Clinical follow-up 3 years after everolimus- and paclitaxel-eluting stents: a pooled analysis from the SPIRIT II (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) and SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) randomized trials.

Abstract

OBJECTIVES:

The purpose of this study was to investigate long-term 3-year clinical outcomes of an everolimus-eluting stent (EES) versus a paclitaxel-eluting stent (PES).

BACKGROUND:

Compared with PES, EES reduced target vessel failure and major adverse cardiac events at 2 years. Whether the benefits of EES are sustained at 3 years has not been reported.

METHODS:

In the SPIRIT II (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) and SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) trials, 1,302 patients were randomly assigned to EES (n = 892) or PES (n = 410). We report the 3-year clinical follow-up of this patient-level pooled analysis.

RESULTS:

At 3 years, EES compared with PES resulted in a significant reduction in myocardial infarction (3.8% vs. 6.7%; relative risk [RR]: 0.56; 95% confidence interval [CI]: 0.34 to 0.94; p = 0.04), and target lesion revascularization (6.8% vs. 12.7%; RR: 0.53; 95% CI: 0.37 to 0.77; p = 0.001). Everolimus-eluting stents resulted in a significant reduction in target vessel failure (13.7% vs. 19.5%; RR: 0.70; 95% CI: 0.54 to 0.92; p = 0.01), and major adverse cardiac events (9.1% vs. 16.3%; RR: 0.56; 95% CI: 0.41 to 0.76; p = 0.0004). The cumulative rates of Academic Research Consortium-defined definite or probable stent thrombosis were 1.2% in EES patients and 1.9% in PES patients (RR: 0.64; 95% CI: 0.25 to 1.68; p = 0.43).

CONCLUSIONS:

In this patient-level pooled analysis, EES compared with PES resulted in a significant and persistent reduction in target vessel failure and major adverse cardiac events at 3 years due to fewer myocardial infarction and ischemic target lesion revascularization events, which is consistent with superior safety and efficacy of the EES platform.

• Authors: Adriano Caixeta, Alexandra J Lansky, Patrick W Serruys, James B Hermiller, Peter Ruygrok, Yoshinobu Onuma, Paul Gordon, Manejeh Yaqub, Karine Miquel-Hebert, Susan Veldhof, Poornima Sood, Xiaolu Su, Lalitha Jonnavithula, Krishnankutty Sudhir, Gregg W Stone, SPIRIT II and III Investigators
• Journal: JACC. Cardiovascular interventions (JACC Cardiovasc Interv) Vol. 3 Issue 12 Pg. 1220-8 (Dec 2010) ISSN: 1876-7605 [Electronic] United States
• PMID: 21232715 (Publication Type: Journal Article)
• Copyright: Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Chemical References

• Antineoplastic Agents, Phytogenic
• Immunosuppressive Agents
• Platelet Aggregation Inhibitors
• Everolimus
• Clopidogrel
• Ticlopidine
• Paclitaxel
• Aspirin
• Sirolimus

Topics

• Angioplasty, Balloon, Coronary
• Antineoplastic Agents, Phytogenic (administration & dosage, therapeutic use)
• Aspirin (therapeutic use)
• Clopidogrel
• Confidence Intervals
• Coronary Artery Disease (drug therapy, mortality, therapy)
• Drug-Eluting Stents
• Everolimus
• Female
• Follow-Up Studies
• Humans
• Immunosuppressive Agents (administration & dosage, therapeutic use)
• Kaplan-Meier Estimate
• Logistic Models
• Male
• Middle Aged
• Paclitaxel (administration & dosage, therapeutic use)
• Platelet Aggregation Inhibitors (therapeutic use)
• Proportional Hazards Models
• Randomized Controlled Trials as Topic
• Risk
• Risk Reduction Behavior
• Sirolimus (administration & dosage, analogs & derivatives, therapeutic use)
• Ticlopidine (analogs & derivatives, therapeutic use)
• Time Factors