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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Comparative Clinical Outcomes of Paclitaxel- and Sirolimus-Eluting Stents

Results From a Large Prospective Multicenter Registry—STENT Group

Charles A. Simonton, MD, FACC, FSCAI^_*,_*, Bruce Brodie, MD, Barrett Cheek, MD, Fred Krainin, MD, Chris Metzger, MD^||, James Hermiller, MD^#, Stanley Juk, MD^_**, Peter Duffy, MD, Angela Humphrey, MS, Marcy Nussbaum, MS, Sherry Laurent, PhD for the STENT Group

^_* Carolinas Heart Institute, Carolinas Medical Center, Charlotte, North Carolina
LeBauer Cardiovascular Research Foundation, Greensboro, North Carolina
High Point Regional Health System, High Point, North Carolina
McLeod Regional Medical Center, Florence, South Carolina
^|| Holston Valley Medical Center, Kingsport, Tennessee
^# Indiana Heart Institute, Indianapolis, Indiana
^_** Sisters of Charity Providence Hospitals, Columbia, South Carolina
Moore Regional Hospital, Pinehurst, North Carolina
R. Stuart Dickson Institute for Health Studies, Carolinas Medical Center, Charlotte, North Carolina.

Manuscript received March 20, 2007; revised manuscript received May 29, 2007, accepted June 18, 2007.

^_* Reprint requests and correspondence: Dr. Charles A. Simonton, Sanger Clinic, 1001 Blythe Boulevard, Suite 300, Charlotte, North Carolina 28203. (Email: Charles.Simonton{at}carolinashealthcare.org).

Objectives: The purpose of this study was to compare the 9-month clinical outcomes of patients treated with paclitaxel-eluting stents (PES) or sirolimus-eluting stents (SES) for coronary artery stenosis.

Background: The STENT (Strategic Transcatheter Evaluation of New Therapies) registry is the first multicenter registry in the U.S. to collect long-term outcomes of drug-eluting stents from "real-world" practice.

Methods: Data on all percutaneous coronary interventions in 8 U.S. hospital centers were collected in the STENT registry between 2003 and 2005. In this prospective, nonrandomized, observational study, the choice of procedures was at the physicians’ discretion. Patients who only received a PES (n = 4,671) or SES (n = 4,555) and completed 9-month follow-up (93.8% of eligible) were included for analysis. Primary end points were death, myocardial infarction (MI), and target vessel revascularization (TVR) at 9 months. Secondary outcomes included major adverse cardiac events (MACE) (any of the 3 primary end points) and stent thrombosis.

Results: At 9 months, death, MI, and TVR occurred in 2.2%, 2.0%, and 4.1%, respectively, of the PES group and 2.5%, 2.2%, and 4.3%, respectively, of the SES group (p = NS); MACE occurred in 7.5% of the PES group and 8.0% of the SES group (p = 0.37). After adjustments for group differences in baseline characteristics, TVR (hazard ratio [HR] 0.88, 95% confidence interval [CI] 0.70 to 1.32; p = 0.26) and MACE (HR 0.95, 95% CI 0.81 to 1.12; p = 0.56) were similar for PES and SES. Stent thrombosis at 9 months occurred in 0.7% of both groups.

Conclusions: The results of this study show that clinical restenosis and MACE events after PES and SES procedures in "real-world" patients are infrequent and similar at 9 months.

Abbreviations and Acronyms   MACE = major adverse cardiac events   MI = myocardial infarction   PCI = percutaneous coronary intervention   PES = paclitaxel-eluting stent(s)   SAT = subacute stent thrombosis   SES = sirolimus-eluting stent(s)   ST = stent thrombosis   TVR = target vessel revascularization

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