Coronary artery disease: atherectomy was not clearly better than angioplasty.

Clinical bottom line (level 1b-)

  1. Patients with coronary artery disease who were given atherectomy had no clear difference in death, MI, coronary artery bypass grafting or the need for nonsurgical coronary intervention, than those given angioplasty.
Topol et al: New England Journal of Medicine 1993; 329 (4): 221-227
Expires March 2003

The study

Unblinded concealed randomised trial with intention-to-treat
Setting: 35 centres, 32 in the US and 3 in Europe with proven experience in both techniques

1012 patients (aged mean 59 years, 73% male) symptomatic ischaemic heart disease deemed suitable for either atherectomy or angioplasty

Excluded if
  • stenosis <60%
  • not suitable for either a 6-French cutter or larger or a 3.0 mm balloon or larger


    • Note:
  • If a patient had multi-vessel disease, a single lesion was targeted.


    • Control Group: (n = 500, 500 analysed): angioplasty
    Experimental Group: (n = 512, 512 analysed): atherectomy
    Aspirin 160 mg per day or more for at least one day was given before the procedure, and at least one dose of a calcium-channel blocker was administered. Heparin was given as a bolus of 10,000 U with additional boluses to maintain the activated clotting time above 350 seconds during the procedure. Aspirin 325 mg per day and a calcium-channel blocker were prescribed for one moth after the procedure.
    99% followed for 6 months

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNH
    (95% CI)
    death, MI, coronary artery bypass surgery or subsequent nonsurgical coronary intervention 6 months 211
    (42.2%)    		 234
    (45.7%)    		 -8.00%
    (-25.0% to 6.00%)    		 -3.50%
    (-9.62% to 2.61%)    		 29
    (NNT = 38 to infinity;
    NNH = 10 to infinity)

  • Restenosis in the atherectomy group was 50% and in the angioplasty group was 57%. NNTs could not be calculated as the number of patients who could be evaluated was only 825, and there was no indication as to how many patients were in each group at this stage.

    • Comments

    1. Each operator had to have performed more than 400 coronary angioplasty procedures with a success rate above 85% and more than 50 atherectomy procedures with a success rate of above 80%.
    2. The rate of crossover from atherectomy to angioplasty was 17%, and from crossover from angioplasty to atherectomy was 4%.
    3. The trials was too small to show any clear difference in outcome between the two groups.

    Citation

    1. Topol EJ, Leya F, Pinkerton CA, et al: A comparison of directional atherectomy with coronary angioplasty in patients with coronary artery disease. New England Journal of Medicine 1993; 329 (4): 221-227
    Contributor: Clare Wotton and Bob Phillips, January 2000
    Reviewer:

    Clinical Question.
    Patient coronary artery disease
    Intervention or Exposure directional atherectomy
    Comparison coronary angioplasty
    Outcome restenosis