The platelet aggregation inhibitor ticagrelor, a P2Y12 receptor antagonist, is widely used after ... more The platelet aggregation inhibitor ticagrelor, a P2Y12 receptor antagonist, is widely used after angioplasty in patients with acute coronary syndrome. Clinical trial data have shown that it is well tolerated by most patients. We present the case of a 62-year-old woman whose ticagrelor-related asymptomatic and persistent sinus pauses after angioplasty resolved when ticagrelor was replaced with prasugrel.
Rotational atherectomy (RA) is an established tool in interventional cardiology for treatment of ... more Rotational atherectomy (RA) is an established tool in interventional cardiology for treatment of calcified coronary lesions. Over 3 decades of clinical experience and research, techniques have matured and outcomes have improved. Heterogeneity exists, however, in RA utilization and technique. We assembled a group of experienced RA operators and device experts to summarize and critique key elements of contemporary RA technique, to identify areas of consensus and controversy, and to offer recommendations for optimal performance for the practicing interventional cardiologist. Evolution in RA strategy toward a focus on lesion modification to facilitate balloon angioplasty and stenting has underpinned major advances in procedural safety, including opportunity to use smaller caliber equipment and radial access. Optimal technique and improved safety have permitted exploratory use of RA for different lesion types and reevaluation of procedural requirements, including flush solution compositi...
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, Jan 14, 2017
Percutaneous coronary intervention (PCI) of severe coronary artery calcification (CAC) is challen... more Percutaneous coronary intervention (PCI) of severe coronary artery calcification (CAC) is challenging. The ORBIT II study demonstrated the safety and efficacy of orbital atherectomy (OA) in patients with severe CAC. Microparticulate liberated during OA may disturb coronary microcirculation. We evaluated OA treatment in patients with left ventricular systolic dysfunction. Patients were grouped by left ventricular ejection fraction (LVEF): 26-40% (n=33), 41-50% (n=90), and >50% (n=314). Procedural success was similar (LVEF 26-40%: 90.9%, LVEF 41-50%: 88.9%, LVEF >50%: 88.4%). Rates of major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction, and target vessel revascularization, were similar in the LVEF 26-40%, 41-50%, and >50% groups, respectively, at 30 days (9.1%, 7.8%, 11.5%) and 1 year (18.2%, 19.1%, 16.0%). Although the 30-day cardiac death rate was 0% in patients with left ventricular dysfunction, 1-year cardiac death was higher compared with...
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, Jan 16, 2016
We report 2-year outcomes of the Evaluate the Safety and Efficacy of OAS in Treating Severely Cal... more We report 2-year outcomes of the Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions (ORBIT II) trial, with emphasis on the impact of stent type. The ORBIT II trial demonstrated the safety and efficacy of the Diamondback 360° Coronary Orbital Atherectomy System (OAS; Cardiovascular Systems, Inc., St. Paul, MN) in the treatment of de novo, severely calcified coronary lesions. ORBIT II was a single-arm trial that enrolled 443 subjects with severely calcified lesions at 49 US sites. All patients were intended to be treated with OAS before stent implantation. The primary safety endpoint was 30-day major adverse cardiac events (MACE: Cardiac death, myocardial infarction, or target vessel revascularization). For the purpose of this study, we divided patients into three groups according to the type of stent implanted (i.e., bare metal stent [BMS], first-generation drug-eluting stent [DES], or second-generation DES). The 2-year MACE rate and its component...
Therapeutic advances in cardiovascular disease, Jan 23, 2015
Patients who undergo percutaneous coronary intervention (PCI) for severely calcified coronary les... more Patients who undergo percutaneous coronary intervention (PCI) for severely calcified coronary lesions have long been known to have worse clinical and economic outcomes than patients with no or mildly calcified lesions. We sought to assess the likely cost-effectiveness of using the Diamondback 360(®) Orbital Atherectomy System (OAS) in the treatment of de novo, severely calcified lesions from a health-system perspective. In the absence of a head-to-head trial and long-term follow up, cost-effectiveness was based on a modeled synthesis of clinical and economic data. A cost-effectiveness model was used to project the likely economic impact. To estimate the net cost impact, the cost of using the OAS technology in elderly (⩾ 65 years) Medicare patients with de novo severely calcified lesions was compared with cost offsets. Elderly OAS patients from the ORBIT II trial (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) [ClinicalTrials.gov identifier: ...
