Long-term clinical outcomes of dissections after intracoronary beta-radiation with rhenium-188-diethylene triamine penta-acetic acid-filled balloon system.

BACKGROUND

Intracoronary radiation with a rhenium-188 ((188)Re)-filled balloon is safe and efficiently reduces restenosis, but there is a potential risk of a (188)Re-filled balloon induced dissection. Little is known about the effect of radiation on dissection resolution and the late clinical outcome of dissection after brachytherapy.

METHODS

After successful catheter-based treatments of de novo or restenotic lesion, 256 patients were randomly assigned to the radiation or control group. The (188)Re-filled balloon system was designed to deliver 17.6 Gy in 1.0-mm tissue depth.

RESULTS

Dissections were identified in 15 patients among the 138 patients of the radiation group (10.9%). Additional stents were deployed in 10 patients to cover the flow-limiting dissection. Binary restenosis rate (53.3% vs. 16.3%, p=0.001) and target vessel revascularization (TVR) rate (53.3% vs. 11.1%, p<0.001) were significantly higher in patients with the dissection at 9 months. Geographic miss (GM) was identified in 4 of the 10 patients who underwent additional stenting. Binary restenosis rate in the GM group (100%; 4 of 4 patients) was significantly higher than the non-GM group (33.3%; 2 of 6 patients, p=0.02). Long-term follow-up of the patients with dissections who had not undergone TVR (n=7, mean follow-up duration: 640.7+/-387.3 days) has demonstrated persistent unhealed dissections.

CONCLUSIONS

Intracoronary radiation impairs the healing process after vessel injury and residual dissection after brachytherapy leads to adverse clinical outcomes, which was mainly due to GM in case of stent implantation.