Trial Outcomes & Findings for TAXUS PERSEUS Small Vessel (NCT NCT00489541)

Last Updated: 2014-05-08

Results Overview

Post-procedure minimum lumen diameter (mm) minus follow-up minimum lumen diameter as determined by quantitative angiography. Minimum lumen diameter is measured within the stent at each time point.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

224 participants

Primary outcome timeframe

9 months post-index procedure

Results posted on

2014-05-08

Participant Flow

Eligible subjects were enrolled at 28 United States centers between July 13, 2007 and August 27, 2008. All subjects were required to undergo angiographic assessment at 9 months. The historic control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522), including 108 with 9-month QCA follow-up.

Participant milestones

Participant milestones
Measure	TAXUS Element Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique	Historical Control Bare Metal Stent (BMS) The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
12-Month Clinical Follow-up STARTED	224	125
12-Month Clinical Follow-up COMPLETED	215	120
12-Month Clinical Follow-up NOT COMPLETED	9	5
9-Month Angiographic Follow-up STARTED	224	125
9-Month Angiographic Follow-up COMPLETED	197	108
9-Month Angiographic Follow-up NOT COMPLETED	27	17

Reasons for withdrawal

Reasons for withdrawal
Measure	TAXUS Element Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique	Historical Control Bare Metal Stent (BMS) The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
12-Month Clinical Follow-up Withdrawal by Subject	2	3
12-Month Clinical Follow-up Lost to Follow-up	2	0
12-Month Clinical Follow-up Missed 12-Month Visit	2	0
12-Month Clinical Follow-up Death	3	2
9-Month Angiographic Follow-up No 9-Month Angiography Performed	23	12
9-Month Angiographic Follow-up Not Evaluable for 9-Month Angiography	4	5