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, Jan 2, 2015
The aim of this analysis is to evaluate potential differences according to gender in terms of acu... more The aim of this analysis is to evaluate potential differences according to gender in terms of acute and 30-day clinical outcomes in patients enrolled in the ORBIT II trial with de novo, severely calcified coronary lesions treated with orbital atherectomy to facilitate stent delivery. Previous studies have shown an increased risk of safety events in females compared to males undergoing percutaneous coronary intervention. ORBIT II, a prospective, nonrandomized, multicenter, single arm study conducted in the US evaluated the safety and efficacy of the coronary OAS to facilitate stent placement in de novo, severely calcified coronary lesions in 443 subjects (286 males and 157 females). The rate of major adverse cardiac events (MACE) defined as a composite of myocardial infarction, target vessel revascularization, and cardiac death was evaluated in-hospital and 30-days postprocedure. For this analysis, the ORBIT II safety and efficacy results were stratified by gender. At baseline, femal...
Percutaneous coronary intervention of severely calcified lesions has historically been associated... more Percutaneous coronary intervention of severely calcified lesions has historically been associated with major adverse cardiac event (MACE) rates as high as 30%. In the ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial, treatment of de novo severely calcified lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) resulted in low rates of procedural and 30-day adverse ischemic events. The long-term results from this trial have not been reported. We sought to determine the 1-year outcomes after orbital atherectomy of severely calcified coronary lesions. ORBIT II was a single-arm trial enrolling 443 subjects at 49 US sites with severely calcified lesions usually excluded from randomized trials. OAS utilizes a centrifugal differential sanding mechanism of action for plaque modification prior to stent implantation. After OAS drug-eluting stents were implanted in 88.2% of the patients. The primary safety end point was 30-day MACE, the composite of cardiac death, myocardial infarction, or target vessel revascularization [TVR]. The present analysis reports the 1-year follow-up results from ORBIT II. One-year data were available in 433 of 443 patients (97.7%), with median follow-up time of 16.7 months. The 1-year MACE rate was 16.4%, including cardiac death (3.0%), myocardial infarction (9.7%), and target vessel revascularization (5.9%). The 1-year target lesion revascularization rate was 4.7%, and stent thrombosis occurred in 1 patient (0.2%). Independent predictors of 1-year MACE and target vessel revascularization were diameter stenosis at baseline and the use of bare-metal stents. In patients with severely calcified lesions who underwent percutaneous coronary intervention, the use of OAS was associated with low rates of 1-year adverse ischemic events compared with historical controls. This finding has important clinical implications for the selection of optimum treatment strategies for patients with severely calcified lesions.
The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Les... more The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial evaluated the safety and efficacy of the coronary Orbital Atherectomy System (OAS) to prepare de novo, severely calcified coronary lesions for stent placement. Despite advances in interventional techniques, treatment of calcified coronary lesions remains a challenge. Stent placement in these lesions may result in stent underexpansion, malapposition, and procedural complications. ORBIT II is a prospective, multicenter, nonblinded clinical trial that enrolled 443 consecutive patients with severely calcified coronary lesions at 49 U.S. sites from May 25, 2010, to November 26, 2012. Investigators used the centrifugal action of the OAS diamond-coated crown to modify calcified lesions prior to stent placement. The pre-procedure mean minimal lumen diameter of 0.5 mm increased to 2.9 mm after the procedure. The primary safety endpoint was 89.6% freedom from 30-day major adverse cardi...
