High-dose intracoronary irradiation after de novo stent implantation results of the EVEREST (Evaluation of Endoluminal Radiation in Elective Stenting) trial

• Published in: Strahlentherapie und Onkologie 2006-01, Vol.182 (1), p.9-15
• Main Authors: Geiger, Matthias H, Ludwig, Josef, Burckhard, Rainer, Scheinert, Dierk, Müller, Reinhold G, Daniel, Werner G, Sauer, Rolf, Strnad, Vratislav
• Format: Article
• Language: English
• Subjects: Aged; Angioplasty, Balloon, Coronary; Brachytherapy; Coronary Angiography; Coronary Restenosis - etiology; Coronary Restenosis - prevention & control; Coronary Vessels - radiation effects; Feasibility Studies; Female; Follow-Up Studies; Humans; Male; Middle Aged; Radiotherapy Dosage; Stents; Time Factors; Ultrasonography, Interventional
• ISSN: 0179-7158; 1439-099X
• DOI: 10.1007/s00066-006-1434-y

This randomized study was designed to compare the efficacy of high-dose coronary beta-radiation after intravascular ultrasound-(IVUS-)guided direct stenting with sham treatment in patients with de novo lesions. 32 patients were enrolled in the study protocol. Following angioplasty procedure, intracoronary brachytherapy was performed with the Novoste Beta-Cath System. The prescribed dose was 24 Gy referred to the lamina elastica externa. Quantitative coronary angiography and IVUS were performed to analyze the treated coronary vessel. Angiographic results revealed a significantly smaller minimal lumen diameter compared with the pos-tprocedural minimal lumen diameter within the stented segment (p = 0.004) in the nonirradiated group. The same significant result was observed in the injured segment of the nonirradiated patients (p = 0.011). The IVUS data revealed a significant increase of the plaque volume after 8 months in the nonirradiated group compared to the post-procedural value (irradiated 5.41 +/- 8.83 mm(3) vs. nonirradiated 21.11 +/- 16.08 mm(3); p = 0.001). Late luminal loss was significantly greater in the nonirradiated group (p = 0.004). The primary clinical endpoint (death, myocardial infarction, repeat target lesion revascularization, percutaneous revascularization, coronary artery bypass surgery) was reached by seven irradiated (33.3%) and four (18.2%) nonirradiated patients (p = 0.623). Late stent thrombosis was observed in one irradiated patient. The EVEREST trial has demonstrated the feasibility of high-dose intracoronary brachytherapy in de novo coronary lesions. There is a significant reduction of neointimal proliferation within the stented segment. Nevertheless, this benefit is vitiated by an increase of restenotic lesions outside the stent segment.