Trial Outcomes & Findings for Plaque Regression and Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen (PREMIER), Phase II (NCT NCT02347098)

Last Updated: 2019-10-30

Results Overview

The primary effectiveness outcome measure was the change in the total atheroma volume within a ≥ 20 mm long segment of the target coronary artery from baseline to 12 weeks post-PCI. The measurement was done via IVUS-VH at 2 time points (baseline during index PCI and 90-day follow-up).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

270 participants

Primary outcome timeframe

12 weeks

Results posted on

2019-10-30

Participant Flow

Subject recruitment for Phase II pivotal study started on March 30, 2015, and the first participant was randomized on April 9, 2015. The recruitment period stopped in July 2017. For all 4 participating sites, Dallas, Nashville, Oklahoma City, and Denver randomized 80, 5, 38, and 6 participants, respectively.

There were 270 subjects consented and enrolled into the study before entering catheterization lab to have the PCI procedure, but 141 subjects were not randomized to treatment assignments with the major exclusion reason as not able to comply with study protocol based on the inclusion/exclusion criteria.

Participant milestones

Participant milestones
Measure	Intensive LDL-lowering Therapy (ILLT) Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to LDL-apheresis in addition to the standard statin therapy of an oral daily dose of 40-80mg of Atorvastatin or equivalent. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks.	Standard Statin Monotherapy (SMT) Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to an oral daily dose of 40-80mg of Atorvastatin or equivalent without LDL-apheresis.
Overall Study STARTED	63	66
Overall Study COMPLETED	56	58
Overall Study NOT COMPLETED	7	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Intensive LDL-lowering Therapy (ILLT) Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to LDL-apheresis in addition to the standard statin therapy of an oral daily dose of 40-80mg of Atorvastatin or equivalent. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks.	Standard Statin Monotherapy (SMT) Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to an oral daily dose of 40-80mg of Atorvastatin or equivalent without LDL-apheresis.
Overall Study Death	1	0
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	2	2
Overall Study Refuse Follow-up Visit	1	5
Overall Study no visit due to illness	2	1

Baseline Characteristics

Plaque Regression and Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen (PREMIER), Phase II

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intensive LDL-lowering Therapy (ILLT) n=63 Participants Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to LDL-apheresis in addition to the standard statin therapy of an oral daily dose of 40-80mg of Atorvastatin or equivalent. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks.	Standard Statin Monotherapy (SMT) n=66 Participants Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to an oral daily dose of 40-80mg of Atorvastatin or equivalent without LDL-apheresis.	Total n=129 Participants Total of all reporting groups
Age, Continuous	64.2 years STANDARD_DEVIATION 9.4 • n=93 Participants	67.3 years STANDARD_DEVIATION 7.7 • n=4 Participants	65.8 years STANDARD_DEVIATION 8.7 • n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Sex: Female, Male Male	62 Participants n=93 Participants	65 Participants n=4 Participants	127 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	13 Participants n=93 Participants	14 Participants n=4 Participants	27 Participants n=27 Participants
Race (NIH/OMB) White	48 Participants n=93 Participants	52 Participants n=4 Participants	100 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	63 Participants n=93 Participants	66 Participants n=4 Participants	129 Participants n=27 Participants
Weight	225.0 pounds STANDARD_DEVIATION 56.7 • n=93 Participants	221.7 pounds STANDARD_DEVIATION 46.7 • n=4 Participants	223.3 pounds STANDARD_DEVIATION 51.6 • n=27 Participants
Height	69.9 inches STANDARD_DEVIATION 2.7 • n=93 Participants	70.0 inches STANDARD_DEVIATION 2.9 • n=4 Participants	70.0 inches STANDARD_DEVIATION 2.8 • n=27 Participants
Heart Rate	79.0 beats/min STANDARD_DEVIATION 16.0 • n=93 Participants	71.8 beats/min STANDARD_DEVIATION 13.6 • n=4 Participants	75.3 beats/min STANDARD_DEVIATION 15.2 • n=27 Participants
Systolic BP	140.0 mmHg STANDARD_DEVIATION 22.1 • n=93 Participants	141.8 mmHg STANDARD_DEVIATION 23.9 • n=4 Participants	140.9 mmHg STANDARD_DEVIATION 22.9 • n=27 Participants
Diastolic BP	78.7 mmHg STANDARD_DEVIATION 13.1 • n=93 Participants	77.0 mmHg STANDARD_DEVIATION 13.1 • n=4 Participants	77.8 mmHg STANDARD_DEVIATION 13.1 • n=27 Participants
Smoker Never	16 Participants n=93 Participants	12 Participants n=4 Participants	28 Participants n=27 Participants
Smoker Current	16 Participants n=93 Participants	14 Participants n=4 Participants	30 Participants n=27 Participants
Smoker Former	31 Participants n=93 Participants	40 Participants n=4 Participants	71 Participants n=27 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Reported results are based on observed data from participants who had primary outcome measured.

