ORBIT II sub-analysis

Impact of impaired renal function following treatment of severely calcified coronary lesions with the Orbital Atherectomy System

Michael S. Lee, Arthur C. Lee, Richard A. Shlofmitz, Brad J. Martinsen, Nick J. Hargus, Mahir D. Elder, Philippe Genereux, Jeffrey W. Chambers

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Objectives: To investigate the safety and efficacy of the coronary Orbital Atherectomy System (OAS) to prepare severely calcified lesions for stent deployment in patients grouped by renal function. Background: Percutaneous coronary intervention (PCI) of severely calcified lesions is associated with increased rates of major adverse cardiac events (MACE), including death, myocardial infarction (MI), and target vessel revascularization (TVR) compared with PCI of non-calcified vessels. Patients with chronic kidney disease (CKD) are at increased risk for MACE after PCI. The impact of CKD on coronary orbital atherectomy treatment has not been well characterized. Methods: ORBIT II was a prospective, multicenter trial in the U.S., which enrolled 443 patients with severely calcified coronary lesions. The MACE rate was defined as a composite of cardiac death, MI, and target vessel revascularization. Results: Of the 441 patients enrolled with known estimated glomerular filtration rate (eGFR) values at baseline, 333 (75.5%) patients had eGFR < 90 ml/min/1.73 m 2 and 108 patients had eGFR ≥ 90 ml/min/1.73 m 2 . The mean eGFR at baseline in the eGFR < 90 ml/min/1.73 m 2 and eGFR ≥ 90 ml/min/1.73 m 2 groups was 65.0 ± 0.9 ml/min/1.73 m 2 and 109.1 ± 2.0 ml/min/1.73 m 2 , respectively. Freedom from MACE was lower in the eGFR < 90 ml/min/1.73 m 2 group at 30 days (87.4% vs. 96.3%, P = 0.02) and 1-year (80.6% vs. 90.7%, P = 0.02). Conclusions: Patients with renal impairment had a higher MACE rate through one year follow-up due to a higher rate of periprocedural MI. Interestingly, the rates of cardiac death and revascularization through 1-year were similar in patients with eGFR < 90 ml/min/1.73 m 2 and eGFR ≥ 90 ml/min/1.73 m 2 . Future studies are needed to identify the ideal revascularization strategy for patients with renal impairment and severely calcified coronary lesions.

Original languageEnglish (US)
Pages (from-to)841-848
Number of pages8
JournalCatheterization and Cardiovascular Interventions
Volume89
Issue number5
DOIs
StatePublished - Apr 1 2017
Externally publishedYes

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Atherectomy
Glomerular Filtration Rate
Kidney
Percutaneous Coronary Intervention
Coronary Atherectomy
Therapeutics
Myocardial Infarction
Chronic Renal Insufficiency
Multicenter Studies
Stents
Safety

All Science Journal Classification (ASJC) codes

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Lee, Michael S. ; Lee, Arthur C. ; Shlofmitz, Richard A. ; Martinsen, Brad J. ; Hargus, Nick J. ; Elder, Mahir D. ; Genereux, Philippe ; Chambers, Jeffrey W. / ORBIT II sub-analysis : Impact of impaired renal function following treatment of severely calcified coronary lesions with the Orbital Atherectomy System. In: Catheterization and Cardiovascular Interventions. 2017 ; Vol. 89, No. 5. pp. 841-848.
@article{05912463989c49d88e732e640bd7d102,
title = "ORBIT II sub-analysis: Impact of impaired renal function following treatment of severely calcified coronary lesions with the Orbital Atherectomy System",
abstract = "Objectives: To investigate the safety and efficacy of the coronary Orbital Atherectomy System (OAS) to prepare severely calcified lesions for stent deployment in patients grouped by renal function. Background: Percutaneous coronary intervention (PCI) of severely calcified lesions is associated with increased rates of major adverse cardiac events (MACE), including death, myocardial infarction (MI), and target vessel revascularization (TVR) compared with PCI of non-calcified vessels. Patients with chronic kidney disease (CKD) are at increased risk for MACE after PCI. The impact of CKD on coronary orbital atherectomy treatment has not been well characterized. Methods: ORBIT II was a prospective, multicenter trial in the U.S., which enrolled 443 patients with severely calcified coronary lesions. The MACE rate was defined as a composite of cardiac death, MI, and target vessel revascularization. Results: Of the 441 patients enrolled with known estimated glomerular filtration rate (eGFR) values at baseline, 333 (75.5{\%}) patients had eGFR < 90 ml/min/1.73 m 2 and 108 patients had eGFR ≥ 90 ml/min/1.73 m 2 . The mean eGFR at baseline in the eGFR < 90 ml/min/1.73 m 2 and eGFR ≥ 90 ml/min/1.73 m 2 groups was 65.0 ± 0.9 ml/min/1.73 m 2 and 109.1 ± 2.0 ml/min/1.73 m 2 , respectively. Freedom from MACE was lower in the eGFR < 90 ml/min/1.73 m 2 group at 30 days (87.4{\%} vs. 96.3{\%}, P = 0.02) and 1-year (80.6{\%} vs. 90.7{\%}, P = 0.02). Conclusions: Patients with renal impairment had a higher MACE rate through one year follow-up due to a higher rate of periprocedural MI. Interestingly, the rates of cardiac death and revascularization through 1-year were similar in patients with eGFR < 90 ml/min/1.73 m 2 and eGFR ≥ 90 ml/min/1.73 m 2 . Future studies are needed to identify the ideal revascularization strategy for patients with renal impairment and severely calcified coronary lesions.",
author = "Lee, {Michael S.} and Lee, {Arthur C.} and Shlofmitz, {Richard A.} and Martinsen, {Brad J.} and Hargus, {Nick J.} and Elder, {Mahir D.} and Philippe Genereux and Chambers, {Jeffrey W.}",
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ORBIT II sub-analysis : Impact of impaired renal function following treatment of severely calcified coronary lesions with the Orbital Atherectomy System. / Lee, Michael S.; Lee, Arthur C.; Shlofmitz, Richard A.; Martinsen, Brad J.; Hargus, Nick J.; Elder, Mahir D.; Genereux, Philippe; Chambers, Jeffrey W.

