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International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) (ISCHEMIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01471522
Recruitment Status : Active, not recruiting
First Posted : November 15, 2011
Results First Posted : July 23, 2020
Last Update Posted : September 17, 2020
Sponsor:
Collaborators:
New York University
Stanford University
National Heart, Lung, and Blood Institute (NHLBI)
Albany Stratton VA Medical Center
Cedars-Sinai Medical Center
Columbia University
Duke University
East Carolina University
Emory University
Harvard University
Massachusetts General Hospital
Montreal Heart Institute
University of British Columbia
University of Missouri, Kansas City
Vanderbilt University
Information provided by (Responsible Party):
NYU Langone Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cardiovascular Diseases
Coronary Disease
Coronary Artery Disease
Heart Diseases
Myocardial Ischemia
Interventions Procedure: cardiac catheterization
Procedure: coronary artery bypass graft surgery
Procedure: percutaneous coronary intervention
Behavioral: Lifestyle
Drug: Medication
Enrollment 5179
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Invasive Strategy (INV) Conservative Strategy
Hide Arm/Group Description

Routine invasive strategy with cardiac catheterization followed by revascularization plus optimal medical therapy.

Cardiac catheterization: Narrowed blood vessels can be opened without surgery using stents or bypassed with surgery. To determine the best approach, the doctor must assess the severity of blood vessel narrowings. This procedure is known as cardiac catheterization.

Coronary artery bypass graft surgery: Artery narrowing is bypassed during surgery with a healthy artery or vein from another part of the body. This is known as coronary artery bypass grafting, or CABG (said, "cabbage"). The surgery creates new routes around narrowed and blocked heart arteries, allowing more blood flow to the heart.

Percutaneous coronary intervention: done as part of the cardiac catheterization procedure. A small, hollow, mesh tube (stent) is inserted into the narrowed part of the artery. The stent pushes the plaque against the artery wall, and opens the vessel to allow better blood flow.

Optimal medical therapy with cardiac catheterization and revascularization reserved for patients with acute coronary syndrome, ischemic heart failure, resuscitated cardiac arrest or refractory symptoms.

