Clinical performance of drug-eluting stents with biodegradable polymeric coating: A meta-analysis and systematic review

EuroIntervention

Volumn 7, Issue 4, 2011, Pages 505-516

  Ahmed, Tarek A N ^a,b   Bergheanu, Sandrin C ^a   Stijnen, Theo ^a   Plevier, Josepha W M ^a   Quax, Paul H A ^a   Jukema, J Wouter ^a  

^a LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^b ASSIUT UNIVERSITY   (Egypt)

Author keywords

Biodegradable polymer druge luting stents; Definite stent thrombosis; Meta analysis; Permanent polymer drug eluting stents; Target lesion revascularisation

Indexed keywords

PACLITAXEL; POLYGLACTIN; POLYLACTIC ACID; RAPAMYCIN; THIENOPYRIDINE DERIVATIVE; UMIROLIMUS;

ACUTE CORONARY SYNDROME; ACUTE HEART INFARCTION; BIODEGRADABILITY; CARDIOVASCULAR PARAMETERS; DRUG ELUTING STENT; HUMAN; MATERIAL COATING; META ANALYSIS; PROGNOSIS; REVIEW; STABLE ANGINA PECTORIS; STENT THROMBOSIS; SYSTEMATIC REVIEW; TARGET LESION REVASCULARIZATION; UNSTABLE ANGINA PECTORIS;

AGED; ANGIOPLASTY, BALLOON, CORONARY; ANIMALS; COATED MATERIALS, BIOCOMPATIBLE; DRUG-ELUTING STENTS; EVIDENCE-BASED MEDICINE; FEMALE; HUMANS; MALE; MIDDLE AGED; ODDS RATIO; POLYMERS; PROSTHESIS DESIGN; RISK ASSESSMENT; RISK FACTORS; THROMBOSIS; TIME FACTORS; TREATMENT OUTCOME;

EID: 80355141633     PISSN: 1774024X     EISSN: 19696213     Source Type: Journal    
DOI: 10.4244/EIJV7I4A81     Document Type: Review

References (58)

1. Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 2003;349:1315-1323. (Pubitemid 37186209)
2. Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 2004;350:221-231. (Pubitemid 38067635)
3. Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Juni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW. 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;369:667-678. (Pubitemid 46281313)
4. Hassan AK, Bergheanu SC, Stijnen T, van der Hoeven BL, Snoep JD, Plevier JW, Schalij MJ, Wouter JJ. Late stent malapposition risk is higher after drug-eluting stent compared with bare-metal stent implantation and associates with late stent thrombosis. Eur Heart J 2010;31:1172-1180.
5. van der Hoeven BL, Pires NM, Warda HM, Oemrawsingh PV, van Vlijmen BJ, Quax PH, Schalij MJ, van der Wall EE, Jukema JW. Drug-eluting stents: results, promises and problems. Int J Cardiol 2005;99:9-17. (Pubitemid 40261018)
6. Cook S, Ladich E, Nakazawa G, Eshtehardi P, Neidhart M, Vogel R, Togni M, Wenaweser P, Billinger M, Seiler C, Gay S, Meier B, Pichler WJ, Juni P, Virmani R, Windecker S. Correlation of intravascular ultrasound findings with histopathological analysis of thrombus aspirates in patients with very late drug-eluting stent thrombosis. Circulation 2009;120:391-399.
7. Vorpahl M, Finn AV, Nakano M, Virmani R. The bioabsorption process: tissue and cellular mechanisms and outcomes. EuroIntervention 2009;5(Supplement F):F28-F35.
8. Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation2007;115:2344-2351. (Pubitemid 46685903)
9. Stijnen T, Hamza TH, Ozdemir P. Random effects meta-analysis of event outcome in the framework of the generalized linear mixed model with applications in sparse data. Stat Med 2010;29: 3046-3067.
10. Verhagen AP, de Vet HC, de Bie RA, Kessels AG, Boers M, Bouter LM, Knipschild PG. The Delphi list: a criteria list for quality assessment of randomized clinical trials for conducting systematic reviews developed by Delphi consensus. J Clin Epidemiol 1998;51:1235-1241. (Pubitemid 29009523)
11. Bhargava B, Karthikeyan G, Shankar PB, Seth S, Singh S, Pr U, Lal AV, Mohanty M. Preclinical and early clinical experience with a biodegradable polymer-based, rapamycin-eluting, Indian drug-eluting coronary stent: the BIO-RAPID study. Indian Heart J 2008;60:228-232.
12. Buszman P, Trznadel S, Milewski K, Rzezniczak J, Przewlocki T, Kosmider M, Wojcik J, Janczak J, Zurakowski A, Kondys M, Krol M, Kinasz L, Jaklik A, Rzeszutko L, Kaluza GL, Kiesz S, Gil R. Novel paclitaxel-eluting, biodegradable polymer coated stent in the treatment of de novo coronary lesions: a prospective multicenter registry. Catheter Cardiovasc Interv 2008;71:51-57. (Pubitemid 351158346)
13. Byrne RA, Kufner S, Tiroch K, Massberg S, Laugwitz KL, Birkmeier A, Schulz S, Mehilli J. Randomised trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis: 2-year follow-up results. Heart 2009;95:1489-1494.
14. Byrne RA, Kastrati A, Kufner S, Massberg S, Birkmeier KA, Laugwitz KL, Schulz S, Pache J, Fusaro M, Seyfarth M, Schomig A, Mehilli J. Randomized, non-inferiority trial of three limus agent-eluting stents with different polymer coatings: the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) Trial. Eur Heart J 2009;30: 2441-2449.
15. Chevalier B, Serruys PW, Silber S, Garcia E, Suryapranata H, Hauptmann K, Wijns W, Schuler G, Fath-Ordoubadi F, Worthley S, Thuesen L, Meredith I, Bressers M, Nagai H, Paunovic D. Randomised comparison of Nobori, biolimus A9-eluting coronary stent with a Taxus(R), paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: the Nobori 1 trial. EuroIntervention 2007;2:426-434.
16. Chevalier B, Silber S, Park SJ, Garcia E, Schuler G, Suryapranata H, Koolen J, Hauptmann KE, Wijns W, Morice MC, Carrie D, van Es GA, Nagai H, Detiege D, Paunovic D, Serruys PW. Randomized comparison of the Nobori Biolimus A9-eluting coronary stent with the Taxus Liberte paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: the NOBORI 1 trial - Phase 2. Circ Cardiovasc Interv 2009;2:188-195.
