PATRICIA OLIVEIRA GUIMARAES
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conferenceObject Aspirin- Free Prasugrel Monotherapy: 30-Day Clinical Outcome After Percutaneous Coronary Intervention in Chronic Coronary Syndrome and Non- ST-Segment Elevation Acute Coronary Syndrome(2023) NAKAZAWA, Gaku; MIYASHITA, Kotaro; MASUDA, Shinichiro; TOBE, Akihiro; LEMOS, Pedro; GUIMARAES, Patricia; MURAMATSU, Takashi; KOTOKU, Nozomi; KAGEYAMA, Shigetaka; NINOMIYA, Kai; TANABE, Kengo; OZAKI, Yukio; KOZUMA, Ken; ONUMA, Yoshinobu; SERRUYS, Patrick- Reporting Clinical End Points and Safety Events in an Acute Coronary Syndrome Trial: Results With Integrated Collection(2017) GUIMARES, Patricia O.; LOPES, Renato D.; STEVENS, Susanna R.; ZIMERMAN, Andre; WRUCK, Lisa; JAMES, Stefan K.; HAQUE, Ghazala; GIRALDEZ, Roberto Rocha C. V.; ALEXANDER, John H.; ALEXANDER, Karen P.Background-End points and adverse events (AEs) are collected separately in clinical trials, yet regulatory requirements for serious AE reporting vary across regions, so classifying end points according to seriousness criteria can be useful in global trials. Methods and Results-In the Apixaban for Prevention of Acute Ischemic Events 2 (APPRAISE-2) trial, patients with a recent acute coronary syndrome were randomized to apixaban or placebo for the prevention of recurrent ischemic events. Suspected end points (myocardial infarction, stroke, or bleeding) were adjudicated by an independent clinical events classification committee. Safety criteria were collected for suspected end points and AEs. Patient-level event rates per 100 patient-days of follow-up, modeled using Poisson regression, explored the influence of region and patient characteristics on event reporting. Overall, 13 909 events were reported by 858 sites in 39 countries; 8.4% (n=1166) were suspected end points, and 91.6% (n=12 743) were AEs. Overall, 66.0% of suspected end points were confirmed by the clinical events classification committee. Most clinical events classification committee-confirmed end points met criteria to be classified as serious (94.0%); many clinical events classification committee-negated end points also did (63.2%), but fewer AEs met seriousness criteria (17.9%). The most common seriousness criterion was hospitalization (79.9%, n=2594). Region explained 28.7% of end point-and 26.4% of serious AE-reporting variation, and patient characteristics explained an additional 25.4% of end point and 13.4% of serious AE variation. Nonserious AE-reporting variation was not explained by adjustment. Conclusions-An integrated collection of end points and serious AEs is feasible in a multinational trial and illustrates the shared characteristics of events. Tailoring event collection to fit the phase and purpose of the trial is achievable and informative.
- REPLY: Elimination of Aspirin From PCI Pharmacotherapy(2021) LEMOS, Pedro A.; KOGAME, Norihiro; GUIMARAES, Patricia O.; MODOLO, Rodrigo; SERRUYS, Patrick W.
- Diagnostic Performance of Coronary Tomography Angiography and Serial Measurements of Sensitive Cardiac Troponin in Patients With Chest Pain and Intermediate Risk for Cardiovascular Events(2022) SOEIRO, Alexandre de Matos; BISELLI, Bruno; LEAL, Tatiana C. A. T.; BOSSA, Aline Siqueira; CESAR, Maria Cristina; JALLAD, Sergio; GOLDSTEIN, Priscila Gherardi; GUIMARAES, Patricia Oliveira; JR, Carlos Vicente Serrano; NOMURA, Cesar Higa; NAKAMURA, Debora; ROCHITTE, Carlos Eduardo; SOARES, Paulo Rogerio; JR, Mucio Tavares de OliveiraBackground: Coronary tomography angiography (CTA) has been mainly used for chest pain evaluation in low-risk patients, and few data exist regarding patients at intermediate risk. Objective: To evaluate the performance of serial measures of sensitive troponin and CTA in intermediate-risk patients. Methods: A total of 100 patients with chest pain, TIMI risk scores of 3 or 4, and negative troponin were prospectively included. All patients underwent CTA and those with coronary stenosis >= 50% were referred to invasive coronary angiography. Patients with coronary lesions <50% were discharged and contacted 30 days later by a telephone call to assess clinical outcomes. Outcomes were hospitalization, death, and myocardial infarction at 30 days. The comparison between methods was performed by Kappa agreement test. The performance of troponin measures and CTA for detecting significant coronary lesions and clinical outcomes was calculated. Results were considered statistically significant when p < 0.05. Results: Coronary stenosis >= 50% on CTA was found in 38% of patients and significant coronary lesions on coronary angiography were found in 31 patients. Two clinical events were observed. Kappa agreement analysis showed low agreement between troponin measures and CTA in the detection of significant coronary lesions (kappa = 0.022, p = 0.78). The performance of CTA for detecting significant coronary lesions on coronary angiography or for predicting clinical events at 30 days was better than sensitive troponin measures (accuracy of 91% versus 60%). Conclusion: CTA performed better than sensitive troponin measures in the detection of significant coronary disease in patients with chest pain and intermediate risk for cardiovascular events.
