Clinical review of the Resolute ® zotarolimus-eluting stent for the treatment of coronary artery disease

Interventional Cardiology

Volumn 4, Issue 1, 2012, Pages 33-43

  Vasaiwala, Samip ^a   Mauri, Laura ^a,b  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

Author keywords

drug eluting stents; restenosis; zotarolimus eluting stent

Indexed keywords

ALLOY; CHROMIUM; COBALT; ZOTAROLIMUS;

ANGIOCARDIOGRAPHY; ANGIOGENESIS; BALLOON CATHETER; BIOCOMPATIBILITY; CLINICAL EFFECTIVENESS; CLINICAL TRIAL (TOPIC); CORONARY ARTERY DISEASE; DEVICE SAFETY; DIABETES MELLITUS; DRUG ELUTING STENT; DRUG MECHANISM; ELUTION; EQUIPMENT DESIGN; HIGH RISK PATIENT; HUMAN; HYDROPHOBIC INTERACTION CHROMATOGRAPHY; INTRAVASCULAR ULTRASOUND; MATERIAL COATING; MONOCYTE; MULTICENTER STUDY (TOPIC); OPTICAL COHERENCE TOMOGRAPHY; PRIORITY JOURNAL; REVIEW; SLOW DRUG RELEASE; TREATMENT OUTCOME; VASCULAR ENDOTHELIUM;

EID: 84857598574     PISSN: 17555302     EISSN: 17555310     Source Type: Journal    
DOI: 10.2217/ica.11.85     Document Type: Review

References (49)

