122 results on '"Johny Nicolas"'
Search Results
2. The Final Word: Current Strategies for the Lifetime Management of Patients with Aortic Valve Stenosis
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Anne H Tavenier, Johny Nicolas, and Roxana Mehran
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Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Published
- 2022
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3. Defining Key Features of Complex Coronary Lesions: An Evidence Based Review of Clinical Practice. Part II: Chronic Total Occlusions, Graft Interventions, In-Stent Restenosis, and Antithrombotic Strategies
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Daniel Feldman, Frans Beerkens, Johny Nicolas, Mohan Satish, Davis Jones, Mehmet Demirhan, and George Dangas
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complex percutaneous intervention ,chronic total occlusion ,in-stent restenosis ,saphenous vein graft ,dual antiplatelet ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Clinicians have long recognized that certain features of coronary artery lesions increase the complexity of intervention. Complex lesions are associated with worse cardiovascular outcomes and a higher risk of subsequent ischemic events. These lesions are categorized by their angiographic features. These features include bifurcation lesions, left main coronary artery disease, calcified lesions, in-stent restenosis, chronic total occlusions and graft interventions. This two-part review aims to highlight the current evidence in the percutaneous management of these lesions. Part two of this review focuses on the indications to treat chronic total occlusions, interventions of failed grafts, tools used to treat in-stent restenosis, as well as antithrombotic strategies.
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- 2022
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4. Antiplatelet Therapy in High-Bleeding Risk Patients Undergoing PCI: Walking a Tightrope
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Davis Jones, Johny Nicolas, Frans Beerkens, Mohan Satish, Daniel Feldman, Davide Cao, Alessando Spirito, and Roxana Mehran
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high bleeding risk ,hbr ,percutaneous coronary intervention ,antiplatelet therapy ,antithrombotic therapy ,dapt ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Historically, prevention from ischemic events with dual antiplatelet therapy (DAPT) post percutaneous coronary intervention (PCI) took precedence over protection from bleeding. However, increasing data suggest that major bleeding complications are as detrimental as ischemic events. Awareness about the prognostic impact of bleeding prompted the search for new strategies aimed at maximizing both ischemic and bleeding protection. This is noteworthy because patients at high bleeding risk (HBR) have generally been underrepresented in clinical trials on DAPT and they often are at increased risk of ischemic events as well. The present review discusses the evidence base for new pharmacotherapeutic strategies to decrease bleeding risk without compromising ischemic protection among HBR patients undergoing PCI, including shortening DAPT duration, early aspirin withdrawal, and P2Y12 inhibitor de-escalation.
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- 2022
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5. Defining Key Features of Complex Coronary Lesions: An Evidence Based Review of Clinical Practice. Part I: Bifurcations, Left Main Disease, and Calcifications
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Daniel Feldman, Frans Beerkens, Johny Nicolas, Mohan Satish, Davis Jones, James W. Johnson, and George Dangas
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complex percutaneous intervention ,left main coronary artery disease ,bifurcation lesions ,calcified lesions ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Clinicians have long recognized that certain features of coronary artery lesions increase the complexity of intervention. Complex lesions are associated with worse cardiovascular outcomes and a higher risk of subsequent ischemic events. These lesions are categorized by their angiographic features. These features include bifurcation lesions, left main coronary artery disease, calcified lesions, in-stent restenosis, chronic total occlusions and graft interventions. This two-part review aims to highlight the current evidence in the percutaneous management of these lesions. Part one of this review focuses on the best techniques to treat bifurcation lesions, indications for intervention of left main coronary artery disease and additional tools used to treat calcified lesions.
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- 2022
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6. Imaging in Percutaneous Coronary Intervention
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Mohan Satish, Anastasios Roumeliotis, David Power, Anton Camaj, Johny Nicolas, Daniel Feldman, Davis Jones, Keisuke Yasumura, Frans Beerkens, Saman Suleman, and George Dangas
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intracoronary imaging ,optical coherence tomography ,intravascular ultrasound ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Intracoronary imaging (ICI) use during percutaneous coronary intervention (PCI) has been shown to effectively improve cardiovascular outcomes, particularly for high-risk subgroups. However, data from randomized controlled trials are limited and the overall utilization rate of ICI remains variable between different countries and centers. Potential benefits of ICI include identification of appropriate lesions for PCI, improved characterization of lesions, and optimization of stent placement. Currently available modalities of ICI include intravascular ultrasound, optical coherence tomography and near infrared spectroscopy. Within this review, we summarize the contemporary evidence surrounding ICI and discuss its application in clinical practice.
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- 2022
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7. TWILIGHT: A Randomized Trial of Ticagrelor Monotherapy Versus Ticagrelor Plus Aspirin Beginning at 3 Months in High-risk Patients Undergoing Percutaneous Coronary Intervention
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Johny Nicolas, Usman Baber, and Roxana Mehran
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Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
A P2Y12 inhibitor-based monotherapy after a short period of dual antiplatelet therapy is emerging as a plausible strategy to decrease bleeding events in high-risk patients receiving dual antiplatelet therapy after percutaneous coronary intervention. Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention (TWILIGHT), a randomized double-blind trial, tested this approach by dropping aspirin at 3 months and continuing with ticagrelor monotherapy for an additional 12 months. The study enrolled 9,006 patients, of whom 7,119 who tolerated 3 months of dual antiplatelet therapy were randomized after 3 months into two arms: ticagrelor plus placebo and ticagrelor plus aspirin. The primary endpoint of interest, Bleeding Academic Research Consortium type 2, 3, or 5 bleeding, occurred less frequently in the experimental arm (HR 0.56; 95% CI [0.45–0.68]; p
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- 2020
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8. Safety and Efficacy of Rituximab in Multiple Sclerosis: A Retrospective Observational Study
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Bassem I. Yamout, Nabil K. El-Ayoubi, Johny Nicolas, Yehya El Kouzi, Samia J. Khoury, and Maya M. Zeineddine
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Immunologic diseases. Allergy ,RC581-607 - Abstract
Objective. To evaluate the efficacy and safety of rituximab in multiple sclerosis in a clinical practice setting. Methods. Clinical data for all adult patients with multiple sclerosis (MS) treated with off-label rituximab at a single MS center in Lebanon between March 2008 and April 2017 were retrospectively collected from medical charts. The main efficacy outcomes assessed were annualized relapse rate (ARR) and proportion of patients free from relapses, disability progression, or magnetic resonance imaging (MRI) activity. Results. A total of 89 rituximab-treated patients were included: 59 relapsing-remitting MS (RRMS) and 30 progressive MS (PMS). Patients were treated with 1000 or 2000 mg rituximab IV every 6–12 months for a mean duration of 22.2 ± 24.8 months. The subjects were 65.2% females with a mean age of 40.5 ± 12.3 years and a mean disease duration of 7.9 ± 6.2 years. During treatment, the ARR decreased from 1.07 at baseline to 0.11 in RRMS (p
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- 2018
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9. Fatal, ischemic and bleeding risk of patients meeting the selection criteria of the TWILIGHT trial: Insights from a large PCI registry
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Alessandro Spirito, Won-Joon Koh, Samantha Sartori, Birgit Vogel, Yihan Feng, Usman Baber, Johny Nicolas, Clayton Snyder, Karim Kamaleldin, Brunna Pileggi, Vahid Rezvanizadeh, Joseph Sweeny, Samin K. Sharma, Annapoorna Kini, Stuart J. Pocock, George Dangas, and Roxana Mehran
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Cardiology and Cardiovascular Medicine - Published
- 2023
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10. Outcomes in Patients With Early Menopause Who Underwent Transcatheter Aortic Valve Implantation
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Madison Edens, Yusuke Watanabe, Johny Nicolas, Samantha Sartori, Clayton Snyder, Birgit Vogel, Alessandro Spirito, Didier Tchetche, Anna Sonia Petronio, Julinda Mehilli, Thierry Lefèvre, Patrizia Presbitero, Piera Capranzano, Alexandra Selberg, Alessandro Iadanza, Gennaro Sardella, Nicolas M. Van Mieghem, Emanuele Meliga, Nicolas Dumonteil, Chiara Fraccaro, Daniela Trabattoni, Ghada Mikhail, Maria-Cruz Ferrer-Gracia, Christoph Naber, Samin Sharma, Marie-Claude Morice, George D. Dangas, Alaide Chieffo, Roxana Mehran, and Cardiology
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SDG 3 - Good Health and Well-being ,Cardiology and Cardiovascular Medicine - Abstract
Early menopause is associated with an increased risk of cardiovascular diseases, including aortic stenosis (AS). We sought to investigate the prevalence and impact of early menopause on clinical outcomes in patients who underwent transcatheter aortic valve implantation (TAVI) for severe symptomatic AS. Women's International TAVI is a multinational, prospective, observational registry of women who underwent TAVI for severe symptomatic AS (n = 1,019). Patients were divided into 2 groups based on age of menopause: early menopause (age ≤45 years) and regular menopause (age >45 years). The primary outcome of interest was Valve Academic Research Consortium 2 efficacy end point, a composite of mortality, stroke, myocardial infarction, hospitalization for valve-related symptoms, or heart failure or valve-related dysfunction at 1-year follow-up. Of 732 patients with available data on menopause age, 173 (23.6%) were classified as having early menopause. These patients presented for TAVI at a younger age (81.6 ± 6.9 vs 82.7 ± 5.9, p = 0.05) and had a significantly lower Society of Thoracic Surgeons score (6.6 ± 4.8 vs 8.2 ± 7.1, p = 0.03) than those with regular menopause. However, the total valve calcium volume was smaller among patients with early versus regular menopause (731.8 ± 850.9 mm3 vs 807.6 ± 633.8 mm3, p = 0.002). Other co-morbidities were similar between the 2 groups. At 1-year follow-up, there were no significant differences in clinical outcomes between patients with early versus regular menopause (hazard ratio 1.00, 95% confidence interval 0.61 to 1.63, p = 1.00). In conclusion, despite presenting for TAVI at a younger age, patients with early menopause had a similar risk of adverse events as patients with regular menopause at 1 year after TAVI.
