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Erschienen in: Cardiovascular Intervention and Therapeutics 4/2023

19.05.2023 | Original Article

Very short-term tissue coverage of the CD34 antibody-covered sirolimus-eluting stent: an optical coherence tomography study

verfasst von: Tadahiro Matsumoto, Hideki Kitahara, Tatsuro Yamazaki, Takashi Hiraga, Daichi Yamashita, Takanori Sato, Yuichi Saito, Ken Kato, Yoshio Kobayashi

Erschienen in: Cardiovascular Intervention and Therapeutics | Ausgabe 4/2023

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Abstract

It is well known that patients with acute myocardial infarction (AMI) have delayed vessel healing despite accelerated endothelial progenitor cells (EPC) mobilization. The COMBO stent is a unique biodegradable-polymer sirolimus-eluting stent with an anti-CD34 antibody coating which captures EPC and potentially promotes vessel healing. However, there are limited data about strut tissue coverage at the very short-term period after COMBO stent implantation. This was a prospective study to investigate strut tissue coverage within 1 month after COMBO stent implantation using optical coherence tomography (OCT). Struts fully covered with tissue were defined as covered, and struts with distance from lumen surface longer than strut plus polymer thickness were defined as malapposed. Mean tissue thickness was measured only in apposed struts. A total of 8173 struts of 33 lesions in 32 patients were analyzed at an average of 19.8 ± 4.6 days after COMBO stent implantation. In lesion-level analysis, the rate of covered struts was 89.6 ± 7.2%, the rate of malapposed struts was 0.9 ± 2.0% and mean tissue thickness was 46.8 ± 14.3 µm. In comparison between AMI (n = 12) and non-AMI (n = 21) patients, there were no significant differences in the rate of covered struts (88.4 ± 8.4% vs. 90.2 ± 6.6%, p = 0.48) and mean tissue thickness (46.8 ± 13.7 µm vs. 46.9 ± 15.0 µm, p = 0.98). Multivariable analysis demonstrated that time from implantation to OCT imaging was significantly associated with mean tissue thickness. The COMBO stent had substantial tissue coverage at the very short-term period after implantation even in AMI patients, and follow-up time had an impact on vessel healing.
Literatur
1.
Zurück zum Zitat Babapulle MN, Joseph L, Bélisle P, Brophy JM, Eisenberg MJ. A hierarchical Bayesian meta-analysis of randomised clinical trials of drug-eluting stents. Lancet. 2004;364:583–91.CrossRefPubMed Babapulle MN, Joseph L, Bélisle P, Brophy JM, Eisenberg MJ. A hierarchical Bayesian meta-analysis of randomised clinical trials of drug-eluting stents. Lancet. 2004;364:583–91.CrossRefPubMed
2.
Zurück zum Zitat Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002;346:1773–80.CrossRefPubMed Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, et al. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002;346:1773–80.CrossRefPubMed
3.
Zurück zum Zitat Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, et al. 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;369:667–78.CrossRefPubMed Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, et al. 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;369:667–78.CrossRefPubMed
4.
Zurück zum Zitat Nakazawa G, Finn AV, Joner M, Ladich E, Kutys R, Mont EK, et al. Delayed arterial healing and increased late stent thrombosis at culprit sites after drug-eluting stent placement for acute myocardial infarction patients: an autopsy study. Circulation. 2008;118:1138–45.CrossRefPubMed Nakazawa G, Finn AV, Joner M, Ladich E, Kutys R, Mont EK, et al. Delayed arterial healing and increased late stent thrombosis at culprit sites after drug-eluting stent placement for acute myocardial infarction patients: an autopsy study. Circulation. 2008;118:1138–45.CrossRefPubMed
5.
Zurück zum Zitat Takano M, Inami S, Jang IK, Yamamoto M, Murakami D, Seimiya K, et al. Evaluation by optical coherence tomography of neointimal coverage of sirolimus-eluting stent three months after implantation. Am J Cardiol. 2007;99:1033–8.CrossRefPubMed Takano M, Inami S, Jang IK, Yamamoto M, Murakami D, Seimiya K, et al. Evaluation by optical coherence tomography of neointimal coverage of sirolimus-eluting stent three months after implantation. Am J Cardiol. 2007;99:1033–8.CrossRefPubMed
6.