Baseline Characteristics

TAXUS PERSEUS Small Vessel

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TAXUS Element n=224 Participants Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique	Historical Control Bare Metal Stent (BMS) n=125 Participants The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).	Total n=349 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	100 Participants n=5 Participants	63 Participants n=7 Participants	163 Participants n=5 Participants
Age, Categorical >=65 years	124 Participants n=5 Participants	62 Participants n=7 Participants	186 Participants n=5 Participants
Age, Continuous	64.7 years STANDARD_DEVIATION 10.3 • n=5 Participants	64.2 years STANDARD_DEVIATION 10.9 • n=7 Participants	64.5 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	81 Participants n=5 Participants	49 Participants n=7 Participants	130 Participants n=5 Participants
Sex: Female, Male Male	143 Participants n=5 Participants	76 Participants n=7 Participants	219 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	11 participants n=5 Participants	3 participants n=7 Participants	14 participants n=5 Participants
Race/Ethnicity, Customized Caucasian	204 participants n=5 Participants	115 participants n=7 Participants	319 participants n=5 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Race/Ethnicity, Customized Black of African heritage	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska native	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Other	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment United States	224 participants n=5 Participants	125 participants n=7 Participants	349 participants n=5 Participants
Cardiac History Previous Percutaneous Coronary Intervention (PCI)	92 participants n=5 Participants	42 participants n=7 Participants	134 participants n=5 Participants
Cardiac History Previous Coronary Artery Bypass Graft (CABG)	41 participants n=5 Participants	24 participants n=7 Participants	65 participants n=5 Participants
Cardiac History Previous Myocardial Infarction (MI)	57 participants n=5 Participants	36 participants n=7 Participants	93 participants n=5 Participants
Cardiac History Congestive Heart Failure	18 participants n=5 Participants	3 participants n=7 Participants	21 participants n=5 Participants
Cardiac History Stable Angina	136 participants n=5 Participants	70 participants n=7 Participants	206 participants n=5 Participants
Cardiac History Unstable Angina	45 participants n=5 Participants	37 participants n=7 Participants	82 participants n=5 Participants
Cardiac History Silent Ischemia	43 participants n=5 Participants	18 participants n=7 Participants	61 participants n=5 Participants
Cardiac History: Ejection Fraction	57.9 ejection fraction percent STANDARD_DEVIATION 9.4 • n=5 Participants	55.0 ejection fraction percent STANDARD_DEVIATION 9.2 • n=7 Participants	56.8 ejection fraction percent STANDARD_DEVIATION 9.4 • n=5 Participants
Cardiac Risk Factors Smoking, Ever	137 participants n=5 Participants	69 participants n=7 Participants	206 participants n=5 Participants
Cardiac Risk Factors Medically Treated Diabetes	82 participants n=5 Participants	40 participants n=7 Participants	122 participants n=5 Participants
Cardiac Risk Factors Hyperlipidemia Requiring Medication	191 participants n=5 Participants	97 participants n=7 Participants	288 participants n=5 Participants
Cardiac Risk Factors Hypertension Requiring Medication	181 participants n=5 Participants	100 participants n=7 Participants	281 participants n=5 Participants
Cardiac Risk Factors Family History of Coronary Artery Disease	144 participants n=5 Participants	73 participants n=7 Participants	217 participants n=5 Participants
Comorbidities History of Peripheral Vascular Disease	24 participants n=5 Participants	14 participants n=7 Participants	38 participants n=5 Participants
Comorbidities Transient Ischemic Attack/Cerebrovascular Accident	21 participants n=5 Participants	5 participants n=7 Participants	26 participants n=5 Participants
Comorbidities History of Renal Disease	9 participants n=5 Participants	0 participants n=7 Participants	9 participants n=5 Participants
Comorbidities History of Gastrointestinal Bleeding	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants
Lesion Characteristic: Target Lesion Vessel Left Anterior Descending	85 participants n=5 Participants	53 participants n=7 Participants	138 participants n=5 Participants
Lesion Characteristic: Target Lesion Vessel Left Circumflex	93 participants n=5 Participants	45 participants n=7 Participants	138 participants n=5 Participants
Lesion Characteristic: Target Lesion Vessel Right Coronary Artery	46 participants n=5 Participants	27 participants n=7 Participants	73 participants n=5 Participants
Lesion Characteristic: Lesion Location Ostial	14 participants n=5 Participants	5 participants n=7 Participants	19 participants n=5 Participants
Lesion Characteristic: Lesion Location Proximal	91 participants n=5 Participants	42 participants n=7 Participants	133 participants n=5 Participants
Lesion Characteristic: Lesion Location Mid	100 participants n=5 Participants	56 participants n=7 Participants	156 participants n=5 Participants
Lesion Characteristic: Lesion Location Distal	19 participants n=5 Participants	22 participants n=7 Participants	41 participants n=5 Participants
Lesion Characteristics Reference Vessel Diameter	2.1 millimeters STANDARD_DEVIATION 0.3 • n=5 Participants	2.2 millimeters STANDARD_DEVIATION 0.4 • n=7 Participants	2.1 millimeters STANDARD_DEVIATION 0.3 • n=5 Participants
Lesion Characteristics Minimum Lumen Diameter	0.6 millimeters STANDARD_DEVIATION 0.2 • n=5 Participants	0.6 millimeters STANDARD_DEVIATION 0.2 • n=7 Participants	0.6 millimeters STANDARD_DEVIATION 0.2 • n=5 Participants
Lesion Characteristics Lesion Length	11.7 millimeters STANDARD_DEVIATION 5.1 • n=5 Participants	12.9 millimeters STANDARD_DEVIATION 5.1 • n=7 Participants	12.1 millimeters STANDARD_DEVIATION 5.1 • n=5 Participants
Lesion Characteristics Sidebranch Stenosis	18.1 millimeters STANDARD_DEVIATION 24.6 • n=5 Participants	16.0 millimeters STANDARD_DEVIATION 21.2 • n=7 Participants	17.4 millimeters STANDARD_DEVIATION 23.4 • n=5 Participants
Percent Diameter Stenosis	73.5 percent STANDARD_DEVIATION 10.2 • n=5 Participants	71.5 percent STANDARD_DEVIATION 10.4 • n=7 Participants	72.8 percent STANDARD_DEVIATION 10.3 • n=5 Participants
Lesion Characteristics Eccentric Lesion	149 participants n=5 Participants	78 participants n=7 Participants	227 participants n=5 Participants
Lesion Characteristics Tortuosity, any	20 participants n=5 Participants	23 participants n=7 Participants	43 participants n=5 Participants
Lesion Characteristics Calcification, any	30 participants n=5 Participants	26 participants n=7 Participants	56 participants n=5 Participants
Lesion Characteristics Total Occlusion	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
Lesion Characteristics Bifurcation	53 participants n=5 Participants	27 participants n=7 Participants	80 participants n=5 Participants
Lesion Characteristics > 45 Degree Bend	14 participants n=5 Participants	15 participants n=7 Participants	29 participants n=5 Participants
Lesion Characteristics > 90 Degree Bend	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Type A	21 participants n=5 Participants	7 participants n=7 Participants	28 participants n=5 Participants
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Type B1	73 participants n=5 Participants	21 participants n=7 Participants	94 participants n=5 Participants
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Type B2	99 participants n=5 Participants	73 participants n=7 Participants	172 participants n=5 Participants
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Type C	31 participants n=5 Participants	24 participants n=7 Participants	55 participants n=5 Participants
Lesion Characteristic: Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow TIMI 0	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Lesion Characteristic: Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow TIMI 1	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Lesion Characteristic: Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow TIMI 2	1 participants n=5 Participants	7 participants n=7 Participants	8 participants n=5 Participants
Lesion Characteristic: Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow TIMI 3	220 participants n=5 Participants	117 participants n=7 Participants	337 participants n=5 Participants

