Stenting of Coronary Arteries in Non Stress/Benestent Disease Trial - SCANDSTENT

Description:

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.

Hypothesis:

Use of SES in patients with complex lesions will be associated with improvements in clinical and angiographic outcomes compared with BMS.

Study Design

Patients Enrolled: 322
Mean Follow Up: 12 months
Mean Patient Age: Mean age 63 years
Female: 23

Patient Populations:

Stable angina, unstable angina, or non-ST elevation MI with presence of a complex lesion

Exclusions:

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

Primary Endpoints:

Minimum lumen diameter and angiographic restenosis (>50%) at six-month angiography

Secondary Endpoints:

Percent diameter stenosis, late lumen loss, and MACE at 6 and 12 months

Drug/Procedures Used:

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.

Principal Findings:

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.

Interpretation:

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.

References:

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.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Chronic Angina

Keywords: Myocardial Infarction, Follow-Up Studies, Angina, Stable, Drug-Eluting Stents, Coronary Disease, Sirolimus, Constriction, Pathologic, Stents, Paclitaxel, Metals, Thrombosis


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