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- 2023
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11. Impact of complex percutaneous coronary intervention features on clinical outcomes in patients with or without chronic kidney disease
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Huazhen Chen, Alessandro Spirito, Samantha Sartori, Johny Nicolas, Davide Cao, Zhongjie Zhang, Usman Baber, Karim Kamaleldin, Jeffers Guthrie, Birgit Vogel, Joseph Sweeny, Prakash Krishnan, Samin K. Sharma, Annapoorna Kini, George Dangas, and Roxana Mehran
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Radiology, Nuclear Medicine and imaging ,General Medicine ,Cardiology and Cardiovascular Medicine - Published
- 2023
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12. Recent Advances in Antiplatelet Therapy in Complex Percutaneous Coronary Intervention
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Alessandro, Spirito, Peter, Cangialosi, Davide, Cao, Johny, Nicolas, and Roxana, Mehran
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Percutaneous Coronary Intervention ,Fibrinolytic Agents ,Dual Anti-Platelet Therapy ,Humans ,Drug-Eluting Stents ,Cardiology and Cardiovascular Medicine ,Platelet Aggregation Inhibitors - Abstract
Antithrombotic therapy is the cornerstone of secondary cardiovascular prevention after percutaneous coronary intervention (PCI). Improvements in drug-eluting stent (DES) design and materials over the last 2 decades have prompted the development of new antithrombotic strategies. Current guidelines recommend to tailor dual antiplatelet therapy (DAPT) according to clinical presentation and individual ischemic and bleeding risk. Given the growing number of complex PCI procedures performed nowadays, it is a priority to define the optimal antithrombotic treatment in this challenging patient subset. In this review article, we sought to summarize and discuss the current evidence on antiplatelet therapy in patients undergoing complex PCI.
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- 2022
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13. Predictors of antiplatelet cessation in a real-world patient population undergoing non-cardiac surgery after PCI
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Anoop N, Koshy, Davide, Cao, Matthew A, Levin, Samantha, Sartori, Gennaro, Giustino, Htoo, Kyaw, Bimmer, Claessen, Zhongjie, Zhang, Johny, Nicolas, Anton, Camaj, Anastasios, Roumeliotis, Rishi, Chandiramani, Rashi, Bedekar, Zaha, Waseem, Shiv, Bagga, Annapoorna, Kini, Samin K, Sharma, and Roxana, Mehran
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Percutaneous Coronary Intervention ,Treatment Outcome ,Aspirin ,Humans ,Drug-Eluting Stents ,Cardiology and Cardiovascular Medicine ,Prasugrel Hydrochloride ,Platelet Aggregation Inhibitors - Abstract
The optimal perioperative management of antiplatelet therapy (APT) therapy in patients undergoing noncardiac surgery (NCS) following percutaneous coronary intervention (PCI) is unclear. We sought to identify predictors of APT cessation in a real-world cohort of patients undergoing NCS within 1 year of PCI.Consecutive patients undergoing PCI at a tertiary center between 2011 and 2018 were prospectively enrolled. Perioperative interruption of APT was defined as cessation of either aspirin or P2YA total of 1092 surgeries corresponding to 747 patients were identified. Overall, there were 487 (44.6%) preoperative antiplatelet interruptions: discontinuation of either P2YIn this contemporary cohort of post-PCI patients undergoing NCS, patient-, angiographic- and surgery-specific factors all affected decision-making regarding APT cessation. Our findings reflective of real-world practice, highlight the importance of a multidisciplinary team approach to individualize decision making in these patients.
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- 2022
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14. Best Practices for Designing Informative Trials Including Women
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Johny, Nicolas, Madison, Edens, Birgit, Vogel, and Roxana, Mehran
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Clinical Trials as Topic ,Biomedical Research ,Patient Selection ,Humans ,Female ,Cardiology and Cardiovascular Medicine - Abstract
Despite mandates from funding agencies and professional societies to broaden inclusivity in medical research, women remain underrepresented in cardiovascular clinical trials. This lack of representation limits the generalizability of the findings and results in uncertainty about the safety and efficacy of many cardiovascular therapies in female patients.Several barriers impact women's participation in clinical trials, including enrollment criteria, common misconceptions, access to tertiary care, and women representation in clinical trial leadership. This short review discusses these barriers and suggests potential solutions to increase women's participation in clinical trials and improve their cardiovascular health.
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- 2022
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15. Guided and unguided de-escalation from potent P2Y(12) inhibitors among patients with acute coronary syndrome
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Samin K. Sharma, Carlo Andrea Pivato, Anne H. Tavenier, George Dangas, Kiyuk Chang, Frans Beerkens, Dominick J. Angiolillo, Marco Valgimigli, Mauro Chiarito, Samantha Sartori, Johny Nicolas, Davide Capodanno, Roxana Mehran, Usman Baber, Renicus S Hermanides, Jur ten Berg, Davide Cao, Annapoorna Kini, Arnoud W J van 't Hof, Matteo Nardin, Cardiologie, MUMC+: MA Med Staf Spec Cardiologie (9), RS: Carim - H01 Clinical atrial fibrillation, and RS: Carim - B04 Clinical thrombosis and Haemostasis
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medicine.medical_specialty ,Acute coronary syndrome ,Ticagrelor ,Prasugrel ,medicine.medical_treatment ,DOSE PRASUGREL ,Hemorrhage ,Percutaneous Coronary Intervention ,Internal medicine ,Humans ,Medicine ,Pharmacology (medical) ,P2Y(12) inhibitor ,Stroke ,ELDERLY-PATIENTS ,POLYMORPHISMS ,Aspirin ,business.industry ,Percutaneous coronary intervention ,DUAL ANTIPLATELET THERAPY ,medicine.disease ,Clopidogrel ,OPEN-LABEL ,GENE ,De-escalation ,ASPIRIN ,Conventional PCI ,Cardiology and Cardiovascular Medicine ,business ,INTERVENTION ,Platelet Aggregation Inhibitors ,medicine.drug - Abstract
Aim Optimal dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) intends to balance ischemic and bleeding risks. Various DAPT de-escalation strategies, defined as switching from a full-dose potent to a reduced dose or less potent P2Y12 inhibitor, have been evaluated in several ACS-PCI trials. We aimed to compare DAPT de-escalation to standard DAPT with full-dose potent P2Y12 inhibitors in ACS patients who underwent PCI. Methods and results PubMed, Google Scholar, and Cochrane Central Register of Controlled Trials were searched for eligible randomized controlled trials. Aspirin monotherapy trials were excluded. Five randomized trials (n = 10 779 patients) that assigned DAPT de-escalation (genetically guided to clopidogrel n = 1242; platelet function guided to clopidogrel n = 1304; unguided to clopidogrel n = 1672; unguided to lower dose n = 1170) vs. standard DAPT (control group n = 5391) were included in this analysis. DAPT de-escalation was associated with a significant reduction in Bleeding Academic Research Consortium ≥2 bleeding (HR 0.57, 95% CI 0.42–0.78; I2 = 77%) as well as major adverse cardiac events, represented in most trials by the composite of cardiovascular mortality, myocardial infarction, stent thrombosis, and stroke (HR 0.77, 95% CI 0.62–0.96; I2 = 0%). Notwithstanding the limited power, consistency was noted across various de-escalation strategies. Conclusion De-escalation of DAPT after PCI for ACS, both unguided and guided by genetic or platelet function testing (PFT), was associated with lower rates of clinically relevant bleeding and ischemic events as compared to standard DAPT with potent P2Y12 inhibitors based on five open-label RCTs reviewed.
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- 2022
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16. Evolution of drug-eluting coronary stents: a back-and-forth journey from the bench to bedside
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Johny Nicolas, Carlo Andrea Pivato, Mauro Chiarito, Frans Beerkens, Davide Cao, and Roxana Mehran
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Physiology ,Physiology (medical) ,Cardiology and Cardiovascular Medicine - Abstract
Coronary stents have revolutionized the treatment of coronary artery disease. Compared with balloon angioplasty, bare-metal stents (BMSs) effectively prevented abrupt vessel closure but were limited by in-stent restenosis (ISR) due to smooth muscle cell proliferation and neointimal hyperplasia. The first-generation drug-eluting stent (DES), with its antiproliferative drug coating, offered substantial advantages over BMSs as it mitigated the risk of ISR. Nonetheless, they had several design limitations that increased the risk of late stent thrombosis. Significant advances in stent design, including thinner struts, enhanced polymers’ formulation, and more potent antiproliferative agents, have led to the introduction of new-generation DES with a superior safety profile. Cardiologists have over 20 different DES types to choose from, each with its unique features and characteristics. This review highlights the evolution of stent design and summarizes the clinical data on the different stent types. We conclude by discussing the clinical implications of stent design in high-risk subsets of patients.
