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Erschienen in: The International Journal of Cardiovascular Imaging 10/2017

21.06.2017 | Original Paper

A head to head comparison of XINSORB bioresorbable sirolimus-eluting scaffold versus metallic sirolimus-eluting stent: 180 days follow-up in a porcine model

verfasst von: Li Shen, Yizhe Wu, Lei Ge, Yaojun Zhang, Qibing Wang, Juying Qian, Zhifen Qiu, Junbo Ge

Erschienen in: The International Journal of Cardiovascular Imaging | Ausgabe 10/2017

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Abstract

We aimed to investigate the safety and efficacy of XINSORB bioresorbable sirolimus-eluting scaffold in porcine model. XINSORB scaffolds and metallic Firebird2™ stents were randomly implanted into minipigs’ coronary arteries. Angiography, optical coherent tomography (OCT) and histopathological analyses were performed at post-procedure and 14-, 28-, 90-, 180-day follow-up. Thirty-two minipigs were enrolled. Eight XINSORB scaffolds and 8 Firebird2 stents were examined at each time point. Quantitative coronary angiography showed that in-scaffold late luminal loss (LLL) of XINSORB scaffold was 0.26 ± 0.13, 0.50 ± 0.16, 0.88 ± 0.29 and 0.43 ± 0.24 mm at 14-, 28, 90-, and 180-day follow-up respectively, and the corresponding diameter stenosis (DS) was 7.3 ± 4.7, 12.0 ± 9.5, 22.1 ± 8.0, and 16.0 ± 9.5%. Neither in-scaffold LLL nor DS of XINSORB scaffold was significantly different in comparison with Firebird2 stent. No difference of luminal area, device area, neointimal hyperplasia, and area stenosis was detected between two devices under OCT. Scaffold area of XINSORB remained steady through the observation. Histopathology revealed the similar findings. The greatest late recoil of XINSORB scaffold was about 4.12% at 90-day follow-up, which was comparable to Firebird2 stent. Both devices showed low injury or inflammation of vessel wall. XINSORB scaffold showed early neointimal coverage on struts within 28 days under scanning electron microscopy. XINSORB scaffold suppressed neointimal hyperplasia as effectively as Firebird2 did without obvious late device recoil during the 180 days follow-up. It is feasible to carry out clinical trial to investigate the safety and efficacy of XINSORB scaffold for patients with coronary artery diseases.
Literatur
1.
Zurück zum Zitat Onuma Y, Serruys PW (2011) Bioresorbable scaffold: the advent of a new era in percutaneous coronary and peripheral revascularization? Circulation 123:779–797CrossRefPubMed Onuma Y, Serruys PW (2011) Bioresorbable scaffold: the advent of a new era in percutaneous coronary and peripheral revascularization? Circulation 123:779–797CrossRefPubMed
2.
Zurück zum Zitat Nishio S, Kosuga K, Igaki K et al (2012) Long-term (>10 years) clinical outcomes of first-in-human biodegradable poly-l-lactic acid coronary stents: Igaki-Tamai stents. Circulation 125:2343–2353CrossRefPubMed Nishio S, Kosuga K, Igaki K et al (2012) Long-term (>10 years) clinical outcomes of first-in-human biodegradable poly-l-lactic acid coronary stents: Igaki-Tamai stents. Circulation 125:2343–2353CrossRefPubMed
3.
Zurück zum Zitat Serruys PW, Ormiston JA, Onuma Y et al (2009) A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet 373:897–910CrossRefPubMed Serruys PW, Ormiston JA, Onuma Y et al (2009) A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet 373:897–910CrossRefPubMed
4.
Zurück zum Zitat Dudek D, Onuma Y, Ormiston JA et al (2012) Four-year clinical follow-up of the ABSORB everolimus-eluting bioresorbable vascular scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention 7:1060–1061CrossRefPubMed Dudek D, Onuma Y, Ormiston JA et al (2012) Four-year clinical follow-up of the ABSORB everolimus-eluting bioresorbable vascular scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention 7:1060–1061CrossRefPubMed
