9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System

Donald E. Cutlip; Kirk N. Garratt; Victor Novack; Mark Barakat; Perwaiz Meraj; Luc Maillard; Andrejs Erglis; Rajiv Jauhar; Jeffrey J. Popma; Robert Stoler; Sigmund Silber; Donald Cutlip; Suhail Allaqaband; Ronald Caputo; Nirat Beohar; David Brown; Kirk Garratt; Rajiv Jauhar; Jon George; Vincent Varghese; Mark Huth; German Larrain; Tommy Lee; Amir Malik; Scott Martin; Thomas McGarry; Charles Phillips; Alpesh Shah; Robert Stoler; Michael Ball; R. Jeffrey Price; Joseph Rossi; Charles Taylor; Thaddeus Tolleson; William Nicholson; Srinivas Kesanakurthy; Mohammad Shoukfeh; Aloke Finn; Chandanreddy Devireddy; Charles Shoultz; Mark Robbins; Radoslaw Kiesz; Pramod Menon; Daniel Weilenmann; Horst Sievert; Goran Stankovic; Jacques Berland; Nicolas Delarche; Jean Lou Hirsch; Luc Maillard; John Shayne; Antonio Serra; Antonio Fernandez-Ortiz; Jean Pierre Monassier; Sigmund Silber

doi:10.1016/j.jcin.2016.10.037

9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System

Donald E. Cutlip, Kirk N. Garratt, Victor Novack, Mark Barakat, Perwaiz Meraj, Luc Maillard, Andrejs Erglis, Rajiv Jauhar, Jeffrey J. Popma, Robert Stoler, Sigmund Silber, Donald Cutlip, Suhail Allaqaband, Ronald Caputo, Nirat Beohar, David Brown, Kirk Garratt, Rajiv Jauhar, Jon George, Vincent VargheseMark Huth, German Larrain, Tommy Lee, Amir Malik, Scott Martin, Thomas McGarry, Charles Phillips, Alpesh Shah, Robert Stoler, Michael Ball, R. Jeffrey Price, Joseph Rossi, Charles Taylor, Thaddeus Tolleson, William Nicholson, Srinivas Kesanakurthy, Mohammad Shoukfeh, Aloke Finn, Chandanreddy Devireddy, Charles Shoultz, Mark Robbins, Radoslaw Kiesz, Pramod Menon, Daniel Weilenmann, Horst Sievert, Goran Stankovic, Jacques Berland, Nicolas Delarche, Jean Lou Hirsch, Luc Maillard, John Shayne, Antonio Serra, Antonio Fernandez-Ortiz, Jean Pierre Monassier, Sigmund Silber

Research output: Contribution to journal › Article › peer-review

34 Scopus citations

Abstract

Objectives The aim of this study was to assess the safety and effectiveness of the COBRA Polyzene-F NanoCoated Coronary Stent System (CeloNova Biosciences, San Antonio, Texas) for the treatment of de novo coronary artery lesions. Background Polyzene-F–coated coronary stents have shown reduced thrombogenicity and inflammation in preclinical studies. Methods Patients with de novo coronary artery lesions meeting eligibility criteria were enrolled in a nonrandomized, prospective clinical trial. The primary endpoint was target vessel failure (TVF) (defined as a composite of cardiac death, myocardial infarction, or clinically driven target vessel revascularization) at 9 months. A pre-specified subset was planned for routine repeat angiographic follow-up at 9 months. The powered secondary endpoint was mean late lumen loss (LL). The comparator was a performance goal derived from meta-analysis of historical bare-metal stent trials of 19.62% for TVF and 1.1 mm for LL. Other secondary endpoints were clinically driven target lesion revascularization and definite or probable stent thrombosis. Results Of 296 enrolled patients, 287 (97%) completed primary endpoint analysis; 130 were planned for angiographic follow-up and 115 (88%) completed. At 9 months, TVF had occurred in 33 patients (11.5%; upper 95% confidence boundary: 15.07%), including 1 (0.3%) cardiac death, 20 (7.0%) myocardial infarctions (17 periprocedural), and 17 (5.9%) target vessel revascularizations. LL was 0.84 ± 0.48 mm (upper 95% confidence boundary: 0.92). Target lesion revascularization occurred in 13 patients (4.6%). There were no stent thrombosis events. Conclusions The COBRA Polyzene-F stent met performance goals for TVF and LL at 9 months. There was an excellent safety profile, with infrequent late myocardial infarction and no stent thrombosis.