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- 2022
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17. Prognostic value of high-sensitivity C-reactive protein among chronic kidney disease patients undergoing percutaneous coronary intervention
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Davis Jones, Alessandro Spirito, Samantha Sartori, Kenneth F. Smith, Carlo Andrea Pivato, Mauro Chiarito, Davide Cao, Johny Nicolas, Frans Beerkens, Madison Edens, Brunna Pileggi, Ananya Sen, Zhongjie Zhang, Birgit Vogel, Joseph Sweeny, Usman Baber, George Dangas, Samin K. Sharma, Annapoorna Kini, and Roxana Mehran
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Cardiology and Cardiovascular Medicine - Published
- 2023
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18. Two years into the COVID-19 pandemic: implications for the cardiac catheterization laboratory and its current practices
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Ashutosh Sharma, Victor Razuk, Johny Nicolas, Frans Beerkens, and George Dangas
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COVID-19 continues to overwhelm healthcare systems. During the peak of the pandemic, cardiac catheterization labs across the world observed a significant decrease in procedure volumes due to several reasons, including reallocation of medical resources, deployment of interventional cardiologists to the COVID-19 wards, and physician and patient concerns about viral transmission. In particular, structural heart disease interventions experienced a significant reduction in volume by more than 90%. To address these challenges, healthcare systems employed new safety measures and protocols, including COVID-19 rapid polymerase chain reaction pretesting, Personal Protective Equipment, and vaccination mandates to ensure safety of patients and healthcare workers. Although these measures partly addressed safety concerns, diagnosis and management of acute myocardial injury remained challenging throughout the pandemic. While the pathophysiological mechanisms leading to myocardial injury is not fully elucidated, most studies have suggested COVID-19 is a pro-inflammatory disease associated with a hypercoagulable state. Ongoing randomized studies are evaluating the efficacy of more aggressive antithrombic regimens in COVID-19. In addition, the presentation of acute coronary syndrome with concomitant COVID-19 infection is variable, more likely atypical, delayed, and is associated with higher rates of adverse cardiovascular events and death. It was necessary to implement protocols to expedite diagnosis, triage and management of patients with acute coronary syndrome, while minimizing the risk of viral transmission to hospital staff. Robotic percutaneous coronary intervention may offer in the future a potential solution to many of the safety concerns faced by interventional cardiologists during the COVID-19 era; however, it has its own set of limitations.
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- 2022
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19. Prognostic Value of Baseline Inflammation in Diabetic and Nondiabetic Patients Undergoing Percutaneous Coronary Intervention
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Carlo Andrea Pivato, Davis Jones, Davide Cao, Samantha Sartori, Mauro Chiarito, Johny Nicolas, Zhongjie Zhang, Frans Beerkens, Matteo Nardin, Hanbo Qiu, Victor Razuk, Daniel Feldman, Vaishali Kumaraguru, Giulio G. Stefanini, Joseph Sweeny, Usman Baber, George Dangas, Samin K. Sharma, Annapoorna Kini, and Roxana Mehran
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Inflammation ,C-Reactive Protein ,Percutaneous Coronary Intervention ,Treatment Outcome ,Risk Factors ,Diabetes Mellitus ,Myocardial Infarction ,Humans ,Prognosis ,Cardiology and Cardiovascular Medicine - Abstract
There is a paucity of data on the prognostic value of high-sensitivity C-reactive protein (hsCRP) levels in diabetic and nondiabetic patients undergoing percutaneous coronary intervention (PCI).All patients with known baseline hsCRP undergoing PCI at a single tertiary care centre from 2010 to 2017 were included. High hsCRP was defined as3 mg/L. Known causes of elevated hsCRP levels and hsCRP10 mg/L represented exclusion criteria. The 1-year primary outcome was major adverse cardiovascular events (MACE), including all-cause mortality, myocardial infarction (MI), and target-vessel revascularisation (TVR).Among a total of 11,979 patients included, high hsCRP levels were observed in 24.7% of patients without diabetes and 29.8% of patients with diabetes (P0.001). Both diabetics and nondiabetics with high hsCRP levels had increased rates of MACE compared with their counterparts with low hsCRP (diabetics: adjusted hazard ratio [aHR] 1.58, 95% CI 1.27-1.96; nondiabetics: aHR 1.45, 95% CI 1.13-1.86; P interaction = 0.981) primarily driven by increased rates all-cause deaths (diabetics: aHR 2.32, 95% CI 1.42-3.80; nondiabetics: aHR 3.14, 95% CI 1.74-5.65; P interaction = 0.415). Although high hsCRP levels were associated with increased rates of TVR (aHR 1.35, 95% CI 1.04-1.75) and MI (aHR 1.86, 95% CI 1.18-2.93) only in patients with diabetes, no significant interactions were observed between inflammation and diabetes (P interaction = 0.749 and 0.602, respectively).Patients undergoing PCI with high levels of hsCRP, defined as3 mg/L, have worse ischemic outcomes regardless of diabetes status.
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- 2022
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20. Perioperative management of P2Y12 inhibitors in patients undergoing cardiac surgery within 1 year of PCI
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Davide Cao, Julie A Swain, Samantha Sartori, Matteo Nardin, Zhongjie Zhang, Anastasios Roumeliotis, Johny Nicolas, Mauro Chiarito, Rishi Chandiramani, Carlo A Pivato, Alessandro Spirito, Gennaro Giustino, Giulio G Stefanini, George D Dangas, Usman Baber, Deepak L Bhatt, David H Adams, Samin K Sharma, Annapoorna S Kini, and Roxana Mehran
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Ticagrelor ,Percutaneous Coronary Intervention ,Purinergic P2Y Receptor Antagonists ,Myocardial Infarction ,Humans ,Hemorrhage ,Pharmacology (medical) ,Cardiac Surgical Procedures ,Cardiology and Cardiovascular Medicine - Abstract
Aims To evaluate the impact of perioperative P2Y12 receptor inhibitor therapy among patients undergoing cardiac surgery within 1 year of percutaneous coronary intervention (PCI). Methods and results Patients undergoing cardiac surgery in the year post-PCI at three tertiary care centres between 2011 and 2018 were stratified into those who had received at least one dose of P2Y12 inhibitor prior to surgery (within 5 days for clopidogrel or prasugrel, or within 3 days for ticagrelor) and those who had not. The outcomes of interest were major adverse cardiac and cerebrovascular events (MACCEs) and bleeding. Among 20 279 PCI patients, 359 (1.8%) underwent cardiac surgery in the ensuing year, 76.3% of whom received coronary artery bypass grafts. Overall, 33 (9.2%) MACCEs and 85 (23.7%) bleeding events occurred within 30 days post-cardiac surgery. Perioperative P2Y12 inhibition (N = 133, 37%) was not associated with the risk of MACCEs or bleeding, despite numerically lower rates of myocardial infarction or stent thrombosis (0.0% vs. 2.6%; P = 0.089). Patients who continued the P2Y12 inhibitor until the day of surgery (N = 60, 17%) had significantly higher bleeding risk [adjusted odds ratio 2.93, 95% confidence interval 1.53–5.59)]. Predictors of MACCEs included a time interval from PCI to cardiac surgery of ≤30 days and reduced ejection fraction, whereas urgent/emergent surgery predicted bleeding. Chronic kidney disease and myocardial infarction as indication for PCI predicted both MACCEs and bleeding. Conclusion Among patients undergoing cardiac surgery in the year after PCI, the perioperative risk of ischaemic and bleeding events might be influenced by P2Y12 inhibitor therapy in addition to other risk parameters, including the timing and urgency of the procedure.
