40 results on '"Francese, Dominic P."'
Search Results
2. How Cox models react to a study-specific confounder in a patient-level pooled dataset: Random-effects better cope with an imbalanced covariate across trials unless baseline hazards differ
- Author
-
McAndrew, Thomas, Redfors, Bjorn, Crowley, Aaron, Zhang, Yiran, Chen, Shmuel, Golomb, Mordechai, Alu, Maria, Francese, Dominic, Ben-Yehuda, Ori, Maehara, Akiko, Mintz, Gary, Stone, Gregg, and Jenkins, Paul
- Subjects
Statistics - Applications - Abstract
Combining patient-level data from clinical trials can connect rare phenomena with clinical endpoints, but statistical techniques applied to a single trial may become problematical when trials are pooled. Estimating the hazard of a binary variable unevenly distributed across trials showcases a common pooled database issue. We studied how an unevenly distributed binary variable can compromise the integrity of fixed and random effects Cox proportional hazards models. We compared fixed effect and random effects Cox proportional hazards models on a set of simulated datasets inspired by a 17-trial pooled database of patients presenting with ST-segment elevation myocardial infarction (STEMI) and non-STEMI undergoing percutaneous coronary intervention. An unevenly distributed covariate can bias hazard ratio estimates, inflate standard errors, raise type I error, and reduce power. While uneveness causes problems for all Cox proportional hazards models, random effects suffer least. Compared to fixed effect models, random effects suffer lower bias and trade inflated type I errors for improved power. Contrasting hazard rates between trials prevent accurate estimates from both fixed and random effects models. When modeling a covariate unevenly distributed across pooled trials with similar baseline hazard rates, Cox proportional hazards models with a random trial effect more accurately estimate hazard ratios than fixed effects. Differing between-trial baseline hazard rates bias both random and fixed effect models. With an unevenly-distributed covariate and similar baseline hazard rates across trials, a random effects Cox proportional hazards model outperforms a fixed effect model, but cannot overcome contrasting baseline hazard rates., Comment: 9 Pages: Cox-Proportional Hazards, Frailty, Fixed-Effects, Random-Effects, Pooling Data
- Published
- 2018
3. F-18 | Comparison of the Safety and Efficacy of Endovascular Interventions for the Treatment of Superficial Femoral Artery Disease: A Network Meta-analysis
- Author
-
Schwartz, Andrew, Shah, Yousuf, Huang, Haocheng, Francese, Dominic P., Shah, Tayyab, and Lansky, Alexandra J.
- Published
- 2024
- Full Text
- View/download PDF
4. Two-year outcomes after percutaneous coronary intervention of calcified lesions with drug-eluting stents
- Author
-
Généreux, Philippe, Redfors, Björn, Witzenbichler, Bernhard, Arsenault, Marie-Pier, Weisz, Giora, Stuckey, Thomas D., Rinaldi, Michael J., Neumann, Franz-Josef, Christopher Metzger, D., Henry, Timothy D., Cox, David A., Duffy, Peter L., Mazzaferri, Ernest L., Jr, Francese, Dominic P., Marquis-Gravel, Guillaume, Mintz, Gary S., Kirtane, Ajay J., Maehara, Akiko, Mehran, Roxana, and Stone, Gregg W.
- Published
- 2017
- Full Text
- View/download PDF
5. Impact of New-Onset Conduction Disturbances following Transcatheter Aortic Valve Replacement on Outcomes: A Single-Center Study
- Author
-
See, Claudia, primary, Wang, Yanting, additional, Huang, Haocheng, additional, Parise, Helen, additional, Yang, Yiping, additional, Tirziu, Daniela, additional, Francese, Dominic P., additional, Papoutsidakis, Nikolaos, additional, Bader, Eric, additional, Kaple, Ryan K., additional, Cleman, Michael, additional, Lansky, Alexandra J., additional, and Forrest, John K., additional
- Published
- 2023
- Full Text
- View/download PDF
6. Dedicated Bifurcation Stent for the Treatment of Bifurcation Lesions Involving Large Side Branches: Outcomes From the Tryton Confirmatory Study
- Author
-
Généreux, Philippe, Kumsars, Indulis, Schneider, Joel E., Lesiak, Maciej, Redfors, Björn, Cornelis, Kristoff, Selmon, Matthew R., Dens, Jo, Hoye, Angela, Metzger, D. Christopher, Muyldermans, Luc, Slagboom, Ton, Francese, Dominic P., Ayele, Girma Minalu, Laak, Linda L., Bartorelli, Antonio L., Cutlip, Donald E., Kaplan, Aaron V., and Leon, Martin B.
- Published
- 2016
- Full Text
- View/download PDF
7. Safety and Efficacy of Bivalirudin in Patients With Diabetes Mellitus Undergoing Percutaneous Coronary Intervention: From the REPLACE-2, ACUITY and HORIZONS-AMI Trials
- Author
-
Giustino, Gennaro, Mehran, Roxana, Bansilal, Sameer, Feit, Frederick, Lincoff, Michael, Deliargyris, Efthymios N., Kirtane, Ajay J., Généreux, Philippe, Redfors, Bjorn, Prats, Jayne, Bernstein, Debra, Brener, Sorin J., Skerjanec, Simona, Lansky, Alexandra J., Francese, Dominic P., Dangas, George D., and Stone, Gregg W.
- Published
- 2016
- Full Text
- View/download PDF
8. Impact of Anemia on Platelet Reactivity and Ischemic and Bleeding Risk: From the Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents Study
- Author
-
Giustino, Gennaro, Kirtane, Ajay J., Baber, Usman, Généreux, Philippe, Witzenbichler, Bernhard, Neumann, Franz-Josef, Weisz, Giora, Maehara, Akiko, Rinaldi, Michael J., Metzger, Christopher, Henry, Timothy D., Cox, David A., Duffy, Peter L., Mazzaferri, Ernest L., Brodie, Bruce R., Stuckey, Thomas D., Gurbel, Paul A., Dangas, George D., Francese, Dominic P., Ozan, Ozgu, Mehran, Roxana, and Stone, Gregg W.
- Published
- 2016
- Full Text
- View/download PDF
9. Relation Between Platelet Count and Platelet Reactivity to Thrombotic and Bleeding Risk: From the Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents Study
- Author
-
Giustino, Gennaro, Kirtane, Ajay J., Généreux, Philippe, Baber, Usman, Witzenbichler, Bernhard, Neumann, Franz-Josef, Weisz, Giora, Maehara, Akiko, Rinaldi, Michael J., Metzger, Christopher, Henry, Timothy D., Cox, David A., Duffy, Peter L., Mazzaferri, Ernest L., Jr., Brodie, Bruce R., Stuckey, Thomas D., Dangas, George D., Francese, Dominic P., Litherland, Claire, Mehran, Roxana, and Stone, Gregg W.
- Published
- 2016
- Full Text
- View/download PDF
10. Angiographic predictors of 2‐year stent thrombosis in patients receiving drug‐eluting stents: Insights from the ADAPT‐DES study
- Author
-
Généreux, Philippe, Redfors, Björn, Witzenbichler, Bernhard, Maehara, Akiko, Yadav, Mayank, Weisz, Giora, Francese, Dominic P., Parvataneni, Rupa, Brener, Sorin J., Mehran, Roxana, Kirtane, Ajay J., and Stone, Gregg W.
