Sirolimus-Eluting Stent vs. Brachytherapy in Patients With Bare Metal In-Stent Restenosis - SISR

Description:

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.

Study Design

Study Design:

Patients Enrolled: 384
Mean Follow Up: Nine months
Mean Patient Age: Mean age 63 years
Female: 33

Patient Populations:

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%

Exclusions:

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

Primary Endpoints:

Target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization at nine months post-procedure

Drug/Procedures Used:

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.

Principal Findings:

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.

Interpretation:

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.

References:

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.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Interventions and Coronary Artery Disease

Keywords: Coronary Artery Disease, Follow-Up Studies, Thrombosis, Drug-Eluting Stents, Constriction, Pathologic, Sirolimus, Angioplasty, Brachytherapy, Percutaneous Coronary Intervention


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