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- 2022
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21. Effect of Elevated C-Reactive Protein on Outcomes After Complex Percutaneous Coronary Intervention for Angina Pectoris
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Anton Camaj, Gennaro Giustino, Nikola Kocovic, Davide Cao, Bimmer E. Claessen, Samantha Sartori, Zhongjie Zhang, Hanbo Qiu, Johny Nicolas, Tomoya Hinohara, Usman Baber, David A. Power, Nitin Barman, Joseph Sweeny, George Dangas, Annapoorna Kini, Samin K. Sharma, Roxana Mehran, Cardiology, and ACS - Atherosclerosis & ischemic syndromes
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C-Reactive Protein ,Percutaneous Coronary Intervention ,Treatment Outcome ,surgical procedures, operative ,Risk Factors ,Humans ,nutritional and metabolic diseases ,cardiovascular diseases ,Cardiology and Cardiovascular Medicine ,Angina Pectoris - Abstract
Inflammation and procedural complexity are individually associated with adverse outcomes after percutaneous coronary intervention (PCI). We aimed to evaluate the association of high sensitivity C-reactive protein (hsCRP) with adverse events according to PCI complexity. We included patients with available hsCRP levels who underwent PCI at our center from 2012 to 2017. We compared patients with hsCRP ≥3 versus 60 mm. The primary end point was major adverse cardiac events (MACEs) (composite of all-cause death, myocardial infarction, or target vessel revascularization) at 1 year. A total of 11,979 patients were included, of which 2,840 (24%) underwent complex PCI. In those, 767 (27%) had hsCRP ≥3 mg/L. The 1-year incidence of MACE was 6% (noncomplex PCI, low hsCRP), 10% (noncomplex PCI, high hsCRP), 10% (complex PCI, low hsCRP), and 15% (complex PCI, high hsCRP). Overall, hsCRP ≥3 mg/L was associated with an increased risk of MACE compared with hsCRP
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- 2022
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22. Impact of Race/Ethnicity on Long Term Outcomes After Percutaneous Coronary Intervention with Drug-Eluting Stents
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Anastasios Roumeliotis, Bimmer Claessen, Samantha Sartori, Davide Cao, Won-Joon Koh, Hanbo Qiu, Johny Nicolas, Rishi Chandiramani, Ridhima Goel, Mauro Chiarito, Joseph Sweeny, Nitin Barman, Prakash Krishnan, Annapoorna Kini, Samin K Sharma, George Dangas, Roxana Mehran, Cardiology, and ACS - Atherosclerosis & ischemic syndromes
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Percutaneous Coronary Intervention ,Treatment Outcome ,Ethnicity ,Myocardial Infarction ,Humans ,ST Elevation Myocardial Infarction ,Drug-Eluting Stents ,Angina, Unstable ,cardiovascular diseases ,Acute Coronary Syndrome ,Cardiology and Cardiovascular Medicine - Abstract
Cardiovascular disease constitutes the leading cause of mortality worldwide, irrespective of race/ethnicity. Previous studies have shown that minority patients with acute coronary syndrome have distinct clinical, anatomic, and socioeconomic characteristics which may affect clinical outcomes. We included patients who underwent percutaneous coronary intervention with drug-eluting stents for ST-segment elevation myocardial infarction (STEMI), non-STEMI, or unstable angina in a single center. Patients were stratified into Caucasian, African-American, Hispanic, and Asian. Caucasians were the reference group. The primary end point was major adverse cardiac and cerebrovascular events, composite of death, spontaneous myocardial infarction, or stroke at 1 year. Of 6,800 patients included, 49.7% were Caucasian, 20.7% Hispanic, 17.0% Asian and 12.6% African-American. Caucasians were the oldest, Hispanics and Asians had the highest prevalence of diabetes mellitus whereas African-Americans had more chronic kidney disease. Hispanics and African-Americans had the highest STEMI rates, whereas Asians were more likely to present with unstable angina. Compared with Caucasians, Asians had a lower rate of major adverse cardiac and cerebrovascular events at 1 year (3.9% vs 7.1%; p
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- 2022
23. SGLT-2 inhibitors and cardiovascular outcomes in patients with and without a history of heart failure: a systematic review and meta-analysis
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Victor Razuk, Mauro Chiarito, Davide Cao, Johny Nicolas, Carlo A Pivato, Anton Camaj, David Power, Frans Beerkens, Davis Jones, Aviv Alter, Alvin Mathew, Alessandro Spirito, Johanna P Contreras, George D Dangas, and Roxana Mehran
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Heart Failure ,Humans ,Stroke Volume ,Pharmacology (medical) ,Cardiology and Cardiovascular Medicine ,Cardiovascular System ,Sodium-Glucose Transporter 2 Inhibitors ,Ventricular Function, Left - Abstract
Aims Sodium–glucose cotransporter 2 (SGLT-2) inhibitors have cardiovascular (CV) benefits in patients with heart failure with reduced ejection fraction (HFrEF). Whether these medications improve CV outcomes irrespective of heart failure history or left ventricular ejection fraction (LVEF) in HFrEF remains unknown. Methods and results All randomized, placebo-controlled trials of SGLT-2 inhibitors reporting similar CV outcomes were searched in PubMed from 1 January 2010 to 1 October 2021. The primary outcome was the composite of hospitalization for heart failure or CV death. Secondary outcomes included all-cause mortality. Pooled hazard ratios (HRs) and 95% confidence intervals (CIs) were used as effect estimates and calculated with a random-effects model. Data from 11 trials and a total of 66 957 patients (n = 36 758 SGLT-2 group, n = 30 199 placebo group) were included. SGLT-2 inhibitors reduced the risk of hospitalization for heart failure or CV death in patients with (HR 0.76, 95% CI 0.71–0.80) and without (HR 0.76, 95% CI 0.68–0.86; Pinteraction = 0.69) heart failure. Patients with (HR 0.87, 95% CI 0.80–0.95) and without (HR 0.84, 95% CI 0.73–0.95; Pinteraction = 0.67) heart failure treated with SGLT-2 inhibitors had a reduction in all-cause mortality. Reduction in the primary outcome was consistently observed in HFrEF patients with (HR 0.68, 95% CI 0.59–0.78) and without (HR 0.84, 95% CI 0.71–0.99; Pinteraction = 0.13) severely reduced LVEF, and in heart failure with preserved ejection fraction patients (HR 0.80, 95% CI 0.70–0.92; Pinteraction = 0.65). Conclusion SGLT-2 inhibitors improved CV outcomes irrespective of heart failure history or type, and severity of LVEF reduction.
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- 2022
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24. Efficacy and Safety of P2Y12 Inhibitor Monotherapy After Complex PCI: A Collaborative Systematic Review and Meta-Analysis
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Johny Nicolas, George Dangas, Mauro Chiarito, Carlo A Pivato, Alessandro Spirito, Davide Cao, Gennaro Giustino, Frans Beerkens, Anton Camaj, Birgit Vogel, Samantha Sartori, Ko Yamamoto, Takeshi Kimura, Byeong-Keuk Kim, Usman Baber, and Roxana Mehran
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Pharmacology (medical) ,Cardiology and Cardiovascular Medicine - Abstract
Aims Complex percutaneous coronary intervention (C-PCI) is associated with an increased risk of ischaemic and bleeding complications. We aimed to assess the safety and efficacy of a 1–3-month dual antiplatelet therapy (DAPT) regimen followed by P2Y12 inhibitor monotherapy after C-PCI. Methods and results We conducted a meta-analysis of randomized trials comparing a 1–3-month DAPT regimen followed by P2Y12 inhibitor monotherapy with standard (≥12 months) DAPT in patients undergoing C-PCI. C-PCI criteria and the co-primary bleeding and ischaemic outcomes were determined according to each trial. Secondary outcomes included major bleeding, all-cause death, myocardial infarction, and stent thrombosis. All outcomes were evaluated at 12 months after randomization. We used hazard ratios (HRs) and 95% confidence interval (CI) as a metric of choice for treatment effects with random-effects models. Among 8299 screened studies, five randomized trials fulfilled the eligibility criteria. In the pooled population of 34 615 patients, 8818 (25.5%) underwent C-PCI. As compared with standard DAPT, a 1–3-month DAPT regimen followed by P2Y12 inhibitor monotherapy reduced the bleeding risk in C-PCI (HR:0.66, 95% CI:0.44–0.98) and non-C-PCI (HR:0.60, 95% CI:0.45–0.79) patients (P-interaction = 0.735). Furthermore, the risk for the primary ischaemic endpoint was similar in patients randomized to either arm, with significant effect modification by PCI complexity showing an enhanced benefit of 1–3-month DAPT in patients undergoing C-PCI (C-PCI, HR:0.69, 95% CI:0.48–1.00; non-C-PCI, HR:1.04, 95% CI:0.84–1.30; P-interaction = 0.028). Conclusion As compared with a standard DAPT, a 1–3-month DAPT regimen followed by P2Y12 inhibitor monotherapy reduced bleeding complications after C-PCI without increasing the risk of ischaemic events. PROSPERO-registered (CRD42021259271)
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- 2022
25. Ticagrelor with and without aspirin in patients with a prior coronary artery bypass graft undergoing percutaneous coronary intervention: the TWILIGHT-CABG study
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Gennaro Sardella, Frans J. Beerkens, George Dangas, Davide Cao, Usman Baber, Samantha Sartori, David J. Cohen, Carlo Briguori, Robert Gil, Johny Nicolas, Zhongjie Zhang, Dariusz Dudek, Vijay Kunadian, Ran Kornowski, Giora Weisz, Bimmer Claessen, Steven Marx, Javier Escaned, Kurt Huber, Timothy Collier, David J. Moliterno, E. Magnus Ohman, Mitchell W. Krucoff, Adnan Kastrati, Phillipe Gabriel Steg, Dominick J. Angiolillo, Shamir Mehta, Richard Shlofmitz, Samin Sharma, Stuart Pocock, Charles Michael Gibson, Roxana Mehran, Cardiology, and ACS - Atherosclerosis & ischemic syndromes
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Stroke ,Ticagrelor ,Percutaneous Coronary Intervention ,Treatment Outcome ,Aspirin ,Myocardial Infarction ,Humans ,Drug Therapy, Combination ,Hemorrhage ,Coronary Artery Bypass ,Cardiology and Cardiovascular Medicine ,Platelet Aggregation Inhibitors - Abstract
BACKGROUND: Prior coronary artery bypass graft surgery (CABG) patients undergoing percutaneous coronary intervention (PCI) are often older and present with multiple comorbidities. Ticagrelor monotherapy after a short course of dual antiplatelet therapy (DAPT) has emerged as an effective bleeding-avoidance strategy among high-risk patients. AIMS: We aimed to examine the effects of ticagrelor with or without aspirin in prior CABG patients undergoing PCI within the TWILIGHT trial. METHODS: After 3 months of ticagrelor plus aspirin, patients were randomised to either aspirin or placebo, in addition to ticagrelor, for 12 months and compared by prior CABG status. The primary endpoint was Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding. The key secondary endpoint was all-cause death, myocardial infarction (MI), or stroke. RESULTS: Out of 7,119 patients, a total of 703 (10.8%) patients had prior CABG within the randomised cohort. Prior CABG patients had more comorbidities and a higher incidence of BARC type 2, 3, or 5 bleeding and death, MI or stroke at 1 year after randomisation, compared with patients without prior CABG. Ticagrelor monotherapy was associated with significantly less BARC 2, 3, or 5 bleeding among prior CABG patients compared with DAPT (4.9% vs 9.6%, hazard ratio [HR] 0.50, 95% confidence interval [CI]: 0.28 to 0.90; pinteraction=0.676) and similar rates of death, MI or stroke (10.0% vs 8.7%, HR 1.14, 95% CI: 0.70 to 1.87; pinteraction=0.484). When comparing target vessel type, treatment effects were consistent among graft- and native-vessel interventions. CONCLUSIONS: In high-risk patients with prior CABG, ticagrelor monotherapy reduced bleeding without compromising ischaemic outcomes compared with ticagrelor plus aspirin.
