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1. Use of low-molecular weight heparin, transfusion and mortality in COVID-19 patients not requiring ventilation

Author

Grandone, E, Tiscia, G, Pesavento, R, De Laurenzo, A, Ceccato, D, Sartori, M, Mirabella, L, Cinnella, G, Mastroianno, M, Dalfino, L, Colaizzo, D, Vettor, R, Intrieri, M, Ostuni, A, Margaglione, M, Alboini, P, Antonioni, A, Aucella, F, Bochicchio, G, Carbonelli, C, Carella, M, Castori, M, Centonze, A, Ciliberti, G, Copetti, M, Corritore, M, De Cosmo, S, D'Aloiso, L, D'Errico, M, de Matthaeis, A, Del Gaudio, A, Di Giorgio, A, Giambra, V, Greco, A, Florio, L, Fontana, A, Inchingolo, V, Inglese, M, Labonia, M, La Marca, A, Latiano, T, Leone, M, Maiello, E, Mangia, A, Marciano, C, Massa, V, Massafra, S, Orciuli, G, Palladino, N, Perna, R, Piscitelli, P, Piemontese, M, Prencipe, M, Raggi, P, Rodriquenz, M, Russo, R, Sancarlo, D, Simeone, A, Trischitta, V, Zarrelli, M, Vaira, P, Vergara, D, Vescovi, A, Grandone E., Tiscia G., Pesavento R., De Laurenzo A., Ceccato D., Sartori M. T., Mirabella L., Cinnella G., Mastroianno M., Dalfino L., Colaizzo D., Vettor R., Intrieri M., Ostuni A., Margaglione M., Alboini P. E., Antonioni A., Aucella F., Bochicchio G. B., Carbonelli C., Carella M., Castori M., Centonze A., Ciliberti G., Copetti M., Corritore M., De Cosmo S., D'Aloiso L., D'Errico M. M., de Matthaeis A., Del Gaudio A., Di Giorgio A., Giambra V., Greco A., Florio L., Fontana A., Inchingolo V., Inglese M., Labonia M., La Marca A., Latiano T., Leone M., Maiello E., Mangia A., Marciano C., Massa V., Massafra S., Orciuli G., Palladino N., Perna R., Piscitelli P., Piemontese M., Prencipe M. A., Raggi P., Rodriquenz M. G., Russo R., Sancarlo D., Simeone A., Trischitta V., Zarrelli M., Vaira P., Vergara D., Vescovi A., Grandone, E, Tiscia, G, Pesavento, R, De Laurenzo, A, Ceccato, D, Sartori, M, Mirabella, L, Cinnella, G, Mastroianno, M, Dalfino, L, Colaizzo, D, Vettor, R, Intrieri, M, Ostuni, A, Margaglione, M, Alboini, P, Antonioni, A, Aucella, F, Bochicchio, G, Carbonelli, C, Carella, M, Castori, M, Centonze, A, Ciliberti, G, Copetti, M, Corritore, M, De Cosmo, S, D'Aloiso, L, D'Errico, M, de Matthaeis, A, Del Gaudio, A, Di Giorgio, A, Giambra, V, Greco, A, Florio, L, Fontana, A, Inchingolo, V, Inglese, M, Labonia, M, La Marca, A, Latiano, T, Leone, M, Maiello, E, Mangia, A, Marciano, C, Massa, V, Massafra, S, Orciuli, G, Palladino, N, Perna, R, Piscitelli, P, Piemontese, M, Prencipe, M, Raggi, P, Rodriquenz, M, Russo, R, Sancarlo, D, Simeone, A, Trischitta, V, Zarrelli, M, Vaira, P, Vergara, D, Vescovi, A, Grandone E., Tiscia G., Pesavento R., De Laurenzo A., Ceccato D., Sartori M. T., Mirabella L., Cinnella G., Mastroianno M., Dalfino L., Colaizzo D., Vettor R., Intrieri M., Ostuni A., Margaglione M., Alboini P. E., Antonioni A., Aucella F., Bochicchio G. B., Carbonelli C., Carella M., Castori M., Centonze A., Ciliberti G., Copetti M., Corritore M., De Cosmo S., D'Aloiso L., D'Errico M. M., de Matthaeis A., Del Gaudio A., Di Giorgio A., Giambra V., Greco A., Florio L., Fontana A., Inchingolo V., Inglese M., Labonia M., La Marca A., Latiano T., Leone M., Maiello E., Mangia A., Marciano C., Massa V., Massafra S., Orciuli G., Palladino N., Perna R., Piscitelli P., Piemontese M., Prencipe M. A., Raggi P., Rodriquenz M. G., Russo R., Sancarlo D., Simeone A., Trischitta V., Zarrelli M., Vaira P., Vergara D., and Vescovi A.

