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Outcomes and complications associated with off-label and untested use of drug-eluting stents.
| Content Provider | Semantic Scholar |
|---|---|
| Author | Beohar, Nirat Goodreau, Lynne Vlachos, Helen Aslanidou Bennett, Charles L. |
| Copyright Year | 2007 |
| Abstract | CONTEXT Limited data exist regarding use of drug-eluting stents outside of approved indications in real-world settings. OBJECTIVES To determine the frequency, safety, and effectiveness of drug-eluting stents for off-label (restenosis, bypass graft lesion, long lesions, vessel size outside of information for use recommendation) and untested (left main, ostial, bifurcation, or total occlusion lesions) indications in percutaneous coronary intervention (PCI). DESIGN, SETTING, AND PATIENTS Observational, prospective, multicenter registry to evaluate in-hospital, 30-day, and 1-year outcomes among patients undergoing PCI between January and June 2005 in 140 US academic and community medical centers. Of 7752 PCI-treated patients, 6993 (90%) received drug-eluting stents; of these, 5851 (84%) received no other devices. Standard, off-label, and untested use was determined in 5541 (95%) of these 5851 patients, constituting the study cohort. MAIN OUTCOME MEASURES Frequency of off-label and untested use, 1-year repeat target vessel revascularization, and composite of death, myocardial infarction (MI), or stent thrombosis at in-hospital follow-up and during 1 year of follow-up. RESULTS Of 5541 patients receiving drug-eluting stents, 2588 (47%) received stents for off-label or untested indications. Adjusted in-hospital risk of death, MI, or stent thrombosis was not statistically different with off-label or untested vs standard use. At 30 days, the risk of this composite end point was significantly higher with off-label use (adjusted hazard ratio [HR], 2.08; 95% confidence interval [CI], 1.24-3.48; P = .005) but not untested use (adjusted HR, 1.45; 95% CI, 0.79-2.67; P = .23). Excluding early events, this end point was not different at 1 year with off-label use (adjusted HR, 1.10; 95% CI, 0.79-1.54; P = .57) or untested use (adjusted HR, 0.91; 95% CI, 0.60-1.38; P = .66). At 1 year, compared with standard use, significantly higher rates of target vessel revascularization were associated with off-label use (adjusted HR, 1.49; 95% CI, 1.13-1.98; P = .005) and untested use (adjusted HR, 1.49; 95% CI, 1.10-2.02; P = .01), although absolute rates were low (standard, 4.4% [n = 113]; off-label, 7.6% [n = 95]; untested, 6.7% [n = 72]). CONCLUSIONS In contemporary US practice, off-label and untested use of drug-eluting stents is common. Compared with standard use, relative early safety is lower with off-label use, and the long-term effectiveness is lower with both off-label and untested use. However, the absolute event rates remain low. |
| Starting Page | 1992 |
| Ending Page | 2000 |
| Page Count | 9 |
| File Format | PDF HTM / HTML |
| Alternate Webpage(s) | http://jama.jamanetwork.com/pdfaccess.ashx?url=/data/journals/jama/5156/joc70045_1992_2000.pdf |
| PubMed reference number | 17488964v1 |
| Volume Number | 297 |
| Issue Number | 18 |
| Journal | JAMA |
| Language | English |
| Access Restriction | Open |
| Subject Keyword | Blood Vessel Tissue CIB1 wt Allele Cessation of life Confidence Intervals Drug-Eluting Stents Ectopia Cordis Hazard Ratio Manuscripts Myocardial Infarction Neoplasms Off-Label Treatment Patients Percutaneous Coronary Intervention Registries Stent Device Component Stent, device Thrombosis Transplanted tissue bypass restenosis revascularization |
| Content Type | Text |
| Resource Type | Article |
