SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2010 by Boston Scientific Corporation.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

Cardialysis BV

Information provided by:

Boston Scientific Corporation

ClinicalTrials.gov Identifier:

NCT00114972

First received: June 20, 2005

Last updated: May 27, 2010

Last verified: May 2010

History of Changes

Results First Received: March 27, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Coronary Artery Disease
Interventions:	Device: Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent Procedure: Coronary Artery Bypass Surgery

Participant Flow

Show Participant Flow

Baseline Characteristics

Hide Baseline Characteristics

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
CABG	Coronary Artery By-pass Graft (CABG)
PCI With DES	Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
Total	Total of all reporting groups

Baseline Measures

	CABG	PCI With DES	Total
Number of Participants [units: participants]	897	903	1800
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	400	397	797
>=65 years	497	506	1003
Age [units: years] Mean ± Standard Deviation	64.96 ± 9.79	65.23 ± 9.66	65.09 ± 9.72
Gender [units: participants]
Female	189	213	402
Male	708	690	1398
Region of Enrollment [units: participants]
United States	122	123	245
Portugal	7	6	13
Finland	12	12	24
Spain	26	27	53
Austria	24	28	52
United Kingdom	132	135	267
Italy	96	101	197
France	105	103	208
Hungary	39	44	83
Czech Republic	20	20	40
Poland	33	33	66
Belgium	47	44	91
Denmark	15	17	32
Norway	4	4	8
Latvia	20	20	40
Netherlands	74	74	148
Germany	93	86	179
Sweden	28	26	54
Angina ^[1] [units: participants]
Participants with Stable Angina at Baseline	513	514	1027
Participants with Unstable Angina at Baseline	251	261	512
Participants with Silent Ischemia at Baseline	74	74	148
Participants with No Angina at Baseline	59	54	113
Bifurcation lesion (per participant) ^[2] [units: participants]
One or more Bifurcated Lesion(s)	652	649	1301
No Bifurcated Lesions	245	254	499
Blood pressure ≥130/85 mmHg ^[3] [units: participants]
Blood Pressure >= 130/85 mmHG	574	622	1196
Blood Pressure <130/85 mmHG	323	281	604
Carotid artery disease ^[4] [units: participants]
Diagnosed Carotid Artery Disease at Baseline	75	73	148
No Diagnosed Carotid Artery Disease at Baseline	822	830	1652
Congestive heart failure ^[5] [units: participants]
Congestive Heart Failure at Baseline	47	36	83
No Congestive Heart Failure at Baseline	850	867	1717
Current smoking ^[6] [units: participants]
Smokers at Baseline	196	167	363
Non-Smokers at Baseline	701	736	1437
Diabetes ^[7] [units: participants]
Diagnosed Diabetes at Baseline	256	255	511
No Diagnosed Diabetes at Baseline	641	648	1289
HDL cholesterol (<40 Male or <50 Female) ^[8] [units: participants]
Participant HDL Less Than Limit at Baseline	404	379	783
Participant HDL Greater Than Limit at Baseline	493	524	1017
Hyperlipidemia ^[9] [units: participants]
Participants with Hyperlipidemia at Baseline	686	705	1391
Participants without Hyperlipidemia at Baseline	211	198	409
Insulin requiring diabetes ^[10] [units: participants]
Participants with Insulin dependent Diabetes	93	89	182
Participants with non-Insulin independent Diabetes	163	166	329
Nondiabetic Participants	641	648	1289
Medically treated Diabetes ^[11] [units: Participants]
Diabetic Participants Medically Treated	221	231	452
Diabetic Participants Treated through Diet only	35	24	59
Non-Diabetic Participants	641	648	1289
Metabolic Syndrome ^[12] [units: participants]
Participants with a Metabolic Syndrome	317	339	656
Participants without a Metabolic Syndrome	580	564	1144
Poor LVEF ^[13] [units: participants]
LVEF <30% at Baseline	22	12	34
LVEF >=30% at Baseline	875	891	1766
Prior MI ^[14] [units: participants]
Myocardial Infarction Before Baseline	300	285	585
No Myocardial Infarction Before Baseline	597	618	1215
Prior Stroke ^[15] [units: participants]
Stroke Prior to Baseline	43	35	78
No Stroke Prior to Baseline	854	868	1722
Prior TIA ^[16] [units: participants]
Transient Ischemic Attack Before Baseline	45	39	84
No Transient Ischemic Attack before baseline	852	864	1716
Total Occlusion (per patient) ^[17] [units: participants]
Participants with at least One Total Occlusion	198	217	415
Participants with Partial Occlusion(s)	699	686	1385
Triglyceride levels ≥150 mg/dL ^[18] [units: participants]
Participants with Triglyceride Levels >= 150 mg/dL	304	275	579
Participants with Triglyceride Levels <150 mg/dL	593	628	1221
Additive Euroscore ^[19] [units: units on a scale] Mean ± Standard Deviation	3.79 ± 2.69	3.75 ± 2.62	3.77 ± 2.66
Body Mass Index (BMI) ^[20] [units: kg/m2] Mean ± Standard Deviation	27.91 ± 4.54	28.11 ± 4.80	28.01 ± 4.67
Number of lesions per partipant ^[21] [units: Number of lesions/Participant] Mean ± Standard Deviation	3.99 ± 1.7	3.94 ± 1.66	3.97 ± 1.68
Parsonnet Score ^[22] [units: units on a scale] Mean ± Standard Deviation	8.43 ± 6.84	8.53 ± 6.95	8.48 ± 6.9
Total Syntax Score ^[23] [units: units on a scale] Mean ± Standard Deviation	29.1 ± 11.37	28.39 ± 11.46	28.7 ± 11.42

