Systemic immunosuppressive therapy with oral sirolimus after bare metal stent implantation: The missing alternative in the prevention of coronary restenosis after percutaneous coronary interventions

Recent Patents on Cardiovascular Drug Discovery

Volumn 3, Issue 3, 2008, Pages 201-208

  Rodriguez, Alfredo E ^a,b   Fernandez Pereira, Carlos ^a  

^a Sanatorio Otamendi y Miroli   (Argentina)

^b NONE   (Argentina)

Author keywords

Angioplasty; Cardiovascular pharmacology; Coronary angioplasty; Coronary restenosis; Drug eluting stents; Immunosuppressive therapy; Paclitaxel eluting stents; Sirolimus; Sirolimus eluting stents; Stent thrombosis; Stents

Indexed keywords

ACETYLSALICYLIC ACID; ANTITHROMBOCYTIC AGENT; CLOPIDOGREL; CORTICOSTEROID; DILTIAZEM; EVEROLIMUS; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; PACLITAXEL; RAPAMYCIN;

ANTIINFLAMMATORY ACTIVITY; ARTERY INTIMA PROLIFERATION; CLINICAL TRIAL; CORONARY ARTERY THROMBOSIS; CORONARY STENT; COST EFFECTIVENESS ANALYSIS; COST OF ILLNESS; DIARRHEA; DRUG BLOOD LEVEL; DRUG ELUTING STENT; DRUG POTENTIATION; DRUG PROTEIN BINDING; DRUG WITHDRAWAL; GINGIVA PAIN; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; LEUKOCYTE COUNT; LEUKOPENIA; LOADING DRUG DOSE; METAL IMPLANTATION; NONHUMAN; OBSERVATIONAL STUDY; PATENT; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; RESTENOSIS; REVIEW; SIDE EFFECT; SINGLE DRUG DOSE; TRANSLUMINAL CORONARY ANGIOPLASTY;

ADMINISTRATION, ORAL; ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY; CORONARY RESTENOSIS; COST-BENEFIT ANALYSIS; DRUG-ELUTING STENTS; HUMANS; IMMUNOSUPPRESSIVE AGENTS; METALS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SIROLIMUS;

EID: 58149133732     PISSN: 15748901     EISSN: None     Source Type: Journal    
DOI: 10.2174/157489008786263998     Document Type: Review

References (54)

