Sirolimus-Eluting Stent vs. Brachytherapy in Patients With Bare Metal In-Stent Restenosis - SISR
The goal of the study was to evaluate intravascular brachytherapy compared with percutaneous coronary intervention (PCI) with a sirolimus-eluting stent for the treatment of in-stent restenosis (ISR) in native coronary lesions.
Patients Enrolled: 384
Mean Follow Up: Nine months
Mean Patient Age: Mean age 63 years
In-stent restenosis >50% (by visual estimation) within a native coronary artery (>2.75-3.5 mm in diameter and >15-40 mm in length) that can be treated with a maximum of three 18 mm stents without additional lesions in the same vessel that require immediate treatment; coronary ischemia attributable to the target stenosis; initial stent placed >4 weeks prior; and ejection fraction >40%
Definite or possible thrombus present in target lesion; Q-wave or non-Q-wave myocardial infarction; impaired renal function (serum creatinine >2.0 mg/dl); unstable angina or peri-infarction angina; perforation of the target vessel; totally occluded vessel (TIMI 0 level); prior stent within 5 mm of target lesion; total occlusion of the restenosed stent; ostial target lesion; and significant (>50%) in-stent restenoses proximal or distal to the target lesion that might require revascularization or impede runoff
Target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization at nine months post-procedure
Patients with in-stent restenosis were randomized in a 2:1 manner to treatment with PCI with sirolimus-eluting stents (n=259) or brachytherapy (n=125). Patients underwent angiographic follow-up at six months. A subset of patients also underwent angiographic follow-up.
Mean lesion length was 17 mm. Device success was similar in both groups (96.5% in the sirolimus-eluting stent group and 96.8% in the brachytherapy group), as was procedure success (97.3% and 99.2%, respectively). Binary angiographic stenosis at six months was nonsignificantly lower in the sirolimus-eluting stent group (19.8% vs. 29.5%, p=0.067). Late lumen loss did not differ by treatment group in the analysis segment (0.27 mm vs. 0.33 mm, p=0.330), but was smaller in the sirolimus-eluting stent group in the distal segment (0.04 mm vs. 0.21 mm, p<0.001).
The primary endpoint of target vessel failure at nine months occurred less often in the sirolimus-eluting stent group (12.4% vs. 21.6%, p=0.023). Likewise, there were fewer target lesion revascularizations (8.5% vs. 19.2%, p=0.004) and target vessel revascularizations (10.8% vs. 21.6%, p=0.008). There were two cases of stent thrombosis in the sirolimus-eluting stent group (0.8%), and none in the brachytherapy group.
Among patients with in-stent restenosis in a native coronary lesion, treatment with sirolimus-eluting stents was associated with a reduction in target vessel failure at nine months compared with treatment with intravascular brachytherapy.
Intravascular brachytherapy is the only currently approved treatment for in-stent restenosis. However, brachytherapy is complex to perform and is only done at a limited number of sites. While not approved, drug-eluting stents have been used for the treatment of ISR and have been shown to be superior to ballon angioplasty for treatment of ISR in the ISAR-DESIRE trial. The present study is the first randomized trial of brachytherapy compared with sirolimus-eluting stents for ISR treatment.
Holmes DR, et al. Sirolimus-Eluting Stents vs Vascular Brachytherapy for In-Stent Restenosis Within Bare-Metal Stents The SISR Randomized Trial. JAMA. 2006;295:1264-1273.
Presented by Dr. David R. Holmes, Jr. at TCT 2005, Washington, DC.
Keywords: Coronary Artery Disease, Follow-Up Studies, Thrombosis, Drug-Eluting Stents, Constriction, Pathologic, Sirolimus, Angioplasty, Brachytherapy, Percutaneous Coronary Intervention
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