Trial Outcomes & Findings for Prospective, Randomized, Multicenter Trial to Assess PROMUS™ Element™ Stent (NCT NCT01285999)
NCT ID: NCT01285999
Last Updated: 2025-03-11
Results Overview
The primary endpoint is in-stent late loss measured by quantitative coronary angiography (QCA) at 9 months post-index procedure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
500 participants
Primary outcome timeframe
9 Months
Results posted on
2025-03-11
Participant Flow
Participant milestones
| Measure |
PROMUS Element
PROMUS Element Everolimus-Eluting Coronary Stent System (PROMUS Element)
PROMUS Element Coronary Stent System: Everolimus-eluting Coronary Stent Drug-Eluting Stent (DES) implantation
|
TAXUS Liberté DES
TAXUS Liberté Paclitaxel-Eluting Coronary Stent System (TAXUS Liberté)
TAXUS Liberté Coronary Stent System: Paclitaxel-eluting Coronary Stent Drug Eluting Stent (DES) implantation
|
|---|---|---|
|
Overall Study
STARTED
|
373
|
127
|
|
Overall Study
COMPLETED
|
373
|
127
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prospective, Randomized, Multicenter Trial to Assess PROMUS™ Element™ Stent
Baseline characteristics by cohort
| Measure |
PROMUS Element
n=373 Participants
PROMUS Element Everolimus-Eluting Coronary Stent System (PROMUS Element)
PROMUS Element Coronary Stent System: Everolimus-eluting Coronary Stent DES implantation
|
TAXUS Liberté DES
n=127 Participants
TAXUS Liberté Paclitaxel-Eluting Coronary Stent System (TAXUS Liberté)
TAXUS Liberté Coronary Stent System: Paclitaxel-eluting Coronary Stent DES implantation
|
Total
n=500 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.12 years
STANDARD_DEVIATION 9.90 • n=5 Participants
|
57.55 years
STANDARD_DEVIATION 9.50 • n=7 Participants
|
57.23 years
STANDARD_DEVIATION 9.70 • n=5 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
268 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
356 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
373 participants
n=5 Participants
|
127 participants
n=7 Participants
|
500 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 MonthsThe primary endpoint is in-stent late loss measured by quantitative coronary angiography (QCA) at 9 months post-index procedure.
Outcome measures
| Measure |
PROMUS Element
n=373 Participants
PROMUS Element Everolimus-Eluting Coronary Stent System (PROMUS Element)
PROMUS Element Coronary Stent System: Everolimus-eluting Coronary Stent DES implantation
|
TAXUS Liberté DES
n=127 Participants
TAXUS Liberté Paclitaxel-Eluting Coronary Stent System (TAXUS Liberté)
TAXUS Liberté Coronary Stent System: Paclitaxel-eluting Coronary Stent DES implantation
|
|---|---|---|
|
9 Month In-stent Late Loss
|
0.11 percentage of Intent-to-treat patients
|
0.40 percentage of Intent-to-treat patients
|
SECONDARY outcome
Timeframe: In hospital and at 2 yearsPopulation: Per Protocol Population
Outcome measures
| Measure |
PROMUS Element
n=373 Participants
PROMUS Element Everolimus-Eluting Coronary Stent System (PROMUS Element)
PROMUS Element Coronary Stent System: Everolimus-eluting Coronary Stent DES implantation
|
TAXUS Liberté DES
n=127 Participants
TAXUS Liberté Paclitaxel-Eluting Coronary Stent System (TAXUS Liberté)
TAXUS Liberté Coronary Stent System: Paclitaxel-eluting Coronary Stent DES implantation
|
|---|---|---|
|
Target Vessel Failure (TVF) Rate
|
3.0 percentage of participant
|
5.5 percentage of participant
|
SECONDARY outcome
Timeframe: In hospital and at 2 yearsOutcome measures
| Measure |
PROMUS Element
n=373 Participants
PROMUS Element Everolimus-Eluting Coronary Stent System (PROMUS Element)
PROMUS Element Coronary Stent System: Everolimus-eluting Coronary Stent DES implantation
|
TAXUS Liberté DES
n=127 Participants
