Angiographic and clinical outcomes of drug-eluting versus bare metal stent deployment in the Occluded Artery Trial†‡
The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung, And Blood Institute or the National Institutes of Health; Brompton Funds Professorship in Interventional Cardiology.
Conflict of interest: Dr. Dzavik reports research, honorarium and Advisory Board member funds from Cordis, Johnson&Johnson, and honoraria from Boston Scientific. Dr. Rankin reports an educational grant from Cordis, Johnson&Johnson. Dr. Buszman owns stock in American Heart of Poland Ltd. and NAFIS SA (Poland). Dr. Hochman reports grant support to her institution from Eli Lilly and Bristol Myers Squibb Medical Imaging and product donation from Millennium Pharmaceuticals, Schering-Plough, Guidant, and Merck for OAT and received consultation fees from Bristol Myers Squibb, honoraria for Steering Committee service from CV Therapeutics, Eli Lilly and Glaxo Smith Kline and honoraria for serving on the Data Safety Monitoring Board of a trial supported by Schering-Plough.
Abstract
Background:
The majority of patients randomized to percutaneous coronary intervention (PCI) in the Occluded Artery Trial (OAT) and its angiographic substudy, the Total Occlusion Study of Canada 2 (TOSCA-2) were treated with bare metal stents (BMS). We aimed to determine if stenting of the target occlusion in OAT with drug-eluting stents (DES) was associated with more favorable angiographic results and clinical outcome when compared with treatment with BMS.
Methods:
TOSCA-2 DES was a prospective nonrandomized substudy that provided 1-year angiographic comparison of late loss and reocclusion in 25 patients treated with DES and in 128 treated with BMS. In addition, all PCI-assigned patients enrolled from the time when DES were first utilized were similarly categorized (DES n = 77, and BMS n = 386) and compared using the 3-year cumulative OAT primary combined endpoint of death, myocardial infarction, or Class-IV heart failure, as well as angina.
Results:
In-segment late loss was 0.14 ± 0.45 mm for DES and 0.75 ± 0.86 mm for BMS (P < 0.001). Corresponding binary restenosis rates were 13.0% and 44.3% (P = 0.005). Occlusion at 1 year was observed in 4.0 and 12.1%, respectively (P = 0.23). The 3-year cumulative primary event rate was 13.8% with DES and 12.5% with BMS (hazard ratio 1.08, 99% confidence intervals 0.44, 2.64; P = 0.83). Angina over time occurred less frequently in the DES group (P = 0.01).
Conclusions:
Although the reduction of late loss and trend to reduction in reocclusion with the use of DES for PCI of persistently occluded IRA 3–28 days post myocardial infarction did not translate into a signal for reduction in death, reinfarction, or Class IV heart failure, DES use was associated with less angina over time. Further follow-up is warranted. © 2009 Wiley-Liss, Inc.
