Clinical and angiographical follow-up after implantation of a 6--12 microCi radioactive stent in patients with coronary artery disease.
OBJECTIVE
This study is the contribution by the Thoraxcenter, Rotterdam, to the European(32)P Dose Response Trial, a non-randomized multicentre trial to evaluate the safety and efficacy of the radioactive Isostent in patients with single coronary artery disease.


RESULTS
The radioactivity of the stent at implantation was 6--12 microCi. All patients received aspirin indefinitely and either ticlopidine or clopidogrel for 3 months. Quantitative coronary angiography measurements of both the stent area and the target lesion (stent area and up to 5 mm proximal and distal to the stent edges) were performed pre- and post-procedure and at the 5-month follow-up. Forty-two radioactive stents were implanted in 40 patients. Treated vessels were the left anterior descending coronary artery (n=20), right coronary artery (n=10) or left circumflex artery (n=10). Eight patients received additional non-radioactive stents. Lesion length measured 10+/-3 mm with a reference diameter of 3.07+/-0.69 mm. Minimal lumen diameter increased from 0.98+/-0.53 mm pre-procedure to 2.29+/-0.52 mm (target lesion) and 2.57+/-0.44 mm (stent area) post-procedure. There was one procedural non-Q wave myocardial infarction, due to transient thrombotic closure. Thirty-six patients returned for angiographical follow-up. Two patients had a total occlusion proximal to the radioactive stent. Of the patent vessels, none had in-stent restenosis. Edge restenosis was observed in 44%, occurring predominantly at the proximal edge. Target lesion revascularization was performed in 10 patients and target vessel revascularization in one patient. No additional clinical end-points occurred during follow-up. The minimal lumen diameter at follow-up averaged 1.66+/-0.71 mm (target lesion) and 2.12+/-0.72 (stent area); therefore late loss was 0.63+/-0.69 (target lesion) and 0.46+/-0.76 (stent area), resulting in a late loss index of 0.65+/-1.15 (target lesion) and 0.30+/-0.53 (stent area).


CONCLUSIONS
These results indicate that the use of radioactive stents is safe and feasible, however, the high incidence of edge restenosis makes this technique currently clinically non-applicable.
Wardeh
A J
AJ
Thoraxcenter Rotterdam, University Hospital Rotterdam, Dijkzigt, The Netherlands.
Knook
A H
AH
Kay
I P
IP
Sabaté
M
M
Coen
V L
VL
Foley
D P
DP
Hamburger
J N
JN
Levendag
P C
PC
van der Giessen
W J
WJ
Serruys
P W
PW
D000328:Adult; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D001918:Brachytherapy / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D017023:Coronary Angiography; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000209:etiology / Q000532:radiotherapy*; D010761:Phosphorus Radioisotopes / Q000009:adverse effects / Q000627:therapeutic use*; D011829:Radiation Dosage; D012008:Recurrence; D012307:Risk Factors; D012449:Safety; D012720:Severity of Illness Index; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome
D010761:Phosphorus Radioisotopes