Feasibility and safety of intra‐coronary Beta irradiation with144Ce/Pr for prevention of restenosis after percutaneous transluminal coronary angioplasty of in‐stent restenotic lesions

Abstract

Endovascular brachytherapy is a proven and efficacious treatment of coronary in-stent restenosis with established long-term benefit. Owing to its complexity and logistic inconveniences, brachytherapy did not find wide acceptance, especially in the current drug-eluting stents era. We conducted a single center, non-randomized pilot trial with 144Ce/Pr, utilizing a new high-energy Beta emitting source, for prevention of restenosis after percutaneous treatment of in-stent restenotic lesions. Thirty consecutive patients presenting in-stent restenosis were enrolled in the study. After conventional balloon angioplasty, 144Ce/Pr was applied to the dilated coronary segment at a dose of 21Gy. Technical feasibility, safety and efficacy of 144Ce/Pr at 9 months clinical and angiographic follow-up were tested. Thirty-seven arterial segments were irradiated with 100% technical success and no in-hospital major adverse cardiac events (MACE). Five MACE were observed (13.5% of the treated segments) during 9 months follow-up, including four target lesion revascularizations and one episode of acute coronary syndrome secondary to sudden late thrombotic occlusion of the irradiated segment. The study confirmed the safety and the feasibility of the intra-coronary Beta irradiation utilizing the 144Ce/Pr source. It also shows some practical advantages compared to traditional Gamma or other Beta sources. Considering the high-risk restenosis profile of the selected patients (i.e. diffuse in-stent restenosis, bifurcation lesions, small vessels) these results are encouraging in terms of restenosis prevention. Late acute thrombosis remains a problem requiring further improvement.