Off Label Indication of Drugs Eluting Stent: National Cardiovascular Center Harapan Kita’s Experiences
Abstract
Background. Food and Drug Administration (FDA) of Unites States set the indication of drug-eluting stent (DES) on the product label (on-label indication). In the clinical practice, many patients received DES implantation outside the indication (off-label indication). Several “real-world” register showed off-label implantation reach prevalence of 50-60% with wide-ranging clinical outcomes.Objectives. To report the frequency, procedural complications, stent thrombosis (ST) and major cardiovascular events (MACE) of DES implantation with off-label indication in the National Cardiac Center Harapan Kita.
Methods. This retrospective cohort study included patients who underwent coronary intervention with one or more DES (sirolimus or paclitaxel) implantation at 2006. Subjects were grouped into on-label and off-label indication. Subjects were followed-up until mid 2008.
Results. 196(59%) of total patients who received DES implantation in 2006 in PJNHK are on off-label indications. The most frequent off-label indication was long-lesion intervention. There were more patients with previous myocardial infarction, PCI and CABG in off-label group. No significant difference of procedural complication rates between on-label and off-label group (2.2% vs. 2.6%, P =0.57). There was no significant difference of stent thrombosis rate. There was higher incident of MACE in off-label than on-labelgroup (17.9% vs. 8.6%, P =0.03). This difference was most contributed by incident of cardiac death. The adjusted hazard ratio of off-label was 1.7 (95% CI 0.8 – 3.6; P = 0.16); with several confounding factors including previous cerebrovascular disease, creatinine clearance <60 mL/min, non-elective PCI and double antiplatelet cessation.
Conclusion. Off-label indication was quite frequent but has non-significant difference of TVR and ST rate compared to on-label indication. There was higher incident of MACE in off-label group, but this may be influenced by several clinical confounders.
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References
Win HK, Caldera AE, Maresh K, et al. Clinical outcomes and stent thrombosis following off-label use of drug-eluting stents. Jama 2007;297(18):2001-9.
Lagerqvist B, James SK, Stenestrand U, Lindback J, Nilsson T, Wallentin L. Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. The New England journal of medicine 2007;356(10):1009-19.
Qasim A, Cosgrave J, Latib A, Colombo A. Long-term follow-up of drug-eluting stents when inserted for on- and off-label indications. The American journal of cardiology 2007;100(11):1619-24.
Buttner HJ, Neumann FJ. Peeling-off labels mounting evidence for benefit of drug-eluting stents with off-label use. Journal of the American College of Cardiology 2007;50(21):2037-8.
Rao SV, Shaw RE, Brindis RG, Klein LW, Weintraub WS, Peterson ED. On- versus off-label use of drug-eluting coronary stents in clinical practice (report from the American College of Cardiology National Cardiovascular Data Registry [NCDR]). The American journal of cardiology 2006;97(10):1478-81.
Daemen J, Serruys PW. Drug-eluting stent update 2007: part II: Unsettled issues. Circulation 2007;116(8):961-8.
Lee MS, Kapoor N, Jamal F, et al. Comparison of coronary artery bypass surgery with percutaneous coronary intervention with drug-eluting stents for unprotected left main coronary artery disease. Journal of the American College of Cardiology 2006;47(4):864-70.
Steigen TK, Maeng M, Wiseth R, et al. Randomized study on simple versus complex stenting of coronary artery bifurcation lesions: the Nordic bifurcation study. Circulation 2006;114(18):1955-61.
Seung K-B, Kim Y-H, Park D-W, Lee B-K. Effectiveness of Sirolimus-Eluting Stent Implantation for the Treatment of Ostial Left Anterior Descending Artery Stenosis With Intravascular Ultrasound Guidance. Journal of the American College of Cardiology 2005;46:787-92.
Braden G. Chronic Total Coronary Occlusions. Cardiology clinics 2006;24:247–54.
Hoye A, Tanabe K, Lemos PA, et al. Significant reduction in restenosis after the use of sirolimus-eluting stents in the treatment of chronic total occlusions. Journal of the American College of Cardiology 2004;43(11):1954-8.
Ruchin PE, Muller DW, Faddy SC, Baron DW, Roy PR, Wilson SH. Long-term clinical follow-up of sirolimus-eluting (CYPHER) coronary stents in the treatment of instent restenosis in an unselected population. Heart, lung & circulation 2007;16(6):440-6.
Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115(17):2344-51.
Lubsen J, Kirwan BA. Combined endpoints: can we use them? Statistics in medicine 2002;21(19):2959-70.
Marroquin OC, Selzer F, Mulukutla SR, et al. A comparison of bare-metal and drug-eluting stents for off-label indications. The New England journal of medicine 2008;358(4): 342-52.
USFDA. Update to FDA Statement on Coronary Drug-Eluting Stents. Available at: http://wwwfdagov/crdhAccessed January 4 2007.
