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 (3.3%) with medical care (absolute difference 3.0% [95% CI 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 withPTCA 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.
RCT Entities:
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 (3.3%) with medical care (absolute difference 3.0% [95% CI 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.