Trial Outcomes & Findings for HARMONEE - Japan-USA Harmonized Assessment by Randomized, Multi-Center Study of OrbusNEich's Combo StEnt (NCT NCT02073565)

NCT ID: NCT02073565

Last Updated: 2022-05-13

Results Overview

The primary clinical endpoint of Target Vessel Failure (TVF), defined as cardiac death, target-vessel myocardial infarction (MI), or ischemia-driven Target Vessel Revascularization(TVR) by percutaneous or surgical methods, at 1 year.

Recruitment status

COMPLETED

Study phase

Target enrollment

572 participants

Primary outcome timeframe

1 year follow-up

Results posted on

2022-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	Combo The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface. OrbusNeich Combo stent™: The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.	Everolimus Eluting Stent (EES) Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V. Everolimus Eluting Stent (EES): Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V.
Intention-To-Treat Subjects-Cohorts AB&C STARTED	287	285
Intention-To-Treat Subjects-Cohorts AB&C COMPLETED	285	279
Intention-To-Treat Subjects-Cohorts AB&C NOT COMPLETED	2	6
Cohort A STARTED	16	14
Cohort A COMPLETED	15	14
Cohort A NOT COMPLETED	1	0
Cohort B STARTED	54	56
Cohort B COMPLETED	53	54
Cohort B NOT COMPLETED	1	2
Cohort C STARTED	217	215
Cohort C COMPLETED	217	211
Cohort C NOT COMPLETED	0	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Combo The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface. OrbusNeich Combo stent™: The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.	Everolimus Eluting Stent (EES) Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V. Everolimus Eluting Stent (EES): Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V.
Cohort A Withdrawal by Subject	1	0
Cohort B Withdrawal by Subject	1	2
Cohort C Withdrawal by Subject	0	2
Cohort C Lost to Follow-up	0	2

Baseline Characteristics

HARMONEE - Japan-USA Harmonized Assessment by Randomized, Multi-Center Study of OrbusNEich's Combo StEnt

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combo n=287 Participants The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface. OrbusNeich Combo stent™: The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.	Everolimus Eluting Stent (EES) n=285 Participants Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V. Everolimus Eluting Stent (EES): Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V.	Total n=572 Participants Total of all reporting groups
Age, Continuous	67.6 years STANDARD_DEVIATION 9.6 • n=5 Participants	66.5 years STANDARD_DEVIATION 10.4 • n=7 Participants	67.0 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	73 Participants n=7 Participants	149 Participants n=5 Participants
Sex: Female, Male Male	211 Participants n=5 Participants	212 Participants n=7 Participants	423 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian (non-Japanese)-	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Japanese	219 Participants n=5 Participants	219 Participants n=7 Participants	438 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Race · White/Caucasian	57 Participants n=5 Participants	59 Participants n=7 Participants	116 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	67 Participants n=5 Participants	66 Participants n=7 Participants	133 Participants n=5 Participants
Region of Enrollment Japan	220 Participants n=5 Participants	219 Participants n=7 Participants	439 Participants n=5 Participants
Non-ST-segment elevation myocardial infarction (Non-STEMI) Presentation	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Multivessel Coronary Artery Disease (MV CAD)	33 Participants n=5 Participants	31 Participants n=7 Participants	64 Participants n=5 Participants
Previous Myocardial Infarction (MI)	45 Participants n=5 Participants	45 Participants n=7 Participants	90 Participants n=5 Participants
Previous Percutaneous Coronary Intervention (PCI)	72 Participants n=5 Participants	83 Participants n=7 Participants	155 Participants n=5 Participants
Previous Coronary Artery Bypass Grafting (CABG)	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Hypertension	218 Participants n=5 Participants	220 Participants n=7 Participants	438 Participants n=5 Participants
Congestive Heart Failure	11 Participants n=5 Participants	24 Participants n=7 Participants	35 Participants n=5 Participants
Diabetes Diabetes: Insulin Dependent	24 Participants n=5 Participants	18 Participants n=7 Participants	42 Participants n=5 Participants
Diabetes Diabetes: Non-insulin Dependent	93 Participants n=5 Participants	75 Participants n=7 Participants	168 Participants n=5 Participants
Diabetes Participants without Diabetes	170 Participants n=5 Participants	192 Participants n=7 Participants	362 Participants n=5 Participants
Cigarette Smoking (current/former)	191 Participants n=5 Participants	175 Participants n=7 Participants	366 Participants n=5 Participants
Chronic Renal Insufficiency	11 Participants n=5 Participants	5 Participants n=7 Participants	16 Participants n=5 Participants
Hypercholesterolemia	225 Participants n=5 Participants	227 Participants n=7 Participants	452 Participants n=5 Participants
Planned Dual Antiplatelet Therapy (DAPT) at 6 months	5 Participants n=5 Participants	11 Participants n=7 Participants	16 Participants n=5 Participants
Planned Dual Antiplatelet Therapy (DAPT) at 1 year	247 Participants n=5 Participants	243 Participants n=7 Participants	490 Participants n=5 Participants
Planned Statins at 1 year	233 Participants n=5 Participants	228 Participants n=7 Participants	461 Participants n=5 Participants
Planned Beta-blockers at 1 year	103 Participants n=5 Participants	100 Participants n=7 Participants	203 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year follow-up