- Published
- 2017
- Full Text
- View/download PDF
11. Antiplatelet strategies in acute coronary syndromes: design and methodology of an international collaborative network meta-analysis of randomized controlled trials
- Author
-
MADHAVAN, Mahesh V., primary, BIKDELI, Behnood, additional, REDFORS, Björn, additional, BIONDI-ZOCCAI, Giuseppe, additional, VARUNOK, Nicholas J., additional, BURTON, John R., additional, CROWLEY, Aaron, additional, FRANCESE, Dominic P., additional, GUPTA, Aakriti, additional, DER NIGOGHOSSIAN, Caroline, additional, CHATTERJEE, Saurav, additional, PALMERINI, Tullio, additional, BENEDETTO, Umberto, additional, YOU, Seng C., additional, OHMAN, Erik M., additional, KASTRATI, Adnan, additional, STEG, Philippe G., additional, GIBSON, Charles M., additional, ANGIOLILLO, Dominick J., additional, KRUMHOLZ, Harlan M., additional, and STONE, Gregg W., additional
- Published
- 2021
- Full Text
- View/download PDF
12. COVID-19 and Thrombotic or Thromboembolic Disease: Implications for Prevention, Antithrombotic Therapy, and Follow-Up: JACC State-of-the-Art Review
- Author
-
Bikdeli, Behnood, Madhavan, Mahesh V, Jimenez, David, Chuich, Taylor, Dreyfus, Isaac, Driggin, Elissa, Nigoghossian, Caroline Der, Ageno, Walter, Madjid, Mohammad, Guo, Yutao, Tang, Liang V, Hu, Yu, Giri, Jay, Cushman, Mary, Quéré, Isabelle, Dimakakos, Evangelos P, Gibson, C Michael, Lippi, Giuseppe, Favaloro, Emmanuel J, Fareed, Jawed, Caprini, Joseph A, Tafur, Alfonso J, Burton, John R, Francese, Dominic P, Wang, Elizabeth Y, Falanga, Anna, McLintock, Claire, Hunt, Beverley J, Spyropoulos, Alex C, Barnes, Geoffrey D, Eikelboom, John W, Weinberg, Ido, Schulman, Sam, Carrier, Marc, Piazza, Gregory, Beckman, Joshua A, Steg, P Gabriel, Stone, Gregg W, Rosenkranz, Stephan, Goldhaber, Samuel Z, Parikh, Sahil A, Monreal, Manuel, Krumholz, Harlan M, Konstantinides, Stavros V, Weitz, Jeffrey I, and Lip, Gregory Y H
- Subjects
SARS-CoV-2 ,anticoagulant ,Pneumonia, Viral ,antithrombotic therapy ,Anticoagulants ,COVID-19 ,antiplatelet ,thrombosis ,Betacoronavirus ,Fibrinolytic Agents ,Humans ,Platelet Aggregation Inhibitors ,Treatment Outcome ,Coronavirus Infections ,Pandemics ,Thromboembolism ,Pneumonia ,Viral - Abstract
Coronavirus disease-2019 (COVID-19), a viral respiratory illness caused by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), may predispose patients to thrombotic disease, both in the venous and arterial circulations, because of excessive inflammation, platelet activation, endothelial dysfunction, and stasis. In addition, many patients receiving antithrombotic therapy for thrombotic disease may develop COVID-19, which can have implications for choice, dosing, and laboratory monitoring of antithrombotic therapy. Moreover, during a time with much focus on COVID-19, it is critical to consider how to optimize the available technology to care for patients without COVID-19 who have thrombotic disease. Herein, the authors review the current understanding of the pathogenesis, epidemiology, management, and outcomes of patients with COVID-19 who develop venous or arterial thrombosis, of those with pre-existing thrombotic disease who develop COVID-19, or those who need prevention or care for their thrombotic disease during the COVID-19 pandemic.
- Published
- 2020
- Full Text
- View/download PDF
13. Pharmacological Agents Targeting Thromboinflammation in COVID-19: Review and Implications for Future Research
- Author
-
Bikdeli, Behnood Madhavan, Mahesh V. Gupta, Aakriti Jimenez, David Burton, John R. Nigoghossian, Caroline Der Chuich, Taylor Nouri, Shayan Nabavi Dreyfus, Isaac Driggin, Elissa and Sethi, Sanjum Sehgal, Kartik Chatterjee, Saurav Ageno, Walter Madjid, Mohammad Guo, Yutao Tang, Liang V. Hu, Yu and Bertoletti, Laurent Giri, Jay Cushman, Mary Quere, Isabelle Dimakakos, Evangelos P. Gibson, C. Michael Lippi, Giuseppe Favaloro, Emmanuel J. Fareed, Jawed Tafur, Alfonso J. Francese, Dominic P. Batra, Jaya Falanga, Anna and Clerkin, Kevin J. Uriel, Nir Kirtane, Ajay McLintock, Claire and Hunt, Beverley J. Spyropoulos, Alex C. Barnes, Geoffrey D. and Eikelboom, John W. Weinberg, Ido Schulman, Sam Carrier, Marc Piazza, Gregory Beckman, Joshua A. Leon, Martin B. and Stone, Gregg W. Rosenkranz, Stephan Goldhaber, Samuel Z. and Parikh, Sahil A. Monreal, Manuel Krumholz, Harlan M. and Konstantinides, Stavros V. Weitz, Jeffrey I. Lip, Gregory Y. H. and Global COVID-19 Thrombosis Collabo
- Abstract
Coronavirus disease 2019 (COVID-19), currently a worldwide pandemic, is a viral illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The suspected contribution of thrombotic events to morbidity and mortality in COVID-19 patients has prompted a search for novel potential options for preventing COVID-19-associated thrombotic disease. In this article by the Global COVID-19 Thrombosis Collaborative Group, we describe novel dosing approaches for commonly used antithrombotic agents (especially heparin-based regimens) and the potential use of less widely used antithrombotic drugs in the absence of confirmed thrombosis. Although these therapies may have direct antithrombotic effects, other mechanisms of action, including anti-inflammatory or antiviral effects, have been postulated. Based on survey results from this group of authors, we suggest research priorities for specific agents and subgroups of patients with COVID-19. Further, we review other agents, including immunomodulators, that may have antithrombotic properties. It is our hope that the present document will encourage and stimulate future prospective studies and randomized trials to study the safety, efficacy, and optimal use of these agents for prevention or management of thrombosis in COVID-19.
- Published
- 2020
14. COVID-19 and Thrombotic or Thromboembolic Disease: Implications for Prevention, Antithrombotic Therapy, and Follow
- Author
-
Bikdeli, Behnood Madhavan, Mahesh V. Jimenez, David Chuich, Taylor Dreyfus, Isaac Driggin, Elissa Der Nigoghossian, Caroline Ageno, Walter Madjid, Mohammad Guo, Yutao Tang, Liang V. Hu, Yu Giri, Jay Cushman, Mary Quere, Isabelle and Dimakakos, Evangelos P. Gibson, C. Michael Lippi, Giuseppe and Favaloro, Emmanuel J. Fareed, Jawed Caprini, Joseph A. and Tafur, Alfonso J. Burton, John R. Francese, Dominic P. Wang, Elizabeth Y. Falanga, Anna McLintock, Claire Hunt, Beverley J. Spyropoulos, Alex C. Barnes, Geoffrey D. Eikelboom, John W. Weinberg, Ido Schulman, Sam Carrier, Marc Piazza, Gregory Beckman, Joshua A. Steg, Gabriel Stone, Gregg W. and Rosenkranz, Stephan Goldhaber, Samuel Z. Parikh, Sahil A. and Monreal, Manuel Krumholz, Harlan M. Konstantinides, Stavros V. and Weitz, Jeffrey I. Lip, Gregory Y. H. Global COVID-19 Thrombosis Collabo ISTH NATF ESVM ESC Working Grp Pulm Ci
- Abstract
Coronavirus disease-2019 (COVID-19), a viral respiratory illness caused by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), may predispose patients to thrombotic disease, both in the venous and arterial circulations, because of excessive inflammation, platelet activation, endothelial dysfunction, and stasis. In addition, many patients receiving antithrombotic therapy for thrombotic disease may develop COVID-19, which can have implications for choice, dosing, and laboratory monitoring of antithrombotic therapy. Moreover, during a time with much focus on COVID-19, it is critical to consider how to optimize the available technology to care for patients without COVID-19 who have thrombotic disease. Herein, the authors review the current understanding of the pathogenesis, epidemiology, management, and outcomes of patients with COVID-19 who develop venous or arterial thrombosis, of those with pre-existing thrombotic disease who develop COVID-19, or those who need prevention or care for their thrombotic disease during the COVID-19 pandemic. (J Am Coll Cardiol 2020;75:2950-73) (c) 2020 by the American College of Cardiology Foundation.
