Trial Outcomes & Findings for Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE) (NCT NCT01930214)

NCT ID: NCT01930214

Last Updated: 2023-07-18

Results Overview

A Kaplan-Meier analysis was performed to determine the percent probability that a study participant experienced a major adverse cardiac event through 30 days. 30-day MACE is composed of: * Cardiac death * Myocardial Infarction (MI) - defined as a Creatine Kinase Myocardial-Band Isoenzyme (CK-MB) level greater than three (3) times the Upper Limit of Lab Normal (ULN) value with or without new pathologic Q wave * Target Vessel Revascularization (TVR) - defined as a revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure

Recruitment status

COMPLETED

Target enrollment

350 participants

Primary outcome timeframe

30 days post procedure

Results posted on

2023-07-18

Participant Flow

Enrollment was completed at 350 treated subjects.

A subject was considered enrolled when a signed informed consent was in place, all inclusion/no exclusion criteria were met, and the study guidewire had crossed the target lesion.

Participant milestones

Participant milestones
Measure	None/Mild Calcification Presence of readily apparent radiopacities within the vascular wall at the site of the stenosis. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Moderate Calcification Presence of radiopacities only during the cardiac cycle before contrast injection with calcium extended partially into the target lesion. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Severe Calcification Presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location, total length of calcium (including segmented) must be at least 15mm and extend partially into the target lesion. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).
Overall Study STARTED	100	117	133
Overall Study COMPLETED	80	96	108
Overall Study NOT COMPLETED	20	21	25

Reasons for withdrawal

Reasons for withdrawal
Measure	None/Mild Calcification Presence of readily apparent radiopacities within the vascular wall at the site of the stenosis. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Moderate Calcification Presence of radiopacities only during the cardiac cycle before contrast injection with calcium extended partially into the target lesion. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Severe Calcification Presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location, total length of calcium (including segmented) must be at least 15mm and extend partially into the target lesion. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).
Overall Study Death	4	4	11
Overall Study Lost to Follow-up	12	13	12
Overall Study Voluntary withdrawal of infomed consent	2	4	2
Overall Study Physician Decision	2	0	0

Baseline Characteristics

Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	None/Mild Calcification n=100 Participants Presence of readily apparent radiopacities within the vascular wall at the site of the stenosis. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Moderate Calcification n=117 Participants Presence of radiopacities only during the cardiac cycle before contrast injection with calcium extended partially into the target lesion. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Severe Calcification n=133 Participants Presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location, total length of calcium (including segmented) must be at least 15mm and extend partially into the target lesion. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Total n=350 Participants Total of all reporting groups
Age, Continuous	62.9 years STANDARD_DEVIATION 10.3 • n=5 Participants	68.9 years STANDARD_DEVIATION 10.6 • n=7 Participants	69.3 years STANDARD_DEVIATION 9.2 • n=5 Participants	67.3 years STANDARD_DEVIATION 10.4 • n=4 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	29 Participants n=7 Participants	34 Participants n=5 Participants	92 Participants n=4 Participants
Sex: Female, Male Male	71 Participants n=5 Participants	88 Participants n=7 Participants	99 Participants n=5 Participants	258 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	19 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	94 Participants n=5 Participants	109 Participants n=7 Participants	128 Participants n=5 Participants	331 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	88 participants n=5 Participants	98 participants n=7 Participants	118 participants n=5 Participants	304 participants n=4 Participants
Race/Ethnicity, Customized Black or African American	9 participants n=5 Participants	13 participants n=7 Participants	6 participants n=5 Participants	28 participants n=4 Participants
Race/Ethnicity, Customized Asian	3 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants	15 participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Race/Ethnicity, Customized Native American	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Race/Ethnicity, Customized Other	0 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants	3 participants n=4 Participants
Region of Enrollment United States	100 participants n=5 Participants	117 participants n=7 Participants	133 participants n=5 Participants	350 participants n=4 Participants

PRIMARY outcome

Timeframe: 30 days post procedure

Population: Subjects were enrolled based on Investigator assessment of calcium; however, all analyses were performed by core lab assessed calcium to ensure consistent methodology. Of the 350 subjects enrolled in the study, 346 had sufficient angiography for core lab stratification (133 none/mild, 99 moderate, and 114 severe).