Outcome measures

Outcome measures
Measure	Intensive LDL-lowering Therapy (ILLT) n=56 Participants Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to LDL-apheresis in addition to the standard statin therapy of an oral daily dose of 40-80mg of Atorvastatin or equivalent. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks.	Standard Statin Monotherapy (SMT) n=58 Participants Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to an oral daily dose of 40-80mg of Atorvastatin or equivalent without LDL-apheresis.
Change in the Total Atheroma Volume From Baseline to 12 Weeks	-7.63 mm^3 Standard Deviation 23.78	-3.10 mm^3 Standard Deviation 17.74

SECONDARY outcome

Timeframe: 12 weeks

Population: Reported results are based on observed data from participants who had secondary outcome measured.

The %NC component of atheroma were obtained via IVUS-VH at 2 time points (baseline during index PCI and 90-day follow-up).

Outcome measures

Outcome measures
Measure	Intensive LDL-lowering Therapy (ILLT) n=45 Participants Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to LDL-apheresis in addition to the standard statin therapy of an oral daily dose of 40-80mg of Atorvastatin or equivalent. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks.	Standard Statin Monotherapy (SMT) n=48 Participants Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to an oral daily dose of 40-80mg of Atorvastatin or equivalent without LDL-apheresis.
Change in % Necrotic Core Component of Atheroma	0.44 percentage of atheroma component Standard Deviation 6.81	0.94 percentage of atheroma component Standard Deviation 9.89

SECONDARY outcome

Timeframe: 12 weeks

Population: Reported results are based on observed data from participants who had secondary outcome measured. This outcome was captured for Dallas site only.

The cell culture assay and quantification of circulating EPC-CFU were performed for patients recruited at the Dallas VA center only. The assay were done at 4 time points (pre-PCI, post-PCI, 30-day follow-up, and 90-day follow-up).

Outcome measures

Outcome measures
Measure	Intensive LDL-lowering Therapy (ILLT) n=37 Participants Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to LDL-apheresis in addition to the standard statin therapy of an oral daily dose of 40-80mg of Atorvastatin or equivalent. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks.	Standard Statin Monotherapy (SMT) n=35 Participants Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to an oral daily dose of 40-80mg of Atorvastatin or equivalent without LDL-apheresis.
Endothelial Progenitor Cell Colony Forming Units/ml of Peripheral Blood Across Time baseline pre-PCI	11.85 colonies/ml Standard Deviation 9.24	11.99 colonies/ml Standard Deviation 11.37
Endothelial Progenitor Cell Colony Forming Units/ml of Peripheral Blood Across Time baseline post-PCI	15.30 colonies/ml Standard Deviation 10.96	17.89 colonies/ml Standard Deviation 16.91
Endothelial Progenitor Cell Colony Forming Units/ml of Peripheral Blood Across Time 30-day	21.60 colonies/ml Standard Deviation 14.78	20.40 colonies/ml Standard Deviation 17.87
Endothelial Progenitor Cell Colony Forming Units/ml of Peripheral Blood Across Time 90-day	16.32 colonies/ml Standard Deviation 13.29	15.06 colonies/ml Standard Deviation 14.33

SECONDARY outcome

Timeframe: 6 months

The number of patients who experienced major adverse cardiovascular endpoints (MACE) including death, myocardial infarction, coronary revascularization, and stroke during the follow-up periods.

