Background: Intracoronary radiotherapy with beta- and gamma-emitters has been shown to reduce the risk of restenosis after balloon angioplasty and after coronary stenting. The present study addresses the question whether intracoronary radiotherapy using the (188)rhenium liquid-filled PTCA balloon system is feasible, safe and effective in cases of in-stent restenosis. Acute and long-term angiographic results as well as clinical events within 1 year after the procedure were evaluated.
Methods and results: From September 1999 to April 2000, 41 patients (mean age 60+/-10 years, 33 male, 8 female) with symptomatic in-stent restenosis underwent repeat PTCA and immediate intracoronary brachytherapy. After successful repeat PTCA (residual stenosis less than 30% in diameter), a second standard PTCA catheter was inflated with liquid (188)rhenium in the redilated in-stent restenosis for 315-880, mean 540+/-155 s with low pressure (3 atm) in order to reach 30 Gy at 0.5 mm depth of the vessel wall. In all patients with successful reintervention, intracoronary radiotherapy was unproblematically performed; in 16 patients, 21 new stents were implanted during the procedure-either immediately before or after radiation therapy. During follow-up, four episodes of stent thrombosis with subsequent myocardial infarction occurred in three patients (8 days, 37 days, 5 months and 6 months after the procedure, respectively). This complication was seen exclusively in patients with newly implanted stents. One patient of the stent group died suddenly 46 days after the procedure. All 40 surviving patients underwent repeat angiography in cases of repeat angina or routinely 6 months after brachytherapy, respectively. In the redilated target vessels without new stenting, restenosis (stenosis >50% in diameter) or reocclusion was observed in only 5 of 25 (=20%) cases, but in the restented target lesions, in 10 of 15 (=67%). Event-free survival (death, myocardial infarction, TVR) at 1 year after repeat dilatation and subsequent brachytherapy was 80% for patients not newly stented, but only 44% for patients with new stents.
Conclusions: Intracoronary radiation therapy with the liquid-filled beta-emitting (188)rhenium balloon is a safe and effective therapy in cases of in-stent restenosis. The positive effect of irradiation, however, is abolished if a new stent is needed. In the not newly stented patients, 1-year follow-up is encouraging.