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Veröffentlicht in:Circulation (New York, N.Y.) N.Y.), 2000-05, Vol.101 (18), p.2165-2171
Hauptverfasser: Waksman, R, White, R L, Chan, R C, Bass, B G, Geirlach, L, Mintz, G S, Satler, L F, Mehran, R, Serruys, P W, Lansky, A J, Fitzgerald, P, Bhargava, B, Kent, K M, Pichard, A D, Leon, M B
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container_end_page 2171
container_issue 18
container_start_page 2165
container_title Circulation (New York, N.Y.)
container_volume 101
creator Waksman, R
White, R L
Chan, R C
Bass, B G
Geirlach, L
Mintz, G S
Satler, L F
Mehran, R
Serruys, P W
Lansky, A J
Fitzgerald, P
Bhargava, B
Kent, K M
Pichard, A D
Leon, M B
description Treatment of in-stent restenosis presents a critical limitation of intracoronary stent implantation. Ionizing radiation has been shown to decrease neointimal formation within stents in animal models and in initial clinical trials. We studied the effects of intracoronary gamma-radiation therapy versus placebo on the clinical and angiographic outcomes of patients with in-stent restenosis. One hundred thirty patients with in-stent restenosis underwent successful coronary intervention and were then blindly randomized to receive either intracoronary gamma-radiation with (192)Ir (15 Gy) or placebo. Four independent core laboratories blinded to the treatment protocol analyzed the angiographic and intravascular ultrasound end points of restenosis. Procedural success and in-hospital and 30-day complications were similar among the groups. At 6 months, patients assigned to radiation therapy required less target lesion revascularization and target vessel revascularization (9 [13.8%] and 17 [26.2%], respectively) compared with patients assigned to placebo (41 [63.1%, P=0.0001] and 44 [67.7%, P=0.0001], respectively). Binary angiographic restenosis was lower in the irradiated group (19% versus 58% for placebo, P=0.001). Freedom from major cardiac events was lower in the radiation group (29.2% versus 67.7% for placebo, P
doi_str_mv 10.1161/01.CIR.101.18.2165
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Ionizing radiation has been shown to decrease neointimal formation within stents in animal models and in initial clinical trials. We studied the effects of intracoronary gamma-radiation therapy versus placebo on the clinical and angiographic outcomes of patients with in-stent restenosis. One hundred thirty patients with in-stent restenosis underwent successful coronary intervention and were then blindly randomized to receive either intracoronary gamma-radiation with (192)Ir (15 Gy) or placebo. Four independent core laboratories blinded to the treatment protocol analyzed the angiographic and intravascular ultrasound end points of restenosis. Procedural success and in-hospital and 30-day complications were similar among the groups. At 6 months, patients assigned to radiation therapy required less target lesion revascularization and target vessel revascularization (9 [13.8%] and 17 [26.2%], respectively) compared with patients assigned to placebo (41 [63.1%, P=0.0001] and 44 [67.7%, P=0.0001], respectively). Binary angiographic restenosis was lower in the irradiated group (19% versus 58% for placebo, P=0.001). Freedom from major cardiac events was lower in the radiation group (29.2% versus 67.7% for placebo, P&lt;0.001). Intracoronary gamma-radiation used as adjunct therapy for patients with in-stent restenosis significantly reduces both angiographic and clinical restenosis.</description><identifier>ISSN: 0009-7322</identifier><identifier>EISSN: 1524-4539</identifier><identifier>DOI: 10.1161/01.CIR.101.18.2165</identifier><identifier>PMID: 10801757</identifier><identifier>CODEN: CIRCAZ</identifier><language>eng</language><publisher>United States: American Heart Association, Inc</publisher><subject>Aged ; Angioplasty, Balloon ; Coronary Disease - physiopathology ; Coronary Disease - radiotherapy ; Coronary Disease - surgery ; Double-Blind Method ; Female ; Gamma Rays - therapeutic use ; Humans ; Male ; Middle Aged ; Recurrence ; Stents ; Treatment Outcome</subject><ispartof>Circulation (New York, N.Y.), 2000-05, Vol.101 (18), p.2165-2171</ispartof><rights>Copyright American Heart Association, Inc. 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subjects Aged
Angioplasty, Balloon
Coronary Disease - physiopathology
Coronary Disease - radiotherapy
Coronary Disease - surgery
Double-Blind Method
Female
Gamma Rays - therapeutic use
Humans
Male
Middle Aged
Recurrence
Stents
Treatment Outcome
title Intracoronary gamma-radiation therapy after angioplasty inhibits recurrence in patients with in-stent restenosis
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