17. Dani S, Kukreja N, Parikh P, Joshi H, Prajapati J, Jain S, Thanvi S, Shah B, Dutta JP. Biodegradable-polymer-based, sirolimus-eluting Supralimus stent: 6-month angiographic and 30-month clinical follow-up results from the series I prospective study. EuroIntervention 2008;4:59-63.
18. Danzi GB, Wiemer M, Koning R, Serra A, Hauptmann KE, Kala P, Carrie D, Fath-Ordoubadhi F, Goicolea J, Wijns W, Koolen J, Chevalier B. First Clinical Report of a Large, All Comers Study with the New Generation DES- NOBORI 2 Study. 1715: 2010. http://www.pcronline.com/EuroPCR/EuroPCR-2010/New-drug-eluting- stents-with-biodegradable-polymers
19. Grube E, Hauptmann KE, Buellesfeld L, Lim V, Abizaid A. Six-month results of a randomized study to evaluate safety and efficacy of a Biolimus A9 eluting stent with a biodegradable polymer coating. EuroIntervention 2005;1:53-57.
20. Grube E, Schofer J, Hauptmann KE, Nickenig G, Curzen N, Allocco DJ, Dawkins KD. A novel paclitaxel-eluting stent with an ultrathin abluminal biodegradable polymer 9-month outcomes with the JACTAX HD stent. JACC Cardiovasc Interv 2010;3:431-438.
21. Han Y, Jing Q, Chen X, Wang S, Ma Y, Liu H, Luan B, Wang G, Li Y, Wang Z, Wang D, Xu B, Gao R. Long-term clinical, angiographic, and intravascular ultrasound outcomes of biodegradable polymer-coated sirolimus-eluting stents. Catheter Cardiovasc Interv 2008;72:177-183.
22. Krucoff MW, Kereiakes DJ, Petersen JL, Mehran R, Hasselblad V, Lansky AJ, Fitzgerald PJ, Garg J, Turco MA, Simonton CA, III, Verheye S, Dubois CL, Gammon R, Batchelor WB, O'Shaughnessy CD, Hermiller JB, Jr., Schofer J, Buchbinder M, Wijns W. A novel bioresorbable polymer paclitaxel-eluting stent for the treatment of single and multivessel coronary disease: primary results of the COSTAR (Cobalt Chromium Stent With Antiproliferative for Restenosis) II study. J Am Coll Cardiol 2008;51:1543-1552. (Pubitemid 351512313)
23. Lemos PA, Moulin B, Perin MA, Oliveira LA, Arruda JA, Lima VC, Lima AA, Caramori PR, Medeiros CR, Barbosa MR, Brito FS, Jr., Ribeiro EE, Martinez EE. Randomized evaluation of two drug- eluting stents with identical metallic platform and biodegradable polymer but different agents (paclitaxel or sirolimus) compared against bare stents: 1-year results of the PAINT trial. Catheter Cardiovasc Interv 2009;74:665-673.
24. Liu HB, Xu B, Qiao SB, Yang YJ, Ma WH, Qin XW, Yao M, Wu YJ, Yuan JQ, Chen J, You SJ, Dai J, Xia R, Li JJ, Chen JL, Gao RL. A comparison of clinical and angiographic outcomes after Excel bioabsorbable polymer versus Firebird durable polymer rapamycin-eluting stent for the treatment of coronary artery disease in a "real world" setting: six-month follow-up results. Chin Med J (Engl) 2007;120:574-577. (Pubitemid 46629912)
25. Mehilli J, Byrne RA, Wieczorek A, Iijima R, Schulz S, Bruskina O, Pache J, Wessely R, Schomig A, Kastrati A. Randomized trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis. Eur Heart J 2008;29: 1975-1982.
26. Ostojic M, Sagic D, Beleslin B, Jung R, Perisic Z, Jagic N, Nedeljkovic M, Mangovski L, Milosavljevic B, Stojkovic S, Orlic D, Antonic Z, Miloradovic V, Topic D, Paunovic D. First clinical comparison of Nobori-Biolimus A9 eluting stents with Cypher-Sirolimus eluting stents: Nobori Core nine months angiographic and one year clinical outcomes. EuroIntervention 2008;3:574-579.
27. Ostovan MA, Mollazadeh R, Kojuri J, Mirabadi M. Experience with paclitaxel-eluting Infinnium coronary stents. Asian Cardiovasc Thorac Ann 2008;16:454-458.
28. Serruys PW, Sianos G, Abizaid A, Aoki J, den HP, Bonnier H, Smits P, McClean D, Verheye S, Belardi J, Condado J, Pieper M, Gambone L, Bressers M, Symons J, Sousa E, Litvack F. The effect of variable dose and release kinetics on neointimal hyperplasia using a novel paclitaxel-eluting stent platform: the Paclitaxel In-Stent Controlled Elution Study (PISCES). J Am Coll Cardiol 2005;46:253-260. (Pubitemid 40966852)
