TAXUS PERSEUS Workhorse - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment
Condition:	Coronary Artery Disease
Interventions:	Device: Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation Device: Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Express) placement

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment of 1264 subjects was planned; 1262 (942 TAXUS Element and 320 TAXUS Express) were enrolled and randomized at 90 centers by October 1, 2008. A total of 330 subjects were randomly assigned to protocol-mandated 9-month angiographic follow-up (angiographic subset).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
TAXUS Element	Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)
TAXUS Express	Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)

Participant Flow for 2 periods

Period 1: 12-Month Clinical Follow-up

	TAXUS Element	TAXUS Express
STARTED	942	320
COMPLETED	914	311
NOT COMPLETED	28	9
Death	6	2
Withdrawal by Subject	4	0
Lost to Follow-up	2	1
Missed 12-Month Visit	13	4
Withdrawn at Investigator's discretion	3	2

Period 2: 9-Month Angiographic Follow-up

	TAXUS Element	TAXUS Express
STARTED	256	74
COMPLETED	228	61
NOT COMPLETED	28	13
No 9-Month Angiography Performed	25	11
Not Evaluable for Angiography Analysis	3	2

Baseline Characteristics

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Reporting Groups

	Description
TAXUS Element	Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)
TAXUS Express	Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)

Baseline Measures

	TAXUS Element	TAXUS Express	Total
Number of Participants [units: participants]	942	320	1262
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	540	163	703
>=65 years	402	157	559
Age [units: years] Mean ± Standard Deviation	62.2 ± 9.6	63.5 ± 9.5	62.5 ± 9.6
Gender [units: participants]
Female	275	100	375
Male	667	220	887
Race/Ethnicity, Customized ^[1] [units: participants]
Hispanic or Latino	10	6	16
Caucasian	872	296	1168
Asian	15	6	21
Black of African heritage	37	13	50
Native Hawaiian or other Pacific Islander	4	1	5
American Indian or Alaska native	3	0	3
Other	4	0	4
Region of Enrollment [units: participants]
United States	859	290	1149
Singapore	6	2	8
Australia	60	22	82
New Zealand	17	6	23
Cardiac History ^[1] [units: participants]
Previous Percutaneous Coronary Intervention (PCI)	216	80	296
Previous Coronary Artery Bypass Graft (CABG)	42	20	62
Previous Myocardial Infarction (MI)	195	60	255
Congestive Heart Failure	56	24	80
Stable Angina	629	213	842
Unstable Angina	195	68	263
Silent Ischemia	117	39	156
Cardiac History: Ejection Fraction [units: ejection fraction percent] Mean ± Standard Deviation
Ejection Fraction	58.0 ± 9.3	57.8 ± 9.8	57.9 ± 9.4
Cardiac Risk Factors ^[1] [units: participants]
Smoking, Ever	611	216	827
Medically Treated Diabetes	232	80	312
Hyperlipidemia Requiring Medication	717	243	960
Hypertension Requiring Medication	709	256	965
Family History of Coronary Artery Disease	589	196	785
Comorbidities ^[1] [units: participants]
History of Peripheral Vascular Disease	99	36	135
History of Transient Ischemic Attack	30	14	44
History of Cerebrovascular Accident	30	12	42
History of Renal Disease	45	11	56
History of Gastrointestinal Bleeding	9	7	16
Lesion Characteristic: Target Lesion Vessel [units: participants]
Left Anterior Descending Artery	406	140	546
Left Circumflex Artery	217	69	286
Right Coronary Artery	319	111	430
Lesion Characteristic: Lesion Location [units: participants]
Ostial	25	8	33
Proximal	368	128	496
Mid	485	154	639
Distal	64	30	94
Lesion Characteristics [units: millimeter] Mean ± Standard Deviation
Reference Vessel Diameter	2.8 ± 0.5	2.8 ± 0.5	2.8 ± 0.5
Minimum Lumen Diameter	0.8 ± 0.3	0.8 ± 0.4	0.8 ± 0.3
Lesion Length	14.2 ± 6.1	14.1 ± 5.8	14.2 ± 6.0
Sidebranch Stenosis	24.4 ± 28.1	25.7 ± 28.8	24.7 ± 28.3
Lesion Characteristic: Percent Diameter Stenosis [units: percent] Mean ± Standard Deviation
Percent Diameter Stenosis	72.1 ± 10.9	71.7 ± 10.9	72.0 ± 10.9
Lesion Characteristics ^[1] [units: participants]
Eccentric Lesion	487	161	648
> 45 Degree Bend	61	22	83
> 90 Degree Bend	2	1	3
Tortuosity, any	59	14	73
Calcification, any	228	86	314
Total Occlusion	6	2	8
Bifurcation	343	129	472
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class ^[2] [units: participants]
Type A	79	28	107
Type B1	233	85	318
Type B2	384	130	514
Type C	246	77	323
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow ^[3] [units: participants]
TIMI 0	2	2	4
TIMI 1	4	0	4
TIMI 2	34	4	38
TIMI 3	902	314	1216