Original language	English (US)
Pages (from-to)	160-167
Number of pages	8
Journal	JACC: Cardiovascular Interventions
Volume	10
Issue number	2
DOIs	https://doi.org/10.1016/j.jcin.2016.10.037
State	Published - Jan 23 2017

Keywords

restenosis
stent(s)
thrombosis

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1016/j.jcin.2016.10.037

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Cutlip, D. E., Garratt, K. N., Novack, V., Barakat, M., Meraj, P., Maillard, L., Erglis, A., Jauhar, R., Popma, J. J., Stoler, R., Silber, S., Cutlip, D., Allaqaband, S., Caputo, R., Beohar, N., Brown, D., Garratt, K., Jauhar, R., George, J., ... Silber, S. (2017). 9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System. JACC: Cardiovascular Interventions, 10(2), 160-167. https://doi.org/10.1016/j.jcin.2016.10.037

Cutlip, DE, Garratt, KN, Novack, V, Barakat, M, Meraj, P, Maillard, L, Erglis, A, Jauhar, R, Popma, JJ, Stoler, R, Silber, S, Cutlip, D, Allaqaband, S, Caputo, R, Beohar, N, Brown, D, Garratt, K, Jauhar, R, George, J, Varghese, V, Huth, M, Larrain, G, Lee, T, Malik, A, Martin, S, McGarry, T, Phillips, C, Shah, A, Stoler, R, Ball, M, Price, RJ, Rossi, J, Taylor, C, Tolleson, T, Nicholson, W, Kesanakurthy, S, Shoukfeh, M, Finn, A, Devireddy, C, Shoultz, C, Robbins, M, Kiesz, R, Menon, P, Weilenmann, D, Sievert, H, Stankovic, G, Berland, J, Delarche, N, Hirsch, JL, Maillard, L, Shayne, J, Serra, A, Fernandez-Ortiz, A, Monassier, JP & Silber, S 2017, '9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System', JACC: Cardiovascular Interventions, vol. 10, no. 2, pp. 160-167. https://doi.org/10.1016/j.jcin.2016.10.037

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title = "9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System",

abstract = "Objectives The aim of this study was to assess the safety and effectiveness of the COBRA Polyzene-F NanoCoated Coronary Stent System (CeloNova Biosciences, San Antonio, Texas) for the treatment of de novo coronary artery lesions. Background Polyzene-F–coated coronary stents have shown reduced thrombogenicity and inflammation in preclinical studies. Methods Patients with de novo coronary artery lesions meeting eligibility criteria were enrolled in a nonrandomized, prospective clinical trial. The primary endpoint was target vessel failure (TVF) (defined as a composite of cardiac death, myocardial infarction, or clinically driven target vessel revascularization) at 9 months. A pre-specified subset was planned for routine repeat angiographic follow-up at 9 months. The powered secondary endpoint was mean late lumen loss (LL). The comparator was a performance goal derived from meta-analysis of historical bare-metal stent trials of 19.62% for TVF and 1.1 mm for LL. Other secondary endpoints were clinically driven target lesion revascularization and definite or probable stent thrombosis. Results Of 296 enrolled patients, 287 (97%) completed primary endpoint analysis; 130 were planned for angiographic follow-up and 115 (88%) completed. At 9 months, TVF had occurred in 33 patients (11.5%; upper 95% confidence boundary: 15.07%), including 1 (0.3%) cardiac death, 20 (7.0%) myocardial infarctions (17 periprocedural), and 17 (5.9%) target vessel revascularizations. LL was 0.84 ± 0.48 mm (upper 95% confidence boundary: 0.92). Target lesion revascularization occurred in 13 patients (4.6%). There were no stent thrombosis events. Conclusions The COBRA Polyzene-F stent met performance goals for TVF and LL at 9 months. There was an excellent safety profile, with infrequent late myocardial infarction and no stent thrombosis.",

