Comparison of Zotarolimus-Eluting and Sirolimus-Eluting Stents in Patients With Native Coronary Artery Disease. A Randomized Controlled Trial

David E. Kandzari, Martin B. Leon, Jeffrey J. Popma, Peter J. Fitzgerald, Charles O'Shaughnessy, Michael W. Ball, Mark Turco, Robert J. Applegate, Paul A. Gurbel, Mark G. Midei, Sejal S. Badre, Laura Mauri, Kweli P. Thompson, LeRoy A. LeNarz, Richard E. Kuntz

Research output: Contribution to journalArticle

Abstract

Objectives: This trial examined the relative clinical efficacy, angiographic outcomes, and safety of zotarolimus-eluting coronary stents (ZES) with a phosphorylcholine polymer versus sirolimus-eluting stents (SES). Background: Whether a cobalt-based alloy stent coated with the novel antiproliferative agent, zotarolimus, and a phosphorylcholine polymer may provide similar angiographic and clinical benefit compared with SES is undetermined. Methods: A prospective, multicenter, 3:1 randomized trial was conducted to evaluate the safety and efficacy of ZES (n = 323) relative to SES (n = 113) in 436 patients undergoing elective percutaneous revascularization of de novo native coronary lesions with reference vessel diameters between 2.5 mm and 3.5 mm and lesion length ≥14 mm and ≤27 mm. The primary end point was 8-month angiographic in-segment late lumen loss. Results: Angiographic in-segment late lumen loss was significantly higher among patients treated with ZES compared with SES (0.34 ± 0.44 mm vs. 0.13 ± 0.32 mm, respectively; p <0.001). In-hospital major adverse cardiac events were significantly lower among patients treated with ZES (0.6% vs. 3.5%, p = 0.04). In-segment binary angiographic restenosis was also higher in the ZES cohort (11.7% vs. 4.3%, p = 0.04). Total (clinically and non-clinically driven) target lesion revascularization rates at 9 months were 9.8% and 3.5% for the ZES and SES groups, respectively (p = 0.04). However, neither clinically driven target lesion revascularization (6.3% zotarolimus vs. 3.5% sirolimus, p = 0.34) nor target vessel failure (12.0% zotarolimus vs. 11.5% sirolimus, p = 1.0) differed significantly. Conclusions: Compared with SES, treatment with a phosphorylcholine polymer-based ZES is associated with significantly higher late lumen loss and binary restenosis at 8-month angiographic follow-up. (The Endeavor III CR; http://clinicaltrials.gov/ct/show/NCT00265668?order=1?).

Original languageEnglish (US)
Pages (from-to)2440-2447
Number of pages8
JournalJournal of the American College of Cardiology
Volume48
Issue number12
DOIs
StatePublished - Dec 19 2006

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Sirolimus
Stents
Coronary Artery Disease
Randomized Controlled Trials
Phosphorylcholine
Polymers
zotarolimus
Safety
Cobalt

ASJC Scopus subject areas

  • Nursing(all)

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Comparison of Zotarolimus-Eluting and Sirolimus-Eluting Stents in Patients With Native Coronary Artery Disease. A Randomized Controlled Trial. / Kandzari, David E.; Leon, Martin B.; Popma, Jeffrey J.; Fitzgerald, Peter J.; O'Shaughnessy, Charles; Ball, Michael W.; Turco, Mark; Applegate, Robert J.; Gurbel, Paul A.; Midei, Mark G.; Badre, Sejal S.; Mauri, Laura; Thompson, Kweli P.; LeNarz, LeRoy A.; Kuntz, Richard E.

In: Journal of the American College of Cardiology, Vol. 48, No. 12, 19.12.2006, p. 2440-2447.

