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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Outcome of Drug-Eluting Versus Bare-Metal Stenting Used According to On- and Off-Label Criteria

Jörg Carlsson, MD, PhD^_*,_*, Stefan K. James, MD, PhD, Johan Lindbäck, PhD, Fredrik Scherstén, MD, PhD, Tage Nilsson, MD, PhD, Ulf Stenestrand, MD, PhD, Bo Lagerqvist, MD, PhD for the SCAAR (Swedish Coronary Angiography and Angioplasty Registry) Study Group

^_* Department of Internal Medicine, Division of Cardiology, Kalmar County Hospital, Kalmar, Sweden
Uppsala Clinical Research Center, Uppsala University Hospital, Uppsala, Sweden
Department of Cardiology, Helsingborg Hospital, Helsingborg, Sweden
Department of Cardiology, Linköping University Hospital, Linköping, Sweden

Manuscript received June 5, 2008; revised manuscript received August 8, 2008, accepted September 18, 2008.

^_* Reprint requests and correspondence: Dr. Jörg Carlsson, Länssjukhuset i Kalmar, Lasarettsvägen, S-39185 Kalmar, Sweden (Email: jorgc{at}ltkalmar.se).

Objectives: The aim of this study was to investigate the outcome of bare-metal stents (BMS) versus drug-eluting stents (DES) after on-label as well as off-label use.

Background: DES lower restenosis rates while not influencing the risk for death and myocardial infarction when used in Federal Food and Drug Administration (FDA)-approved indications. It is debated whether the clinical results of this so-called on-label use might be extrapolated to off-label situations.

Methods: The SCAAR (Swedish Coronary Angiography and Angioplasty Registry) was used to investigate the outcomes in 17,198 patients who underwent stenting with an on-label indication (10,431 BMS and 6,767 DES patients) and 16,355 patients in the context of an off-label indication (9,907 BMS and 6,448 DES patients). The patients were included from 2003 to 2005 with a minimum follow-up of 1 year and a maximum of 4 years. The analysis was adjusted for differences in baseline characteristics.

Results: There were not significant differences between on-label DES and BMS (adjusted hazard ratio: 1.02; 95% confidence interval: 0.92 to 1.13) or between off-label DES and BMS (adjusted hazard ratio: 0.95; 95% confidence interval: 0.87 to 1.04) use with regard to the incidence of myocardial infarction and death. Off-label use of DES did not lead to significant differences in the combined risk of death and myocardial infarction compared with BMS throughout the whole spectrum of clinical indications.

Conclusions: In contemporary Swedish practice, neither on- nor off-label use of DES is associated with worse outcome than use of BMS.

Key Words: BMS • DES • off-label • on-label • outcome

Abbreviations and Acronyms   BMS = bare-metal stent(s)   CABG = coronary artery bypass graft   CAD = coronary artery disease   CI = confidence interval   DES = drug-eluting stent(s)   IQR = interquartile range   MI = myocardial infarction   PCI = percutaneous coronary intervention   RR = relative risk   SES = sirolimus-eluting stent(s)   STEMI = ST-segment elevation myocardial infarction

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