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- 2022
26. Types of myocardial injury and mid-term outcomes in patients with COVID-19
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Valentin Fuster, Zhongjie Zhang, Johny Nicolas, Mauro Chiarito, Matteo Nardin, Samantha Sartori, Samin K. Sharma, Roxana Mehran, Davide Cao, Annapoorna Kini, Carlo Andrea Pivato, George Dangas, Yuliya Vengrenyuk, and Parasuram Krishnamoorthy
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Adult ,Male ,medicine.medical_specialty ,Myocardial Infarction ,Comorbidity ,Coronary Artery Disease ,Coronary artery disease ,Internal medicine ,Outcome Assessment, Health Care ,medicine ,Humans ,Myocardial infarction ,Mortality ,Renal Insufficiency, Chronic ,Aged ,Retrospective Studies ,Aged, 80 and over ,Heart Failure ,biology ,SARS-CoV-2 ,business.industry ,Health Policy ,Mortality rate ,Hazard ratio ,COVID-19 ,Middle Aged ,Prognosis ,medicine.disease ,Troponin ,Heart failure ,Acute Disease ,Chronic Disease ,Cardiology ,biology.protein ,Female ,New York City ,Cardiology and Cardiovascular Medicine ,business ,Kidney disease - Abstract
Aims To evaluate the acute and chronic patterns of myocardial injury among patients with coronavirus disease-2019 (COVID-19), and their mid-term outcomes. Methods and results Patients with laboratory-confirmed COVID-19 who had a hospital encounter within the Mount Sinai Health System (New York City) between 27 February 2020 and 15 October 2020 were evaluated for inclusion. Troponin levels assessed between 72 h before and 48 h after the COVID-19 diagnosis were used to stratify the study population by the presence of acute and chronic myocardial injury, as defined by the Fourth Universal Definition of Myocardial Infarction. Among 4695 patients, those with chronic myocardial injury (n = 319, 6.8%) had more comorbidities, including chronic kidney disease and heart failure, while acute myocardial injury (n = 1168, 24.9%) was more associated with increased levels of inflammatory markers. Both types of myocardial injury were strongly associated with impaired survival at 6 months [chronic: hazard ratio (HR) 4.17, 95% confidence interval (CI) 3.44–5.06; acute: HR 4.72, 95% CI 4.14–5.36], even after excluding events occurring in the first 30 days (chronic: HR 3.97, 95% CI 2.15–7.33; acute: HR 4.13, 95% CI 2.75–6.21). The mortality risk was not significantly different in patients with acute as compared with chronic myocardial injury (HR 1.13, 95% CI 0.94–1.36), except for a worse prognostic impact of acute myocardial injury in patients Conclusion Chronic and acute myocardial injury represent two distinctive patterns of cardiac involvement among COVID-19 patients. While both types of myocardial injury are associated with impaired survival at 6 months, mortality rates peak in the early phase of the infection but remain elevated even beyond 30 days during the convalescent phase.
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- 2021
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27. Perioperative risk and antiplatelet management in patients undergoing non-cardiac surgery within 1 year of PCI
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Ridhima Goel, Matthew A. Levin, Samin K. Sharma, Zaha Waseem, Bonnie Lupo, George Dangas, Annapoorna Kini, Mauro Chiarito, Rashi Bedekar, Roxana Mehran, Davide Cao, Anastasios Roumeliotis, Samantha Sartori, Jeffrey S. Jhang, Deepak L. Bhatt, Rishi Chandiramani, Johny Nicolas, Usman Baber, Zhongjie Zhang, and Bimmer E. Claessen
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medicine.medical_specialty ,Hematology ,Blood transfusion ,business.industry ,medicine.medical_treatment ,Percutaneous coronary intervention ,Perioperative ,medicine.disease ,Surgery ,Internal medicine ,Conventional PCI ,Medicine ,In patient ,cardiovascular diseases ,Myocardial infarction ,Cardiology and Cardiovascular Medicine ,business ,Mace - Abstract
Perioperative cardiovascular complications are important causes of morbidity and mortality associated with non-cardiac surgery, especially in patients with recent percutaneous coronary intervention (PCI). We aimed to illustrate the types and timing of different surgeries occurring after PCI, and to evaluate the risk of thrombotic and bleeding events according to the perioperative antiplatelet management. Patients undergoing urgent or elective non-cardiac surgery within 1 year of PCI at a tertiary-care center between 2011 and 2018 were included. The primary outcome was major adverse cardiac events (MACE; composite of death, myocardial infarction, or stent thrombosis) at 30 days. Perioperative bleeding was defined as ≥ 2 units of blood transfusion. A total of 1092 surgeries corresponding to 747 patients were classified by surgical risk (low: 50.9%, intermediate: 38.4%, high: 10.7%) and priority (elective: 88.5%, urgent/emergent: 11.5%). High-risk and urgent/emergent surgeries tended to occur earlier post-PCI compared to low-risk and elective ones, and were associated with an increased risk of both MACE and bleeding. Preoperative interruption of antiplatelet therapy (of any kind) occurred in 44.6% of all NCS and was more likely for procedures occurring later post-PCI and at intermediate risk. There was no significant association between interruption of antiplatelet therapy and adverse cardiac events. Among patients undergoing NCS within 1 year of PCI, perioperative ischemic and bleeding events primarily depend on the estimated surgical risk and urgency of the procedure, which are increased early after PCI. Preoperative antiplatelet interruption was not associated with an increased risk of cardiac events.
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- 2021
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28. Anticoagulation and Subclinical Valve Thrombosis After TAVR
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George Dangas and Johny Nicolas
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Transcatheter Aortic Valve Replacement ,Treatment Outcome ,Aortic Valve ,Heart Valve Prosthesis ,Anticoagulants ,Humans ,Thrombosis ,Aortic Valve Stenosis ,Cardiology and Cardiovascular Medicine - Published
- 2022
29. New Criteria to Identify Patients at Higher Risk for Cardiovascular Complications After Percutaneous Coronary Intervention
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Alessandro Spirito, Ashutosh Sharma, Davide Cao, Samantha Sartori, Zhongjie Zhang, Johny Nicolas, Carlo Andrea Pivato, Rebecca Cohen, Usman Baber, Joseph Sweeny, Samin K. Sharma, George Dangas, Annapoorna Kini, Sorin J. Brener, and Roxana Mehran
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Cardiology and Cardiovascular Medicine - Abstract
A universal definition to identify patients at higher risk of complications after percutaneous coronary intervention (PCI) is lacking. We aimed to validate a recently developed score to identify patients at increased risk of all-cause death after PCI. All consecutive patients from a large PCI registry not presenting with ST-elevation myocardial infarction or cardiogenic shock were included. Each patient was assigned a score obtained by summing the points associated with the following variables: age80 years (3 points), dialysis (6 points), left ventricular ejection fraction30% (2 points), and multivessel PCI (2 points). Patients were stratified in 3 groups: low risk (score 0), intermediate risk (score 2 to 3), or high risk (score ≥4). The primary outcome was all-cause death, and the secondary outcomes were major adverse cardiovascular events and major bleeding. Events were assessed at 1 year after PCI. Between January 2014 and December 2019, 12,689 patients underwent PCI. Compared with the 9,884 patients at low risk, those at intermediate and high risk had a fourfold (hazard ratio 3.99, 95% confidence interval 2.95 to 5.38) and ninefold (hazard ratio 9.55, 95% confidence interval 6.89 to 13.2) higher hazard for all-cause death at 1 year, respectively. The score had a good predictive value for all-cause death at 1 year (area under the curve 0.70). The risk of major adverse cardiovascular events and major bleeding increased consistently from the low- to the high-risk group. In conclusion, in patients who underwent PCI for stable ischemic heart disease or non-ST-elevation acute coronary syndrome, a score based on 4 variables well predicted the risk of all-cause death at 1 year.