5.
Zurück zum Zitat Wu Y, Shen L, Wang Q et al (2012) Comparison of acute recoil between bioabsorbable poly-L-lactic acid XINSORB scaffold and metallic stent in porcine model. J Biomed Biotechnol. doi:10.1155/2012/413956 (Epub 2012 Oct 3) Wu Y, Shen L, Wang Q et al (2012) Comparison of acute recoil between bioabsorbable poly-L-lactic acid XINSORB scaffold and metallic stent in porcine model. J Biomed Biotechnol. doi:10.​1155/​2012/​413956 (Epub 2012 Oct 3)
6.
Zurück zum Zitat Shen L, Wang Q, Wu Y, et al (2012) Short-term effects of fully bioabsorbable PLLA coronary stents in a porcine model. Polym Bull 68:1171–1181CrossRef Shen L, Wang Q, Wu Y, et al (2012) Short-term effects of fully bioabsorbable PLLA coronary stents in a porcine model. Polym Bull 68:1171–1181CrossRef
7.
Zurück zum Zitat Ge JB, Zhang F, Qian JY et al (2011) Six-month clinical outcomes of Firebird2™ sirolimus-eluting stent implantation in real-world patients with coronary artery diseases. Chin Med J 124:831–835PubMed Ge JB, Zhang F, Qian JY et al (2011) Six-month clinical outcomes of Firebird2™ sirolimus-eluting stent implantation in real-world patients with coronary artery diseases. Chin Med J 124:831–835PubMed
8.
Zurück zum Zitat National Research Council (US) (2011) Committee for the update of the guide for the care and use of laboratory animals. Guide for the care and use of laboratory animals, 8th edn. National Academies Press, Washington (DC) National Research Council (US) (2011) Committee for the update of the guide for the care and use of laboratory animals. Guide for the care and use of laboratory animals, 8th edn. National Academies Press, Washington (DC)
9.
Zurück zum Zitat Tanigawa J, Barlis P, Di Mario C (2007) Intravascular optical coherence tomography: optimisation of image acquisition and quantitative assessment of stent strut apposition. EuroIntervention 3:128–136PubMed Tanigawa J, Barlis P, Di Mario C (2007) Intravascular optical coherence tomography: optimisation of image acquisition and quantitative assessment of stent strut apposition. EuroIntervention 3:128–136PubMed
10.
Zurück zum Zitat Gomez-Lara J, Radu M, Brugaletta S et al (2011) Serial analysis of the malapposed and uncovered struts of the new generation of everolimus-eluting bioresorbable scaffold with optical coherence tomography. JACC Cardiovasc Interv 4:992–1001CrossRefPubMed Gomez-Lara J, Radu M, Brugaletta S et al (2011) Serial analysis of the malapposed and uncovered struts of the new generation of everolimus-eluting bioresorbable scaffold with optical coherence tomography. JACC Cardiovasc Interv 4:992–1001CrossRefPubMed
11.
Zurück zum Zitat Garcia-Garcia HM, Serruys PW, Campos CM et al (2014) Assessing bioresorbable coronary devices: methods and parameters. JACC Cardiovasc Imaging 7:1130–1148CrossRefPubMed Garcia-Garcia HM, Serruys PW, Campos CM et al (2014) Assessing bioresorbable coronary devices: methods and parameters. JACC Cardiovasc Imaging 7:1130–1148CrossRefPubMed
12.
Zurück zum Zitat Schwartz RS, Edelman ER, Carter A et al (2002) Drug-eluting stents in preclinical studies: recommended evaluation from a consensus group. Circulation 106:1867–1873CrossRefPubMed Schwartz RS, Edelman ER, Carter A et al (2002) Drug-eluting stents in preclinical studies: recommended evaluation from a consensus group. Circulation 106:1867–1873CrossRefPubMed
13.
