Prospective Randomized Multi-Center Head-to-Head Comparison of the Sirolimus-Eluting Stent (Cypher) and the Paclitaxel-Eluting Stent (Taxus) - REALITY

Description:

The goal of the trial was to evaluate treatment with sirolimus-eluting stents compared with paclitaxel-eluting stents among patients with de novo coronary lesions.

Hypothesis:

Treatment with sirolimus-eluting stents will be compared to treatment with paclitaxel-eluting stents among patients with de novo coronary lesions.

Study Design

Study Design:

Patients Enrolled: 1,386
Mean Follow Up: 24 months (12-month data reported to date)
Mean Patient Age: Mean age 63 years
Female: 27

Patient Populations:

Presence of one or two de novo lesions in a native coronary artery between 2.25 mm and 3.00 mm in diameter

Exclusions:

Acute MI within 72 hours, ostial lesions, unprotected left main, in-stent restenosis, or left ventricular ejection fraction ≤25%

Primary Endpoints:

In-lesion binary restenosis at eight-month angiographic follow-up

Secondary Endpoints:

MACE at 1, 8, 12, 18, and 24 months

Drug/Procedures Used:

Patients were randomized to stent implantation with either the paclitaxel-eluting stent (n=685 patients; 941 lesions) or the sirolimus-eluting stent (n=701 patients; 970 lesions). Direct stenting was allowed, as was treatment of bifurcation lesions and ostial lesions. Patients underwent angiographic follow-up at eight months.

Concomitant Medications:

Aspirin and clopidogrel (75 mg/day); glycoprotein IIb/IIIa inhibitor at the physician discretion

Principal Findings:

There were 1,911 lesions in the 1,353 patients with treatment attempted, with an average of 1.94 stents used per patient. Baseline clinical and angiographic characteristics were well-matched between the treatment groups, with 28% diabetics. Lesions were relatively complex, with 86% classified as BII or C and 27% >20 mm in length. Procedural success was 95% in each group.

At eight-month angiographic follow-up, the sirolimus-eluting stent group had larger in-stent minimum lumen diameter (2.00 mm vs. 1.85 mm), less late lumen loss (0.09 mm vs. 0.31 mm), and smaller diameter stenosis (23.1% vs. 26.7%), (p<0.001 for all comparisons). However, the primary endpoint of binary in-lesion restenosis did not differ between the treatment groups (9.6% for sirolimus-eluting stent group vs. 11.1% for paclitaxel-eluting stent group, p=0.31).

At 12-month clinical follow-up, there was no difference in major adverse cardiac events (MACE) (10.7% for sirolimus-eluting stent group vs. 11.4% for paclitaxel-eluting stent group, p=0.73) or any component of MACE (death 2.3% vs. 1.3%, p=0.23; myocardial infarction [MI] 5.1% vs. 6.0%, p=0.55; target lesion revascularization 6.0% vs. 6.1%, p=0.99, respectively). Stent thrombosis was higher in the paclitaxel-eluting stent group (1.9% vs. 0.7%, p=0.06).

Interpretation:

Among patients with de novo coronary lesions, treatment with the sirolimus-eluting stent was not associated with a difference in binary restenosis on eight-month angiographic follow-up compared to treatment with the paclitaxel-eluting stent.

While other trials such as ISAR DESIRE and ISAR DIABETES have compared the two drug-eluting stents in a head-to-head comparison for treatment of in-stent restenosis and in diabetic patients, respectively, the present trial along with the SIRTAX trial are the first large-scale randomized trials to evaluate the stents in a wide patient population. Unlike the REALITY trial, sirolimus-eluting stent use was associated with a reduction in MACE compared with paclitaxel-eluting stent use in the SIRTAX trial.

Despite improvements in angiographic parameters at eight months in minimum lumen diameter, late lumen loss, and percent diameter stenosis in the sirolimus-eluting stent group in the REALITY trial, there was no difference in the primary endpoint of binary restenosis or in the clinical MACE rate at 12 months, suggesting both drug-eluting stents are effective in reducing restenosis. It is not clear if the threshold of 50% for binary restenosis is the optimal surrogate for clinical restenosis. The clinical meaning of reductions in minimum lumen diameter, likewise, is not entirely clear. While this was an intermediate-term angiographic analysis at eight months, the impact of late remodeling with these two stents is not known.

Although the absolute number of stent thrombosis was small, the increase in stent thrombosis in the paclitaxel-eluting stent group warrants further monitoring. Patients will be followed for late stent thrombosis through two years. There was no difference in stent thrombosis in the SIRTAX trial.

References:

Morice MC, et al. Sirolimus- vs Paclitaxel-Eluting Stents in De Novo Coronary Artery Lesions: The REALITY Trial: A Randomized Controlled Trial. JAMA 2006;295 895-904.

Presented by Dr. Marie-Claude Morice at the March 2005 ACC Annual Scientific Session, Orlando, FL.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Atherosclerotic Disease (CAD/PAD), Interventions and Coronary Artery Disease

Keywords: Paclitaxel, Coronary Artery Disease, Myocardial Infarction, Follow-Up Studies, Pyridinolcarbamate, Thrombosis, Drug-Eluting Stents, Constriction, Pathologic, Sirolimus, Diabetes Mellitus, Stents


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