29. Takeshita S, Saito S, Muramatsu T, Iwabuchi M, Hayashi Y, Ikari Y, Fujii K, Nanto S, Inoue N, Kimura T, Namiki A, Hirayama H, Doi O, Kashida M, Yajima J, Mitsudo K. A Randomized Comparison of Nobori Biolimus A9 Eluting Stent with Cypher Sirolimus Eluting Stent for Coronary Revascularization in Japanese Population. 1702: 2010. http://www.pcronline.com/EuroPCR/EuroPCR-2010/New-drug- eluting-stents-with-biodegradable-polymers
30. Tin HE, Hou XM, Lim J, Low A, Teo SG, Tan HC, Lee CH. A novel drug-eluting stent using bioabsorbable polymer technology: two-year follow-up of the CURAMI registry. Int J Cardiol 2009;131:272-274.
31. Vranckx P, Serruys PW, Gambhir S, Sousa E, Abizaid A, Lemos P, Ribeiro E, Dani SI, Dalal JJ, Mehan V, Dhar A, Dutta AL, Reddy KN, Chand R, Ray A, Symons J. Biodegradable-polymer-based, paclitaxel-eluting Infinnium stent: 9-Month clinical and angio- graphic follow-up results from the SIMPLE II prospective multi- centre registry study. EuroIntervention 2006;2:310-317.
32. Wessely R, Kastrati A, Mehilli J, Dibra A, Pache J, Schomig A. Randomized trial of rapamycin- and paclitaxel-eluting stents with identical biodegradable polymeric coating and design. Eur Heart J 2007;28:2720-2725. (Pubitemid 350135534)
33. Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di MC, Davies S, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Juni P. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet 2008;372:1163-1173.
34. Luscher TF, Steffel J, Eberli FR, Joner M, Nakazawa G, Tanner FC, Virmani R. Drug-eluting stent and coronary thrombosis: biological mechanisms and clinical implications. Circulation 2007;115: 1051-1058. (Pubitemid 46328299)
35. Waugh J, Wagstaff AJ. The paclitaxel (TAXUS)-eluting stent: a review of its use in the management of de novo coronary artery lesions. Am J Cardiovasc Drugs 2004;4:257-268. (Pubitemid 39206620)
36. Wykrzykowska J, Garg S, Girasis C, Buszman P, Linke A, Ischinger T, Klauss V, Corti R, Eberli F, Wijns W, Morice MC, di MC, van Geuns RJ, Juni P, Windecker S, Serruys PW. Biolimus-eluting stent reduces mortality in patients with high SYNTAX scores in the "all-comers" LEADERS trial. 1430: 2010. http://www.pcronline.com/Lectures/2010/Biolimus-eluting-stent-reduces- mortality-in-patients-with-high-SYNTAX-scores-in-the-all-comers-LEADERS-trial
37. Serruys PW, Onuma Y, Garg S, Sarno G, van den Brand M, Kappetein AP, Van DN, Mack M, Holmes D, Feldman T, Morice MC, Colombo A, Bass E, Leadley K, Dawkins KD, van Es GA, Morel MA, Mohr FW. Assessment of the SYNTAX score in the Syntax study. EuroIntervention 2009;5:50-56.
38. Serruys PW, Buszman P, Linke A, Ischinger T, Eberli F, Corti R, Klauss V, Wijns W, Morice MC, di MC, van Geuns RJ, Eerdmans P, van Es GA, Juni P, Windecker S. LEADERS, A Prospective, Randomized, Non-Inferiority Trial Comparing Biolimus-Eluting Stent with Biodegradable Polymer Versus Sirolimus-Eluting Stent With Durable Polymer. 3-Year Clinical Follow-up. 2010 Sep 21; TCT 2010. www.tctmd.com
39. Grube E, Buellesfeld L. BioMatrix Biolimus A9-eluting coronary stent: a next-generation drug-eluting stent for coronary artery disease. Expert Rev Med Devices 2006;3:731-741. (Pubitemid 46017613)
40. Huang S, Bjornsti MA, Houghton PJ. Rapamycins: mechanism of action and cellular resistance. Cancer Biol Ther 2003;2: 222-232.
41. Kahan BD. Sirolimus: a comprehensive review. Expert Opin Pharmacother 2001;2:1903-1917. (Pubitemid 33069483)
42. Sehgal SN. Sirolimus: its discovery, biological properties, and mechanism of action. Transplant Proc 2003;35(3 Suppl):7S-14S. (Pubitemid 36547910)
43. Ostojic M, Sagic D, Jung R, Zhang YL, Nedeljkovic M, Mangovski L, Stojkovic S, Debeljacki D, Colic M, Beleslin B, Milosavljevic B, Orlic D, Topic D, Karanovic N, Paunovic D, Christians U. The pharmacokinetics of Biolimus A9 after elution from the Nobori stent in patients with coronary artery disease: the NOBORI PK study. Catheter Cardiovasc Interv 2008;72:901-908.
