Author + information
- Received May 10, 2010
- Revision received November 4, 2010
- Accepted November 15, 2010
- Published online February 1, 2011.
- Eberhard Grube, MD⁎,⁎ (, )
- Bernard Chevalier, MD†,
- Peter Smits, MD, PhD‡,
- Vladimir Džavík, MD§,
- Tejas M. Patel, MD∥,
- Ajit S. Mullasari, MD¶,
- Jochen Wöhrle, MD#,
- Marrianne Stuteville, BSN⁎⁎,
- Cécile Dorange, MSc⁎⁎,
- Upendra Kaul, MD, DM††,
- SPIRIT V Investigators
- ↵⁎Reprint requests and correspondence:
Dr. Eberhard Grube, Department of Cardiology, University Hospital Bonn, Sigmund Freud Strasse 25, 53105 Bonn, Germany
Objectives The SPIRIT V (A Clinical Evaluation of the XIENCE V Everolimus-Eluting Coronary Stent System in the Treatment of Patients With De Novo Coronary Artery Lesions) study is a post-market surveillance experience of the XIENCE V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) in patients with higher-risk coronary anatomy.
Background Previous pre-approval studies have shown the safety and efficacy of EES in highly selected groups of patients.
Methods The SPIRIT V trial is a prospective, open label, single arm, multicenter study. Two thousand seven hundred patients with multiple de novo coronary artery lesions suitable for treatment with a planned maximum of 4 EES were enrolled at 93 centers in Europe, Asia Pacific, Canada, and South Africa. Lesions had a reference vessel diameter between 2.25 and 4.0 mm and a length of ≤28 mm by visual estimation. An independent clinical events committee adjudicated all end point-related events. The primary end point was the composite rate of all death, myocardial infarction (MI), and target vessel revascularization at 30 days. Secondary end points included stent thrombosis and acute success (clinical device and procedure success).
Results At 30 days, the primary composite end point of all death, MI, and target vessel revascularization was 2.7%. At 1 year, rates of cardiac death, overall MI, and target lesion revascularization were 1.1%, 3.5%, and 1.8%, respectively. The cumulative rate of definite and probable stent thrombosis was low at 0.66% at 1 year.
Conclusions Use of EES in patients with multiple, complex de novo lesions yielded 1-year major adverse cardiac events, stent thrombosis, and target lesion revascularization rates that are comparable to those of the more controlled SPIRIT II and SPIRIT III trials—which included patients with restricted inclusion/exclusion criteria—and other all-comer population, physician-initiated studies like the X-SEARCH (Xience Stent Evaluated At Rotterdam Cardiology Hospital) and COMPARE (A Randomized Controlled Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice) trials.
Dr. Grube is a member of the Abbott Vascular Advisory Board. Dr. Smits has received speaker fees from Abbott Vascular. Dr. Džavík has received an unrestricted research grant from Abbott Vascular and an unrestricted educational grant to run a course from Cordis (greater than 10,000). Dr. Chevalier is a consultant for Abbott Vascular. Ms. Stuteville and Ms. Dorange are employees of Abbott Vascular. All other authors have reported that they have no relationships to disclose.
- Received May 10, 2010.
- Revision received November 4, 2010.
- Accepted November 15, 2010.
- American College of Cardiology Foundation