CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY
Impact of Routine Angiographic Follow-Up on the Clinical Benefits of Paclitaxel-Eluting Stents
Results From the TAXUS-IV Trial
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* for the TAXUS-IV Investigators
* Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts
Columbia University Medical Center and Cardiovascular Research Foundation, New York, New York
Cleveland Clinic Foundation, Cleveland, Ohio
Mid Carolina Cardiology, Charlotte, North Carolina
|| St. Vincent’s Hospital, Indianapolis, Indiana
¶ Elyria Memorial Hospital, Elyria, Ohio
# WakeMed, Raleigh, North Carolina
** Washington Adventist Hospital, Tacoma Park, Maryland
St. Joseph’s Hospital, Syracuse, New York
Brigham and Women’s Hospital, Boston, Massachusetts
Boston Scientific Corporation, Natick, Massachusetts
Manuscript received November 18, 2005;
revised manuscript received February 22, 2006,
accepted February 28, 2006.
* Reprint requests and correspondence: Dr. Duane S. Pinto, Division of Cardiology, Beth Israel Deaconess Medical Center, 1 Deaconess Road, Boston, Massachusetts 02115. (Email: dpinto{at}bidmc.harvard.edu).
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.
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Abbreviations and Acronyms
| | BMS = bare-metal stent | | DES = drug-eluting stent | | PCI = percutaneous coronary intervention | | PES = paclitaxel-eluting stent | | TLR = target lesion revascularization | | TVR = target vessel revascularization |
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