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A strategy of oral rapamycin plus bare metal stenting (BMS) is more cost-effective at 5 years than using first-generation drug-eluting stents (DES), according to a study published online December 16, 2013, ahead of print in American Journal of Cardiology. Oral rapamycin and BMS also led to a reduction in adverse events and mortality compared with DES with no difference in efficacy.
For the ORAR (Oral Rapamycin in ARgentina) 3 trial, Alfredo E. Rodriguez, MD, PhD, of Centro de Estudios en Cardiología Intervencionista (Buenos Aires, Argentina), and colleagues randomized 200 patients with de novo stenosis to receive oral rapamycin plus BMS (n = 100; 131 vessels and 158 lesions) or first-generation DES (n = 100; 142 vessels and 170 lesions) from January 2006 to September 2007 at 3 Argentinian hospitals. A total of 347 stents were implanted; DES included:
BMS Cheaper than DES in the Long-term
At 1, 3, and 5 years, cumulative cost was higher with DES (P < 0.001 for all), though clinical outcomes were similar at 1 and 3 years. At 5 years, the majority of cost components were all higher for DES compared with BMS (table 1).
Table 1. Initial Procedure and Follow-up Costs at 5 Years
Oral Rapamycin + BMS(n = 100)
DES(n = 100)
Overall Initial Costs
Follow-up CostsHospital Discharge to 1 Year1-5 Years0-5 Years
Cost differences were driven by a higher incidence of TVR after 1 year in the DES group (P < 0.001). Additionally, average follow-up cost for patients with adverse cardiac events was higher in those treated with DES compared with BMS ($10,727.70 vs. $6,588.70; P < 0.001).
At 5 years, rates of mortality, MACE (death, MI, and cerebrovascular accident), and any stent thrombosis were higher with DES than BMS, and TLR, TVR, and TVF were numerically higher (table 2).
Table 2. Clinical Outcomes at 5 Years
RR (95 % CI)
Any Stent Thrombosis
When patients were stratified by age, those younger than 65 reported similar outcomes regardless of randomization. However, in those 65 and older, rapamycin and BMS was favored over DES in terms of the incidence of MACE (P = 0.026), MI (P = 0.05), and TVF (P = 0.06) at 5 years. Elderly patients treated with DES also had more frequent hospital admissions during follow-up than those treated with BMS (P = 0.011).
In an overall multivariate analysis, DES assignment was the only independent predictor of poor outcomes at 5 years (RR 2.22; 95% CI 1.12-4.43; P = 0.022). Within the DES group, multivessel disease was the only independent predictor of MACE (RR 2.65; 95% CI 1.19-5.09; P = 0.017).
Dr. Rodriguez and colleagues observe that in contrast with prior studies, “patients in the [oral rapamycin] plus BMS group had an unpredicted, but significant, reduction in mortality and MACE.”
They say the cost-effectiveness advantage BMS can be explained by “the high procedural cost of DES and its requirements for long-term antiplatelet therapy [were] never counterbalanced, since repeat revascularization procedures beyond 1 year increased more” with DES vs. BMS, the authors explain. “Furthermore . . . patients who suffered cardiovascular complications during follow-up developed significantly higher in-hospital costs [with DES vs. BMS].”
The authors acknowledge that“[f]irst-generation DES used in ORAR-3 [have] been largely replaced by the newer-generation DES, which [have] shown better clinical outcomes. Therefore, the study results cannot be directly applied to compare [oral rapamycin] plus BMS against current-generation
DES and additional studies are warranted.”
All patients received aspirin 325 mg daily and a loading dose of clopidogrel 300 mg followed by 75 mg daily for 1 month in the BMS group and 1 year in the DES group.