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• W2297363020 abstract "The past 3 decades have been marked by extraordinary advancements in percutaneous coronary intervention (PCI) including advancements in the design, safety, and efficacy of stents. Although the groundbreaking development of the bare-metal stent (BMS) greatly reduced the incidence of acute vessel closure and target lesion revascularization associated with balloon angioplasty, the advent of the antiproliferative drug-eluting stent (DES) has further lead to significant reductions in in-stent restenosis.1Simard T. Hibbert B. Ramirez F.D. et al.The evolution of coronary stents: a brief review.Can J Cardiol. 2014; 30: 35-45Abstract Full Text Full Text PDF PubMed Scopus (113) Google Scholar However, the actual use of the DES in clinical practice has been widely variable, following the typical phases of product lifecycle over the years—unbridled enthusiasm, false sense of security, rude awakening, resetting of expectations, and persistent mistrust.2Bangalore S. Gupta N. Guo Y. Feit F. Trend in the use of drug eluting stents in the United States: insight from over 8.1 million coronary interventions.Int J Cardiol. 2014; 175: 108-119Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar The introduction of the first-generation DES (in 2003) led to an explosive shift (unbridled enthusiasm, false sense of security) away from the use of the BMS, until 2007 amidst reports of a 23% greater risk of late and very late stent thrombosis (rude awakening) with the use of the DES compared with the BMS.3Lagerqvist B. James S.K. Stenestrand U. et al.Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden.N Engl J Med. 2007; 356: 1009-1019Crossref PubMed Scopus (1135) Google Scholar This increased risk of stent thrombosis resulted in a decline in the use of the first-generation DES as a consequence of concerns of patient compliance with prolonged dual antiplatelet therapy (DAPT).2Bangalore S. Gupta N. Guo Y. Feit F. Trend in the use of drug eluting stents in the United States: insight from over 8.1 million coronary interventions.Int J Cardiol. 2014; 175: 108-119Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar The most recent Canadian Cardiovascular Society and the American College of Cardiology/American Heart Association guidelines provide class I recommendations to use a BMS in patients with high bleeding risk, inability to comply with 1 year of DAPT, or anticipated invasive procedures in the next year.4Levine G.N. Bates E.R. Blankenship J.C. et al.2015 ACC/AHA/SCAI focused update on primary percutaneous coronary intervention for patients with ST-elevation myocardial infarction: an update of the 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention and the 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Society for Cardiovascular Angiography and Interventions.Circulation. 2016; 133: 1135-1147Crossref PubMed Scopus (313) Google Scholar, 5Love M.P. Schampaert E. Cohen E.A. et al.The Canadian Association of Interventional Cardiology and the Canadian Cardiovascular Society joint statement on drug-eluting stents.Can J Cardiol. 2007; 23: 121-123Abstract Full Text PDF PubMed Scopus (16) Google Scholar However, continued developments have led to tremendous improvements in DES design including thinner struts, thinner and more biocompatible polymer such that the second-generation everolimus and zotarolimus-eluting stents provide for faster vascular healing6Kim J.S. Kim J.H. Shin D.H. et al.Serial randomized comparison of strut coverage of everolimus- and first-generation sirolimus-eluting stents.Can J Cardiol. 2015; 31: 723-730Abstract Full Text Full Text PDF PubMed Scopus (15) Google Scholar with superior clinical performance including reduction in restenosis, stent thrombosis, death, or MI when compared with a BMS alone.7Bangalore S. Kumar S. Fusaro M. et al.Short- and long-term outcomes with drug-eluting and bare-metal coronary stents: a mixed-treatment comparison analysis of 117 762 patient-years of follow-up from randomized trials.Circulation. 2012; 125: 2873-2891Crossref PubMed Scopus (485) Google Scholar, 8Bangalore S. Toklu B. Amoroso N. et al.Bare metal stents, durable polymer drug eluting stents, and biodegradable polymer drug eluting stents for coronary artery disease: mixed treatment comparison meta-analysis.BMJ. 2013; 347: f6625Crossref PubMed Scopus (247) Google Scholar As such, the second-generation DES, especially the everolimus-eluting stent, have been touted to be safer than that of a BMS.7Bangalore S. Kumar S. Fusaro M. et al.Short- and long-term outcomes with drug-eluting and bare-metal coronary stents: a mixed-treatment comparison analysis of 117 762 patient-years of follow-up from randomized trials.Circulation. 2012; 125: 2873-2891Crossref PubMed Scopus (485) Google Scholar, 8Bangalore S. Toklu B. Amoroso N. et al.Bare metal stents, durable polymer drug eluting stents, and biodegradable polymer drug eluting stents for coronary artery disease: mixed treatment comparison meta-analysis.BMJ. 2013; 347: f6625Crossref PubMed Scopus (247) Google Scholar Consequently, the use of a second-generation DES has arguably become the standard of care in revascularization, from the standpoint of not only efficacy but also safety.2Bangalore S. Gupta N. Guo Y. Feit F. Trend in the use of drug eluting stents in the United States: insight from over 8.1 million coronary interventions.Int J Cardiol. 