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Outcomes and Complications With Off-Label Use of Drug-Eluting Stents

Results From the STENT (Strategic Transcatheter Evaluation of New Therapies) Group

Bruce R. Brodie, MD^_*,_*, Thomas Stuckey, MD^_*, William Downey, MD^_*, Angela Humphrey, MS, Barbara Bradshaw, RN^_*, Chris Metzger, MD, James Hermiller, MD, Fred Krainin, MD^||, Stanley Juk, MD^¶, Barry Cheek, MD^#, Peter Duffy, MD^_**, Henry Smith, MD, John Edmunds, MD, Jay Varanasi, MD, Charles A. Simonton, MD STENT (Strategic Transcatheter Evaluation of New Therapies) Group

^_* LeBauer Cardiovascular Research Foundation, Greensboro, North Carolina
R. Stuart Dickson Institute for Health Studies, Charlotte, North Carolina
Holston Valley Medical Center, Kingsport, Tennessee
Indiana Heart Institute, Indianapolis, Indiana
^|| McLeod Regional Medical Center, Florence, South Carolina
^¶ Sisters of Charity Providence Hospitals, Columbia, South Carolina
^# High Point Regional Health System, High Point, North Carolina
^_** Moore Regional Medical Center, Pinehurst, North Carolina
Eagle Cardiology, Greensboro, North Carolina
Carolinas Medical Center, Charlotte, North Carolina.

^_* Reprint requests and correspondence: Dr. Bruce R. Brodie, 1126 North Church Street, Suite 300, Greensboro, North Carolina 27401. (Email: bbrodie{at}triad.rr.com).

Objectives: This study evaluates outcomes and complications in patients treated with drug-eluting stents (DES) for "off-label" indications.

Background: Drug-eluting stents have been effective in randomized trials, but their safety and efficacy for off-label indications has not been well studied.

Methods: The STENT (Strategic Transcatheter Evaluation of New Therapies) Registry is the largest multicenter U.S. registry evaluating outcomes of DES. Off-label indications included ostial, left main, long, bifurcation, and in-stent restenotic lesions, saphenous vein grafts, chronic total occlusions, small or large vessels, multilesion or multivessel percutaneous coronary interventions, and ST-segment elevation myocardial infarction. Outcomes were adjusted using Cox proportional hazards regression and propensity analyses.

Results: Drug-eluting stents were used in an off-label manner in 59% of patients. The patients who received off-label treatment were more often male, had a higher incidence of prior infarction and bypass surgery, and lower ejection fractions. Off-label versus "on-label" use of DES was associated with higher rates of death, myocardial infarction, target vessel revascularization, major adverse cardiac events, and stent thrombosis at 9 months and 2 years. Off-label use of DES compared with off-label use of bare-metal stents (BMS) had lower rates of death, myocardial infarction, target vessel revascularization, and major adverse cardiac events at 9 months and 2 years and lower rates of stent thrombosis at 9 months.

Conclusions: Off-label use of DES is associated with higher event rates compared with on-label use of DES, which is consistent with a higher risk clinical and lesion profile. However, event rates with off-label use of DES are lower compared with off-label use of BMS. Pending results from randomized trials, our data support the use of DES for off-label indications in selected patients.

Key Words: drug-eluting stents • off-label indications • percutaneous coronary intervention (PCI)

Abbreviations and Acronyms   BMS = bare-metal stent(s)   DES = drug-eluting stent(s)   MACE = major adverse cardiac events   PCI = percutaneous coronary intervention   STEMI = ST-segment elevation myocardial infarction   TLR = target lesion revascularization   TVR = target vessel revascularization

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