Research output: Contribution to journalArticle

Kandzari, DE, Leon, MB, Popma, JJ, Fitzgerald, PJ, O'Shaughnessy, C, Ball, MW, Turco, M, Applegate, RJ, Gurbel, PA, Midei, MG, Badre, SS, Mauri, L, Thompson, KP, LeNarz, LA & Kuntz, RE 2006, 'Comparison of Zotarolimus-Eluting and Sirolimus-Eluting Stents in Patients With Native Coronary Artery Disease. A Randomized Controlled Trial', Journal of the American College of Cardiology, vol. 48, no. 12, pp. 2440-2447. https://doi.org/10.1016/j.jacc.2006.08.035
Kandzari, David E. ; Leon, Martin B. ; Popma, Jeffrey J. ; Fitzgerald, Peter J. ; O'Shaughnessy, Charles ; Ball, Michael W. ; Turco, Mark ; Applegate, Robert J. ; Gurbel, Paul A. ; Midei, Mark G. ; Badre, Sejal S. ; Mauri, Laura ; Thompson, Kweli P. ; LeNarz, LeRoy A. ; Kuntz, Richard E. / Comparison of Zotarolimus-Eluting and Sirolimus-Eluting Stents in Patients With Native Coronary Artery Disease. A Randomized Controlled Trial. In: Journal of the American College of Cardiology. 2006 ; Vol. 48, No. 12. pp. 2440-2447.
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abstract = "Objectives: This trial examined the relative clinical efficacy, angiographic outcomes, and safety of zotarolimus-eluting coronary stents (ZES) with a phosphorylcholine polymer versus sirolimus-eluting stents (SES). Background: Whether a cobalt-based alloy stent coated with the novel antiproliferative agent, zotarolimus, and a phosphorylcholine polymer may provide similar angiographic and clinical benefit compared with SES is undetermined. Methods: A prospective, multicenter, 3:1 randomized trial was conducted to evaluate the safety and efficacy of ZES (n = 323) relative to SES (n = 113) in 436 patients undergoing elective percutaneous revascularization of de novo native coronary lesions with reference vessel diameters between 2.5 mm and 3.5 mm and lesion length ≥14 mm and ≤27 mm. The primary end point was 8-month angiographic in-segment late lumen loss. Results: Angiographic in-segment late lumen loss was significantly higher among patients treated with ZES compared with SES (0.34 ± 0.44 mm vs. 0.13 ± 0.32 mm, respectively; p <0.001). In-hospital major adverse cardiac events were significantly lower among patients treated with ZES (0.6{\%} vs. 3.5{\%}, p = 0.04). In-segment binary angiographic restenosis was also higher in the ZES cohort (11.7{\%} vs. 4.3{\%}, p = 0.04). Total (clinically and non-clinically driven) target lesion revascularization rates at 9 months were 9.8{\%} and 3.5{\%} for the ZES and SES groups, respectively (p = 0.04). However, neither clinically driven target lesion revascularization (6.3{\%} zotarolimus vs. 3.5{\%} sirolimus, p = 0.34) nor target vessel failure (12.0{\%} zotarolimus vs. 11.5{\%} sirolimus, p = 1.0) differed significantly. Conclusions: Compared with SES, treatment with a phosphorylcholine polymer-based ZES is associated with significantly higher late lumen loss and binary restenosis at 8-month angiographic follow-up. (The Endeavor III CR; http://clinicaltrials.gov/ct/show/NCT00265668?order=1?).",
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T1 - Comparison of Zotarolimus-Eluting and Sirolimus-Eluting Stents in Patients With Native Coronary Artery Disease. A Randomized Controlled Trial

AU - Kandzari, David E.

AU - Leon, Martin B.

AU - Popma, Jeffrey J.

AU - Fitzgerald, Peter J.

AU - O'Shaughnessy, Charles

AU - Ball, Michael W.

AU - Turco, Mark

AU - Applegate, Robert J.

AU - Gurbel, Paul A.

AU - Midei, Mark G.

AU - Badre, Sejal S.

AU - Mauri, Laura

AU - Thompson, Kweli P.

AU - LeNarz, LeRoy A.

AU - Kuntz, Richard E.