2014; 175: 108-119Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar Yet, despite the trends in increased DES utilization nationally, data from several studies show a persistence in the disparate use of the DES, with decreased use among the African-American and Hispanic populations, and among lower-income or nonprivate insurance holders,2Bangalore S. Gupta N. Guo Y. Feit F. Trend in the use of drug eluting stents in the United States: insight from over 8.1 million coronary interventions.Int J Cardiol. 2014; 175: 108-119Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar, 9Yong C.M. Abnousi F. Asch S.M. Heidenreich P.A. Socioeconomic inequalities in quality of care and outcomes among patients with acute coronary syndrome in the modern era of drug eluting stents.J Am Heart Assoc. 2014; 3: e001029Crossref Scopus (49) Google Scholar a trend that mirrors many other disparities in medicine in which these same subgroups are less likely to be provided with standard of care treatments, particularly with regard to expensive interventions, such as PCI.10Ferguson J.A. Tierney W.M. Westmoreland G.R. et al.Examination of racial differences in management of cardiovascular disease.J Am Coll Cardiol. 1997; 30: 1707-1713Abstract Full Text Full Text PDF PubMed Scopus (68) Google Scholar, 11Sonel A.F. Good C.B. Mulgund J. et al.Racial variations in treatment and outcomes of black and white patients with high-risk non-ST-elevation acute coronary syndromes: insights from CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA Guidelines?).Circulation. 2005; 111: 1225-1232Crossref PubMed Scopus (188) Google Scholar Moreover, these individual groups have worse outcomes, of which ischemic heart disease is no exception.12Kumar R.S. Douglas P.S. Peterson E.D. et al.Effect of race and ethnicity on outcomes with drug-eluting and bare metal stents: results in 423 965 patients in the linked National Cardiovascular Data Registry and centers for Medicare and Medicaid services payer databases.Circulation. 2013; 127: 1395-1403Crossref PubMed Scopus (51) Google Scholar In this issue of the Canadian Journal of Cardiology, Hannan and colleagues13Hannan E.L. Racz M.J. Walford G. et al.Disparities in the use of drug-eluting coronary stents by race, ethnicity, payer, and hospital.Can J Cardiol. 2016; 32: 987.e25-987.e31Scopus (11) Google Scholar present the results of an analysis of the New York State registry of 84,643 patients who underwent PCI with placement of a DES and/or BMS between 2011 and 2012. Although most patients (83.2%) received a DES, (of which 91.3% were a second-generation DES), the authors found significant variability in the utilization of the DES on the basis of race, ethnicity, and insurance status, with patients of Hispanic ethnicity, African-American race, and nonprivate insurance holders independently less likely to receive a DES. Moreover, these disparities persisted despite controlling for complex patient comorbidities that might influence providers to preferentially select a BMS on the basis of a perceived safety advantage, such as contraindication to antiplatelet therapy or stent thrombosis. In addition to variability in stent use according to race, the authors identified significant variability in DES use according to the surgeon (15% to 100% usage) and according to the hospital (52% to 90%). Why does this trend in differential utilization persistent among racial and socioeconomic groups, even in the modern era of appropriate increased DES utilization? One must question if there is an inherent difference in outcomes according to stent type on the basis of racial group or socioeconomic status. Traditionally, racial minorities are under-represented in PCI clinical trials. Are there heterogeneous efficacy and safety profiles of stent types on the basis of race that might justify this disparity? In a recent study, Olafiranye et al. reported consistent superiority of the DES compared with the BMS across racial groups, with DES use associated with lower rates of death or MI in African American and white patients as well as lower rates of repeat revascularization, with no significant difference in stent thrombosis between racial groups.14Olafiranye O. Vlachos H. Mulukutla S.R. et al.Comparison of long-term safety and efficacy outcomes after drug-eluting and bare-metal stent use across racial groups: insights from NHLBI Dynamic Registry.Int J Cardiol. 2015; 184: 79-85Abstract Full Text Full Text PDF PubMed Scopus (9) Google Scholar As such, these data should validate the use of a DES over a BMS in all patients regardless of race. One might speculate that perception of patient compliance with antiplatelet therapy might provide a rationale for the favoured use of a BMS in certain patients, or by certain providers, because current guidelines recommend only 1 month of DAPT after BMS placement.4Levine G.N. Bates E.R. Blankenship J.C. et al.2015 ACC/AHA/SCAI focused update on primary percutaneous coronary intervention for patients with ST-elevation myocardial infarction: an update of the 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention and the 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Society for Cardiovascular Angiography and Interventions.Circulation. 2016; 133: 1135-1147Crossref PubMed Scopus (313) Google Scholar As a result, surgeons might perceive the BMS to be safer secondary to a shorter mandatory duration of DAPT with lower rates of stent thrombosis. The data on safety of 1-month DAPT for patients with BMS implantation is not supported by randomized trial data. In the DAPT trial of 12- vs 30-month DAPT, extended DAPT (30 months) reduced the risks of stent thrombosis and major adverse cardiovascular and cerebrovascular events but increased risk of bleeding in patients who had placement of a DES.15Mauri L. Kereiakes D.J. Yeh R.W. et al.Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents.N Engl J Med. 2014; 371: 2155-2166Crossref PubMed Scopus (1490) Google Scholar The authors noted that there was no significant interaction between stent type (DES vs BMS) and outcomes such that the benefits of extended DAPT were applicable even to patients who received a BMS.16Kereiakes D.J. Yeh R.W. Massaro J.M. et al.Antiplatelet therapy duration following bare metal or drug-eluting coronary stents: the dual antiplatelet therapy randomized clinical trial.JAMA. 2015; 313: 1113-1121Crossref PubMed Scopus (85) Google Scholar Although there is no effective way to capture the perception of patient compliance for study purposes, because of the superiority of the second-generation DES from safety and efficacy standpoints, is it acceptable to withhold this treatment on the basis of concerns of adherence to long-term DAPT? The optimal duration of continuing DAPT is controversial, with mounting evidence that shorter-duration treatment, potentially as minimal as 3-6 months, might be sufficient with the second-generation DES in certain clinical scenarios, such as stable coronary artery disease or low-risk acute coronary syndrome patients.17Feres F. Costa R.A. Abizaid A. et al.Three vs twelve months of dual antiplatelet therapy after zotarolimus-eluting stents: the OPTIMIZE randomized trial.JAMA. 2013; 310: 2510-2522PubMed Google Scholar, 18Costa F. Vranckx P. Leonardi S. et al.Impact of clinical presentation on ischaemic and bleeding outcomes in patients receiving 6- or 24-month duration of dual-antiplatelet therapy after stent implantation: a pre-specified analysis from the PRODIGY (Prolonging Dual-Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia) trial.Eur Heart J. 2015; 36: 1242-1251Crossref PubMed Scopus (72) Google Scholar, 19El-Hayek G. Messerli F. Bangalore S. et al.Meta-analysis of randomized clinical trials comparing short-term versus long-term dual antiplatelet therapy following drug-eluting stents.Am J Cardiol. 2014; 114: 236-242Abstract Full Text Full Text PDF PubMed Scopus (65) Google Scholar Providers should be further reassured that even for patients at high risk for bleeding or thrombotic complications, a cohort of patients traditionally excluded from PCI trials, implantation of a DES with a truncated course of DAPT—as little as 1 month—resulted in markedly superior outcomes with a significant reduction in the overall rates of MI, target vessel revascularization, a composite of death or MI, and stent thrombosis in favour of the DES (specifically zotarolimus stents) over BMS.20Valgimigli M. Patialiakas A. Thury A. et al.Zotarolimus-eluting versus bare-metal stents in uncertain drug-eluting stent candidates.J Am Coll Cardiol. 2015; 65: 805-815Abstract Full Text Full Text PDF PubMed Scopus (224) Google Scholar These impressive findings and additional mounting evidence must shift our mentality as clinicians that the second-generation DES should represent the benchmark of safety in PCI. Finally, one of the potential reasons for the variability in the use of stents is the cost difference between the DES and the BMS. However, such upfront cost savings with a BMS should be weighed against increased overall cost because of longer-term increase in the rates of restenosis, stent thrombosis, myocardial infarction, and death.21Ferko N. Ferrante G. Hasegawa J.T. et al.TCT-566 cost-effectiveness of the Xience cobalt chromium everolimus eluting stent compared with bare metal stents: a United States payer perspective.J Am Coll Cardiol. 2015; 66Google Scholar Moreover, the wide variability in hospital utilization of the DES could be the result of decreased awareness of the physician of the improved safety of the second-generation DES and residual effect of the safety concerns of the first-generation DES. Although Hannan et al.13Hannan E.L. Racz M.J. Walford G. et al.Disparities in the use of drug-eluting coronary stents by race, ethnicity, payer, and hospital.Can J Cardiol. 2016; 32: 987.e25-987.e31Scopus (11) Google Scholar evaluated DES use patterns in 2011 and 2012, there have been a number of publications since then attesting to the safety of the second-generation DES and it will be interesting to see if the magnitude of variability across hospitals and between patients would decrease in more recent time periods. In conclusion, Hannan et al. highlight practice inconsistencies among surgeons, independent of patient characteristics, which ultimately raise concerns over the physician's perceptions of safety and efficacy when selecting stent type. There most certainly might be complex patient characteristics that cannot be captured in this retrospective study, however one must question for whom a BMS is deemed appropriate. Most importantly, the authors identify important and ongoing issues in health care disparities and quality of care in cardiology as preferential treatments, seemingly influenced by income, race, and insurance payer, have not yet been mitigated despite clear superiority of the newer-generation DES over the BMS. Sripal Bangalore has received grant support from Abbott Vascular and honoraria from Abbott Vascular and travel grants from Boston Scientific and Medtronic. Mina Owlia has no conflicts of interest to disclose." @default.
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• W2297363020 title "Is the Use of Bare-Metal Stents Justifiable in the Era of Second-Generation Drug-Eluting Stents?" @default.
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