Outcomes and Complications With Off-Label Use of Drug-Eluting StentsResults 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.
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Figure 1 Study Population (9-Month Follow-Up)
Our study population (9-month follow-up) consists of all patients who had DES-only stents used for off-label indications and who had 9-month clinical follow-up. BMS = bare-metal stent(s); DES = drug-eluting stent(s); f/u = follow-up.
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Figure 2 Study Population (2-Year Follow-Up)
Our study population (2-year follow-up) consists of all patients who had DES-only stents used for off-label indications and who had 2 year clinical follow-up. Abbreviations as in Figure 1.
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Figure 3 Comparison of Event Rates Between Off-Label and On-Label Use of DES
Kaplan-Meier estimates comparing event rates at 9 months and 2 years between off-label and on-label use of DES: (A) target vessel revascularization (TVR), (B) death or myocardial infarction (Death/MI), and (C) stent thrombosis (ST). Abbreviations as in Figure 1.
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Figure 4 Comparison of Event Rates Between Off-Label Use of DES and BMS
Kaplan-Meier estimates comparing event rates at 9 months and 2 years between off-label use of DES and off-label use of BMS: (A) TVR, (B) death/MI, and (C) ST. Abbreviations as in Figures 1 and 3.
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Figure 5 Comparison of Event Rates Between DES and BMS in Subgroups of Off-Label Use
Adjusted 9-month outcomes in subgroups of off-label use comparing rates of TVR and death/MI between DES and BMS. BIFUR = bifurcation lesion; CTO = chronic total occlusion; ISR = in-stent restenosis; LL = long lesion; LM = left main artery; LV = large vessel; ML = multilesion percutaneous coronary intervention; MV = multivessel percutaneous coronary intervention; STEMI = ST-segment elevation myocardial infarction; SV = small vessel; SVG = saphenous vein graft; other abbreviations as in Figures 1 and 3.
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