Trial Outcomes & Findings for ISCHEMIA-Chronic Kidney Disease Trial (NCT NCT01985360)
NCT ID: NCT01985360
Last Updated: 2021-10-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
777 participants
Primary outcome timeframe
2.2 years
Results posted on
2021-10-18
Participant Flow
Participant milestones
| Measure |
Invasive Strategy (INV)
Routine invasive strategy with cardiac catheterization followed by revascularization + optimal medical therapy.
* Cardiac Catheterization: Narrowed blood vessels can be opened without surgery using stents or bypassed with surgery. The doctor will examine blood vessels to determine the location and extent of narrowings.
* Coronary Artery Bypass Graft Surgery (CABG): Artery narrowing is bypassed during surgery with a healthy artery or vein from another part of the body. This creates new routes around narrowed/blocked heart arteries.
* Percutaneous Coronary Intervention: 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.
Lifestyle: Diet, physical activity, smoking cessation Medication: antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies
|
Conservative Strategy (CON)
Optimal medical therapy with cardiac catheterization and revascularization reserved for patients with OMT failure.
Lifestyle: Diet, physical activity, smoking cessation
Medication: antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies
|
|---|---|---|
|
Overall Study
STARTED
|
388
|
389
|
|
Overall Study
COMPLETED
|
379
|
386
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
Reasons for withdrawal
| Measure |
Invasive Strategy (INV)
Routine invasive strategy with cardiac catheterization followed by revascularization + optimal medical therapy.
* Cardiac Catheterization: Narrowed blood vessels can be opened without surgery using stents or bypassed with surgery. The doctor will examine blood vessels to determine the location and extent of narrowings.
* Coronary Artery Bypass Graft Surgery (CABG): Artery narrowing is bypassed during surgery with a healthy artery or vein from another part of the body. This creates new routes around narrowed/blocked heart arteries.
* Percutaneous Coronary Intervention: 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.
Lifestyle: Diet, physical activity, smoking cessation Medication: antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies
|
Conservative Strategy (CON)
Optimal medical therapy with cardiac catheterization and revascularization reserved for patients with OMT failure.
Lifestyle: Diet, physical activity, smoking cessation
Medication: antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
Baseline Characteristics
ISCHEMIA-Chronic Kidney Disease Trial
Baseline characteristics by cohort
| Measure |
Invasive Strategy (INV)
n=388 Participants
Routine invasive strategy with cardiac catheterization followed by revascularization + optimal medical therapy.
* Cardiac Catheterization: Narrowed blood vessels can be opened without surgery using stents or bypassed with surgery. The doctor will examine blood vessels to determine the location and extent of narrowings.
* Coronary Artery Bypass Graft Surgery (CABG): Artery narrowing is bypassed during surgery with a healthy artery or vein from another part of the body. This creates new routes around narrowed/blocked heart arteries.
* Percutaneous Coronary Intervention: 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.
Lifestyle: Diet, physical activity, smoking cessation Medication: antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies
|
Conservative Strategy (CON)
n=389 Participants
Optimal medical therapy with cardiac catheterization and revascularization reserved for patients with OMT failure.
Lifestyle: Diet, physical activity, smoking cessation
Medication: antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies
|
Total
n=777 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
64 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
268 Participants
n=5 Participants
|
267 Participants
n=7 Participants
|
535 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
54 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
318 Participants
n=5 Participants
|
319 Participants
n=7 Participants
|
637 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
North America
|
95 participants
n=5 Participants
|
88 participants
n=7 Participants
|
183 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
120 participants
n=5 Participants
|
119 participants
n=7 Participants
|
239 participants
n=5 Participants
|
|
Region of Enrollment
Africa
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Pacifica
|
3 participants
n=5 Participants
|
7 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Middle East
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
South America
|
27 participants
n=5 Participants
|
22 participants
n=7 Participants
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2.2 yearsOutcome measures
| Measure |
Invasive Strategy
n=388 Participants
Invasive Strategy
|
Conservative Strategy
n=389 Participants
Conservative Strategy
|
|---|---|---|
|
Incidence of Death From Any Cause or Myocardial Infarction
|
123 Participants
|
129 Participants
|
PRIMARY outcome
Timeframe: 3 yearsThis measure represents the estimated cumulative probability of experiencing Death from any cause 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).
Outcome measures
| Measure |
Invasive Strategy
n=388 Participants
Invasive Strategy
|
Conservative Strategy
n=389 Participants
Conservative Strategy
|
|---|---|---|
|
Cumulative Event Rate of Death From Any Cause or Myocardial Infarction
|
36.4 cumulative event rate - %
Interval 30.5 to 42.2
|
36.7 cumulative event rate - %
Interval 31.1 to 42.4
|
Adverse Events
Invasive Strategy
Serious events: 75 serious events
Other events: 0 other events
Deaths: 94 deaths
Conservative Strategy
Serious events: 61 serious events
Other events: 0 other events
Deaths: 98 deaths
Serious adverse events
| Measure |
Invasive Strategy
n=388 participants at risk
Invasive Strategy
|
Conservative Strategy
n=389 participants at risk
Conservative Strategy
|
|---|---|---|
|
Renal and urinary disorders
Death from any cause or Initiation of dialysis
|
19.3%
75/388 • Number of events 75 • 3 years
|
15.7%
61/389 • Number of events 61 • 3 years
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place