Trial Outcomes & Findings for A Prospective, Multi-center Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) (NCT NCT00824434)

Last Updated: 2012-08-30

Results Overview

Percentage of patients who had a myocardial infarction, cardiac death, target lesion revascularization, or stent thrombosis (defined as definite or probable per the Academic Research Consortium \[ARC\] definitions); see below for definitions of individual components.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

100 participants

Primary outcome timeframe

30 days

Results posted on

2012-08-30

Participant Flow

Enrollment of 100 subjects was planned, 100 were enrolled at 14 investigative sites in the Asia Pacific region by July 22, 2009.

Participant milestones

Participant milestones
Measure	PROMUS Element Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Overall Study STARTED	100
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Prospective, Multi-center Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PROMUS Element n=100 Participants Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants
Age, Categorical >=65 years	40 Participants n=5 Participants
Age Continuous	61.82 years STANDARD_DEVIATION 9.92 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	77 Participants n=5 Participants
Race/Ethnicity, Customized Asian	16 Participant n=5 Participants
Race/Ethnicity, Customized Caucasian	78 Participant n=5 Participants
Race/Ethnicity, Customized Maori	1 Participant n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	2 Participant n=5 Participants
Race/Ethnicity, Customized Other	3 Participant n=5 Participants
Region of Enrollment Malaysia	9 participants n=5 Participants
Region of Enrollment Singapore	3 participants n=5 Participants
Region of Enrollment Australia	49 participants n=5 Participants
Region of Enrollment New Zealand	39 participants n=5 Participants
General Medical History Smoking, Ever	64 Participant n=5 Participants
General Medical History Medically Treated Diabetes	19 Participant n=5 Participants
General Medical History Hyperlipidemia Requiring Medication	81 Participant n=5 Participants
General Medical History Hypertension Requiring. Medication	66 Participant n=5 Participants
General Medical History History of Bleeding Disorder	3 Participant n=5 Participants
Cardiac History Stable Angina	57 Participant n=5 Participants
Cardiac History Unstable Angina	38 Participant n=5 Participants
Cardiac History No Angina	5 Participant n=5 Participants
Cardiac History Silent Ischemia	2 Participant n=5 Participants
Cardiac History Family History of Coronary Artery Disease	49 Participant n=5 Participants
Cardiac History Previous MI	39 Participant n=5 Participants
Cardiac History History of Percutaneous Coronary Intervention	31 Participant n=5 Participants
Cardiac History History of Coronary Artery Bypass Graft	5 Participant n=5 Participants
Cardiac History History of Arrhythmia	4 Participant n=5 Participants
Cardiac History History of Multivessel Disease	34 Participant n=5 Participants
Cardiac History History of Left Main Disease	2 Participant n=5 Participants
Cardiac History-Left Ventricular Ejection Fraction	64.41 Percent ejection fraction STANDARD_DEVIATION 13.30 • n=5 Participants
Neurologic History History of Transient Ischemic Attack	2 Participant n=5 Participants
Neurologic History History of Cerebrovascular Accident	3 Participant n=5 Participants
Renal and Peripheral History History of Renal Disease	1 Participant n=5 Participants
Renal and Peripheral History History of Peripheral Vascular Disease	3 Participant n=5 Participants
Lesion Characteristic-Target Vessel Left Anterior Descending Artery	35 Lesion n=5 Participants
Lesion Characteristic-Target Vessel Left Circumflex Artery	30 Lesion n=5 Participants
Lesion Characteristic-Target Vessel Right Coronary Artery	35 Lesion n=5 Participants
Lesion Location Proximal	37 Lesions n=5 Participants
Lesion Location Mid	54 Lesions n=5 Participants
Lesion Location Distal	7 Lesions n=5 Participants
Lesion Location Ostial	2 Lesions n=5 Participants
Lesion Characteristics Reference Vessel Diameter	2.72 millimeters STANDARD_DEVIATION 0.53 • n=5 Participants
Lesion Characteristics Minimum Lumen Diameter	0.71 millimeters STANDARD_DEVIATION 0.34 • n=5 Participants
Lesion Characteristics Lesion Length	15.40 millimeters STANDARD_DEVIATION 7.03 • n=5 Participants
Lesion Characteristic-Diameter Stenosis	74.09 Percent Diameter Stenosis STANDARD_DEVIATION 10.93 • n=5 Participants
Lesion Characteristics Eccentric Lesion	53 Lesions n=5 Participants
Lesion Characteristics Bend >45%	12 Lesions n=5 Participants
Lesion Characteristics Tortuosity	9 Lesions n=5 Participants
Lesion Characteristics Calcification, any	18 Lesions n=5 Participants
Lesion Characteristics Total Occlusion	1 Lesions n=5 Participants
Lesion Characteristics Branch Vessel Disease	6 Lesions n=5 Participants
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class A	5 Lesions n=5 Participants
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class B1	28 Lesions n=5 Participants
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class B2	42 Lesions n=5 Participants
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class C	25 Lesions n=5 Participants
Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow 0	1 Lesion n=5 Participants
Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow 1	0 Lesion n=5 Participants
Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow 2	1 Lesion n=5 Participants
Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow 3	98 Lesion n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.