Grines CL. Off-label use of drug-eluting stents putting it in perspective. Journal of the American College of Cardiology 2008;51(6):615-7.
Beohar N, Davidson CJ, Kip KE, et al. Outcomes and complications associated with off-label and untested use of drug-eluting stents. Jama 2007;297(18):1992-2000.
Applegate RJ, Sacrinty MT, Kutcher MA, et al. “Off-label” stent therapy 2-year comparison of drug-eluting versus bare-metal stents. Journal of the American College of Cardiology 2008;51(6):607-14.
Roy P, Buch AN, Javaid A, et al. Impact of “off-label” utilization of drug-eluting stents on clinical outcomes in patients undergoing percutaneous coronary intervention. The American journal of cardiology 2008;101(3):293-9.
Lagerqvist B, James SK, Stenestrand U, Lindback J, Nilsson T, Wallentin L. Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. The New England journal of medicine 2007;356(10):1009-19.
Qasim A, Cosgrave J, Latib A, Colombo A. Long-term follow-up of drug-eluting stents when inserted for on- and off-label indications. The American journal of cardiology 2007;100(11):1619-24.
Buttner HJ, Neumann FJ. Peeling-off labels mounting evidence for benefit of drug-eluting stents with off-label use. Journal of the American College of Cardiology 2007;50(21):2037-8.
Rao SV, Shaw RE, Brindis RG, Klein LW, Weintraub WS, Peterson ED. On- versus off-label use of drug-eluting coronary stents in clinical practice (report from the American College of Cardiology National Cardiovascular Data Registry [NCDR]). The American journal of cardiology 2006;97(10):1478-81.
Daemen J, Serruys PW. Drug-eluting stent update 2007: part II: Unsettled issues. Circulation 2007;116(8):961-8.
Lee MS, Kapoor N, Jamal F, et al. Comparison of coronary artery bypass surgery with percutaneous coronary intervention with drug-eluting stents for unprotected left main coronary artery disease. Journal of the American College of Cardiology 2006;47(4):864-70.
Steigen TK, Maeng M, Wiseth R, et al. Randomized study on simple versus complex stenting of coronary artery bifurcation lesions: the Nordic bifurcation study. Circulation 2006;114(18):1955-61.
Seung K-B, Kim Y-H, Park D-W, Lee B-K. Effectiveness of Sirolimus-Eluting Stent Implantation for the Treatment of Ostial Left Anterior Descending Artery Stenosis With Intravascular Ultrasound Guidance. Journal of the American College of Cardiology 2005;46:787-92.
Braden G. Chronic Total Coronary Occlusions. Cardiology clinics 2006;24:247–54.
Hoye A, Tanabe K, Lemos PA, et al. Significant reduction in restenosis after the use of sirolimus-eluting stents in the treatment of chronic total occlusions. Journal of the American College of Cardiology 2004;43(11):1954-8.
Ruchin PE, Muller DW, Faddy SC, Baron DW, Roy PR, Wilson SH. Long-term clinical follow-up of sirolimus-eluting (CYPHER) coronary stents in the treatment of instent restenosis in an unselected population. Heart, lung & circulation 2007;16(6):440-6.
Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115(17):2344-51.
Lubsen J, Kirwan BA. Combined endpoints: can we use them? Statistics in medicine 2002;21(19):2959-70.
Marroquin OC, Selzer F, Mulukutla SR, et al. A comparison of bare-metal and drug-eluting stents for off-label indications. The New England journal of medicine 2008;358(4): 342-52.
USFDA. Update to FDA Statement on Coronary Drug-Eluting Stents. Available at: http://wwwfdagov/crdhAccessed January 4 2007.
Grines CL. Off-label use of drug-eluting stents putting it in perspective. Journal of the American College of Cardiology 2008;51(6):615-7.
Beohar N, Davidson CJ, Kip KE, et al. Outcomes and complications associated with off-label and untested use of drug-eluting stents. Jama 2007;297(18):1992-2000.
Applegate RJ, Sacrinty MT, Kutcher MA, et al. “Off-label” stent therapy 2-year comparison of drug-eluting versus bare-metal stents. Journal of the American College of Cardiology 2008;51(6):607-14.
Roy P, Buch AN, Javaid A, et al. Impact of “off-label” utilization of drug-eluting stents on clinical outcomes in patients undergoing percutaneous coronary intervention. The American journal of cardiology 2008;101(3):293-9.
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How to Cite
Ariwibowo, D., Tobing, D., Ng, S., Munawar, M., & Soerianata, S. (1). Off Label Indication of Drugs Eluting Stent: National Cardiovascular Center Harapan Kita’s Experiences. Indonesian Journal of Cardiology, 29(2), 71-79. https://doi.org/10.30701/ijc.v29i2.190
Section
Clinical Research
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