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- 2022
30. Current state-of-the-art antiplatelet and anticoagulation therapy in diabetic patients with coronary artery disease
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Victor Razuk, Roxana Mehran, Johny Nicolas, and Gennaro Giustino
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medicine.medical_specialty ,business.industry ,medicine.drug_class ,Anticoagulant ,Complex disease ,Anticoagulants ,Coronary Artery Disease ,medicine.disease ,law.invention ,Coronary artery disease ,Fibrinolytic Agents ,Randomized controlled trial ,law ,Diabetes mellitus ,Antithrombotic ,Diabetes Mellitus ,medicine ,Humans ,Molecular Medicine ,In patient ,Cardiology and Cardiovascular Medicine ,business ,Intensive care medicine ,Platelet Aggregation Inhibitors ,Organ system - Abstract
Diabetes mellitus is a complex disease that leads to long-term damage to various organ systems. Among the numerous cardiovascular disease-related complications, thrombotic events frequently occur in patients with diabetes. Although guidelines exist for treating and preventing most diabetes-related co-morbidities, the evidence on antithrombotic therapy in primary and secondary prevention is limited due to the scarcity of randomized trials dedicated to patients with diabetes mellitus. Most of the available data are derived from studies that only included a small proportion of patients with diabetes. The present review provides an overview of the status of knowledge on antiplatelet and anticoagulation therapy in patients with diabetes, focusing on the risk-benefit balance of these therapies and future treatment strategies.Lay abstract Patients with diabetes are at increased risk for heart diseases. In fact, heart attacks often occur silently in diabetic patients. Other complications, such as acute decrease in brain or limb perfusion, are also common especially in high-risk diabetic patients. Over the last decade, several drugs for the treatment of diabetes and its associated complications have emerged. Among these therapies, antithrombotic drugs play a pivotal role in preventing these accidents. However, the evidence on antithrombotic drugs use in prevention is limited due to the scarcity of studies dedicated to patients with diabetes. In this review, we provide an aerial view of the latest evidence on the optimal use of antithrombotic drugs in patients with diabetes and heart disease.
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- 2021
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31. Radial versus femoral access for coronary interventions: An updated systematic review and meta‐analysis of randomized trials
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Bimmer E. Claessen, George Dangas, Mauro Chiarito, Ridhima Goel, Davide Cao, Roxana Mehran, Johny Nicolas, Anton Camaj, Giulio G. Stefanini, David A. Power, Rishi Chandiramani, Anastasios Roumeliotis, and Samantha Sartori
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medicine.medical_specialty ,Percutaneous ,medicine.medical_treatment ,Psychological intervention ,030204 cardiovascular system & hematology ,law.invention ,03 medical and health sciences ,Percutaneous Coronary Intervention ,0302 clinical medicine ,Randomized controlled trial ,Risk Factors ,law ,Internal medicine ,Catheterization, Peripheral ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,030212 general & internal medicine ,Myocardial infarction ,Stroke ,Randomized Controlled Trials as Topic ,business.industry ,Percutaneous coronary intervention ,General Medicine ,medicine.disease ,Femoral Artery ,Treatment Outcome ,Meta-analysis ,Radial Artery ,Conventional PCI ,Cardiology ,Cardiology and Cardiovascular Medicine ,business - Abstract
OBJECTIVE It is still debated if benefits associated with radial versus femoral access for coronary angiography and percutaneous coronary interventions (PCI) are due to the access site selection itself, operator expertise or other underlying mechanisms. METHODS We searched PubMed, Embase, and meeting abstracts for randomized trials comparing radial versus femoral access site for coronary angiography and PCI. Primary safety endpoint was major bleeding. Coprimary efficacy endpoints were stroke and myocardial infarction (MI). This study is registered with PROSPERO. RESULTS We identified 31 trials (30,096 patients, PCI performed in 21,225 patients). Radial compared to femoral access was associated with a significant risk reduction in major bleeding (OR 0.53, 95%CI 0.42-0.66, I2 = 3.3%). Findings were consistent regardless of clinical characteristics or whether coronary angiography was performed with or without PCI. The benefit of radial access was significantly increased in studies published before 2010 and in patients with chronic coronary syndrome. Risk for stroke (OR 1.11, 95%CI 0.76-1.64, I2 = 0%) and MI (OR 0.90, 95%CI 0.79-1.04, I2 = 0%) were comparable between the groups. Risk for mortality and vascular complications were significantly lower with radial than femoral access. CONCLUSION In patients undergoing coronary angiography and PCI, radial access is associated with a significant risk reduction in bleeding, vascular complications, and mortality compared to femoral access. The risk of stroke or MI were comparable in patients with radial or femoral access.
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- 2021
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32. Evolving Devices and Material in Transcatheter Aortic Valve Replacement: What to Use and for Whom
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Mauro Chiarito, Alessandro Spirito, Johny Nicolas, Alexandra Selberg, Giulio Stefanini, Antonio Colombo, Bernhard Reimers, Annapoorna Kini, Samin K. Sharma, George D. Dangas, and Roxana Mehran
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General Medicine - Abstract
Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of aortic stenosis, providing a viable alternative to surgical aortic valve replacement (SAVR) for patients deemed to be at prohibitive surgical risk, but also for selected patients at intermediate or low surgical risk. Nonetheless, there still exist uncertainties regarding the optimal management of patients undergoing TAVR. The selection of the optimal bioprosthetic valve for each patient represents one of the most challenging dilemmas for clinicians, given the large number of currently available devices. Limited follow-up data from landmark clinical trials comparing TAVR with SAVR, coupled with the typically elderly and frail population of patients undergoing TAVR, has led to inconclusive data on valve durability. Recommendations about the use of one device over another in given each patient’s clinical and procedural characteristics are largely based on expert consensus. This review aims to evaluate the available evidence on the performance of different devices in the presence of specific clinical and anatomic features, with a focus on patient, procedural, and device features that have demonstrated a relevant impact on the risk of poor hemodynamic valve performance and adverse clinical events.
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- 2022
33. Antithrombotic strategy variability in atrial fibrillation and obstructive coronary disease revascularised with percutaneous coronary intervention: primary results from the AVIATOR 2 international registry
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Jaya Chandrasekhar, Usman Baber, Samantha Sartori, Ridhima Goel, Johny Nicolas, Birgit Vogel, Clayton Snyder, Annapoorna Kini, Carlo Briguori, Bernhard Witzenbichler, Ioannis Iakovou, Gennaro Sardella, Kevin Marzo, Anthony DeFranco, Thomas Stuckey, Alaide Chieffo, Antonio Colombo, Richard Shlofmitz, Davide Capodanno, George Dangas, Stuart Pocock, and Roxana Mehran
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Aged, 80 and over ,Male ,Anticoagulants ,Hemorrhage ,Coronary Artery Disease ,Middle Aged ,Stroke ,Percutaneous Coronary Intervention ,Fibrinolytic Agents ,Atrial Fibrillation ,Humans ,Female ,Registries ,Cardiology and Cardiovascular Medicine ,Platelet Aggregation Inhibitors ,Aged - Abstract
Managing percutaneous coronary intervention (PCI) patients with atrial fibrillation (AF) presents challenges given that there are several potential antithrombotic therapy (ATT) strategies.We examined ATT patterns, agreement between subjective physician ratings and validated risk scores, physician-patient perceptions influencing ATT and 1-year outcomes.The AVIATOR 2 prospective registry enrolled 514 non-valvular AF-PCI patients from 11 sites. Treating physicians selected ATT and completed smartphone surveys rating stroke and bleeding risks, compared against CHAThe mean patient age was 73.2±9.0 years, including 25.8% females. Triple therapy (TT: 1 anticoagulant and 2 antiplatelet agents) was prescribed in 66.5%, dual antiplatelet therapy (DAPT) in 20.7% and dual therapy (1 anticoagulant+1 antiplatelet agent) in 12.8% of patients. Physician ratings and validated risk scores showed poor agreement (stroke: kappa=0.03; bleeding: kappa=0.07). Physicians rated bleeding-related safety (93.8%) as the main factor affecting ATT choice. Patients worried about stroke over bleeding (50.6% vs 14.8%). No group differences by ATT strategy were observed in 1-year MACCE (TT 14.1% vs dual therapy 12.7% vs DAPT 18.5%; p=0.25), or actionable bleeding (14.7% vs 7.9% vs 15.1%, respectively; p=0.89).The AVIATOR 2 study is the first digital health study examining physician-patient perspectives on ATT choices after AF-PCI. TT was the most common strategy without differences in 1-year outcomes in ATT strategy. Physicians rated safety first when prescribing ATT; patients feared stroke over bleeding.gov: NCT02362659.
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- 2022
34. Depression and ischemic heart disease
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Carlo A. Pivato, Rishi Chandiramani, Marija Petrovic, Johny Nicolas, Alessandro Spirito, Davide Cao, and Roxana Mehran
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Inflammation ,Depression ,Myocardial Ischemia ,Humans ,Cardiology and Cardiovascular Medicine ,Atherosclerosis ,Autonomic Nervous System - Abstract
Depression is common in patients with ischemic heart disease, and depressed patients are more likely to develop atherosclerosis and experience major cardiac events compared with the general population. The underlying pathophysiological mechanisms of these two diseases are highly interwoven and include an increased release of stress hormones, dysregulation of the autonomic nervous system, alterations of pathways related to primary and secondary hemostasis, endothelial dysfunction, and higher level of residual inflammation. Furthermore, depression negatively impacts compliance with medication regimens. As such, early recognition and treatment of depression provide the opportunity to improve outcomes of patients with ischemic heart disease. In the present review, we provide a summary of the evidence on the epidemiology, pathophysiology and management of depression in patients with ischemic heart disease.
