"Off-Label" Stent Therapy2-Year Comparison of Drug-Eluting Versus Bare-Metal Stents
Robert J. Applegate, MD, FACC*,
Matthew T. Sacrinty, MPH,
Michael A. Kutcher, MD, FACC,
Renato M. Santos, MD, FACC,
Sanjay K. Gandhi, MD, FACC,
Talal T. Baki, MD, FACC and
William C. Little, MD, FACC
Section of Cardiology, Wake Forest University School of Medicine, Winston-Salem, North Carolina.
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Figure 1 Kaplan-Meier Plots of Cumulative Events for BMS and DES up to 2 Years
The number of patients at risk for each follow-up period is given below each graph. All adverse outcomes were lower with drug-eluting stents (DES) than with bare-metal stents (BMS), whereas cumulative stent thrombosis rates were similar. MI = myocardial infarction.
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Figure 2 Kaplan-Meier Plots of Cumulative Events up to 2 Years for "On-Label" and "Off-Label" BMS and DES Indications
The number of patients at risk for each follow-up period is given below the graph. All adverse outcomes were lower with DES than with BMS for both "on-label" and "off-label" indications, and event rates were lower for "on-label" compared with "off-label" indications regardless of stent type. Abbreviations as in Figure 1.
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Figure 3 Timing of Stent Thrombosis up to 2 Years
No stent thrombosis occurred with "on-label" indications, although late stent thrombosis >1 year occurred only with "off-label" DES use. Abbreviations as in Figure 1.
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Figure 4 Hazard Ratio of Nonfatal MI or Death Comparing BMS With DES by Subgroup
The hazard of nonfatal MI or death was lower for DES use than for BMS use in all high-risk subgroups evaluated. *Number of patients who did not have censored follow-up data before 2 years.  Eight patients did not have history of renal failure data available.  Seven patients did not have diabetes mellitus data available. ACS = acute coronary syndrome; CHF = congestive heart failure; CI = confidence interval; other abbreviations as in Figure 1.
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