Trial Outcomes & Findings for PLATINUM Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions-Pharmacokinetics (PLATINUM PK) (NCT NCT01510327)

NCT ID: NCT01510327

Last Updated: 2019-03-26

Results Overview

Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 22 participants
• Primary outcome timeframe: Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours
• Results posted on: 2019-03-26

Participant Flow

From October 9, 2009 to February 9, 2010 there were 11 patients enrolled at 2 investigative sites in the United States and 11 patients enrolled at 3 sites in Japan. All enrolled patients received a PROMUS Element study stent.

Participant milestones

Measure	PROMUS Element Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
Overall Study STARTED	22
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PLATINUM Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions-Pharmacokinetics (PLATINUM PK)

Baseline characteristics by cohort

Measure	PROMUS Element n=22 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
Cardiac History Previous Coronary Artery Bypass Graft (CABG)	2 Participants n=93 Participants
Cardiac History Previous Myocardial Infarction (MI)	4 Participants n=93 Participants
Cardiac History Stable Angina	15 Participants n=93 Participants
Cardiac History Unstable Angina	2 Participants n=93 Participants
Cardiac History Silent Ischemia	5 Participants n=93 Participants
Cardiac History History of Multivessel Disease	9 Participants n=93 Participants
Comorbidities History of Transient Ischemic Attack	2 Participants n=93 Participants
Cardiac History - Left Ventricular Ejection Fraction	59.64 Percent (of blood emptied) STANDARD_DEVIATION 10.09 • n=93 Participants
Height	165.57 Centimeters STANDARD_DEVIATION 12.55 • n=93 Participants
Weight	73.68 Kilograms STANDARD_DEVIATION 19.60 • n=93 Participants
Body Mass Index	26.52 kg/m^2 STANDARD_DEVIATION 4.79 • n=93 Participants
Cardiac Risk Factors Smoking, ever	14 Participants n=93 Participants
Cardiac Risk Factors Medically Treated Diabetes	5 Participants n=93 Participants
Cardiac Risk Factors Hyperlipidemia Requiring Medication	16 Participants n=93 Participants
Cardiac Risk Factors Hypertension Requiring Medication	18 Participants n=93 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=93 Participants
Age, Categorical >=65 years	9 Participants n=93 Participants
Age, Continuous	64.6 years STANDARD_DEVIATION 9.5 • n=93 Participants
Sex: Female, Male Female	4 Participants n=93 Participants
Sex: Female, Male Male	18 Participants n=93 Participants
Region of Enrollment United States	11 participants n=93 Participants
Region of Enrollment Japan	11 participants n=93 Participants
Cardiac History Previous Percutaneous Coronary Intervention (PCI)	9 Participants n=93 Participants
Comorbidities History of Cerebrovascular Accident	3 Participants n=93 Participants
Comorbidities History of Peripheral Vascular Disease	2 Participants n=93 Participants
Comorbidities History of Renal Disease	0 Participants n=93 Participants
Lesion Characteristic: Target Lesion Vessel Left Anterior Descending Artery	4 Lesions n=93 Participants
Lesion Characteristic: Target Lesion Vessel Left Circumflex Artery	7 Lesions n=93 Participants
Lesion Characteristic: Target Lesion Vessel Right Coronary Artery	13 Lesions n=93 Participants
Lesion Characteristic: Lesion Location Proximal	9 Participants n=93 Participants
Lesion Characteristic: Lesion Location Mid	13 Participants n=93 Participants
Lesion Characteristic: Lesion Location Distal	2 Participants n=93 Participants
Lesion Characteristics: Reference Vessel Diameter, Minimum Lumen Diameter, Length Reference Vessel Diameter	2.64 millimeters STANDARD_DEVIATION 0.46 • n=93 Participants
Lesion Characteristics: Reference Vessel Diameter, Minimum Lumen Diameter, Length Minimum Lumen Diameter	0.73 millimeters STANDARD_DEVIATION 0.38 • n=93 Participants
Lesion Characteristics: Reference Vessel Diameter, Minimum Lumen Diameter, Length Lesion Length	12.11 millimeters STANDARD_DEVIATION 4.69 • n=93 Participants
Lesion Characteristic-Percent Diameter Stenosis	73.15 Percent STANDARD_DEVIATION 11.24 • n=93 Participants
Lesion Characteristics Eccentric Lesion	13 Lesions n=93 Participants
Lesion Characteristics Bend >45 Degrees	13 Lesions n=93 Participants
Lesion Characteristics Bend >90 Degrees	2 Lesions n=93 Participants
Lesion Characteristics Tortuosity, any	1 Lesions n=93 Participants
Lesion Characteristics Calcification, any	4 Lesions n=93 Participants
Lesion Characteristics Bifurcation	1 Lesions n=93 Participants
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class A	1 Lesions n=93 Participants
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class B1	4 Lesions n=93 Participants
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class B2	15 Lesions n=93 Participants
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class C	4 Lesions n=93 Participants
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow TIMI 0	0 Lesions n=93 Participants
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow TIMI 1	0 Lesions n=93 Participants
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow TIMI 2	0 Lesions n=93 Participants
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow TIMI 3	24 Lesions n=93 Participants