Abstract

It is still debated whether prophylactic doses of low-molecular- weight heparin (LMWH) are always effective in preventing Venous Thromboembolism (VTE) and mortality in COVID-19. Furthermore, there is paucity of data for those patients not requiring ventilation. We explored mortality and the safety/efficacy profile of LMWH in a cohort of Italian patients with COVID-19 who did not undergo ventilation. From the initial cohort of 422 patients, 264 were enrolled. Most (n = 156, 87.7%) received standard LMWH prophylaxis during hospitalization, with no significant difference between medical wards and Intensive Care Unit (ICU). Major or not major but clinically relevant hemorrhages were recorded in 13 (4.9%) patients: twelve in those taking prophylactic LMWH and one in a patient taking oral anticoagulants (p: n.s.). Thirty-nine patients (14.8%) with median age 75 years. were transfused. Hemoglobin (Hb) at admission was significantly lower in transfused patients and Hb at admission inversely correlated with the number of red blood cells units transfused (p < 0.001). In-hospital mortality occurred in 76 (28.8%) patients, 46 (24.3%) of whom admitted to medical wards. Furthermore, Hb levels at admittance were significantly lower in fatalities (g/dl 12.3; IQR 2.4 vs. 13.3; IQR 2.8; Mann–Whitney U-test; p = 0.001). After the exclusion of patients treated by LMWH intermediate or therapeutic doses (n = 32), the logistic regression showed that prophylaxis significantly and independently reduced mortality (OR 0.31, 95% CI 0.13–0.85). Present data show that COVID-19 patients who do not require ventilation benefit from prophylactic doses of LMWH.

