Time to Revisit Your Procedural Anticoagulation Strategy for PCI?

Summary and Comment |
August 27, 2017

Time to Revisit Your Procedural Anticoagulation Strategy for PCI?

  1. Harlan M. Krumholz, MD, SM

A Swedish registry-based trial casts doubt on bivalirudin's superiority over heparin in contemporary practice settings.

  1. Harlan M. Krumholz, MD, SM

What is the best anticoagulation strategy for patients with acute myocardial infarction (MI) undergoing percutaneous coronary intervention (PCI)? Some previous studies have indicated that compared with heparin, bivalirudin reduces the risk for bleeding; however the relevance of these findings in an era of radial artery access and the use of potent P2Y12 inhibitors with rescue-only glycoprotein IIb/IIIa inhibitors (GPIIb/IIIa) is uncertain.

In VALIDATE-SWEDEHEART (NCT02311231), a registry-based randomized trial, investigators compared bivalirudin with heparin in 6006 patients with acute MI undergoing PCI at 25 centers in Sweden. Radial access was used in 90% of the patients. Ticagrelor was used in 95% and prasugrel in 2% of the patients. Almost two thirds of the patients in the bivalirudin group received a prolonged infusion. Rescue GPIIb/IIIa therapy was deployed in <3% of patients in both groups.

Rates of the primary outcome, a composite of death from any cause, MI, and major bleeding events, did not differ significantly between the two groups at 30 days or 6 months. The results were consistent across subgroups. Major bleeding also did not differ between the two groups.


These findings suggest that bivalirudin, perhaps useful in an earlier era, may no longer be worth the added expense compared with heparin. An editorialist, however, points out the study's limitations and concludes that, in his opinion, whether the two drugs should now be considered equivalent remains uncertain. While we await the results of forthcoming meta-analyses, I believe it is reasonable to question the relevance of the older trials. Maybe it is time to try a rapid, registry-based trial in the U.S. like the one these researchers completed in Sweden. In the meantime, debate about whether the more expensive treatment is still delivering benefit is likely to continue.

Editor Disclosures at Time of Publication

  • Disclosures for Harlan M. Krumholz, MD, SM at time of publication Consultant / Advisory board United Healthcare; Element Science; Aetna; IBM Watson Equity ImageCor; Me2Health Grant / Research support Agency for Healthcare Research and Quality; Food and Drug Administration; Robert Wood Johnson Foundation; Medtronic; SI-Bone; Johnson & Johnson; Centers for Medicare & Medicaid Services Editorial boards BMJ.com/US; American Journal of Managed Care; American Journal of Medicine; Critical Pathways in Cardiology; Current Cardiovascular Risk Reports; JACC: Cardiovascular Imaging;Circulation: Cardiovascular Quality and Outcomes; Circulation; JAMA; The Lancet; New England Journal of Medicine


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