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- 2022
35. The mega COMBO collaboration: An individual patient data pooled analysis of patients undergoing PCI with COMBO stent
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Matteo Nardin, Carlo Andrea Pivato, Davide Cao, Samantha Sartori, Zhongjie Zhang, Birgit Vogel, Johny Nicolas, Mauro Chiarito, Hanbo Qiu, Jaya Chandrasekhar, Alessandro Spirito, Alexandre Abizaid, Evald Høj Christiansen, Antonio Colombo, Robbert J. de Winter, Michael Haude, Lars Jakobsen, Lisette Okkels Jensen, Mitchell W. Krucoff, Ulf Landmesser, Shigeru Saito, Harry Suryapranata, Giuseppe De Luca, George Dangas, Roxana Mehran, Cardiology, and ACS - Atherosclerosis & ischemic syndromes
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Male ,Time Factors ,Vascular damage Radboud Institute for Health Sciences [Radboudumc 16] ,Myocardial Infarction ,Coronary Artery Disease ,Middle Aged ,Prosthesis Design ,Individual patient data analysis ,Percutaneous coronary intervention ,All institutes and research themes of the Radboud University Medical Center ,Percutaneous Coronary Intervention ,Treatment Outcome ,Risk Factors ,Humans ,Dual-therapy stent ,Female ,Cardiology and Cardiovascular Medicine ,COMBO stent ,Aged - Abstract
Item does not contain fulltext BACKGROUND: COMBO (OrbusNeich Medical, Hong Kong) is a dual-therapy coronary stent featuring sirolimus as antiproliferative drug and an anti-CD34+ antibody coating to attract endothelial progenitor cells favoring rapid stent re-endothelization. The Mega COMBO collaboration aimed to evaluate the performance of the COMBO stent in a large contemporary cohort of patients undergoing percutaneous coronary intervention (PCI). METHODS: Patient-level data of subjects undergoing PCI with the COMBO stent from the REMEDEE-Trial, REMEDEE-OCT, HARMONEE, REDUCE, SORT OUT X, REMEDEE-Registry and MASCOT studies were pooled together. The primary endpoint was 1-year target lesion failure (TLF), a composite of cardiovascular death, target vessel myocardial infarction (TV-MI) or clinically driven target lesion revascularization (CD-TLR). Secondary outcomes were the individual components of the primary endpoint and stent thrombosis (ST). Endpoints were evaluated against performance goals based on the EAPCI (the European Association of Percutaneous Coronary Intervention) recommendations for new drug-eluting stents. RESULTS: A total of 6753 patients (mean age 63.7 ± 11.4 years, 23% women) were included. At 1-year follow-up, TLF occurred in 303 (4.6%) patients. The rates of cardiovascular death, TV-MI, and CD-TLR were 1.3%, 1.8%, and 2.5%, respectively. The rate of definite/probable ST was 0.73%, early ST (
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- 2022
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36. Impact of High-Density Lipoprotein Levels on Cardiovascular Outcomes of Patients Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents
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Adam Reisman, Samin K. Sharma, Bimmer E. Claessen, Ridhima Goel, Nitin Barman, Mauro Chiarito, Rebecca Torguson, Johny Nicolas, Rishi Chandiramani, Roxana Mehran, Madhav Sharma, Davide Cao, Dhrubajyoti Bandyopadhyay, Usman Baber, Anastasios Roumeliotis, Samantha Sartori, George Dangas, Annapoorna Kini, and Joseph Sweeny
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Male ,Drug ,medicine.medical_specialty ,medicine.medical_treatment ,media_common.quotation_subject ,New York ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,03 medical and health sciences ,chemistry.chemical_compound ,Percutaneous Coronary Intervention ,0302 clinical medicine ,High-density lipoprotein ,Risk Factors ,Internal medicine ,medicine ,Humans ,In patient ,Registries ,cardiovascular diseases ,030212 general & internal medicine ,Aged ,Retrospective Studies ,media_common ,business.industry ,Incidence ,Percutaneous coronary intervention ,Drug-Eluting Stents ,Middle Aged ,Prognosis ,Survival Rate ,surgical procedures, operative ,chemistry ,Conventional PCI ,Cardiology ,Female ,lipids (amino acids, peptides, and proteins) ,Lipoproteins, HDL ,Cardiology and Cardiovascular Medicine ,business ,Cardiovascular outcomes ,Biomarkers ,Follow-Up Studies ,Lipoprotein - Abstract
Low levels of high-density lipoprotein (HDL) have been associated with adverse cardiovascular events in epidemiologic studies. Evidence regarding its role in patients who underwent percutaneous coronary intervention (PCI) is scarce. We evaluated consecutive patients who underwent PCI with drug-eluting stents from 2012 to 2017, excluding those with unavailable baseline HDL, age18 years, presentation with ST-segment elevation myocardial infarction (MI) or shock, and coexisting neoplastic disease. The final population was stratified according to baseline HDL levels into reduced and nonreduced HDL cohorts, with cut-off value 40 mg/dl in males and 50 mg/dl in females. The primary end point was 1-year major adverse cardiovascular events (MACE), defined as the composite of death, MI, or target vessel revascularization (TVR). Among 10,843 patients included, 6,511 (60%) had reduced HDL, and 4,332 (40%) nonreduced HDL. The rate of 1-year MACE was similar between the 2 groups (7.5% vs 6.6%; p = 0.14). Although mortality and MI rates were comparable, reduced HDL was associated with significantly higher TVR 5.2% vs 4.0%; p = 0.02, a finding that attenuated after multivariable adjustment (adjusted hazard ratio 1.18, p = 0.14). Sex subgroup analysis included 7,718 (71.2%) males and 3,125 (28.8%) females. Among men, there was a trend toward higher MACE in those with reduced HDL (7.4% vs 6.0%; p = 0.08) mostly driven by TVR (5.4% vs 3.7%; p = 0.005). No association between HDL and 1-year outcomes was evident in females. Assessment for interaction between sex and reduced HDL did not reach statistical significance. In conclusion, reduced baseline HDL was not associated with increased risk of MACE in a contemporary PCI population.
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- 2020
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37. Implications of Kidney Disease in the Cardiac Patient
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Roxana Mehran, Bimmer E. Claessen, and Johny Nicolas
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Male ,medicine.medical_specialty ,Population ,Contrast Media ,Tetrazoles ,030204 cardiovascular system & hematology ,Coronary artery disease ,Angiotensin Receptor Antagonists ,03 medical and health sciences ,Percutaneous Coronary Intervention ,0302 clinical medicine ,Risk Factors ,Internal medicine ,Prevalence ,medicine ,Humans ,030212 general & internal medicine ,Renal Insufficiency, Chronic ,education ,Sodium-Glucose Transporter 2 Inhibitors ,Aged ,education.field_of_study ,Kidney ,business.industry ,Aminobutyrates ,Biphenyl Compounds ,Prognosis ,medicine.disease ,Pathophysiology ,Drug Combinations ,medicine.anatomical_structure ,Cardiovascular Diseases ,Heart failure ,Cardiology ,Valsartan ,Female ,Presentation (obstetrics) ,Cardiology and Cardiovascular Medicine ,Disease manifestation ,business ,Factor Xa Inhibitors ,Kidney disease - Abstract
Cardiovascular and renal diseases share common pathophysiological grounds, risk factors, and therapies. The 2 entities are closely interlinked and often coexist. The prevalence of kidney disease among cardiac patients is increasing. Patients have an atypical clinical presentation and variable disease manifestation versus the general population. Renal impairment limits therapeutic options and worsens prognosis. Meticulous treatment and close monitoring are required to ensure safety and avoid deterioration of kidney and heart functions. This review highlights recent advances in the diagnosis and treatment of cardiac pathologies, including coronary artery disease, arrhythmia, and heart failure, in patients with decreased renal function.
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- 2020
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38. Hypoattenuated Leaflet Thickening After Transcatheter Aortic Valve Replacement: Additional Data, Yet Still Many Unanswered Questions
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Johny Nicolas and George Dangas
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Transcatheter Aortic Valve Replacement ,Treatment Outcome ,Aortic Valve ,Heart Valve Prosthesis ,Humans ,Cardiology and Cardiovascular Medicine - Published
- 2022
39. Outcomes After Transcatheter Aortic Valve Implantation in Men Versus Women
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Jochen Wöhrle, Martine Gilard, Romain Didier, Annapoorna Kini, Annerieke H. Tavenier, Jan G.P. Tijssen, Samantha Sartori, Clayton Snyder, Johny Nicolas, Julia Seeger, Ulf Landmesser, Giuseppe Tarantini, Anita Asgar, Helge Möllmann, Holger Thiele, Piera Capranzano, Bernhard Reimers, Giulio Stefanini, Raul Moreno, Anna Sonia Petronio, Ghada Mikhail, Samir Kapadia, David Hildick-Smith, Christian Hengstenberg, Roxana Mehran, Stephan Windecker, George D. Dangas, Cardiology, and ACS - Heart failure & arrhythmias
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Male ,Hemorrhage ,Thrombosis ,Aortic Valve Stenosis ,Stroke ,Transcatheter Aortic Valve Replacement ,Treatment Outcome ,Risk Factors ,Aortic Valve ,Humans ,Female ,Cardiology and Cardiovascular Medicine ,610 Medicine & health - Abstract
Gender-based differences in outcomes after successful transcatheter aortic valve implantation (TAVI) in patients without an indication for oral anticoagulation have not been well studied. We aim to evaluate gender-based differences in clinical outcomes after TAVI. In the present analysis of the GALILEO (Global study comparing a rivaroxaban-based antithrombotic strategy to an antiplatelet-based strategy after transcatheter aortic valve replacement to optimize clinical outcomes) trial, patients with symptomatic severe aortic stenosis and who underwent successful TAVI were stratified by gender. The primary outcome was major adverse cardiac and cerebrovascular events (MACCEs), a composite of all-cause mortality or thromboembolic events (including any stroke, myocardial infarction, symptomatic valve thrombosis, systemic embolism, deep-vein thrombosis, or pulmonary embolism). Major bleeding was defined as a composite of major, life-threatening, or disabling Valve Academic Research Consortium-2 bleeding. Of 1,644 patients, 813 were female, and 831 were male. At baseline, female patients were older and at higher surgical risk (Society of Thoracic Surgeons risk score: 4.7 ± 3.6 versus 3.6 ± 3.0, plt;0.0001) than male patients. After adjustment for differences in baseline clinical and procedural parameters, female patients had lower rates of MACCE (hazard ratio [HR] 0.69, 95% confidence interval [CI] 0.49 to 0.96), all-cause mortality (HR 0.54, 95% CI 0.34 to 0.87), and noncardiovascular mortality (HR 0.33, 95% CI 0.15 to 0.75) at a median of 17 months of follow-up. By landmark analyses, these differences appeared to emerge with a longer follow-up time. No significant differences in major, life-threatening, or disabling bleeding, cardiovascular mortality, and stroke were noted. In conclusion, compared with male patients, female patients with severe symptomatic aortic stenosis had a lower risk of MACCE and mortality but a similar risk of bleeding events after TAVI.