Outcome measures

Outcome measures
Measure	PROMUS Element n=100 Participants Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Cardiac Events (Composite)	1.0 percentage of participants

SECONDARY outcome

Timeframe: 9 months

Population: Analysis was intention to treat; all patients in the study with workhorse lesions (visual reference vessel diameter \[RVD\] ≥2.5 mm and ≤4.25 mm and visual lesion length ≤24 mm) underwent clinical follow up to provide the information needed for this endpoint.

In-stent late loss by quantitative coronary angiography in workhorse target lesions (visual reference vessel diameter \[RVD\] ≥2.5 mm and ≤4.25 mm and visual lesion length ≤24 mm)

Outcome measures

Outcome measures
Measure	PROMUS Element n=73 Participants Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
In-stent Late Loss	0.17 millimeters Standard Deviation 0.25

SECONDARY outcome

Timeframe: Post-procedure

Population: Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device) and who underwent intravascular ultrasound to determine extent of stent apposition

Percentage of participants who experience incomplete stent apposition as determined immediately post-procedure by intravascular ultrasound

Outcome measures

Outcome measures
Measure	PROMUS Element n=88 Participants Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Occurance of Post-procedure Incomplete Stent Apposition	5.7 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.

New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin \>upper limit of normal(ULN); if no new Q-waves total CK levels \>3×ULN (peri-percutaneous coronary intervention \[PCI\]) or \>2×ULN (spontaneous) with elevated CK-MB or troponin \>3×ULN (peri-PCI) or \>2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin \>5×ULN

Outcome measures

Outcome measures
Measure	PROMUS Element n=100 Participants Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Myocardial Infarction (MI)	0.0 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.

Outcome measures

Outcome measures
Measure	PROMUS Element n=100 Participants Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
All-cause Mortality	0.0 percentage of participants

SECONDARY outcome

Timeframe: 30 Days

Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.

Target lesion revascularization (TLR) is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.

Outcome measures

Outcome measures
Measure	PROMUS Element n=100 Participants Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Target Lesion Revascularization (TLR)	1.0 percentage of participants

SECONDARY outcome

Timeframe: 12 Months

Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.

Outcome measures

Outcome measures
Measure	PROMUS Element n=100 Participants Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Target Lesion Revascularization (TLR)	1.0 percentage of participants

SECONDARY outcome

Timeframe: 30 Days

Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.

Target vessel revascularization (TVR) is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.

Outcome measures

Outcome measures
Measure	PROMUS Element n=100 Participants Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Target Vessel Revascularization (TVR)	1.0 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.

Outcome measures

Outcome measures
Measure	PROMUS Element n=100 Participants Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Target Vessel Revascularization (TVR)	1.0 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.

Target lesion failure (TLF) is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.

Outcome measures

Outcome measures
Measure	PROMUS Element n=100 Participants Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Target Lesion Failure (TLF)	1.0 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.

Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.

Outcome measures

Outcome measures
Measure	PROMUS Element n=100 Participants Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Target Vessel Failure (TVF)	1.0 percentage of participants

SECONDARY outcome

Timeframe: 24 hours

Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.

DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: \>24 hours to 30 days post; late ST: \>30 days to 1 year post; Very late ST: \>1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).

Outcome measures

Outcome measures
Measure	PROMUS Element n=100 Participants Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition	1.0 percentage of participants

SECONDARY outcome

Timeframe: >24 hr-30 days

Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.

Outcome measures

Outcome measures
Measure	PROMUS Element n=100 Participants Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition	0.0 percentage of participants

SECONDARY outcome

Timeframe: >30 days-1 year

Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.

Outcome measures

Outcome measures
Measure	PROMUS Element n=100 Participants Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition	0.0 percentage of participants

SECONDARY outcome

Timeframe: Duration of hospital stay (usually 1-2 days)

Population: Analysis was intention to treat

Mean lesion diameter stenosis \< 30% with TIMI 3 flow without the occurrence of in-hospital cardiac death, MI, or TVR

Outcome measures

Outcome measures
Measure	PROMUS Element n=100 Participants Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Clinical Procedural Success	99.0 percentage of participants

SECONDARY outcome

Timeframe: Acute-At time of index procedure

Population: Intention to treat

Successful delivery and deployment of the study stent to the target lesion, without balloon rupture or embolization, summarized per stent.