1. Roger VL, Go AS, Lloyd-Jones DM et al. Heart disease and stroke statistics: 2011 update: A report from the American Heart Association. Circulation 123(4), e18-e209 (2011).
2. Kirtane AJ, Gupta A, Iyengar S et al. Safety and efficacy of drug-eluting and bare-metal stents: Comprehensive meta-analysis of randomized trials and observational studies. Circulation 119(25), 3198-3206 (2009).
3. Stettler C, Wandel S, Allemann S et al. Outcomes associated with drug-eluting and bare-metal stents: A collaborative network meta-analysis. Lancet 370(9591), 937-948 (2007).
4. Abbott JD, Voss MR, Nakamura M et al. Unrestricted use of drug-eluting stents compared with bare-metal stents in routine clinical practice: findings from the National Heart, Lung and Blood Institute Dynamic Registry. J. Am. Coll. Cardiol. 50(21), 2029-2036 (2007).
5. Farb A, Weber DK, Kolodgie FD, Burke AP, Virmani R. Morphological predictors of restenosis after coronary stenting in humans. Circulation 105(25), 2974-2980 (2002).
6. 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. 349(14), 1315-1323 (2003).
7. Stone GW, Ellis SG, Cox DA et al. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N. Engl. J. Med. 350(3), 221-231 (2004).
8. Curfman GD, Morrissey S, Jarcho JA, Drazen JM. Drug-eluting coronary stents - promise and uncertainty. N. Engl. J. Med. 356(10), 1059-1060 (2007).
9. Stone GW, Moses JW, Ellis SG et al. Safety and efficacy of sirolimus-and paclitaxel-eluting coronary stents. N. Engl. J. Med. 356(10), 998-1008 (2007).
10. Wenaweser P, Daemen J, Zwahlen M et al. Incidence and correlates of drug-eluting stent thrombosis in routine clinical practice. 4-year results from a large 2-institutional cohort study. J. Am. Coll. Cardiol. 52(14), 1134-1140 (2008).
11. Windecker S, Serruys PW, Wandel S et al. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): A randomized non-inferiority trial. Lancet 372(9644), 1163-1173 (2008).
12. King SB 3rd, Smith SC Jr, Hirshfeld JW Jr et al. 2007 focused update of the ACC/AHA/ SCAI 2005 guideline update for percutaneous coronary intervention: A report of the American College of Cardiology/American Heart Association Task Force on practice guidelines. J. Am. Coll. Cardiol. 51(2), 172-209 (2008).
13. Mauri L, Massaro JM, Jiang S et al. Long-term clinical outcomes with zotarolimus-eluting versus bare-metal coronary stents. JACC Cardiovasc. Interv. 3(12), 1240-1249 (2010).
14. Camenzind E, Wijns W, Mauri L et al. Rationale and design of the Patient Related OuTcomes with Endeavor versus Cypher stenting Trial (PROTECT), randomized controlled trial comparing the incidence of stent thrombosis and clinical events after sirolimus or zotarolimus drug-eluting stent implantation. Am. Heart J. 158(6), 902-909 (2009).
15. Meredith IT, Worthley S, Whitbourn R et al. Clinical and angiographic results with the next-generation resolute stent system: A prospective, multicenter, first-in-human trial. JACC Cardiovasc. Interv. 2(10), 977-985 (2009).
16. Udipi K, Melder RJ, Chen M et al. The next generation Endeavor Resolute Stent: Role of the BioLinx Polymer System. EuroIntervention 3(1), 137-139 (2007).
17. Carter A, Ozdil F, Virmani R, Wilcox JN. In vivo performance of a novel copolymer system for extended release of zotarolimus in a next generation drug-eluting stent. Presented at: Transcatheter Cardiovascular Therapeutics Symposium. Washington, DC, USA, 22-27 October 2006.
18. Meredith IT, Worthley S, Whitbourn R et al. The next-generation Endeavor Resolute stent: 4-month clinical and angiographic results from the Endeavor Resolute first-in-man trial. EuroIntervention 3(1), 50-53 (2007).
19. Waseda K, Ako J, Yamasaki M et al. Short-and mid-term intravascular ultrasound analysis of the new zotarolimus-eluting stent with durable polymer: Results from the RESOLUTE trial. Circulation J. 74(10), 2097-2102 (2010).
20. Gutierrez-Chico JL, van Geuns RJ, Regar E et al. Tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent vs a fluoropolymer-coated everolimus-eluting stent at 13-month follow-up: An optical coherence tomography substudy from the RESOLUTE All Comers trial. Eur. Heart J. 32(19), 2454-2463 (2011).
21. Burke SE, Kuntz RE, Schwartz LB. Zotarolimus (ABT-578) eluting stents. Adv. Drug Deliv. Rev. 58(3), 437-446 (2006).
22. Brugaletta S, Burzotta F, Sabate M. Zotarolimus for the treatment of coronary artery disease: Pathophysiology, DES design, clinical evaluation and future perspective. Expert Opin. Pharmacother. 10, 1047-1058 (2009).
23. Segev A, Aviezer D, Safran M, Gross Z, Yayon A. Inhibition of vascular smooth muscle cell proliferation by a novel fibroblast growth factor receptor antagonist. Cardiovasc. Res. 53(1), 232-241 (2002).
24. Badimon L, Meyer BJ, Badimon JJ. Thrombin in arterial thrombosis. Haemostasis 24(2), 69-80 (1994).
25. Garcia-Touchard A, Burke SE, Toner JL, Cromack K, Schwartz RS. Zotarolimus-eluting stents reduce experimental coronary artery neointimal hyperplasia after 4 weeks. Eur. Heart J. 27(8), 988-993 (2006).
