“Post-PCI bivalirudin did not reduce the composite outcome of ischemic and bleeding outcomes, including stent thrombosis risk, as compared to no post-PCI bivalirudin infusion,” reported lead investigator Marco Valgimigli, MD, PhD, the Swiss Cardiovascular Center in Bern, Switzerland.
The results, presented as a Hot Line at ESC congress 2015, with simultaneous publication in the New England Journal of Medicine, leave open the debate about prolonging or discontinuing post-PCI bivalirudin.
“Both treatment options are allowed per current European label and observational studies,” said Professor Valgimigli. “Hence, I believe the option to prolong or stop bivalirudin infusion after PCI remains open for clinicians, who will have to decide based on the ischemic and bleeding risk of individual patients as well as perhaps based on type of acute coronary syndrome, timing of loading dose and type of oral P2Y12 inhibitors. This is in keeping with the current labelling of the drug in EU and USA.”
The 78-centre study, included 3,610 patients with acute coronary syndrome, randomized to receive bivalirudin either during PCI only (n=1,188), or both during and after the procedure (n=1,799).
The drug was administered according to the product labelling, with a bolus of 0.75 mg per kilogram followed immediately by an infusion of 1.75 mg per kilogram per hour until completion of PCI.
For patients receiving prolonged treatment, the post-PCI dose could be either the full dose for 4 hours or a reduced dose of 0.25 mg per kilogram per hour for at least 6 hours, at the discretion of treating physicians.
Rates of the primary outcome – a composite of urgent target vessel revascularization, definite stent thrombosis, and net adverse clinical events up to 30 days – were similar in both groups (11.0% of patients with post-procedure bivalirudin versus 11.9% of patients with none; relative risk [RR] 0.91; P=0.34).
Bleeding was assessed according to three scales: BARC (Bleeding Academic Research Consortium), TIMI (Thrombolysis In Myocardial Infarction) and GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries).
“One interesting observation is that the post-PCI bivalirudin regimen, whether the full 1.75 mg dose, or the low 0.25 mg regimen, may be a treatment modifier,” said Professor Valgimigli. “I would like to caution against the over interpretation of these results as the choice of post-PCI bivalirudin regimen was not randomised, but rather left to the discretion of the investigators. However, taking these words of caution into great account, what we saw is that the full dose regimen may be able to significantly reduce stent thrombosis risk without increasing bleeding. This may be in keeping with previous observations from the EUROMAX trial.”
— ENDS —
Notes to editor
SOURCES OF FUNDING: Funded by The Medicines Company and Terumo.
DISCLOSURES: Professor Valgimigli reports grants from The Medicines Company, grants from Terumo, during the conduct of the study; grants and personal fees from AstraZeneca, personal fees and nonfinancial support from The Medicines Company, personal fees from Terumo, personal fees from St Jude Vascular, personal fees from Alvimedica, personal fees from Abbott Vascular, personal fees from Correvio, outside the submitted work.
The press conference timetable is available here
* Non Hot Line releases will be available under embargo on AlphaGalileo and EurekAlert a few days before ESC Congress. Hot Line releases will only be available when the embargo is lifted, online and on-site
* Information on Hot Line sessions is available here
ESC Press Office
For background information or assistance, please contact the ESC Press Office.
For independent comment on site or interviews, please contact the ESC spokesperson coordinator: +44 7785 467 947
About the European Society of Cardiology
The European Society of Cardiology (ESC) represents more than 90 000 cardiology professionals across Europe and worldwide. Its mission is to reduce the burden of cardiovascular disease in Europe.
About ESC Congress 2015
ESC Congress is the world’s largest and most influential cardiovascular event contributing to global awareness of the latest clinical trials and breakthrough discoveries. ESC Congress 2015 takes place 29 August to 2 September at ExCel London in London, UK. Access the scientific programme. More information is available from the ESC Press Office at email@example.com.
To access all the scientific resources from the sessions during the congress, visit ESC Congress 365.
This press release accompanies both a presentation and an ESC press conference at the ESC Congress 2015. Edited by the ESC from material supplied by the investigators themselves, this press release does not necessarily reflect the opinion of the European Society of Cardiology. The content of the press release has been approved by the presenter.