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 randomised,  controlled ORAR III (Oral Rapamycin in ARgentina) study.
OBJECTIVE
Previous randomised studies have shown a significant reduction in restenosis when oral rapamycin (OR) is administered to patients undergoing bare metal stent (BMS) implantation. How this regimen compares to drug eluting stents (DES) is unknown.


RESULTS
Two-hundred patients with de novo coronary lesions were randomised to treatment with OR plus BMS (100 pts) or with DES (100 pts). OR was given as a bolus of 10 mg per day before PCI followed by daily doses of 3 mg during following 13 days. Primary endpoints were to compare hospital, follow-up and overall cost at one, two, three and five years of follow-up. The secondary endpoints included death, myocardial infarction (MI) and stroke and were analysed as major adverse cardiovascular events (MACCE). Target vessel (TVR) and target lesion revascularisation (TLR) were independently analysed. Costs included procedural resources, hospitalisation, medications, repeat revascularisation procedures and professional fees. Baseline demographic, clinical and angiographic characteristics were similar. At 18.3 +/- 7 months of follow-up, the initial strategy of OR plus BMS resulted in significant cost saving when compared to DES (p=0.0001). TLR rate was 8.2% with DES and 7.0% with OR plus BMS (p=0.84), similarly no differences in TVR rate in both groups was seen (10.6% and 10.5% in OR and DES group respectively, p=0.86). Non-inferiority testing, determined that DES therapy failed to be cost saving compared to OR in all possible cost scenarios.


CONCLUSIONS
A strategy of OR plus BMS is cost saving compared to DES in patients undergoing PCI for de novo coronary lesions.
Rodriguez
Alfredo E
AE
Cardiovascular Research Center (CECI), Sanatorio Otamendi, Buenos Aires, Argentina. rodrigueza@sanatorio-otamendi.com.ar
Maree
Andrew
A
Tarragona
Sonia
S
Fernandez-Pereira
Carlos
C
Santaera
Omar
O
Rodriguez Granillo
Alfredo M
AM
Rodriguez-Granillo
Gaston A
GA
Russo-Felssen
Miguel
M
Kukreja
Neville
N
Antoniucci
David
D
Palacios
Igor F
IF
Serruys
Patrick W
PW
D000284:Administration, Oral; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation* / Q000401:mortality; D001118:Argentina; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000191:economics / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000191:economics / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D017046:Cost Savings; D054855:Drug-Eluting Stents; D005260:Female; D017048:Health Care Costs; D017052:Hospital Mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D018570:Risk Assessment; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D020521:Stroke / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents; D008670:Metals; D020123:Sirolimus