Author + information
- Received November 18, 2005
- Revision received February 22, 2006
- Accepted February 28, 2006
- Published online July 4, 2006.
- Duane S. Pinto, MD, FACC⁎,⁎ (, )
- Gregg W. Stone, MD, FACC†,
- Stephen G. Ellis, MD, FACC‡,
- David A. Cox, MD, FACC§,
- James Hermiller, MD, FACC∥,
- Charles O’Shaughnessy, MD, FACC¶,
- J. Tift Mann, MD, FACC#,
- Roxana Mehran, MD, FACC†,
- Yingbo Na, MSc†,
- Mark Turco, MD, FACC⁎⁎,
- Ronald Caputo, MD, FACC††,
- Jeffrey J. Popma, MD, FACC‡‡,
- Donald E. Cutlip, MD, FACC⁎,
- Mary E. Russell, MD, FACC§§,
- David J. Cohen, MD, MSc⁎,
- TAXUS-IV Investigators
- ↵⁎Reprint requests and correspondence:
Dr. Duane S. Pinto, Division of Cardiology, Beth Israel Deaconess Medical Center, 1 Deaconess Road, Boston, Massachusetts 02115.
Objectives The objectives of the study were to evaluate the effect of angiographic follow-up on revascularization rates in the TAXUS-IV trial and to determine whether the relative benefit of paclitaxel-eluting stent implantation compared with bare metal stent implantation was modified by angiographic follow-up.
Background Although several clinical trials have demonstrated that drug-eluting stents (DES) reduce restenosis compared with bare-metal stents (BMS), virtually all of these studies have incorporated angiographic follow-up.
Methods In the TAXUS-IV trial, 1,314 percutaneous coronary intervention patients were randomized to receive paclitaxel-eluting stents (PES) (n = 662) or identical-appearing BMS (n = 652). Clinical outcomes were compared, stratified by assignment to angiographic follow-up or clinical follow-up alone.
Results Compared with clinical follow-up alone, angiographic follow-up patients had a significantly higher rate of target vessel revascularization (TVR) at 1 year (adjusted hazard ratio [HR] 1.46; p = 0.04), with similar relative increases in PES and BMS patients. Because PES reduced TVR by ∼60% regardless of type of follow-up, assignment to angiographic follow-up tended to overestimate the absolute benefit of PES relative to clinical follow-up alone. In contrast, assessment of end points immediately before the time of follow-up angiography led to substantial underestimation of the absolute benefit of PES implantation.
Conclusions Performance of mandatory angiographic follow-up increases rates of TVR among patients receiving both BMS and PES and overestimates the absolute clinical benefits of PES relative to clinical follow-up alone. Nonetheless, PES substantially reduces TVR regardless of assignment to mandatory angiographic follow-up or not. Future studies designed to determine the true clinical benefits of DES should either forgo routine angiographic follow-up or separate the time of repeat angiography from the primary clinical end point by as long as possible.
Supported by a grant from Boston Scientific Corporation.
- Received November 18, 2005.
- Revision received February 22, 2006.
- Accepted February 28, 2006.
- American College of Cardiology Foundation