Invasive versus medical management in patients with prior coronary artery bypass surgery with a non-ST segment elevation acute coronary syndrome: a pilot randomized controlled trial

Background: The benefits of routine invasive management in patients with prior coronary artery bypass grafts presenting with non-ST elevation acute coronary syndromes are uncertain because these patients were excluded from pivotal trials. Methods: In a multicenter trial, non-ST elevation acute coronary syndromes patients with prior coronary artery bypass graft were prospectively screened in 4 acute hospitals. Medically stabilized patients were randomized to invasive management (invasive group) or noninvasive management (medical group). The primary outcome was adherence with the randomized strategy by 30 days. A blinded, independent Clinical Event Committee adjudicated predefined composite outcomes for efficacy (all-cause mortality, rehospitalization for refractory ischemia/angina, myocardial infarction, hospitalization because of heart failure) and safety (major bleeding, stroke, procedure-related myocardial infarction, and worsening renal function). Results: Two hundred seventeen patients were screened and 60 (mean±SD age, 71±9 years, 72% male) were randomized (invasive group, n=31; medical group, n=29). One-third (n=10) of the participants in the invasive group initially received percutaneous coronary intervention. In the medical group, 1 participant crossed over to invasive management on day 30 but percutaneous coronary intervention was not performed. During 2-years’ follow-up (median [interquartile range], 744 [570–853] days), the composite outcome for efficacy occurred in 13 (42%) subjects in the invasive group and 13 (45%) subjects in the medical group. The composite safety outcome occurred in 8 (26%) subjects in the invasive group and 9 (31%) subjects in the medical group. An efficacy or safety outcome occurred in 17 (55%) subjects in the invasive group and 16 (55%) subjects in the medical group. Health status (EuroQol 5 Dimensions) and angina class in each group were similar at 12 months. Conclusions: More than half of the population experienced a serious adverse event. An initial noninvasive management strategy is feasible. A substantive health outcomes trial of invasive versus noninvasive management in non-ST elevation acute coronary syndromes patients with prior coronary artery bypass grafts appears warranted. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01895751

Invasive versus medically managed acute coronary syndromes with prior bypass (CABG-ACS): insights into the registry versus randomised trial populations

Background: Coronary artery bypass graft (CABG) patients are under-represented in acute coronary syndrome (ACS) trials. We compared characteristics and outcomes for patients who did and did not participate in a randomised trial of invasive versus non-invasive management (CABG-ACS). Methods: ACS patients with prior CABG in four hospitals were randomised to invasive or non-invasive management. Non-randomised patients entered a registry. Primary efficacy (composite of all-cause mortality, rehospitalisation for refractory ischaemia/angina, myocardial infarction (MI), heart failure) and safety outcomes (composite of bleeding, stroke, procedure-related MI, worsening renal function) were independently adjudicated. Results: Of 217 patients screened, 84 (39%) screenfailed, of whom 24 (29%) did not consent and 60 (71%) were ineligible. Of 133 (61%) eligible, 60 (mean±SD age, 71±9 years, 72% male) entered the trial and 73 (age, 72±10 years, 73% male) entered a registry (preferences: physician (79%), patient (38%), both (21%)). Compared with trial participants, registry patients had more valve disease, lower haemoglobin, worse New York Heart Association class and higher frailty. At baseline, invasive management was performed in 52% and 49% trial and registry patients, respectively, of whom 32% and 36% had percutaneous coronary intervention at baseline, respectively (p=0.800). After 2 years follow-up (694 (median, IQR 558–841) days), primary efficacy (43% trial vs 49% registry (HR 1.14, 95% CI 0.69 to 1.89)) and safety outcomes (28% trial vs 22% registry (HR 0.74, 95% CI 0.37 to 1.46)) were similar. EuroQol was lower in registry patients at 1 year. Conclusions: Compared with trial participants, registry participants had excess morbidity, but longer-term outcomes were similar. Trial registration number: NCT01895751

Non-Invasive Versus Invasive Management in Patients With Prior Coronary Artery Bypass Surgery With a Non-ST Segment Elevation Acute Coronary Syndrome: Comparisons Between the Randomized Controlled Pilot Trial and Registry