Published
2021

2. D-dimer and reduced-dose apixaban for extended treatment after unprovoked venous thromboembolism: the Apidulcis study

Author

Palareti, G., Poli, D., Pesavento, R., Legnani, C., Antonucci, E., Bucherini, E., Testa, S., Paoletti, O., Chistolini, A., Ceccato, D., Martinelli, I., Bucciarelli, P., Falanga, A., Tosetto, A., Sarti, L., Mastroiacovo, D., Cosmi, B., Visona, A., Santoro, R. C., Zanatta, N., Grandone, E., Bertu, L., Pengo, V., Caiano, L., Prandoni, P., Lotti, E., Crudele, F., Ageno, W., Abenante, A., Colombo, G., Guarascio, M., Cancellieri, E., Morandini, R., Zambelli, S., Martini, S., Vastola, M., Serrao, A., Abbattista, M., Artoni, A., Capecchi, M., Gianniello, F., Scimeca, B., Barcella, L., Gamba, S., Lerede, T., Maggioni, A., Schieppati, F., Russo, L., Zunino, F., Artuso, A., Bellesso, S., Cadau, J., Carli, G., Nichele, I., Perbellini, O., Caronna, A., Gabrielli, F., Lami, F., Nicolini, A., Scaglioni, F., Pinelli, M., Desideri, G., Borgese, L., Favaretto, E., Libra, A., Migliaccio, L., Sartori, M., Panzavolta, C., Scandiuzzi, T., Zalunardo, B. -M., Ierardi, A., Leotta, M., Strangio, A., Guzzon, S., Colaizzo, D., Favuzzi, G., Lombardi, M. R., Ferrini, P. M., Tassoni, M. I., Corradini, S., Iotti, M., Lambertini, I., Veropalumbo, M. R., Lessiani, G., Parisi, R., Bortoluzzi, C., Vo, H. N., Chiarugi, P., Casini, M., Violo, C., Nuti, M., Angeloni, L., Carrozzi, L., Pancani, R., Chimera, D., Conti, V., Meschi, C., Cattaneo, M., Podda, G., Birocchi, S., Cuppini, S., Marzolo, M., Milan, M., Martini, G., Merelli, S., Pontoglio, S., Portesi, N., Villalta, S., De Lucchi, L., Sponghiado, A., Becattini, C., Giustozzi, M., Vinci, A., Pignatelli, P., Bucci, T., Menichelli, D., Pastori, D., Pomero, F., Casalis, S., Galli, E., Ciammaichella, M., Maida, R., De Cristofaro, Raimondo, Alberelli, M. A., Basso, M. R., De Candia, Erica, Di Gennaro, Leonardo, Mumoli, N., Capra, R., Orlando, M., Porta, C., Rotiroti, G., Demarco, M., Petrillo, P., Rossi, E., Bartolomei, Francesca, Soldati, D., Russo, U., Burgo, I., Ziliotti, M., Pataccini, C., Terroni, L., Ugolotti, M. C., Di Giorgio, A., Cavagna, L., Mete, F., Gino, M., Santoro, A., De Carlo, A., Cappelli, R., Bicchi, M., Dyrmo, L., Grifoni, E., Masotti, L., Ria, L., Spagnolo, M., Rupoli, S., Federici, I., Morsia, E., Scortechini, A. R., Torre, E., Franchini, M., Montorsi, P., Galgano, G., De Luca, A., Muiesan, M. L., Paini, A., Stassaldi, D., Denas, G., De Cristofaro R. (ORCID:0000-0002-8066-8849), De Candia E. (ORCID:0000-0003-0942-2819), Di Gennaro L., Bartolomei F., Palareti, G., Poli, D., Pesavento, R., Legnani, C., Antonucci, E., Bucherini, E., Testa, S., Paoletti, O., Chistolini, A., Ceccato, D., Martinelli, I., Bucciarelli, P., Falanga, A., Tosetto, A., Sarti, L., Mastroiacovo, D., Cosmi, B., Visona, A., Santoro, R. C., Zanatta, N., Grandone, E., Bertu, L., Pengo, V., Caiano, L., Prandoni, P., Lotti, E., Crudele, F., Ageno, W., Abenante, A., Colombo, G., Guarascio, M., Cancellieri, E., Morandini, R., Zambelli, S., Martini, S., Vastola, M., Serrao, A., Abbattista, M., Artoni, A., Capecchi, M., Gianniello, F., Scimeca, B., Barcella, L., Gamba, S., Lerede, T., Maggioni, A., Schieppati, F., Russo, L., Zunino, F., Artuso, A., Bellesso, S., Cadau, J., Carli, G., Nichele, I., Perbellini, O., Caronna, A., Gabrielli, F., Lami, F., Nicolini, A., Scaglioni, F., Pinelli, M., Desideri, G., Borgese, L., Favaretto, E., Libra, A., Migliaccio, L., Sartori, M., Panzavolta, C., Scandiuzzi, T., Zalunardo, B. -M., Ierardi, A., Leotta, M., Strangio, A., Guzzon, S., Colaizzo, D., Favuzzi, G., Lombardi, M. R., Ferrini, P. M., Tassoni, M. I., Corradini, S., Iotti, M., Lambertini, I., Veropalumbo, M. R., Lessiani, G., Parisi, R., Bortoluzzi, C., Vo, H. N., Chiarugi, P., Casini, M., Violo, C., Nuti, M., Angeloni, L., Carrozzi, L., Pancani, R., Chimera, D., Conti, V., Meschi, C., Cattaneo, M., Podda, G., Birocchi, S., Cuppini, S., Marzolo, M., Milan, M., Martini, G., Merelli, S., Pontoglio, S., Portesi, N., Villalta, S., De Lucchi, L., Sponghiado, A., Becattini, C., Giustozzi, M., Vinci, A., Pignatelli, P., Bucci, T., Menichelli, D., Pastori, D., Pomero, F., Casalis, S., Galli, E., Ciammaichella, M., Maida, R., De Cristofaro, Raimondo, Alberelli, M. A., Basso, M. R., De Candia, Erica, Di Gennaro, Leonardo, Mumoli, N., Capra, R., Orlando, M., Porta, C., Rotiroti, G., Demarco, M., Petrillo, P., Rossi, E., Bartolomei, Francesca, Soldati, D., Russo, U., Burgo, I., Ziliotti, M., Pataccini, C., Terroni, L., Ugolotti, M. C., Di Giorgio, A., Cavagna, L., Mete, F., Gino, M., Santoro, A., De Carlo, A., Cappelli, R., Bicchi, M., Dyrmo, L., Grifoni, E., Masotti, L., Ria, L., Spagnolo, M., Rupoli, S., Federici, I., Morsia, E., Scortechini, A. R., Torre, E., Franchini, M., Montorsi, P., Galgano, G., De Luca, A., Muiesan, M. L., Paini, A., Stassaldi, D., Denas, G., De Cristofaro R. (ORCID:0000-0002-8066-8849), De Candia E. (ORCID:0000-0003-0942-2819), Di Gennaro L., and Bartolomei F.

