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 approximately 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.
RCT Entities:
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 approximately 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.
Authors: Moshe Vardi; Robert W Yeh; Charles A Herzog; Wolfgang C Winkelmayer; Soko Setoguchi; David M Charytan Journal: Clin J Am Soc Nephrol Date: 2013-08-22 Impact factor: 8.237
Authors: Masanori Taniwaki; Maria D Radu; Hector M Garcia-Garcia; Dik Heg; Henning Kelbæk; Lene Holmvang; Aris Moschovitis; Stephane Noble; Giovanni Pedrazzini; Kari Saunamäki; Jouke Dijkstra; Ulf Landmesser; Peter Wenaweser; Bernhard Meier; Giulio G Stefanini; Marco Roffi; Thomas F Lüscher; Stephan Windecker; Lorenz Räber Journal: Int J Cardiovasc Imaging Date: 2015-02-28 Impact factor: 2.357
Authors: Matthew R Reynolds; Duane S Pinto; Chunxue Shi; Joshua Walczak; Ronna Berezin; David R Holmes; David J Cohen Journal: Am Heart J Date: 2007-09-06 Impact factor: 4.749
Authors: Giuseppe G L Biondi-Zoccai; Elena Giraudi; Claudio Moretti; Filippo Sciuto; Pierluigi Omedè; Dario Sillano; Paolo Garrone; Gian Paolo Trevi; Imad Sheiban Journal: Clin Res Cardiol Date: 2010-01-03 Impact factor: 5.460