- Patients with COVID-19 who experience a myocardial infarction have complex coronary morphology and high in-hospital mortality: Primary results of a nationwide angiographic study(2021) ABIZAID, Alexandre; CAMPOS, Carlos M.; GUIMARAES, Patricia O.; JR, Jose de Ribamar Costa; FALCAO, Breno A. A.; MANGIONE, Fernanda; CAIXETA, Adriano; LEMOS, Pedro A.; BRITO, Fabio S. de; CAVALCANTE, Ricardo; BEZERRA, Cristiano Guedes; CORTES, Leandro; RIBEIRO, Henrique B.; SOUZA, Francis R. de; HUEMER, Natassja; VAL, Renata M. do; CARAMELLI, Bruno; CALDERARO, Daniela; LIMA, Felipe G.; HAJJAR, Ludhmila A.; MEHRAN, Roxana; KALIL FILHO, RobertoObjectives We aimed to explore angiographic patterns and in-hospital outcomes of patients with concomitant coronavirus disease-19 (COVID-19) and myocardial infarction (MI). Background Patients with COVID-19 may experience MI during the course of the viral infection. However, this association is currently poorly understood. Methods This is a multicenter prospective study of consecutive patients with concomitant COVID-19 and MI who underwent coronary angiography. Quantitative and qualitative coronary angiography were analyzed by two observers in an independent core lab. Results A total of 152 patients were included, of whom 142 (93.4%) had COVID-19 diagnosis confirmation. The median time between symptom onset and hospital admission was 5 (1-10) days. A total of 83 (54.6%) patients presented with ST-elevation MI. The median angiographic Syntax score was 16 (9.0-25.3) and 69.0% had multi-vessel disease. At least one complex lesion was found in 73.0% of patients, 51.3% had a thrombus containing lesion, and 57.9% had myocardial blush grades 0/1. The overall in-hospital mortality was 23.7%. ST-segment elevation MI presentation and baseline myocardial blush grades 0 or 1 were independently associated with a higher risk of death (HR 2.75, 95%CI 1.30-5.80 and HR 3.73, 95%CI 1.61-8.61, respectively). Conclusions Patients who have a MI in the context of ongoing COVID-19 mostly present complex coronary morphologies, implying a background of prior atherosclerotic disease superimposed on a thrombotic milieu. The in-hospital prognosis is poor with a markedly high mortality, prompting further investigation to better clarify this newly described condition.
- Effect of Alirocumab on Incidence of Atrial Fibrillation After Acute Coronary Syndromes: Insights from the ODYSSEY OUTCOMES Trial(2022) LOPES, Renato D.; GUIMARAES, Patr Icia O.; SCHWARTZ, Gregory G.; BHATT, Deepak L.; BITTNER, Vera A.; BUDAJ, Andrzej; DALBY, Anthony J.; DIAZ, Rafael; GOODMAN, Shaun G.; HARRINGTON, Robert A.; JUKEMA, J. Wouter; KISS, Robert Gabor; LOY, Megan; PORDY, Robert; POULOUIN, Yann; SZAREK, Michael; WHITE, Harvey D.; STEG, Philippe GabrielBACKGROUND: Using data from the ODYSSEY OUTCOMES trial (NCT01663402), we sought to identify factors associated with the development of incident atrial fibrillation in patients with recent acute coronary syndrome without prior atrial fibrillation and to determine whether alirocumab treatment influenced risk of incident atrial fibrillation. METHODS: ODYSSEY OUTCOMES compared alirocumab treatment with placebo in 18,924 patients with recent acute coronary syndrome and dyslipidemia despite high-intensity or maximum-tolerated statin therapy. The primary outcome of major adverse cardiovascular events (MACE) comprised death from coronary heart disease, non-fatal myocardial infarction, fatal or non-fatal ischemic stroke, or unstable angina requiring hospitalization. Patients were classified as having previous atrial fibrillation (present prior to or at randomization) or no previous atrial fibrillation. A multivariable model was used to determine factors associated with incident atrial fibrillation. RESULTS: Among 18,262 participants without prior atrial fibrillation at baseline, 499 (2.7%) had incident atrial fibrillation during follow-up. Older age, history of heart failure or myocardial infarction, and higher body mass index were significantly associated with incident atrial fibrillation. Treatment with alirocumab or placebo did not influence the cumulative incidence of atrial fibrillation (hazard ratio 0.91; 95% confidence interval, 0.77-1.09). Patients with vs without a history of atrial fibrillation had a higher incidence of MACE (8.8 vs 3.7 events per 100 patient-years), without significant interaction between atrial fibrillation and randomized treatment on risk of MACE (P-interaction =.78). CONCLUSIONS: While alirocumab did not modify risk of incident atrial fibrillation after acute coronary syndrome, it did reduce the risk of MACE, regardless of prior atrial fibrillation history. History of atrial fibrillation is an independent predictor of recurrent cardiovascular events after acute coronary syndrome. (c) 2022 The Authors.
