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Long-Term Outcome of a Routine versus Selective Invasive Strategy in Patients with non-ST elevation ACS PowerPoint Presentation
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Long-Term Outcome of a Routine versus Selective Invasive Strategy in Patients with non-ST elevation ACS . Keith AA Fox, Tim C Clayton, Peter Damman, Stuart J Pocock, Robbert J de Winter, Jan GP Tijssen, Bo Lagerqvist, Lars Wallentin. FIR collaboration: F RISC I CTUS R ITA.

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slide1
Long-Term Outcome of a Routine versus Selective Invasive Strategy in Patients with non-ST elevation ACS

Keith AA Fox, Tim C Clayton, Peter Damman,

Stuart J Pocock, Robbert J de Winter, Jan GP Tijssen, Bo Lagerqvist, Lars Wallentin

FIR collaboration: FRISC ICTUS RITA

acc aha recommendations for invasive and medical strategies in patients with nste acs
ACC/AHA Recommendations for Invasive and Medical Strategies in Patients with NSTE-ACS
  • Class I
    • An early invasive strategy in patients with high-risk indicators
    • In the absence of any of the above high-risk indicators, either an early conservative or an early invasive strategy
  • Class IIb Level of Evidence: B
    • In initially stabilized patients a selectively invasive strategy may be considered as a treatment strategy

Available at www.acc.org/clinical/guidelines/unstable/unstable.pdf.

routine versus selective intervention in acs
Routine versus selective intervention in ACS

European Heart Journal (2007) 28, 1598–1660

Early invasive strategy: OR 0.84 (95% CI 0.73-0.97)

slide4

RITA-3: 5-year mortality

FRISC II: 5-year mortality

n = 2457

RR 0.95 (95%CI: 0.75-1.21, p=0.693)

Selective invasive

ICTUS: 5-year mortality

HR 1.13 (95%CI: 0.80-1.60, p=0.52)

n = 1190

Routine invasive

Routine invasive

Selective

invasive

n = 1810

OR 0.76 (95%CI: 0.58-1.00, p=0.054)

Selective invasive

Routine

invasive

slide5
Short-term outcomes (up to one year) showed a net benefit (death/MI) , but long term outcomes were inconsistent in individual studies
  • Aims of the Meta-analysis:
  • To determine whether;
  • A routine invasive strategy reduces cardiovascular death
  • or MI using a meta-analysis of individual patient data from
  • all randomised studies with 5 year outcome
  • The results are influenced by baseline risk of the patients
fir patient pooled database
FIR patient-pooled database
  • Core variables:
    • Demographics
    • Clinical history
    • Risk factors for CAD
    • Baseline ECG characteristics
    • Baseline laboratory results
    • 5-year clinical outcomes
  • 5467 patients with nSTE-ACS included
procedures
Procedures
  • Routine invasive strategy
    • “Early” angiography with subsequent PCI or CABG
  • Selective invasive strategy
    • Angiography only if refractory angina or rest ischemia occurs despite optimal medical therapy
timing of first coronary revascularization
Timing of first coronary revascularization

100

Selective invasive

Routine invasive

80

60

Cumulative percentage

40

20

0

0

1

2

3

4

5

Follow-up time (years)

64.1% 71.8% 73.3%

17.6% 41.6% 47.8%

slide10

Primary outcomes at 5 years

Table 2: Outcomes by study and treatment

slide11

Outcomes at 5 years

Table 2: Outcomes by study and treatment

meta analysis for cv death or mi
Meta-analysis for CV death or MI

Study

Hazard ratio (95% CI)

FRISC-II (N=2457)

0.79 (0.66, 0.95)

0.79 (0.66, 0.95)

RITA-3 (N=1810)

0.75 (0.58, 0.96)

0.75 (0.58, 0.96)

ICTUS (N=1200)

0.99 (0.72, 1.35)

0.99 (0.72, 1.35)

Overall

0.81 (0.71, 0.93)

0.81 (0.71, 0.93)

0.5

0.75

1

1.33

2

Favors routine invasive Favors selective invasive

Hazard ratio

cumulative risk of cv death or mi
Cumulative risk of CV death or MI

25

Selective invasive

Routine invasive

20

15

Cumulative percentage

10

5

0

0

1

2

3

4

5

Follow-up time (years)

SI

2746

2452

2351

2178

2077

1880

RI

2721

2485

2410

2235

2166

1952

17.9%

14.7%

HR 0.81 95% CI 0.71-0.93

p = 0.002

are the results influenced by the baseline risk of the patients
Are the results influenced by the baseline risk of the patients?
  • Univariable and multivariable predictors of outcome derived (Cox regression). p<0.01 for inclusion in multivariable model (Wald test)
  • Simplified integer score derived:
    • Age, diabetes, prior MI, ST depression, hypertension, BMI
cumulative risk of cv death or mi by risk group
Cumulative risk of CV death or MI by risk group

50

Selective invasive

Routine invasive

40

30

Cumulative percentage

20

10

0

0

1

2

3

4

5

Follow-up time (years)

SI

2746

2452

2351

2178

2077

1880

RI

2721

2485

2410

2235

2166

1952

Intermediate

Low

cumulative risk of cv death or mi by risk group1
Cumulative risk of CV death or MI by risk group

50

Selective invasive

Routine invasive

40

High

30

Cumulative percentage

Intermediate

20

Low

10

0

0

1

2

3

4

5

Follow-up time (years)

SI

2746

2452

2351

2178

2077

1880

RI

2721

2485

2410

2235

2166

1952

cumulative risk of mi by risk group
Cumulative risk of MI by risk group

50

Selective invasive

Routine invasive

40

30

Cumulative percentage

High

20

Intermediate

10

Low

0

0

1

2

3

4

5

Follow-up time (years)

SI

2746

2452

2351

2178

2077

1880

RI

2721

2485

2410

2235

2166

1952

probability of cv death or mi at 5 years
Probability of CV death or MI at 5 years

70

Predicted risk on selective invasive

Predicted risk on routine invasive

60

50

40

Risk of CV death or MI within 5 years

30

ROC statistic 0.69

20

10

0

0

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

Integer score

Integer score components : age 0-5: Diabetes 0-4:

Hypertension 0-1: ST depression 0-2: BMI 0-2

summary
Summary
  • The routine invasive strategy reduces cardiovascular death or MI at long-term follow-up
    • 3.2% absolute risk reduction in CV death/MI
    • 19% relative risk reduction
  • Risk stratification identifies the patient group with the greatest absolute benefits
    • 11.1% absolute risk reduction in highest risk patients
  • The absolute risk reductions in CV death/MI in low (2.0%) and Intermediate groups (3.8%) exceed those seen in many trials of pharmacological agents