Bottomline-CS
Trial question
What is the effect of multisite tissue oxygenation-guided care in patients who were scheduled for elective off-pump CABG?
Study design
Single center
Open label
RCT
Population
Characteristics of study participants
30.0% female
70.0% male
N = 1941
1941 patients (580 female, 1361 male).
Inclusion criteria: adult patients, aged ≥ 60 years, who were scheduled for elective off-pump CABG.
Key exclusion criteria: preoperative dependence on respiratory support; use of an external cardiac assist device; urgent or emergent surgery; life expectancy ≤ 30 days.
Interventions
N=967 guided care (multisite monitoring of tissue oxygen saturation by use of near-infrared spectroscopy and hemodynamic monitoring).
N=974 usual care (standard perioperative care managed by clinical staff).
Primary outcome
Postoperative complications at day 30
47.3%
47.8%
47.8 %
35.8 %
23.9 %
11.9 %
0.0 %
Guided
care
Usual
care
No significant
difference ↔
No significant difference in postoperative complications at day 30 (47.3% vs. 47.8%; RR 0.99, 99% CI 0.9 to 1.08).
Secondary outcomes
No significant difference in cerebral complications (32.2% vs. 31.7%; RR 1.01, 95% CI 0.89 to 1.15).
No significant difference in cardiac complications (9.4% vs. 8.4%; RR 1.12, 95% CI 0.84 to 1.49).
No significant difference in AF (30.3% vs. 30.3%; RR 1, 95% CI 0.87 to 1.15).
Conclusion
In adult patients, aged ≥ 60 years, who were scheduled for elective off-pump CABG, guided care was not superior to usual care with respect to postoperative complications at day 30.
Reference
Jiange Han, Wenqian Zhai, Zhenhua Wu et al. Care guided by tissue oxygenation and haemodynamic monitoring in off-pump coronary artery bypass grafting (Bottomline-CS): assessor blind, single centre, randomised controlled trial. BMJ. 2025 Mar 24:388:e082104.
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