1. Morice MC, Serruys PW, Sousa JE, et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 2002; 346(23): 1773-1780.
2. Moses JW, Leon MB, Popma JJ, et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 2003; 349(14): 1315-1323.
3. Schofer J, Schluter M, Gershlick AH, et al. Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: Double-blind, randomised controlled trial (ESIRIUS). Lancet 2003; 362(9390): 1093-1099.
4. Stone GW, Ellis SG, Cox DA, et al. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 2004; 350(3): 221-231.
5. Colombo A, Drzewiecki J, Banning A, et al. Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation 2003; 108(7): 788-794.
6. Pfisterer M, Brunner-La RHP, et al. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents. J Am Coll Cardiol 2006; 48(12): 2584-2591.
7. Spaulding C, Daemen J, Boersma E, Cutlip DE, Serruys PW. A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med 2007; 356(10): 989-997.
8. McFadden EP, Stabile E, Regar E, et al. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet 2004; 364(9444): 1519-1521.
9. Rodriguez AE, Mieres J, Fernandez-Pereira C, et al. Coronary stent thrombosis in the current drug-eluting stent era: Insights from the ERACI III trial. J Am Coll Cardio 2006; 47(1): 205-207.
10. Daemen J, Wenaweser P, Tsuchida K, et al. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: Data from a large two-institutional cohort study. Lancet 2007; 369(9562): 667-678.
11. Beohar N, Davidson CJ, Kip KE, et al. Outcomes and complications associated with off-label and untested use of drug-eluting stents. JAMA 2007; 297(18): 1992-2000.
12. Win HK, Caldera AE, Maresh K, et al. Clinical outcomes and stent thrombosis following off-label use of drug-eluting stents. JAMA 2007; 297(18): 2001-2009.
13. Al Suwaidi J, Holmes DR, Salam AM, Lennon R, Berger PB. Impact of coronary artery stents on mortality and nonfatal myocardial infarction: Meta-analysis of randomized trials comparing a strategy of routine stenting with that of balloon angioplasty. Am Heart J 2004; 147: 815-822.
14. Mercado N, Wijns W, Serruys PW, et al. One year outcome of coronary artery bypass graft surgery versus percutaneous coronary intervention with multiple stenting for multisystem disease: A meta-analysis of individual patient data from randomized clinical trials. J Thorac Cardiovasc Surg 2005; 130: 512-519.
15. Rodriguez A, Baldi J, Fernandez-Pereira C, et al. Five years follow up of the Argentine randomized trial of coronary angioplasty with stenting versus coronary bypass surgery in patients with multiple vessel disease (ERACI II). J Am Coll Cardiol 2005; 46: 582-588.
16. Serruys PW, Ong ATL, van Herwerden LA et al. Five years outcomes after coronary stenting versus bypass surgery for the treatment of multi-vessel disease: The final analysis of the Arterial Revascularization Therapy Study (ARTS) J Am Coll Cardiol 2005; 46: 575-581.
17. Rodriguez AE, Maree AO, Mieres J, et al. Late loss of early benefit from drug-eluting stents when compared with bare-metal stents and coronary artery bypass surgery: 3 years follow-up of the ERACI III registry. Eur Heart J 2007; 28(17): 2118-2125.
18. Agostoni P, Valgimigli M, Abbate A, Cosgrave J, Pilati M, Biondi-Zoccai GG. Is late luminal loss an accurate predictor of the clinical effectiveness of drug-eluting stents in the coronary arteries? Am J Cardiol 2006; 97(5): 603-605.
19. Rodriguez AE, Maree AO, Grinfeld L, et al. Revascularization strategies of coronary multiple vessel disease in the drug eluting stent era: One year follow-up results of the ERACI III trial. Euro Interv 2006; 2: 53-60.
20. Seung BK, Park DW, Kim HY, et al. Stents versus coronary bypass grafting for left main coronary artery disease. N Engl J Med 2008; 358-369.
21. Stone GW, Ellis SG, Cannon L, et al. 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(10): 1215-1223.
22. Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007; 115(17): 2344-2351.
23. Morice MC, Colombo A, Meier B, et al. Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions: the REALITY trial: A randomized controlled trial. JAMA 2006; 295(8): 895-904.
24. Kandzari DE, Leon MB, Popma JJ, et al. Comparison of zotarolimus-eluting and sirolimus-eluting stents in patients with native coronary artery disease: A randomized controlled trial. J Am Coll Cardiol 2006; 48(12): 2440-2447.
25. Serruys PW, Ruygrok P, Neuzner J, et al. A randomized comparison of an everolimus-eluting coronary stent versus paclitaxel-eluting coronary stent: The SPIRIT II trial. Euro Interv 2006; 2: 286-294
26. Galloe AM, Thuessen L, Kelbaek H, et al. Comparison of Paclitaxel and Sirolimus-eluting stents in everyday clinical practice: The SORT OUTII randomized trial. JAMA 2008; 299(4): 409-416.
27. Joner M, Finn AV, Farb A, et al. Pathology of drug-eluting stents in humans: Delayed healing and late thrombotic risk. J Am Coll Cardiol 2006; 48(1): 193-202.
