Multicentre clinical trials in stable ischaemic heart disease
| Name | Registration & funding | Objective | Sample size | Main finding and conclusion |
| ART | ISRCTN46552265 BHF | To compare 10-year survival rates associated with bilateral and single internal-thoracic-artery grafting and secondary outcomes included clinical events, quality of life and health economic measures. | 1548 | Regarding the composite outcome of death, myocardial infarction or stroke, there were 385 patients (24.9%) with an event in the bilateral-graft group and 425 patients (27.3%) with an event in the single-graft group (HR, 0.90; 95% CI 0.79 to 1.03). |
| BCIS-1 | BCIS | To assess the utility of elective IABP use during high-risk PCI. | 301 | All-cause mortality at follow-up was 33% in the overall cohort, with significantly fewer deaths occurring in the elective IABP group (n=42) than in the group that underwent PCI without planned IABP support (n=58) (HR, 0.66; 95% CI 0.44 to 0.98; p=0.039). |
| CEMARC 2 | NCT01664858 BHF | To test the hypothesis that among patients with suspected CHD, CMR-guided care is superior to NICE guidelines-directed care and MPS-guided care in reducing unnecessary angiography. | 1202 | The number of patients with invasive coronary angiography after 12 months was 102 in the NICE guidelines group (42.5%(95% CI 36.2% to 49.0%))], 85 in the CMR group (17.7% (95% CI 14.4% to 21.4%)) and 78 in the MPS group (16.2% (95% CI 13.0% to 19.8%)). Study-defined unnecessary angiography occurred in 69 (28.8%) in the NICE guidelines group, 36 (7.5%) in the CMR group and 34 (7.1%) in the MPS group; adjusted OR of unnecessary angiography: CMR group vs NICE guidelines group, 0.21 (95% CI 0.12 to 0.34, p<0.001); CMR group vs the MPS group, 1.27 (95% CI 0.79 to 2.03, p=0.32). In patients with suspected angina, investigation by CMR resulted in a lower probability of unnecessary angiography within 12 months than NICE guideline-directed care, with no statistically significant difference between CMR and MPS strategies. |
| CorMicA | NCT03193294 BHF | To assess whether stratified medicine involving tests of coronary function changes the diagnosis and treatment and improves health and economic outcomes | Registry—391 Trial—151 | The intervention resulted in a mean improvement of 11.7 U in the Seattle Angina Questionnaire summary score at 6 months (95% CI 5.0 to 18.4; p=0.001). In addition, the intervention led to improvements in the mean quality-of-life score (EQ-5D index 0.10 U; 95% CI 0.01 to 0.18; p=0.024) and visual analogue score (14.5 U; 95% CI 7.8 to 21.3; p<0.001). Stratified medical therapy was routinely feasible and improved angina in patients with no obstructive CAD. |
| EUROPA | Servier | To assess whether the ACE inhibitor perindopril reduced cardiovascular risk in a low-risk population with stable coronary heart disease and no apparent heart failure. | 13 655 | 10% placebo and 8% perindopril patients experienced the primary endpoint, which yields a 20% relative risk reduction (95% CI 9 to 29, p=0.0003) with perindopril. |
| ORBITA | NIHR Imperial Biomedical Research Centre | To assess the placebo-controlled efficacy of PCI on symptoms in stable CAD | 200 | There was no significant difference in the primary endpoint of exercise time increment between groups (PCI minus placebo 16.6 s, 95% CI –8.9 to 42.0, p=0.200). |
| RITA | UK Department of Health BHF BCS | To compare the efficacy of CABG vs PTCA on the primary endpoint of death or non-fatal MI in stable CAD | 1011 | There was no difference in the predefined primary endpoint of death or non-fatal MI which occurred in 17% PTCA-group patients and 16% CABG-group patients (p=0.64). |
| RITA-2 | BHF MRC | To compare the long-term effects of PTCA and conservative (medical) care in patients with CAD considered suitable for either treatment option. | 1018 | Death or definite myocardial infarction occurred in 6.3% treated with PTCA and in 3.3% with medical care (absolute difference 3.0%(95% CI 0.4% to 5.7%), p=0.02). |
| SCOT-HEART | Chief Scientific Office of Scottish Government | To assess if the use of coronary computed tomographic angiography (CTA) improves diagnostic certainty in the assessment of patients with stable chest pain and improves 5 year clinical outcomes. | 4146 | The 5 year rate of the primary end point of death from coronary heart disease or nonfatal MI was lower in the CTA group than in the standard-care group (2.3% vs 3.9%; HR, 0.59; 95% CI, 0.41 to 0.84; p=0.004). |
BCS, British Cardiovascular Society; BHF, British Heart Foundation; CABG, coronary artery bypass surgery; CAD, coronary artery disease; CMR, cardiovascular magnetic resonance; IABP, intra-aortic balloon pump; MPS, myocardial perfusion scintigraphy; NICE, National Institute for Health and Care Excellence; PCI, percutaneous coronary intervention; PTCA, percutaneous transluminal coronary angioplasty.