Randomized comparison of ridaforolimusand zotarolimus-eluting coronary stents in patients with coronary artery disease

Primary results from the BIONICS trial (BioNIR ridaforolimus-eluting coronary stent system in coronary stenosis)

David E. Kandzari, Pieter C. Smits, Michael P. Love, Ori Ben-Yehuda, Shmuel Banai, Simon D. Robinson, Michael Jonas, Ran Kornowski, Rodrigo Bagur, Andres Iniguez, Haim Danenberg, Robert Feldman, Rajiv Jauhar, Harish Chandna, Manish Parikh, Gidon Y. Perlman, Mercedes Balcells, Peter Markham, Melek Ozgu Ozan, Philippe Genereux & 3 others Elazer R. Edelman, Martin B. Leon, Gregg W. Stone

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

BACKGROUND: The safety and efficacy of a novel cobalt alloybased coronary stent with a durable elastomeric polymer eluting the antiproliferative agent ridaforolimus for treatment of patients with coronary artery disease is undetermined. METHODS: A prospective, international 1:1 randomized trial was conducted to evaluate in a noninferiority design the relative safety and efficacy of ridaforolimus-eluting stents (RESs) and slow-release zotarolimus-eluting stents among 1919 patients undergoing percutaneous coronary intervention at 76 centers. Inclusion criteria allowed enrollment of patients with recent myocardial infarction, total occlusions, bifurcations lesions, and other complex conditions. RESULTS: Baseline clinical and angiographic characteristics were similar between the groups. Overall, mean age was 63.4 years, 32.5% had diabetes mellitus, and 39.7% presented with acute coronary syndromes. At 12 months, the primary end point of target lesion failure (composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization) was 5.4% for both devices (upper bound of 1-sided 95% confidence interval 1.8%, Pnoninferiority=0.001). Definite/probable stent thrombosis rates were low in both groups (0.4% RES versus 0.6% zotarolimus-eluting stent, P=0.75); 13-month angiographic in-stent late lumen loss was 0.22±0.41 mm and 0.23±0.39 mm (Pnoninferiority=0.004) for the RES and zotarolimus-eluting stent groups, respectively, and intravascular ultrasound percent neointimal hyperplasia was 8.10±5.81 and 8.85±7.77, respectively (Pnoninferiority=0.01). CONCLUSIONS: In the present trial, which allowed broad inclusion criteria, the novel RESs met the prespecified criteria for noninferiority compared with zotarolimus-eluting stents for the primary end point of target lesion failure at 12 months and had similar measures of late lumen loss. These findings support the safety and efficacy of RESs in patients who are representative of clinical practice.

Original languageEnglish (US)
Pages (from-to)1304-1314
Number of pages11
JournalCirculation
Volume136
Issue number14
DOIs
StatePublished - Oct 1 2017

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Coronary Stenosis
Stents
Coronary Artery Disease
Safety
zotarolimus
ridaforolimus
Myocardial Infarction
Patient Advocacy
Percutaneous Coronary Intervention
Acute Coronary Syndrome
Cobalt
Hyperplasia
Diabetes Mellitus
Polymers
Thrombosis
Confidence Intervals

