Angina: stent implantation reduced repeat angioplasty.

Clinical bottom line (level 1b)

  1. Patients with stable angina who had stent insertion during angioplasty, had fewer events (death, MI, stroke, revascularisation) (NNT = 12 at 12 months) .
  2. Patients had fewer repeat angioplasties (NNT = 9 at 12 months) .
Macaya et al: Journal of the American College of Cardiology 1996; 27 (2): 255-261
Expires June 2003

The study

Unblinded concealed randomised trial with intention-to-treat
Setting: fourteen clinical centres, Europe

516 patients (aged mean 58 years, 81% male) stable angina and a single new lesion of the native coronary circulation. The target lesion had to be <15 mm long and located in a vessel >3 mm in diammeter

Excluded if
  • ostial and bifurcation lesions, intracoronary thrombus, previously grafted vessels or severe vessel tortuosity
  • age <30 or >75 years
  • contraindication to anticoagulant or antiplatelet therapy
  • ineligibility for coronary bypass surgery
  • any surgical intervention planned for the next six months


Note:
  • Randomisation was stratified according to centre, with blocks of six treatment assignments.


Control Group: (n = 257, 257 analysed): balloon angioplasty
Experimental Group: (n = 259, 259 analysed): angioplasty and stent implantation (Palmaz-Schatz). Received dextran during procedure and warfarin (adjusted to INR 2.5 to 3.5) for at least three months after
All patients received aspirin 250-500 mg po once daily and dipyridamole 75 mg po once daily from at least the day before to six months after the intervention, and all received heparin during the procedure.
99% followed for 12 months
Outcome notes:
  • any event : death, cerebrovascular accident, myocardial infarction, need for bypass surgery or a further percutaneous intervention on the treated lesion

The evidence

Outcome Time to outcome CEREERRRR
(95% CI)		ARR
(95% CI)		NNT
(95% CI)
repeat angioplasty 12 months 53
(20.6%)		 26
(10.0%)		 51%
(25% to 69%)		 10.6%
(4.43% to 16.7%)		 9
(6 to 23)
any event 12 months 81
(31.5%)		 60
(23.2%)		 26%
(2% to 45%)		 8.35%
(0.69% to 16.0%)		 12
(6 to 140)

Comments

  1. Data for follow-up beyond 12 months are still lacking.

Citation

  1. Macaya C, Serruys PW, Ruygrok P, et al: Continued benefit of coronary stenting versus balloon angioplasty: one-year clinical follow-up of Benestent trial. Journal of the American College of Cardiology 1996; 27 (2): 255-261
Search Terms: angina in Best Evidence
Contributor: Chris Ball and Clare Wotton, June 2000
Reviewer: Andreas Michaelides

Clinical Question.
Patient angina
Intervention or Exposure angioplasty and stent implantation
Comparison balloon angioplasty
Outcome any event