Feasibility and safety of intra-coronary Beta irradiation with 144Ce/Pr for prevention of restenosis after percutaneous transluminal coronary angioplasty of in-stent restenotic lesions

Abstract

Background: 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.

Methods and results: 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.

Conclusions: 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.