Primary and secondary outcomes over follow-up period (≥18 months; median 694 (IQR 558–841) days)
| Outcome | Trial N=60 | Registry N=73 | HR (registry vs trial) (95% CI) |
| Primary efficacy outcome | |||
| Composite of all-cause mortality, rehospitalisation for refractory ischaemia/angina, MI and HF | 26 (43%) | 36 (49%) | 1.14 (0.69 to 1.89) |
| Primary safety outcome | |||
| Composite of bleeding (BARC≥2), stroke, procedure-related MI and worsening renal function during the index hospitalisation | 17 (28%) | 16 (22%) | 0.74 (0.37 to 1.46) |
| Experienced both primary efficacy and safety outcomes | 10 (17%) | 8 (11%) | 0.64 (0.25 to 1.63) |
| Experienced either primary efficacy or safety outcomes | 33 (55%) | 44 (60%) | 1.05 (0.67 to 1.65) |
| Components of primary efficacy outcome | |||
| All-cause mortality | 8 (13%) | 17 (23%) | |
| Cardiovascular death | 2 (3%) | 10 (14%) | |
| Non-cardiovascular death | 4 (7%) | 5 (7%) | |
| Unknown cause of death | 2 (3%) | 2 (3%) | |
| Rehospitalisation for refractory ischaemia/angina | 0 (0%) | 0 (0%) | |
| Non-fatal MI | 22 (37%) | 18 (25%) | |
| HF | 7 (12%) | 11 (15%) | |
| Primary efficacy outcome at 12 months | |||
| Composite of all-cause mortality, rehospitalisation for refractory ischaemia/angina, MI and HF at 12 months | 20 (33%) | 23 (32%) | |
| All-cause mortality at 12 months | 5 (8%) | 9 (12%) | |
| Components of primary safety outcome | |||
| Bleeding (BARC 2–4) | 11 (18%) | 10 (14%) | |
| Stroke | 0 (0%) | 2 (3%) | |
| Procedure-related MI | 0 (0%) | 0 (0%) | |
| Worsening renal function during the index hospitalisation | 8 (13%) | 5 (7%) | |
| Primary safety outcome at 12 months | |||
| Composite of bleeding (BARC≥2), stroke, procedure-related MI and worsening renal function during the index hospitalisation at 12 months | 12 (20%) | 14 (19%) | |
| Other secondary outcomes | |||
| Total number of SAE | 170 | 117 | |
| Number of patients with a SAE | 40 (67%) | 49 (67%) | |
| Number of SAEs per patient, median (IQR) | 1(0, 2) | 1(0, 2) | |
| Number of patients experiencing | |||
| Rehospitalisation | 39 (65%) | 47 (64%) | |
| Invasive management (coronary angiography) | 46 (77%) | 40 (55%) | |
| PCI | 21 (35%) | 18 (25%) | |
| Redo CABG | 0 (-) | 1 (1%) | |
| Coronary revascularisation (PCI or CABG) | 21 (35%) | 18 (25%) | |
| Quality of life and angina | |||
| EQ-VAS health status, 6 months, median (IQR) | 75 (60-80) | 50 (40-75) | |
| EQ-5D-5L score, 6 months, median (IQR) | 0.82 (0.53-0.94) | 0.61 (0.29-0.82) | |
| CCS angina class, 6 months, median (IQR) | 3.0 (1.0-3.0) | 3.0 (2.0-4.0) | |
| EQ-VAS health status, 12 months, median (IQR) | 70 (50-80) | 58 (40-75) | |
| EQ-5D-5L score, 12 months, median (IQR) | 0.82 (0.62-0.95) | 0.78 (0.50-0.89) | |
| CCS angina class, 12 months, median (IQR) | 3.0 (3.0-4.0) | 3.0 (2.0-4.0) | |
HRs and corresponding 95% CI from an unadjusted Cox model are given for the time from study entry to occurrence of primary outcomes only, comparing the registry to the trial group. Median (IQRs) are used for non-normally distributed data. Follow-up period was over median 694 (IQR 558–841) days.
BARC, Bleeding Academic Research Consortium; CABG, coronary artery bypass graft; CCS, Canadian Cardiovascular Society; EQ-5D-5L, EuroQol 5 Dimensions 5 Levels; EQ-VAS, EuroQol Visual Analogue Scale; HF, heart failure; MI, myocardial infarction; PCI, percutaneous coronary intervention; SAE, serious adverse event.