Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions - SPIRIT II: Results Through 3 Years

Description:

The goal of the SPIRIT II study was to evaluate the safety and efficacy of the XIENCE V everolimus-eluting cobalt chromium coronary stent compared with the TAXUS paclitaxel-eluting stent among patients with de novo coronary lesions.

Hypothesis:

The XIENCE V everolimus-eluting stent would be noninferior to the TAXUS paclitaxel-eluting stent in reducing angiographic in-stent late loss in patients with coronary artery disease.

Study Design

Patients Enrolled: 300
Mean Follow Up: 3 years
Mean Patient Age: 62 years
Female: 25

Patient Populations:

  • One or two de novo coronary target lesions
  • Stable angina
  • Target vessel reference diameter 2.5-4.0 mm, lesion length ≤28 mm, and stenosis ≥50%
  • Stenosis between 50-99%
  • > TIMI 1 flow

Exclusions:

  • MI within 3 days
  • Left ventricular ejection fraction
  • Awaiting heart transplantation
  • Known sensitivity or contraindications to aspirin, heparin, bivalirudin, clopidogrel or ticlopidine, cobalt, chromium, nickel, tungsten, everolimus, paclitaxel, acrylic, and fluoropolymers
  • Left main disease
  • Lesion within 2 mm of the origin of the left anterior descending or left circumflex artery
  • Heavy calcification
  • Thrombus

Primary Endpoints:

  • In-stent late lumen loss at 2 years in one randomly selected lesion per patient, evaluated for noninferiority

Secondary Endpoints:

  • In-segment, proximal, and distal late loss at 2 years
  • IVUS in-stent percent volume obstruction and incomplete stent apposition
  • MACE, defined as cardiac death, MI, and ischemic driven target lesion revascularization

Drug/Procedures Used:

Patients were randomized in a 3:1 ratio to everolimus-eluting stent (n = 223) or paclitaxel-eluting stent (n = 77). Follow-up angiography was performed at 6 months. A subset of 152 patients also underwent intravascular ultrasound (IVUS) and angiography at 6 months and 2 years.

Principal Findings:

One lesion was stented in 83.4% of patients and two lesions in 16.6% in the everolimus group. About 41% of the target lesions were left anterior descending in the everolimus group. Device success was 98.8% in the everolimus group.

The primary endpoint of in-stent late loss in a single lesion per patient at 6 months met the criteria for noninferiority and superiority for the everolimus-eluting stent group compared with the paclitaxel-eluting stent group (0.11 mm for everolimus vs. 0.36 mm for paclitaxel, p

Major adverse cardiac events (MACE) at 2 years occurred in 6.6% of the everolimus group and 11.0% of the paclitaxel group (p = 0.31), the majority of which were ischemia-driven target lesion revascularizations (3.8% vs. 6.8%, p = 0.33). The incidence of cardiac death and myocardial infarction (MI) at 2 years was 0.5% and 1.4% (p = 0.45), and 2.8% and 5.5% (p = 0.29) in the everolimus and paclitaxel arms, respectively. The rate of stent thrombosis at 2 years was 0.9% and 1.4% in the two arms, respectively (p = NS). Both the stent thrombosis episodes in the everolimus arm occurred after 1 year.

At 3 years, the incidence of MACE was numerically lower with the everolimus-eluting compared with the paclitaxel-eluting stent (7.2% vs. 15.9%, p = 0.05). Target vessel failure (11.8% vs. 17.4%, p = 0.30), MI (3.6% vs. 4.3%, p = 0.72), all-cause mortality (4.4% vs. 9.6%, p = 0.14), and stent thrombosis (1.0% vs. 2.9%, p > 0.05) were similar between the two arms at the end of 3 years.

Interpretation:

Among patients with de novo coronary lesions, use of everolimus-eluting stents was associated with a reduction in in-stent late lumen loss at 6-month angiographic follow-up compared with use of paclitaxel-eluting stents. However, this difference was not seen at the end of 2 years. There also seemed to be a lag between the incidence of clinical events such as MACE and the incidence of angiographic late lumen loss in the everolimus arm.

The 3-year data seem to indicate that although not statistically significant, outcomes were numerically lower with the everolimus-eluting compared with the paclitaxel-eluting stent.

Further long-term data on the performance of these stents are necessary.

References:

Garg S, Serruys P, Onuma Y, et al. 3-Year Clinical Follow-Up of the XIENCE V Everolimus-Eluting Coronary Stent System in the Treatment of Patients With De Novo Coronary Artery Lesions: The SPIRIT II Trial (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions). JACC Cardiovasc Interv 2009;2:1190-8.

Presented by Dr. Patrick Serruys at the SCAI-ACC i2 Summit/American College of Cardiology Annual Scientific Session, Chicago, IL, March/April 2008.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Atherosclerotic Disease (CAD/PAD), Interventions and Coronary Artery Disease, Chronic Angina

Keywords: Coronary Artery Disease, Myocardial Infarction, Follow-Up Studies, Angina, Stable, Cobalt, Drug-Eluting Stents, Immunosuppressive Agents, Constriction, Pathologic, Sirolimus, Stents, Paclitaxel, Thrombosis, Chromium


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