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Kandzari, David E. ; Smits, Pieter C. ; Love, Michael P. ; Ben-Yehuda, Ori ; Banai, Shmuel ; Robinson, Simon D. ; Jonas, Michael ; Kornowski, Ran ; Bagur, Rodrigo ; Iniguez, Andres ; Danenberg, Haim ; Feldman, Robert ; Jauhar, Rajiv ; Chandna, Harish ; Parikh, Manish ; Perlman, Gidon Y. ; Balcells, Mercedes ; Markham, Peter ; Ozan, Melek Ozgu ; Genereux, Philippe ; Edelman, Elazer R. ; Leon, Martin B. ; Stone, Gregg W. / Randomized comparison of ridaforolimusand zotarolimus-eluting coronary stents in patients with coronary artery disease : Primary results from the BIONICS trial (BioNIR ridaforolimus-eluting coronary stent system in coronary stenosis). In: Circulation. 2017 ; Vol. 136, No. 14. pp. 1304-1314.
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title = "Randomized comparison of ridaforolimusand zotarolimus-eluting coronary stents in patients with coronary artery disease: Primary results from the BIONICS trial (BioNIR ridaforolimus-eluting coronary stent system in coronary stenosis)",
abstract = "BACKGROUND: The safety and efficacy of a novel cobalt alloybased coronary stent with a durable elastomeric polymer eluting the antiproliferative agent ridaforolimus for treatment of patients with coronary artery disease is undetermined. METHODS: A prospective, international 1:1 randomized trial was conducted to evaluate in a noninferiority design the relative safety and efficacy of ridaforolimus-eluting stents (RESs) and slow-release zotarolimus-eluting stents among 1919 patients undergoing percutaneous coronary intervention at 76 centers. Inclusion criteria allowed enrollment of patients with recent myocardial infarction, total occlusions, bifurcations lesions, and other complex conditions. RESULTS: Baseline clinical and angiographic characteristics were similar between the groups. Overall, mean age was 63.4 years, 32.5{\%} had diabetes mellitus, and 39.7{\%} presented with acute coronary syndromes. At 12 months, the primary end point of target lesion failure (composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization) was 5.4{\%} for both devices (upper bound of 1-sided 95{\%} confidence interval 1.8{\%}, Pnoninferiority=0.001). Definite/probable stent thrombosis rates were low in both groups (0.4{\%} RES versus 0.6{\%} zotarolimus-eluting stent, P=0.75); 13-month angiographic in-stent late lumen loss was 0.22±0.41 mm and 0.23±0.39 mm (Pnoninferiority=0.004) for the RES and zotarolimus-eluting stent groups, respectively, and intravascular ultrasound percent neointimal hyperplasia was 8.10±5.81 and 8.85±7.77, respectively (Pnoninferiority=0.01). CONCLUSIONS: In the present trial, which allowed broad inclusion criteria, the novel RESs met the prespecified criteria for noninferiority compared with zotarolimus-eluting stents for the primary end point of target lesion failure at 12 months and had similar measures of late lumen loss. These findings support the safety and efficacy of RESs in patients who are representative of clinical practice.",
author = "Kandzari, {David E.} and Smits, {Pieter C.} and Love, {Michael P.} and Ori Ben-Yehuda and Shmuel Banai and Robinson, {Simon D.} and Michael Jonas and Ran Kornowski and Rodrigo Bagur and Andres Iniguez and Haim Danenberg and Robert Feldman and Rajiv Jauhar and Harish Chandna and Manish Parikh and Perlman, {Gidon Y.} and Mercedes Balcells and Peter Markham and Ozan, {Melek Ozgu} and Philippe Genereux and Edelman, {Elazer R.} and Leon, {Martin B.} and Stone, {Gregg W.}",
year = "2017",
month = "10",
day = "1",
doi = "10.1161/CIRCULATIONAHA.117.028885",
language = "English (US)",
volume = "136",
pages = "1304--1314",
journal = "Circulation",
issn = "0009-7322",
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Kandzari, DE, Smits, PC, Love, MP, Ben-Yehuda, O, Banai, S, Robinson, SD, Jonas, M, Kornowski, R, Bagur, R, Iniguez, A, Danenberg, H, Feldman, R, Jauhar, R, Chandna, H, Parikh, M, Perlman, GY, Balcells, M, Markham, P, Ozan, MO, Genereux, P, Edelman, ER, Leon, MB & Stone, GW 2017, 'Randomized comparison of ridaforolimusand zotarolimus-eluting coronary stents in patients with coronary artery disease: Primary results from the BIONICS trial (BioNIR ridaforolimus-eluting coronary stent system in coronary stenosis)', Circulation, vol. 136, no. 14, pp. 1304-1314. https://doi.org/10.1161/CIRCULATIONAHA.117.028885

Randomized comparison of ridaforolimusand zotarolimus-eluting coronary stents in patients with coronary artery disease : Primary results from the BIONICS trial (BioNIR ridaforolimus-eluting coronary stent system in coronary stenosis). / Kandzari, David E.; Smits, Pieter C.; Love, Michael P.; Ben-Yehuda, Ori; Banai, Shmuel; Robinson, Simon D.; Jonas, Michael; Kornowski, Ran; Bagur, Rodrigo; Iniguez, Andres; Danenberg, Haim; Feldman, Robert; Jauhar, Rajiv; Chandna, Harish; Parikh, Manish; Perlman, Gidon Y.; Balcells, Mercedes; Markham, Peter; Ozan, Melek Ozgu; Genereux, Philippe; Edelman, Elazer R.; Leon, Martin B.; Stone, Gregg W.

In: Circulation, Vol. 136, No. 14, 01.10.2017, p. 1304-1314.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Randomized comparison of ridaforolimusand zotarolimus-eluting coronary stents in patients with coronary artery disease

T2 - Primary results from the BIONICS trial (BioNIR ridaforolimus-eluting coronary stent system in coronary stenosis)

AU - Kandzari, David E.

AU - Smits, Pieter C.

AU - Love, Michael P.

