Author + information
- Received July 1, 2013
- Accepted July 3, 2013
- Published online December 1, 2013.
- Hemal Gada, MD, MBA∗,
- Ajay J. Kirtane, MD, SM∗,
- William Newman, MD†,
- Mark Sanz, MD‡,
- James B. Hermiller, MD§,
- Kenneth W. Mahaffey, MD‖,
- Donald E. Cutlip, MD¶,
- Krishnankutty Sudhir, MD, PhD#,
- Liming Hou, PhD#,
- Kai Koo, PhD# and
- Gregg W. Stone, MD∗∗ ()
- ∗Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York
- †Wake Medical Center, Raleigh, North Carolina
- ‡St. Patrick Hospital, Missoula, Montana
- §The Heart Center of Indiana, Indianapolis, Indiana
- ‖Duke Clinical Research Institute, Durham, North Carolina
- ¶Harvard Clinical Research Institute, Boston, Massachusetts
- #Abbott Vascular, Santa Clara, California
- ↵∗Reprint requests and correspondence:
Dr. Gregg W. Stone, Columbia University Medical Center, New York-Presbyterian Hospital, The Cardiovascular Research Foundation, 111 East 59th Street, 11th Floor, New York, New York 10022.
Objectives This study sought to evaluate the long-term safety and efficacy of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in patients with obstructive coronary artery disease.
Background The use of EES compared to PES has been shown to result in improved clinical outcomes in patients undergoing PCI. However, there have been concerns regarding the durability of these benefits over longer-term follow-up.
Methods SPIRIT III was a prospective, multicenter trial in which 1,002 patients were randomized 2:1 to EES versus PES. Endpoints included ischemia-driven target vessel failure (TVF) (death, myocardial infarction (MI), or ischemia-driven target vessel revascularization [TVR]), the pre-specified primary endpoint), target lesion failure (TLF) (cardiac death, target-vessel MI, or ischemia-driven target lesion revascularization [TLR]), major adverse cardiac events (MACE) (cardiac death, MI, or ischemia-driven TLR), their individual components and stent thrombosis.
Results Five-year follow-up was available in 91.9% of patients. Treatment with EES versus PES resulted in lower 5-year Kaplan-Meier rates of TVF (19.3% vs. 24.5%, p = 0.05), TLF (12.7% vs. 19.0%, p = 0.008), and MACE (13.2% vs. 20.7%, p = 0.007). EES also resulted in reduced rates of all-cause death (5.9% vs. 10.1%, p = 0.02), with nonsignificantly different rates of MI, stent thrombosis, and TLR, and no evidence of late catch-up of TLR over time.
Conclusions At 5 years after treatment, EES compared to PES resulted in durable benefits in composite safety and efficacy measures as well as all-cause mortality. Additionally, the absolute difference in TLR between devices remained stable over time without deterioration of effect during late follow-up.
- coronary artery disease
- drug-eluting stent(s)
- in-stent restenosis
- stent thrombosis
- target vessel failure
Abbott Vascular was the sponsor of the SPIRIT III clinical trial. Dr. Stone is a consultant to Boston Scientific. Dr. Sudhir is a stockholder in Abbott Vascular. Dr. Cutlip has received research support from Medtronic, Abbott Vascular, and Boston Scientific; and is a consultant to Celonova. Dr. Hermiller is a consultant to Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 1, 2013.
- Accepted July 3, 2013.
- American College of Cardiology Foundation