Author + information
- Received June 28, 2004
- Revision received November 1, 2004
- Accepted November 15, 2004
- Published online April 19, 2005.
- Stephen G. Ellis, MD⁎,⁎ (, )
- Jeffrey J. Popma, MD†,
- John M. Lasala, MD, PhD‡,
- Joerg J. Koglin, MD§,
- David A. Cox, MD∥,
- James Hermiller, MD¶,
- Charles O’Shaughnessy, MD#,
- James Tift Mann, MD⁎⁎,
- Mark Turco, MD††,
- Ronald Caputo, MD‡‡,
- Patrick Bergin, MD§§,
- Joel Greenberg, MD∥∥ and
- Gregg W. Stone, MD¶¶,##
- ↵⁎Reprint requests and correspondence:
Dr. Stephen G. Ellis, Department of Cardiovascular Medicine, The Cleveland Clinic Foundation, 9500 Euclid Avenue, Desk F25, Cleveland, Ohio 44195.
Objectives We sought to evaluate the relationship between angiographic late loss and clinical outcomes in the drug-eluting stent era.
Background The interrelationship between angiographic late loss, binary restenosis, and clinical recurrence (target lesion revascularization [TLR]) after coronary stent implantation has been incompletely evaluated.
Methods Using the angiographic substudy of the TAXUS-IV trial, in which 1,314 patients with de novo coronary lesions were randomized to either the paclitaxel-eluting TAXUS stent or to its bare-metal equivalent, we defined the relationship between in-stent and analysis segment late loss, the shape of the late loss histogram (variance and skewedness), and nine-month TLR.
Results Late loss by several measures was closely related to TLR (area under the receiver-operator curve >0.90). For individual vessels of the size in this study (2.8 ± 0.5 mm), the likelihood of TLR did not exceed 5% until analysis segment late loss was >0.5 mm, and did not exceed 10% until late loss was >0.65 mm. At greater late losses, the late loss TLR relationship was steep and nearly linear. For the overall patient cohort, the rate of TLR was related, however, not only to median late loss, but also to measures of its statistical distribution (TLR increased with lack of homogeneous biologic response [greater variance and greater right skewedness]). Similar relationships held for late loss measured within the confines of the stent itself.
Conclusions Coronary stents result in large lumens with “room” to accommodate up to ∼0.5 to 0.65 mm of tissue (angiographic analysis segment late loss) before the likelihood of clinical restenosis (TLR) exceeds 5% to 10%. These data have important implications toward understanding the absolute and relative efficacy of drug-eluting stents.
Drs. Ellis and Popma receive research support from Boston Scientific; Drs. Ellis, Stone, and Hermiller are consultants for Boston Scientific; and Dr. Koglin is an employee of Boston Scientific. The data reside with, but were also reviewed externally from, Boston Scientific. Dr. Ellis feels as an investigator in the filed, he has “conflict” with all major U.S. stent manufacturers, and hence feels “conflicted” in a “balanced” fashion.
- Received June 28, 2004.
- Revision received November 1, 2004.
- Accepted November 15, 2004.
- American College of Cardiology Foundation