The aim of this study was to compare 5-year cost-effectiveness and clinical outcomes
of patients with oral rapamycin (OR) plus bare-metal stent versus the drug-eluting
stent (DES) strategy. During 2006 to 2007, a total of 200 patients were randomized
to OR (n = 100) and DES (n = 100). Primary end point was to compare costs of initial
procedure and cost-effectiveness of both revascularization strategies. Safety was
evaluated by the composite of death, myocardial infarction, and cerebrovascular accident.
Efficacy was assessed by target vessel and target lesion revascularizations. The 2
groups had similar baseline demographic, clinical, and angiographic characteristics.
In the DES group, paclitaxel-, zotarolimus-, and sirolimus-eluting stents were used.
Five-year clinical follow-up was accomplished in 99% patients. The DES group had significantly
higher procedural (p <0.001), discharge to first-year (p = 0.02), and 1- to 5-year
costs (p <0.001) compared with the OR group. At 5 years, the composite end point of
death, myocardial infarction, and cerebrovascular accident (12% in the OR group vs
25% in the DES group, p = 0.01) was significantly less in the OR group. Target vessel
revascularization (14.5% in the OR group vs 21% in the DES group, p = 0.16) and target
lesion revascularization (10% in the OR group vs 17.6% in the DES group, p = 0.05)
were not significantly different. In conclusion, a strategy of OR plus bare-metal
stent was cost saving than a first-generation DES.
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References
- Percutaneous coronary intervention with oral sirolimus and bare metal stents has comparable safety and efficacy to treatment with drug eluting stents, but with significant cost saving: long-term follow-up results from the randomized, controlled ORAR III (Oral Rapamycin in ARgentina) study.Euro Intervention. 2009; 5: 255-264
- Randomized comparison of cost-saving and effectiveness of oral rapamycin plus bare-metal stents with drug-eluting stents: three-year outcome from the randomized oral rapamycin in Argentina (ORAR) III trial.Catheter Cardiovasc Interv. 2012; 80: 385-394
- Revascularization strategies of coronary multiple vessel disease in the drug eluting stent era: one year follow-up results of the ERACI III trial.Euro Intervention. 2006; 2: 53-60
- Coronary stent thrombosis in the current drug eluting stent era: insights from the ERACI III trial.J Am Coll Cardiol. 2006; 47: 205-207
- Identifying stent thrombosis, a critical appraisal of the Academic Research Consortium (ARC) consensus definitions: a lighthouse and as a toe in the water.Euro Intervention. 2008; 4: C39-C44
- Cost-Effectiveness in Health and Medicine.Oxford University Press, 1996
- Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery.N Engl J Med. 2003; 349: 1315-1323
- Comparison of a polymer based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial.JAMA. 2005; 294: 1215-1223
- 5-Year clinical outcomes after sirolimus eluting stent implantation: insights from a patient-level pooled analysis of 4 randomized trials comparing sirolimus-eluting stents with bare-metal stents.J Am Coll Cardiol. 2009; 54: 894-902
- Long term safety and efficacy of paclitaxel eluting stents.J Am Coll Cardiol Intv. 2011; 4: 530-542
- Very late stent thrombosis and late target lesion revascularization after sirolimus-eluting stent implantation: five-year outcome of the j-Cypher Registry.Circulation. 2012; 125: 584-591
- The pathology of neoatherosclerosis in human coronary implants bare-metal and drug-eluting stents.J Am Coll Cardiol. 2011; 57: 1314-1322
- Five-year clinical and angiographic outcomes of a randomized comparison of sirolimus-eluting and paclitaxel-eluting stent: results of the Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization LATE trail.Circulation. 2011; 123: 2819-2828
- Comparative effectiveness of revascularization strategies.N Eng J Med. 2012; 366: 1467-1476
- Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial.Lancet. 2013; 381: 629-638
- Strategies for multivessel revascularization in patients with diabetes.N Engl J Med. 2012; 367: 2375-2384
- The effect of age on outcomes of coronary artery bypass surgery compared with balloon angioplasty or bare-metal stent implantation among patients with multivessel coronary disease. A collaborative analysis of individual patient data from 10 randomized trials.J Am Coll Cardiol. 2012; 60: 2150-2157
- Drug-eluting compared with bare-metal coronary stents among elderly.J Am Coll Cardiol. 2008; 51: 2017-2024
- Pilot study of oral rapamycin to prevent restenosis in patients undergoing Coronary stent therapy: Argentina Single-Center Study (ORAR Trial).J Invasive Cardiol. 2003; 15: 581-584
- Oral rapamycin to inhibit restenosis after stenting of de novo coronary lesions: the Oral Rapamune to Inhibit Restenosis (ORBIT) study.J Am Coll Cardiol. 2004; 44: 1386-1392
- Oral rapamycin after coronary bare-metal stent implantation to prevent restenosis: the Prospective, Randomized Oral Rapamycin in Argentina (ORAR II) Study.J Am Coll Cardiol. 2006; 47: 1522-1529
- Randomized, double-blind, placebo-controlled trial of oral sirolimus for restenosis prevention in patients with in-stent restenosis: the Oral Sirolimus to Inhibit Recurrent In-stent Stenosis (OSIRIS) trial.Circulation. 2004; 110: 790-795
- Systemic rapamycin without loading dose for restenosis prevention after coronary bare metal stent implantation.Catheter Cardiovasc Interv. 2010; 75: 317-325
- Immunosuppressive therapy for the prevention of restenosis after coronary artery stent implantation (IMPRESS Study).J Am Coll Cardiol. 2002; 40: 1935-1942
- Long-term clinical follow-up of the multicenter, randomized study to test immunosuppressive therapy with oral prednisone for the prevention of restenosis after percutaneous coronary interventions: Cortisone plus BMS or DES veRsus BMS alone to EliminAte Restenosis (CEREA DES).Eur Heart J. 2013 Jun; 34: 1740-1748
- Preventing restenosis after implantation of bare stents with oral rapamycin: a randomized angiographic and intravascular ultrasound study with a 5-year clinical follow-up.Cardiology. 2010; 115: 77-86
- Colchicine treatment for the prevention of bare-metal stent restenosis in diabetic patients.J Am Coll Cardiol. 2013; 61: 1679-1685
- Would SYNTAX have been a positive trial if XIENCE V have been used instead TAXUS? A meta-analysis of a first-generation vs a second generation drug-eluting system.Neth Heart J. 2010; 18: 451-453
- Cost effectiveness of DES in US Medicare system: a cost utility analysis of 3 years clinical follow up data.Value. Health. 2009; 12: 649-656
Article info
Publication history
Published online: December 16, 2013
Accepted:
November 14,
2013
Received in revised form:
November 14,
2013
Received:
September 17,
2013
Footnotes
A complete list of investigators is available in the Supplementary Data.
See page 820 for disclosure information.
Identification
Copyright
© 2014 Elsevier Inc. Published by Elsevier Inc. All rights reserved.