- Published
- 2020
15. Individual Patient Data Pooled Analysis of Randomized Trials of Bivalirudin versus Heparin in Acute Myocardial Infarction : Rationale and Methodology
- Author
-
Bikdeli, Behnood, McAndrew, Thomas, Crowley, Aaron, Chen, Shmuel, Mehdipoor, Ghazaleh, Redfors, Bjorn, Liu, Yangbo, Zhang, Zixuan, Liu, Mengdan, Zhang, Yiran, Francese, Dominic P., Erlinge, David, James, Stefan, Han, Yaling, Li, Yi, Kastrati, Adnan, Schuepke, Stefanie, Stables, Rod H., Shahzad, Adeel, Steg, Philippe Gabriel, Goldstein, Patrick, Frigoli, Enrico, Mehran, Roxana, Valgimigli, Marco, Stone, Gregg W., Bikdeli, Behnood, McAndrew, Thomas, Crowley, Aaron, Chen, Shmuel, Mehdipoor, Ghazaleh, Redfors, Bjorn, Liu, Yangbo, Zhang, Zixuan, Liu, Mengdan, Zhang, Yiran, Francese, Dominic P., Erlinge, David, James, Stefan, Han, Yaling, Li, Yi, Kastrati, Adnan, Schuepke, Stefanie, Stables, Rod H., Shahzad, Adeel, Steg, Philippe Gabriel, Goldstein, Patrick, Frigoli, Enrico, Mehran, Roxana, Valgimigli, Marco, and Stone, Gregg W.
- Abstract
Background Individual randomized controlled trials (RCTs) of periprocedural anticoagulation with bivalirudin versus heparin during percutaneous coronary intervention (PCI) have reported conflicting results. Study-level meta-analyses lack granularity to adjust for confounders, explore heterogeneity, or identify subgroups that may particularly benefit or be harmed. Objective To overcome these limitations, we sought to develop an individual patient-data pooled database of RCTs comparing bivalirudin versus heparin. Methods We conducted a systematic review to identify RCTs in which ≥1,000 patients with acute myocardial infarction (AMI) undergoing PCI were randomized to bivalirudin versus heparin. Results From 738 identified studies, 8 RCTs met the prespecified criteria. The principal investigators of each study agreed to provide patient-level data. The data were pooled and checked for accuracy against trial publications, with discrepancies addressed by consulting with the trialists. Consensus-based definitions were created to resolve differing antithrombotic, procedural, and outcome definitions. The project required 3.5 years to complete, and the final database includes 27,409 patients (13,346 randomized to bivalirudin and 14,063 randomized to heparin). Conclusion We have created a large individual patient database of bivalirudin versus heparin RCTs in patients with AMI undergoing PCI. This endeavor may help identify the optimal periprocedural anticoagulation regimen for patient groups with different relative risks of adverse ischemic versus bleeding events, including those with ST-segment and non-ST-segment elevation MI, radial versus femoral access, use of a prolonged bivalirudin infusion or glycoprotein inhibitors, and others. Adherence to standardized techniques and rigorous validation processes should increase confidence in the accuracy and robustness of the results. .
- Published
- 2020
- Full Text
- View/download PDF
16. COVID-19 and Thrombotic or Thromboembolic Disease: Implications for Prevention, Antithrombotic Therapy, and Follow
- Author
-
Bikdeli, Behnood, Madhavan, Mahesh V., Jimenez, David, Chuich, Taylor, Dreyfus, Isaac, Driggin, Elissa, Der Nigoghossian, Caroline, Ageno, Walter, Madjid, Mohammad, Guo, Yutao, Tang, Liang V., Hu, Yu, Giri, Jay, Cushman, Mary, Quere, Isabelle, Dimakakos, Evangelos P., Gibson, C. Michael, Lippi, Giuseppe, Favaloro, Emmanuel J., Fareed, Jawed, Caprini, Joseph A., Tafur, Alfonso J., Burton, John R., Francese, Dominic P., Wang, Elizabeth Y., Falanga, Anna, McLintock, Claire, Hunt, Beverley J., Spyropoulos, Alex C., Barnes, Geoffrey D., Eikelboom, John W., Weinberg, Ido, Schulman, Sam, Carrier, Marc, Piazza, Gregory, Beckman, Joshua A., Steg, Gabriel, Stone, Gregg W., Rosenkranz, Stephan, Goldhaber, Samuel Z., Parikh, Sahil A., Monreal, Manuel, Krumholz, Harlan M., Konstantinides, Stavros V., Weitz, Jeffrey I., Lip, Gregory Y. H., Bikdeli, Behnood, Madhavan, Mahesh V., Jimenez, David, Chuich, Taylor, Dreyfus, Isaac, Driggin, Elissa, Der Nigoghossian, Caroline, Ageno, Walter, Madjid, Mohammad, Guo, Yutao, Tang, Liang V., Hu, Yu, Giri, Jay, Cushman, Mary, Quere, Isabelle, Dimakakos, Evangelos P., Gibson, C. Michael, Lippi, Giuseppe, Favaloro, Emmanuel J., Fareed, Jawed, Caprini, Joseph A., Tafur, Alfonso J., Burton, John R., Francese, Dominic P., Wang, Elizabeth Y., Falanga, Anna, McLintock, Claire, Hunt, Beverley J., Spyropoulos, Alex C., Barnes, Geoffrey D., Eikelboom, John W., Weinberg, Ido, Schulman, Sam, Carrier, Marc, Piazza, Gregory, Beckman, Joshua A., Steg, Gabriel, Stone, Gregg W., Rosenkranz, Stephan, Goldhaber, Samuel Z., Parikh, Sahil A., Monreal, Manuel, Krumholz, Harlan M., Konstantinides, Stavros V., Weitz, Jeffrey I., and Lip, Gregory Y. H.
- Abstract
Coronavirus disease-2019 (COVID-19), a viral respiratory illness caused by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), may predispose patients to thrombotic disease, both in the venous and arterial circulations, because of excessive inflammation, platelet activation, endothelial dysfunction, and stasis. In addition, many patients receiving antithrombotic therapy for thrombotic disease may develop COVID-19, which can have implications for choice, dosing, and laboratory monitoring of antithrombotic therapy. Moreover, during a time with much focus on COVID-19, it is critical to consider how to optimize the available technology to care for patients without COVID-19 who have thrombotic disease. Herein, the authors review the current understanding of the pathogenesis, epidemiology, management, and outcomes of patients with COVID-19 who develop venous or arterial thrombosis, of those with pre-existing thrombotic disease who develop COVID-19, or those who need prevention or care for their thrombotic disease during the COVID-19 pandemic. (J Am Coll Cardiol 2020;75:2950-73) (c) 2020 by the American College of Cardiology Foundation.
- Published
- 2020
17. Pharmacological Agents Targeting Thromboinflammation in COVID-19: Review and Implications for Future Research
- Author
-
Bikdeli, Behnood, Madhavan, Mahesh V., Gupta, Aakriti, Jimenez, David, Burton, John R., Nigoghossian, Caroline Der, Chuich, Taylor, Nouri, Shayan Nabavi, Dreyfus, Isaac, Driggin, Elissa, Sethi, Sanjum, Sehgal, Kartik, Chatterjee, Saurav, Ageno, Walter, Madjid, Mohammad, Guo, Yutao, Tang, Liang V., Hu, Yu, Bertoletti, Laurent, Giri, Jay, Cushman, Mary, Quere, Isabelle, Dimakakos, Evangelos P., Gibson, C. Michael, Lippi, Giuseppe, Favaloro, Emmanuel J., Fareed, Jawed, Tafur, Alfonso J., Francese, Dominic P., Batra, Jaya, Falanga, Anna, Clerkin, Kevin J., Uriel, Nir, Kirtane, Ajay, McLintock, Claire, Hunt, Beverley J., Spyropoulos, Alex C., Barnes, Geoffrey D., Eikelboom, John W., Weinberg, Ido, Schulman, Sam, Carrier, Marc, Piazza, Gregory, Beckman, Joshua A., Leon, Martin B., Stone, Gregg W., Rosenkranz, Stephan, Goldhaber, Samuel Z., Parikh, Sahil A., Monreal, Manuel, Krumholz, Harlan M., Konstantinides, Stavros V., Weitz, Jeffrey I., Lip, Gregory Y. H., Bikdeli, Behnood, Madhavan, Mahesh V., Gupta, Aakriti, Jimenez, David, Burton, John R., Nigoghossian, Caroline Der, Chuich, Taylor, Nouri, Shayan Nabavi, Dreyfus, Isaac, Driggin, Elissa, Sethi, Sanjum, Sehgal, Kartik, Chatterjee, Saurav, Ageno, Walter, Madjid, Mohammad, Guo, Yutao, Tang, Liang V., Hu, Yu, Bertoletti, Laurent, Giri, Jay, Cushman, Mary, Quere, Isabelle, Dimakakos, Evangelos P., Gibson, C. Michael, Lippi, Giuseppe, Favaloro, Emmanuel J., Fareed, Jawed, Tafur, Alfonso J., Francese, Dominic P., Batra, Jaya, Falanga, Anna, Clerkin, Kevin J., Uriel, Nir, Kirtane, Ajay, McLintock, Claire, Hunt, Beverley J., Spyropoulos, Alex C., Barnes, Geoffrey D., Eikelboom, John W., Weinberg, Ido, Schulman, Sam, Carrier, Marc, Piazza, Gregory, Beckman, Joshua A., Leon, Martin B., Stone, Gregg W., Rosenkranz, Stephan, Goldhaber, Samuel Z., Parikh, Sahil A., Monreal, Manuel, Krumholz, Harlan M., Konstantinides, Stavros V., Weitz, Jeffrey I., and Lip, Gregory Y. H.