AU - Ben-Yehuda, Ori

AU - Banai, Shmuel

AU - Robinson, Simon D.

AU - Jonas, Michael

AU - Kornowski, Ran

AU - Bagur, Rodrigo

AU - Iniguez, Andres

AU - Danenberg, Haim

AU - Feldman, Robert

AU - Jauhar, Rajiv

AU - Chandna, Harish

AU - Parikh, Manish

AU - Perlman, Gidon Y.

AU - Balcells, Mercedes

AU - Markham, Peter

AU - Ozan, Melek Ozgu

AU - Genereux, Philippe

AU - Edelman, Elazer R.

AU - Leon, Martin B.

AU - Stone, Gregg W.

PY - 2017/10/1

Y1 - 2017/10/1

N2 - BACKGROUND: The safety and efficacy of a novel cobalt alloybased coronary stent with a durable elastomeric polymer eluting the antiproliferative agent ridaforolimus for treatment of patients with coronary artery disease is undetermined. METHODS: A prospective, international 1:1 randomized trial was conducted to evaluate in a noninferiority design the relative safety and efficacy of ridaforolimus-eluting stents (RESs) and slow-release zotarolimus-eluting stents among 1919 patients undergoing percutaneous coronary intervention at 76 centers. Inclusion criteria allowed enrollment of patients with recent myocardial infarction, total occlusions, bifurcations lesions, and other complex conditions. RESULTS: Baseline clinical and angiographic characteristics were similar between the groups. Overall, mean age was 63.4 years, 32.5% had diabetes mellitus, and 39.7% presented with acute coronary syndromes. At 12 months, the primary end point of target lesion failure (composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization) was 5.4% for both devices (upper bound of 1-sided 95% confidence interval 1.8%, Pnoninferiority=0.001). Definite/probable stent thrombosis rates were low in both groups (0.4% RES versus 0.6% zotarolimus-eluting stent, P=0.75); 13-month angiographic in-stent late lumen loss was 0.22±0.41 mm and 0.23±0.39 mm (Pnoninferiority=0.004) for the RES and zotarolimus-eluting stent groups, respectively, and intravascular ultrasound percent neointimal hyperplasia was 8.10±5.81 and 8.85±7.77, respectively (Pnoninferiority=0.01). CONCLUSIONS: In the present trial, which allowed broad inclusion criteria, the novel RESs met the prespecified criteria for noninferiority compared with zotarolimus-eluting stents for the primary end point of target lesion failure at 12 months and had similar measures of late lumen loss. These findings support the safety and efficacy of RESs in patients who are representative of clinical practice.

AB - BACKGROUND: The safety and efficacy of a novel cobalt alloybased coronary stent with a durable elastomeric polymer eluting the antiproliferative agent ridaforolimus for treatment of patients with coronary artery disease is undetermined. METHODS: A prospective, international 1:1 randomized trial was conducted to evaluate in a noninferiority design the relative safety and efficacy of ridaforolimus-eluting stents (RESs) and slow-release zotarolimus-eluting stents among 1919 patients undergoing percutaneous coronary intervention at 76 centers. Inclusion criteria allowed enrollment of patients with recent myocardial infarction, total occlusions, bifurcations lesions, and other complex conditions. RESULTS: Baseline clinical and angiographic characteristics were similar between the groups. Overall, mean age was 63.4 years, 32.5% had diabetes mellitus, and 39.7% presented with acute coronary syndromes. At 12 months, the primary end point of target lesion failure (composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization) was 5.4% for both devices (upper bound of 1-sided 95% confidence interval 1.8%, Pnoninferiority=0.001). Definite/probable stent thrombosis rates were low in both groups (0.4% RES versus 0.6% zotarolimus-eluting stent, P=0.75); 13-month angiographic in-stent late lumen loss was 0.22±0.41 mm and 0.23±0.39 mm (Pnoninferiority=0.004) for the RES and zotarolimus-eluting stent groups, respectively, and intravascular ultrasound percent neointimal hyperplasia was 8.10±5.81 and 8.85±7.77, respectively (Pnoninferiority=0.01). CONCLUSIONS: In the present trial, which allowed broad inclusion criteria, the novel RESs met the prespecified criteria for noninferiority compared with zotarolimus-eluting stents for the primary end point of target lesion failure at 12 months and had similar measures of late lumen loss. These findings support the safety and efficacy of RESs in patients who are representative of clinical practice.

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U2 - 10.1161/CIRCULATIONAHA.117.028885

DO - 10.1161/CIRCULATIONAHA.117.028885

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EP - 1314

JO - Circulation

JF - Circulation

SN - 0009-7322

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