PRIMARY outcome

Timeframe: Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours

Population: The analysis groups reported here had 3 or more subjects.

Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent

Outcome measures

Measure	Everolimus Dose of 95.4 µg n=4 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents	Everolimus Dose of 102.4 µg n=7 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.	Everolimus Dose of 138.6 µg n=3 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
Maximum Observed Everolimus Blood Concentration (Cmax)	0.71 ng/mL Standard Deviation 0.09	0.67 ng/mL Standard Deviation 0.15	0.91 ng/mL Standard Deviation 0.20

SECONDARY outcome

Timeframe: Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours

Population: The analysis groups reported here had 3 or more subjects.

Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent; t is the last time at which concentration can be quantified

Outcome measures

Measure	Everolimus Dose of 95.4 µg n=4 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents	Everolimus Dose of 102.4 µg n=7 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.	Everolimus Dose of 138.6 µg n=3 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
Area Under the Concentration Versus Time Curve (AUC 0-t) Everolimus	7.27 ng*hr/mL Standard Deviation 4.97	6.45 ng*hr/mL Standard Deviation 5.26	10.87 ng*hr/mL Standard Deviation 7.36

SECONDARY outcome

Timeframe: Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours

Population: The analysis groups reported here had 3 or more subjects.

Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent

Outcome measures

Measure	Everolimus Dose of 95.4 µg n=4 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents	Everolimus Dose of 102.4 µg n=7 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.	Everolimus Dose of 138.6 µg n=3 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
Area Under the Concentration Versus Time Curve (AUC 0-24), Everolimus	6.83 ng*hr/mL Standard Deviation 2.03	6.14 ng*hr/mL Standard Deviation 1.10	9.51 ng*hr/mL Standard Deviation 0.64

SECONDARY outcome

Timeframe: Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours

Population: Analysis groups have ≥3 subjects. Everolimus concentrations declined rapidly in all subjects; AUC0-∞ could be inaccurately determined for a subset of samples. AUC0-∞ determined by extrapolation of terminal phase. Concentrations not above detection limit in the terminal phase for enough time points for most subjects to accurately determine AUC0-∞.

Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after implantation of the last study stent.

Outcome measures

Measure	Everolimus Dose of 95.4 µg n=4 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents	Everolimus Dose of 102.4 µg n=7 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.	Everolimus Dose of 138.6 µg n=3 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
Area Under the Concentration Versus Time Curve (AUC 0-infinity) Everolimus	19.26 ng*hr/mL Standard Deviation 11.69	12.95 ng*hr/mL Standard Deviation 2.05	60.74 ng*hr/mL Standard Deviation 25.95

SECONDARY outcome

Timeframe: Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours

Population: Analysis groups reported here had 3 or more subjects.

Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent

Outcome measures

Measure	Everolimus Dose of 95.4 µg n=4 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents	Everolimus Dose of 102.4 µg n=7 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.	Everolimus Dose of 138.6 µg n=3 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
Time of Occurrence of Maximum Everolimus Concentration (Tmax)	0.47 hours Standard Deviation 0.03	0.62 hours Standard Deviation 0.23	0.52 hours Standard Deviation 0.09

SECONDARY outcome

Timeframe: Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours

Population: Analysis groups have ≥3 subjects. Everolimus concentrations declined rapidly in all subjects; half-life could be inaccurately determined for a subset of samples; determined by extrapolation of terminal phase. Concentrations not above detection limit in the terminal phase for enough time points for most subjects to accurately determine half-life.

Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent.