PY - 2006/12/19

Y1 - 2006/12/19

N2 - Objectives: This trial examined the relative clinical efficacy, angiographic outcomes, and safety of zotarolimus-eluting coronary stents (ZES) with a phosphorylcholine polymer versus sirolimus-eluting stents (SES). Background: Whether a cobalt-based alloy stent coated with the novel antiproliferative agent, zotarolimus, and a phosphorylcholine polymer may provide similar angiographic and clinical benefit compared with SES is undetermined. Methods: A prospective, multicenter, 3:1 randomized trial was conducted to evaluate the safety and efficacy of ZES (n = 323) relative to SES (n = 113) in 436 patients undergoing elective percutaneous revascularization of de novo native coronary lesions with reference vessel diameters between 2.5 mm and 3.5 mm and lesion length ≥14 mm and ≤27 mm. The primary end point was 8-month angiographic in-segment late lumen loss. Results: Angiographic in-segment late lumen loss was significantly higher among patients treated with ZES compared with SES (0.34 ± 0.44 mm vs. 0.13 ± 0.32 mm, respectively; p <0.001). In-hospital major adverse cardiac events were significantly lower among patients treated with ZES (0.6% vs. 3.5%, p = 0.04). In-segment binary angiographic restenosis was also higher in the ZES cohort (11.7% vs. 4.3%, p = 0.04). Total (clinically and non-clinically driven) target lesion revascularization rates at 9 months were 9.8% and 3.5% for the ZES and SES groups, respectively (p = 0.04). However, neither clinically driven target lesion revascularization (6.3% zotarolimus vs. 3.5% sirolimus, p = 0.34) nor target vessel failure (12.0% zotarolimus vs. 11.5% sirolimus, p = 1.0) differed significantly. Conclusions: Compared with SES, treatment with a phosphorylcholine polymer-based ZES is associated with significantly higher late lumen loss and binary restenosis at 8-month angiographic follow-up. (The Endeavor III CR; http://clinicaltrials.gov/ct/show/NCT00265668?order=1?).

AB - Objectives: This trial examined the relative clinical efficacy, angiographic outcomes, and safety of zotarolimus-eluting coronary stents (ZES) with a phosphorylcholine polymer versus sirolimus-eluting stents (SES). Background: Whether a cobalt-based alloy stent coated with the novel antiproliferative agent, zotarolimus, and a phosphorylcholine polymer may provide similar angiographic and clinical benefit compared with SES is undetermined. Methods: A prospective, multicenter, 3:1 randomized trial was conducted to evaluate the safety and efficacy of ZES (n = 323) relative to SES (n = 113) in 436 patients undergoing elective percutaneous revascularization of de novo native coronary lesions with reference vessel diameters between 2.5 mm and 3.5 mm and lesion length ≥14 mm and ≤27 mm. The primary end point was 8-month angiographic in-segment late lumen loss. Results: Angiographic in-segment late lumen loss was significantly higher among patients treated with ZES compared with SES (0.34 ± 0.44 mm vs. 0.13 ± 0.32 mm, respectively; p <0.001). In-hospital major adverse cardiac events were significantly lower among patients treated with ZES (0.6% vs. 3.5%, p = 0.04). In-segment binary angiographic restenosis was also higher in the ZES cohort (11.7% vs. 4.3%, p = 0.04). Total (clinically and non-clinically driven) target lesion revascularization rates at 9 months were 9.8% and 3.5% for the ZES and SES groups, respectively (p = 0.04). However, neither clinically driven target lesion revascularization (6.3% zotarolimus vs. 3.5% sirolimus, p = 0.34) nor target vessel failure (12.0% zotarolimus vs. 11.5% sirolimus, p = 1.0) differed significantly. Conclusions: Compared with SES, treatment with a phosphorylcholine polymer-based ZES is associated with significantly higher late lumen loss and binary restenosis at 8-month angiographic follow-up. (The Endeavor III CR; http://clinicaltrials.gov/ct/show/NCT00265668?order=1?).

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