A randomized, open-label clinical trial using optical coherence tomography to compare two sirolimus-eluting stents, one with a biodegradable polymer and the other with a permanent polymer

Tian,Feng; Chen,Yundai; Liu,Changfu; Jin,Qinhua; Chen,Lian; Sun,Zhijun; Liu,Hongbin; Guo,Jun; Gai,Luyue

doi:10.3892/mmr.2013.1313

A randomized, open-label clinical trial using optical coherence tomography to compare two sirolimus-eluting stents, one with a biodegradable polymer and the other with a permanent polymer

Authors:
- Feng Tian
- Yundai Chen
- Changfu Liu
- Qinhua Jin
- Lian Chen
- Zhijun Sun
- Hongbin Liu
- Jun Guo
- Luyue Gai
View Affiliations

Affiliations: Department of Cardiology, Chinese PLA General Hospital, Beijing 100853, P.R. China
Published online on: February 7, 2013 https://doi.org/10.3892/mmr.2013.1313
Pages: 1191-1196

Metrics: Total Views: 0 (Spandidos Publications: | PMC Statistics: )

Metrics: Total PDF Downloads: 0 (Spandidos Publications: | PMC Statistics: )

Cited By (CrossRef): 0 citations Loading Articles...

Abstract

Intimal hyperplasia appears to differ after implanting a drug-eluting stent (DES) with a biodegradable or a permanent polymer. The aim of the present study was to compare biodegradable with permanent polymer DES, since the available data are limited. One hundred patients with de novo coronary artery stenosis were included in this study. The patients were classified into 2 groups: DES with a biodegradable polymer (n=50) and DES with a permanent polymer (n=50). Optical coherence tomography (OCT) examination was performed before and after stent implantation. A follow‑up OCT, performed 1 year after stent implantation, compared the morphologies of intimal hyperplasia in the 2 groups. The frequencies of uncovered stent struts (2.27 vs. 1.87%, P=0.145) and stent strut malapposition (1.9 vs. 2.02%, P=0.655) upon the first-year follow-up were not significantly different. Average neointimal thickness was lower in the biodegradable compared with the permanent polymer group (106.12±80.65 vs. 181.20±146.96 µm, P<0.001). The frequencies of neointimal thickness <100 µm were significantly higher in the biodegradable compared with the permanent polymer group (62.1 vs. 35.9%, P<0.001). The average intimal thickness was also lower in the biodegradable compared with the permanent polymer group (57.7±24.6 vs. 67.6±22.4 µm, P<0.001). In conclusion, biodegradable polymer DES resulted in significantly lower intimal hyperplasia and had well-proportioned intimal coverage compared with permanent polymer DES.