Abstract

D-dimer assay is used to stratify patients with unprovoked venous thromboembolism (VTE) for the risk of recurrence. However, this approach was never evaluated since direct oral anticoagulants are available. With this multicenter, prospective cohort study, we aimed to assess the value of an algorithm incorporating serial D-dimer testing and administration of reduced-dose apixaban (2.5 mg twice daily) only to patients with a positive test. A total of 732 outpatients aged 18 to 74 years, anticoagulated for ≥12 months after a first unprovoked VTE, were included. Patients underwent D-dimer testing with commercial assays and preestablished cutoffs. If the baseline D-dimer during anticoagulation was negative, anticoagulation was stopped and testing repeated after 15, 30, and 60 days. Patients with serially negative results (286 [39.1%]) were left without anticoagulation. At the first positive result, the remaining 446 patients (60.9%) were given apixaban for 18 months. All patients underwent follow-up planned for 18 months. The study was interrupted after a planned interim analysis for the high rate of primary outcomes (7.3%; 95% confidence interval [CI], 4.5-11.2), including symptomatic proximal deep vein thrombosis (DVT) or pulmonary embolism (PE) recurrence, death for VTE, and major bleeding occurring in patients off anticoagulation vs that in those receiving apixaban (1.1%; 95% CI, 0.4-2.6; adjusted hazard ratio [HR], 8.2; 95% CI, 3.2-25.3). In conclusion, in patients anticoagulated for ≥1 year after a first unprovoked VTE, the decision to further extend anticoagulation should not be based on D-dimer testing. The results confirmed the high efficacy and safety of reduced-dose apixaban against recurrences. This trial was registered at www.clinicaltrials.gov as #NCT03678506.

Published
2022

3. Genome-Wide Association Study Identifies First Locus Associated with Susceptibility to Cerebral Venous Thrombosis

Author

Ken-Dror, G, Cotlarciuc, I, Martinelli, I, Grandone, E, Hiltunen, S, Lindgren, E, Margaglione, M, Duchez, VLC, Triquenot, AB, Zedde, M, Mancuso, M, Ruigrok, YM, Marjot, T, Worrall, B, Majersik, JJ, Metso, TM, Putaala, J, Haapaniemi, E, Zuurbier, SM, Brouwer, MC, Passamonti, SM, Abbattista, M, Bucciarelli, P, Mitchell, BD, Kittner, SJ, Lemmens, R, Jern, C, Pappalardo, E, Costa, P, Colombi, M, de Sousa, DA, Rodrigues, S, Canhao, P, Tkach, A, Santacroce, R, Favuzzi, G, Arauz, A, Colaizzo, D, Spengos, K, Hodge, A, Ditta, R, Pezzini, A, Debette, S, Coutinho, JM, Thijs, V, Jood, K, Pare, G, Tatlisumak, T, Ferro, JM, Sharma, P, Ken-Dror, G, Cotlarciuc, I, Martinelli, I, Grandone, E, Hiltunen, S, Lindgren, E, Margaglione, M, Duchez, VLC, Triquenot, AB, Zedde, M, Mancuso, M, Ruigrok, YM, Marjot, T, Worrall, B, Majersik, JJ, Metso, TM, Putaala, J, Haapaniemi, E, Zuurbier, SM, Brouwer, MC, Passamonti, SM, Abbattista, M, Bucciarelli, P, Mitchell, BD, Kittner, SJ, Lemmens, R, Jern, C, Pappalardo, E, Costa, P, Colombi, M, de Sousa, DA, Rodrigues, S, Canhao, P, Tkach, A, Santacroce, R, Favuzzi, G, Arauz, A, Colaizzo, D, Spengos, K, Hodge, A, Ditta, R, Pezzini, A, Debette, S, Coutinho, JM, Thijs, V, Jood, K, Pare, G, Tatlisumak, T, Ferro, JM, and Sharma, P