Background: Elderly patients with multi-morbidity are often under-represented in clinical trials. The CABG-ACS pilot trial (NCT01895751) prospectively assessed reasons for entering the trial or registry and subsequent outcomes. Methods: Patients with a non-ST segment elevation acute coronary syndrome (NSTE-ACS) and prior coronary artery bypass graft (CABG) admitted to 4 hospitals were randomized to invasive or non-invasive management. Non-randomized patients entered a follow-up registry. The primary efficacy outcome was a composite of all-cause death, rehospitalization for refractory ischemia/angina, myocardial infarction (MI) and hospitalization due to heart failure. The primary safety outcome was the composite of bleeding, stroke, procedure-related MI and worsening renal function. A blinded Clinical Event Committee independently assessed events. EuroQol-5 Dimensions (EQ-5D) was assessed at 6 monthly intervals for ≥18 months. Results: 217 patients with prior CABG and unplanned hospitalization for suspected ACS were screened. 84 subjects did not consent (≥1 reasons): 43 not NSTE-ACS, 35 unsuitable for invasive management, 9 refractory ischemia, 3 unable to consent. Of 133 eligible subjects, 60 (mean±SD age 71±9 years, 28% female) entered the trial and 73 (age 72±10 years, 27% female) entered the registry (preferences: physician 79%, patient 40% or both 18%). Compared to trial patients, registry patients had significantly more valve disease, lower hemoglobin, worse New York Heart Association class and higher frailty index. Baseline EQ-5D, medications and left internal mammary artery grafts were similar. Registry patients had significantly more medication changes due to recurrent angina and more urgent inpatient invasive procedures. The primary efficacy outcome occurred in 49% registry vs. 43% trial patients (HR (95% CI) 1.12 (0.77,1.63); p=0.601). Primary safety outcomes were similar (22% registry vs. 28% trial; HR 0.76 (0.42,1.38); p=0.425). EQ-5D health status was lower in the registry at 6 months (p=0.011) but not at 1 year (p=0.068). Conclusion: Compared to trial patients, the registry had excess morbidity but their longer term health outcomes were similar

Ueber S. Berti' Beitraege zur Intervallarithmetik

SIGLECopy held by FIZ Karlsruhe; available from UB/TIB Hannover / FIZ - Fachinformationszzentrum Karlsruhe / TIB - Technische InformationsbibliothekDEGerman

Routine Non-invasive vs Invasive Management in Patients With Prior CABG With a NSTE-ACS: a Randomised Controlled Trial

Background: There is an evidence-gap about how to best treat patients with a history of prior CABG presenting with a NSTE-ACS because these patients were excluded from key randomised trials. Methods: The CABG-ACS pilot trial (NCT01895751) randomised patients with a NSTE-ACS and prior CABG to routine invasive or non-invasive management. The primary efficacy outcome was a composite of all-cause death, rehospitalisation for refractory ischaemia/angina, MI and HF hospitalisation. The primary safety outcome was a composite of bleeding, stroke, procedure-related MI and worsening renal function. A CEC assessed events. Results: 60 patients (mean ±SD age 71±9 years, 28% female) were randomised to invasive (n=31) or non-invasive (n=29) management. The invasive group had worse NYHA class (p=0.044) and less valve disease (17% vs 27%; p=0.035). Other comorbidities, age, sex, CCS grade, frailty score and medications were similar. Baseline LIMA grafts were similar (p=0.720). All invasive group patients had invasive management (mean BCIS-1 Jeopardy Score 7±4) and 6 (19%) had PCI. 6 non-invasive group patients ended up having invasive management and 3 (50%) had PCI. No patients had redo CABG. The primary efficacy outcome occurred in 42% invasive vs 45% non-invasive groups (RR (95% CI) 0.94 (0.52, 1.67); p=1.000). The primary safety outcome occurred in 26% invasive vs 31% non-invasive groups (RR 0.83 (0.37, 1.86); p=0.777). EQ-5D was similar at 1 year. Conclusion: Compared with routine non-invasive management, a strategy of routine invasive management was not associated with patient benefits