Comparison of long-term in-stent vascular response between abluminal groove-filled biodegradable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent: 3-year OCT follow-up from the TARGET I trial
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The study sought to compare long-term optical coherence tomography (OCT)-based in-stent vascular response between the abluminal groove-filled biodegradable polymer sirolimus-eluting stent (SES) and the durable polymer everolimus-eluting stent (EES) in the TARGET I trial. The TARGET I trial was a prospective, multicenter, randomized clinical trial which enrolled 458 patients with single de novo lesions treated by abluminal groove-filled biodegradable polymer SES and EES. A subset of 43 patients underwent angiography and OCT examinations at 3 years. All OCT images were analyzed at 0.4 mm intervals. A similar increase in angiographic late lumen loss was observed in SES and EES (from 0.05 ± 0.05 vs. 0.05 ± 0.05 mm [p = 0.84] at 9 months to 0.25 ± 0.37 vs. 0.26 ± 0.19 mm [p = 0.99] at 3 years, respectively), without significant differences at 3 years in mean neointimal thickness of stent struts (SES: 0.13 ± 0.02 mm vs. EES: 0.13 ± 0.02 mm, p = 0.80); mean percentage of covered struts (SES: 99.2 % vs. EES: 99.3 %, p = 0.53), or malapposed strut rates (SES: 0.08 % vs. EES: 0.06 %, p = 0.15). The OCT-based in-stent vascular response evaluation found similar vascular healing for the two studied devices, indicating that the luminal loss in EES from 9 months to 3 years cannot be imputed on its coated biocompatible polymer.
KeywordsOptical coherence tomography In-stent vascular response Biodegradable polymer Everolimus-eluting stent
The study was sponsored by MicroPort.
Compliance with ethical standards
Conflicts of interest
All authors have no personal conflicts of interest to disclose.
- 1.Stefanini GG, Byrne RA, Serruys PW, de Waha A, Meier B, Massberg S et al (2012) Biodegradable polymer drug-eluting stents reduce the risk of stent thrombosis at 4 years in patients undergoing percutaneous coronary intervention: a pooled analysis of individual patient data from the ISAR-TEST 3, ISAR-TEST 4, and LEADERS randomized trials. Eur Heart J 33:1214–1222CrossRefPubMedGoogle Scholar
- 2.Serruys PW, Farooq V, Kalesan B, de Vries T, Buszman P, Linke A et al (2013) Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial. JACC Cardiovasc Interv 6:777–789CrossRefPubMedGoogle Scholar
- 4.Gao RL, Xu B, Lansky AJ, Yang YJ, Ma CS, Han YL et al (2013) A randomised comparison of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: clinical and angiographic follow-up of the TARGET I trial. EuroIntervention 9:75–83CrossRefPubMedGoogle Scholar
- 5.Navarese EP, Tandjung K, Claessen B, Andreotti F, Kowalewski M, Kandzari DE et al (2013) Safety and efficacy outcomes of first and second generation durable polymer drug eluting stents and biodegradable polymer biolimus eluting stents in clinical practice: comprehensive network meta-analysis. BMJ 347:f6530PubMedCentralCrossRefPubMedGoogle Scholar
- 6.Zhang YJ, Zhu LL, Bourantas CV, Iqbal J, Dong SJ, Campos CM et al (2014) The impact of everolimus versus other rapamycin derivative-eluting stents on clinical outcomes in patients with coronary artery disease: a meta-analysis of 16 randomized trials. J Cardiol 64(3):185–193CrossRefPubMedGoogle Scholar
- 7.Claessen BE, Beijk MA, Legrand V, Ruzyllo W, Manari A, Varenne O et al (2009) Two-year clinical, angiographic, and intravascular ultrasound follow-up of the XIENCE V everolimus-eluting stent in the treatment of patients with de novo native coronary artery lesions: the SPIRIT II trial. Circ Cardiovasc Interv 2:339–347CrossRefPubMedGoogle Scholar
- 8.Zhang YJ, Iqbal J, Nakatani S, Bourantas CV, Campos CM, Ishibashi Y et al (2014) Scaffold and edge vascular response following implantation of everolimus-eluting bioresorbable vascular scaffold: a 3-year serial optical coherence tomography study. JACC Cardiovasc Interv 7:1361–1369CrossRefPubMedGoogle Scholar
- 9.Gogas BD, Garcia-Garcia HM, Onuma Y, Muramatsu T, Farooq V, Bourantas CV et al (2013) Edge vascular response after percutaneous coronary intervention: an intracoronary ultrasound and optical coherence tomography appraisal: from radioactive platforms to first- and second-generation drug-eluting stents and bioresorbable scaffolds. JACC Cardiovasc Interv 6:211–221CrossRefPubMedGoogle Scholar
- 11.Schabenberger O. Introducing the GLIMMIX procedure for generalized linear mixed models. In: SUGI 30 Proceedings, 196-30 2005Google Scholar
- 13.Windecker S, Haude M, Neumann FJ, Stangl K, Witzenbichler B, Slagboom T et al (2015) Comparison of a novel biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: results of the randomized BIOFLOW-II trial. Circ Cardiovasc Interv 8:e001441CrossRefPubMedGoogle Scholar
- 14.Xu B, Zhao Y, Yang Y, Zhang R, Li H, Ma C et al (2014) Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: 12-month results from the TARGET II trial. Chin Med J (Engl) 127:1027–1032Google Scholar
- 15.Xu B, Gao RL, Zhang RY, Wang HC, Li ZQ, Yang YJ et al (2013) Efficacy and safety of FIREHAWK(R) abluminal groove filled biodegradable polymer sirolimus-eluting stents for the treatment of long coronary lesions: nine-month angiographic and one-year clinical results from TARGET I trial long cohort. Chin Med J (Engl) 126:1026–1032Google Scholar
- 16.Qian J, Xu B, Lansky AJ, Yang YJ, Qiao SB, Wu YJ et al (2012) First report of a novel abluminal groove filled biodegradable polymer rapamycin-eluting stent in de novo coronary artery disease: results of the first in man FIREHAWK trial. Chin Med J (Engl) 125:970–976Google Scholar
- 19.Parodi G, La Manna A, Di VL, Valgimigli M, Fineschi M, Bellandi B et al (2013) Stent-related defects in patients presenting with stent thrombosis: differences at optical coherence tomography between subacute and late/very late thrombosis in the mechanism of stent thrombosis (MOST) study. EuroIntervention 9:936–944PubMedGoogle Scholar
- 23.Gutierrez-Chico JL, Juni P, Garcia-Garcia HM, Regar E, Nuesch E, Borgia F et al (2011) Long-term tissue coverage of a biodegradable polylactide polymer-coated biolimus-eluting stent: comparative sequential assessment with optical coherence tomography until complete resorption of the polymer. Am Heart J 162:922–931CrossRefPubMedGoogle Scholar