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Drug-Eluting Stents vs. Bare Metal Stents In Saphenous Vein Graft Angioplasty (DIVA)

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ClinicalTrials.gov Identifier: NCT01121224
Recruitment Status : Completed
First Posted : May 12, 2010
Results First Posted : February 1, 2018
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Saphenous Vein Graft Atherosclerosis
Interventions: Device: Bare Metal Stent
Device: Drug-Eluting Stent
Drug: Blinded clopidogrel
Drug: Placebo
Drug: Thienopyridine (open-label)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Bare Metal Stent Group

Patients who receive a bare metal stent (BMS) in the saphenous vein graft target lesion(s).

Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion.

Placebo: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive only BMS.

Thienopyridine (open-label): For ACS patients who receive BMS or Drug Eluting Stent (DES) in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
Drug Eluting Stent Group

Patients who receive a drug-eluting stent (DES) in the saphenous vein graft target lesion(s).

Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion.

Blinded clopidogrel: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion.

Thienopyridine (open-label): For ACS patients who receive Bare Metal Stent (BMS) or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Participant Flow:   Overall Study
    Bare Metal Stent Group   Drug Eluting Stent Group
STARTED   305   292 
COMPLETED   280   275 
NOT COMPLETED   25   17 



  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
BMS Group

Patients who receive a bare metal stent in the saphenous vein graft target lesion(s).

Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion.

Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS.

Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
DES Group

Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s).

Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion.

Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion.

Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
Total Total of all reporting groups

Baseline Measures
   BMS Group   DES Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 305   292   597 
Age 
[Units: Years]
Mean (Standard Deviation) 		 68.2  (7.7)   69.0  (7.4)   68.6  (7.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      0   0.0%      2   0.7%      2   0.3% 
Male      305 100.0%      290  99.3%      595  99.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants 		     
Hispanic or Latino      14   4.6%      16   5.5%      30   5.0% 
Not Hispanic or Latino      286  93.8%      270  92.5%      556  93.1% 
Unknown or Not Reported      5   1.6%      6   2.1%      11   1.8% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants 		     
Caucasian      254  83.3%      263  90.1%      517  86.6% 
Black/African American      32  10.5%      17   5.8%      49   8.2% 
Other      13   4.3%      7   2.4%      20   3.4% 
Not Answered      6   2.0%      5   1.7%      11   1.8% 
Region of Enrollment 
[Units: Participants]
Count of Participants 		     
United States   305   292   597 


  Outcome Measures

1.  Primary:   Number of Participants With Target Vessel Failure (TVF), Which Will be Defined as the Composite of Cardiac Death, Target Vessel Myocardial Infarction and Target Vessel Revascularization.   [ Time Frame: 12 months ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participant Deaths (All Cause and Cardiac). All Deaths Will be Considered Cardiac Unless an Unequivocal Non-cardiac Cause Can be Established.   [ Time Frame: 12 months ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants With Myocardial Infarction (MI) After Discharge From the Initial Stenting Procedure.   [ Time Frame: 12 months ]
  Show Outcome Measure 3

4.  Secondary:   Number of Participants With Definite Stent Thrombosis as Defined Using the Academic Research Consortium (ARC) Definition   [ Time Frame: 12 months ]
  Show Outcome Measure 4

5.  Secondary:   Number of Participants With Target Vessel Revascularization (TVR)   [ Time Frame: 12 months ]
  Show Outcome Measure 5

6.  Secondary:   Number of Participants With Target Lesion Revascularization (TLR)   [ Time Frame: 12 months ]
  Show Outcome Measure 6

7.  Secondary:   Number of Participants With Target Vessel Myocardial Infarction   [ Time Frame: 12 months ]
  Show Outcome Measure 7

8.  Secondary:   Number of Participants With Any Revascularization   [ Time Frame: 12 months ]
  Show Outcome Measure 8

9.  Secondary:   Number of Participants With Definite or Probable Stent Thrombosis   [ Time Frame: 12 months ]
  Show Outcome Measure 9

10.  Secondary:   Incremental Cost-effectiveness of DES Relative to BMS.   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   09/2018  

11.  Secondary:   Procedural Success and Complications (Post-procedural Myocardial Infarction and Post-procedural Bleeding).   [ Time Frame: Index hospitalization ]
Results not yet reported.   Anticipated Reporting Date:   09/2018  

12.  Secondary:   Patient-oriented and Device-oriented (for Target Lesion Failure) Composite Endpoints Will be Used as Secondary Outcomes as Proposed by Cutlip et al, and as Recommended in the Draft FDA Guidance for Industry Statement.   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   09/2018  

13.  Secondary:   In Patients Who Clinically Require Follow-up Angiography, Two Angiographic Endpoints Will be Assessed: (a) In-segment Binary Restenosis and (b) Angiographic Late In-segment Luminal Loss.   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   09/2018  

14.  Secondary:   Stroke.   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   09/2018  

15.  Secondary:   Incremental Cost-effectiveness Ratios (ICERs) for Subgroups of Patients, Such as Those With Highest Risk of Restenosis, Tallies of Cost by Type, and a Cost-outcomes Analysis Such as Cost Per Restenosis Avoided.   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   09/2018  

16.  Secondary:   In-stent Neointima Proliferation as Measured by Intravascular Ultrasonography.   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   09/2018  


  Serious Adverse Events


  Other Adverse Events


  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

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Subhash Banerjee
Organization: VA North Texas Health Care System
phone: (214) 857-1608
e-mail: Subhash.Banerjee@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01121224     History of Changes
Other Study ID Numbers: 571
First Submitted: May 7, 2010
First Posted: May 12, 2010
Results First Submitted: January 5, 2018
Results First Posted: February 1, 2018
Last Update Posted: March 8, 2018