Zurück zum Zitat Kim JS, Fan C, Choi D, Jang IK, Lee JM, Kim TH, et al. Different patterns of neointimal coverage between acute coronary syndrome and stable angina after various types of drug-eluting stents implantation; 9-month follow-up optical coherence tomography study. Int J Cardiol. 2011;146:341–6.CrossRefPubMed Kim JS, Fan C, Choi D, Jang IK, Lee JM, Kim TH, et al. Different patterns of neointimal coverage between acute coronary syndrome and stable angina after various types of drug-eluting stents implantation; 9-month follow-up optical coherence tomography study. Int J Cardiol. 2011;146:341–6.CrossRefPubMed
7.
Zurück zum Zitat Shintani S, Murohara T, Ikeda H, Ueno T, Honma T, Katoh A, et al. Mobilization of endothelial progenitor cells in patients with acute myocardial infarction. Circulation. 2001;103:2776–9.CrossRefPubMed Shintani S, Murohara T, Ikeda H, Ueno T, Honma T, Katoh A, et al. Mobilization of endothelial progenitor cells in patients with acute myocardial infarction. Circulation. 2001;103:2776–9.CrossRefPubMed
8.
Zurück zum Zitat Leone AM, Rutella S, Bonanno G, Abbate A, Rebuzzi AG, Giovannini S, et al. Mobilization of bone marrow-derived stem cells after myocardial infarction and left ventricular function. Eur Heart J. 2005;26:1196–204.CrossRefPubMed Leone AM, Rutella S, Bonanno G, Abbate A, Rebuzzi AG, Giovannini S, et al. Mobilization of bone marrow-derived stem cells after myocardial infarction and left ventricular function. Eur Heart J. 2005;26:1196–204.CrossRefPubMed
9.
Zurück zum Zitat Asahara T, Murohara T, Sullivan A, Silver M, van der Zee R, Li T, et al. Isolation of putative progenitor endothelial cells for angiogenesis. Science. 1997;275:964–7.CrossRefPubMed Asahara T, Murohara T, Sullivan A, Silver M, van der Zee R, Li T, et al. Isolation of putative progenitor endothelial cells for angiogenesis. Science. 1997;275:964–7.CrossRefPubMed
10.
Zurück zum Zitat Woudstra P, Kalkman DN, den Heijer P, Menown IB, Erglis A, Suryapranata H, et al. 1-Year results of the REMEDEE registry: clinical outcomes after deployment of the abluminal sirolimus-coated bioengineered (Combo) stent in a multicenter, prospective all-comers registry. JACC Cardiovasc Interv. 2016;9:1127–34.CrossRefPubMed Woudstra P, Kalkman DN, den Heijer P, Menown IB, Erglis A, Suryapranata H, et al. 1-Year results of the REMEDEE registry: clinical outcomes after deployment of the abluminal sirolimus-coated bioengineered (Combo) stent in a multicenter, prospective all-comers registry. JACC Cardiovasc Interv. 2016;9:1127–34.CrossRefPubMed
11.
Zurück zum Zitat Saito S, Krucoff MW, Nakamura S, Mehran R, Maehara A, Al-Khalidi HR, et al. Japan-United States of America harmonized assessment by randomized multicentre study of OrbusNEich’s Combo StEnt (Japan-USA HARMONEE) study: primary results of the pivotal registration study of combined endothelial progenitor cell capture and drug-eluting stent in patients with ischaemic coronary disease and non-ST-elevation acute coronary syndrome. Eur Heart J. 2018;39:2460–8.CrossRefPubMedPubMedCentral Saito S, Krucoff MW, Nakamura S, Mehran R, Maehara A, Al-Khalidi HR, et al. Japan-United States of America harmonized assessment by randomized multicentre study of OrbusNEich’s Combo StEnt (Japan-USA HARMONEE) study: primary results of the pivotal registration study of combined endothelial progenitor cell capture and drug-eluting stent in patients with ischaemic coronary disease and non-ST-elevation acute coronary syndrome. Eur Heart J. 2018;39:2460–8.CrossRefPubMedPubMedCentral
12.