Zurück zum Zitat van der Giessen WJ, Lincoff AM, Schwartz RS et al (1996) Marked inflammatory sequelae to implantation of biodegradable and nonbiodegradable polymers in porcine coronary arteries. Circulation 94:1690–1697CrossRefPubMed van der Giessen WJ, Lincoff AM, Schwartz RS et al (1996) Marked inflammatory sequelae to implantation of biodegradable and nonbiodegradable polymers in porcine coronary arteries. Circulation 94:1690–1697CrossRefPubMed
14.
Zurück zum Zitat Ormiston JA, Serruys PW, Onuma Y et al (2012) First serial assessment at 6 months and 2 years of the second generation of absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study. Circ Cardiovasc Interv 5:620–632CrossRefPubMed Ormiston JA, Serruys PW, Onuma Y et al (2012) First serial assessment at 6 months and 2 years of the second generation of absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study. Circ Cardiovasc Interv 5:620–632CrossRefPubMed
15.
Zurück zum Zitat Serruys PW, Chevalier B, Dudek D et al (2015) A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet 385:43–54CrossRefPubMed Serruys PW, Chevalier B, Dudek D et al (2015) A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet 385:43–54CrossRefPubMed
16.
Zurück zum Zitat Brugaletta S, Gori T, Low AF et al (2015) Absorb bioresorbable vascular scaffold versus everolimus-eluting metallic stent in ST-segment elevation myocardial infarction: 1-year results of a propensity score matching comparison: the BVS-EXAMINATION Study (bioresorbable vascular scaffold-a clinical evaluation of everolimus eluting coronary stents in the treatment of patients with ST-segment elevation myocardial infarction). JACC Cardiovasc Interv 8:189–197CrossRefPubMed Brugaletta S, Gori T, Low AF et al (2015) Absorb bioresorbable vascular scaffold versus everolimus-eluting metallic stent in ST-segment elevation myocardial infarction: 1-year results of a propensity score matching comparison: the BVS-EXAMINATION Study (bioresorbable vascular scaffold-a clinical evaluation of everolimus eluting coronary stents in the treatment of patients with ST-segment elevation myocardial infarction). JACC Cardiovasc Interv 8:189–197CrossRefPubMed
17.
Zurück zum Zitat Kimura T, Kozuma K, Tanabe K et al (2015) A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds versus everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan. Eur Heart J 36:3332–3342CrossRefPubMed Kimura T, Kozuma K, Tanabe K et al (2015) A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds versus everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan. Eur Heart J 36:3332–3342CrossRefPubMed
18.
Zurück zum Zitat Gao R, Yang Y, Han Y et al (2015) Bioresorbable vascular scaffolds versus metallic stents in patients with coronary artery disease: ABSORB China Trial. J Am Coll Cardiol 66:2298–2309CrossRefPubMed Gao R, Yang Y, Han Y et al (2015) Bioresorbable vascular scaffolds versus metallic stents in patients with coronary artery disease: ABSORB China Trial. J Am Coll Cardiol 66:2298–2309CrossRefPubMed
19.
Zurück zum Zitat Ellis SG, Kereiakes DJ, Metzger DC et al (2015) Everolimus-eluting bioresorbable scaffolds for coronary artery disease. N Engl J Med 373:1905–1915CrossRefPubMed Ellis SG, Kereiakes DJ, Metzger DC et al (2015) Everolimus-eluting bioresorbable scaffolds for coronary artery disease. N Engl J Med 373:1905–1915CrossRefPubMed
20.
Zurück zum Zitat Tanimoto S, Serruys PW, Thuesen L et al (2007) Comparison of in vivo acute stent recoil between the bioabsorbable everolimus-eluting coronary stent and the everolimus-eluting cobalt chromium coronary stent: insights from the ABSORB and SPIRIT trials. Catheter Cardiovasc Interv 70:515–523CrossRefPubMed Tanimoto S, Serruys PW, Thuesen L et al (2007) Comparison of in vivo acute stent recoil between the bioabsorbable everolimus-eluting coronary stent and the everolimus-eluting cobalt chromium coronary stent: insights from the ABSORB and SPIRIT trials. Catheter Cardiovasc Interv 70:515–523CrossRefPubMed