The platelet aggregation inhibitor ticagrelor, a P2Y12 receptor antagonist, is widely used after ... more The platelet aggregation inhibitor ticagrelor, a P2Y12 receptor antagonist, is widely used after angioplasty in patients with acute coronary syndrome. Clinical trial data have shown that it is well tolerated by most patients. We present the case of a 62-year-old woman whose ticagrelor-related asymptomatic and persistent sinus pauses after angioplasty resolved when ticagrelor was replaced with prasugrel.
Rotational atherectomy (RA) is an established tool in interventional cardiology for treatment of ... more Rotational atherectomy (RA) is an established tool in interventional cardiology for treatment of calcified coronary lesions. Over 3 decades of clinical experience and research, techniques have matured and outcomes have improved. Heterogeneity exists, however, in RA utilization and technique. We assembled a group of experienced RA operators and device experts to summarize and critique key elements of contemporary RA technique, to identify areas of consensus and controversy, and to offer recommendations for optimal performance for the practicing interventional cardiologist. Evolution in RA strategy toward a focus on lesion modification to facilitate balloon angioplasty and stenting has underpinned major advances in procedural safety, including opportunity to use smaller caliber equipment and radial access. Optimal technique and improved safety have permitted exploratory use of RA for different lesion types and reevaluation of procedural requirements, including flush solution compositi...
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, Jan 14, 2017
Percutaneous coronary intervention (PCI) of severe coronary artery calcification (CAC) is challen... more Percutaneous coronary intervention (PCI) of severe coronary artery calcification (CAC) is challenging. The ORBIT II study demonstrated the safety and efficacy of orbital atherectomy (OA) in patients with severe CAC. Microparticulate liberated during OA may disturb coronary microcirculation. We evaluated OA treatment in patients with left ventricular systolic dysfunction. Patients were grouped by left ventricular ejection fraction (LVEF): 26-40% (n=33), 41-50% (n=90), and >50% (n=314). Procedural success was similar (LVEF 26-40%: 90.9%, LVEF 41-50%: 88.9%, LVEF >50%: 88.4%). Rates of major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction, and target vessel revascularization, were similar in the LVEF 26-40%, 41-50%, and >50% groups, respectively, at 30 days (9.1%, 7.8%, 11.5%) and 1 year (18.2%, 19.1%, 16.0%). Although the 30-day cardiac death rate was 0% in patients with left ventricular dysfunction, 1-year cardiac death was higher compared with...
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, Jan 16, 2016
We report 2-year outcomes of the Evaluate the Safety and Efficacy of OAS in Treating Severely Cal... more We report 2-year outcomes of the Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions (ORBIT II) trial, with emphasis on the impact of stent type. The ORBIT II trial demonstrated the safety and efficacy of the Diamondback 360° Coronary Orbital Atherectomy System (OAS; Cardiovascular Systems, Inc., St. Paul, MN) in the treatment of de novo, severely calcified coronary lesions. ORBIT II was a single-arm trial that enrolled 443 subjects with severely calcified lesions at 49 US sites. All patients were intended to be treated with OAS before stent implantation. The primary safety endpoint was 30-day major adverse cardiac events (MACE: Cardiac death, myocardial infarction, or target vessel revascularization). For the purpose of this study, we divided patients into three groups according to the type of stent implanted (i.e., bare metal stent [BMS], first-generation drug-eluting stent [DES], or second-generation DES). The 2-year MACE rate and its component...
Therapeutic advances in cardiovascular disease, Jan 23, 2015
Patients who undergo percutaneous coronary intervention (PCI) for severely calcified coronary les... more Patients who undergo percutaneous coronary intervention (PCI) for severely calcified coronary lesions have long been known to have worse clinical and economic outcomes than patients with no or mildly calcified lesions. We sought to assess the likely cost-effectiveness of using the Diamondback 360(®) Orbital Atherectomy System (OAS) in the treatment of de novo, severely calcified lesions from a health-system perspective. In the absence of a head-to-head trial and long-term follow up, cost-effectiveness was based on a modeled synthesis of clinical and economic data. A cost-effectiveness model was used to project the likely economic impact. To estimate the net cost impact, the cost of using the OAS technology in elderly (⩾ 65 years) Medicare patients with de novo severely calcified lesions was compared with cost offsets. Elderly OAS patients from the ORBIT II trial (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) [ClinicalTrials.gov identifier: ...