TAXUS Liberté Paclitaxel-Eluting Coronary Stent System (TAXUS Liberté)
TAXUS Liberté Coronary Stent System: Paclitaxel-eluting Coronary Stent DES implantation
|
|---|---|---|
|
Target Lesion Revascularization (TLR) Rate
|
2.4 percentage of participants
|
4.7 percentage of participants
|
SECONDARY outcome
Timeframe: In hospital and at 2 yearsOutcome measures
| Measure |
PROMUS Element
n=373 Participants
PROMUS Element Everolimus-Eluting Coronary Stent System (PROMUS Element)
PROMUS Element Coronary Stent System: Everolimus-eluting Coronary Stent DES implantation
|
TAXUS Liberté DES
n=127 Participants
TAXUS Liberté Paclitaxel-Eluting Coronary Stent System (TAXUS Liberté)
TAXUS Liberté Coronary Stent System: Paclitaxel-eluting Coronary Stent DES implantation
|
|---|---|---|
|
Target Vessel Revascularization (TVR) Rate
|
3.0 percentage of participants
|
5.5 percentage of participants
|
SECONDARY outcome
Timeframe: In hospital and at 2 yearsOutcome measures
| Measure |
PROMUS Element
n=373 Participants
PROMUS Element Everolimus-Eluting Coronary Stent System (PROMUS Element)
PROMUS Element Coronary Stent System: Everolimus-eluting Coronary Stent DES implantation
|
TAXUS Liberté DES
n=127 Participants
TAXUS Liberté Paclitaxel-Eluting Coronary Stent System (TAXUS Liberté)
TAXUS Liberté Coronary Stent System: Paclitaxel-eluting Coronary Stent DES implantation
|
|---|---|---|
|
Target Lesion Failure (TLF) Rate
|
2.4 percentage of participants
|
4.7 percentage of participants
|
SECONDARY outcome
Timeframe: In hospital and at 2 yearsOutcome measures
| Measure |
PROMUS Element
n=373 Participants
PROMUS Element Everolimus-Eluting Coronary Stent System (PROMUS Element)
PROMUS Element Coronary Stent System: Everolimus-eluting Coronary Stent DES implantation
|
TAXUS Liberté DES
n=127 Participants
TAXUS Liberté Paclitaxel-Eluting Coronary Stent System (TAXUS Liberté)
TAXUS Liberté Coronary Stent System: Paclitaxel-eluting Coronary Stent DES implantation
|
|---|---|---|
|
Major Adverse Cardiac Event (MACE) Rate
|
3.0 percentage of participants
|
7.1 percentage of participants
|
SECONDARY outcome
Timeframe: In hospital and at 2 yearsOutcome measures
| Measure |
PROMUS Element
n=373 Participants
PROMUS Element Everolimus-Eluting Coronary Stent System (PROMUS Element)
PROMUS Element Coronary Stent System: Everolimus-eluting Coronary Stent DES implantation
|
TAXUS Liberté DES
n=127 Participants
TAXUS Liberté Paclitaxel-Eluting Coronary Stent System (TAXUS Liberté)
TAXUS Liberté Coronary Stent System: Paclitaxel-eluting Coronary Stent DES implantation
|
|---|---|---|
|
Myocardial Infarction (MI)(Q-wave and Non-Q-wave) Rate
|
0.3 percentage of participants
|
1.6 percentage of participants
|
SECONDARY outcome
Timeframe: In hospital and at 2 yearsOutcome measures
| Measure |
PROMUS Element
n=373 Participants
PROMUS Element Everolimus-Eluting Coronary Stent System (PROMUS Element)
PROMUS Element Coronary Stent System: Everolimus-eluting Coronary Stent DES implantation
|
TAXUS Liberté DES
n=127 Participants
TAXUS Liberté Paclitaxel-Eluting Coronary Stent System (TAXUS Liberté)
TAXUS Liberté Coronary Stent System: Paclitaxel-eluting Coronary Stent DES implantation
|
|---|---|---|
|
Cardiac Death Rate
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: In hospital and at 2 yearsOutcome measures
| Measure |
PROMUS Element
n=373 Participants
PROMUS Element Everolimus-Eluting Coronary Stent System (PROMUS Element)
PROMUS Element Coronary Stent System: Everolimus-eluting Coronary Stent DES implantation
|
TAXUS Liberté DES
n=127 Participants
TAXUS Liberté Paclitaxel-Eluting Coronary Stent System (TAXUS Liberté)
TAXUS Liberté Coronary Stent System: Paclitaxel-eluting Coronary Stent DES implantation