26. Udipi K, Chen M, Cheng P et al. Development of a novel biocompatible polymer system for extended drug release in a next-generation drug-eluting stent. J. Biomed. Mat. Res. 85(4), 1064-1071 (2008).
27. Serruys PW, Silber S, Garg S et al. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N. Engl. J. Med. 363(2), 136-146 (2010).
28. Neumann FJ, Belardi JA. One-year outcomes of patients with the zotarolimus-eluting coronary stent: RESOLUTE International Registry. Eurointervention (2011) (In press).
29. Yeung AC, Leon MB, Jain A et al. Clinical evaluation of the Resolute zotarolimus-eluting coronary stent system in the treatment of de novo lesions in native coronary arteries: The RESOLUTE US clinical trial. J. Am. Coll. Cardiol. 57(17), 1778-1783 (2011).
30. Tsuchida K, Piek JJ, Neumann FJ et al. One-year results of a durable polymer everolimus-eluting stent in de novo coronary narrowings (the Spirit First trial). EuroIntervention 1(3), 266-272 (2005).
31. 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 295(8), 895-904 (2006).
32. Meredith IT, Worthley S, Whitbourn R et al. The next-generation endeavor resolute stent: 4-month clinical and angiographic results from the endeavor resolute first-in-man trial. EuroIntervention 3(1), 50-53 (2007).
33. Meredith IT. TCT-238: 4-year clinical outcomes from the RESOLUTE first-in-man trial. J. Am. Coll. Cardiol. 56(13), B55 (2010).
34. Silber S, Windecker S, Vranckx P, Serruys PW. Unrestricted randomised use of two new generation drug-eluting coronary stents: 2-year patient-related versus stent-related outcomes from the Resolute All Comers trial. Lancet 377(9773), 1241-1247 (2011).
35. Fajadet J, Wijns W, Laarman GJ et al. Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine- encapsulated stent for treatment of native coronary artery lesions: Clinical and angiographic results of the ENDEAVOR II trial. Circulation 114(8), 798-806 (2006).
36. Leon MB, Mauri L, Popma JJ et al. A randomized comparison of the ENDEAVOR zotarolimus-eluting stent versus the TAXUS paclitaxel-eluting stent in de novo native coronary lesions 12-month outcomes from the Endeavor IV trial. J. Am. Coll. Cardiol. 55(6), 543-554 (2010).
37. Schultheiss HP, Grube E, Kuck KH et al. Safety of direct stenting with the Endeavor stent: Results of the Endeavor II continued access registry. EuroIntervention 3(1), 76-81 (2007).
38. Mauri L, Leon M, Yeung A et al. Pooled analysis of the Resolute programme clinical safety results. Presented at: EuroPCR 2011. Paris, France, 17-20 May 2011.
39. Stefanini GG, Serruys PW, Silber S et al. The impact of patient and lesion complexity on clinical and angiographic outcomes after revascularization with zotarolimus-and everolimus-eluting stents: A substudy of the RESOLUTE All Comers Trial (a randomized comparison of a zotarolimus-eluting stent with an everolimus-eluting stent for percutaneous coronary intervention). J. Am. Coll. Cardiol. 57(22), 2221-2232 (2011).
40. Beckman JA, Creager MA, Libby P. Diabetes and atherosclerosis: epidemiology, pathophysiology and management. JAMA 287(19), 2570-2581 (2002).
41. Stein B, Weintraub WS, Gebhart SP et al. Influence of diabetes mellitus on early and late outcome after percutaneous transluminal coronary angioplasty. Circulation 91(4), 979-989 (1995).
42. Donahoe SM, Stewart GC, McCabe CH et al. Diabetes and mortality following acute coronary syndromes. JAMA 298(7), 765-775 (2007).
43. Elezi S, Kastrati A, Pache J et al. Diabetes mellitus and the clinical and angiographic outcome after coronary stent placement. J. Am. Coll. Cardiol. 32(7), 1866-1873 (1998).
44. Mehran R, Dangas GD, Kobayashi Y et al. Short-and long-term results after multivessel stenting in diabetic patients. J. Am. Coll. Cardiol. 43(8), 1348-1354 (2004).
45. Banning AP, Westaby S, Morice MC et al. Diabetic and nondiabetic patients with left main and/or 3-vessel coronary artery disease: Comparison of outcomes with cardiac surgery and paclitaxel-eluting stents. J. Am. Coll. Cardiol. 55(11), 1067-1075 (2010).
46. Stankovic G, Darremont O, Ferenc M et al. Percutaneous coronary intervention for bifurcation lesions: 2008 consensus document from the fourth meeting of the European Bifurcation Club. EuroIntervention 5(1), 39-49 (2009).
47. Tommasino A, Burzotta F, Sciahbasi A et al. Procedural and clinical evaluation of the novel zotarolimus-eluting resolute stent in patients with unselected bifurcated coronary stensis treated by provisional approach: A multicenter registry. J. Invas. Cardiol. 23, 50-54 (2011).
48. TCT-282: one year outcomes of patients with Resolute zotarolimus eluting stent: Results of the RESOLUTE International Registry. J. Am. Coll. Cardiol. doi:10.1016/j. jacc.2010.08.306 (2012).
49. Saito S. Medtronic Resolute® drug-eluting stent shows superiority to Taxus® DES in study of patients with coronary artery disease. Presented at: The 2011 Annual Metting of the Japanese Association of Cardiovascular Intervention and Therapeutics. Osaka, Japan, July 2011.