Lifestyle: diet, physical activity, smoking cessation

Medication: antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies

Period Title: Overall Study
Started 2588 2591
Completed 2524 2543
Not Completed 64 48
Reason Not Completed
Withdrawal by Subject             28             22
Lost to Follow-up             36             26
Arm/Group Title Invasive Strategy (INV) Conservative Strategy Total
Hide Arm/Group Description Invasive Strategy (INV) Conservative Strategy Total of all reporting groups
Overall Number of Baseline Participants 2588 2591 5179
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 2588 participants 2591 participants 5179 participants
64
(58 to 70)
64
(58 to 70)
64
(58 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2588 participants 2591 participants 5179 participants
Female
606
  23.4%
562
  21.7%
1168
  22.6%
Male
1982
  76.6%
2029
  78.3%
4011
  77.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2588 participants 2591 participants 5179 participants
Hispanic or Latino
372
  14.4%
391
  15.1%
763
  14.7%
Not Hispanic or Latino
2030
  78.4%
2022
  78.0%
4052
  78.2%
Unknown or Not Reported
186
   7.2%
178
   6.9%
364
   7.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2588 participants 2591 participants 5179 participants
American Indian or Alaska Native
8
   0.3%
5
   0.2%
13
   0.3%
Asian
747
  28.9%
738
  28.5%
1485
  28.7%
Native Hawaiian or Other Pacific Islander
5
   0.2%
7
   0.3%
12
   0.2%
Black or African American
96
   3.7%
108
   4.2%
204
   3.9%
White
1706
  65.9%
1697
  65.5%
3403
  65.7%
More than one race
7
   0.3%
5
   0.2%
12
   0.2%
Unknown or Not Reported
19
   0.7%
31
   1.2%
50
   1.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2588 participants 2591 participants 5179 participants
Africa
8
   0.3%
5
   0.2%
13
   0.3%
Asia
791
  30.6%
786
  30.3%
1577
  30.4%
Europe
853
  33.0%
865
  33.4%
1718
  33.2%
Latin America
239
   9.2%
239
   9.2%
478
   9.2%
Middle East
10
   0.4%
10
   0.4%
20
   0.4%
North America
648
  25.0%
652
  25.2%
1300
  25.1%
Pacifica
39
   1.5%
34
   1.3%
73
   1.4%
1.Primary Outcome
Title Primary Composite Outcome: Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, Heart Failure, or Resuscitated Cardiac Arrest
Hide Description [Not Specified]
Time Frame 3.2 year follow-up (median)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Invasive Strategy (INV) Conservative Strategy
Hide Arm/Group Description:
Invasive Strategy (INV)
Conservative Strategy
Overall Number of Participants Analyzed 2588 2591
Measure Type: Count of Participants
Unit of Measure: Participants
318
  12.3%
352
  13.6%
2.Primary Outcome
Title Cumulative Event Rate of Primary Composite Outcome (Death From Cardiovascular Causes, Myocardial Infarction, or Hospitalization for Unstable Angina, Heart Failure, or Resuscitated Cardiac Arrest)
Hide Description This measure represents the estimated cumulative probability of experiencing the primary endpoint within the indicated timeframe in each treatment group. The interpretation of the measure is similar to Kaplan-Meier event rates. Estimates are expressed as percentages ranging from 0% (endpoint is certain not to occur) to 100% (endpoint is certain to occur).
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Invasive Strategy (INV) Conservative Strategy
Hide Arm/Group Description:
Invasive Strategy (INV)
Conservative Strategy
Overall Number of Participants Analyzed 2588 2591
Measure Type: Number
Unit of Measure: cumulative event rate - %
At 6 months 5.3 3.4
At 1 year 7.0 5.4
At 2 years 9.0 9.5
At 3 years 11.3 12.7
At 4 years 13.3 15.5
At 5 years 16.4 18.2
3.Primary Outcome
Title Number of Participants That Experienced Death From Cardiovascular Causes or Myocardial Infarction
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Invasive Strategy (INV) Conservative Strategy
Hide Arm/Group Description:
Invasive Strategy (INV)
Conservative Strategy
Overall Number of Participants Analyzed 2588 2591
Measure Type: Count of Participants
Unit of Measure: Participants
276
  10.7%
314
  12.1%
4.Primary Outcome
Title Cumulative Event Rate of Death From Cardiovascular Causes or Myocardial Infarction
Hide Description This measure represents the estimated cumulative probability of experiencing Death from cardiovascular causes or myocardial infarction within the indicated timeframe in each treatment group. The interpretation of the measure is similar to Kaplan-Meier event rates. Estimates are expressed as percentages ranging from 0% (endpoint is certain not to occur) to 100% (endpoint is certain to occur).
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Invasive Strategy (INV) Conservative Strategy
Hide Arm/Group Description:
Invasive Strategy (INV)
Conservative Strategy
Overall Number of Participants Analyzed 2588 2591
Measure Type: Number
Unit of Measure: Cumulative event rate -- %
At 6 months 4.8 2.9
At 1 year 6.2 4.6
At 2 years 7.9 8.2
At 3 years 9.7 11.0
At 4 years 11.7 13.9
At 5 years 14.2 16.5
5.Primary Outcome
Title Number of Participants That Experienced Death From Any Cause
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Invasive Strategy (INV) Conservative Strategy
Hide Arm/Group Description:
Invasive Strategy (INV)
Conservative Strategy
Overall Number of Participants Analyzed 2588 2591
Measure Type: Count of Participants
Unit of Measure: Participants
145
   5.6%
144
   5.6%
6.Primary Outcome
Title Cumulative Event Rate of Death From Any Cause
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Invasive Strategy (INV) Conservative Strategy
Hide Arm/Group Description:
Invasive Strategy (INV)
Conservative Strategy
Overall Number of Participants Analyzed 2588 2591
Measure Type: Number
Unit of Measure: Cumulative event rate -- %
At 6 months 0.8 0.4
At 1 year 1.7 1.0
At 2 years 2.8 2.9
At 3 years 4.3 4.3
At 4 years 6.5 6.4
At 5 years 9.0 8.3
7.Primary Outcome
Title Number of Participants That Experienced Myocardial Infarction
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Invasive Strategy (INV) Conservative Strategy
Hide Arm/Group Description:
Invasive Strategy (INV)
Conservative Strategy
Overall Number of Participants Analyzed 2588 2591
Measure Type: Count of Participants
Unit of Measure: Participants
210
   8.1%
233
   9.0%
8.Primary Outcome
Title Cumulative Event Rate of Myocardial Infarction
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Invasive Strategy (INV) Conservative Strategy
Hide Arm/Group Description:
Invasive Strategy (INV)
Conservative Strategy
Overall Number of Participants Analyzed 2588 2591
Measure Type: Number
Unit of Measure: Cumulative event rate -- %
At 6 months 4.3 2.6
At 1 year 5.3 3.8
At 2 years 6.3 6.5
At 3 years 7.7 8.5
At 4 years 8.9 10.1
At 5 years 10.3 11.9
9.Primary Outcome
Title Estimated Difference in Cumulative Event Rate ( %) of Primary Composite Outcome: Invasive Minus Conservative
Hide Description The primary composite outcome includes death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Invasive = 2588; Conservative = 2591
Arm/Group Title Between Invasive and Conservative Strategy Arms
Hide Arm/Group Description:
Invasive vs. Conservative
Overall Number of Participants Analyzed 5179
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: cumulative event rate - %
At 6 months
1.9
(0.8 to 3.0)
At 1 year
1.5
(0.2 to 2.9)
At 2 years
-0.5
(-2.1 to 1.1)
At 3 years
-1.3
(-3.2 to 0.6)
At 4 years
-2.2
(-4.4 to 0)
At 5 years
-1.8
(-4.7 to 1.0)
10.Primary Outcome
Title Estimated Difference in Cumulative Event Rate of Death From Cardiovascular Causes: Invasive Minus Conservative or Myocardial Infarction Between Invasive and Conservative Strategies
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Invasive = 2588; Conservative = 2591
Arm/Group Title Between Invasive and Conservative Strategy Arms
Hide Arm/Group Description:
Invasive vs. Conservative
Overall Number of Participants Analyzed 5179
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: cumulative event rate - %
At 6 months
1.9
(0.9 to 3.0)
At 1 year
1.6
(0.4 to 2.8)
At 2 years
-0.3
(-1.8 to 1.2)
At 3 years
-1.3
(-3.1 to 0.5)
At 4 years
-2.2
(-4.4 to -0.1)
At 5 years
-2.3
(-5.0 to 0.4)
11.Primary Outcome
Title Estimated Difference in Cumulative Event Rate of Death From Any Cause: Invasive Minus Conservative
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Invasive = 2588; Conservative = 2591
Arm/Group Title Between Invasive and Conservative Strategy Arms
Hide Arm/Group Description:
Invasive vs. Conservative
Overall Number of Participants Analyzed 5179
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: cumulative event rate - %
At 6 months
0.4
(0 to 0.8)
At 1 year
0.7
(0 to 1.3)
At 2 years
-0.1
(-1.0 to 0.9)
At 3 years
0
(-1.2 to 1.2)
At 4 years
0.1
(-1.5 to 1.8)
At 5 years
0.7
(-1.6 to 3.1)
12.Primary Outcome
Title Estimated Difference in Cumulative Event Rate of Myocardial Infarction: Invasive Minus Conservative
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Invasive = 2588; Conservative = 2591
Arm/Group Title Between Invasive and Conservative Strategy Arms
Hide Arm/Group Description:
Invasive vs. Conservative
Overall Number of Participants Analyzed 5179
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: cumulative event rate - %
At 6 months
1.8
(0.8 to 2.8)
At 1 year
1.5
(0.3 to 2.6)
At 2 years
-0.1
(-1.5 to 1.2)
At 3 years
-0.7
(-2.3 to 0.8)
At 4 years
-1.2
(-3.0 to 0.6)
At 5 years
-1.6
(-3.9 to 0.7)
Time Frame 5 years
Adverse Event Reporting Description SAEs were collected as part of the Primary Composite Outcome
 