Zurück zum Zitat Lee SW, Lam SC, Tam FC, Chan KK, Shea CP, Kong SL, et al. Evaluation of early healing profile and neointimal transformation over 24 months using longitudinal sequential optical coherence tomography assessments and 3-year clinical results of the new dual-therapy endothelial progenitor cell capturing sirolimus-eluting combo stent: the EGO-combo study. Circ Cardiovasc Interv. 2016;9: e003469.CrossRefPubMed Lee SW, Lam SC, Tam FC, Chan KK, Shea CP, Kong SL, et al. Evaluation of early healing profile and neointimal transformation over 24 months using longitudinal sequential optical coherence tomography assessments and 3-year clinical results of the new dual-therapy endothelial progenitor cell capturing sirolimus-eluting combo stent: the EGO-combo study. Circ Cardiovasc Interv. 2016;9: e003469.CrossRefPubMed
13.
Zurück zum Zitat Watanabe H, Domei T, Morimoto T, Natsuaki M, Shiomi H, Toyota T, et al. Effect of 1-month dual antiplatelet therapy followed by clopidogrel vs 12-month dual antiplatelet therapy on cardiovascular and bleeding events in patients receiving PCI: the STOPDAPT-2 randomized clinical trial. JAMA. 2019;321:2414–27.CrossRefPubMedPubMedCentral Watanabe H, Domei T, Morimoto T, Natsuaki M, Shiomi H, Toyota T, et al. Effect of 1-month dual antiplatelet therapy followed by clopidogrel vs 12-month dual antiplatelet therapy on cardiovascular and bleeding events in patients receiving PCI: the STOPDAPT-2 randomized clinical trial. JAMA. 2019;321:2414–27.CrossRefPubMedPubMedCentral
14.
Zurück zum Zitat Kogame N, Guimarães PO, Modolo R, De Martino F, Tinoco J, Ribeiro EE, et al. Aspirin-free prasugrel monotherapy following coronary artery stenting in patients with stable CAD: the ASET pilot study. JACC Cardiovasc Interv. 2020;13:2251–62.CrossRefPubMed Kogame N, Guimarães PO, Modolo R, De Martino F, Tinoco J, Ribeiro EE, et al. Aspirin-free prasugrel monotherapy following coronary artery stenting in patients with stable CAD: the ASET pilot study. JACC Cardiovasc Interv. 2020;13:2251–62.CrossRefPubMed
15.
Zurück zum Zitat Saito Y, Kobayashi Y, Fujii K, Sonoda S, Tsujita K, Hibi K, et al. Clinical expert consensus document on intravascular ultrasound from the Japanese Association of Cardiovascular Intervention and Therapeutics (2021). Cardiovasc Interv Ther. 2022;37:40–51.CrossRefPubMed Saito Y, Kobayashi Y, Fujii K, Sonoda S, Tsujita K, Hibi K, et al. Clinical expert consensus document on intravascular ultrasound from the Japanese Association of Cardiovascular Intervention and Therapeutics (2021). Cardiovasc Interv Ther. 2022;37:40–51.CrossRefPubMed
16.
Zurück zum Zitat Ozaki Y, Hara H, Onuma Y, Katagiri Y, Amano T, Kobayashi Y, et al. CVIT expert consensus document on primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) update 2022. Cardiovasc Interv Ther. 2022;37:1–34.CrossRefPubMedPubMedCentral Ozaki Y, Hara H, Onuma Y, Katagiri Y, Amano T, Kobayashi Y, et al. CVIT expert consensus document on primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) update 2022. Cardiovasc Interv Ther. 2022;37:1–34.CrossRefPubMedPubMedCentral
17.
Zurück zum Zitat Fujii K, Kubo T, Otake H, Nakazawa G, Sonoda S, Hibi K, et al. Expert consensus statement for quantitative measurement and morphological assessment of optical coherence tomography: update 2022. Cardiovasc Interv Ther. 2022;37:248–54.CrossRefPubMed Fujii K, Kubo T, Otake H, Nakazawa G, Sonoda S, Hibi K, et al. Expert consensus statement for quantitative measurement and morphological assessment of optical coherence tomography: update 2022. Cardiovasc Interv Ther. 2022;37:248–54.CrossRefPubMed
18.
Zurück zum Zitat Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, et al. Fourth universal definition of myocardial infarction (2018). J Am Coll Cardiol. 2018;72:2231–64.CrossRefPubMed Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, et al. Fourth universal definition of myocardial infarction (2018). J Am Coll Cardiol. 2018;72:2231–64.CrossRefPubMed
19.