Abstract

OBJECTIVE: Cerebral venous thrombosis (CVT) is an uncommon form of stroke affecting mostly young individuals. Although genetic factors are thought to play a role in this cerebrovascular condition, its genetic etiology is not well understood. METHODS: A genome-wide association study was performed to identify genetic variants influencing susceptibility to CVT. A 2-stage genome-wide study was undertaken in 882 Europeans diagnosed with CVT and 1,205 ethnicity-matched control subjects divided into discovery and independent replication datasets. RESULTS: In the overall case-control cohort, we identified highly significant associations with 37 single nucleotide polymorphisms (SNPs) within the 9q34.2 region. The strongest association was with rs8176645 (combined p = 9.15 × 10-24 ; odds ratio [OR] = 2.01, 95% confidence interval [CI] = 1.76-2.31). The discovery set findings were validated across an independent European cohort. Genetic risk score for this 9q34.2 region increases CVT risk by a pooled estimate OR = 2.65 (95% CI = 2.21-3.20, p = 2.00 × 10-16 ). SNPs within this region were in strong linkage disequilibrium (LD) with coding regions of the ABO gene. The ABO blood group was determined using allele combination of SNPs rs8176746 and rs8176645. Blood groups A, B, or AB, were at 2.85 times (95% CI = 2.32-3.52, p = 2.00 × 10-16 ) increased risk of CVT compared with individuals with blood group O. INTERPRETATION: We present the first chromosomal region to robustly associate with a genetic susceptibility to CVT. This region more than doubles the likelihood of CVT, a risk greater than any previously identified thrombophilia genetic risk marker. That the identified variant is in strong LD with the coding region of the ABO gene with differences in blood group prevalence provides important new insights into the pathophysiology of CVT. ANN NEUROL 2021;90:777-788.

Published
2021

4. Thrombocytopenia and Mortality Risk in Patients With Atrial Fibrillation: An Analysis From the START Registry

Author

Pastori, D, Antonucci, E, Violi, F, Palareti, G, Pignatelli, P, Testa, S, Paoletti, O, Cosmi, B, Guazzaloca, G, Migliaccio, L, Poli, D, Marcucci, R, Maggini, N, Pengo, V, Falanga, A, Lerede, T, Ruocco, L, Martini, G, Pedrini, S, Bertola, F, Masciocco, L, Saracino, P, Benvenuto, A, Vasselli, C, Grandone, E, Colaizzo, D, Marzolo, M, Pinelli, M, Mastroiacovo, D, Ageno, W, Colombo, G, Bucherini, E, Serra, D, Toma, A, Barbera, P, Paparo, C, Insana, A, Rupoli, S, Malcangi, G, Zighetti, M, Mangione, C, Lione, D, Casasco, P, Nante, G, Tosetto, A, Oriana, V, Liberato, N, Zighetti, ML, Liberato, NL, Pastori, D, Antonucci, E, Violi, F, Palareti, G, Pignatelli, P, Testa, S, Paoletti, O, Cosmi, B, Guazzaloca, G, Migliaccio, L, Poli, D, Marcucci, R, Maggini, N, Pengo, V, Falanga, A, Lerede, T, Ruocco, L, Martini, G, Pedrini, S, Bertola, F, Masciocco, L, Saracino, P, Benvenuto, A, Vasselli, C, Grandone, E, Colaizzo, D, Marzolo, M, Pinelli, M, Mastroiacovo, D, Ageno, W, Colombo, G, Bucherini, E, Serra, D, Toma, A, Barbera, P, Paparo, C, Insana, A, Rupoli, S, Malcangi, G, Zighetti, M, Mangione, C, Lione, D, Casasco, P, Nante, G, Tosetto, A, Oriana, V, Liberato, N, Zighetti, ML, and Liberato, NL