Arm/Group Title Invasive Strategy (INV) Conservative Strategy
Hide Arm/Group Description Invasive Strategy (INV) Conservative Strategy
All-Cause Mortality
Invasive Strategy (INV) Conservative Strategy
Affected / at Risk (%) Affected / at Risk (%)
Total   145/2588 (5.60%)      144/2591 (5.56%)    
Hide Serious Adverse Events
Invasive Strategy (INV) Conservative Strategy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   318/2588 (12.29%)      352/2591 (13.59%)    
Cardiac disorders     
Cardiovascular Death   92/2588 (3.55%)  92 111/2591 (4.28%)  111
Procedural Myocardial Infarction   70/2588 (2.70%)  70 24/2591 (0.93%)  24
Non-procedural Myocardial Infarction   130/2588 (5.02%)  130 196/2591 (7.56%)  196
Hospitalization for Unstable Angina   16/2588 (0.62%)  16 32/2591 (1.24%)  32
Hospitalization for Heart Failure   51/2588 (1.97%)  51 25/2591 (0.96%)  25
Resuscitated Cardiac Arrest   5/2588 (0.19%)  5 5/2591 (0.19%)  5
Stroke   45/2588 (1.74%)  45 38/2591 (1.47%)  38
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Invasive Strategy (INV) Conservative Strategy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2588 (0.00%)      0/2591 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anna Naumova
Organization: NYU Langone Health
Phone: 212.263.6927
EMail: Anna.Naumova@nyulangone.org
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Maron DJ, Hochman JS, Reynolds HR, Bangalore S, O'Brien SM, Boden WE, Chaitman BR, Senior R, López-Sendón J, Alexander KP, Lopes RD, Shaw LJ, Berger JS, Newman JD, Sidhu MS, Goodman SG, Ruzyllo W, Gosselin G, Maggioni AP, White HD, Bhargava B, Min JK, Mancini GBJ, Berman DS, Picard MH, Kwong RY, Ali ZA, Mark DB, Spertus JA, Krishnan MN, Elghamaz A, Moorthy N, Hueb WA, Demkow M, Mavromatis K, Bockeria O, Peteiro J, Miller TD, Szwed H, Doerr R, Keltai M, Selvanayagam JB, Steg PG, Held C, Kohsaka S, Mavromichalis S, Kirby R, Jeffries NO, Harrell FE Jr, Rockhold FW, Broderick S, Ferguson TB Jr, Williams DO, Harrington RA, Stone GW, Rosenberg Y; ISCHEMIA Research Group. Initial Invasive or Conservative Strategy for Stable Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1395-1407. doi: 10.1056/NEJMoa1915922. Epub 2020 Mar 30.
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT01471522    
Other Study ID Numbers: 11-00498
1U01HL105907 ( U.S. NIH Grant/Contract )
First Submitted: November 10, 2011
First Posted: November 15, 2011
Results First Submitted: June 29, 2020
Results First Posted: July 23, 2020
Last Update Posted: September 17, 2020