Table 2

Multicentre clinical trials in stable ischaemic heart disease

NameRegistration & fundingObjectiveSample sizeMain finding and conclusion
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.1548Regarding 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-1BCISTo assess the utility of elective IABP use during high-risk PCI.301All-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 2NCT01664858
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.1202The 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.
To assess whether stratified medicine involving tests of coronary function changes the diagnosis and treatment and improves health and economic outcomesRegistry—391
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.
EUROPAServierTo 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 65510% 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.
ORBITANIHR Imperial Biomedical Research CentreTo assess the placebo-controlled efficacy of PCI on symptoms in stable CAD200There 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).
RITAUK Department of Health
To compare the efficacy of CABG vs PTCA on the primary endpoint of death or non-fatal MI in stable CAD1011There 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).
To compare the long-term effects of PTCA and conservative (medical) care in patients with CAD considered suitable for either treatment option.1018Death 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-HEARTChief Scientific Office of Scottish GovernmentTo 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.4146The 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.