In: Catheterization and Cardiovascular Interventions, Vol. 89, No. 5, 01.04.2017, p. 841-848.

Research output: Contribution to journalArticle

TY - JOUR

T1 - ORBIT II sub-analysis

T2 - Impact of impaired renal function following treatment of severely calcified coronary lesions with the Orbital Atherectomy System

AU - Lee, Michael S.

AU - Lee, Arthur C.

AU - Shlofmitz, Richard A.

AU - Martinsen, Brad J.

AU - Hargus, Nick J.

AU - Elder, Mahir D.

AU - Genereux, Philippe

AU - Chambers, Jeffrey W.

PY - 2017/4/1

Y1 - 2017/4/1

N2 - Objectives: To investigate the safety and efficacy of the coronary Orbital Atherectomy System (OAS) to prepare severely calcified lesions for stent deployment in patients grouped by renal function. Background: Percutaneous coronary intervention (PCI) of severely calcified lesions is associated with increased rates of major adverse cardiac events (MACE), including death, myocardial infarction (MI), and target vessel revascularization (TVR) compared with PCI of non-calcified vessels. Patients with chronic kidney disease (CKD) are at increased risk for MACE after PCI. The impact of CKD on coronary orbital atherectomy treatment has not been well characterized. Methods: ORBIT II was a prospective, multicenter trial in the U.S., which enrolled 443 patients with severely calcified coronary lesions. The MACE rate was defined as a composite of cardiac death, MI, and target vessel revascularization. Results: Of the 441 patients enrolled with known estimated glomerular filtration rate (eGFR) values at baseline, 333 (75.5%) patients had eGFR < 90 ml/min/1.73 m 2 and 108 patients had eGFR ≥ 90 ml/min/1.73 m 2 . The mean eGFR at baseline in the eGFR < 90 ml/min/1.73 m 2 and eGFR ≥ 90 ml/min/1.73 m 2 groups was 65.0 ± 0.9 ml/min/1.73 m 2 and 109.1 ± 2.0 ml/min/1.73 m 2 , respectively. Freedom from MACE was lower in the eGFR < 90 ml/min/1.73 m 2 group at 30 days (87.4% vs. 96.3%, P = 0.02) and 1-year (80.6% vs. 90.7%, P = 0.02). Conclusions: Patients with renal impairment had a higher MACE rate through one year follow-up due to a higher rate of periprocedural MI. Interestingly, the rates of cardiac death and revascularization through 1-year were similar in patients with eGFR < 90 ml/min/1.73 m 2 and eGFR ≥ 90 ml/min/1.73 m 2 . Future studies are needed to identify the ideal revascularization strategy for patients with renal impairment and severely calcified coronary lesions.

AB - Objectives: To investigate the safety and efficacy of the coronary Orbital Atherectomy System (OAS) to prepare severely calcified lesions for stent deployment in patients grouped by renal function. Background: Percutaneous coronary intervention (PCI) of severely calcified lesions is associated with increased rates of major adverse cardiac events (MACE), including death, myocardial infarction (MI), and target vessel revascularization (TVR) compared with PCI of non-calcified vessels. Patients with chronic kidney disease (CKD) are at increased risk for MACE after PCI. The impact of CKD on coronary orbital atherectomy treatment has not been well characterized. Methods: ORBIT II was a prospective, multicenter trial in the U.S., which enrolled 443 patients with severely calcified coronary lesions. The MACE rate was defined as a composite of cardiac death, MI, and target vessel revascularization. Results: Of the 441 patients enrolled with known estimated glomerular filtration rate (eGFR) values at baseline, 333 (75.5%) patients had eGFR < 90 ml/min/1.73 m 2 and 108 patients had eGFR ≥ 90 ml/min/1.73 m 2 . The mean eGFR at baseline in the eGFR < 90 ml/min/1.73 m 2 and eGFR ≥ 90 ml/min/1.73 m 2 groups was 65.0 ± 0.9 ml/min/1.73 m 2 and 109.1 ± 2.0 ml/min/1.73 m 2 , respectively. Freedom from MACE was lower in the eGFR < 90 ml/min/1.73 m 2 group at 30 days (87.4% vs. 96.3%, P = 0.02) and 1-year (80.6% vs. 90.7%, P = 0.02). Conclusions: Patients with renal impairment had a higher MACE rate through one year follow-up due to a higher rate of periprocedural MI. Interestingly, the rates of cardiac death and revascularization through 1-year were similar in patients with eGFR < 90 ml/min/1.73 m 2 and eGFR ≥ 90 ml/min/1.73 m 2 . Future studies are needed to identify the ideal revascularization strategy for patients with renal impairment and severely calcified coronary lesions.

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SN - 1522-1946

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