Abstract

Background Thrombocytopenia is associated with increased mortality in the general population, but few data exist in patients with atrial fibrillation (AF) taking oral anticoagulants. We investigated factor determinants of thrombocytopenia in a large cohort of patients affected by AF and its association with total mortality. Methods and Results Multicenter prospective cohort study, including 5215 patients with AF from the START (Survey on Anticoagulated Patients Register) registry, 3877 (74.3%) and 1338 (25.7%) on vitamin K or non-vitamin K antagonist oral anticoagulants, respectively. Thrombocytopenia was defined by a platelet count <150×109/L. Determinants of thrombocytopenia were investigated, and all-cause mortality was the primary survival end point of the study. Thrombocytopenia was present in 592 patients (11.4%). At multivariable logistic regression analysis, chronic kidney disease (odds ratio [OR], 1.257; P=0.030), active cancer (OR, 2.065; P=0.001), liver cirrhosis (OR, 7.635; P<0.001), and the use of diuretics (OR, 1.234; P=0.046) were positively associated with thrombocytopenia, whereas female sex (OR, 0.387; P<0.001) and the use of calcium channel blockers (OR, 0.787; P=0.032) were negatively associated. During a median follow-up of 19.2 months (9942 patient-years), 391 deaths occurred (rate, 3.93%/year). Mortality rate increased from 3.8%/year to 9.9%/year in patients with normal platelet count and in those with moderate-severe thrombocytopenia, respectively (log-rank test, P=0.009). The association between moderate-severe thrombocytopenia and mortality persisted after adjustment for CHA2DS2 VASc score (hazard ratio, 2.431; 95% CI, 1.254-4.713; P=0.009), but not in the fully adjusted multivariable Cox regression analysis model. Conclusions Thrombocytopenia is common in patients with AF. Despite an increased incidence of mortality, thrombocytopenia was not associated with mortality at multivariable analysis. Thrombocytopenia may reflect the pres

Published
2019

5. Rationale and design of two prospective, multicenter, observational studies on reproductive outcome in women with recurrent failures after spontaneous or assisted conception: OTTILIA and FIRST registries

Author

Villani, M., Baldini, D., Totaro, P., Larciprete, G., Kovac, M., Carone, D., Passamonti, S. M., Permunian, E. T., Bartolotti, T., Lojacono, A., Cacciola, R., Pinto, G. L., Bucherini, E., De Stefano, Valerio, Lodigiani, C., Lavopa, C., Cho, Y. S., Pizzicaroli, C., Colaizzo, D., Grandone, E., De Stefano V. (ORCID:0000-0002-5178-5827), Villani, M., Baldini, D., Totaro, P., Larciprete, G., Kovac, M., Carone, D., Passamonti, S. M., Permunian, E. T., Bartolotti, T., Lojacono, A., Cacciola, R., Pinto, G. L., Bucherini, E., De Stefano, Valerio, Lodigiani, C., Lavopa, C., Cho, Y. S., Pizzicaroli, C., Colaizzo, D., Grandone, E., and De Stefano V. (ORCID:0000-0002-5178-5827)

