Bivalirudin vs. Heparin for Improving Clinical Outcomes in PCI patients

Akpan Anani, Mercer College of Pharmacy

For patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS), anticoagulant therapy is necessitated by risk of thrombotic events. [1] Angiomax® (bivalirudin) is a direct thrombin inhibitor indicated for patients undergoing PCI and concurrently using a glycoprotein IIb/IIIa inhibitor (GPI). [2] Bivalirudin has been shown in some studies to cause less major bleeding than Hep-Lock® (heparin) in myocardial infarction (MI) patients needing anticoagulation [1,3]; however, limited research exists comparing bivalirudin to heparin for assessment of repeat MI or all-cause mortality risk.

Bivalirudin versus Heparin Monotherapy in Myocardial Infarction [4]
Design A multicenter, randomized, registry-based, open-label clinical trial; N= 6,006
Objective To compare the effectiveness of bivalirudin compared to heparin in patients undergoing PCI
Study Groups Bivalirudin group; n= 3,004

Heparin group; n= 3,002

Methods Participants were STEMI or NSTEMI patients undergoing PCI and currently on antiplatelet therapy. Randomization to either bivalirudin or heparin occurred in a 1:1 ratio during PCI. Bivalirudin was given as an IV bolus of 0.75 mg/kg followed by infusion until after PCI was completed. Heparin was administered at 70 to 100 U/kg.

Measurements of activated clotting time occurred 10 minute after the initiation of treatment interventions. Follow-up occurred at 180 days.

Duration June 2014 to September 2016
Primary Outcome Measure A composite of death from any cause, myocardial infarction, or major bleeding during 180 days of follow-up
Baseline Characteristics  

Characteristic Bivalirudin group

(n= 3004)

Heparin group

(n= 3002)

STEMI—no. (%) 1501 (50.0) 1504 (50.1)
Male—no. (%) 2229 (74.2) 2177 (72.5)
Median age—yr 68.0 68.0
Weight<60 kg.—no. (%) 139 (4.6) 156 (5.2)
Diabetes—no. (%) 491 (16.3) 508 (16.9)
Hypertension—no. (%) 1557 (51.8) 1548 (51.6)
Previous MI—no. (%) 490 (16.3) 484 (16.1)
Previous PCI—no. (%) 456 (15.2) 426 (14.2)
Previous stroke—no. (%) 115 (3.8) 125 (4.2)

 

 

Results  

Clinical Outcomes at 180 days
Outcome Bivalirudin group

N= 3004

Heparin group

N= 3002

Hazard ratio

(95% CI)

p value
Primary end point: death from any cause, MI, or major bleeding 369 (12.3) 383 (12.8) 0.96 (0.83-1.10) 0.54

 

 

Adverse Events Common Adverse Events: N/A
Serious Adverse Events: N/A
Percentage Discontinued due to Adverse Events: N/A
Study Author Conclusions The rate of composite of death from any cause, myocardial infarction, or major bleeding was not lower in the bivalirudin group compared to the heparin group.

A major limitation of this study is the open-label design; potential bias is introduced if the healthcare provider can link outcome events to the source intervention. An additional limitation is that the trial population may not be indicative of all patients undergoing PCI for an acute MI, given the fact that the primary outcome would be more likely in individuals not enrolled in study (e.g. less stringent observation and acute management). Lack of statistical significance for the primary endpoint lends credence to the authors’ conclusion of no difference between treatment with bivalirudin and heparin, allowing practitioners to consider use of either agent in the patient population.

 

References

[1] Stone GW, Witzenbichler B, Guagliumi G, et al. Bivalirudin during primary PCI in acute myocardial infarction. N Engl J Med. 2008;358(21):2218-30.

[2] ANGIOMAX® injection. [package insert]. Parsippany, NJ: The Medicines Company; 2016.

[3] Stone GW, Mclaurin BT, Cox DA, et al. Bivalirudin for patients with acute coronary syndromes. N Engl J Med. 2006;355(21):2203-16.

[4] Erlinge D, Omerovic E, Fröbert O, et al. Bivalirudin versus heparin monotherapy in myocardial infarction. N Engl J Med. 2017.

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