Results from a large observational study reported at EuroPCR 2013 today question whether bivalirudin is superior to heparin in the absence of GPIIb/IIIa blockade, showing similar 30-day mortality in patients with non-ST segment elevation acute coronary syndromes (NSTE-ACS) undergoing percutaneous coronary intervention (PCI).
European and US NSTE-ACS guidelines currently recommend bivalirudin alone as an alternative to unfractionated heparin plus GP IIb/IIIa receptor inhibitors in patients undergoing an intended urgent or early invasive strategy.
Researchers compared 30-day mortality with heparin alone to that with bivalirudin alone in patients with NSTE-ACS undergoing PCI between 2005 and 2011 in the Swedish coronary angiography and angioplasty registry (SCAAR). The registry records all coronary angiographies and PCIs carried out in Sweden. Results were analysed for 31,351 patients treated with heparin alone and 10,186 given bivalirudin.
Oskar Angerås, Consultant Cardiology at Sahlgrenska University Hospital, Gothenburg, Sweden, reported that the adjusted odds ratio for 30-day mortality favoured heparin (1.53 for complete case analysis).
"One should be very careful when interpreting the results, however none of our models show that treatment with bivalirudin improves outcome. The results therefore question the superiority of bivalirudin to heparin in the absence of GP IIb/IIIa blockade in patients with NSTE-ACS undergoing PCI," concluded Angerås. "The clinical implication is that if we use heparin alone, we can be assured that it's enough. For those using bivalirudin, switching to heparin achieves similar outcomes and will reduce the cost of procedures." He said that a prospective, randomised trial comparing bivalirudin with heparin in this group of patients is warranted. He added that his group has started the registry-based randomised VALIDATE-SWEDEHEART trial comparing bivalirudin to heparin in patients pretreated with novel ADP-receptor blockers, with the aim of recruiting a total of 6,000 patients.
Commenting on the data, William Wijns, Chairman of PCR and Course Director of EuroPCR, said, "This new data comparing heparin with bivalirudin in NSTE-ACS patients undergoing PCI is very interesting and we await results from new trials looking at this further."