Outcome measures

Measure	Everolimus Dose of 95.4 µg n=4 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents	Everolimus Dose of 102.4 µg n=7 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.	Everolimus Dose of 138.6 µg n=3 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
Terminal Phase Half-life (t1/2) Everolimus	34.19 Hours Standard Deviation 20.81	22.83 Hours Standard Deviation 7.20	136.06 Hours Standard Deviation 62.08

SECONDARY outcome

Timeframe: Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours

Population: Analysis groups have ≥3 subjects. Everolimus concentrations declined rapidly in all subjects; CL could be inaccurately determined for a subset of samples; determined by extrapolation of terminal phase. Concentrations not above detection limit in the terminal phase for enough time points for most subjects to accurately determine CL value.

Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent.

Outcome measures

Measure	Everolimus Dose of 95.4 µg n=4 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents	Everolimus Dose of 102.4 µg n=7 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.	Everolimus Dose of 138.6 µg n=3 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
Total Blood Clearance - Everolimus (CL)	6445 L/h Standard Deviation 3924	8044 L/h Standard Deviation 1276	2511 L/h Standard Deviation 1073

SECONDARY outcome

Timeframe: 6 months

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

Number of participants no longer alive

Outcome measures

Measure	Everolimus Dose of 95.4 µg n=22 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents	Everolimus Dose of 102.4 µg Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.	Everolimus Dose of 138.6 µg Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
All Death	0.0 percentage of participants who died	—	—

SECONDARY outcome

Timeframe: 6 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 (CK) MB or troponin >normal; if no new Q-waves total CK levels >3× normal (peri-percutaneous coronary intervention [PCI]) or >2× normal (spontaneous) with elevated CK-MB or troponin >3× normal (peri-PCI) or >2× normal (spontaneous) plus at least 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, or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5× normal

Outcome measures

Measure	Everolimus Dose of 95.4 µg n=22 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents	Everolimus Dose of 102.4 µg Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.	Everolimus Dose of 138.6 µg Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
Myocardial Infarction (MI) Related to the Target Vessel	0.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: 6 months

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

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

Measure	Everolimus Dose of 95.4 µg n=22 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents	Everolimus Dose of 102.4 µg Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.	Everolimus Dose of 138.6 µg Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
Target Vessel Revascularization (TVR)	0.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: 6 months

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

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

Measure	Everolimus Dose of 95.4 µg n=22 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents	Everolimus Dose of 102.4 µg Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.	Everolimus Dose of 138.6 µg Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
Target Lesion Revascularization (TLR)	0.0 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

Measure	Everolimus Dose of 95.4 µg n=22 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents	Everolimus Dose of 102.4 µg Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.	Everolimus Dose of 138.6 µg Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition	0.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: >24 hours-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.

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

Measure	Everolimus Dose of 95.4 µg n=22 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents	Everolimus Dose of 102.4 µg Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.	Everolimus Dose of 138.6 µg Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
Definite + Probable Stent Thrombosis Rate 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.

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

Measure	Everolimus Dose of 95.4 µg n=22 Participants Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents	Everolimus Dose of 102.4 µg Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.	Everolimus Dose of 138.6 µg Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition	0.0 percentage of participants	—	—

Adverse Events

PROMUS Element

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	PROMUS Element n=22 participants at risk Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
Gastrointestinal disorders Gastritis erosive	4.5% 1/22 • Number of events 1 • 6 months
Injury, poisoning and procedural complications Vascular pseudoaneurysm	4.5% 1/22 • Number of events 1 • 6 months
Musculoskeletal and connective tissue disorders Synovial cyst	4.5% 1/22 • Number of events 1 • 6 months
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	4.5% 1/22 • Number of events 1 • 6 months
Vascular disorders Deep vein thrombosis	4.5% 1/22 • Number of events 1 • 6 months

Other adverse events

Measure	PROMUS Element n=22 participants at risk Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
General disorders Catheter site haematoma	18.2% 4/22 • Number of events 4 • 6 months
Musculoskeletal and connective tissue disorders Back pain	9.1% 2/22 • Number of events 2 • 6 months
General disorders Non-cardiac chest pain	9.1% 2/22 • Number of events 2 • 6 months
Cardiac disorders Angina pectoris	13.6% 3/22 • Number of events 3 • 6 months

Additional Information

Ruth Starzyk, PhD

Boston Scientific

Phone: 508-683-6577

Email: ruth.starzyk@bsci.com

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 45 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.
• Publication restrictions are in place

Restriction type: OTHER