Orbital atherectomy for treating de novo, severely calcified coronary lesions

3-year results of the pivotal ORBIT II trial

Michael Lee, Philippe Genereux, Richard Shlofmitz, Daniel Phillipson, Bynthia M. Anose, Brad J. Martinsen, Stevan I. Himmelstein, Jeff W. Chambers

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

Background/purpose The presence of heavy coronary artery calcification increases the complexity of percutaneous coronary intervention (PCI) and increases the incidence of major adverse cardiac events (MACE): death, myocardial infarction (MI), target vessel revascularization (TVR), and stent thrombosis. The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial reported low rates of procedural, 30-day, 1-year, and 2-year ischemic complications after treatment of de novo, severely calcified lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) (Cardiovascular Systems, Inc.). Methods/materials ORBIT II was a single-arm trial that enrolled 443 patients at 49 U.S. sites; in this study, de novo, severely calcified coronary lesions were treated with OAS prior to stenting. The primary safety endpoint was 30-day MACE: the composite of cardiac death, MI, and TVR (inclusive of target lesion revascularization (TLR)). The primary efficacy endpoint was procedural success: stent delivery with a residual stenosis of <50% without the occurrence of in-hospital MACE.The present analysis reports the final, 3-year follow-up results from ORBIT II. Results The majority of subjects (88.2%) underwent PCI with drug-eluting stents after orbital atherectomy. There were 360 (81.3%) subjects who completed the protocol-mandated 3-year visit.The overall cumulative rate of 3-year MACE was 23.5%, including cardiac death (6.7%), MI (11.2%), and TVR (10.2%). The 3-year target lesion revascularization rate was 7.8%. Conclusions In the final 3-year analysis of the ORBIT II trial, orbital atherectomy of severely calcified coronary lesions followed by stenting resulted in a low rate of adverse ischemic events compared with historical controls.Orbital atherectomy represents a safe and effective revascularization strategy for patients with severely calcified coronary lesions. Summary The ORBIT II trial enrolled 443 subjects to study orbital atherectomy followed by stenting for de novo severely calcified coronary lesions. The overall cumulative 3-year MACE rate was 23.5%, including cardiac death (6.7%), MI (11.2%), and TVR (10.2%); the 3-year target lesion revascularization rate was 7.8%. Orbital atherectomy of heavily calcified coronary lesions followed by stenting results in a low rate of adverse ischemic events compared with historical controls; it represents a reasonable revascularization strategy for patients with severely calcified coronary lesions.

Original languageEnglish (US)
Pages (from-to)261-264
Number of pages4
JournalCardiovascular Revascularization Medicine
Volume18
Issue number4
DOIs
StatePublished - Jun 1 2017
Externally publishedYes

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Atherectomy
Myocardial Infarction
Percutaneous Coronary Intervention
Stents
Coronary Atherectomy
Safety
Drug-Eluting Stents
Cardiovascular System
Coronary Vessels
Pathologic Constriction
Thrombosis
Incidence

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Lee, Michael ; Genereux, Philippe ; Shlofmitz, Richard ; Phillipson, Daniel ; Anose, Bynthia M. ; Martinsen, Brad J. ; Himmelstein, Stevan I. ; Chambers, Jeff W. / Orbital atherectomy for treating de novo, severely calcified coronary lesions : 3-year results of the pivotal ORBIT II trial. In: Cardiovascular Revascularization Medicine. 2017 ; Vol. 18, No. 4. pp. 261-264.
@article{823c9e5d9f46444ea225fc1259ef480b,
title = "Orbital atherectomy for treating de novo, severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial",
abstract = "Background/purpose The presence of heavy coronary artery calcification increases the complexity of percutaneous coronary intervention (PCI) and increases the incidence of major adverse cardiac events (MACE): death, myocardial infarction (MI), target vessel revascularization (TVR), and stent thrombosis. The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial reported low rates of procedural, 30-day, 1-year, and 2-year ischemic complications after treatment of de novo, severely calcified lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) (Cardiovascular Systems, Inc.). Methods/materials ORBIT II was a single-arm trial that enrolled 443 patients at 49 U.S. sites; in this study, de novo, severely calcified coronary lesions were treated with OAS prior to stenting. The primary safety endpoint was 30-day MACE: the composite of cardiac death, MI, and TVR (inclusive of target lesion revascularization (TLR)). The primary efficacy endpoint was procedural success: stent delivery with a residual stenosis of <50{\%} without the occurrence of in-hospital MACE.The present analysis reports the final, 3-year follow-up results from ORBIT II. Results The majority of subjects (88.2{\%}) underwent PCI with drug-eluting stents after orbital atherectomy. There were 360 (81.3{\%}) subjects who completed the protocol-mandated 3-year visit.The overall cumulative rate of 3-year MACE was 23.5{\%}, including cardiac death (6.7{\%}), MI (11.2{\%}), and TVR (10.2{\%}). The 3-year target lesion revascularization rate was 7.8{\%}. Conclusions In the final 3-year analysis of the ORBIT II trial, orbital atherectomy of severely calcified coronary lesions followed by stenting resulted in a low rate of adverse ischemic events compared with historical controls.Orbital atherectomy represents a safe and effective revascularization strategy for patients with severely calcified coronary lesions. Summary The ORBIT II trial enrolled 443 subjects to study orbital atherectomy followed by stenting for de novo severely calcified coronary lesions. The overall cumulative 3-year MACE rate was 23.5{\%}, including cardiac death (6.7{\%}), MI (11.2{\%}), and TVR (10.2{\%}); the 3-year target lesion revascularization rate was 7.8{\%}. Orbital atherectomy of heavily calcified coronary lesions followed by stenting results in a low rate of adverse ischemic events compared with historical controls; it represents a reasonable revascularization strategy for patients with severely calcified coronary lesions.",
author = "Michael Lee and Philippe Genereux and Richard Shlofmitz and Daniel Phillipson and Anose, {Bynthia M.} and Martinsen, {Brad J.} and Himmelstein, {Stevan I.} and Chambers, {Jeff W.}",
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doi = "10.1016/j.carrev.2017.01.011",
language = "English (US)",
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Orbital atherectomy for treating de novo, severely calcified coronary lesions : 3-year results of the pivotal ORBIT II trial. / Lee, Michael; Genereux, Philippe; Shlofmitz, Richard; Phillipson, Daniel; Anose, Bynthia M.; Martinsen, Brad J.; Himmelstein, Stevan I.; Chambers, Jeff W.