- Abstract
Coronavirus disease 2019 (COVID-19), currently a worldwide pandemic, is a viral illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The suspected contribution of thrombotic events to morbidity and mortality in COVID-19 patients has prompted a search for novel potential options for preventing COVID-19-associated thrombotic disease. In this article by the Global COVID-19 Thrombosis Collaborative Group, we describe novel dosing approaches for commonly used antithrombotic agents (especially heparin-based regimens) and the potential use of less widely used antithrombotic drugs in the absence of confirmed thrombosis. Although these therapies may have direct antithrombotic effects, other mechanisms of action, including anti-inflammatory or antiviral effects, have been postulated. Based on survey results from this group of authors, we suggest research priorities for specific agents and subgroups of patients with COVID-19. Further, we review other agents, including immunomodulators, that may have antithrombotic properties. It is our hope that the present document will encourage and stimulate future prospective studies and randomized trials to study the safety, efficacy, and optimal use of these agents for prevention or management of thrombosis in COVID-19.
- Published
- 2020
18. Antiplatelet strategies in acute coronary syndromes: design and methodology of an international collaborative network meta-analysis of randomized controlled trials
- Author
-
Madhavan, Mahesh V., primary, Bikdeli, Behnood, additional, Redfors, Björn, additional, Biondi-Zoccai, Giuseppe, additional, Varunok, Nicholas J., additional, Burton, John R., additional, Crowley, Aaron, additional, Francese, Dominic P., additional, Gupta, Aakriti, additional, Der Nigoghossian, Caroline, additional, Chatterjee, Saurav, additional, Palmerini, Tullio, additional, Benedetto, Umberto, additional, You, Seng-Chan, additional, Ohman, Magnus, additional, Kastrati, Adnan, additional, Steg, Philippe G., additional, Gibson, C. Michael, additional, Angiolillo, Dominick J., additional, Krumholz, Harlan M., additional, and Stone, Gregg W., additional
- Published
- 2020
- Full Text
- View/download PDF
19. Individual Patient Data Pooled Analysis of Randomized Trials of Bivalirudin versus Heparin in Acute Myocardial Infarction: Rationale and Methodology
- Author
-
Bikdeli, Behnood, additional, McAndrew, Thomas, additional, Crowley, Aaron, additional, Chen, Shmuel, additional, Mehdipoor, Ghazaleh, additional, Redfors, Björn, additional, Liu, Yangbo, additional, Zhang, Zixuan, additional, Liu, Mengdan, additional, Zhang, Yiran, additional, Francese, Dominic P., additional, Erlinge, David, additional, James, Stefan K., additional, Han, Yaling, additional, Li, Yi, additional, Kastrati, Adnan, additional, Schüpke, Stefanie, additional, Stables, Rod H., additional, Shahzad, Adeel, additional, Steg, Philippe Gabriel, additional, Goldstein, Patrick, additional, Frigoli, Enrico, additional, Mehran, Roxana, additional, Valgimigli, Marco, additional, and Stone, Gregg W., additional
- Published
- 2019
- Full Text
- View/download PDF
20. How Cox models react to a study-specific confounder in a patient-level pooled dataset: random effects better cope with an imbalanced covariate across trials unless baseline hazards differ
- Author
-
McAndrew, Thomas, primary, Redfors, Bjorn, additional, Crowley, Aaron, additional, Zhang, Yiran, additional, Chen, Shmuel, additional, Golomb, Mordechai, additional, Alu, Maria C., additional, Francese, Dominic P., additional, Ben-Yehuda, Ori, additional, Maehara, Akiko, additional, Mintz, Gary S., additional, Stone, Gregg W., additional, and Jenkins, Paul L., additional
- Published
- 2019
- Full Text
- View/download PDF
21. Sulodexide versus Control and the Risk of Thrombotic and Hemorrhagic Events: Meta-Analysis of Randomized Trials.
- Author
-
Bikdeli, Behnood, Chatterjee, Saurav, Kirtane, Ajay J., Parikh, Sahil A., Andreozzi, Giuseppe M., Desai, Nihar R., Francese, Dominic P., Gibson, C Michael, Piazza, Gregory, Goldhaber, Samuel Z., Eikelboom, John W., Krumholz, Harlan M., and Stone, Gregg W.
- Subjects
PERIPHERAL vascular diseases ,VENOUS thrombosis ,DERMATAN sulfate ,PULMONARY embolism ,CARDIOVASCULAR diseases risk factors - Abstract
Thrombotic cardiovascular disease (myocardial infarction [MI], stroke, and venous thromboembolism [VTE]) remains a major cause of death and disability. Sulodexide is an oral glycosaminoglycan containing heparan sulfate and dermatan sulfate. We conducted a systematic review and meta-analysis to determine the cardiovascular efficacy, and safety of sulodexide versus control in randomized controlled trials (RCTs). We searched MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials for RCTs reporting cardiovascular outcomes in patients receiving sulodexide versus control (placebo or no treatment). Outcomes included all-cause mortality, cardiovascular mortality, MI, stroke, deep vein thrombosis (DVT), pulmonary embolism, and bleeding. We used inverse variance random-effects models with odds ratio (OR) as the effect measure. After screening 360 records, 6 RCTs including 7,596 patients (median follow-up duration: 11.6 months) were included. Patients were enrolled for history of MI, VTE, peripheral arterial disease, or cardiovascular risk factors plus nephropathy. Use of sulodexide compared with control was associated with reduced odds of all-cause mortality (OR 0.67, 95% confidence interval [CI] 0.52–0.85, p = 0.001), cardiovascular mortality (OR 0.44, 95% CI 0.22–0.89, p = 0.02), and MI (OR 0.70, 95% CI 0.51–0.96, p = 0.03), and nonsignificantly reduced odds of stroke (OR 0.78, 95% CI 0.45–1.35, p = 0.38). Sulodexide was associated with significantly reduced odds of VTE (OR 0.44, 95% CI 0.24–0.81, p = 0.008), including DVT (OR 0.41, 95% CI 0.26–0.65, p < 0.001), but not pulmonary embolism (OR 0.92, 95% CI 0.40–2.15, p = 0.86). Bleeding events were not significantly different in the two groups (OR 1.14, 95% CI 0.47–2.74, p = 0.48). In six RCTs across a variety of clinical indications, use of sulodexide compared with placebo or no treatment was associated with reduced odds of all-cause mortality, cardiovascular mortality, MI, and DVT, without a significant increase in bleeding. Additional studies with this agent are warranted. [ABSTRACT FROM AUTHOR]
- Published
- 2020
- Full Text
- View/download PDF
22. Outcomes of a Dedicated Stent in Coronary Bifurcations with Large Side Branches: A Subanalysis of the Randomized TRYTON Bifurcation Study
- Author
-