keywords = "restenosis, stent(s), thrombosis",

author = "Cutlip, {Donald E.} and Garratt, {Kirk N.} and Victor Novack and Mark Barakat and Perwaiz Meraj and Luc Maillard and Andrejs Erglis and Rajiv Jauhar and Popma, {Jeffrey J.} and Robert Stoler and Sigmund Silber and Donald Cutlip and Suhail Allaqaband and Ronald Caputo and Nirat Beohar and David Brown and Kirk Garratt and Rajiv Jauhar and Jon George and Vincent Varghese and Mark Huth and German Larrain and Tommy Lee and Amir Malik and Scott Martin and Thomas McGarry and Charles Phillips and Alpesh Shah and Robert Stoler and Michael Ball and Price, {R. Jeffrey} and Joseph Rossi and Charles Taylor and Thaddeus Tolleson and William Nicholson and Srinivas Kesanakurthy and Mohammad Shoukfeh and Aloke Finn and Chandanreddy Devireddy and Charles Shoultz and Mark Robbins and Radoslaw Kiesz and Pramod Menon and Daniel Weilenmann and Horst Sievert and Goran Stankovic and Jacques Berland and Nicolas Delarche and Hirsch, {Jean Lou} and Luc Maillard and John Shayne and Antonio Serra and Antonio Fernandez-Ortiz and Monassier, {Jean Pierre} and Sigmund Silber",

note = "Publisher Copyright: {\textcopyright} 2017 American College of Cardiology Foundation",

year = "2017",

month = jan,

day = "23",

doi = "10.1016/j.jcin.2016.10.037",

language = "English (US)",

volume = "10",

pages = "160--167",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

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TY - JOUR

T1 - 9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System

AU - Cutlip, Donald E.

AU - Garratt, Kirk N.

AU - Novack, Victor

AU - Barakat, Mark

AU - Meraj, Perwaiz

AU - Maillard, Luc

AU - Erglis, Andrejs

AU - Jauhar, Rajiv

AU - Popma, Jeffrey J.

