Elsevier

The Lancet

Volume 350, Issue 9076, 16 August 1997, Pages 461-468
The Lancet

Articles
Coronary angioplasty versus medical therapy for angina: the second Randomised Intervention Treatment of Angina (RITA-2) trial

https://doi.org/10.1016/S0140-6736(97)07298-XGet rights and content

Summary

Background

The role of percutaneous transluminal coronary angioplasty (PTCA) in the management of patients with angina remains controversial, particularly in patients whose symptoms are adequately controlled by medical treatment.

Methods

RITA-2 is a randomised trial comparing the long-term effects of PTCA and conservative (medical) care in patients with coronary artery disease considered suitable for either treatment option. 1018 patients were recruited from 20 cardiology centres in UK and Ireland. The 504 randomised to PTCA were intended to have dilatation within 3 months. The 514 assigned to medical treatment received antianginal drugs; those whose symptoms were not controlled by optimum medical therapy could cross-over to myocardial revascularisation. The primary endpoint was the combined frequency of death from all causes and definite non-fatal myocardial infarction.

Findings

This report covers a median 2·7 years' follow-up. At randomisation 53% of patients had grade 2 or worse angina, and 40% had two or more diseased coronary arteries. 93% of patients randomised to PTCA had this procedure carried out, within a median of 5 weeks. Death or definite myocardial infarction occurred in 32 patients (6·3%) treated with PTCA and in 17 patients (3·0%) with medical care (absolute difference 3·0% [95% Cl 0·4–5·7%], p=0·02). This difference was mainly due to one death and seven non-fatal myocardial infarctions related to the randomised procedures. There were 18 deaths (11 PTCA, seven medical) of which ten were not due to heart disease. Of the patients in the PTCA group, 40 (7·9%) required coronary artery bypass grafting (CABG), including nine instead of PTCA and seven emergencies following unsuccessful PTCA. 56 other PTCA patients (11·1%) required further non-randomised PTCA. In the medical group 118 patients (23·0%) underwent a revascularisation procedure during follow-up, mostly because of worsening symptoms. Angina improved in both groups, but more so in the PTCA group. There was a 16·5% absolute excess of grade 2 or worse angina in the medical group 3 months after randomisation (p < 0·001), which attenuated to 7·6% after 2 years. Total exercise time (Bruce protocol) also improved in both groups, again with a treatment difference in favour of PTCA: mean advantage of 35 s at 3 months (p < 0·001). These benefits of PTCA were greater in patients with more severe angina at baseline, judged by high initial grade of angina and short initial exercise-time.

Interpretation

In patients with coronary artery disease considered suitable for either PTCA or medical care, early intervention with PTCA was associated with greater symptomatic improvement, especially in patients with more severe angina. When managing individuals with angina, clinicians must balance these benefits against the small excess hazard associated with PTCA due to procedure-related complications.

Introduction

For patients with angina who require revascularisation, randomised trials comparing the long-term effects of coronary angioplasty and coronary artery bypass surgery1, 2, 3 have provided important information for clinical management. Randomised trials are also needed to determine whether patients in whom myocardial revascularisation is not essential should be treated by early angioplasty, or can have revascularisation deferred. The Veterans Administration Angioplasty Compared to Medicine trial4 is relevant but had limited power to detect clinically important differences.

The second Randomised Intervention Treatment of Angina (RITA-2) trial was designed to compare the effects of initial strategies of coronary angioplasty and conservative (medical) care over at least 5 years' follow-up in patients deemed suitable for either treatment. We present the interim results of RITA-2 after a median 2·7 years' follow-up.

Section snippets

Patients

Patients were recruited at 20 centres in the UK and Ireland. The ethics committee of each centre approved the protocol. Patients with coronary artery disease proven arteriographically were considered if the supervising cardiologist thought that both continued medical therapy and coronary angioplasty were acceptable alternatives. All eligible patients had a significant stenosis in at least one major epicardial vessel that appeared technically amenable to balloon dilatation. Patients had to be

Results

1018 patients were randomised to coronary angioplasty (504) or continued medical treatment (514). This report concerns follow-up to Nov 30, 1996, which was complete for 98% of patients. Minimum and median follow-ups were 6 months and 2·7 years respectively.

Discussion

RITA-2 was designed to compare initial policies of PTCA and medical care in patients with coronary artery disease in whom both treatments were deemed acceptable. Our patients ranged from those with no angina and single-vessel disease to those with severe symptoms and multivessel disease. Most had mild symptoms, one-vessel or two-vessel disease and preserved left-ventricular-function scores, and would be predicted to be at low cardiovascular risk.6, 13, 14 The patients were therefore not

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