Abstract

Background: Spontaneous pregnancy loss and implantation failure after assisted reproductive technologies (ART) are very common occurrences. Although 50-60% of all cases remains unexplained, various predisposing factors, including thrombophilias, have been identified. Thus, the potential benefit of a prophylaxis with low-molecular-weight heparins in improving outcomes has been often investigated over the years. However, the majority of studies are observational and results from randomized clinical trials (RCTs) are inconclusive, probably due to heterogeneity and limited sample size. To cover these unmet needs and to have further data mainly based on the real-life clinical management, we designed these multicenter registries. Methods: OTTILIA (Observational sTudy on antiThrombotic prevention in thrombophILIA and pregnancy loss) and FIRST (recurrent Failures in assIsted Reproductive Techniques) registries are two prospective, multicenter, observational studies to evaluate pregnancy or ART outcomes in consecutive women with previous reproductive failures after spontaneous or assisted conception, respectively. All enrolled women are observed from their first visit after positive pregnancy test (OTTILIA) or before commencing a new ART cycle (FIRST) until the end of pregnancy or ART procedure (negative pregnancy test/end of pregnancy, if successful cycle), respectively. Data are collected by means of questionnaires and recorded in a central database. Follow-up investigations are performed during hospital stay, routine clinical follow-up visits or telephone interviews. Primary outcome is live birth rate in the OTTILIA register and clinical pregnancy rate in the FIRST. Discussion: Although RCTs are the 'gold standard' for evaluating treatment outcomes, we believe that our registries represent a valid alternative in improving knowledge on mechanisms involved in reproductive failures and supporting future clinical decisions. Trial registration: NCT 02385461, retrospectively re

Published
2019

6. Towards the genetic basis of cerebral venous thrombosis-the BEAST Consortium: a study protocol

Author

Cotlarciuc, I, Marjot, T, Khan, MS, Hiltunen, S, Haapaniemi, E, Metso, TM, Putaala, J, Zuurbier, SM, Brouwer, MC, Passamonti, SM, Bucciarelli, P, Pappalardo, E, Patel, T, Costa, P, Colombi, M, Canhao, P, Tkach, A, Santacroce, R, Margaglione, M, Favuzzi, G, Grandone, E, Colaizzo, D, Spengos, K, Arauz, A, Hodge, A, Ditta, R, Debette, S, Zedde, M, Pare, G, Ferro, JM, Thijs, V, Pezzini, A, Majersik, JJ, Martinelli, I, Coutinho, JM, Tatlisumak, T, Sharma, P, Cotlarciuc, I, Marjot, T, Khan, MS, Hiltunen, S, Haapaniemi, E, Metso, TM, Putaala, J, Zuurbier, SM, Brouwer, MC, Passamonti, SM, Bucciarelli, P, Pappalardo, E, Patel, T, Costa, P, Colombi, M, Canhao, P, Tkach, A, Santacroce, R, Margaglione, M, Favuzzi, G, Grandone, E, Colaizzo, D, Spengos, K, Arauz, A, Hodge, A, Ditta, R, Debette, S, Zedde, M, Pare, G, Ferro, JM, Thijs, V, Pezzini, A, Majersik, JJ, Martinelli, I, Coutinho, JM, Tatlisumak, T, and Sharma, P

Abstract

INTRODUCTION: Cerebral venous thrombosis (CVT) is a rare cerebrovascular condition accounting for <1% of all stroke cases and mainly affects young adults. Its genetic aetiology is not clearly elucidated. METHODS AND ANALYSIS: To better understand the genetic basis of CVT, we have established an international biobank of CVT cases, Biorepository to Establish the Aetiology of Sinovenous Thrombosis (BEAST) which aims to recruit highly phenotyped cases initially of European descent and later from other populations. To date we have recruited 745 CVT cases from 12 research centres. As an initial step, the consortium plans to undertake a genome-wide association analysis of CVT using the Illumina Infinium HumanCoreExome BeadChip to assess the association and impact of common and low-frequency genetic variants on CVT risk by using a case-control study design. Replication will be performed to confirm putative findings. Furthermore, we aim to identify interactions of genetic variants with several environmental and comorbidity factors which will likely contribute to improve the understanding of the biological mechanisms underlying this complex disease. ETHICS AND DISSEMINATION: BEAST meets all ethical standards set by local institutional review boards for each of the participating sites. The research outcomes will be published in international peer-reviewed open-access journals with high impact and visibility. The results will be presented at national and international meetings to highlight the contributions into improving the understanding of the mechanisms underlying this uncommon but important disease. This international DNA repository will become an important resource for investigators in the field of haematological and vascular disorders.

