American College of Cardiology Foundation

11/16/2019 | Press release | Distributed by Public on 11/16/2019 17:44

International Study of Comparative Health Effectiveness With Medical and Invasive Approaches–Chronic Kidney Disease

Contribution To Literature:

The ISCHEMIA-CKD trial failed to show that routine invasive therapy was associated with a reduction in death/myocardial infarction vs. medical therapy among stable patients with moderate ischemia and chronic kidney disease.

Description:

The goal of the trial was to evaluate routine invasive therapy compared with optimal medical therapy among patients with stable ischemic heart disease, moderate to severe myocardial ischemia on noninvasive stress testing, and advanced chronic kidney disease.

Study Design

Patients with stable ischemic heart disease, moderate to severe ischemia, and chronic kidney disease were randomized to routine invasive therapy (n = 388) versus medical therapy (n = 389).

In the routine invasive therapy group, subjects underwent coronary angiography and percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) as appropriate.

In the medical therapy groups, subjects underwent coronary angiography only for failure of medical therapy.

  • Total number of enrollees: 777
  • Duration of follow-up: 2.3 years
  • Mean patient age: 63 years
  • Percentage female: 31%
  • Percentage with diabetes: 57%

Inclusion criteria:

  • Patients >20 years of age
  • Moderate to severe ischemia on noninvasive stress testing (nuclear ≥10% ischemia; echo ≥3 segments of ischemia; cardiac magnetic resonance ≥12% ischemia and/or ≥3 segments with ischemia; exercise treadmill test ≥1.5 mm ST depression in ≥2 leads or ≥2 mm ST depression in single lead at <7 METs with angina)

Exclusion criteria:

  • Recent acute coronary syndrome
  • Left ventricular ejection fraction <35%
  • Unacceptable angina at baseline
  • New York Heart Association class III-IV heart failure
  • Prior PCI or CABG within the last year

Angina frequency at baseline:

  • None, 34%
  • Several times per month, 44%
  • Daily/weekly, 22%

Other salient features/characteristics:

  • Over the entire follow-up period, cardiac catheterization was performed in 85% of the invasive group vs. 22% of the medical therapy group
  • Over the entire follow-up period, coronary revascularization was performed in 50% of the invasive group vs. 12% of the medical therapy group

Principal Findings:

The primary outcome, death or myocardial infarction at 2.3 years, occurred in 36.4% of the routine invasive group compared with 36.7% of the medical therapy group (p = 0.95).

  • Among those with severe ischemia: (invasive/medical therapy hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.46-1.05)
  • Among those with moderate ischemia: (invasive/medical therapy HR 1.30, 95% CI 0.94-1.79; p for interaction = 0.02)

Secondary outcomes:

  • Death, myocardial infarction, hospitalization for unstable angina or heart failure, or resuscitated cardiac arrest: 38.5% of the routine invasive group compared with 39.7% of the medical therapy group (p = 0.93)
  • All-cause death: 27.8% of the routine invasive group compared with 27.2% of the medical therapy group (p = 0.91)
  • Periprocedural myocardial infarction: (invasive/conservative HR 2.03, 95% CI 0.59-7.01)
  • Spontaneous myocardial infarction: (invasive/conservative HR 0.72, 95% CI 0.47-1.09)
  • Stroke: (invasive/conservative HR 3.76, 95% CI 1.52-9.32)
  • Dialysis <30 days after procedure: 2.1% of the routine invasive group compared with 0.6% of the medical therapy group (p = 0.13)

Quality of life outcomes: Improvement in symptoms was observed among those with daily/weekly/monthly angina, but not in those without angina.

Interpretation:

Among patients with stable ischemic heart disease, moderate to severe ischemia on noninvasive stress testing, and advanced chronic kidney disease, routine invasive therapy failed to reduce the incidence of death or myocardial infarction compared with optimal medical therapy. There was also no benefit from invasive therapy regarding all-cause mortality. There was a large proportion of subjects with no angina at baseline. Routine invasive therapy failed to improve angina symptoms and quality of life compared with medical therapy. These results do not apply to patients with current/recent acute coronary syndrome, highly symptomatic patients, or left ventricular ejection fraction <35%. Overall, mortality was high and not impacted (positively or negatively) by routine invasive therapy.

References:

Presented by Sripal Bangalore at the American Heart Association Annual Scientific Sessions (AHA 2019), Philadelphia, PA, November 16, 2019.

Presented by John A. Spertus at the American Heart Association Annual Scientific Sessions (AHA 2019), Philadelphia, PA, November 16, 2019 (quality of life outcomes).

Clinical Topics:Acute Coronary Syndromes, Arrhythmias and Clinical EP, Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Atherosclerotic Disease (CAD/PAD), Implantable Devices, SCD/Ventricular Arrhythmias, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Cardiac Surgery and SIHD, Acute Heart Failure, Interventions and ACS, Interventions and Coronary Artery Disease, Interventions and Imaging, Angiography, Magnetic Resonance Imaging, Nuclear Imaging

Keywords:AHA Annual Scientific Sessions, AHA19, Acute Coronary Syndrome, Angina Pectoris, Angina, Unstable, Cardiac Catheterization, Coronary Angiography, Coronary Artery Bypass, Coronary Artery Disease, Exercise Test, Heart Arrest, Heart Failure, Kidney Diseases, Magnetic Resonance Imaging, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Percutaneous Coronary Intervention, Renal Dialysis, Renal Insufficiency, Chronic, Secondary Prevention, Stroke, Stroke Volume


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