Background: Few reports have addressed the value of unfractionated heparin (UFH) or low-molecular-weight heparin in treating the full spectrum of patients with venous thromboembolism (VTE), including recurrent VTE and pulmonary embolism. Methods: In an open, multicenter clinical trial, 720 consecutive patients with acute symptomatic VTE, including 119 noncritically ill patients (16.5%) with pulmonary embolism and 102 (14.2%) with recurrent VTE, were randomly assigned to treatment with subcutaneous UFH with dose adjusted by activated partial thromboplastin time by means of a weight-based algorithm (preceded by an intravenous loading dose), or fixed-dose (adjusted only to body weight) subcutaneous nadroparin calcium. Oral anticoagulant therapy was started concomitantly and continued for at least 3 months. We recorded the incidence of major bleeding during the initial heparin treatment and that of recurrent VTE and death during 3 months of follow-up. Results: Fifteen (4.2%) of the 360 patients assigned to UFH had recurrent thromboembolic events, as compared with 14 (3.9%) of the 360 patients assigned to nadroparin (absolute difference between rates, 0.3%; 95% confidence interval, -2.5% to 3.1%). Four patients assigned to UFH (1.1%) and 3 patients assigned to nadroparin (0.8%) had episodes of major bleeding (absolute difference between rates, 0.3%; 95% confidence interval, -1.2% to 1.7%). Overall mortality was 3.3% in each group. Conclusions: Subcutaneous UFH with dose adjusted by activated partial thromboplastin time by means of a weight-based algorithm is as effective and safe as fixed-dose nadroparin for the initial treatment of patients with VTE, including those with pulmonary embolism and recurrent VTE.
Subcutaneous adjusted-dose unfractionated heparin vs fixed-dose low-molecular-weight heparin in the initial treatment of venous thromboembolism / Girolami, A; Prandoni, P; Iacobelli, M; Lensing, Awa; Prins, Mh; Bernardi, E; Simioni, P; Verlato, F; Camporese, G; Andreozzi, Gm; Prandoni, P; Marchiori, A; Bagatella, P; Carnovali, M; Iacobelli, M; Clerici, G; Piccioli, P; Tormene, D; Mosena, L; Frulla, M; Sartor, D; Girolami, A; Ghirarduzzi, A; Silingardi, M; Ieran, M; Girolami, B; Fedele, P; Lombardi, A; Fossa, C; Dente, A; Baggio, G; Tropeano, Pf; Scremin, M; Cal, S; Carpeggiani, G; De Santi, L; Pupin, Pl; Stefanon, C; Mercante, Wp; Carnovali, M; Alatri, A; Aliverti, M; Bonzani, M; Crespi, E; Scarcella, R; Sommariva, M; Toiolo, S; Vecchio, C; Quintavalla, R; Accorsi, F; Astorino, G; Aluigi, L; Arienti, V; Moia, M; Bucciarelli, P; Scannapieco, G; Pagliara, V; Rossi, M; Cogo, A; Villalta, S; Zenesini, F; Foscolo, G; Todini, Ar; Paiella, Ml; Parente, F; Castrignano, G; Valacca, A; Forese, P; Campobasso, M; Poti, R; Imberti, D; Prati, C; Cavallotti, P; Agnelli, G; Rossi, R; Sartori, D; Vinante, O; Cuppini, S; Vescovo, G; Cora, F. - In: ARCHIVES OF INTERNAL MEDICINE. - ISSN 0003-9926. - 164:10(2004), pp. 1077-1083.
Subcutaneous adjusted-dose unfractionated heparin vs fixed-dose low-molecular-weight heparin in the initial treatment of venous thromboembolism
Imberti D;
2004-01-01
Abstract
Background: Few reports have addressed the value of unfractionated heparin (UFH) or low-molecular-weight heparin in treating the full spectrum of patients with venous thromboembolism (VTE), including recurrent VTE and pulmonary embolism. Methods: In an open, multicenter clinical trial, 720 consecutive patients with acute symptomatic VTE, including 119 noncritically ill patients (16.5%) with pulmonary embolism and 102 (14.2%) with recurrent VTE, were randomly assigned to treatment with subcutaneous UFH with dose adjusted by activated partial thromboplastin time by means of a weight-based algorithm (preceded by an intravenous loading dose), or fixed-dose (adjusted only to body weight) subcutaneous nadroparin calcium. Oral anticoagulant therapy was started concomitantly and continued for at least 3 months. We recorded the incidence of major bleeding during the initial heparin treatment and that of recurrent VTE and death during 3 months of follow-up. Results: Fifteen (4.2%) of the 360 patients assigned to UFH had recurrent thromboembolic events, as compared with 14 (3.9%) of the 360 patients assigned to nadroparin (absolute difference between rates, 0.3%; 95% confidence interval, -2.5% to 3.1%). Four patients assigned to UFH (1.1%) and 3 patients assigned to nadroparin (0.8%) had episodes of major bleeding (absolute difference between rates, 0.3%; 95% confidence interval, -1.2% to 1.7%). Overall mortality was 3.3% in each group. Conclusions: Subcutaneous UFH with dose adjusted by activated partial thromboplastin time by means of a weight-based algorithm is as effective and safe as fixed-dose nadroparin for the initial treatment of patients with VTE, including those with pulmonary embolism and recurrent VTE.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