Généreux, Philippe, Kini, Annapoorna, Lesiak, Maciej, Kumsars, Indulis, Fontos, Géza, Slagboom, Ton, Ungi, Imre, Metzger, D. Christopher, Wykrzykowska, Joanna J., Stella, Pieter R., Bartorelli, Antonio L., Fearon, William F., Lefèvre, Thierry, Feldman, Robert L., Tarantini, Giuseppe, Bettinger, Nicolas, Minalu Ayele, Girma, LaSalle, Laura, Francese, Dominic P., Onuma, Yoshinobu, Grundeken, Maik J., Garcia-Garcia, Hector M., Laak, Linda L., Cutlip, Donald E., Kaplan, Aaron V., Serruys, Patrick W., Leon, Martin B., and Cardiology
- Subjects
Male ,Time Factors ,Myocardial Infarction ,Coronary Artery Disease ,Coronary Angiography ,Prosthesis Design ,Severity of Illness Index ,coronary stent ,Risk Factors ,Nuclear Medicine and Imaging ,Journal Article ,Humans ,Comparative Study ,Single-Blind Method ,Prospective Studies ,Angioplasty, Balloon, Coronary ,coronary bifurcation ,Aged ,Medicine (all) ,Coronary Thrombosis ,Coronary Stenosis ,PCI ,Middle Aged ,Radiology, Nuclear Medicine and Imaging ,Cardiology and Cardiovascular Medicine ,Multicenter Study ,Treatment Outcome ,Radiology Nuclear Medicine and imaging ,Randomized Controlled Trial ,Female ,Stents ,Radiology - Abstract
Objectives: To examine the benefit of the Tryton dedicated side branch (SB) stent compared with provisional stenting in the treatment of complex bifurcation lesions involving large SBs. Background: The TRYTON Trial was designed to evaluate the utility of a dedicated SB stent to treat true bifurcation lesions involving large (≥2.5 mm by visual estimation) SBs. Patient enrolled in the trial had smaller SB diameters than intended (59% SB ≤2.25 mm by Core Lab QCA). The TRYTON Trial did not meet its primary endpoint due to an increased rate of peri-procedural myocardial infarctions (MIs). Methods: The TRYTON Trial randomized 704 patients to the Tryton SB stent with main vessel DES versus provisional SB treatment with main vessel DES. The rates of the primary end point of target vessel failure and the secondary powered end point of angiographic percent diameter stenosis in the SB at 9 months were assessed and compared between the two treatment strategies among patients with a SB ≥2.25 mm diameter at baseline determined by Core Lab QCA. Results: Among the 704 patients enrolled in the TRYTON Trial, 289 patients (143 provisional and 146 Tryton stent; 41% of entire cohort) had a SB ≥2.25 mm. The primary end point of TVF was numerically lower in the Tryton group compared with the provisional group (11.3% vs. 15.6%, P = 0.38), and was within the non-inferiority margin. No difference among the rates of clinically driven target vessel revascularization (3.5% vs. 4.3% P = 0.77) or cardiac death (0% both groups) were seen. In-segment percent diameter stenosis of the SB was significantly lower in the Tryton group compared with the provisional group (30.4% vs. 40.6%, P = 0.004). Conclusions: Analysis of the TRYTON Trial cohort of SB ≥2.25 mm supports the safety and efficacy of the Tryton SB stent compared with a provisional stenting strategy in the treatment of bifurcation lesions involving large SBs.
- Published
- 2016
23. Mortality, Length of Stay, and Cost Implications of Procedural Bleeding After Percutaneous Interventions Using Large-Bore Catheters
- Author
-
Redfors, Björn, primary, Watson, Brendan M., additional, McAndrew, Thomas, additional, Palisaitis, Emilie, additional, Francese, Dominic P., additional, Razavi, Mehdi, additional, Safirstein, Jordan, additional, Mehran, Roxana, additional, Kirtane, Ajay J., additional, and Généreux, Philippe, additional
- Published
- 2017
- Full Text
- View/download PDF
24. Biomarkers in Aortic Stenosis: A Systematic Review
- Author
-
Redfors, Björn, primary, Furer, Ariel, additional, Lindman, Brian R., additional, Burkhoff, Daniel, additional, Marquis-Gravel, Guillaume, additional, Francese, Dominic P., additional, Ben-Yehuda, Ori, additional, Pibarot, Philippe, additional, Gillam, Linda D., additional, Leon, Martin B., additional, and Généreux, Philippe, additional
- Published
- 2017
- Full Text
- View/download PDF
25. Outcomes of a dedicated stent in coronary bifurcations with large side branches: A subanalysis of the randomized TRYTON bifurcation study
- Author
-
Cardiologie, Circulatory Health, Généreux, Philippe, Kini, Annapoorna, Lesiak, Maciej, Kumsars, Indulis, Fontos, Géza, Slagboom, Ton, Ungi, Imre, Metzger, D. Christopher, Wykrzykowska, Joanna J., Stella, Pieter R., Bartorelli, Antonio L., Fearon, William F., Lefèvre, Thierry, Feldman, Robert L., Tarantini, Giuseppe, Bettinger, Nicolas, Minalu Ayele, Girma, LaSalle, Laura, Francese, Dominic P., Onuma, Yoshinobu, Grundeken, Maik J., Garcia-Garcia, Hector M., Laak, Linda L., Cutlip, Donald E., Kaplan, Aaron V., Serruys, Patrick W., Leon, Martin B., Cardiologie, Circulatory Health, Généreux, Philippe, Kini, Annapoorna, Lesiak, Maciej, Kumsars, Indulis, Fontos, Géza, Slagboom, Ton, Ungi, Imre, Metzger, D. Christopher, Wykrzykowska, Joanna J., Stella, Pieter R., Bartorelli, Antonio L., Fearon, William F., Lefèvre, Thierry, Feldman, Robert L., Tarantini, Giuseppe, Bettinger, Nicolas, Minalu Ayele, Girma, LaSalle, Laura, Francese, Dominic P., Onuma, Yoshinobu, Grundeken, Maik J., Garcia-Garcia, Hector M., Laak, Linda L., Cutlip, Donald E., Kaplan, Aaron V., Serruys, Patrick W., and Leon, Martin B.
- Published
- 2016
26. Angiographic predictors of 2-year stent thrombosis in patients receiving drug-eluting stents: Insights from the ADAPT-DES study
- Author
-
Généreux, Philippe, primary, Redfors, Björn, additional, Witzenbichler, Bernhard, additional, Maehara, Akiko, additional, Yadav, Mayank, additional, Weisz, Giora, additional, Francese, Dominic P., additional, Parvataneni, Rupa, additional, Brener, Sorin J., additional, Mehran, Roxana, additional, Kirtane, Ajay J., additional, and Stone, Gregg W., additional
- Published
- 2016
- Full Text
- View/download PDF
27. A randomized trial of a dedicated bifurcation stent versus provisional stenting in the treatment of coronary bifurcation lesions
- Author
-
Généreux, Philippe, Kumsars, Indulis, Lesiak, Maciej, Kini, Annapoorna, Fontos, Géza, Slagboom, Ton, Ungi, Imre, Metzger, D. Christopher, Wykrzykowska, Joanna J., Stella, Pieter R., Bartorelli, Antonio L., Fearon, William F., Lefèvre, Thierry, Feldman, Robert L., Lasalle, Laura, Francese, Dominic P., Onuma, Yoshinobu, Grundeken, Maik J., Garcia-Garcia, Hector M., Laak, Linda L., Cutlip, Donald E., Kaplan, Aaron V., Serruys, Patrick W., Leon, Martin B., Généreux, Philippe, Kumsars, Indulis, Lesiak, Maciej, Kini, Annapoorna, Fontos, Géza, Slagboom, Ton, Ungi, Imre, Metzger, D. Christopher, Wykrzykowska, Joanna J., Stella, Pieter R., Bartorelli, Antonio L., Fearon, William F., Lefèvre, Thierry, Feldman, Robert L., Lasalle, Laura, Francese, Dominic P., Onuma, Yoshinobu, Grundeken, Maik J., Garcia-Garcia, Hector M., Laak, Linda L., Cutlip, Donald E., Kaplan, Aaron V., Serruys, Patrick W., and Leon, Martin B.