PRIMARY outcome

Timeframe: 9 months post-index procedure

Population: The primary analysis population for the superiority testing of the primary endpoint, 9-month in-stent late loss, is the intent-to-treat (ITT) population, i.e. all patients who had a study device implanted at the target lesion and completed their angiographic follow-up.

Post-procedure minimum lumen diameter (mm) minus follow-up minimum lumen diameter as determined by quantitative angiography. Minimum lumen diameter is measured within the stent at each time point.

Outcome measures

Outcome measures
Measure	TAXUS Element n=197 Participants Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique	Historical Control Bare Metal Stent (BMS) n=108 Participants The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
In-stent Late Loss Measured by Quantitative Coronary Angiography (QCA)	0.38 millimeter Standard Deviation 0.51	0.80 millimeter Standard Deviation 0.53

SECONDARY outcome

Timeframe: 12 months post-index procedure

Population: Intent-to-Treat. All enrolled patients are included in the analysis.

The number of participants who experience a TLF through 365 days post-procedure out of the patients who have either had a TLF within 365 days post-procedure or who were TLF-free with last follow-up at least 335 days post-procedure.

Outcome measures

Outcome measures
Measure	TAXUS Element n=218 Participants Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique	Historical Control Bare Metal Stent (BMS) n=121 Participants The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
Number of Participants With Target Lesion Failure (TLF) at 12 Months Post-index Procedure. TLF is Defined as Any Ischemia-driven Revascularization of the Target Lesion, Myocardial Infarction (Q-wave and Non-Q-wave), or Death Related to the Target Vessel.	16 participants	27 participants

Adverse Events

TAXUS Element

Serious events: 100 serious events

Other events: 75 other events

Deaths: 0 deaths

Historical Control Bare Metal Stent (BMS)