Published
2016

7. Aspirin for Preventing the Recurrence of Venous Thromboembolism

Author

Becattini, C, Agnelli, G, Schenone, A, Eichinger, S, Bucherini, E, Silingardi, M, Bianchi, M, Moia, M, Ageno, W, Vandelli, M, Grandone, E, Prandoni, P, Duranti, M, Radicchia, S, Guercini, F, Vedovati, M, Tormene, D, Perlati, M, Barbar, S, Poggio, R, Leischer, L, Galimberti, D, Leone, M, Beretta, A, Carugati, A, Braham, S, Romualdi, E, Tiscia, G, Colaizzo, D, Grilli, M, Siragusa, S, Salvi, R, Miccio, M, Ria, L, Zanatta, N, Poli, D, Camporese, G, Verlato, F, Salvi, A, Nitti, C, Santi, R, Cimminiello, C, Scannapieco, G, Barillari, G, Pasca, S, De Gaudenzi, E, Cappelli, R, Di Minno, G, Tufano, A, Frausini, G, Bova, C, Pogliani, E, Signorelli, S, Testa, S, Alatri, A, Mancuso, G, Grifoni, S, Lodigiani, C, Vedovati, MC, Leone, MF, Signorelli, SS, Lodigiani, C., BIANCHI, MARCO STEFANO, Becattini, C, Agnelli, G, Schenone, A, Eichinger, S, Bucherini, E, Silingardi, M, Bianchi, M, Moia, M, Ageno, W, Vandelli, M, Grandone, E, Prandoni, P, Duranti, M, Radicchia, S, Guercini, F, Vedovati, M, Tormene, D, Perlati, M, Barbar, S, Poggio, R, Leischer, L, Galimberti, D, Leone, M, Beretta, A, Carugati, A, Braham, S, Romualdi, E, Tiscia, G, Colaizzo, D, Grilli, M, Siragusa, S, Salvi, R, Miccio, M, Ria, L, Zanatta, N, Poli, D, Camporese, G, Verlato, F, Salvi, A, Nitti, C, Santi, R, Cimminiello, C, Scannapieco, G, Barillari, G, Pasca, S, De Gaudenzi, E, Cappelli, R, Di Minno, G, Tufano, A, Frausini, G, Bova, C, Pogliani, E, Signorelli, S, Testa, S, Alatri, A, Mancuso, G, Grifoni, S, Lodigiani, C, Vedovati, MC, Leone, MF, Signorelli, SS, Lodigiani, C., and BIANCHI, MARCO STEFANO

Abstract

BACKGROUND: About 20% of patients with unprovoked venous thromboembolism have a recurrence within 2 years after the withdrawal of oral anticoagulant therapy. Extending anticoagulation prevents recurrences but is associated with increased bleeding. The benefit of aspirin for the prevention of recurrent venous thromboembolism is unknown. METHODS:In this multicenter, investigator-initiated, double-blind study, patients with first-ever unprovoked venous thromboembolism who had completed 6 to 18 months of oral anticoagulant treatment were randomly assigned to aspirin, 100 mg daily, or placebo for 2 years, with the option of extending the study treatment. The primary efficacy outcome was recurrence of venous thromboembolism, and major bleeding was the primary safety outcome. RESULTS:Venous thromboembolism recurred in 28 of the 205 patients who received aspirin and in 43 of the 197 patients who received placebo (6.6% vs. 11.2% per year; hazard ratio, 0.58; 95% confidence interval [CI], 0.36 to 0.93) (median study period, 24.6 months). During a median treatment period of 23.9 months, 23 patients taking aspirin and 39 taking placebo had a recurrence (5.9% vs. 11.0% per year; hazard ratio, 0.55; 95% CI, 0.33 to 0.92). One patient in each treatment group had a major bleeding episode. Adverse events were similar in the two groups. CONCLUSIONS: Aspirin reduced the risk of recurrence when given to patients with unprovoked venous thromboembolism who had discontinued anticoagulant treatment, with no apparent increase in the risk of major bleeding. (Funded by the University of Perugia and others; WARFASA ClinicalTrials.gov number, NCT00222677.)

Published
2012

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