title: Bivalirudin versus unfractionated heparin during percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndrome initially treated with fondaparinux: results from an international, multicenter, randomized pilot study (SWITCH III).
abstract: We aimed to determine the optimal adjunctive anticoagulation regimen for percutaneous coronary intervention (PCI) in patients presenting with acute coronary syndrome (ACS) initially treated with fondaparinux. The optimal adjunctive anticoagulation regimen for PCI in these patients is unclear. In this open-label, prospective, randomized, multicenter pilot study, we compared treatment with unfractionated heparin (UFH) versus bivalirudin in patients with non-ST-segment elevation ACS initially treated with fondaparinux and undergoing early invasive strategy. The randomized population consisted of 100 patients (62.7 ± 12.7 years, 68% men), all of whom were on clopidogrel. During the angioplasty, patients were randomized to either bivalirudin or UFH therapy in a 1:1 fashion. Baseline clinical and angiographic characteristics were similar except for a higher body mass index in the UFH group (29.4 ± 4.7 vs. 27.3 ± 4.2, P = 0.02). Major bleeding was the primary outcome; a major bleeding event was documented in only 1 patient from the bivalirudin group (2%) and in none from the UFH group (P = 0.49). There was no death, Q-wave MI, or acute revascularization in either group. There was no documentation of stent thrombosis, reinfarction, and catheter thrombus. Data from this prospective, multicenter pilot study suggest that bivalirudin, compared to standard-dose UFH, has a similar safety profile in terms of peri-PCI bleeding and thrombotic events and can be used safely in ACS patients initially treated with upstream fondaparinux who undergo PCI.
authors.affiliation: Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia 20010, USA. ron.waksman@medstar.net
authors.forename: Ron
authors.initials: R
authors.lastname: Waksman
authors.forename: Olivier
authors.initials: O
authors.lastname: Bertrand
authors.forename: Mitchell
authors.initials: M
authors.lastname: Driesman
authors.forename: Luis
authors.initials: L
authors.lastname: Gruberg
authors.forename: Joseph
authors.initials: J
authors.lastname: Rossi
authors.forename: Shamir
authors.initials: S
authors.lastname: Mehta
authors.forename: Stacy
authors.initials: S
authors.lastname: Swymelar
authors.forename: Danny
authors.initials: D
authors.lastname: Dvir
authors.forename: Zhenyi
authors.initials: Z
authors.lastname: Xue
authors.forename: Rebecca
authors.initials: R
authors.lastname: Torguson
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy* / Q000601:surgery; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000379:methods; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D000991:Antithrombins / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D000077425:Fondaparinux; D006470:Hemorrhage / Q000139:chemically induced / Q000188:drug therapy; D006493:Heparin / Q000009:adverse effects / Q000627:therapeutic use*; D006629:Hirudins / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects* / Q000379:methods; D010865:Pilot Projects; D011134:Polysaccharides / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D011134:Polysaccharides; D011994:Recombinant Proteins; D006493:Heparin; D000077425:Fondaparinux; C074619:bivalirudin