Serious events: 70 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	TAXUS Element n=224 participants at risk Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique	Historical Control Bare Metal Stent (BMS) n=125 participants at risk The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
Cardiac disorders Angina pectoris	14.3% 32/224 • Number of events 38 • Serious adverse events are reported through 365 days. Non-serious adverse events exceeding 5% threshold are reported through 270 days. Per the study protocol, non-serious adverse events are reported through the 9-month follow-up assessment (primary endpoint). Past the 9-month assessment, reporting of events was limited to major adverse cardiac events and serious adverse events only.	18.4% 23/125 • Number of events 24 • Serious adverse events are reported through 365 days. Non-serious adverse events exceeding 5% threshold are reported through 270 days. Per the study protocol, non-serious adverse events are reported through the 9-month follow-up assessment (primary endpoint). Past the 9-month assessment, reporting of events was limited to major adverse cardiac events and serious adverse events only.
Gastrointestinal disorders Nausea	5.4% 12/224 • Number of events 12 • Serious adverse events are reported through 365 days. Non-serious adverse events exceeding 5% threshold are reported through 270 days. Per the study protocol, non-serious adverse events are reported through the 9-month follow-up assessment (primary endpoint). Past the 9-month assessment, reporting of events was limited to major adverse cardiac events and serious adverse events only.	5.6% 7/125 • Number of events 8 • Serious adverse events are reported through 365 days. Non-serious adverse events exceeding 5% threshold are reported through 270 days. Per the study protocol, non-serious adverse events are reported through the 9-month follow-up assessment (primary endpoint). Past the 9-month assessment, reporting of events was limited to major adverse cardiac events and serious adverse events only.
General disorders Non-cardiac chest pain	10.7% 24/224 • Number of events 25 • Serious adverse events are reported through 365 days. Non-serious adverse events exceeding 5% threshold are reported through 270 days. Per the study protocol, non-serious adverse events are reported through the 9-month follow-up assessment (primary endpoint). Past the 9-month assessment, reporting of events was limited to major adverse cardiac events and serious adverse events only.	0.00% 0/125 • Serious adverse events are reported through 365 days. Non-serious adverse events exceeding 5% threshold are reported through 270 days. Per the study protocol, non-serious adverse events are reported through the 9-month follow-up assessment (primary endpoint). Past the 9-month assessment, reporting of events was limited to major adverse cardiac events and serious adverse events only.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.8% 13/224 • Number of events 13 • Serious adverse events are reported through 365 days. Non-serious adverse events exceeding 5% threshold are reported through 270 days. Per the study protocol, non-serious adverse events are reported through the 9-month follow-up assessment (primary endpoint). Past the 9-month assessment, reporting of events was limited to major adverse cardiac events and serious adverse events only.	0.00% 0/125 • Serious adverse events are reported through 365 days. Non-serious adverse events exceeding 5% threshold are reported through 270 days. Per the study protocol, non-serious adverse events are reported through the 9-month follow-up assessment (primary endpoint). Past the 9-month assessment, reporting of events was limited to major adverse cardiac events and serious adverse events only.
General disorders Catheter site haematoma	2.2% 5/224 • Number of events 5 • Serious adverse events are reported through 365 days. Non-serious adverse events exceeding 5% threshold are reported through 270 days. Per the study protocol, non-serious adverse events are reported through the 9-month follow-up assessment (primary endpoint). Past the 9-month assessment, reporting of events was limited to major adverse cardiac events and serious adverse events only.	6.4% 8/125 • Number of events 8 • Serious adverse events are reported through 365 days. Non-serious adverse events exceeding 5% threshold are reported through 270 days. Per the study protocol, non-serious adverse events are reported through the 9-month follow-up assessment (primary endpoint). Past the 9-month assessment, reporting of events was limited to major adverse cardiac events and serious adverse events only.
General disorders Chest pain	0.89% 2/224 • Number of events 2 • Serious adverse events are reported through 365 days. Non-serious adverse events exceeding 5% threshold are reported through 270 days. Per the study protocol, non-serious adverse events are reported through the 9-month follow-up assessment (primary endpoint). Past the 9-month assessment, reporting of events was limited to major adverse cardiac events and serious adverse events only.	6.4% 8/125 • Number of events 10 • Serious adverse events are reported through 365 days. Non-serious adverse events exceeding 5% threshold are reported through 270 days. Per the study protocol, non-serious adverse events are reported through the 9-month follow-up assessment (primary endpoint). Past the 9-month assessment, reporting of events was limited to major adverse cardiac events and serious adverse events only.
General disorders Fatigue	4.0% 9/224 • Number of events 10 • Serious adverse events are reported through 365 days. Non-serious adverse events exceeding 5% threshold are reported through 270 days. Per the study protocol, non-serious adverse events are reported through the 9-month follow-up assessment (primary endpoint). Past the 9-month assessment, reporting of events was limited to major adverse cardiac events and serious adverse events only.	6.4% 8/125 • Number of events 8 • Serious adverse events are reported through 365 days. Non-serious adverse events exceeding 5% threshold are reported through 270 days. Per the study protocol, non-serious adverse events are reported through the 9-month follow-up assessment (primary endpoint). Past the 9-month assessment, reporting of events was limited to major adverse cardiac events and serious adverse events only.

Additional Information

Andrey Nersesov, Clinical Project Manager

Boston Scientific

Phone: 508-683-4988

Email: [email protected]

Results disclosure agreements

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