|
|---|---|---|
|
Non-cardiac Death Rate
|
0.0 percentage of participants
|
1.6 percentage of participants
|
SECONDARY outcome
Timeframe: In hospital and at 2 yearsOutcome measures
| Measure |
PROMUS Element
n=373 Participants
PROMUS Element Everolimus-Eluting Coronary Stent System (PROMUS Element)
PROMUS Element Coronary Stent System: Everolimus-eluting Coronary Stent DES implantation
|
TAXUS Liberté DES
n=127 Participants
TAXUS Liberté Paclitaxel-Eluting Coronary Stent System (TAXUS Liberté)
TAXUS Liberté Coronary Stent System: Paclitaxel-eluting Coronary Stent DES implantation
|
|---|---|---|
|
All Death Rate
|
0.0 percentage of participants
|
1.6 percentage of participants
|
SECONDARY outcome
Timeframe: In hospital and at 2 yearsOutcome measures
| Measure |
PROMUS Element
n=373 Participants
PROMUS Element Everolimus-Eluting Coronary Stent System (PROMUS Element)
PROMUS Element Coronary Stent System: Everolimus-eluting Coronary Stent DES implantation
|
TAXUS Liberté DES
n=127 Participants
TAXUS Liberté Paclitaxel-Eluting Coronary Stent System (TAXUS Liberté)
TAXUS Liberté Coronary Stent System: Paclitaxel-eluting Coronary Stent DES implantation
|
|---|---|---|
|
Cardiac Death or MI Rate
|
0.3 percentage of participants
|
3.1 percentage of participants
|
SECONDARY outcome
Timeframe: In hospital and at 2 yearsOutcome measures
| Measure |
PROMUS Element
n=373 Participants
PROMUS Element Everolimus-Eluting Coronary Stent System (PROMUS Element)
PROMUS Element Coronary Stent System: Everolimus-eluting Coronary Stent DES implantation
|
TAXUS Liberté DES
n=127 Participants
TAXUS Liberté Paclitaxel-Eluting Coronary Stent System (TAXUS Liberté)
TAXUS Liberté Coronary Stent System: Paclitaxel-eluting Coronary Stent DES implantation
|
|---|---|---|
|
Stent Thrombosis Rate (Definite or Probable by Academic Research Consortium [ARC] Definitions)
|
0.3 percentage of participants
|
0.8 percentage of participants
|
SECONDARY outcome
Timeframe: 9 monthsOutcome measures
| Measure |
PROMUS Element
n=373 Participants
PROMUS Element Everolimus-Eluting Coronary Stent System (PROMUS Element)
PROMUS Element Coronary Stent System: Everolimus-eluting Coronary Stent DES implantation
|
TAXUS Liberté DES
n=127 Participants
TAXUS Liberté Paclitaxel-Eluting Coronary Stent System (TAXUS Liberté)
TAXUS Liberté Coronary Stent System: Paclitaxel-eluting Coronary Stent DES implantation
|
|---|---|---|
|
Angiographic Endpoints: In-stent and In-segment Percent Diameter Stenosis (%DS), In-segment Late Loss , In-stent and In-segment Minimum Lumen Diameter (MLD)
In-stent percent diameter stenosis
|
11.06 percentage
Standard Deviation 13.86
|
22.20 percentage
Standard Deviation 16.00
|
|
Angiographic Endpoints: In-stent and In-segment Percent Diameter Stenosis (%DS), In-segment Late Loss , In-stent and In-segment Minimum Lumen Diameter (MLD)
in-segment percent diameter stenosis
|
21.51 percentage
Standard Deviation 12.17
|
28.42 percentage
Standard Deviation 14.92
|
|
Angiographic Endpoints: In-stent and In-segment Percent Diameter Stenosis (%DS), In-segment Late Loss , In-stent and In-segment Minimum Lumen Diameter (MLD)
In-segment late loss
|
0.06 percentage
Standard Deviation 0.36
|
0.27 percentage
Standard Deviation 0.45
|
|
Angiographic Endpoints: In-stent and In-segment Percent Diameter Stenosis (%DS), In-segment Late Loss , In-stent and In-segment Minimum Lumen Diameter (MLD)
In-stent minimum lumen diameter
|
2.52 percentage
Standard Deviation 0.53
|
2.24 percentage
Standard Deviation 0.57
|
|
Angiographic Endpoints: In-stent and In-segment Percent Diameter Stenosis (%DS), In-segment Late Loss , In-stent and In-segment Minimum Lumen Diameter (MLD)
in-segment minimum lumen diameter
|
2.24 percentage