- Published
- 2015
28. A randomized trial of a dedicated bifurcation stent versus provisional stenting in the treatment of coronary bifurcation lesions
- Author
-
Cardiologie, Circulatory Health, Généreux, Philippe, Kumsars, Indulis, Lesiak, Maciej, Kini, Annapoorna, Fontos, Géza, Slagboom, Ton, Ungi, Imre, Metzger, D. Christopher, Wykrzykowska, Joanna J., Stella, Pieter R., Bartorelli, Antonio L., Fearon, William F., Lefèvre, Thierry, Feldman, Robert L., Lasalle, Laura, Francese, Dominic P., Onuma, Yoshinobu, Grundeken, Maik J., Garcia-Garcia, Hector M., Laak, Linda L., Cutlip, Donald E., Kaplan, Aaron V., Serruys, Patrick W., Leon, Martin B., Cardiologie, Circulatory Health, Généreux, Philippe, Kumsars, Indulis, Lesiak, Maciej, Kini, Annapoorna, Fontos, Géza, Slagboom, Ton, Ungi, Imre, Metzger, D. Christopher, Wykrzykowska, Joanna J., Stella, Pieter R., Bartorelli, Antonio L., Fearon, William F., Lefèvre, Thierry, Feldman, Robert L., Lasalle, Laura, Francese, Dominic P., Onuma, Yoshinobu, Grundeken, Maik J., Garcia-Garcia, Hector M., Laak, Linda L., Cutlip, Donald E., Kaplan, Aaron V., Serruys, Patrick W., and Leon, Martin B.
- Published
- 2015
29. Risk stratification of patients undergoing medical therapy after coronary angiography
- Author
-
Bettinger, Nicolas, primary, Palmerini, Tullio, additional, Caixeta, Adriano, additional, Dressler, Ovidiu, additional, Litherland, Claire, additional, Francese, Dominic P., additional, Giustino, Gennaro, additional, Mehran, Roxana, additional, Leon, Martin B., additional, Stone, Gregg W., additional, and Généreux, Philippe, additional
- Published
- 2015
- Full Text
- View/download PDF
30. Reasonable incomplete revascularisation after percutaneous coronary intervention: the SYNTAX Revascularisation Index
- Author
-
Généreux, Philippe, primary, Campos, Carlos M., additional, Yadav, Mayank, additional, Palmerini, Tullio, additional, Caixeta, Adriano, additional, Xu, Ke, additional, Francese, Dominic P., additional, Dangas, George D., additional, Mehran, Roxana, additional, Leon, Martin B., additional, Serruys, Patrick W., additional, and Stone, Gregg W., additional
- Published
- 2015
- Full Text
- View/download PDF
31. TCT-491 Incidence of Peri-Procedural Myocardial Infarction after Bifurcation Percutaneous Coronary Intervention According to Different Definitions: Insight from the Tryton IDE randomized trial
- Author
-
Lesiak, Maciej, primary, Bartorelli, Antonio L., additional, Grundeken, Maik J., additional, Genereux, Philippe, additional, Wykrzykowska, Joanna J., additional, Francese, Dominic P., additional, Kumsars, Indulis, additional, Kini, Annapoorna, additional, Lefevre, Thierry, additional, Garcia-Garcia, Hector M., additional, Fontos, Geza, additional, Stella, Pieter R., additional, Ungi, Imre, additional, Laak, Linn L., additional, Kaplan, Aaron, additional, Onuma, Yoshinobu, additional, Leon, Martin, additional, and Serruys, Patrick W., additional
- Published
- 2015
- Full Text
- View/download PDF
32. Outcomes of a dedicated stent in coronary bifurcations with large side branches: A subanalysis of the randomized TRYTON bifurcation study
- Author
-
Généreux, Philippe, primary, Kini, Annapoorna, additional, Lesiak, Maciej, additional, Kumsars, Indulis, additional, Fontos, Géza, additional, Slagboom, Ton, additional, Ungi, Imre, additional, Metzger, D. Christopher, additional, Wykrzykowska, Joanna J., additional, Stella, Pieter R., additional, Bartorelli, Antonio L., additional, Fearon, William F., additional, Lefèvre, Thierry, additional, Feldman, Robert L., additional, Tarantini, Giuseppe, additional, Bettinger, Nicolas, additional, Minalu Ayele, Girma, additional, LaSalle, Laura, additional, Francese, Dominic P., additional, Onuma, Yoshinobu, additional, Grundeken, Maik J., additional, Garcia-Garcia, Hector M., additional, Laak, Linda L., additional, Cutlip, Donald E., additional, Kaplan, Aaron V., additional, Serruys, Patrick W., additional, and Leon, Martin B., additional
- Published
- 2015
- Full Text
- View/download PDF
33. Incidence, Predictors, and Impact of Post-Discharge Bleeding After Percutaneous Coronary Intervention
- Author
-
Généreux, Philippe, primary, Giustino, Gennaro, additional, Witzenbichler, Bernhard, additional, Weisz, Giora, additional, Stuckey, Thomas D., additional, Rinaldi, Michael J., additional, Neumann, Franz-Josef, additional, Metzger, D. Christopher, additional, Henry, Timothy D., additional, Cox, David A., additional, Duffy, Peter L., additional, Mazzaferri, Ernest, additional, Yadav, Mayank, additional, Francese, Dominic P., additional, Palmerini, Tullio, additional, Kirtane, Ajay J., additional, Litherland, Claire, additional, Mehran, Roxana, additional, and Stone, Gregg W., additional
- Published
- 2015
- Full Text
- View/download PDF
34. A Randomized Trial of a Dedicated Bifurcation Stent Versus Provisional Stenting in the Treatment of Coronary Bifurcation Lesions
- Author
-
Généreux, Philippe, primary, Kumsars, Indulis, additional, Lesiak, Maciej, additional, Kini, Annapoorna, additional, Fontos, Géza, additional, Slagboom, Ton, additional, Ungi, Imre, additional, Metzger, D. Christopher, additional, Wykrzykowska, Joanna J., additional, Stella, Pieter R., additional, Bartorelli, Antonio L., additional, Fearon, William F., additional, Lefèvre, Thierry, additional, Feldman, Robert L., additional, LaSalle, Laura, additional, Francese, Dominic P., additional, Onuma, Yoshinobu, additional, Grundeken, Maik J., additional, Garcia-Garcia, Hector M., additional, Laak, Linda L., additional, Cutlip, Donald E., additional, Kaplan, Aaron V., additional, Serruys, Patrick W., additional, and Leon, Martin B., additional
- Published
- 2015
- Full Text
- View/download PDF
35. Risk stratification of patients undergoing medical therapy after coronary angiography.
- Author
-
Bettinger, Nicolas, Palmerini, Tullio, Caixeta, Adriano, Dressler, Ovidiu, Litherland, Claire, Francese, Dominic P., Giustino, Gennaro, Mehran, Roxana, Leon, Martin B., Stone, Gregg W., and Généreux, Philippe
- Abstract
Aim: We sought to investigate the prognostic impact of the SYNTAX (Synergy between PCI with TAXUS and Cardiac Surgery) score (SS) on 1-year clinical outcomes in patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS) undergoing medical therapy only. Methods and results: Among the 13 819 patients enrolled in the ACUITY trial and undergoing coronary angiogram, 4491 patients were treated with medical therapy as the initial strategy. Of those, baseline SS and complete angiographic analysis were available in 1275 patients. Patients were divided in four groups based on the presence or absence of coronary artery disease (CAD) and subsequently, among patients with CAD, by SS. Major adverse cardiac events (MACE) and its individual components (death, myocardial infarction, and unplanned revascularization) were compared between groups. Among the 1275 patients, the mean SS was 3.5+7.0 (range 0-45). SYNTAX score was 0 in 842 patients, .0 and =5 in 170, .5 and =11 in 119, and .11 in 144 patients. The 1-year rates of MACE were higher in patients with CAD and higher SS. By multivariable analysis, the SS was a strong predictor of all adverse ischaemic events, including mortality. By receiver operator characteristic analysis, an SS cut-off of 8 showed the best prognostic accuracy for death and MACE. Conclusion: In patients with NSTE ACS undergoing medical therapy, the SS, especially when .8, was shown to be a strong predictor of 1-year MACE, including mortality. This finding has important clinical implications for risk stratification of patients with NSTE ACS undergoing medical therapy after an initial angiogram. [ABSTRACT FROM AUTHOR]