[1]	number of particpiants with stable, unstable, or no angina at baseline
[2]	Number of participants with at least one bifurcation lesion as determined by the angiographic core laboratory on the baseline angiogram
[3]	number of participants with blood pressure equal or higher than 130/85mmHg
[4]	number of particpants with diagnosed carotid artery disease at baseline
[5]	number of particpants with congestive heart failure at baseline
[6]	Number of participants that were smoking at baseline
[7]	All participants with diagnosed diabetes at baseline
[8]	number of male participants with a high-density lipoprotein (HDL)<40 and female particpants with a HDL<50 determined by the central chemistry laboratory
[9]	participants with hyperlipidemia at baseline
[10]	Number of participants with diabetes treated with insulin
[11]	Number of participants with medically treated diabetes.Excludes participants with diabetes treated with diet only.
[12]	number of participants that met the criteria of metabolic syndrome defined by the American Heart Association
[13]	number of participants with left ventricular ejection fraction <30% at baseline
[14]	Number of participants who had a myocardial infarction before baseline
[15]	number of participants who had a stroke before baseline
[16]	number of partipants who had a Transient Ischemic Attack before baseline
[17]	Number of participants with at least one total occlusion as determined by the angiografic core laboratory on the baseline angiogram
[18]	participants with Triglyceride levels ≥150 mg/dL as determined by a central chemistry laboratorium at baseline
[19]	Additive EuroSCORE is a prognostic scoring system calculating predicted operative mortality for patients undergoing cardiac surgery; it has been the most rigorously evaluated scoring system in cardiac surgery. A predetermined weighted score is assigned for specified patient-, cardiac-, and operation-related factors; for example, pulmonary hypertension is assigned a score of 2. The sum of scores is the additive EuroSCORE. EuroSCORE is calculated from site reported baseline data. A score of greater than 6 is considered as being predictive of an increased mortality risk. (www.euroscore.org)
[20]	Body Mass Index calculated from participants heigth and weight.
[21]	Average number of lesions per participant as determined by the investigator
[22]	The first scoring system in cardiac surgery to calculate mortality risk and to become popular was the Parsonnet risk stratification system, which was developed in the United States in the 1980s. A predetermined weighted score is assigned for several specified patient-, cardiac-, and operation-related factors; for example, dialysis is assigned a score of 10. A score of greater than 15 is considered as being predictive of an increased mortality risk. Parsonette score is calculated from baseline information.
[23]	The SYNTAX score characterizes the coronary vasculature. It combines the importance of a diseased coronary artery segment (Leaman score), adverse characteristics of a lesion (ACC/AHA lesion classification) and the modified Duke/ICPS classification for bifurcation lesions. Higher SYNTAX scores are indicative of more complex lesions and disease; thus higher scores would predict worse short-term outcomes. Calculated from angiographic corelab analysis of baseline angiogram. (www.syntaxscore.com)

