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J Am Coll Cardiol, 2006; 48:32-36, doi:10.1016/j.jacc.2006.02.060 (Published online 7 June 2006).
© 2006 by the American College of Cardiology Foundation
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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{dagger}, Stephen G. Ellis, MD, FACC{ddagger}, David A. Cox, MD, FACC§, James Hermiller, MD, FACC||, Charles O’Shaughnessy, MD, FACC, J. Tift Mann, MD, FACC#, Roxana Mehran, MD, FACC{dagger}, Yingbo Na, MSc{dagger}, Mark Turco, MD, FACC**, Ronald Caputo, MD, FACC{dagger}{dagger}, Jeffrey J. Popma, MD, FACC{ddagger}{ddagger}, 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
{dagger} Columbia University Medical Center and Cardiovascular Research Foundation, New York, New York
{ddagger} 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
{dagger}{dagger} St. Joseph’s Hospital, Syracuse, New York
{ddagger}{ddagger} 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.

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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