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

Shigeru Saito, Mitchell W. Krucoff, Shigeru Nakamura, Roxana Mehran, Akiko Maehara, Hussein R. Al-Khalidi, Stephen M. Rowland, Gudaye Tasissa, Debbie Morrell, Diane Joseph, Yumiko Okaniwa, Yoshisato Shibata, Barry D. Bertolet, Mark D. Rothenberg, Philippe Genereux, Hiram Bezerra, David F. Kong

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Aims Harmonized Assessment by Randomized Multicentre Study of OrbusNEich's Combo StEnt (HARMONEE) (NCT02073565) was a randomized pivotal registration trial of the Combo stent, which combined sirolimus and an abluminal bioabsorbable polymer with a novel endoluminal anti-CD34+ antibody coating designed to capture endothelial progenitor cells (EPC) and promote percutaneous coronary intervention (PCI) site healing. Methods and results Clinically stabilized PCI subjects were randomized 1:1 to receive Combo or everolimus-eluting stents (EES). Between February 2014 and June 2016, 572 subjects with 675 coronary lesions underwent 1-year angiography and fractional flow reserve, with optical coherence tomography (OCT) in the first 140 patients. The primary clinical endpoint was non-inferior 1-year target vessel failure (TVF). The primary mechanistic endpoint of EPC capture activity was superior strut coverage by OCT. Target vessel failure occurred in 7.0% Combo (20/287) vs. 4.2% EES (12/285), a 2.8% [95% confidence interval (95% CI) -1.0%, 6.5%] difference, meeting the non-inferiority hypothesis (P = 0.02). There were no cardiac deaths, with one stent thrombosis observed in the EES group. Quantitative coronary angiography late loss with Combo was equivalent to EES. Optical coherence tomography strut coverage at 1 year was superior with Combo vs. EES [91.3% (95% CI 88.7%, 93.8%) vs. 74.8% (95% CI 70.0%, 79.6%), P < 0.001], with homogeneous tissue in 81.2% vs. 68.8%, respectively. Conclusion Combo stent demonstrated non-inferior 1-year TVF and late loss in a randomized comparison to EES, with superior strut-based tissue coverage by OCT as a surrogate of EPC capture technology activity.

Original languageEnglish (US)
Pages (from-to)2460-2468
Number of pages9
JournalEuropean Heart Journal
Volume39
Issue number26
DOIs
StatePublished - Jul 7 2018

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Drug-Eluting Stents
Acute Coronary Syndrome
Multicenter Studies
Stents
Coronary Disease
Japan
Optical Coherence Tomography
Confidence Intervals
Percutaneous Coronary Intervention
Endothelial Progenitor Cells
Sirolimus
Coronary Angiography
Everolimus
Anti-Idiotypic Antibodies
Angiography
Polymers
Thrombosis
Technology

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Saito, Shigeru ; Krucoff, Mitchell W. ; Nakamura, Shigeru ; Mehran, Roxana ; Maehara, Akiko ; Al-Khalidi, Hussein R. ; Rowland, Stephen M. ; Tasissa, Gudaye ; Morrell, Debbie ; Joseph, Diane ; Okaniwa, Yumiko ; Shibata, Yoshisato ; Bertolet, Barry D. ; Rothenberg, Mark D. ; Genereux, Philippe ; Bezerra, Hiram ; Kong, David F. / 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. In: European Heart Journal. 2018 ; Vol. 39, No. 26. pp. 2460-2468.
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title = "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",
abstract = "Aims Harmonized Assessment by Randomized Multicentre Study of OrbusNEich's Combo StEnt (HARMONEE) (NCT02073565) was a randomized pivotal registration trial of the Combo stent, which combined sirolimus and an abluminal bioabsorbable polymer with a novel endoluminal anti-CD34+ antibody coating designed to capture endothelial progenitor cells (EPC) and promote percutaneous coronary intervention (PCI) site healing. Methods and results Clinically stabilized PCI subjects were randomized 1:1 to receive Combo or everolimus-eluting stents (EES). Between February 2014 and June 2016, 572 subjects with 675 coronary lesions underwent 1-year angiography and fractional flow reserve, with optical coherence tomography (OCT) in the first 140 patients. The primary clinical endpoint was non-inferior 1-year target vessel failure (TVF). The primary mechanistic endpoint of EPC capture activity was superior strut coverage by OCT. Target vessel failure occurred in 7.0{\%} Combo (20/287) vs. 4.2{\%} EES (12/285), a 2.8{\%} [95{\%} confidence interval (95{\%} CI) -1.0{\%}, 6.5{\%}] difference, meeting the non-inferiority hypothesis (P = 0.02). There were no cardiac deaths, with one stent thrombosis observed in the EES group. Quantitative coronary angiography late loss with Combo was equivalent to EES. Optical coherence tomography strut coverage at 1 year was superior with Combo vs. EES [91.3{\%} (95{\%} CI 88.7{\%}, 93.8{\%}) vs. 74.8{\%} (95{\%} CI 70.0{\%}, 79.6{\%}), P < 0.001], with homogeneous tissue in 81.2{\%} vs. 68.8{\%}, respectively. Conclusion Combo stent demonstrated non-inferior 1-year TVF and late loss in a randomized comparison to EES, with superior strut-based tissue coverage by OCT as a surrogate of EPC capture technology activity.",
author = "Shigeru Saito and Krucoff, {Mitchell W.} and Shigeru Nakamura and Roxana Mehran and Akiko Maehara and Al-Khalidi, {Hussein R.} and Rowland, {Stephen M.} and Gudaye Tasissa and Debbie Morrell and Diane Joseph and Yumiko Okaniwa and Yoshisato Shibata and Bertolet, {Barry D.} and Rothenberg, {Mark D.} and Philippe Genereux and Hiram Bezerra and Kong, {David F.}",
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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. / Saito, Shigeru; Krucoff, Mitchell W.; Nakamura, Shigeru; Mehran, Roxana; Maehara, Akiko; Al-Khalidi, Hussein R.; Rowland, Stephen M.; Tasissa, Gudaye; Morrell, Debbie; Joseph, Diane; Okaniwa, Yumiko; Shibata, Yoshisato; Bertolet, Barry D.; Rothenberg, Mark D.; Genereux, Philippe; Bezerra, Hiram; Kong, David F.

