The fact that we are still debating the utility of the bare metal stent (BMS) in 2009 would have seemed unthinkable when the first drug-eluting stent (DES) was approved by the Food and Drug Administration for clinical use in the U.S. in 2003. Within two months, the demand for DES had exceeded supply and the competition with the BMS had become a one-horse race. The anti-restenotic benefits of DES were quickly established in multiple patient and lesion subsets and the use of these devices became ubiquitous.1 However, the euphoria over the conquest of restenosis soon turned to worry about late stent thrombosis and concerns emerged regarding long-term safety of drug-eluting stents.2,3 Data from the BASKET-/ BASKET-LATE trial demonstrated a reduction in reintervention rates with DES but there was an increased risk of death and myocardial infarction with DES when focusing exclusively on outcomes beyond 6 months after DES implantation.4 Corroborating evidence emerged suggesting worsening endothelial function and collateral flow with DES and registry data suggested worse mortality in patients treated with DES.5–7 The pendulum quickly swung the other way even while data supporting safety of DES started to accumulate.8,9 During the last years, the use of DES has again started to dominate clinical practice10 and the love affair of the interventional cardiology community with the DES continues, albeit with ongoing reflection.
In this issue of JIC, Yock and colleagues11 address the impact of DES on reintervention rates in the “real world.” The authors present the results of their study of 1-year follow up data from a large prospective multicenter registry. They compared reintervention rates of 14,459 patients treated between 1998 and 2003 with a BMS and 9,575 patients treated with a drug-eluting stent DES in 2005. The authors found a significantly lower rate for target lesion revascularization for DES compared to DES (4.7% vs. 8.1%), but this lower rate was equalized when accounting for procedures in previously remote segments (7.8% vs. 4.3%) resulting in an overall re-intervention rate of 12.5% vs. 12.3%. This definitely represents an interesting finding which may have been neglected in previous studies where the focus usually was on target-lesion or target-vessel revascularization. This study nicely illustrates that advances in medical treatment are rarely associated with a cost reduction.
Some limitations of the study must be recognized. Rather than directly comparing BMS to DES, the study compares outcomes from two different eras, the BMS only and the DES era. The introduction of DES was accompanied by use of percutaneous coronary interventions (PCI) in patients with more extensive disease and those at higher risk of restenosis. In the pre-DES era, these patients were likely referred for surgical revascularization. Further, a large number of interventions in the DES cohort were performed within the first 2 months after the index intervention suggesting staging of procedures and likely the presence of more complex disease. Also, it is somewhat problematic that more than 2,000 patients were excluded due to incomplete data and selection bias cannot be excluded.
Nevertheless, the study provides an important societal perspective. The use of DES reduces target lesion revascularization but the simultaneous change in clinical practice with interventions in patients with more advanced disease resulted in an increase in reinterventions in remote areas. Thus, the true economic impact of the shift from BMS to DES cannot be simply gauged from a comparison of PCI costs. Such an estimate would involve the impact of CABG avoided, the extra cost of prolonged dual anti-platelet therapy, the cost of extra bleeding events and rehospitalizations associated with revascularization and stent thrombosis, and the healthcare related episodic loss of economic productivity. It is unclear however if the results of such an analysis would support universal DES use, but the falling DES cost may have improved the cost effectiveness of DES compared with earlier analysis.
We would like to conclude by echoing the authors: “The effect of DES on repeat PCI procedures in routine clinical practice is more complex than suggested by pivotal randomized trials.” This study certainly provides interesting information regarding real-world use of DES and BMS and adds to the ongoing debate on reasons for differences in outcomes between randomized controlled “perfect world” data and observational “real-world” data.12 The indication for PCI continues to evolve over time, we are able to do more complex interventions and treat sicker patients thanks to the progress in interventional technology, technique and pharmacotherapy and that this fact, overall, counterbalances the reduced need for reinterventions. The true cost effectiveness of such an approach remains a ripe target for further research.
From the University of Michigan Cardiovascular Center, Ann Arbor, Michigan, and Veterans Affairs Ann Arbor Health Care system, Ann Arbor, Michigan.
The authors report no conflicts of interest regarding the content herein.
Address for correspondence: Dr. Hitinder Gurm, University of Michigan Cardiovascular Center, 2A394, 1500 E. Medical Center Drive, Ann Arbor, MI 48109-5853. E-mail: hgurm@med.umich.edu
1. Boyden TF, Nallamothu BK, Moscucci M, Chan PS, Grossman PM, Tsai TT, Chetcuti SJ, Bates ER, Gurm HS. Meta-analysis of randomized trials of drug-eluting stents versus bare metal stents in patients with diabetes mellitus. Am J Cardiol 2007;99:1399–1402.
2. Lagerqvist B, James SK, Stenestrand U, et al. Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. N Engl J Med 2007;356:1009–1019.
3. Bavry AA, Kumbhani DJ, Helton TJ, et al. Late thrombosis of drug-eluting stents: A meta-analysis of randomized clinical trials. Am J Med 2006;119:1056–1061.
4. Pfisterer M, Brunner-La Rocca HP, et al. Long-term benefit-risk balance of drug-eluting vs. bare-metal stents in daily practice: Does stent diameter matter? Three-year follow-up of BASKET. Eur Heart J 2009;30:16–24.
5. Togni M, Windecker S, Cocchia R, et al. Sirolimus-eluting stents associated with paradoxic coronary vasoconstriction. J Am Coll Cardiol 2005;46:231–236.
6. Meier P, Zbinden R, Togni M, et al. Coronary collateral function long after drug-eluting stent implantation. J Am Coll Cardiol 2007;49:15–20.
7. Steg PG, Fox KA, Eagle KA, et al. Mortality following placement of drug-eluting and bare-metal stents for ST-segment elevation acute myocardial infarction in the Global Registry of Acute Coronary Events. Eur Heart J 2009;30:321–329.
8. Roe MT, Chen AY, Cannon CP, et al, Participants ObotCaAGR. Temporal changes in the use of drug-eluting stents for patients with non–ST-segment-elevation myocardial infarction undergoing percutaneous coronary intervention from 2006 to 2008. Circ Cardiovasc Qual Outcomes (published online ahead of print Jul 28, 2009) 2009.
9. James SK, Stenestrand U, Lindback J, et al. Long-term safety and efficacy of drug-eluting versus bare-metal stents in Sweden. N Engl J Med 2009;360:1933–1945.
10. Gualano S, Gurm H, Share D, et al. Temporal trends in the use of drug eluting stents for approved and off-label indications: A longitudinal analysis of a large multi-center PCI registry. Cardiology 2010;in press.
11. Yock CA, Isbill JM, King SB III, Hlatky MA. Repeat coronary revascularization procedures after bare-metal or drug-eluting stent implantation J Invasive Cardiol 2010;22:27–33.
12. Nallamothu BK, Hayward RA, Bates ER. Beyond the randomized clinical trial: The role of effectiveness studies in evaluating cardiovascular therapies. Circulation 2008;118:1294–1303.