Outcome Measures

Show All Outcome Measures

1. Primary:

Primary Clinical Endpoint of 12-Month Binary MACCE. [ Time Frame: 12 months post enrollment ]

Show Outcome Measure 1

2. Primary:

12-month Composite Safety Endpoint. [ Time Frame: 12 months after enrollment ]

Show Outcome Measure 2

3. Primary:

Repeat Revascularization (PCI and/or CABG). [ Time Frame: 12 Months post enrollment ]

Show Outcome Measure 3

4. Secondary:

Overall MACCE at 1 Month Post-procedure and at 6 Months, 3 Years, and 5 Years Post-allocation. [ Time Frame: 1 month after procedure and 6 months, 3 years, and 5 years post allocation ]

Show Outcome Measure 4

5. Secondary:

Individual Components of MACCE at 1 Month Post-procedure. [ Time Frame: 1 month after procedure ]

Show Outcome Measure 5

6. Secondary:

Individual Components of MACCE at 6 Months Post-allocation. [ Time Frame: 6 months post allocation ]

Show Outcome Measure 6

7. Secondary:

Individual Components of MACCE at 1 Year Post-allocation. [ Time Frame: 1 year post allocation ]

Show Outcome Measure 7

8. Secondary:

Freedom From MACCE and Its Components at 1 Year Post-allocation. [ Time Frame: 1 year post allocation ]

Show Outcome Measure 8

9. Secondary:

Freedom From MACCE and Its Components at 3 Years Post-allocation [ Time Frame: 3 years post allocation ]

Results not yet reported. Anticipated Reporting Date: No text entered. Safety Issue: Yes

10. Secondary:

Freedom From MACCE and Its Components at 5 Years Post-allocation [ Time Frame: 5 years post allocation ]

Results not yet reported. Anticipated Reporting Date: No text entered. Safety Issue: Yes

11. Secondary:

Quality of Life at 1 Month Post-procedure and at 6 Months, 1, 3 and 5 Years Post-allocation [ Time Frame: 1 month after procedure and 6 months, 1, 3 and 5 years post allocation ]

Results not yet reported. Anticipated Reporting Date: No text entered. Safety Issue: No

12. Secondary:

Cost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation [ Time Frame: 1 year, 3 and 5 years post allocation ]

Results not yet reported. Anticipated Reporting Date: No text entered. Safety Issue: No

13. Secondary:

The Characteristics (Including Co-morbidity and Coronary Vascular Lesion Complexity Scoring Referred to as the SYNTAX Score) of the Following: PCI Versus CABG Randomized Cohort, PCI Registry Cohort (CABG Ineligible), CABG Registry Cohort (PCI Ineligible) [ Time Frame: 5 Years ]

Results not yet reported. Anticipated Reporting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Hide Other Adverse Events

Time Frame	1 year
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
CABG	Coronary Artery By-pass Graft (CABG)
PCI With DES	Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)

Other Adverse Events

	CABG	PCI With DES
Total, other (not including serious) adverse events
# participants affected / at risk	509/897 (56.74%)	405/903 (44.85%)
Blood and lymphatic system disorders
Anaemia ^{* 1}
# participants affected / at risk	104/897 (11.59%)	23/903 (2.55%)
# events	109	24
Cardiac disorders
Angina pectoris ^{* 1}
# participants affected / at risk	26/897 (2.90%)	61/903 (6.76%)
# events	28	70
Atrial fibrillation ^{* 1}
# participants affected / at risk	123/897 (13.71%)	25/903 (2.77%)
# events	129	28
General disorders
All other Adverse Events ^{* 1 [3]}
# participants affected / at risk	509/897 (56.74%)	405/903 (44.85%)
# events	1099	854
Infections and infestations
Wound infection ^{* 1}
# participants affected / at risk	56/897 (6.24%)	2/903 (0.22%)
# events	58	2
Injury, poisoning and procedural complications
Incision site complication ^{* 1}
# participants affected / at risk	47/897 (5.24%)	3/903 (0.33%)
# events	52	3
Respiratory, thoracic and mediastinal disorders
Pleural effusion ^{* 1}
# participants affected / at risk	54/897 (6.02%)	2/903 (0.22%)
# events	55	2

*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA (8.0)
[3]	Total of all other adverse events with an occurrence below the 5% treshold.

Limitations and Caveats

Hide 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
No text entered.

More Information

Show More Information

To Top