In: European Heart Journal, Vol. 39, No. 26, 07.07.2018, p. 2460-2468.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Japan-United States of America Harmonized Assessment by Randomized Multicentre Study of OrbusNEich's Combo StEnt (Japan-USA HARMONEE) study

T2 - 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

AU - Saito, Shigeru

AU - Krucoff, Mitchell W.

AU - Nakamura, Shigeru

AU - Mehran, Roxana

AU - Maehara, Akiko

AU - Al-Khalidi, Hussein R.

AU - Rowland, Stephen M.

AU - Tasissa, Gudaye

AU - Morrell, Debbie

AU - Joseph, Diane

AU - Okaniwa, Yumiko

AU - Shibata, Yoshisato

AU - Bertolet, Barry D.

AU - Rothenberg, Mark D.

AU - Genereux, Philippe

AU - Bezerra, Hiram

AU - Kong, David F.

PY - 2018/7/7

Y1 - 2018/7/7

N2 - Aims Harmonized Assessment by Randomized Multicentre Study of OrbusNEich's Combo StEnt (HARMONEE) (NCT02073565) was a randomized pivotal registration trial of the Combo stent, which combined sirolimus and an abluminal bioabsorbable polymer with a novel endoluminal anti-CD34+ antibody coating designed to capture endothelial progenitor cells (EPC) and promote percutaneous coronary intervention (PCI) site healing. Methods and results Clinically stabilized PCI subjects were randomized 1:1 to receive Combo or everolimus-eluting stents (EES). Between February 2014 and June 2016, 572 subjects with 675 coronary lesions underwent 1-year angiography and fractional flow reserve, with optical coherence tomography (OCT) in the first 140 patients. The primary clinical endpoint was non-inferior 1-year target vessel failure (TVF). The primary mechanistic endpoint of EPC capture activity was superior strut coverage by OCT. Target vessel failure occurred in 7.0% Combo (20/287) vs. 4.2% EES (12/285), a 2.8% [95% confidence interval (95% CI) -1.0%, 6.5%] difference, meeting the non-inferiority hypothesis (P = 0.02). There were no cardiac deaths, with one stent thrombosis observed in the EES group. Quantitative coronary angiography late loss with Combo was equivalent to EES. Optical coherence tomography strut coverage at 1 year was superior with Combo vs. EES [91.3% (95% CI 88.7%, 93.8%) vs. 74.8% (95% CI 70.0%, 79.6%), P < 0.001], with homogeneous tissue in 81.2% vs. 68.8%, respectively. Conclusion Combo stent demonstrated non-inferior 1-year TVF and late loss in a randomized comparison to EES, with superior strut-based tissue coverage by OCT as a surrogate of EPC capture technology activity.

AB - Aims Harmonized Assessment by Randomized Multicentre Study of OrbusNEich's Combo StEnt (HARMONEE) (NCT02073565) was a randomized pivotal registration trial of the Combo stent, which combined sirolimus and an abluminal bioabsorbable polymer with a novel endoluminal anti-CD34+ antibody coating designed to capture endothelial progenitor cells (EPC) and promote percutaneous coronary intervention (PCI) site healing. Methods and results Clinically stabilized PCI subjects were randomized 1:1 to receive Combo or everolimus-eluting stents (EES). Between February 2014 and June 2016, 572 subjects with 675 coronary lesions underwent 1-year angiography and fractional flow reserve, with optical coherence tomography (OCT) in the first 140 patients. The primary clinical endpoint was non-inferior 1-year target vessel failure (TVF). The primary mechanistic endpoint of EPC capture activity was superior strut coverage by OCT. Target vessel failure occurred in 7.0% Combo (20/287) vs. 4.2% EES (12/285), a 2.8% [95% confidence interval (95% CI) -1.0%, 6.5%] difference, meeting the non-inferiority hypothesis (P = 0.02). There were no cardiac deaths, with one stent thrombosis observed in the EES group. Quantitative coronary angiography late loss with Combo was equivalent to EES. Optical coherence tomography strut coverage at 1 year was superior with Combo vs. EES [91.3% (95% CI 88.7%, 93.8%) vs. 74.8% (95% CI 70.0%, 79.6%), P < 0.001], with homogeneous tissue in 81.2% vs. 68.8%, respectively. Conclusion Combo stent demonstrated non-inferior 1-year TVF and late loss in a randomized comparison to EES, with superior strut-based tissue coverage by OCT as a surrogate of EPC capture technology activity.

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JO - European Heart Journal

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