Three-year follow-up after intracoronary beta-radiation therapy for in-stent restenosis.
BACKGROUND
Most studies that proved intracoronary radiation therapy (IRT) to be highly effective to reduce recurrent restenosis after treatment of in-stent restenosis (ISR) have looked at time periods up to 12 months. Whether the beneficial effect from radiation is sustained during long-term follow-up remains a concern. This study sought to evaluate the effectiveness of IRT using a beta-emitter during a 3-year follow-up period.


METHODS
One hundred twenty-eight consecutive symptomatic patients (mean age, 63 +/- 11 years) with 134 in-stent restenotic lesions were treated for ISR with IRT (noncentred beta-emitter, Novoste; radiation dosis 21.1 +/- 3.1 Gy). Six-month angiographic follow-up was obtained in 104 patients (81%) with 105 lesions (78%). All patients underwent 36-month clinical follow-up.


RESULTS
Six-month angiographic restenosis rate was 22% in stent (29% in lesion) with an in-stent late loss of 0.49 +/- 0.62 mm. Target lesion resvascularization (TLR) at 6-month follow-up was performed in 23 cases (18%). MACE (death, myocardial infarction, and target vessel revascularisation) was observed in 24 patients (19%). At 36-month follow-up, TLR increased to 36 cases (28%) and MACE was observed in 47 patients (37%). In a multivariate analysis, minimal lumen diameter before treatment of ISR using IRT was the only predictor of recurrent TLR at 36 months (OR = 0.131; 95% CI, 0.068-0.254; p = 0.002). In a subgroup of patients (N = 15) without restenosis at 6-month angiography but with clinically driven recurrent late angiography (mean, 18 +/- 7 months); in-lesion late loss increased from 0.47 +/- 0.54 mm at 6 months to 1.27 +/- 0.76 mm at repeated angiography (p = 0.005).


CONCLUSIONS
There is a considerable number of delayed recurrent restenosis post IRT for ISR. This is due to ongoing late loss more than 6-month post IRT. The minimal lumen diameter before IRT predicts the need for recurrent TLR at 36 months.
Medical Clinic I, University RWTH Aachen, Aachen, Germany.
Ekaterina
E
Iofina
Peter
P
Radke
Daniela
D
Schubert
Roswitha
R
Langenberg
Rüdiger
R
Blindt
Peter
P
Hanrath
Rainer
R
Hoffmann
D000368:Aged; D001610:Beta Particles / Q000627:therapeutic use; D001918:Brachytherapy; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000000981:diagnostic imaging / Q000209:etiology* / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011859:Radiography; D012008:Recurrence; D012086:Reoperation; D015607:Stents / Q000009:adverse effects*; D013997:Time Factors; D016896:Treatment Outcome