[1]	The same participant may be included in more than one category, therefore the number of participants for this baseline measure does not equal the total number of participants in the group.
[2]	Type A lesions: minimally complex, readily accessible, non angulated, smooth contour, little to no calcification, less than totally occlusive, not ostial in location, no major side branch involvement, and an absense of thrombus. Type B lesions: moderately complex, eccentric, moderate tortuosity and angulation, moderate or heavy calcification, total occlusion < 3 months old, ostial in location, with presence of thrombus. Type C lesions: severely complex, diffuse, excessive tortuosity and angulation, total occlusions > 3 months old, degenerated vein grafts and friable lesions.
[3]	TIMI 0 - No perfusion TIMI 1 - Penetration with minimal perfusion TIMI 2 - Partial perfusion TIMI 3 - Complete perfusion

[1]

The same participant may be included in more than one category, therefore the number of participants for this baseline measure does not equal the total number of participants in the group.

[2]

Type A lesions: minimally complex, readily accessible, non angulated, smooth contour, little to no calcification, less than totally occlusive, not ostial in location, no major side branch involvement, and an absense of thrombus.

Type B lesions: moderately complex, eccentric, moderate tortuosity and angulation, moderate or heavy calcification, total occlusion < 3 months old, ostial in location, with presence of thrombus.

Type C lesions: severely complex, diffuse, excessive tortuosity and angulation, total occlusions > 3 months old, degenerated vein grafts and friable lesions.

[3]

TIMI 0 - No perfusion TIMI 1 - Penetration with minimal perfusion TIMI 2 - Partial perfusion TIMI 3 - Complete perfusion

Outcome Measures

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1. Primary:

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. [ Time Frame: 12 months post-index procedure ]

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2. Secondary:

In-segment Percent Diameter Stenosis at 9 Months Post-index Procedure [ Time Frame: 9 months post-index procedure ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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 sixty (60) 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The comparator control for PERSEUS Workhorse study was chosen based on commercially available stent (TAXUS Express) at the time of study enrollment. Thus, the comparator group does not represent the most recently available paclitaxel-eluting stent.

Results Point of Contact:

Name/Title: Andrey Nersesov, Clinical Project Manager
Organization: Boston Scientific
phone: 508-683-4988
e-mail: andrey.nersesov@bsci.com

No publications provided by Boston Scientific Corporation

Publications automatically indexed to this study:

Kereiakes DJ, Cannon LA, Feldman RL, Popma JJ, Magorien R, Whitbourn R, Dauber IM, Rabinowitz AC, Ball MW, Bertolet B, Kabour A, Foster MC, Wang JC, Underwood P, Dawkins KD. Clinical and angiographic outcomes after treatment of de novo coronary stenoses with a novel platinum chromium thin-strut stent: primary results of the PERSEUS (Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System) trial. J Am Coll Cardiol. 2010 Jul 20;56(4):264-71. Epub 2010 May 20.

Allocco DJ, Cannon LA, Britt A, Heil JE, Nersesov A, Wehrenberg S, Dawkins KD, Kereiakes DJ. A prospective evaluation of the safety and efficacy of the TAXUS Element paclitaxel-eluting coronary stent system for the treatment of de novo coronary artery lesions: design and statistical methods of the PERSEUS clinical program. Trials. 2010 Jan 7;11:1.

Responsible Party:	Amy Britt, Boston Scientific
ClinicalTrials.gov Identifier:	NCT00484315 History of Changes
Other Study ID Numbers:	S2037, S2037-PIVOT-2006
Study First Received:	June 6, 2007
Results First Received:	April 28, 2011
Last Updated:	June 2, 2011
Health Authority:	United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration New Zealand: Medsafe Singapore: Health Sciences Authority