Ischaemic heart disease: no clear benefit from treating ECG changes rather than symptoms.

Clinical bottom line (level 1b-)

  1. There was no clear difference between treating patients with coronary artery disease for angina or silent ischaemia on deaths, MI, revascularisations or subsequent hospital admissions.
Rogers et al: Journal of the American College of Cardiology 1995; 26 (3): 594-605
Expires March 2003

The study

Unblinded concealed randomised trial with intention-to-treat
Setting: ten acute hospitals, North America and UK

558 patients (aged mean 61 years, 86% male) coronary artery disease ( = 50% stenosis on angiogram) amenable to revascularisation with one or more episodes of asymptomatic ischaemia on 48 hour ECG or exercise stress testing

Excluded if
  • MI within previous four weeks
  • angioplasty within previous six months


    • Control Group: (n = 183, 183 analysed): pharmacological therapy for angina
    Experimental Group: (n = 183, 183 analysed): pharmacological therapy to suppress both angina and ambulatory ECG evidence of ischaemia (ST deviation = 1 mm from baseline for = 1 minute)
    Experimental Group: (n = 192, 192 analysed): revascularisation (PTCA or CABG) within four weeks of entry
    Pharmacological therapy involved atenolol and sustained-release nifedipine if needed, or diltiazem and sustained-release isosorbide dinitrate if needed.
    96% followed for 12 months

    The evidence

    angina vs ischaemia control
    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    need for additional medication 12 months 48
    (26.3%)    		 57
    (31.2%)    		 -19%
    (-64% to 14%)    		 -4.92%
    (-14.2% to 4.34%)    		 -20
    (NNT = 23 to infinity;
    NNH = 7 to infinity)
    death 12 months 8
    (4.37%)    		 3
    (1.64%)    		 63%
    (-39% to 90%)    		 2.73%
    (-0.75% to 6.22%)    		 37
    (NNT = 16 to infinity;
    NNH = 130 to infinity)
    death, MI, revascularisation, hospital admission 12 months 59
    (32.2%)    		 57
    (31.2%)    		 3%
    (-31% to 28%)    		 1.09%
    (-8.44% to 10.6%)    		 91
    (NNT = 9 to infinity;
    NNH = 12 to infinity)

    angina vs revascularisation
    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    death 12 months 8
    (4.37%)    		 0
    (0.00%)    		 100%
    (% to %)    		 4.37%
    (1.41% to 7.33%)    		 23
    (14 to 71)
    death, MI, revascularisation, hospital admission 12 months 59
    (32.2%)    		 35
    (18.2%)    		 43%
    (18% to 61%)    		 14.0%
    (5.31% to 22.7%)    		 7
    (4 to 19)

    Comments

    1. RITA-2 has shown that angioplasty improve symptoms better than medical therapy but leads to more deaths and infarcts. The ACIP study may have produced different results because revascularisation procedures were performed on physician's preferences rather than protocol- this event was the major difference noted between the groups. Since angioplasty improves symptoms more effectively, patients are less likely to require further intervention than the other two groups.
    2. The above comment, combined with the unblinded nature of the trial makes the results more prone to bias.

    Citation

    1. Rogers WJ, Bourassa MG, Andrews TC, et al: Asymptomatic cardiac ischemia pilot (ACIP) study: outcome at 1 year for patients with asymptomatic ischemia randomized to medical therapy or revascularisation. Journal of the American College of Cardiology 1995; 26 (3): 594-605
    Search Terms: angin* in Cochrane
    Contributor: Chris Ball and Clare Wotton, June 2000
    Reviewer:

    Clinical Question.
    Patient coronary artery disease
    Intervention or Exposure pharmacological treatment for angina and ischaemia or revascularisation
    Comparison pharmacological treatment for angina
    Outcome death, MI, revascularisation, hospital admission