Intracoronary Beta Irradiation to Reduce Restenosis After Balloon Angioplasty - GENEVA

May 16, 2002
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Date Presented:
01/01/1997
Date Published:
01/01/1997
Date Updated:
05/16/2002
Original Posted Date:
05/16/2002
References

Description:

Safety and feasibility trial of beta-radiation brachytherapy to treat coronary restenosis

Hypothesis:

Beta-radiation can be safely and effectively delivered to native coronary arteries to treat restenotic lesions.

Study Design

Study Design:

Patients Enrolled: 15
Mean Follow Up: 6 months
Mean Patient Age: 71 +/- 5 years
Female: 40

Patient Populations:

Patients >64 years old Target lesion >50% diameter stenosis by QCA Target lesion <20 mm long Target vessel diameter >2.5 mm

Exclusions:

(1) contraindication to bypass surgery if needed (2) anticipated difficulties with long-term follow-up, (3) extreme tortuosity of the coronary artery proximal to the target lesion. (4) failed PTCA (5) failed intra-arterial centering balloon positioning(6) failed dummy wire insertion or retrieval

Primary Endpoints:

Successful technical completion of the procedure MACE at 6 months

Secondary Endpoints:

Restenosis rates at 6 months

Drug/Procedures Used:

PTCA to treat restenotic lesions Y-90 metallic source delivered through a centering catheter to deliver 18 Gray to the endothelial surface

Principal Findings:

The beta-radiation procedure was completed successfully in all 15 cases. During the follow-up period of 178±17 days (range, 150 to 225 days), no complication occurred that could be attributed to radiation therapy. No aneurysm or angiographically detectable thrombus was observed in any of the irradiated arterial segments. The clinical event rate (4 of 15 patients underwent further target lesion revascularization) and the angiographic follow-up (6 of 15 patients had a >50%-diameter stenosis at the previously treated site) did not suggest a marked impact on the expected restenosis rate.

Interpretation:

This early experience demonstrated that beta-radiation brachytherapy using this approach is feasible, and no side effects attributable to radiation were noted during a 6-month period of follow-up. The impact of beta-radiation brachytherapy on restenosis rates was demonstrated in later studies.

References:

Circulation. 1997;95:1138-1144.

Keywords: Coronary Restenosis, Thrombosis, Constriction, Pathologic, Coronary Vessels, Angioplasty, Balloon, Coronary, Brachytherapy, Stents


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