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Sirolimus vs. Paclitaxel Drug-Eluting Stents for Long Lesions in the Left Anterior Descending Artery - Sirolimus vs. Paclitaxel Drug-Eluting Stents for Long Lesions in the Left Anterior Descending Artery
Description:
The goal of the trial was to evaluate the effect of sirolimus versus paclitaxel drug-eluting stents on neointimal hyperplasia using intravascular ultrasound (IVUS) among patients with complex lesions in the left anterior descending artery (LAD) undergoing percutaneous coronary intervention (PCI).
Study Design
Study Design:
Patients Screened: 759
Patients Enrolled: 100
Mean Follow Up: 9 months
Mean Patient Age: Mean age 63 years
Female: 18
Patient Populations:
Presence of an angiographically significant stenosis in the proximal and/or mid-portion of the LAD; lesion class B2 or C requiring a stent ≥16 mm in length; vessel reference diameter of 2.5-3.7 mm at lesion site; and consent to undergo follow-up angiography at 9 months
Exclusions:
ST-segment elevation acute MI; intolerance to aspirin or clopidogrel; severe comorbidity; or participation in another clinical study
Primary Endpoints:
Percent of mean neointimal hyperplasia area at follow-up
Secondary Endpoints:
1) Change in percent of mean persistent plaque area from baseline to follow-up; and 2) angiographic late loss at follow-up
Drug/Procedures Used:
Patients were randomized to PCI using sirolimus-eluting stents (SES; n = 50) or paclitaxel-eluting stents (PES; n = 50). Holter monitoring was performed at baseline, 3 months, and 12 months. IVUS and angiography were performed post-PCI and at 9 months.
Concomitant Medications:
Pre-PCI: aspirin 100 mg and clopidogrel 300 mg;
Post-PCI: aspirin 100 mg/day indefinitely, clopidogrel 75 mg/day for ≥6 months, and simvastatin 20 or 40 mg/day indefinitely
Principal Findings:
IVUS data at baseline and follow-up were available in 42 patients in the SES group and 43 patients in the PES group. Multivessel disease was present in 75% of patients, 31% had prior myocardial infarction (MI), and 25% had diabetes. Mean lesion length at baseline was 20.6 mm.
The primary endpoint of percent of mean neointimal hyperplasia area at follow-up was significantly lower with SES versus PES (7.4% vs. 15.4%; p < 0.001). There was no difference between groups in vessel, plaque, or lumen areas. The stent length free of neointimal hyperplasia was significantly shorter in the PES group (69.8% vs. 43.9%, p < 0.001).
Percent of mean persistent plaque area was significantly lower with SES (-4% vs. 0%; p = 0.01). Mean in-stent late loss on angiography was significantly lower with SES (0.16 mm vs. 0.32 mm; p = 0.003). Mean percent stenosis was 10.7% for SES and 16.8% for PES (p = 0.04). Major adverse cardiac events by 9 months did not differ between groups (4.8% for SES vs. 6.8% for PES, p = NS).
Interpretation:
Among patients with complex lesions in the LAD undergoing PCI, use of SES was associated with more inhibition of neointimal hyperplasia compared with PES at 9-month IVUS follow-up.
Prior studies have shown greater reductions in neointimal hyperplasia on IVUS with drug-eluting stents compared with bare-metal stents. Additionally, prior IVUS studies have shown greater reductions in neointimal hyperplasia on IVUS with SES compared with PES, but the studies involved primarily shorter, less complex lesions. In the LONG DES II study, SES were associated with reductions in angiographic binary restenosis compared with PES for long lesions.
Data from the present study further extend these findings to demonstrate more inhibition of neointimal hyperplasia with SES compared with PES for complex lesions. The clinical implications of these IVUS findings are unknown, as the optimal degree of inhibition of neointimal hyperplasia is not yet known.
References:
Petronio AS, De Carlo M, Branchitta G, et al. Randomized comparison of sirolimus and paclitaxel drug-eluting stents for long lesions in the left anterior descending artery: an intravascular ultrasound study. J Am Coll Cardiol 2007;49:539–46.
Keywords: Coronary Artery Disease, Myocardial Infarction, Follow-Up Studies, Drug-Eluting Stents, Sirolimus, Constriction, Pathologic, Hyperplasia, Percutaneous Coronary Intervention, Stents, Paclitaxel, Metals, Electrocardiography, Ambulatory, Diabetes Mellitus
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