Angina: angioplasty reduced need for antianginal medication and revascularisation, but increased death and MI.

Clinical bottom line (level 1b)

  1. Patients with angiographically-proven coronary artery disease who had angioplasty were at increased risk of dying or having a non-fatal compared with medical therapy alone (NNH = 33 at 3 years) .
  2. Patients given angioplasty were more likely to be on one antianginal drug or less (NNT = 4 at 6 months) (NNT = 4 at 3 years) , and were less likely to require further revascularisation (NNT = 19 at 3 years) , than patients on medical therapy alone.
  3. There was no clear effect on the number of subsequent admissions with unstable angina.
RITA participants : Lancet 1997; 350: 461-468
Expires June 2003

The study

Unblinded concealed randomised trial with intention-to-treat
Setting: twenty acute hospitals, UK and Ireland

1018 patients (aged median 58 years, 82% male) angiographically-proven coronary artery disease (significant stenosis >50% in at least one major epicardial vessel technically amenable to balloon angioplasty). Patients with multivessel disease, occluded coronary arteries, impaired left ventricular function or recent unstable angina (most recent episode within seven days) were included.

Excluded if
  • <18 years
  • unable to have continued medical therapy or coronary angioplasty
  • early angioplasty or CABG indicated for symptom relief or prognostic benefit
  • previous revascularisation, left main stem disease, haemodynamically significant valve disease
  • life-threatening non-cardiac disease likely to limit survival

Control Group: (n = 514, 514 analysed): medical therapy- antianginal medication for symptom relief. Patients had revascularisation procedures only if symptoms not adequately controlled by optimal medical therapy (typically a beta-blocker with calcium antagonist and/or long-acting nitrate)
Experimental Group: (n = 504, 504 analysed): angioplasty within 3 months by experienced operators- stents permissible if initial dilatation was unsatisfactory

98% followed for 2.7 years
Outcome notes:
  • death or non-fatal MI : MI- new pathological Q-waves within 7 days of any revascularisation procedure or convincing clinical history with two cardiac enzymes raised more than twice normal
  • revascularisation : CABG or angioplasty

The evidence

Outcome Time to outcome CEREERRRR
(95% CI)		ARR
(95% CI)		NNT
(95% CI)
death or non-fatal MI 2.7 years 17
(3.31%)		 32
(6.35%)		 -92%
(-241% to -8%)		 -3.04%
(-5.67% to -0.41%)		 -33
(-240 to -18)
revascularisation 2.7 years 131
(25.5%)		 102
(20.2%)		 21%
(0% to 37%)		 5.25%
(0.10% to 10.4%)		 19
(10 to 990)
unstable angina 2.7 years 47
(9.14%)		 50
(9.92%)		 -8%
(-58% to 26%)		 -0.78%
(-4.39% to 2.83%)		 -130
(NNT = 23 to infinity;
NNH = 35 to infinity)
one antianginal drug or less 6 months 207
(40.8%)		 338
(67.7%)		 -66%
(-88% to -47%)		 -27.0%
(-32.9% to -21.1%)		 -4
(-5 to -3)
one antianginal drug or less 3 years 95
(46.8%)		 141
(75.0%)		 -60%
(-90% to -35%)		 -28.2%
(-37.4% to -19.0%)		 -4
(-5 to -3)
  • 508 control patients and 499 angioplasty patients were analysed for antianginal drugs at 6 months, and 203 and 188 at 3 years. 
  • 93% of patients randomised to angioplasty received it, 91% within 12 weeks - 71% for single-vessel lesions. 
  • There were seven non-fatal infarcts related to the procedures, seven patients required emergency CABG, and there was one death from haemorrhage during angioplasty. 
  • Some of the increase in mortality and morbidity in the angioplasty group relates directly to complications of the procedure. 
  • Patients given angioplasty reported less angina throughout the study.

Comments

  1. Given current standard use of stents and new anti-platelet agents, the initial disadvantages of PCI may be overcome. Some evidence of this exists (e.g. EPISTENT)

Citation

  1. RITA participants , : Coronary angioplasty versus medical therapy for angina: the second Randomised Intervention Treatment for Angina (RITA-2). Lancet 1997; 350: 461-468
Search Terms: angina and angioplast* in Cochrane
Contributor: Nick Shenker, Chris Ball and Clare Wotton, June 2000
Reviewer: Etsuo Tsuchikane

Clinical Question.
Patient coronary artery disease
Intervention or Exposure angioplasty
Comparison medical therapy
Outcome death, MI, angina, revascularisation