- Hospitalization Among Patients With Atrial Fibrillation and a Recent Acute Coronary Syndrome or Percutaneous Coronary Intervention Treated With Apixaban or Aspirin Insights From the AUGUSTUS Trial(2019) VORA, Amit N.; ALEXANDER, John H.; WOJDYLA, Daniel M.; ARONSON, Ronald; GRANGER, Christopher B.; DARIUS, Harald; WINDECKER, Stephan; MEHRAN, Roxana; AVERKOV, Oleg; BUDAJ, Andrzej; KONG, David F.; KOBALAVA, Zhanna; MEHTA, Rajendra H.; MIRZA, Zulfiqar; GUIMARAES, Patricia Oliveira; PARKHOMENKO, Alexander; QUADROS, Alexandre; THIELE, Holger; GOODMAN, Shaun G.; LOPES, Renato D.
conferenceObject A 30-Day Pooled Analysis of Acetyl Salicylic Elimination Trials (ASET) in Brazil and Japan: Synergy Stent with Prasugrel Monotherapy Without Aspirin(2023) ONUMA, Yoshinobu; MASUDA, Shinichiro; MURAMATSU, Takashi; ISHIBASHI, Yuki; KOZUMA, Ken; KAWASHIMA, Hideyuki; NAKAZAWA, Gaku; TAKAHASHI, Kuniaki; TANABE, Kengo; KOGAME, Norihiro; NAKAMURA, Masato; ASANO, Taku; OKAMURA, Takayuki; MIYAZAKI, Yosuke; TATEISHI, Hiroki; OZAKI, Yukio; NAKATANI, Shimpei; KATAGIRI, Yuki; MORINO, Yoshihiro; NINOMIYA, Kai; KAGEYAMA, Shigetaka; KOTOKU, Nozomi; GUIMARAES, Patricia O.; LEMOS, Pedro A.; SERRUYS, Patrick W.conferenceObject Causes of death in patients with atrial fibrillation and a recent acute coronary syndrome or percutaneous coronary intervention: insights from the AUGUSTUS trial(2022) GUIMARAES, P.; WOJDYLA, D. M.; ALEXANDER, J. H.; GOODMAN, S. G.; ARONSON, R.; WINDECKER, S.; MEHRAN, R.; GRANGER, C. B.; LOPES, R. D.- Association between perivascular inflammation and downstream myocardial perfusion in patients with suspected coronary artery disease(2020) NOMURA, Cesar H.; ASSUNCAO-JR, Antonildes N.; GUIMARAES, Patricia O.; LIBERATO, Gabriela; MORAIS, Thamara C.; FAHEL, Mateus G.; GIORGI, Maria C. P.; MENEGHETTI, Jose C.; PARGA, Jose R.; DANTAS-JR, Roberto N.; CERRI, Giovanni G.Aims To investigate the association between pericoronary adipose tissue (PCAT) computed tomography (CT) attenuation derived from coronary computed tomography angiography (CTA) and coronary flow reserve (CFR) by positron emission tomography (PET) in patients with suspected coronary artery disease (CAD). Methods and results PCAT CT attenuation was measured in proximal segments of all major epicardial coronary vessels of 105 patients with suspected CAD. We evaluated the relationship between PCAT CT attenuation and other quantitative/qualitative CT-derived anatomic parameters with CFR by PET. Overall, the mean age was 60 +/- 12 years and 93% had intermediate pre-test probability of obstructive CAD. Obstructive CAD (>= 50% stenosis) was detected in 37 (35.2%) patients and impaired CFR (<2.0) in 32 (30.5%) patients. On a per-vessel analysis (315 vessels), obstructive CAD, non-calcified plaque volume, and PCAT CT attenuation were independently associated with CFR. In patients with coronary calcium score (CCS) <100, those with high-PCAT CT attenuation presented significantly lower CFR values than those with low-PCAT CT attenuation (2.47 +/- 0.95 vs. 3.13 +/- 0.89, P = 0.003). Among those without obstructive CAD, CFR was significantly lower in patients with high-PCAT CT attenuation (2.51 +/- 0.95 vs. 3.02 +/- 0.84, P = 0.021). Conclusion Coronary perivascular inflammation by CTA was independently associated with downstream myocardial perfusion by PET. In patients with low CCS or without obstructive CAD, CFR was lower in the presence of higher perivascular inflammation. PCAT CT attenuation might help identifying myocardial ischaemia particularly among patients who are traditionally considered non-high risk for future cardiovascular events.