Abstract 3137: Long-term Outcomes Following Sirolimus-Eluting Stent Implantation for Off Label Indications
Introduction: Only limited long term data exist following SES implantation and these primarily come from the randomized trials which enrolled highly selected patients. Due to the risk of stent thrombosis long term safety concerns exist particularly following off label SES implantation.
Hypothesis: Off label implantation of SES has a favorable long term safety profile.
Methods: All consecutive patients successfully treated with SES prior to March 2003 were considered for analysis. The endpoints analyzed were MACE, death, myocardial infarction (MI), target vessel revascularization (TVR) and target lesion revascularization (TLR) and late stent thrombosis. We considered the following as off-label indications: ostial lesions, chronic total occlusions, bifurcations, left main stem lesions, saphenous vein grafts, internal mammary artery, ejection fraction < 30 %, restenotic lesions.
Results: Our cohort comprised 445 patients with 954 lesions. At least one off label indication was present in 322 (72%) of patients and 161 (36.2%) had more than 1 off label indication (Table⇓). Median clinical follow-up was 4.4 years and 78% of patients had at least 4 years of follow-up. There was a trend towards a higher MACE rate in the off-label group due in the main to a significantly higher repeat revascularization rate. There were no differences in the incidence of death or myocardial infarction. The overall rate of late thrombosis was similar to that seen in the literature (1–2%) and while there was a slightly higher number in the off-label group this did not reach statistical significance.
Conclusions: In our experience off label implantation of SES is associated with higher MACE rates due to the increased need for repeat revascularization. This can be explained by the complexity of this cohort with a large number of lesion types not included in randomized trials. Of note long term safety is acceptable with no difference in death or MI when compared to on-label indications.