Angina and angioplasty: stents led to less restenosis, but not fewer further events.

Clinical bottom line (level 1b)

  1. Patients with symptomatic ischaemic heart disease who had a stent inserted during angioplasty had less restenosis at six months than those who had standard angioplasty (NNT = 10 at 6 months) .
  2. There was no difference in subsequent number of deaths, MI or revascularisation procedures.
  3. The effect on bleeding or vascular complications from angioplasty is unclear.
Fischman et al: New England Journal of Medicine 1994; 331 (8): 496-501
George : American Journal of Cardiology 1998; 81: 860-865
Expires June 2003

The study

Unblinded concealed randomised trial without intention-to-treat
Setting: twenty centres in North America, Japan and Italy

410 patients (aged mean 60 years, 78% male) symptomatic ischaemic heart disease and new lesions <15 mm in length, with >70% stenosis in a coronary vessel >3 mm in diammeter

Excluded if
  • myocardial infarction (MI) within the past seven days
  • contraindication to aspirin, dipyridamole or warfarin
  • left ventricular ejection fraction <40%
  • coronary thrombus, multiple focal lesions or diffuse disease
  • serious disease in the left main coronary artery
  • ostial lesion, or severe vessel tortuosity



Control Group: (n = 203, 202 analysed): standard balloon angioplasty
Experimental Group: (n = 207, 205 analysed): stent placement (using stainless steel Palmaz-Schatz stent). Patients had 325 mg aspirin po once daily, dipyridamole 75 mg po twice daily, and a calcium-channel blocker, all started 24 hours before the procedure
All patients had dextran and heparin during the procedure; patients were anticoagulated with warfarin (INR 2.0 to 3.5) with heparin continued for at least 72 hours. Warfarin and dipyridamole were continued for one month.
99% followed for 6 months
Outcome notes:

  • restenosis : >49% stenosis on follow-up angiogram
  • any cardiovascular event : death, MI, CABG or repeat angioplasty
  • bleeding and vascular complications : stroke, vascular repair, bleeding requiring transfusion

The evidence

Outcome Time to outcome CEREERRRR
(95% CI)		ARR
(95% CI)		NNT
(95% CI)
restenosis 6 months 85
(42.1%)		 65
(31.7%)		 25%
(2% to 42%)		 10.4%
(1.05% to 19.7%)		 10
(5 to 95)
any cardiovascular event 6 months 48
(23.8%)		 37
(18.1%)		 24%
(-11% to 48%)		 5.71%
(-2.17% to 13.6%)		 18
(NNT = 7 to infinity;
NNH = 46 to infinity)
bleeding and vascular complications 6 months 8
(3.96%)		 14
(6.83%)		 -72%
(-302% to 26%)		 -2.87%
(-7.25% to 1.51%)		 -35
(NNT = 66 to infinity;
NNH = 14 to infinity)
any event 12 months 61
(30.2%)		 51
(24.9%)		 18%
(-13% to 40%)		 5.32%
(-3.35% to 14.0%)		 19
(NNT = 7 to infinity;
NNH = 30 to infinity)

94% patients were followed for 12 months.

Clinical success rates were 96% in the stent group and 90% in the angioplasty group (p=0.01).

The mean hospital stay was longer in the stent group than in the angioplasty group (5.8 vs 2.8 days; p<0.001).

Comments

  1. Lesions included in this study are highly selected; short lesions in large vessels. The results of the present study should not be applied to all lesions.

Citation

  1. Fischman DL, Leon MB, Baim DS, et al: A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. New England Journal of Medicine 1994; 331 (8): 496-501
  2. George CJ, : One-year follow-up of the stent restenosis (STRESS 1) study. American Journal of Cardiology 1998; 81: 860-865
Search Terms: unstable angina in Best Evidence
Contributor: Chris Ball and Clare Wotton, June 2000
Reviewer: Etsuo Tsuchikane

Clinical Question.
Patient symptomatic heart disease
Intervention or Exposure stent placement
Comparison standard balloon angioplasty
Outcome restenosis