View Figures

View References

1	Iakovou I, Schmidt T, Bonizzoni E, et al: Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA. 293:2126–2130. 2005. View Article : Google Scholar : PubMed/NCBI
2	Kuchulakanti PK, Chu WW, Torguson R, et al: Correlates and long-term outcomes of angiographically proven stent thrombosis with sirolimus- and paclitaxel-eluting stents. Circulation. 113:1108–1113. 2006. View Article : Google Scholar
3	McFadden EP, Stabile E, Regar E, et al: Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 364:1519–1521. 2004. View Article : Google Scholar : PubMed/NCBI
4	Guagliumi G, Farb A, Musumeci G, Valsecchi O, Tespili M, Motta T and Virmani R: Images in cardiovascular medicine. Sirolimus-eluting stent implanted in human coronary artery for 16 months: pathological findings. Circulation. 107:1340–1341. 2003. View Article : Google Scholar
5	Byrne RA, Joner M and Kastrati A: Polymer coatings and delayed arterial healing following drug-eluting stent implantation. Minerva Cardioangiol. 57:567–584. 2009.PubMed/NCBI
6	Takano M, Inami S, Jang IK, Yamamoto M, Murakami D, Seimiya K, Ohba T and Mizuno K: Evaluation by optical coherence tomography of neointimal coverage of sirolimus-eluting stent three months after implantation. Am J Cardiol. 99:1033–1038. 2007. View Article : Google Scholar : PubMed/NCBI
7	Matsumoto D, Shite J, Shinke T, Otake H, Tanino Y, Ogasawara D, Sawada T, Paredes OL, Hirata K and Yokoyama M: Neointimal coverage of sirolimus-eluting stents at 6-month follow-up: evaluated by optical coherence tomography. Eur Heart J. 28:961–967. 2007. View Article : Google Scholar : PubMed/NCBI
8	Yabushita H, Bouma BE, Houser SL, Aretz HT, Jang IK, Schlendorf KH, Kauffman CR, Shishkov M, Kang DH, Halpern EF and Tearney GJ: Characterization of human atherosclerosis by optical coherence tomography. Circulation. 106:1640–1645. 2002. View Article : Google Scholar : PubMed/NCBI
9	Jang IK, Tearney GJ, MacNeill B, Takano M, Moselewski F, Iftima N, Shishkov M, Houser S, Aretz HT, Halpern EF and Bouma BE: In vivo characterization of coronary atherosclerotic plaque by use of optical coherence tomography. Circulation. 111:1551–1555. 2005. View Article : Google Scholar : PubMed/NCBI
10	Manfrini O, Mont E, Leone O, Arbustini E, Eusebi V, Virmani R and Bugiardini R: Sources of error and interpretation of plaque morphology by optical coherence tomography. Am J Cardiol. 98:156–159. 2006. View Article : Google Scholar : PubMed/NCBI
11	Kume T, Akasaka T, Kawamoto T, Ogasawara Y, Watanabe N, Toyota E, Neishi Y, Sukmawan R, Sadahira Y and Yoshida K: Assessment of coronary arterial thrombus by optical coherence tomography. Am J Cardiol. 97:1713–1717. 2006. View Article : Google Scholar : PubMed/NCBI
12	Kotani J, Awata M, Nanto S, Uematsu M, Oshima F, Minamiguchi H, Mintz GS and Nagata S: Incomplete neointimal coverage of sirolimus-eluting stents: angioscopic findings. J Am Coll Cardiol. 47:2108–2111. 2006. View Article : Google Scholar : PubMed/NCBI
13	Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK and Virmani R: Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 48:193–202. 2006. View Article : Google Scholar : PubMed/NCBI
14	Onuma Y, Serruys P, den Heijer P, et al: MAHOROBA, first-in-man study: 6-month results of a biodegradable polymer sustained release tacrolimus-eluting stent in de novo coronary stenoses. Eur Heart J. 30:1477–1485. 2009. View Article : Google Scholar : PubMed/NCBI
15	Byrne RA, Kastrati A, Massberg S, et al: Biodegradable polymer versus permanent polymer drug-eluting stents and everolimus- versus sirolimus-eluting stents in patients with coronary artery disease: 3-year outcomes from a randomized clinical trial. J Am Coll Cardiol. 58:1325–1331. 2011.
16	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 randomised non-inferiority trial. Lancet. 372:1163–1173. 2008. View Article : Google Scholar
17	Barlis P, Regar E, Serruys PW, et al: An optical coherence tomography study of a biodegradable vs. durable polymer-coated limus-eluting stent: a LEADERS trial sub-study. Eur Heart J. 31:165–176. 2010. View Article : Google Scholar : PubMed/NCBI
18	Guagliumi G, Sirbu V, Musumeci G, et al: Strut coverage and vessel wall response to a new-generation paclitaxel-eluting stent with an ultrathin biodegradable abluminal polymer: Optical Coherence Tomography Drug-Eluting Stent Investigation (OCTDESI). Circ Cardiovasc Interv. 3:367–375. 2010. View Article : Google Scholar
19	Ahmed TA, Bergheanu SC, Stijnen T, Plevier JW, Quax PH and Jukema JW: Clinical performance of drug-eluting stents with biodegradable polymeric coating: a meta-analysis and systematic review. EuroIntervention. 7:505–516. 2011. View Article : Google Scholar : PubMed/NCBI
20	Kim JS, Jang IK, Kim JS, Kim TH, Takano M, Kume T, Hur NW, Ko YG, Choi D, Hong MK and Jang Y: Optical coherence tomography evaluation of zotarolimus-eluting stents at 9-month follow-up: comparison with sirolimus-eluting stents. Heart. 95:1907–1912. 2009. View Article : Google Scholar : PubMed/NCBI
21	Han Y, Jing Q, Xu B, et al: Safety and efficacy of biodegradable polymer-coated sirolimus-eluting stents in ‘real-world’ practice: 18-month clinical and 9-month angiographic outcomes. JACC Cardiovasc Interv. 2:303–309. 2009.
22	Gonzalo N, Barlis P, Serruys PW, Garcia-Garcia HM, Onuma Y, Ligthart J and Regar E: Incomplete stent apposition and delayed tissue coverage are more frequent in drug-eluting stents implanted during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction than in drug-eluting stents implanted for stable/unstable angina: insights from optical coherence tomography. JACC Cardiovasc Interv. 2:445–452. 2009.
23	Guagliumi G, Costa MA, Sirbu V, et al: Strut coverage and late malapposition with paclitaxel-eluting stents compared with bare metal stents in acute myocardial infarction: optical coherence tomography substudy of the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) Trial. Circulation. 123:274–281. 2011.
24	Finn AV, Nakazawa G, Kolodgie FD and Virmani R: Temporal course of neointimal formation after drug-eluting stent placement: is our understanding of restenosis changing? JACC Cardiovasc Interv. 2:300–302. 2009. View Article : Google Scholar : PubMed/NCBI
25	Finn AV, Kolodgie FD, Harnek J, Guerrero LJ, Acampado E, Tefera K, Skorija K, Weber DK, Gold HK and Virmani R: Differential response of delayed healing and persistent inflammation at sites of overlapping sirolimus- or paclitaxel-eluting stents. Circulation. 112:270–278. 2005. View Article : Google Scholar : PubMed/NCBI