Standard Deviation 0.52
|
2.07 percentage
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: In hospitalOutcome measures
| Measure |
PROMUS Element
n=373 Participants
PROMUS Element Everolimus-Eluting Coronary Stent System (PROMUS Element)
PROMUS Element Coronary Stent System: Everolimus-eluting Coronary Stent DES implantation
|
TAXUS Liberté DES
n=127 Participants
TAXUS Liberté Paclitaxel-Eluting Coronary Stent System (TAXUS Liberté)
TAXUS Liberté Coronary Stent System: Paclitaxel-eluting Coronary Stent DES implantation
|
|---|---|---|
|
Periprocedural Endpoints: Technical Success Rate, Clinical Procedural Success Rate
Technical success rate
|
99.5 percentage of participants
|
99.2 percentage of participants
|
|
Periprocedural Endpoints: Technical Success Rate, Clinical Procedural Success Rate
Clinical procedural success rate
|
100.00 percentage of participants
|
100.00 percentage of participants
|
SECONDARY outcome
Timeframe: 9 monthOutcome measures
| Measure |
PROMUS Element
n=373 Participants
PROMUS Element Everolimus-Eluting Coronary Stent System (PROMUS Element)
PROMUS Element Coronary Stent System: Everolimus-eluting Coronary Stent DES implantation
|
TAXUS Liberté DES
n=127 Participants
TAXUS Liberté Paclitaxel-Eluting Coronary Stent System (TAXUS Liberté)
TAXUS Liberté Coronary Stent System: Paclitaxel-eluting Coronary Stent DES implantation
|
|---|---|---|
|
Angiographic Endpoints: In-stent and In-segment Binary Restenosis Rate, Stent Fracture Rate
In-stent binary restenosis rate
|
2.1 percentage of participants
|
5.2 percentage of participants
|
|
Angiographic Endpoints: In-stent and In-segment Binary Restenosis Rate, Stent Fracture Rate
in-segment binary restenosis rate
|
3.0 percentage of participants
|
7.8 percentage of participants
|
|
Angiographic Endpoints: In-stent and In-segment Binary Restenosis Rate, Stent Fracture Rate
Stent fracture rate
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: In hospitalOutcome measures
| Measure |
PROMUS Element
n=373 Participants
PROMUS Element Everolimus-Eluting Coronary Stent System (PROMUS Element)
PROMUS Element Coronary Stent System: Everolimus-eluting Coronary Stent DES implantation
|
TAXUS Liberté DES
n=127 Participants
TAXUS Liberté Paclitaxel-Eluting Coronary Stent System (TAXUS Liberté)
TAXUS Liberté Coronary Stent System: Paclitaxel-eluting Coronary Stent DES implantation
|
|---|---|---|
|
Minimal Lumen Diameter (QCA), Acute Gain (QCA)
In-Stent MLD
|
2.64 mm
|
2.65 mm
|
|
Minimal Lumen Diameter (QCA), Acute Gain (QCA)
Proximal Edge MLD
|
2.84 mm
|
2.94 mm
|
|
Minimal Lumen Diameter (QCA), Acute Gain (QCA)
Distal Edge MLD
|
2.44 mm
|
2.43 mm
|
|
Minimal Lumen Diameter (QCA), Acute Gain (QCA)
In-Stent Acute gain (QCA)
|
1.73 mm
|
1.77 mm
|
|
Minimal Lumen Diameter (QCA), Acute Gain (QCA)
In Segment Acute gain (QCA)
|
1.41 mm
|
1.46 mm
|
Adverse Events
PROMUS Element
Serious events: 57 serious events
Other events: 86 other events
Deaths: 0 deaths
TAXUS Liberté DES
Serious events: 23 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PROMUS Element
n=373 participants at risk
PROMUS Element Everolimus-Eluting Coronary Stent System (PROMUS Element)
PROMUS Element Coronary Stent System: Everolimus-eluting Coronary Stent DES implantation
|
TAXUS Liberté DES
n=127 participants at risk
TAXUS Liberté Paclitaxel-Eluting Coronary Stent System (TAXUS Liberté)
TAXUS Liberté Coronary Stent System: Paclitaxel-eluting Coronary Stent DES implantation
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
2.4%
9/373 • Number of events 11 • 2 years
|
3.9%
5/127 • Number of events 7 • 2 years
|
|
Cardiac disorders
Angina unstable
|
2.7%
10/373 • Number of events 10 • 2 years
|
1.6%
2/127 • Number of events 2 • 2 years
