Examinando por Autor "Lopes, Renato D."
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- PublicaciónAcceso abiertoRisk Categorization Using New American College of Cardiology/American Heart Association Guidelines for Cholesterol Management and Its Relation to Alirocumab Treatment Following Acute Coronary Syndromes(Circulation, 2019-11-05) Roe, Matthew T.; Li, Qian H.; Bhatt, Deepak L.; Bittner, Vera A.; Diaz, Rafael; Goodman, Shaun G.; Harrington, Robert A.; Jukema, J. Wouter; Lopez-Jaramillo, Patricio; Lopes, Renato D.; Louie, Michael J.; Moriarty, Patrick M.; Szarek, Michael; Vogel, Robert; White, Harvey D.; Zeiher, Andreas M.; Baccara-Dinet, Marie T.; Steg, Gabriel; Schwartz, Gregory G.; EverestBackground: The 2018 US cholesterol management guidelines recommend additional lipid-lowering therapies for secondary prevention in patients with low-density lipoprotein cholesterol ≥70 mg/dL or non-high-density lipoprotein cholesterol ≥100 mg/dL despite maximum tolerated statin therapy. Such patients are considered at very high risk (VHR) based on a history of >1 major atherosclerotic cardiovascular disease (ASCVD) event or a single ASCVD event and multiple high-risk conditions. We investigated the association of US guideline-defined risk categories with the occurrence of ischemic events after acute coronary syndrome and reduction of those events by alirocumab, a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor. Methods: In the ODYSSEY OUTCOMES trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab), patients with recent acute coronary syndrome and residual dyslipidemia despite optimal statin therapy were randomly assigned to alirocumab or placebo. The primary trial outcome (major adverse cardiovascular events, ie, coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, or hospitalization for unstable angina) was examined according to American College of Cardiology/American Heart Association risk category. Results: Of 18 924 participants followed for a median of 2.8 years, 11 935 (63.1%) were classified as VHR: 4450 (37.3%) had multiple prior ASCVD events and 7485 (62.7%) had 1 major ASCVD event and multiple high-risk conditions. Major adverse cardiovascular events occurred in 14.4% of placebo-treated patients at VHR versus 5.6% of those not at VHR. In the VHR category, major adverse cardiovascular events occurred in 20.4% with multiple prior ASCVD events versus 10.7% with 1 ASCVD event and multiple high-risk conditions. Alirocumab was associated with consistent relative risk reductions in both risk categories (hazard ratio=0.84 for VHR; hazard ratio=0.86 for not VHR; Pinteraction=0.820) and by stratification within the VHR group (hazard ratio=0.86 for multiple prior ASCVD events; hazard ratio=0.82 for 1 major ASCVD event and multiple high-risk conditions; Pinteraction=0.672). The absolute risk reduction for major adverse cardiovascular events with alirocumab was numerically greater (but not statistically different) in the VHR group versus those not at VHR (2.1% versus 0.8%; Pinteraction=0.095) and among patients at VHR with multiple prior ASCVD events versus a single prior ASCVD event (2.4% versus 1.8%; Pinteraction=0.661). Conclusions: The US guideline criteria identify patients with recent acute coronary syndrome and dyslipidemia who are at VHR for recurrent ischemic events and who may derive a larger absolute benefit from treatment with alirocumab.
- PublicaciónAcceso abiertoThe Anti-Coronavirus Therapies (ACT) Trials: Design, Baseline Characteristics, and Challenges(2022-06-05) Eikelboom, John; Rangarajan, Sumathy; Jolly, Sanjit S.; Belley-Cote, Emilie P.; Whitlock, Richard; Beresh, Heather; Lewis, Gayle; Xu, Lizhen; Chan, Noel; Bangdiwala, Shrikant; Diaz, Rafael; Orlandini, Andres; Hassany, Mohamed; Tarhuni, Wadea M.; Yusufali, A.M.; Sharma, Sanjib Kumar; Kontsevaya, Anna; Lopez-Jaramillo, Patricio; Avezum, Alvaro; Dans, Antonio L.; Wasserman, Sean; Felix, Camilo; Kazmi, Khawar; Pais, Prem; Xavier, Denis; Lopes, Renato D.; Berwanger, Otavio; Nkeshimana, Menelas; Harper, William; Loeb, Mark; Choudhri, Shurjeel; Farkouh, Michael E.; Bosch, Jackie; Anand, Sonia S.; Yusuf, Salim; MasiraBackground: Effective treatments for COVID-19 are urgently needed, but conducting randomized trials during the pandemic has been challenging.Methods: The Anti-Coronavirus Therapy (ACT) trials are parallel factorial international trials that aimed to enroll 3500 outpatients and 2500 inpatients with symptomatic COVID-19. The outpatient trial is evaluating colchicine vs usual care, and aspirin vs usual care. The primary outcome for the colchicine randomization is hospitalization or death, and for the aspirin randomization, it is major thrombosis, hospitalization, or death. The inpatient trial is evaluating colchicine vs usual care, and the combination of rivaroxaban 2.5 mg twice daily and aspirin 100 mg once daily vs usual care. The primary outcome for the colchicine randomization is need for high-flow oxygen, need for mechanical ventilation, or death, and for the rivaroxaban plus aspirin randomization, it is major thrombotic events, need for high-flow oxygen, need for mechanical ventilation, or death. Results: At the completion of enrollment on February 10, 2022, the outpatient trial had enrolled 3917 patients, and the inpatient trial had enrolled 2611 patients. Challenges encountered included lack of preliminary data about the interventions under evaluation, uncertainties related to the expected event rates, delays in regulatory and ethics approvals, and in obtaining study interventions, as well as the changing pattern of the COVID-19 pandemic. Conclusions: The ACT trials will determine the efficacy of antiinflammatory therapy with colchicine, and antithrombotic therapy with aspirin given alone or in combination with rivaroxaban, across the spectrum of mild, moderate, and severe COVID-19. Lessons learned from the conduct of these trials will inform planning of future trials.