BACKGROUND:Low-molecular-weight heparin (LMWH) has a more predictable anticoagulant effect than unfractionated heparin (UFH), is easier to administer, and does not require monitoring. Minimal data are available on LMWH combined with platelet glycoprotein (GP) IIb/IIIa inhibitors. METHODS: In the Platelet IIb/IIIa Antagonist for the Reduction of Acute Coronary Syndrome Events in a Global Organization Network B (PARAGON B) trial, patients with an acute coronary syndrome were randomized to receive the IIb/IIIa inhibitor lamifiban or a placebo. To rigorously explore the potential benefits of LWMH and GP IIb/IIIa inhibition, we analyzed the rates of ischemic complications and safety outcomes in PARAGON B. RESULTS: Approximately one fifth of the patients received LMWH (805 vs 4395 UFH). For the overall cohort, the incidence of death/myocardial infarction (MI)/severe recurrent ischemia (SRI) was 12.2%, and this composite end point was numerically lowest in the lamifiban with LMWH group (10.2%). Similarly, the incidence of death/MI was 11.0% for the entire cohort and lowest in the lamifiban and LMWH group (9.0%). The lower event rate for patients taking LMWH in the lamifiban group was sustained at 6 months, with a lower revascularization rate (51.5% vs 42.8%) and a lower composite of death/MI (13.8% vs 11.9%). Bleeding was comparable in the 2 heparin groups (1.4% with UFH vs 0.9% with LMWH). The propensity adjusted odds ratio for 30-day revascularization was significantly lower with LMWH (odds ratio 0.67, 95% CI 0.57-0.79, P <.001). There were no significant differences in death/MI/SRI at 30 days (P =.465), death/MI at 30 days (P =.264), and stroke at 30 days with the type of heparin use (P =.201) after propensity risk adjustment. CONCLUSIONS: In the PARAGON B trial, use of LMWH in conjunction with a GP IIb/IIIa inhibitor was safe and associated with a lower revascularization rate. These findings support the rationale and promise for combining GP IIb/IIIa blockers and LMWH for future management of acute coronary syndrome.
RCT Entities:
BACKGROUND: Low-molecular-weight heparin (LMWH) has a more predictable anticoagulant effect than unfractionated heparin (UFH), is easier to administer, and does not require monitoring. Minimal data are available on LMWH combined with platelet glycoprotein (GP) IIb/IIIa inhibitors. METHODS: In the Platelet IIb/IIIa Antagonist for the Reduction of Acute Coronary Syndrome Events in a Global Organization Network B (PARAGON B) trial, patients with an acute coronary syndrome were randomized to receive the IIb/IIIa inhibitor lamifiban or a placebo. To rigorously explore the potential benefits of LWMH and GP IIb/IIIa inhibition, we analyzed the rates of ischemic complications and safety outcomes in PARAGON B. RESULTS: Approximately one fifth of the patients received LMWH (805 vs 4395 UFH). For the overall cohort, the incidence of death/myocardial infarction (MI)/severe recurrent ischemia (SRI) was 12.2%, and this composite end point was numerically lowest in the lamifiban with LMWH group (10.2%). Similarly, the incidence of death/MI was 11.0% for the entire cohort and lowest in the lamifiban and LMWH group (9.0%). The lower event rate for patients taking LMWH in the lamifiban group was sustained at 6 months, with a lower revascularization rate (51.5% vs 42.8%) and a lower composite of death/MI (13.8% vs 11.9%). Bleeding was comparable in the 2 heparin groups (1.4% with UFH vs 0.9% with LMWH). The propensity adjusted odds ratio for 30-day revascularization was significantly lower with LMWH (odds ratio 0.67, 95% CI 0.57-0.79, P <.001). There were no significant differences in death/MI/SRI at 30 days (P =.465), death/MI at 30 days (P =.264), and stroke at 30 days with the type of heparin use (P =.201) after propensity risk adjustment. CONCLUSIONS: In the PARAGON B trial, use of LMWH in conjunction with a GP IIb/IIIa inhibitor was safe and associated with a lower revascularization rate. These findings support the rationale and promise for combining GP IIb/IIIa blockers and LMWH for future management of acute coronary syndrome.
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Authors: José Carlos Nicolau; Gilson Soares Feitosa Filho; João Luiz Petriz; Remo Holanda de Mendonça Furtado; Dalton Bertolim Précoma; Walmor Lemke; Renato Delascio Lopes; Ari Timerman; José A Marin Neto; Luiz Bezerra Neto; Bruno Ferraz de Oliveira Gomes; Eduardo Cavalcanti Lapa Santos; Leopoldo Soares Piegas; Alexandre de Matos Soeiro; Alexandre Jorge de Andrade Negri; Andre Franci; Brivaldo Markman Filho; Bruno Mendonça Baccaro; Carlos Eduardo Lucena Montenegro; Carlos Eduardo Rochitte; Carlos José Dornas Gonçalves Barbosa; Cláudio Marcelo Bittencourt das Virgens; Edson Stefanini; Euler Roberto Fernandes Manenti; Felipe Gallego Lima; Francisco das Chagas Monteiro Júnior; Harry Correa Filho; Henrique Patrus Mundim Pena; Ibraim Masciarelli Francisco Pinto; João Luiz de Alencar Araripe Falcão; Joberto Pinheiro Sena; José Maria Peixoto; Juliana Ascenção de Souza; Leonardo Sara da Silva; Lilia Nigro Maia; Louis Nakayama Ohe; Luciano Moreira Baracioli; Luís Alberto de Oliveira Dallan; Luis Augusto Palma Dallan; Luiz Alberto Piva E Mattos; Luiz Carlos Bodanese; Luiz Eduardo Fonteles Ritt; Manoel Fernandes Canesin; Marcelo Bueno da Silva Rivas; Marcelo Franken; Marcos José Gomes Magalhães; Múcio Tavares de Oliveira Júnior; Nivaldo Menezes Filgueiras Filho; Oscar Pereira Dutra; Otávio Rizzi Coelho; Paulo Ernesto Leães; Paulo Roberto Ferreira Rossi; Paulo Rogério Soares; Pedro Alves Lemos Neto; Pedro Silvio Farsky; Rafael Rebêlo C Cavalcanti; Renato Jorge Alves; Renato Abdala Karam Kalil; Roberto Esporcatte; Roberto Luiz Marino; Roberto Rocha Corrêa Veiga Giraldez; Romeu Sérgio Meneghelo; Ronaldo de Souza Leão Lima; Rui Fernando Ramos; Sandra Nivea Dos Reis Saraiva Falcão; Talia Falcão Dalçóquio; Viviana de Mello Guzzo Lemke; William Azem Chalela; Wilson Mathias Júnior Journal: Arq Bras Cardiol Date: 2021-07 Impact factor: 2.667
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