Impact of routine angiographic follow-up on the clinical benefits of paclitaxel-eluting stents : Results from the TAXUS-IV trial

• Published in: Journal of the American College of Cardiology 2006-07, Vol.48 (1), p.32-36
• Main Authors: PINTO, Duane S, STONE, Gregg W, CAPUTO, Ronald, POPMA, Jeffrey J, CUTLIP, Donald E, RUSSELL, Mary E, COHEN, David J, ELLIS, Stephen G, COX, David A, HERMILLER, James, O'SHAUGHNESSY, Charles, TIFT MANN, J, MEHRAN, Roxana, YINGBO NA, TURCO, Mark
• Format: Article
• Language: English
• Subjects: Angioplasty, Balloon, Coronary; Biological and medical sciences; Cardiology; Cardiology. Vascular system; Clinical outcomes; Coronary Angiography; Coronary Restenosis - diagnostic imaging; Coronary Restenosis - prevention & control; Coronary vessels; Drug therapy; Female; Follow-Up Studies; Heart attacks; Humans; Male; Medical sciences; Metals; Middle Aged; Paclitaxel - administration & dosage; Stents
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2006.02.060

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. 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. 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. 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. 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.