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Cardiac disorders
Cardiac failure
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Cardiac disorders
Cor pulmonale
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Cardiac disorders
Coronary artery disease
|
0.80%
3/373 • Number of events 3 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Cardiac disorders
Coronary artery occlusion
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Cardiac disorders
Coronary artery stenosis
|
2.1%
8/373 • Number of events 9 • 2 years
|
3.9%
5/127 • Number of events 5 • 2 years
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.00%
0/373 • 2 years
|
1.6%
2/127 • Number of events 2 • 2 years
|
|
Cardiac disorders
Myocardial infarction
|
0.27%
1/373 • Number of events 1 • 2 years
|
2.4%
3/127 • Number of events 3 • 2 years
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Cardiac disorders
Ventricular tachycardia
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Eye disorders
Cataract
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.27%
1/373 • Number of events 2 • 2 years
|
0.00%
0/127 • 2 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/373 • 2 years
|
1.6%
2/127 • Number of events 2 • 2 years
|
|
General disorders
Asthenia
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
General disorders
Chest discomfort
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
General disorders
Chest pain
|
0.54%
2/373 • Number of events 2 • 2 years
|
0.00%
0/127 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
2.1%
8/373 • Number of events 8 • 2 years
|
0.79%
1/127 • Number of events 2 • 2 years
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Infections and infestations
Genital infection fungal
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Infections and infestations
Lung infection
|
0.54%
2/373 • Number of events 2 • 2 years
|
0.00%
0/127 • 2 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Infections and infestations
Tuberculous pleurisy
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Nervous system disorders
Cerebral infarction
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Nervous system disorders
Diabetic neuropathy
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Nervous system disorders
Dizziness
|
0.54%
2/373 • Number of events 2 • 2 years
|
0.00%
0/127 • 2 years
|
|
Nervous system disorders
Headache
|
0.54%
2/373 • Number of events 2 • 2 years
|
0.00%
0/127 • 2 years
|
|
Renal and urinary disorders
Renal disorder
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Vascular disorders
Femoral artery aneurysm
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
Other adverse events
| Measure |
PROMUS Element
n=373 participants at risk
PROMUS Element Everolimus-Eluting Coronary Stent System (PROMUS Element)
PROMUS Element Coronary Stent System: Everolimus-eluting Coronary Stent DES implantation
|
TAXUS Liberté DES
n=127 participants at risk
TAXUS Liberté Paclitaxel-Eluting Coronary Stent System (TAXUS Liberté)
TAXUS Liberté Coronary Stent System: Paclitaxel-eluting Coronary Stent DES implantation
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Cardiac disorders
Angina unstable
|
0.54%
2/373 • Number of events 2 • 2 years
|
1.6%
2/127 • Number of events 2 • 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/373 • 2 years
|
1.6%
2/127 • Number of events 3 • 2 years
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Cardiac disorders
Coronary artery disease
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Cardiac disorders
Coronary artery dissection
|
1.1%
4/373 • Number of events 5 • 2 years
|
1.6%
2/127 • Number of events 2 • 2 years
|
|
Cardiac disorders
Coronary artery stenosis
|
0.54%
