Impact of routine angiographic follow-up on the clinical benefits of paclitaxel-eluting stents: results from the TAXUS-IV trial.
OBJECTIVE
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.
Pinto
Duane S
DS
Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts 02115, USA. dpinto@bidmc.harvard.edu
Stone
Gregg W
GW
Ellis
Stephen G
SG
Cox
David A
DA
Hermiller
James
J
O'Shaughnessy
Charles
C
Mann
J Tift
JT
Mehran
Roxana
R
Na
Yingbo
Y
Turco
Mark
M
Caputo
Ronald
R
Popma
Jeffrey J
JJ
Cutlip
Donald E
DE
Russell
Mary E
ME
Cohen
David J
DJ
D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging* / Q000517:prevention & control; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D015607:Stents
D008670:Metals; D017239:Paclitaxel