Intracoronary beta brachytherapy as a treatment option for high-risk refractory in-stent restenosis; Compassionate use.
BACKGROUND
Vascular (VBT) has clearly been shown in multiple clinical trials to decrease restenosis rates for in-stent restenosis (ISR). However, patients enrolled in these randomized clinical trials represent a select group, and the efficacy of VBT in patients with ISR who were excluded from these controlled trials due to more complex coronary anatomy requires further investigation. This study sought to define the angiographic and clinical profile and outcomes of these high-risk patients with ISR who were excluded from the randomized clinical trials and who received VBTusing Strontium-90 (Sr-90) using the Novoste Beta-Cath System through a Compassionate Use Protocol (CUP).


METHODS
The study was designed as a single center, prospective, open label registry trial evaluating the use of VBT on complex instent restenotic lesions in patients who were excluded from the START and START 40 trials. In general, these patients included those with saphenous vein graft (SVG) lesions, long lesions (>35 mm), and patients with a history of more than three prior interventions. VBT using Sr-90 was delivered using the Novoste Beta-Cath System after successful angioplasty. The predetermined primary endpoint was freedom from target vessel revascularization (TVR) at 8 months, one and two years. The secondary endpoint was a composite of death, myocardial infarction (MI) and TVR at 8 months, one year, and two years.


RESULTS
Between September 4, 1998 and December 6, 2000, 32 patients were treated with VBT under the UCP protocol. The mean duration of follow up was 15.3 +/- 8.3 months. There were 9 major cardiac events at eight months including one death, one acute myocardial infarction and 7 TVR. Excluding the one patient who died, 33 lesions were available for follow-up. The rate of TVR in this high-risk patient population was 21.1% (n = 7/33 lesions). The method of revascularization included one bypass surgery and 6 repeat percutaneous coronary interventions.


CONCLUSIONS
This trial demonstrates that utilization of the Beta-Cath System using Sr-90 for the treatment of ISR in a patient population excluded from the randomized clinical trials due to unfavorable lesions characteristics is feasible appears to be associated TVR rates that compare favorably with the event rates of patients enrolled in other trials enrolling lower-risk groups.
Rush University Medical Center, Rush Heart Institute, and Rush Medical College, Chicago, IL, USA.
Susie
S
Kim
Francis Q
FQ
Almeda
Meechai
M
Tessalee
R Jeffrey
RJ
Snell
Sandeep
S
Nathan
Stephen
S
Thew
Cam
C
Nguyen
James C H
JC
Chu
Gary L
GL
Schaer
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000379:methods; D001918:Brachytherapy / Q000379:methods*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000532:radiotherapy*; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011859:Radiography; D015642:Radiology, Interventional; D018570:Risk Assessment; D012720:Severity of Illness Index; D016037:Single-Blind Method; D015607:Stents / Q000009:adverse effects*; D015996:Survival Rate; D016896:Treatment Outcome