TY - JOUR
T1 - A multicenter, randomized, dose-finding study of gamma intracoronary radiation therapy to inhibit recurrent restenosis after stenting
AU - Price, Matthew J.
AU - Moses, Jeffrey W.
AU - Leon, Martin B.
AU - Mehran, Roxana
AU - Negoita, Manuela
AU - Lansky, Alexandra
AU - Collins, Michael
AU - Giap, Huan
AU - Lin, Ray
AU - Jani, Shirish
AU - Steuterman, Stephen
AU - Balter, Stephen
AU - Dalton, Jack
AU - Lipsztein, Roberto
AU - Tripuraneni, Prabhakar
AU - Teirstein, Paul S.
PY - 2006/4
Y1 - 2006/4
N2 - OBJECTIVES: The objective of this double-blind, randomized study was to determine the safety and efficacy of intracoronary radiation therapy (ICRT) with a dose of 17 Gray (Gy) compared to the currently recommended dose prescription of 14 Gy for the treatment of in-stent restenosis within bare metal stents. BACKGROUND: While gamma ICRT for in-stent restenosis has been proven efficacious, the optimal dose is unknown, and radiation failure due to recurrent neointimal hyperplasia remains a significant clinical problem for some patients. A higher radiation dose may improve outcomes, but may potentially increase adverse events. METHODS: Following coronary intervention, 336 patients with in-stent restenosis were randomly assigned to receive ICRT with either 14 Gy or 17 Gy at 2 mm from an 192-iridium source. RESULTS: At 8-month follow up, fewer patients in the 17 Gy group underwent target lesion revascularization (TLR ≤ 15.2% versus 27.2%; p ≤ 0.01), target vessel revascularization (21.3% versus 33.1%; p ≤ 0.02), or reached the composite endpoint of death, myocardial infarction, thrombosis, or TLR (17.1% versus 28.4%; p ≤ 0.02). There were no differences in late thrombosis or mortality between treatment groups. There was a strong trend toward reduced in-lesion late loss (0.36 ± 0.63 mm vs. 0.51 ± 0.64 mm; p ≤ 0.09) and a significantly lower rate of binary restenosis (23.9% versus 38.1%; p ≤ 0.031) in the high dose group. CONCLUSIONS: Gamma ICRT with 17 Gy is safe and, compared to 14 Gy, reduces recurrent stenosis and clinical events at 8-month follow up. An increase in the currently recommended gamma radiation dose prescription from 14 Gy to 17 Gy should be strongly considered.
AB - OBJECTIVES: The objective of this double-blind, randomized study was to determine the safety and efficacy of intracoronary radiation therapy (ICRT) with a dose of 17 Gray (Gy) compared to the currently recommended dose prescription of 14 Gy for the treatment of in-stent restenosis within bare metal stents. BACKGROUND: While gamma ICRT for in-stent restenosis has been proven efficacious, the optimal dose is unknown, and radiation failure due to recurrent neointimal hyperplasia remains a significant clinical problem for some patients. A higher radiation dose may improve outcomes, but may potentially increase adverse events. METHODS: Following coronary intervention, 336 patients with in-stent restenosis were randomly assigned to receive ICRT with either 14 Gy or 17 Gy at 2 mm from an 192-iridium source. RESULTS: At 8-month follow up, fewer patients in the 17 Gy group underwent target lesion revascularization (TLR ≤ 15.2% versus 27.2%; p ≤ 0.01), target vessel revascularization (21.3% versus 33.1%; p ≤ 0.02), or reached the composite endpoint of death, myocardial infarction, thrombosis, or TLR (17.1% versus 28.4%; p ≤ 0.02). There were no differences in late thrombosis or mortality between treatment groups. There was a strong trend toward reduced in-lesion late loss (0.36 ± 0.63 mm vs. 0.51 ± 0.64 mm; p ≤ 0.09) and a significantly lower rate of binary restenosis (23.9% versus 38.1%; p ≤ 0.031) in the high dose group. CONCLUSIONS: Gamma ICRT with 17 Gy is safe and, compared to 14 Gy, reduces recurrent stenosis and clinical events at 8-month follow up. An increase in the currently recommended gamma radiation dose prescription from 14 Gy to 17 Gy should be strongly considered.
UR - http://www.scopus.com/inward/record.url?scp=33745077726&partnerID=8YFLogxK
M3 - Article
C2 - 16732060
AN - SCOPUS:33745077726
SN - 1042-3931
VL - 18
SP - 169
EP - 173
JO - Journal of Invasive Cardiology
JF - Journal of Invasive Cardiology
IS - 4
ER -