In: Cardiovascular Revascularization Medicine, Vol. 18, No. 4, 01.06.2017, p. 261-264.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Orbital atherectomy for treating de novo, severely calcified coronary lesions

T2 - 3-year results of the pivotal ORBIT II trial

AU - Lee, Michael

AU - Genereux, Philippe

AU - Shlofmitz, Richard

AU - Phillipson, Daniel

AU - Anose, Bynthia M.

AU - Martinsen, Brad J.

AU - Himmelstein, Stevan I.

AU - Chambers, Jeff W.

PY - 2017/6/1

Y1 - 2017/6/1

N2 - Background/purpose The presence of heavy coronary artery calcification increases the complexity of percutaneous coronary intervention (PCI) and increases the incidence of major adverse cardiac events (MACE): death, myocardial infarction (MI), target vessel revascularization (TVR), and stent thrombosis. The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial reported low rates of procedural, 30-day, 1-year, and 2-year ischemic complications after treatment of de novo, severely calcified lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) (Cardiovascular Systems, Inc.). Methods/materials ORBIT II was a single-arm trial that enrolled 443 patients at 49 U.S. sites; in this study, de novo, severely calcified coronary lesions were treated with OAS prior to stenting. The primary safety endpoint was 30-day MACE: the composite of cardiac death, MI, and TVR (inclusive of target lesion revascularization (TLR)). The primary efficacy endpoint was procedural success: stent delivery with a residual stenosis of <50% without the occurrence of in-hospital MACE.The present analysis reports the final, 3-year follow-up results from ORBIT II. Results The majority of subjects (88.2%) underwent PCI with drug-eluting stents after orbital atherectomy. There were 360 (81.3%) subjects who completed the protocol-mandated 3-year visit.The overall cumulative rate of 3-year MACE was 23.5%, including cardiac death (6.7%), MI (11.2%), and TVR (10.2%). The 3-year target lesion revascularization rate was 7.8%. Conclusions In the final 3-year analysis of the ORBIT II trial, orbital atherectomy of severely calcified coronary lesions followed by stenting resulted in a low rate of adverse ischemic events compared with historical controls.Orbital atherectomy represents a safe and effective revascularization strategy for patients with severely calcified coronary lesions. Summary The ORBIT II trial enrolled 443 subjects to study orbital atherectomy followed by stenting for de novo severely calcified coronary lesions. The overall cumulative 3-year MACE rate was 23.5%, including cardiac death (6.7%), MI (11.2%), and TVR (10.2%); the 3-year target lesion revascularization rate was 7.8%. Orbital atherectomy of heavily calcified coronary lesions followed by stenting results in a low rate of adverse ischemic events compared with historical controls; it represents a reasonable revascularization strategy for patients with severely calcified coronary lesions.

AB - Background/purpose The presence of heavy coronary artery calcification increases the complexity of percutaneous coronary intervention (PCI) and increases the incidence of major adverse cardiac events (MACE): death, myocardial infarction (MI), target vessel revascularization (TVR), and stent thrombosis. The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial reported low rates of procedural, 30-day, 1-year, and 2-year ischemic complications after treatment of de novo, severely calcified lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) (Cardiovascular Systems, Inc.). Methods/materials ORBIT II was a single-arm trial that enrolled 443 patients at 49 U.S. sites; in this study, de novo, severely calcified coronary lesions were treated with OAS prior to stenting. The primary safety endpoint was 30-day MACE: the composite of cardiac death, MI, and TVR (inclusive of target lesion revascularization (TLR)). The primary efficacy endpoint was procedural success: stent delivery with a residual stenosis of <50% without the occurrence of in-hospital MACE.The present analysis reports the final, 3-year follow-up results from ORBIT II. Results The majority of subjects (88.2%) underwent PCI with drug-eluting stents after orbital atherectomy. There were 360 (81.3%) subjects who completed the protocol-mandated 3-year visit.The overall cumulative rate of 3-year MACE was 23.5%, including cardiac death (6.7%), MI (11.2%), and TVR (10.2%). The 3-year target lesion revascularization rate was 7.8%. Conclusions In the final 3-year analysis of the ORBIT II trial, orbital atherectomy of severely calcified coronary lesions followed by stenting resulted in a low rate of adverse ischemic events compared with historical controls.Orbital atherectomy represents a safe and effective revascularization strategy for patients with severely calcified coronary lesions. Summary The ORBIT II trial enrolled 443 subjects to study orbital atherectomy followed by stenting for de novo severely calcified coronary lesions. The overall cumulative 3-year MACE rate was 23.5%, including cardiac death (6.7%), MI (11.2%), and TVR (10.2%); the 3-year target lesion revascularization rate was 7.8%. Orbital atherectomy of heavily calcified coronary lesions followed by stenting results in a low rate of adverse ischemic events compared with historical controls; it represents a reasonable revascularization strategy for patients with severely calcified coronary lesions.

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DO - 10.1016/j.carrev.2017.01.011

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JO - Cardiovascular Revascularization Medicine

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