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Beneficial effects of complement inhibition with soluble complement receptor 1 (TP10) during cardiac surgery: is
Harold L Lazar1, Taha Keilani, Carmel A Fitzgerald
1Department of Cardiothoracic Surgery, Boston University School of Medicine and the Boston Medical Center, 88 East Newton Street, Suite B402, Boston, MA 02118, USA. harold.lazar@bmc.org
Insights
TP10 effectively inhibited complement activation in high-risk female patients during cardiac surgery but did not reduce the incidence of death or myocardial infarction, suggesting gender-related benefits.
Area of Science:
- Cardiology
- Immunology
- Pharmacology
Background:
- TP10, a complement inhibitor, reduced death and myocardial infarction (MI) in high-risk male cardiac surgery patients.
- The efficacy of TP10 in high-risk female patients undergoing cardiopulmonary bypass (CPB) remained undefined due to limited prior study data.
Purpose of the Study:
- To investigate the potential gender-specific effects of TP10 in high-risk female patients undergoing cardiac surgery.
- To determine if TP10 limits ischemic damage in females, similar to its observed effects in males.
Main Methods:
- A prospective, double-blind, placebo-controlled, multi-center trial involving 297 high-risk female patients randomized to TP10 or placebo.
- TP10 (5 mg/kg IV infusion) or placebo administered pre-surgery; primary endpoint was 28-day incidence of death or MI.
- Complement activation assessed via CH50 and SC5b-9 levels during and after CPB.
Main Results:
- TP10 was well-tolerated with no significant differences in safety profiles between groups.
- TP10 effectively suppressed complement activation (CH50 and SC5b-9 levels significantly reduced, P<0.0001).
- No significant difference in the primary endpoint (death or MI) between TP10 (21%) and placebo (17%) groups (P=0.2550).
Conclusions:
- The therapeutic benefits of TP10 appear to be gender-dependent, observed in males but not females in this study.
- Mechanisms beyond complement activation likely contribute to myocardial injury in high-risk females during CPB.
- Further research is needed to understand the gender-related efficacy of TP10 in cardiac surgery.
Background:
TP10, a potent inhibitor of complement activation during cardiopulmonary bypass (CPB) has been shown to significantly reduce the incidence of death and myocardial infarction (MI) in high-risk male patients undergoing cardiac surgery. However, the effect of TP10 in females was undefined because of the limited number of females studied. To examine the possibility of a gender effect, this phase 2 multi-center trial was undertaken to determine whether TP10 would also limit ischemic damage in a larger sample size of high-risk females undergoing cardiac surgery on cardiopulmonary bypass (CPB).
Methods And Results:
This prospective, double-blind, placebo-controlled, multi-center trial involved 297 high-risk (urgent surgery, CABG + Valve, reoperations, ejection fraction <30%) female patients randomized to receive a 5 mg/kg dose of TP10 (n=150) or placebo (n=147) as a 30-minute intravenous infusion before surgery. The primary end point was the incidence of death or MI at 28 days after surgery. Complement activation was assessed by levels of CH50 and SC5b-9 during and after CPB. TP10 was well tolerated and there were no differences in the safety profiles of the 2 groups. Although TP10 effectively suppressed complement activation (at 2 hours after CPB CH50 (mean+SD % change from baseline) 50+/-17% placebo versus 4+/-14% TP10; P=0.0001; SC5b-9 (ng/mL) 917+/-1067 placebo versus 204+/-79 TP10; P=0.0001), there was no difference in the primary end point between the groups (17% placebo versus 21% TP10; P=0.2550).
Conclusions:
The benefits of TP10 appear to be gender-related. and mechanisms other than complement activation may be responsible for myocardial injury in high-risk female patients during cardiac surgery on CPB.
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