44. Fuke S, Maekawa K, Kawamoto K, Saito H, Sato T, Hioka T, Ohe T. Impaired endothelial vasomotor function after sirolimus-eluting stent implantation. Circ J 2007;71:220-225. (Pubitemid 46182696)
45. Hofma SH, van der Giessen WJ, van Dalen BM, Lemos PA, McFadden EP, Sianos G, Ligthart JM, van ED, de Feyter PJ, Serruys PW. Indication of long-term endothelial dysfunction after sirolimus-eluting stent implantation. Eur Heart J 2006;27: 166-170. (Pubitemid 43069032)
46. Togni M, Windecker S, Cocchia R, Wenaweser P, Cook S, Billinger M, Meier B, Hess OM. Sirolimus-eluting stents associated with paradoxic coronary vasoconstriction. J Am Coll Cardiol 2005;46:231-236. (Pubitemid 40966848)
47. Togni M, Raber L, Cocchia R, Wenaweser P, Cook S, Windecker S, Meier B, Hess OM. Local vascular dysfunction after coronary paclitaxel-eluting stent implantation. Int J Cardiol 2007;120: 212-220. (Pubitemid 47042255)
48. Hamilos MI, Ostojic M, Beleslin B, Sagic D, Mangovski L, Stojkovic S, Nedeljkovic M, Orlic D, Milosavljevic B, Topic D, Karanovic N, Wijns W. Differential effects of drug-eluting stents on local endothelium-dependent coronary vasomotion. J Am Coll Cardiol 2008;51:2123-2129. (Pubitemid 351721001)
49. Vetrovec GW, Rizik D, Williard C, Snead D, Piotrovski V, Kopia G. Sirolimus PK trial: a pharmacokinetic study of the sirolimus-eluting Bx velocity stent in patients with de novo coronary lesions. Catheter Cardiovasc Interv 2006;67:32-37. (Pubitemid 43062605)
50. Schomig A, Dibra A, Windecker S, Mehilli J, Suarez de LJ, Kaiser C, Park SJ, Goy JJ, Lee JH, Di LE, Wu J, Juni P, Pfisterer ME, Meier B, Kastrati A. A meta-analysis of 16 randomized trials of sirolimus-eluting stents versus paclitaxel-eluting stents in patients with coronary artery disease. J Am Coll Cardiol 2007;50: 1373-1380. (Pubitemid 47449734)
51. Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabate M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Juni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet 2007;370: 937-948. (Pubitemid 47393576)
52. Ostojic MC, Perisic Z, Sagic D, Jung R, Zhang YL, Bendrick- Peart J, Betts R, Christians U. The pharmacokinetics of Biolimus A9 after elution from the BioMatrix II stent in patients with coronary artery disease: The Stealth PK Study. Eur J Clin Pharmacol 2011;67:389-398.
53. Wilson GJ, Nakazawa G, Schwartz RS, Huibregtse B, Poff B, Herbst TJ, Baim DS, Virmani R. Comparison of inflammatory response after implantation of sirolimus- and paclitaxel-eluting stents in porcine coronary arteries. Circulation 2009;120:141-142.
54. van der Giessen WJ, Lincoff AM, Schwartz RS, van Beusekom HM, Serruys PW, Holmes DR, Jr., Ellis SG, Topol EJ. Marked inflammatory sequelae to implantation of biodegradable and nonbiodegradable polymers in porcine coronary arteries. Circulation1996;94:1690-1697. (Pubitemid 26320276)
55. Lockwood NA, Hergenrother RW, Patrick LM, Stucke SM, Steendam R, Pacheco E, Virmani R, Kolodgie FD, Hubbard B. In vitro and in vivo characterization of novel biodegradable polymers for application as drug-eluting stent coatings. J Biomater Sci Polym Ed 2010;21:529-552.
56. Mehilli J, Kastrati A, Wessely R, Dibra A, Hausleiter J, Jaschke B, Dirschinger J, Schomig A. Randomized trial of a nonpolymer-based rapamycin-eluting stent versus a polymer-based paclitaxel-eluting stent for the reduction of late lumen loss. Circulation2006;113:273-279.
57. Tada N, Virmani R, Grant G, Bartlett L, Black A, Clavijo C, Christians U, Betts R, Savage D, Su SH, Shulze J, Kar S. Polymer-free biolimus a9-coated stent demonstrates more sustained intimal inhibition, improved healing, and reduced inflammation compared with a polymer-coated sirolimus-eluting cypher stent in a porcine model. Circ Cardiovasc Interv 2010;3:174-183.
58. Cook DJ, Guyatt GH, Ryan G, Clifton J, Buckingham L, Willan A, McIlroy W, Oxman AD. Should unpublished data be included in meta-analyses? Current convictions and controversies. JAMA1993;269:2749-2753.