Outcome measures

Outcome measures
Measure	None/Mild Calcification n=133 Participants Presence of readily apparent radiopacities within the vascular wall at the site of the stenosis as assessed by the angiographic core lab. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Moderate Calcification n=99 Participants Presence of radiopacities only during the cardiac cycle before contrast injection with calcium extended partially into the target lesion as assessed by the angiographic core lab. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Severe Calcification n=114 Participants Presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location, total length of calcium (including segmented) must be at least 15mm and extend partially into the target lesion as assessed by the angiographic core lab. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).
MACE at 30 Days	2.3 Percent probability of MACE Interval 0.0 to 4.8	3.1 Percent probability of MACE Interval 0.0 to 6.5	15 Percent probability of MACE Interval 8.4 to 21.6

SECONDARY outcome

Timeframe: One (1) year post procedure

A Kaplan-Meier analysis was performed to determine the percent probability that a study participant experienced a major adverse cardiac event through 1 year. 1-year MACE is composed of: * Cardiac death * Myocardial Infarction (MI) - defined as a Creatine Kinase Myocardial-Band Isoenzyme (CK-MB) level greater than three (3) times the Upper Limit of Lab Normal (ULN) value with or without new pathologic Q wave * Target Vessel Revascularization (TVR) - defined as a revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure

Outcome measures

Outcome measures
Measure	None/Mild Calcification n=133 Participants Presence of readily apparent radiopacities within the vascular wall at the site of the stenosis as assessed by the angiographic core lab. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Moderate Calcification n=99 Participants Presence of radiopacities only during the cardiac cycle before contrast injection with calcium extended partially into the target lesion as assessed by the angiographic core lab. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Severe Calcification n=114 Participants Presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location, total length of calcium (including segmented) must be at least 15mm and extend partially into the target lesion as assessed by the angiographic core lab. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).
MACE at One (1) Year	5.4 Percent probability of MACE Interval 1.5 to 9.2	8.5 Percent probability of MACE Interval 2.8 to 14.2	24.2 Percent probability of MACE Interval 16.1 to 32.4

SECONDARY outcome

Timeframe: Participants were followed from baseline procedure through hospital discharge, an expected average of 24 hours

Procedural success is defined as success in facilitating stent delivery with a residual stenosis of \<50% and without the occurrence of an in-hospital MACE.

Outcome measures

Outcome measures
Measure	None/Mild Calcification n=133 Participants Presence of readily apparent radiopacities within the vascular wall at the site of the stenosis as assessed by the angiographic core lab. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Moderate Calcification n=99 Participants Presence of radiopacities only during the cardiac cycle before contrast injection with calcium extended partially into the target lesion as assessed by the angiographic core lab. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Severe Calcification n=114 Participants Presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location, total length of calcium (including segmented) must be at least 15mm and extend partially into the target lesion as assessed by the angiographic core lab. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).
Procedural Success	97.7 Percent of Procedures Interval 93.5 to 99.5	96 Percent of Procedures Interval 90.0 to 98.9	86.8 Percent of Procedures Interval 79.2 to 92.4

SECONDARY outcome

Timeframe: During the procedure

Lesion success is defined as success in facilitating stent delivery with a post-procedural result of \<50% residual stenosis for a given lesion treated during the procedure without severe angiographic complications.