AU - Stoler, Robert

AU - Silber, Sigmund

AU - Cutlip, Donald

AU - Allaqaband, Suhail

AU - Caputo, Ronald

AU - Beohar, Nirat

AU - Brown, David

AU - Garratt, Kirk

AU - Jauhar, Rajiv

AU - George, Jon

AU - Varghese, Vincent

AU - Huth, Mark

AU - Larrain, German

AU - Lee, Tommy

AU - Malik, Amir

AU - Martin, Scott

AU - McGarry, Thomas

AU - Phillips, Charles

AU - Shah, Alpesh

AU - Stoler, Robert

AU - Ball, Michael

AU - Price, R. Jeffrey

AU - Rossi, Joseph

AU - Taylor, Charles

AU - Tolleson, Thaddeus

AU - Nicholson, William

AU - Kesanakurthy, Srinivas

AU - Shoukfeh, Mohammad

AU - Finn, Aloke

AU - Devireddy, Chandanreddy

AU - Shoultz, Charles

AU - Robbins, Mark

AU - Kiesz, Radoslaw

AU - Menon, Pramod

AU - Weilenmann, Daniel

AU - Sievert, Horst

AU - Stankovic, Goran

AU - Berland, Jacques

AU - Delarche, Nicolas

AU - Hirsch, Jean Lou

AU - Maillard, Luc

AU - Shayne, John

AU - Serra, Antonio

AU - Fernandez-Ortiz, Antonio

AU - Monassier, Jean Pierre

AU - Silber, Sigmund

PY - 2017/1/23

Y1 - 2017/1/23

N2 - Objectives The aim of this study was to assess the safety and effectiveness of the COBRA Polyzene-F NanoCoated Coronary Stent System (CeloNova Biosciences, San Antonio, Texas) for the treatment of de novo coronary artery lesions. Background Polyzene-F–coated coronary stents have shown reduced thrombogenicity and inflammation in preclinical studies. Methods Patients with de novo coronary artery lesions meeting eligibility criteria were enrolled in a nonrandomized, prospective clinical trial. The primary endpoint was target vessel failure (TVF) (defined as a composite of cardiac death, myocardial infarction, or clinically driven target vessel revascularization) at 9 months. A pre-specified subset was planned for routine repeat angiographic follow-up at 9 months. The powered secondary endpoint was mean late lumen loss (LL). The comparator was a performance goal derived from meta-analysis of historical bare-metal stent trials of 19.62% for TVF and 1.1 mm for LL. Other secondary endpoints were clinically driven target lesion revascularization and definite or probable stent thrombosis. Results Of 296 enrolled patients, 287 (97%) completed primary endpoint analysis; 130 were planned for angiographic follow-up and 115 (88%) completed. At 9 months, TVF had occurred in 33 patients (11.5%; upper 95% confidence boundary: 15.07%), including 1 (0.3%) cardiac death, 20 (7.0%) myocardial infarctions (17 periprocedural), and 17 (5.9%) target vessel revascularizations. LL was 0.84 ± 0.48 mm (upper 95% confidence boundary: 0.92). Target lesion revascularization occurred in 13 patients (4.6%). There were no stent thrombosis events. Conclusions The COBRA Polyzene-F stent met performance goals for TVF and LL at 9 months. There was an excellent safety profile, with infrequent late myocardial infarction and no stent thrombosis.

AB - Objectives The aim of this study was to assess the safety and effectiveness of the COBRA Polyzene-F NanoCoated Coronary Stent System (CeloNova Biosciences, San Antonio, Texas) for the treatment of de novo coronary artery lesions. Background Polyzene-F–coated coronary stents have shown reduced thrombogenicity and inflammation in preclinical studies. Methods Patients with de novo coronary artery lesions meeting eligibility criteria were enrolled in a nonrandomized, prospective clinical trial. The primary endpoint was target vessel failure (TVF) (defined as a composite of cardiac death, myocardial infarction, or clinically driven target vessel revascularization) at 9 months. A pre-specified subset was planned for routine repeat angiographic follow-up at 9 months. The powered secondary endpoint was mean late lumen loss (LL). The comparator was a performance goal derived from meta-analysis of historical bare-metal stent trials of 19.62% for TVF and 1.1 mm for LL. Other secondary endpoints were clinically driven target lesion revascularization and definite or probable stent thrombosis. Results Of 296 enrolled patients, 287 (97%) completed primary endpoint analysis; 130 were planned for angiographic follow-up and 115 (88%) completed. At 9 months, TVF had occurred in 33 patients (11.5%; upper 95% confidence boundary: 15.07%), including 1 (0.3%) cardiac death, 20 (7.0%) myocardial infarctions (17 periprocedural), and 17 (5.9%) target vessel revascularizations. LL was 0.84 ± 0.48 mm (upper 95% confidence boundary: 0.92). Target lesion revascularization occurred in 13 patients (4.6%). There were no stent thrombosis events. Conclusions The COBRA Polyzene-F stent met performance goals for TVF and LL at 9 months. There was an excellent safety profile, with infrequent late myocardial infarction and no stent thrombosis.

KW - restenosis

KW - stent(s)

KW - thrombosis

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9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System

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