Angioplasty and stent insertion: fewer complications using aspirin and ticlopidine.

Clinical bottom line (level 1b)

  1. Patients with stents inserted during angioplasty who had aspirin and ticlopidine compared with aspirin and phenocoumaron, had fewer complications ( (NNT = 22 at 30 days) for cardiac complications, (NNT = 9 at 30 days) for non-cardiac complications).
Schomig et al: New ENgland Journal of Medicine 1996; 334 (17): 1084-1089
Expires June 2003

The study

Unblinded concealed randomised trial with intention-to-treat
Setting: university medical centre, Germany

517 patients (aged mean 62 years, 76% male) had coronary artery stents successfully placed after percutaneous transluminal coronary angioplasty (PTCA)

Excluded if
  • contraindication to the study drugs
  • indication for anticoagulant therapy
  • stenting done primarily as a bridge to aortocoronary bypass grafting
  • cardiogenic shock or needed mechanical ventilation before having PTCA


    • Control Group: (n = 260, 260 analysed): phenprocoumon for four weeks, adjusted so INR 3.5-4.5. A heparin infusion (adjusted so aPTT 80-100 sec) was started before PTCA and maintained until INR was reached
    Experimental Group: (n = 257, 257 analysed): ticlopidine , 250 mg twice daily started immediately after the procedure for four weeks. A heparin infusion (adjusted so aPTT 80-100 sec) was started before PTCA and was discontinued 12 hours after stent placement
    All patients had 100 mg aspirin twice daily po.
    100% followed for 30 days
    Outcome notes:
    • cardiac endpoint : death from cardiac causes or occurrence of myocardial infarction, aortocoronary bypass surgery, or repeated PTCA
    • non-cardiac endpoint : death from noncardiac causes or the occurrence of cerebrovascular accident, or severe peripheral vascular or haemorrhagic events requiring surgery or blood transfusions

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    cardiac endpoint 30 days 16
    (6.15%)    		 4
    (1.56%)    		 75%
    (25% to 91%)    		 4.60%
    (1.31% to 7.89%)    		 22
    (13 to 76)
    non-cardiac endpoint 30 days 32
    (12.3%)    		 3
    (1.17%)    		 91%
    (69% to 97%)    		 11.1%
    (6.94% to 15.3%)    		 9
    (7 to 14)

    Comments

    1. Patients who received anticoagulation had longer on heparin- this if anything should reduce the differences seen between the two groups.
    2. The mechanism behind the additional benefit of a combination of antiplatelet drugs is, as yet, unclear.

    Citation

    1. Schomig A, Neumann FJ, Kastrati A, et al: A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronary-artery stents. New ENgland Journal of Medicine 1996; 334 (17): 1084-1089
    Search Terms: unstable angina in Best Evidence
    Contributor: Chris Ball and Clare Wotton, June 2000
    Reviewer: Etsuo Tsuchikane

    Clinical Question.
    Patient coronary artery stents
    Intervention or Exposure ticlopidine
    Comparison phenprocoumon
    Outcome cardiac events