Outcome measures

Outcome measures
Measure	None/Mild Calcification n=133 Participants Presence of readily apparent radiopacities within the vascular wall at the site of the stenosis as assessed by the angiographic core lab. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Moderate Calcification n=99 Participants Presence of radiopacities only during the cardiac cycle before contrast injection with calcium extended partially into the target lesion as assessed by the angiographic core lab. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Severe Calcification n=114 Participants Presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location, total length of calcium (including segmented) must be at least 15mm and extend partially into the target lesion as assessed by the angiographic core lab. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).
Lesion Success	94.7 Percentage of Procedures	88.9 Percentage of Procedures	83.3 Percentage of Procedures

Adverse Events

None/Mild Calcification

Serious events: 62 serious events

Other events: 0 other events

Deaths: 6 deaths

Moderate Calcification

Serious events: 47 serious events

Other events: 0 other events

Deaths: 1 deaths

Severe Calcification

Serious events: 64 serious events

Other events: 0 other events

Deaths: 7 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Clinical Project Manager

Cardiovascular Systems Inc.

Phone: 6512591600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any previously unpublished information provided to the Investigators by the Sponsor is confidential and will remain the sole property of the Sponsor. The Investigator agrees to use this information only in accomplishing this study not use it for other purposes without the Sponsor's written consent. An Investigator can generate additional publication ideas based on the trial data. The Sponsor reserves the right to review the manuscript prior to submission in order to verify accuracy of the data
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	None/Mild Calcification n=134 participants at risk • Presence of readily apparent radiopacities within the vascular wall at the site of the stenosis. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Moderate Calcification n=99 participants at risk • Presence of radiopacities only during the cardiac cycle before contrast injection with calcium extended partially into the target lesion. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).	Severe Calcification n=117 participants at risk • Presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location, total length of calcium (including segmented) must be at least 15mm and extend partially into the target lesion. Percutaneous Coronary Intervention: Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).
Cardiac disorders Acute MI, Q-wave	0.00% 0/134 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/99 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.85% 1/117 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Cardiac disorders Acute MI, non Q-wave	6.7% 9/134 • Number of events 9 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	6.1% 6/99 • Number of events 7 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	14.5% 17/117 • Number of events 19 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Cardiac disorders Acute congestive heart failure	0.75% 1/134 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/99 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.85% 1/117 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Cardiac disorders Angina pectoris	12.7% 17/134 • Number of events 23 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	10.1% 10/99 • Number of events 14 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	10.3% 12/117 • Number of events 21 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Cardiac disorders Arrhythmia, unspecified	0.75% 1/134 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/99 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/117 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Cardiac disorders Atrial Fibrillation	3.7% 5/134 • Number of events 5 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	4.0% 4/99 • Number of events 5 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	4.3% 5/117 • Number of events 5 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Cardiac disorders Atrioventricular block, III degree	0.00% 0/134 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/99 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.85% 1/117 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Cardiac disorders Cardiogenic shock	0.75% 1/134 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/99 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/117 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Cardiac disorders Chest Pain	6.0% 8/134 • Number of events 8 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	3.0% 3/99 • Number of events 3 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.85% 1/117 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Cardiac disorders Chest Pain, non ischemic	4.5% 6/134 • Number of events 6 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	3.0% 3/99 • Number of events 3 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	3.4% 4/117 • Number of events 4 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Cardiac disorders Chronic CHF, or exacerbation	2.2% 3/134 • Number of events 4 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	3.0% 3/99 • Number of events 4 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	2.6% 3/117 • Number of events 3 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Cardiac disorders Coronary artery restenosis	1.5% 2/134 • Number of events 3 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	1.0% 1/99 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	7.7% 9/117 • Number of events 13 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Cardiac disorders Elevated CK-MB	0.00% 0/134 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	1.0% 1/99 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.85% 1/117 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Cardiac disorders Elevated Troponin	0.75% 1/134 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/99 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.85% 1/117 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Cardiac disorders Elevated cardiac enzymes	0.00% 0/134 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	1.0% 1/99 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/117 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Cardiac disorders Other cardiovascular system related AE	1.5% 2/134 • Number of events 2 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	1.0% 1/99 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.85% 