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, Jan 2, 2015
The aim of this analysis is to evaluate potential differences according to gender in terms of acu... more The aim of this analysis is to evaluate potential differences according to gender in terms of acute and 30-day clinical outcomes in patients enrolled in the ORBIT II trial with de novo, severely calcified coronary lesions treated with orbital atherectomy to facilitate stent delivery. Previous studies have shown an increased risk of safety events in females compared to males undergoing percutaneous coronary intervention. ORBIT II, a prospective, nonrandomized, multicenter, single arm study conducted in the US evaluated the safety and efficacy of the coronary OAS to facilitate stent placement in de novo, severely calcified coronary lesions in 443 subjects (286 males and 157 females). The rate of major adverse cardiac events (MACE) defined as a composite of myocardial infarction, target vessel revascularization, and cardiac death was evaluated in-hospital and 30-days postprocedure. For this analysis, the ORBIT II safety and efficacy results were stratified by gender. At baseline, femal...
Percutaneous coronary intervention of severely calcified lesions has historically been associated... more Percutaneous coronary intervention of severely calcified lesions has historically been associated with major adverse cardiac event (MACE) rates as high as 30%. In the ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial, treatment of de novo severely calcified lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) resulted in low rates of procedural and 30-day adverse ischemic events. The long-term results from this trial have not been reported. We sought to determine the 1-year outcomes after orbital atherectomy of severely calcified coronary lesions. ORBIT II was a single-arm trial enrolling 443 subjects at 49 US sites with severely calcified lesions usually excluded from randomized trials. OAS utilizes a centrifugal differential sanding mechanism of action for plaque modification prior to stent implantation. After OAS drug-eluting stents were implanted in 88.2% of the patients. The primary safety end point was 30-day MACE, the composite of cardiac death, myocardial infarction, or target vessel revascularization [TVR]. The present analysis reports the 1-year follow-up results from ORBIT II. One-year data were available in 433 of 443 patients (97.7%), with median follow-up time of 16.7 months. The 1-year MACE rate was 16.4%, including cardiac death (3.0%), myocardial infarction (9.7%), and target vessel revascularization (5.9%). The 1-year target lesion revascularization rate was 4.7%, and stent thrombosis occurred in 1 patient (0.2%). Independent predictors of 1-year MACE and target vessel revascularization were diameter stenosis at baseline and the use of bare-metal stents. In patients with severely calcified lesions who underwent percutaneous coronary intervention, the use of OAS was associated with low rates of 1-year adverse ischemic events compared with historical controls. This finding has important clinical implications for the selection of optimum treatment strategies for patients with severely calcified lesions.
The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Les... more The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial evaluated the safety and efficacy of the coronary Orbital Atherectomy System (OAS) to prepare de novo, severely calcified coronary lesions for stent placement. Despite advances in interventional techniques, treatment of calcified coronary lesions remains a challenge. Stent placement in these lesions may result in stent underexpansion, malapposition, and procedural complications. ORBIT II is a prospective, multicenter, nonblinded clinical trial that enrolled 443 consecutive patients with severely calcified coronary lesions at 49 U.S. sites from May 25, 2010, to November 26, 2012. Investigators used the centrifugal action of the OAS diamond-coated crown to modify calcified lesions prior to stent placement. The pre-procedure mean minimal lumen diameter of 0.5 mm increased to 2.9 mm after the procedure. The primary safety endpoint was 89.6% freedom from 30-day major adverse cardi...
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Papers by Arthur Lee