Outcome measures

Outcome measures
Measure	Combo n=287 Participants The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface. OrbusNeich Combo stent™: The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.	Everolimus Eluting Stent (EES) n=285 Participants Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V. Everolimus Eluting Stent (EES): Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V.
Number of Participants With Target Vessel Failure (TVF)	20 Participants	12 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Cohorts A and B - Subjects with analyzable Optical coherence tomography (OCT) follow-up

The secondary efficacy endpoint is mechanistic Optical coherence tomography (OCT) healthy level of intimal tissue coverage, determined by the OCT core laboratory at 1 year for subjects in Cohorts A and B. This reports the percentage of healthy tissue coverage that was great than 40 micrometers.

Outcome measures

Outcome measures
Measure	Combo n=62 lesions The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface. OrbusNeich Combo stent™: The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.	Everolimus Eluting Stent (EES) n=60 lesions Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V. Everolimus Eluting Stent (EES): Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V.
Percentage of Healthy Tissue Coverage That Was Greater Than 40 Micrometers	91.27 Healthy Tissue Strut Coverage (>40 µm) % Interval 88.71 to 93.84	74.82 Healthy Tissue Strut Coverage (>40 µm) % Interval 70.02 to 79.62

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Clinically and functionally ischemia-driven target lesion revascularization (TLR), including use of target-vessel Fractional Flow Reserve (FFR), analyzed dichotomously using the Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation (FAME) study criteria of 0.8 during a 2 minute infusion of adenosine or adenosine triphosphate.34 Abnormal FFR-driven interventions at 1 year will be included in the evaluation of ischemia-driven TLR.

Outcome measures

Outcome measures
Measure	Combo n=287 Participants The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface. OrbusNeich Combo stent™: The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.	Everolimus Eluting Stent (EES) n=285 Participants Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V. Everolimus Eluting Stent (EES): Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V.
Number of Patients With Clinically and Functionally Ischemia-Driven Target Lesion Revascularization (TLR)	12 Participants	8 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day of device implantation, 30 days, 12 months

Population: Cohort B - Please note that for the "1 Year HAMA Responders" Row in the Combo arm, 52 participants were analyzed (1 participant withdrew and 1 participant died). For the "1 Year HAMA Responders" Row in the EES arm, 52 participants were analyzed (2 participants withdrew and 2 participants were not present for the 1 year visit).

Serum will be assessed for HAMA development at index, 30 days, and 12 months in Cohort B subjects. Human antimurine antibody plasma assessment will be with blood draws performed during index procedure, 30 day follow-up visit, and 1 year catheterizations.

Outcome measures

Outcome measures
Measure	Combo n=54 Participants The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface. OrbusNeich Combo stent™: The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.	Everolimus Eluting Stent (EES) n=56 Participants Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V. Everolimus Eluting Stent (EES): Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V.
Number of Patients Exhibiting Human Antimurine Antibody (HAMA) Reaction Baseline HAMA Responders	0 Participants	0 Participants
Number of Patients Exhibiting Human Antimurine Antibody (HAMA) Reaction 30 day HAMA Responders	0 Participants	0 Participants
Number of Patients Exhibiting Human Antimurine Antibody (HAMA) Reaction 1 Year HAMA Responders	0 Participants	0 Participants

Adverse Events

Combo

Serious events: 42 serious events

Other events: 0 other events

Deaths: 2 deaths

Everolimus Eluting Stent (EES)

Serious events: 42 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Debbie Morrell, Clinical Research Manager