Outcome measures

Outcome measures
Measure	PROMUS Element n=108 stents attempted in the target vessel Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Technical Success	100.0 percentage of stents attempted

Adverse Events

PROMUS Element

Serious events: 27 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PROMUS Element n=100 participants at risk Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Cardiac disorders Angina pectoris	4.0% 4/100 • Number of events 5 • Site reported adverse events were collected through 365 days.
Cardiac disorders Angina unstable	3.0% 3/100 • Number of events 5 • Site reported adverse events were collected through 365 days.
Cardiac disorders Coronary artery dissection	3.0% 3/100 • Number of events 4 • Site reported adverse events were collected through 365 days.
Cardiac disorders Myocardial infarction	2.0% 2/100 • Number of events 2 • Site reported adverse events were collected through 365 days.
Cardiac disorders Arteriospasm coronary	1.0% 1/100 • Number of events 1 • Site reported adverse events were collected through 365 days.
Cardiac disorders Coronary artery disease	1.0% 1/100 • Number of events 1 • Site reported adverse events were collected through 365 days.
Cardiac disorders Coronary artery stenosis	1.0% 1/100 • Number of events 1 • Site reported adverse events were collected through 365 days.
Cardiac disorders Coronary artery thrombosis	1.0% 1/100 • Number of events 1 • Site reported adverse events were collected through 365 days.
General disorders Non-cardiac chest pain	8.0% 8/100 • Number of events 8 • Site reported adverse events were collected through 365 days.
General disorders Catheter site discharge	1.0% 1/100 • Number of events 1 • Site reported adverse events were collected through 365 days.
General disorders Catheter site haemorrhage	1.0% 1/100 • Number of events 1 • Site reported adverse events were collected through 365 days.
General disorders Chest pain	1.0% 1/100 • Number of events 1 • Site reported adverse events were collected through 365 days.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	3.0% 3/100 • Number of events 3 • Site reported adverse events were collected through 365 days.
Musculoskeletal and connective tissue disorders Back pain	1.0% 1/100 • Number of events 1 • Site reported adverse events were collected through 365 days.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.0% 1/100 • Number of events 1 • Site reported adverse events were collected through 365 days.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.0% 1/100 • Number of events 1 • Site reported adverse events were collected through 365 days.
Infections and infestations Appendicitis	1.0% 1/100 • Number of events 1 • Site reported adverse events were collected through 365 days.
Infections and infestations Diverticulitis	1.0% 1/100 • Number of events 1 • Site reported adverse events were collected through 365 days.
Infections and infestations Gastroenteritis viral	1.0% 1/100 • Number of events 1 • Site reported adverse events were collected through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	1.0% 1/100 • Number of events 1 • Site reported adverse events were collected through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	1.0% 1/100 • Number of events 1 • Site reported adverse events were collected through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	1.0% 1/100 • Number of events 1 • Site reported adverse events were collected through 365 days.
Eye disorders Blindness unilateral	1.0% 1/100 • Number of events 1 • Site reported adverse events were collected through 365 days.
Eye disorders Macular hole	1.0% 1/100 • Number of events 1 • Site reported adverse events were collected through 365 days.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	1.0% 1/100 • Number of events 1 • Site reported adverse events were collected through 365 days.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.0% 1/100 • Number of events 1 • Site reported adverse events were collected through 365 days.
Vascular disorders Intermittant claudication	2.0% 2/100 • Number of events 2 • Site reported adverse events were collected through 365 days.

Other adverse events

Other adverse events
Measure	PROMUS Element n=100 participants at risk Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
General disorders Non-cardiac chest pain	8.0% 8/100 • Number of events 9 • Site reported adverse events were collected through 365 days.
Cardiac disorders Angina pectoris	7.0% 7/100 • Number of events 7 • Site reported adverse events were collected through 365 days.
General disorders Catheter site haematoma	7.0% 7/100 • Number of events 8 • Site reported adverse events were collected through 365 days.
General disorders Adverse drug reaction	6.0% 6/100 • Number of events 7 • Site reported adverse events were collected through 365 days.
General disorders Catheter site discharge	6.0% 6/100 • Number of events 7 • Site reported adverse events were collected through 365 days.
General disorders Chest pain	5.0% 5/100 • Number of events 5 • Site reported adverse events were collected through 365 days.
Cardiac disorders Coronary artery dissection	8.0% 8/100 • Number of events 8 • Site reported adverse events were collected through 365 days.
Cardiac disorders Myocardial infarction	8.0% 8/100 • Number of events 8 • Site reported adverse events were collected through 365 days.
Investigations Troponin increased	12.0% 12/100 • Number of events 12 • Site reported adverse events were collected through 365 days.

Additional Information

Ruth Starzyk, PhD

Boston Scientific

Phone: 508-683-6577

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Principal Investigator shall have the right to publish the results, provided that before publishing, the PI shall submit copies of any proposed publication or presentation to Sponsor for review at least 40 days in advance of submission for publication or presentation to a publisher or other third party. Sponsor reserves the right to delete any confidential information or other proprietary information of Sponsor from the proposed publication or presentation.
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