COMPARES OPTIMAL MEDICAL THERAPY WITH INVASIVE THERAPY IN A PATIENT WITH STABLE ISCHEMIC HEART DISEASE WITH MODERATE TO SEVERE MYOCARDIAL ISCHEMIA ON NON INVASIVE STRESS TESTING

1. ISCHEMIA TRIAL
By
Dr VASANTHI
DNB CTVS
MADRAS MEDICAL MISSION

2. • International Study of Comparative Health Effectiveness With
Medical and Invasive Approaches(ISCHEMIA)
• Sponsor: National Heart Lung and blood institute
• Goal : evaluate routine invasive therapy compared with optimal medical
therapy among patients with stable ischemic heart disease and moderate to
severe myocardial ischemia on noninvasive stress testing.

3. • Study Design
• Randomized
• Parallel
• Patients with stable ischemic heart disease and moderate to severe ischemia were
randomized to routine invasive therapy (n = 2,588) versus medical therapy (n =
2,591).
• Total number of enrollees: 5,179
• Duration of follow-up: 3.3 years
• Mean patient age: 64 years
• Percentage female: 23%
• Percentage with diabetes: 41%

4. Inclusion criteria:
• Age > 21 years
• moderate or severe ischemia is defined as:
• Nuclear > 10% left ventricular ischemia (summed difference score of >
7)
• Stress echo with > 3 segments with stress induced moderate to severe
hypokinesis or akinesis.
• CMR with Perfusion > 12% myocardial ischemia and/or Wall motion >
3/16 segments with stress induced severe hypokinesis or akinesis.
• Exercise tolerance testing (ETT) with > 1.5 mm ST depression in > 2
leads or >2 mm ST depression in single lead at <7 METS with angina.

5. Exclusion criteria:
1.New York Heart Association Class III-IV functional class
2.Unacceptable angina despite medical therapy
3.Left Ventricular Ejection Fraction (LVEF) <35%.
4.Acute coronary syndrome within the last 2 months
5.Percutaneous coronary intervention or coronary artery bypass graft within
the last 1 year
6.eGFR <30ml/min on dialysis

6. The coronary CT angiogram Eligibility Criteria
were:
• Inclusion Criteria:
1.> 50% stenosis in a major epicardial vessel
2.> 70% stenosis in a proximal or mid vessel
• Major Exclusion Criteria:
1.> 50% stenosis in unprotected left main disease.

7. • Primary outcome of cardiovascular death, myocardial infarction,
resuscitated cardiac arrest, or hospitalization for unstable angina or heart
failure at 3.3 years occurred in
invasive group 13.3%
OMT
15.5%
p = 0.34.

8. • Secondary outcomes:
• Invasive arm was associated with a higher rate of periprocedural myocardial infarction
within the first 6 months post coronary revascularization (invasive/conservative hazard ratio
[HR] 2.98, 95% confidence interval [CI] 1.87-4.74).
• greater incidence of spontaneous myocardial infarction in the conservative arm compared
with the invasive arm that was seen after 3 years (invasive/conservative HR 0.67, 95% CI
0.53-0.83).
Invasive group Medical
therapy
P value
death or
myocardial
infarction
11.7% 13.9% 0.21
All-cause
death
6.4% 6.5% 0.67

9. • Relationship of heart failure on clinical outcomes:
• Among subjects with HF/LVDys , the cumulative incidence rate was 22.7
compared with 13.8 among those without HF/LVDys
Invasive conservative
HF/LVDys 17.2% 29.3 %
Without HF/LVDys 13% 14.6%

10. • Study Limitations:
• unblinded trial
• not applicable to patients with EF< 35%,
• significant (> 50%) left main stenosis
• very symptomatic patients
• acute coronary syndromes within the previous 2 months.
• limited amount of women enrolled in the study (23%)

11. Interpretation :
• overall of this trial was negative,
• there were mixed findings with evidence for both harm and benefit.
• This signals that:
• significant durable improvements in angina control and quality of life with an invasive strategy if
they had angina occuring daily/weekly or monthly.
• However, in patients without angina, an invasive strategy led to minimal symptom improvement
or quality of life benefits as compared with a conservative strategy.
• An early invasive strategy was not associated with a significant reduction in clinical events.

12. •THANK YOU