Impact of “Off-Label” Utilization of Drug-Eluting Stents on Clinical Outcomes in Patients Undergoing Percutaneous Coronary Intervention

• Published in: The American journal of cardiology 2008-02, Vol.101 (3), p.293-299
• Main Authors: Roy, Probal, MD, Buch, Ashesh N., MBChB, Javaid, Aamir, MD, Okabe, Teruo, MD, Raya, Vikram, MD, Pinto Slottow, Tina L., MD, Steinberg, Daniel H., MD, Smith, Kimberly, BS, Xue, Zhenyi, MS, Gevorkian, Natalie, MD, Satler, Lowell F., MD, Kent, Kenneth M., MD, Suddath, William O., MD, Pichard, Augusto D., MD, Lindsay, Joseph, MD, Waksman, Ron, MD
• Format: Article
• Language: English
• Subjects: Aged; Angioplasty, Balloon, Coronary; Biological and medical sciences; Cardiology. Vascular system; Cardiovascular; Coronary Restenosis - epidemiology; Coronary Restenosis - prevention & control; Diseases of the cardiovascular system; Drug Labeling; Drug-Eluting Stents - standards; Drug-Eluting Stents - utilization; Female; Humans; Male; Medical sciences; Middle Aged; Myocardial Infarction - epidemiology; Myocardial Infarction - prevention & control; Prosthesis Design; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Retreatment; Retrospective Studies; Safety; United States
• ISSN: 0002-9149; 1879-1913
• DOI: 10.1016/j.amjcard.2007.08.048

The utilization of drug-eluting stents (DES) in “real world” practice has deviated from Food and Drug Administration-approved indications. Safety concerns have arisen from recent reports that suggested increased mortality and nonfatal myocardial infarction (MI) with DES usage. Little is known about the clinical outcomes of patients undergoing intracoronary DES implantation for unapproved indications as a group compared with outcomes after bare metal stent (BMS) placement. The clinical outcomes of 546 patients undergoing DES implantation for ≥1 non–Food and Drug Administration-approved (“off label”) indication since the approval of the device were assessed. The group was then matched by propensity score with 546 patients receiving BMSs prior to DES approval for the same indications. The primary endpoint was major adverse cardiac events (cardiac death, nonfatal Q-wave myocardial infarction [MI], and target vessel revascularization) at 12 months. Baseline clinical and angiographic characteristics were well matched between BMS and DES groups. The use of debulking devices was higher in the BMS group. Patients in the BMS group were more likely to be treated with larger diameter and shorter stents. There was no significant difference in the rate of in-hospital and 30-day adverse cardiac events. At 12 months, the primary endpoint of major adverse cardiac events was significantly reduced in the DES group (23.6% vs 16.7%, p = 0.004), driven by reductions in the need for repeat revascularization (target lesion revascularization: 16.4% vs 7.8%, p