Key result
Reintroduction of heparin instead of bivalirudin for primary PCI resulted in similar 180-day mortality (11.29% vs 11.03%; HR 0.98, 95% CI 0.72-1.33) and 30-day bleeding, with major cost reductions.
Why the study?
Does heparin compared to bivalirudin improve clinical outcomes and reduce costs in patients undergoing primary PCI?
Cohort (n=1,291)
Open-label
No
Does heparin compared to bivalirudin improve clinical outcomes and reduce costs in patients undergoing primary PCI?
Hazard Ratio: 0.98 (95% CI 0.72–1.33)
Absolute Event Rate: 11.29% vs 11.03%
p-value: p=0.88
Reintroducing heparin instead of bivalirudin as standard anticoagulation for primary PCI maintained similar clinical and safety outcomes while substantially reducing treatment costs.
May support heparin reintroduction for PPCI cost savings; leaves open randomized confirmation of safety.
Background: The evidence for benefits of bivalirudin over heparin has recently been challenged. We aimed to analyse the safety and cost-effectiveness following reintroduction of heparin instead of bivalirudin as the standard anticoagulation for primary percutaneous coronary intervention (PPCI) in a high-volume centre. Methods and results: This analysis was an open-label, prospective registry including all patients admitted to our centre for PPCI from April 2014 to April 2016. Heparin was reintroduced as standard anticoagulant in April 2015. During the 2 years, 1291 patients underwent a PPCI, 662 in the Bivalirudin protocol period (Cohort B) and 629 in the Heparin protocol period (Cohort H). Baseline and procedural characteristics were not significantly different, except for a higher use of thromboaspiration and femoral access in the earlier Cohort B. Glycoprotein 2b3a (Gp2b3a) antagonists were used in 24% of the patients in Cohort B versus 28% in Cohort H (P<0.01). We did not observe any differences in death at 180 days (11.03% in Cohort B vs 11.29% in Cohort H)(HR 95% CI 0.98 (0.72 to 1.33), P=0.88). The incidence of any bleeding complications at 30 days did not differ between the two periods (21.9% vs 21.9%, P=0.99). The cost related to the anticoagulants amounted to £246 236 in Cohort B versus £4483 in Cohort H (£324 406 vs £102 347 when adding Gp2b3a antagonists). Conclusion: We did not find clinically relevant changes in patient outcomes, including bleeding complications with reintroduction of heparin in our PPCI protocol. However, the use of heparin was associated with a major reduction in treatment costs.
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Deharo et al. (2018) conducted a cohort in Primary percutaneous coronary intervention (PPCI) (n=1,291). Heparin vs. Bivalirudin was evaluated on Death at 180 days (HR 0.98, 95% CI 0.72 to 1.33, p=0.88). Reintroduction of heparin instead of bivalirudin for primary PCI resulted in similar 180-day mortality (11.29% vs 11.03%; HR 0.98, 95% CI 0.72-1.33) and 30-day bleeding, with major cost reductions.
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