Angiographic and clinical outcome for the treatment of in-stent restenosis with sirolimus-eluting stent compared to vascular brachytherapy.
BACKGROUND
With the use of coronary stents for the treatment of coronary artery disease, in-stent restenosis became a major clinical problem. In this non-randomized study, we examined the use of stent-based delivery of sirolimus (rapamycin) for the treatment of in-stent restenosis in comparison to intracoronary beta-brachytherapy, regarding the clinical effectiveness and the angiographic results for the treatment of in-stent restenosis after 6-9 months.


RESULTS
Between July 2001 and May 2002, 28 patients (65+/-11 years) with instent restenosis were treated with intracoronary brachytherapy. Consecutively, between May 2002 and April 2003, 28 patients (65+/-10 years) with in-stent restenosis were treated with the implantation of a sirolimus-eluting stent (SES). Patients with in-stent restenosis treated by implantation of a SES had significantly lower incidence of in-stent restenosis (1/28 (3.6%) vs 10/28 (36%); p=0.007) and insegment restenosis (4/28 (14%) vs 14/28 (50%); p=0.013) compared to patients treated with brachytherapy. Target lesion and target vessel revascularization rate tended to be lower in the SES group (14 vs 25%) but did not yet reach statistical significance. One patient died in the group treated by implantation of a SES eight months after stenting, one patient suffered from myocardial infarction due to a subtotal in-stent restenosis after brachytherapy. Two patients after brachytherapy underwent surgical revascularization due to recurrent in-stent restenosis similar to the patient with in-stent restenosis after SES implantation.


CONCLUSIONS
In this study we show the feasibility and safety of the treatment of in-stent restenosis by implantation of sirolimus-eluting stents and demonstrate a lower incidence of recurrent in-stent restenosis as well as lower late luminal loss compared to treatment by intravascular brachytherapy.
Pohl
T
T
Department of Internal Medicine I, Grosshadern University Hospital, Munich, Germany.
Kupatt
C
C
Steinbeck
G
G
Boekstegers
P
P
D017677:Age Distribution; D000368:Aged; D001807:Blood Vessel Prosthesis / Q000706:statistics & numerical data*; D001918:Brachytherapy / Q000706:statistics & numerical data*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging* / Q000453:epidemiology / Q000628:therapy*; D018572:Disease-Free Survival; D005260:Female; D005858:Germany / Q000453:epidemiology; D006083:Graft Occlusion, Vascular / Q000000981:diagnostic imaging* / Q000453:epidemiology / Q000628:therapy*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D008297:Male; D011859:Radiography; D018570:Risk Assessment / Q000379:methods; D012307:Risk Factors; D017678:Sex Distribution; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents / Q000706:statistics & numerical data*; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D020123:Sirolimus