2/373 • Number of events 2 • 2 years
|
3.1%
4/127 • Number of events 4 • 2 years
|
|
Cardiac disorders
Myocardial infarction
|
5.4%
20/373 • Number of events 20 • 2 years
|
7.1%
9/127 • Number of events 9 • 2 years
|
|
Cardiac disorders
Palpitations
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Endocrine disorders
Goitre
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Eye disorders
Conjunctival haemorrhage
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Eye disorders
Diplopia
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Gastrointestinal disorders
Gingivitis
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Gastrointestinal disorders
Haematochezia
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Toothache
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
General disorders
Adverse drug reaction
|
2.9%
11/373 • Number of events 11 • 2 years
|
2.4%
3/127 • Number of events 3 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
1.9%
7/373 • Number of events 7 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
General disorders
Pyrexia
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Immune system disorders
Contrast media allergy
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/373 • 2 years
|
1.6%
2/127 • Number of events 2 • 2 years
|
|
Infections and infestations
Bronchitis
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Infections and infestations
Genital infection fungal
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Infections and infestations
Influenza
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Infections and infestations
Pharyngitis
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Infections and infestations
Upper respiratory tract infection
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Investigations
Blood creatine phosphokinase MB increased
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Investigations
Blood creatine phosphokinase increased
|
0.54%
2/373 • Number of events 2 • 2 years
|
0.00%
0/127 • 2 years
|
|
Investigations
Troponin I increased
|
1.3%
5/373 • Number of events 5 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.54%
2/373 • Number of events 2 • 2 years
|
0.00%
0/127 • 2 years
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.80%
3/373 • Number of events 3 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.54%
2/373 • Number of events 2 • 2 years
|
0.00%
0/127 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
4/373 • Number of events 4 • 2 years
|
0.00%
0/127 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.27%
1/373 • Number of events 2 • 2 years
|
0.00%
0/127 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.27%
1/373 • Number of events 2 • 2 years
|
0.00%
0/127 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Nervous system disorders
Aphasia
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Nervous system disorders
Dizziness
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Nervous system disorders
Headache
|
0.80%
3/373 • Number of events 3 • 2 years
|
0.00%
0/127 • 2 years
|
|
Renal and urinary disorders
Haematuria
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.54%
2/373 • Number of events 2 • 2 years
|
0.00%
0/127 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.1%
4/373 • Number of events 4 • 2 years
|
0.00%
0/127 • 2 years
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.27%
1/373 • Number of events 1 • 2 years
|
0.00%
0/127 • 2 years
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/373 • 2 years
|
0.79%
1/127 • Number of events 1 • 2 years
|
Additional Information
Dr. Runlin Gao
Cardiovascular Institute and Fu Wai Hospital
Phone: +861068314466
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place