21.
Zurück zum Zitat Onuma Y, Serruys PW, Gomez J et al (2011) Comparison of in vivo acute stent recoil between the bioresorbable everolimus-eluting coronary scaffolds (revision 1.0 and 1.1) and the metallic everolimus-eluting stent. Catheter Cardiovasc Interv 78:3–12CrossRefPubMed Onuma Y, Serruys PW, Gomez J et al (2011) Comparison of in vivo acute stent recoil between the bioresorbable everolimus-eluting coronary scaffolds (revision 1.0 and 1.1) and the metallic everolimus-eluting stent. Catheter Cardiovasc Interv 78:3–12CrossRefPubMed
22.
Zurück zum Zitat Onuma Y, Serruys PW, Perkins LE et al (2010) Intracoronary optical coherence tomography and histology at 1 month and 2, 3, and 4 years after implantation of everolimus-eluting bioresorbable vascular scaffolds in a porcine coronary artery model: an attempt to decipher the human optical coherence tomography images in the ABSORB trial. Circulation 122:2288–2300CrossRefPubMed Onuma Y, Serruys PW, Perkins LE et al (2010) Intracoronary optical coherence tomography and histology at 1 month and 2, 3, and 4 years after implantation of everolimus-eluting bioresorbable vascular scaffolds in a porcine coronary artery model: an attempt to decipher the human optical coherence tomography images in the ABSORB trial. Circulation 122:2288–2300CrossRefPubMed
23.
Zurück zum Zitat Brugaletta S, Gomez-Lara J, Garcia-Garcia HM et al (2012) Analysis of 1 year virtual histology changes in coronary plaque located behind the struts of the everolimus eluting bioresorbable vascular scaffold. Int J Cardiovasc Imaging 28:1307–1314CrossRefPubMed Brugaletta S, Gomez-Lara J, Garcia-Garcia HM et al (2012) Analysis of 1 year virtual histology changes in coronary plaque located behind the struts of the everolimus eluting bioresorbable vascular scaffold. Int J Cardiovasc Imaging 28:1307–1314CrossRefPubMed
24.
Zurück zum Zitat Wu YZ, Shen L, Wang QB et al (2012) Safety and efficacy of cobalt chromium alloy based sirolimus-eluting stent with bioabsorbable polymer in porcine model. Chin Med J 125:983–989PubMed Wu YZ, Shen L, Wang QB et al (2012) Safety and efficacy of cobalt chromium alloy based sirolimus-eluting stent with bioabsorbable polymer in porcine model. Chin Med J 125:983–989PubMed
25.
Zurück zum Zitat Yamamoto T, Shibata R, Ishii M et al (2013) Therapeutic reendothelialization by induced pluripotent stem cells after vascular injury–brief report. Arterioscler Thromb Vasc Biol 33:2218–2221CrossRefPubMed Yamamoto T, Shibata R, Ishii M et al (2013) Therapeutic reendothelialization by induced pluripotent stem cells after vascular injury–brief report. Arterioscler Thromb Vasc Biol 33:2218–2221CrossRefPubMed
26.
Zurück zum Zitat Versari D, Lerman LO, Lerman A (2007) The importance of reendothelialization after arterial injury. Curr Pharm Des 13:1811–1824CrossRefPubMed Versari D, Lerman LO, Lerman A (2007) The importance of reendothelialization after arterial injury. Curr Pharm Des 13:1811–1824CrossRefPubMed
Metadaten
Titel
A head to head comparison of XINSORB bioresorbable sirolimus-eluting scaffold versus metallic sirolimus-eluting stent: 180 days follow-up in a porcine model
verfasst von
Li Shen
Yizhe Wu
Lei Ge
Yaojun Zhang
Qibing Wang
Juying Qian
Zhifen Qiu
Junbo Ge
Publikationsdatum
21.06.2017
Verlag
Springer Netherlands
Erschienen in
The International Journal of Cardiovascular Imaging / Ausgabe 10/2017
Print ISSN: 1569-5794
Elektronische ISSN: 1875-8312
DOI
https://doi.org/10.1007/s10554-017-1148-5

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