Outcome measures

Outcome measures
Measure	Intensive LDL-lowering Therapy (ILLT) n=63 Participants Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to LDL-apheresis in addition to the standard statin therapy of an oral daily dose of 40-80mg of Atorvastatin or equivalent. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks.	Standard Statin Monotherapy (SMT) n=66 Participants Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to an oral daily dose of 40-80mg of Atorvastatin or equivalent without LDL-apheresis.
Major Adverse CV Events	5 Participants	2 Participants

Adverse Events

Intensive LDL-lowering Therapy (ILLT)

Serious events: 28 serious events

Other events: 42 other events

Deaths: 2 deaths

Standard Statin Monotherapy (SMT)

Serious events: 28 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intensive LDL-lowering Therapy (ILLT) n=63 participants at risk Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to LDL-apheresis in addition to the standard statin therapy of an oral daily dose of 40-80mg of Atorvastatin or equivalent. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks.	Standard Statin Monotherapy (SMT) n=66 participants at risk Patient of acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is randomized to an oral daily dose of 40-80mg of Atorvastatin or equivalent without LDL-apheresis.
Cardiac disorders Coronary artery disease	7.9% 5/63 • Number of events 5 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	3.0% 2/66 • Number of events 2 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.
Cardiac disorders Cardiac failure congestive	0.00% 0/63 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	10.6% 7/66 • Number of events 7 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.
Cardiac disorders Coronary artery stenosis	0.00% 0/63 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	7.6% 5/66 • Number of events 5 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.
Cardiac disorders Myocardial infarction	1.6% 1/63 • Number of events 1 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	4.5% 3/66 • Number of events 3 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.
Cardiac disorders Atrial fibrillation	4.8% 3/63 • Number of events 3 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	1.5% 1/66 • Number of events 1 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.
Cardiac disorders Coronary artery occlusion	1.6% 1/63 • Number of events 1 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	3.0% 2/66 • Number of events 2 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.
Cardiac disorders Angina unstable	1.6% 1/63 • Number of events 1 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	3.0% 2/66 • Number of events 2 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.
General disorders Chest pain	7.9% 5/63 • Number of events 5 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	7.6% 5/66 • Number of events 5 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.
General disorders Vascular stent restenosis	4.8% 3/63 • Number of events 3 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	6.1% 4/66 • Number of events 4 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.
Nervous system disorders Cerebrovascular accident	3.2% 2/63 • Number of events 2 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	1.5% 1/66 • Number of events 1 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.
Infections and infestations Pneumonia	3.2% 2/63 • Number of events 2 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	0.00% 0/66 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	1.6% 1/63 • Number of events 1 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	1.5% 1/66 • Number of events 1 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	3.2% 2/63 • Number of events 2 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	0.00% 0/66 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.
Vascular disorders Hypertension	3.2% 2/63 • Number of events 2 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.	0.00% 0/66 • AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE. All AE/SAE/UADE including both those related to the study intervention and those not related to the intervention, will be collected and recorded on the appropriate case report forms (CRF). For the purpose of safety monitoring, the study intervention is defined as the use of 1) statins with or without the addition of LDL-apheresis, 2) LDL-apheresis, and 3) cardiac catheterization and IVUS-VH as described in this protocol.

Other adverse events

Additional Information

Dr. Subhash Banerjee

VA North Texas Health Care System, Dallas, TX and University of Texas Southwestern Medical Center

Phone: 214-857-1608

Email: [email protected], [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place