Zurück zum Zitat Suzuki N, Asano T, Nakazawa G, Aoki J, Tanabe K, Hibi K, et al. Clinical expert consensus document on quantitative coronary angiography from the Japanese Association of Cardiovascular Intervention and Therapeutics. Cardiovasc Interv Ther. 2020;35:105–16.CrossRefPubMedPubMedCentral Suzuki N, Asano T, Nakazawa G, Aoki J, Tanabe K, Hibi K, et al. Clinical expert consensus document on quantitative coronary angiography from the Japanese Association of Cardiovascular Intervention and Therapeutics. Cardiovasc Interv Ther. 2020;35:105–16.CrossRefPubMedPubMedCentral
20.
Zurück zum Zitat Jinnouchi H, Otsuka F, Sato Y, Bhoite RR, Sakamoto A, Torii S, et al. Healthy strut coverage after coronary stent implantation: an ex vivo human autopsy study. Circ Cardiovasc Interv. 2020;13: e008869.CrossRefPubMed Jinnouchi H, Otsuka F, Sato Y, Bhoite RR, Sakamoto A, Torii S, et al. Healthy strut coverage after coronary stent implantation: an ex vivo human autopsy study. Circ Cardiovasc Interv. 2020;13: e008869.CrossRefPubMed
21.
Zurück zum Zitat Jakobsen L, Christiansen EH, Freeman P, Kahlert J, Veien K, Maeng M, et al. Randomized clinical comparison of the dual-therapy CD34 antibody-covered sirolimus-eluting combo stent with the sirolimus-eluting orsiro stent in patients treated with percutaneous coronary intervention: the SORT OUT X trial. Circulation. 2021;143:2155–65.CrossRefPubMed Jakobsen L, Christiansen EH, Freeman P, Kahlert J, Veien K, Maeng M, et al. Randomized clinical comparison of the dual-therapy CD34 antibody-covered sirolimus-eluting combo stent with the sirolimus-eluting orsiro stent in patients treated with percutaneous coronary intervention: the SORT OUT X trial. Circulation. 2021;143:2155–65.CrossRefPubMed
22.
Zurück zum Zitat Nardin M, Pivato CA, Cao D, Sartori S, Zhang Z, Vogel B, et al. The mega COMBO collaboration: an individual patient data pooled analysis of patients undergoing PCI with COMBO stent. Int J Cardiol. 2023;370:149–55.CrossRefPubMed Nardin M, Pivato CA, Cao D, Sartori S, Zhang Z, Vogel B, et al. The mega COMBO collaboration: an individual patient data pooled analysis of patients undergoing PCI with COMBO stent. Int J Cardiol. 2023;370:149–55.CrossRefPubMed
23.
Zurück zum Zitat Jaguszewski M, Aloysius R, Wang W, Bezerra HG, Hill J, De Winter RJ, et al. The REMEDEE-OCT study: an evaluation of the bioengineered COMBO dual-therapy CD34 antibody-covered sirolimus-eluting coronary stent compared with a cobalt-chromium everolimus-eluting stent in patients with acute coronary syndromes: insights from optical coherence tomography imaging analysis. JACC Cardiovasc Interv. 2017;10:489–99.CrossRefPubMed Jaguszewski M, Aloysius R, Wang W, Bezerra HG, Hill J, De Winter RJ, et al. The REMEDEE-OCT study: an evaluation of the bioengineered COMBO dual-therapy CD34 antibody-covered sirolimus-eluting coronary stent compared with a cobalt-chromium everolimus-eluting stent in patients with acute coronary syndromes: insights from optical coherence tomography imaging analysis. JACC Cardiovasc Interv. 2017;10:489–99.CrossRefPubMed
24.
Zurück zum Zitat Takahara M, Kitahara H, Nishi T, Miura K, Miyayama T, Sugimoto K, et al. Very early tissue coverage after drug-eluting stent implantation: an optical coherence tomography study. Int J Cardiovasc Imaging. 2017;33:25–30.CrossRefPubMed Takahara M, Kitahara H, Nishi T, Miura K, Miyayama T, Sugimoto K, et al. Very early tissue coverage after drug-eluting stent implantation: an optical coherence tomography study. Int J Cardiovasc Imaging. 2017;33:25–30.CrossRefPubMed
25.