OrbusNeich

Phone: 954-730-0711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Combo n=287 participants at risk The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface. OrbusNeich Combo stent™: The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.	Everolimus Eluting Stent (EES) n=284 participants at risk Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V. Everolimus Eluting Stent (EES): Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V.
Blood and lymphatic system disorders Anaemia	0.70% 2/287 • Number of events 2 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.00% 0/284 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Cardiac disorders Angina pectoris	1.0% 3/287 • Number of events 4 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.00% 0/284 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Cardiac disorders Angina unstable	0.70% 2/287 • Number of events 2 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	1.1% 3/284 • Number of events 3 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Cardiac disorders Arteriospasm coronary	0.35% 1/287 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.00% 0/284 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Cardiac disorders Atrial tachycardia	0.35% 1/287 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.00% 0/284 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Cardiac disorders Atrial fibrillation	0.00% 0/287 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.70% 2/284 • Number of events 2 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Cardiac disorders Atrioventricular block complete	0.35% 1/287 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.00% 0/284 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Cardiac disorders Cardiac failure acute	0.00% 0/287 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.35% 1/284 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Cardiac disorders Cardiac failure chronic	0.00% 0/287 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.35% 1/284 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Cardiac disorders Cardiac failure congestive	0.35% 1/287 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.00% 0/284 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Cardiac disorders Coronary artery disection	0.35% 1/287 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.35% 1/284 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Cardiac disorders Prinzmetal angina	0.00% 0/287 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.35% 1/284 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Cardiac disorders Sinus node dysfunction	0.35% 1/287 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.00% 0/284 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Cardiac disorders Ventricular extrasystoles	0.00% 0/287 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.35% 1/284 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Cardiac disorders Ventricular fibrillation	0.00% 0/287 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.35% 1/284 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Cardiac disorders Ventricular tachycardia	0.35% 1/287 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.00% 0/284 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Eye disorders Cataract	1.0% 3/287 • Number of events 4 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	1.1% 3/284 • Number of events 3 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Eye disorders Diabetic retinopathy	0.00% 0/287 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.35% 1/284 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Eye disorders Diplopia	0.35% 1/287 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.00% 0/284 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Eye disorders Vitreous haemorrhage	0.35% 1/287 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.00% 0/284 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Gastrointestinal disorders Colitis	0.00% 0/287 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.35% 1/284 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/287 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.35% 1/284 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/287 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.35% 1/284 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.35% 1/287 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.00% 0/284 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Gastrointestinal disorders Melaena	0.35% 1/287 • Number of events 2 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.70% 2/284 • Number of events 2 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Gastrointestinal disorders Oesophagitis	0.00% 0/287 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.35% 1/284 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
General disorders Catheter site erosion	0.35% 1/287 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.00% 0/284 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
General disorders Non-cardiac chest pain	1.4% 4/287 • Number of events 4 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	1.1% 3/284 • Number of events 3 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
General disorders Vascular stent restenosis	0.35% 1/287 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.00% 0/284 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/287 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.70% 2/284 • Number of events 2 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Hepatobiliary disorders Hepatic function abnormal	0.35% 1/287 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.00% 0/284 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Infections and infestations Diverticulitis	0.00% 0/287 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.35% 1/284 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Infections and infestations Endocarditis	0.00% 0/287 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.35% 1/284 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Infections and infestations Hand-foot-and-mouth disease	0.00% 0/287 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.35% 1/284 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Infections and infestations Pneumonia	0.35% 1/287 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.00% 0/284 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Infections and infestations Sepsis	0.35% 1/287 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.70% 2/284 • Number of events 2 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Infections and infestations Urinary tract infection	0.35% 1/287 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.00% 0/284 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Injury, poisoning and procedural complications Fractured ischium	0.00% 0/287 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.35% 1/284 • Number of events 1 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Injury, poisoning and procedural complications Postoperative ileus	0.70% 2/287 • Number of events 4 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.00% 0/284 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/287 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.	0.35% 1/284 • Number of events 2 • Per the protocol, all adverse events will be collected from the point of subject enrollment through the 1-year follow-up. All adverse events listed as protocol-specific endpoints (Death, Cardiac death, MI, Target vessel MI, TLR (ischemia driven), TVR (ischemia driven), Stroke, transient ischemic attack (TIA), and Stent Thrombosis (ARC definition)) will be collected from 1-year follow to the completion of the study at the 5-year follow-up. The data reported below is at 1 year.