28. Obata JE, Kitta Y, Takano H, et al. Sirolimus-eluting stent implantation aggravates endothelial vasomotor dysfunction in the infarct-related coronary artery in patients with acute myocardial infarction. J Am Coll Cardiol 2007; 50(14): 1305-1309.
29. Togni M, Windecker S, Cocchia R, et al. Sirolimus-eluting stents associated with paradoxic coronary vasoconstriction. J Am Coll Cardiol 2005; 46(2): 231-236.
30. Kotani J, Awata M, Nanto S, et al. Incomplete neointimal coverage of sirolimus-eluting stents: angioscopic findings. J Am Coll Cardiol 2006; 47(10): 2108-2111.
31. Serruys P, Daemen J, Morice MC, et al. Three year follow up of the ARTS II-sirolimus eluting stents-for the treatment of patients with multi-vessel coronary artery disease. Euro Interv 2007; 3: 450-459.
32. Marx, S.O., Marks, A.R.: US20087364586 (2008).
33. Yang, J.: WO080085293 (2008).
34. Kornowoski R, Hong MK, Tio FO, et al. In-stent restenosis: Contributions of inflammatory responses and arterial injury to neointimal hyperplasia. J Am Coll Cardiol 1998; 31: 224.
35. Ge J, Shen C, Liang C, et al. Elevated matrix metalloproteinase expression after stent implatantation is associated with restenosis. Int J Cardiol 2006; 112(1): 85-90.
36. Ferrero V, Ribichini F, Pesarini G, et al. Comparison of efficacy and safety of lower-dose to higher-dose oral prednisone after percutaneous coronary interventions (the IMPRESS-LD study). Am J Cardiol 2007; 99(8): 1082-1086.
37. Serruys PW, de Feyter P, Macaya C, et al. Fluovastatin for prevention of cardiac events following successful first percutaneous coronary interventions. JAMA 2002; 287: 3215-3222.
38. Serruys P, Foley D, Jackson G, et al. A randomized placebo controlled trial of Fluovastation for prevention of restenosis after successful coronary balloon angioplasty: Final results of the Fluovastatin angiographic restenosis (FLARE). Trial Eur Heart J 1999; 20: 58-69.
39. Gallo R, Padurean A, Jayaraman T, et al. Inhibition of intimal thickening after balloon angioplasty in porcine coronary arteries by targeting regulators of the cell cycle. Circulation 1999; 99(16): 2164-2170.
40. Poon M, Marx SO, Gallo R, Badimon JJ, Taubman MB, Marks AR. Rapamycin inhibits vascular smooth muscle cell migration. J Clin Invest 1996; 98(10): 2277-2283.
41. Jhon M, Acampado E, et al. Oral Everolimus inhibits in-stent neointimal growth. Circulation 2002; 106: 2379-2384.
42. Dong-Woon K, Jin-Sook K, Young-Gyu K, et al. Novel oral formulation of Paclitaxel inhibits neointimal hyperplasia in a rat carotid artery injury model. Circulation 2004; 109: 1558-63.
43. Westedt U, Kalinowski M, Wittmar M, et al. Poly (vinyl-alcohol) graft-poly(lactide-co-glycolide) nanoparticles for local delivery of paclitaxel for restenosis treatment. J Control Release 2007; 119: 41-51.
44. Elford, H.L., Cardounel, A.J.: US20080050414A1 (2008)
45. Rodriguez AE, Alemparte MR, Vigo CF, et al. 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(10): 581-584.
46. Hausleiter J, Kastrati A, Mehilli J, et al. 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(7): 790-795.
47. Waksman R, Ajani AE, Pichard AD, et al. 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(7): 1386-1392.
48. Rodriguez AE, Rodríguez-Alemparte M, Vigo CF, et al. Role of oral rapamycin to prevent restenosis in patients with de novo lesions undergoing coronary stenting: Results of the Argentina single centre study (ORAR trial). Heart 2005; 91(11): 1433-1437.
49. Rodriguez AE, Granada JF, Rodriguez-Alemparte M, et al. 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(8): 1522-1529.
50. Rodriguez A, Mieres J, Rodriguez-Granillo AM, et al. Is Oral rapamycin plus bare metal stents a feasible alternative to drug eluting stent to prevent restenosis? A cost effective follow up analysis from the randomized, controlled ORAR III Study. European Society Congress, Vienna, Austria 2007.
51. Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost-effectiveness in health and medicine. Oxford University Press 19 September 1996.
52. Brunner-La RHP, Kaiser C, Bernheim A, et al. Cost-effectiveness of drug-eluting stents in patients at high or low risk of major cardiac events in the Basel Stent KostenEffektivitats Trial (BASKET): An 18-month analysis. Lancet 2007; 370(9598): 1552-1559.
53. Cohen DJ, Bakhai A, Shi C, et al. Cost-effectiveness of sirolimus-eluting stents for treatment of complex coronary stenoses: Results from the sirolimus-eluting balloon expandable stent in the treatment of patients with de novo native coronary artery lesions (SIRIUS) trial. Circulation 2004; 110(5): 508-514.
54. Bakhai A, Stone GW, Mahoney E, et al. Cost effectiveness of paclitaxel-eluting stents for patients undergoing percutaneous coronary revascularization: Results from the TAXUS-IV Trial. J Am Coll Cardiol 2006; 48(2): 253-261.