1/117 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Cardiac disorders Sinus bradycardia	0.75% 1/134 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/99 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.85% 1/117 • Number of events 2 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Cardiac disorders Supraventricular tachycardia	0.75% 1/134 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/99 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/117 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Cardiac disorders Ventricular fibrillation	0.00% 0/134 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	1.0% 1/99 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/117 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Injury, poisoning and procedural complications Abrupt or threatened closure of coronary artery	0.75% 1/134 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/99 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	1.7% 2/117 • Number of events 2 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Injury, poisoning and procedural complications Coronary artery vasospasm	0.00% 0/134 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	1.0% 1/99 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/117 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Injury, poisoning and procedural complications Coronary vessel dissection present (A-F)	9.0% 12/134 • Number of events 12 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	16.2% 16/99 • Number of events 16 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	21.4% 25/117 • Number of events 25 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Injury, poisoning and procedural complications Coronary vessel perforation present	0.75% 1/134 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/99 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.85% 1/117 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Injury, poisoning and procedural complications Slow flow or no reflow phenomena	2.2% 3/134 • Number of events 3 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/99 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	1.7% 2/117 • Number of events 2 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Vascular disorders Deep vein thrombosis (DVT)	0.75% 1/134 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/99 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.85% 1/117 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Vascular disorders Hematoma at access site, not requiring intervention	2.2% 3/134 • Number of events 3 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	3.0% 3/99 • Number of events 3 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	1.7% 2/117 • Number of events 2 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Vascular disorders Hemorrhage, major, requiring transfusion	0.75% 1/134 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/99 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	3.4% 4/117 • Number of events 4 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Vascular disorders Hemorrhage, minor, without transfusion	3.0% 4/134 • Number of events 4 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	3.0% 3/99 • Number of events 4 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	2.6% 3/117 • Number of events 3 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Vascular disorders Hypertension	0.00% 0/134 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/99 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.85% 1/117 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Vascular disorders Hypotension	0.00% 0/134 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	1.0% 1/99 • Number of events 2 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.85% 1/117 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Vascular disorders Peripheral artery pseudoaneurysm	0.75% 1/134 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	1.0% 1/99 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.85% 1/117 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Vascular disorders Peripheral artery/vascular disease	1.5% 2/134 • Number of events 2 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	3.0% 3/99 • Number of events 4 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/117 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Vascular disorders Peripheral vessel damage requiring surgical repair	0.00% 0/134 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/99 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.85% 1/117 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Nervous system disorders Cerebrovascular accident (CVA)	0.00% 0/134 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	1.0% 1/99 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.85% 1/117 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Respiratory, thoracic and mediastinal disorders Dyspnea/Shortness of breath	0.75% 1/134 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	1.0% 1/99 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	1.7% 2/117 • Number of events 2 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
Renal and urinary disorders Renal insufficiency	1.5% 2/134 • Number of events 2 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/99 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/117 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
General disorders Allergic reaction to contrast dye	0.00% 0/134 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	1.0% 1/99 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/117 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
General disorders Anemia	0.75% 1/134 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/99 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	2.6% 3/117 • Number of events 3 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
General disorders Fever	0.00% 0/134 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/99 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.85% 1/117 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.
General disorders Infection, systemic	0.75% 1/134 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.00% 0/99 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.	0.85% 1/117 • Number of events 1 • 3 years AE collection was limited to cardiac event, death, serious injury, MAEs, bleeding and angio complications related to the index procedure. Angio core lab (CL) assessed the presence of dissections and perforations; CEC adjudicated: bleed, angio events not assessed by CL, death, MI, TVR, TLR and any non-endpoint event that the CEC deemed necessary to adjudicate as study related. Groups based on CL calcification for 346/350; remaining (4) subjects were included based on site reported calcification.