- Published
- 2016
- Full Text
- View/download PDF
36. Pharmacological Agents Targeting Thromboinflammation in COVID-19: Review and Implications for Future Research.
- Author
-
Bikdeli B, Madhavan MV, Gupta A, Jimenez D, Burton JR, Der Nigoghossian C, Chuich T, Nouri SN, Dreyfus I, Driggin E, Sethi S, Sehgal K, Chatterjee S, Ageno W, Madjid M, Guo Y, Tang LV, Hu Y, Bertoletti L, Giri J, Cushman M, Quéré I, Dimakakos EP, Gibson CM, Lippi G, Favaloro EJ, Fareed J, Tafur AJ, Francese DP, Batra J, Falanga A, Clerkin KJ, Uriel N, Kirtane A, McLintock C, Hunt BJ, Spyropoulos AC, Barnes GD, Eikelboom JW, Weinberg I, Schulman S, Carrier M, Piazza G, Beckman JA, Leon MB, Stone GW, Rosenkranz S, Goldhaber SZ, Parikh SA, Monreal M, Krumholz HM, Konstantinides SV, Weitz JI, and Lip GYH
- Subjects
- Animals, Anti-Inflammatory Agents therapeutic use, Anticoagulants therapeutic use, Antiviral Agents therapeutic use, Betacoronavirus, COVID-19, Coronavirus Infections complications, Coronavirus Infections drug therapy, Glycosaminoglycans therapeutic use, Hemostasis, Humans, Inflammation complications, Inflammation immunology, Pandemics, Platelet Aggregation Inhibitors therapeutic use, Pneumonia, Viral complications, Pneumonia, Viral drug therapy, SARS-CoV-2, Thrombosis complications, Thrombosis immunology, COVID-19 Drug Treatment, Coronavirus Infections immunology, Fibrinolytic Agents therapeutic use, Inflammation drug therapy, Pneumonia, Viral immunology, Thrombosis drug therapy
- Abstract
Coronavirus disease 2019 (COVID-19), currently a worldwide pandemic, is a viral illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The suspected contribution of thrombotic events to morbidity and mortality in COVID-19 patients has prompted a search for novel potential options for preventing COVID-19-associated thrombotic disease. In this article by the Global COVID-19 Thrombosis Collaborative Group, we describe novel dosing approaches for commonly used antithrombotic agents (especially heparin-based regimens) and the potential use of less widely used antithrombotic drugs in the absence of confirmed thrombosis. Although these therapies may have direct antithrombotic effects, other mechanisms of action, including anti-inflammatory or antiviral effects, have been postulated. Based on survey results from this group of authors, we suggest research priorities for specific agents and subgroups of patients with COVID-19. Further, we review other agents, including immunomodulators, that may have antithrombotic properties. It is our hope that the present document will encourage and stimulate future prospective studies and randomized trials to study the safety, efficacy, and optimal use of these agents for prevention or management of thrombosis in COVID-19., Competing Interests: No specific funding was sought or received for this manuscript. A list of Disclosures for co-authors is available online in the Supplementary Material (available in the online version)., (Georg Thieme Verlag KG Stuttgart · New York.)
- Published
- 2020
- Full Text
- View/download PDF
37. Individual Patient Data Pooled Analysis of Randomized Trials of Bivalirudin versus Heparin in Acute Myocardial Infarction: Rationale and Methodology.
- Author
-
Bikdeli B, McAndrew T, Crowley A, Chen S, Mehdipoor G, Redfors B, Liu Y, Zhang Z, Liu M, Zhang Y, Francese DP, Erlinge D, James SK, Han Y, Li Y, Kastrati A, Schüpke S, Stables RH, Shahzad A, Steg PG, Goldstein P, Frigoli E, Mehran R, Valgimigli M, and Stone GW
- Subjects
- Algorithms, Databases, Factual, Drug Administration Schedule, Hirudins, Humans, Medical Informatics, Outcome Assessment, Health Care, Randomized Controlled Trials as Topic, Recombinant Proteins therapeutic use, Risk, Treatment Outcome, Anticoagulants therapeutic use, Data Interpretation, Statistical, Heparin therapeutic use, Myocardial Infarction drug therapy, Peptide Fragments therapeutic use, Percutaneous Coronary Intervention
- Abstract
Background: Individual randomized controlled trials (RCTs) of periprocedural anticoagulation with bivalirudin versus heparin during percutaneous coronary intervention (PCI) have reported conflicting results. Study-level meta-analyses lack granularity to adjust for confounders, explore heterogeneity, or identify subgroups that may particularly benefit or be harmed., Objective: To overcome these limitations, we sought to develop an individual patient-data pooled database of RCTs comparing bivalirudin versus heparin., Methods: We conducted a systematic review to identify RCTs in which ≥1,000 patients with acute myocardial infarction (AMI) undergoing PCI were randomized to bivalirudin versus heparin., Results: From 738 identified studies, 8 RCTs met the prespecified criteria. The principal investigators of each study agreed to provide patient-level data. The data were pooled and checked for accuracy against trial publications, with discrepancies addressed by consulting with the trialists. Consensus-based definitions were created to resolve differing antithrombotic, procedural, and outcome definitions. The project required 3.5 years to complete, and the final database includes 27,409 patients (13,346 randomized to bivalirudin and 14,063 randomized to heparin)., Conclusion: We have created a large individual patient database of bivalirudin versus heparin RCTs in patients with AMI undergoing PCI. This endeavor may help identify the optimal periprocedural anticoagulation regimen for patient groups with different relative risks of adverse ischemic versus bleeding events, including those with ST-segment and non-ST-segment elevation MI, radial versus femoral access, use of a prolonged bivalirudin infusion or glycoprotein inhibitors, and others. Adherence to standardized techniques and rigorous validation processes should increase confidence in the accuracy and robustness of the results., Competing Interests: B.B.: Research grant (significant) – National Heart, Lung, and Blood Institute, National Institutes of Health, through grant number T32 HL007854. B.B. reports that he has been a consulting expert (on behalf of the plaintiff) for litigation related to a specific type of IVC filters. T.M.: None. A.C.: None. S.C.: None. G.M.: None. B.R.: None. Y.L.: None. Z.Z.: None. M.L.: None. Y.Z.: None. D.P.F.: None. DE.: Research grant (significant) – The VALIDATE-SWEDEHEART study was supported by the Swedish Heart–Lung Foundation, the Swedish Research Council, AstraZeneca, The Medicines Company, and the Swedish Foundation for Strategic Research. S.K.J.: The VALIDATE-SWEDEHEART study was supported by the Swedish Heart–Lung Foundation, the Swedish Research Council, AstraZeneca, The Medicines Company, and the Swedish Foundation for Strategic Research Y.H.: Research grant (significant) – The BRIGHT trial was supported by a general research fund from the General Hospital of Shenyang Military Region, as well as profit grants from the Chinese Government National Key Research and Development. Y.L.: None. A.K.: Research grant (significant) – ISAR-REACT-4 was supported in part by Nycomed Pharma, Unterschleissheim, Germany (former distributor of bivalirudin in Europe), and a grant (KKF 04–06 [974404]) from Deutsches Herzzentrum. S.S.: Dr. Schüpke has received the Else Kröner-Memorial grant from the Else Kröner-Fresenius-Stiftung. R.H.S.: Research grant (significant) – HEAT-PPCI was funded by Liverpool Heart and Chest Hospital, UK National Institute of Health Research, The Medicines Company, AstraZeneca, and The Bentley Drivers Club (UK). A.S.: None. P.G.S.: Research grant (significant) – the EUROMAX trial was funded by The Medicines Company. P.G.S. also reports research grants from Bayer, Merck, Sanofi, and Servier; and speaking or consulting fees from Amarin, Amgen, AstraZeneca, Bayer/Janssen, Boehringer Ingelheim, Bristol-Myers Squibb, and Lilly. P.G.: Dr. Goldstein receives honorarium as a speaker and consultant from Boehringer Ingelheim, and honorarium as a speaker from AstraZeneca. E.F.: None. R.M.: Institutional Grant Support (funding to the institution) - AstraZeneca, Bayer, Beth Israel Deaconess, BMS, CSL Behring, DSI, BSC, Novartis Pharmaceuticals, OrbusNeich; Consulting Fees - Medscape, Regeneron Pharmaceuticals (no fee, Sanofi, Abbott Laboratories (personal fees for speaking engagements; consultant (paid to the institution), Abiomed and The Medicines Company (consultant – spouse); Scientific Advisory Board/Advisory Board - PLx Opco Inc./PLx Pharma Inc. (scientific advisory board), Bristol Myers Squibb (advisory board; funding to the institution); Equity <1% - Claret Medical, Elixir Medical; Executive Committee (paid to the institution) - Janssen Pharmaceuticals; DSMB Membership - Watermark Research Partners. M.V.: Research grant (significant) – the MATRIX trial was supported by The Medicines Company and Terumo Medical. Dr. Valgimigli also reports grants and personal fees from Abbott, personal fees from Chiesi, personal fees from Bayer, personal fees from Daiichi Sankyo, and personal fees from Amgen. G.W.S.: Consultant to MAIA Pharmaceuticals., (Georg Thieme Verlag KG Stuttgart · New York.)