Zurück zum Zitat Oka N, Fujii K, Kadohira T, Kitahara H, Fujimoto Y, Takahara M, et al. Assessment of strut coverage of everolimus-eluting platinum chromium stent 2 weeks after implantation by optical coherence tomography. Heart Vessels. 2019;34:1258–65.CrossRefPubMed Oka N, Fujii K, Kadohira T, Kitahara H, Fujimoto Y, Takahara M, et al. Assessment of strut coverage of everolimus-eluting platinum chromium stent 2 weeks after implantation by optical coherence tomography. Heart Vessels. 2019;34:1258–65.CrossRefPubMed
26.
Zurück zum Zitat Morino Y, Terashita D, Otake H, Kikuchi T, Fusazaki T, Kuriyama N, et al. Early vascular responses to everolimus-eluting cobalt-chromium stent in the culprit lesions of st-elevation myocardial infarction: results from a multicenter prospective optical coherence tomography study (MECHANISM-AMI 2-week follow-up study). Cardiovasc Interv Ther. 2019;34:14–24.CrossRefPubMed Morino Y, Terashita D, Otake H, Kikuchi T, Fusazaki T, Kuriyama N, et al. Early vascular responses to everolimus-eluting cobalt-chromium stent in the culprit lesions of st-elevation myocardial infarction: results from a multicenter prospective optical coherence tomography study (MECHANISM-AMI 2-week follow-up study). Cardiovasc Interv Ther. 2019;34:14–24.CrossRefPubMed
27.
Zurück zum Zitat Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2018;39:213–60.CrossRefPubMed Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2018;39:213–60.CrossRefPubMed
28.
Zurück zum Zitat Nakamura M, Kimura K, Kimura T, Ishihara M, Otsuka F, Kozuma K, et al. JCS 2020 guideline focused update on antithrombotic therapy in patients with coronary artery disease. Circ J. 2020;84:831–65.CrossRefPubMed Nakamura M, Kimura K, Kimura T, Ishihara M, Otsuka F, Kozuma K, et al. JCS 2020 guideline focused update on antithrombotic therapy in patients with coronary artery disease. Circ J. 2020;84:831–65.CrossRefPubMed
29.
Zurück zum Zitat Natsuaki M, Morimoto T, Yamaji K, Watanabe H, Yoshikawa Y, Shiomi H, et al. Prediction of thrombotic and bleeding events after percutaneous coronary intervention: CREDO-Kyoto thrombotic and bleeding risk scores. J Am Heart Assoc. 2018;7: e008708.CrossRefPubMedPubMedCentral Natsuaki M, Morimoto T, Yamaji K, Watanabe H, Yoshikawa Y, Shiomi H, et al. Prediction of thrombotic and bleeding events after percutaneous coronary intervention: CREDO-Kyoto thrombotic and bleeding risk scores. J Am Heart Assoc. 2018;7: e008708.CrossRefPubMedPubMedCentral
30.
Zurück zum Zitat Baber U, Mehran R, Giustino G, Cohen DJ, Henry TD, Sartori S, et al. Coronary thrombosis and major bleeding after PCI with drug-eluting stents: risk scores from PARIS. J Am Coll Cardiol. 2016;67:2224–34.CrossRefPubMed Baber U, Mehran R, Giustino G, Cohen DJ, Henry TD, Sartori S, et al. Coronary thrombosis and major bleeding after PCI with drug-eluting stents: risk scores from PARIS. J Am Coll Cardiol. 2016;67:2224–34.CrossRefPubMed
Metadaten
Titel
Very short-term tissue coverage of the CD34 antibody-covered sirolimus-eluting stent: an optical coherence tomography study
verfasst von
Tadahiro Matsumoto
Hideki Kitahara
Tatsuro Yamazaki
Takashi Hiraga
Daichi Yamashita
Takanori Sato
Yuichi Saito
Ken Kato
Yoshio Kobayashi
Publikationsdatum
19.05.2023
Verlag
Springer Nature Singapore
Erschienen in
Cardiovascular Intervention and Therapeutics / Ausgabe 4/2023
Print ISSN: 1868-4300
Elektronische ISSN: 1868-4297
DOI
https://doi.org/10.1007/s12928-023-00938-7

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