Stenting of Coronary Arteries in Non Stress/Benestent Disease Trial - SCANDSTENT
The goal of the study was to evaluate treatment with sirolimus-eluting stents (SES) compared with bare metal stents (BMS) in patients with complex lesions.
Use of SES in patients with complex lesions will be associated with improvements in clinical and angiographic outcomes compared with BMS.
Patients Enrolled: 322
Mean Follow Up: 12 months
Mean Patient Age: Mean age 63 years
Stable angina, unstable angina, or non-ST elevation MI with presence of a complex lesion
MI within three days, gastrointestinal bleed within one month, renal insufficiency, unprotected left main disease, lesions with visible thrombus, or heavy calcification impeding stent implantation
Minimum lumen diameter and angiographic restenosis (>50%) at six-month angiography
Percent diameter stenosis, late lumen loss, and MACE at 6 and 12 months
Patients with complex lesions (occluded, bifurcational, ostial, or angulated) were randomized to receive either SES (n=163) or BMS (n=159). Patients underwent follow-up angiography at six months.
Baseline clinical and angiographic characteristics were similar between the two treatment groups. Patients met the criteria for complex lesions by having occlusions (36%), bifurcation lesions (33%), ostial lesions (23%), or angulated lesions (8%).
There were no differences by treatment group in the clinical endpoints of death (0.6% each), myocardial infarction (MI) (0.6% for SES vs. 3.2% for BMS), or stent thrombosis (0.6% vs. 3.1%). Target lesion revascularization (TLR) was significantly lower in the SES group (2.4% vs. 29.6%, p<0.001). As a result of the TLR reduction, overall major adverse cardiac events (MACE) was lower in the SES group (3.1% vs. 30.2%, p<0.001).
On six-month angiographic follow-up, minimum lumen diameter was larger in the SES group than the BMS group (2.48 mm vs. 1.63 mm, p<0.0001), as was late lumen loss (0.04 mm vs. 0.94 mm, p<0.0001). Both percent diameter stenosis (19.3% vs. 43.8%, p<0.0001) and binary restenosis (2.0% vs. 31.9%, p<0.0001) were lower in the SES group compared with the BMS group.
Among patients with complex lesions, use of SES was associated with a reduction in TLR and improvements in diameter stenosis at six-month follow-up compared with BMS.
Prior studies such as SIRIUS have shown a similar benefit with SES over BMS in patients with simple de novo lesions. Additionally, a prior study by Colombo, et al. reported a benefit in bifurcation lesions. Finally, the TAXUS V trial recently demonstrated a reduction in target vessel revascularization with paclitaxel-eluting stents for a variety of complex coronary lesions. As with other drug-eluting stent trials, improvements were seen in TLR and stenosis, but no difference was observed in other clinical events.
Kelbaek H, Thuesen L, Helqvist S, et al. The Stenting Coronary Arteries in Non-stress/benestent Disease (SCANDSTENT) trial. J Am Coll Cardiol. 2006 Jan 17;47(2):449-55.
Presented by Dr. Henning Kelbaek at the March 2005 ACC Annual Scientific Session, Orlando, FL.
Keywords: Myocardial Infarction, Follow-Up Studies, Angina, Stable, Drug-Eluting Stents, Coronary Disease, Sirolimus, Constriction, Pathologic, Stents, Paclitaxel, Metals, Thrombosis
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