- Published
- 2020
- Full Text
- View/download PDF
38. Impact of Chronic Total Occlusions on Revascularization Scores and Outcome Prediction.
- Author
-
Redfors B, Palmerini T, Caixeta A, Ayele GM, Francese DP, Mehran R, Brilakis ES, Kirtane AJ, Karmpaliotis D, Stone GW, and Généreux P
- Subjects
- Chronic Disease, Coronary Angiography, Coronary Occlusion complications, Coronary Occlusion surgery, Female, Humans, Incidence, Male, Middle Aged, Non-ST Elevated Myocardial Infarction diagnosis, Non-ST Elevated Myocardial Infarction epidemiology, Prognosis, Risk Factors, Survival Rate trends, Treatment Outcome, United States epidemiology, Coronary Occlusion diagnosis, Myocardial Revascularization, Non-ST Elevated Myocardial Infarction etiology
- Abstract
Objectives: To evaluate the contribution of chronic total occlusion (CTO)-related SYNTAX score (SS) to the overall SS for patients with CTO and compare the traditional SS to a simplified variant. The SS algorithm assigns CTO lesions a greater weight (5× points) than non-CTO lesions (50% to <100% diameter stenosis; 2× points)., Methods: We calculated the SS and the simplified SS (2× points also to CTO lesions) for 4356 patients from the angiographic substudy of the Acute Catheterization and Urgent Intervention Triage StrategY (ACUITY) trial. We compared the association between SS and 1-year mortality and major adverse cardiac events for patients with and without a CTO. We also compared the simplified SS with the traditional SS., Results: The median SS was 20 (interquartile range, 13-27.5) for patients with a CTO and 8 (interquartile range, 2-16) for patients without a CTO. For patients with a CTO, the CTO lesion(s) contributed 67 ± 26% of the total SS. The simplified SS reclassified 187/603 (31.0%) of patients with a SS >22 to a SS ≤22. The traditional SS did not improve discrimination indices for predicting outcomes compared with the simplified SS., Conclusions: CTO lesions contribute considerably to the total SS in patients with a CTO. A simplified SS that does not differentiate between CTO and non-CTO lesions appeared equivalent to the traditional SS for risk prediction, but reclassified a substantial proportion of patients to a SS ≤22 and may impact choice of revascularization strategy for patients with complex coronary artery disease involving a CTO lesion.
- Published
- 2017
39. Outcomes of a dedicated stent in coronary bifurcations with large side branches: A subanalysis of the randomized TRYTON bifurcation study.
- Author
-
Généreux P, Kini A, Lesiak M, Kumsars I, Fontos G, Slagboom T, Ungi I, Metzger DC, Wykrzykowska JJ, Stella PR, Bartorelli AL, Fearon WF, Lefèvre T, Feldman RL, Tarantini G, Bettinger N, Minalu Ayele G, LaSalle L, Francese DP, Onuma Y, Grundeken MJ, Garcia-Garcia HM, Laak LL, Cutlip DE, Kaplan AV, Serruys PW, and Leon MB
- Subjects
- Aged, Angioplasty, Balloon, Coronary adverse effects, Angioplasty, Balloon, Coronary mortality, Coronary Angiography, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease mortality, Coronary Stenosis diagnostic imaging, Coronary Stenosis mortality, Coronary Thrombosis etiology, Female, Humans, Male, Middle Aged, Myocardial Infarction etiology, Prospective Studies, Prosthesis Design, Risk Factors, Severity of Illness Index, Single-Blind Method, Time Factors, Treatment Outcome, Angioplasty, Balloon, Coronary instrumentation, Coronary Artery Disease therapy, Coronary Stenosis therapy, Stents
- Abstract
Objectives: To examine the benefit of the Tryton dedicated side branch (SB) stent compared with provisional stenting in the treatment of complex bifurcation lesions involving large SBs., Background: The TRYTON Trial was designed to evaluate the utility of a dedicated SB stent to treat true bifurcation lesions involving large (≥2.5 mm by visual estimation) SBs. Patient enrolled in the trial had smaller SB diameters than intended (59% SB ≤2.25 mm by Core Lab QCA). The TRYTON Trial did not meet its primary endpoint due to an increased rate of peri-procedural myocardial infarctions (MIs)., Methods: The TRYTON Trial randomized 704 patients to the Tryton SB stent with main vessel DES versus provisional SB treatment with main vessel DES. The rates of the primary end point of target vessel failure and the secondary powered end point of angiographic percent diameter stenosis in the SB at 9 months were assessed and compared between the two treatment strategies among patients with a SB ≥2.25 mm diameter at baseline determined by Core Lab QCA., Results: Among the 704 patients enrolled in the TRYTON Trial, 289 patients (143 provisional and 146 Tryton stent; 41% of entire cohort) had a SB ≥2.25 mm. The primary end point of TVF was numerically lower in the Tryton group compared with the provisional group (11.3% vs. 15.6%, P = 0.38), and was within the non-inferiority margin. No difference among the rates of clinically driven target vessel revascularization (3.5% vs. 4.3% P = 0.77) or cardiac death (0% both groups) were seen. In-segment percent diameter stenosis of the SB was significantly lower in the Tryton group compared with the provisional group (30.4% vs. 40.6%, P = 0.004)., Conclusions: Analysis of the TRYTON Trial cohort of SB ≥2.25 mm supports the safety and efficacy of the Tryton SB stent compared with a provisional stenting strategy in the treatment of bifurcation lesions involving large SBs. © 2015 Wiley Periodicals, Inc., (© 2015 Wiley Periodicals, Inc.)
- Published
- 2016
- Full Text
- View/download PDF
40. The association between the extent of coronary artery disease and major bleeding events after percutaneous coronary intervention: from the ACUITY trial.
- Author
-
Madhavan MV, Généreux P, Palmerini T, Caixeta A, Xu K, McAndrew TC, Francese DP, Kirtane AJ, Mehran R, and Stone GW
- Subjects
- Aged, Coronary Artery Bypass, Coronary Artery Disease diagnostic imaging, Female, Humans, Male, Middle Aged, Multicenter Studies as Topic, Multivariate Analysis, Postoperative Hemorrhage epidemiology, Postoperative Hemorrhage mortality, Proportional Hazards Models, Prospective Studies, Randomized Controlled Trials as Topic, Risk Factors, Acute Coronary Syndrome surgery, Coronary Angiography, Coronary Artery Disease complications, Percutaneous Coronary Intervention adverse effects, Postoperative Hemorrhage etiology
- Abstract
Objective: We sought to evaluate the relation between the extent of coronary artery disease (CAD) and bleeding risk in patients undergoing percutaneous coronary intervention (PCI) for non-ST segment elevation acute coronary syndrome (NSTEACS)., Background: Patients with severe CAD undergoing PCI for NSTEACS are at high risk for recurrent adverse events. Hemorrhagic events after PCI are associated with high rates of morbidity and mortality. Despite sharing many common risk factors, the relationship between the extent of CAD and bleeding after PCI remains understudied., Methods: The SYNTAX score (SS) was used to quantify the extent and severity of CAD. We stratified 2627 patients from the ACUITY PCI cohort into SS groups based on score tertiles from the ACUITY trial (<7, 7-12, and >12). Thirty-day major bleeding rates were determined for each group., Results: When stratified by ACUITY tertiles, 30-day major bleeding rates were significantly greater in the highest SS tertile (>12) than in the intermediate and lowest tertiles (P<.01). By multivariable analysis, the SS (by augmentation of 1 point) remained independently associated with 30-day major bleeding (hazard ratio = 1.03; 95% confidence interval, 1.01-1.04; P<.01)., Conclusion: The results of this large-scale study suggest that in addition to its previously described association with adverse ischemic events, the extent of CAD, as assessed by the SS, was independently associated with major bleeding after PCI for NSTEACS.
- Published
- 2015
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.