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Healio
October 28, 2015
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Protamine use after CEA decreases bleeding complications

The use of protamine after carotid endarterectomy appears to yield decreased bleeding complications without increasing thrombotic events, according to recent findings.

In the meta-analysis, researchers queried the Medline, Embase and Cochrane Library databases, clinical trial registries, and proceedings/abstracts from the annual Society for Vascular Surgery and American Heart Association Scientific Sessions meetings to identify 12 observational studies (n = 10,621) comparing heparin reversal with protamine sulfate vs. no protamine in patients undergoing carotid revascularization.

The study’s main outcome of interest was stroke, and secondary outcomes included thromboembolic complications, including death, MI and transient ischemic attack. The researchers also analyzed bleeding events as a secondary outcome to determine the possible benefits conferred with protamine use. They used random-effects models to determine RRs.

The researchers found that of the nine studies (n = 9,932) that addressed patients undergoing carotid endarterectomy (CEA) and had usable data on periprocedural stroke, the rate of perioperative stroke was 1.59% in patients who received protamine. Among the 6,025 patients who underwent CEA without receiving protamine, the rate of periprocedural stroke was 2.02%. Based on the weighted summary estimate, there was no significant difference between groups (RR = 0.84; 95% CI, 0.55-1.29). There was a low heterogeneity among trials, implying a significant lack of disparity in stroke risk between those who were and were not treated with protamine. Sensitivity analyses accounting for high bias risk, older studies or larger sample size did not alter these findings.

Pooling the findings across 10 studies of patients with CEA (n = 8,553) that included data on major bleeding, the researchers found that the risk for major bleeding was 1.7% among patients receiving protamine and 3.5% in patients who did not receive protamine. In the weighted pooled estimate, a statistically significant difference in favor of protamine use was seen across all 10 studies (RR = 0.52; 95% CI, 0.34-0.8).

Data on all-cause mortality among patients with CEA were available for seven studies. Pooling these findings, the researchers found no significant differences among patients treated with protamine (1.2%) and those who were not (1.7%; weighted pooled estimate: RR = 0.9; 95% CI, 0.62-1.29). Likewise, rates of MI in the three studies addressing this outcome after CEA found no difference between protamine vs. no protamine (RR = 0.89; 95% CI, 0.53-1.51).

In a related editorial, Claudio Baracchini, MD, and Enzo Ballotta, MD, of the University of Padua School of Medicine in Italy, wrote that these findings strongly support the routine use of protamine in CEA.

“Commendably, Newhall et al have conducted a meta-analysis that has significant clinical implications: Surgeons should consider routinely using protamine during CEA because of a reduced risk for bleeding,” they wrote. “Failing to reverse heparin would simply result in more unpredicted life-threatening sequelae of surgical re-explorations, with the potential for greater morbidity and mortality.” – by Jennifer Byrne

Disclosure: The researchers report no relevant financial disclosures.

Sources/Disclosures

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Source:

Baracchini C, Ballotta E. JAMA Surg. 2015;doi:10.1001/jamasurg.2015.3615.
Newhall KA, et al. JAMA Surg. 2015;doi:10.1001/jamasurg.2015.3592.