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- 2022
40. Current State and Future Perspectives of Artificial Intelligence for Automated Coronary Angiography Imaging Analysis in Patients with Ischemic Heart Disease
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Mitchel A. Molenaar, Jasper L. Selder, Johny Nicolas, Bimmer E. Claessen, Roxana Mehran, Javier Oliván Bescós, Mark J. Schuuring, Berto J. Bouma, Niels J. Verouden, and Steven A. J. Chamuleau
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Image processing ,Artificial Intelligence ,Coronary Stenosis ,Myocardial Ischemia ,Humans ,Deep learning ,Coronary Artery Disease ,Cardiology and Cardiovascular Medicine ,Coronary Angiography - Abstract
Purpose of Review Artificial intelligence (AI) applications in (interventional) cardiology continue to emerge. This review summarizes the current state and future perspectives of AI for automated imaging analysis in invasive coronary angiography (ICA). Recent Findings Recently, 12 studies on AI for automated imaging analysis In ICA have been published. In these studies, machine learning (ML) models have been developed for frame selection, segmentation, lesion assessment, and functional assessment of coronary flow. These ML models have been developed on monocenter datasets (in range 31–14,509 patients) and showed moderate to good performance. However, only three ML models were externally validated. Summary Given the current pace of AI developments for the analysis of ICA, less-invasive, objective, and automated diagnosis of CAD can be expected in the near future. Further research on this technology in the catheterization laboratory may assist and improve treatment allocation, risk stratification, and cath lab logistics by integrating ICA analysis with other clinical characteristics.
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- 2022
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41. Impact of Small Valve Size on 1-Year Outcomes After Transcatheter Aortic Valve Implantation in Women (from the WIN-TAVI Registry)
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Carlo A. Pivato, Davide Cao, Alessandro Spirito, Samantha Sartori, Johny Nicolas, Mauro Chiarito, Clayton Snyder, Julinda Mehilli, Thierry Lefèvre, Giulio G. Stefanini, Patrizia Presbitero, Piera Capranzano, Didier Tchetche, Alessandro Iadanza, Birgit Vogel, Gennaro Sardella, Nicolas M. Van Mieghem, Matteo Nardin, Anne H. Tavenier, Emanuele Meliga, Nicholas Dumonteil, Chiara Fraccaro, Daniela Trabattoni, Ghada Mikhail, Samin Sharma, Maria Cruz Ferrer, Christoph Naber, Peter Kievit, Usman Baber, Anna S. Petronio, Marie C. Morice, Alaide Chieffo, George Dangas, Roxana Mehran, and Cardiology
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Male ,Heart Valve Prosthesis Implantation ,Transcatheter Aortic Valve Replacement ,Time Factors ,Treatment Outcome ,Risk Factors ,Aortic Valve ,Heart Valve Prosthesis ,Humans ,Female ,Registries ,Aortic Valve Stenosis ,Cardiology and Cardiovascular Medicine - Abstract
Although most patients with small aortic annulus are women, there is paucity of data on the prognostic impact of small aortic prosthesis in women who underwent transcatheter aortic valve implantation (TAVI). Therefore, we aimed to evaluate the impact of small valve size on 1-year clinical outcomes after TAVI in women. The Women's INternational Transcatheter Aortic Valve Implantation is an all-women registry evaluating patients with severe aortic stenosis who underwent TAVI. Based on the size of the aortic bioprosthesis implanted, women were stratified into small (≤23 mm) and nonsmall (>23 mm) valve. The primary efficacy endpoint was the Valve Academic Research Consortium-2 composite of all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction at 1-year follow-up. Of 934 women who underwent TAVI, 388 (41.5%) received a small valve. Women with a small valve size had a lower body mass index, lower surgical risk scores, were less likely to suffer from atrial fibrillation, less often required postdilation and had a lower rate of residual aortic regurgitation grade ≥2. The occurrence of the Valve Academic Research Consortium-2 efficacy endpoint was similar between women treated with small and nonsmall valve (16.0% vs 16.3%, p = 0.881; adjusted hazard ratio 1.34, 95% confidence interval 0.90 to 2.00). Likewise, there were no significant differences in the occurrence of other secondary endpoints after multivariable adjustment. In conclusion, women with severe aortic stenosis who underwent TAVI with the implantation of a small valve bioprosthesis had similar 1-year outcomes as those receiving a nonsmall bioprosthesis.
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- 2022
42. Ticagrelor monotherapy after PCI in patients with concomitant diabetes mellitus and chronic kidney disease : TWILIGHT DM-CKD
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Payam Dehghani, Davide Cao, Usman Baber, Johny Nicolas, Samantha Sartori, Carlo A Pivato, Zhongjie Zhang, George Dangas, Dominick J Angiolillo, Carlo Briguori, David J Cohen, Timothy Collier, Dariusz Dudek, Michael Gibson, Robert Gil, Kurt Huber, Upendra Kaul, Ran Kornowski, Mitchell W Krucoff, Vijay Kunadian, Shamir Mehta, David J Moliterno, E Magnus Ohman, Javier Escaned, Gennaro Sardella, Samin K Sharma, Richard Shlofmitz, Giora Weisz, Bernhard Witzenbichler, Stuart Pocock, and Roxana Mehran
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Stroke ,Ticagrelor ,Percutaneous Coronary Intervention ,Aspirin ,Diabetes Mellitus ,Myocardial Infarction ,Humans ,Drug Therapy, Combination ,Hemorrhage ,Pharmacology (medical) ,Renal Insufficiency, Chronic ,Cardiology and Cardiovascular Medicine ,Platelet Aggregation Inhibitors - Abstract
Aims We aimed to evaluate the treatment effects of ticagrelor monotherapy in the very high risk cohort of patients with concomitant diabetes mellitus (DM) and chronic kidney disease (CKD) undergoing percutaneous coronary intervention (PCI). Methods and results In the TWILIGHT (Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention) trial, after 3-month dual antiplatelet therapy with ticagrelor and aspirin post-PCI, event-free patients were randomized to either aspirin or placebo in addition to ticagrelor for 12 months. Those with available information on DM and CKD status were included in this subanalysis and were stratified by the presence or absence of either condition: 3391 (54.1%) had neither DM nor CKD (DM−/CKD−), 1822 (29.0%) had DM only (DM+/CKD−), 561 (8.9%) had CKD only (DM−/CKD+), and 8.0% had both DM and CKD (DM+/CKD+). The incidence of the primary endpoint of Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding did not differ according to DM/CKD status (P-trend = 0.13), but there was a significant increase in BARC 3 or 5 bleeding (P-trend < 0.001) as well as the key secondary endpoint of death, myocardial infarction, or stroke (P-trend < 0.001). Ticagrelor plus placebo reduced bleeding events compared with ticagrelor plus aspirin across all four groups, including DM+/CKD+ patients with respect to BARC 2–5 [4.5% vs. 8.7%; hazard ratio (HR) 0.49, 95% confidence interval (CI) 0.24–1.01] as well as BARC 3–5 (0.8% vs. 5.3%; HR 0.15, 95% CI 0.03–0.53) bleeding, with no evidence of heterogeneity. The risk of death, myocardial infarction, or stroke was similar between treatment arms across all groups. Conclusion Irrespective of the presence of DM, CKD, and their combination, ticagrelor monotherapy reduced the risk of bleeding without a significant increase in ischaemic events compared with ticagrelor plus aspirin.
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- 2022
43. IMPACT OF BODY SURFACE AREA ON OUTCOMES IN WOMEN AND MEN UNDERGOING PERCUTANEOUS CORONARY INTERVENTION
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Roxana Mehran, Madison Edens, Samantha Sartori, Alessandro Spirito, Birgit Vogel, Johny Nicolas, Kenneth Smith, Usman Baber, Ruiqi Yan, Karim Kamaleldin, Pooja Vijay, Jeffers Guthrie, Sahil Khera, Joseph M. Sweeny, Samin K. Sharma, Annapoorna Subhash Kini, Parasuram Melarcode Krishnamoorthy, and George D. Dangas
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Cardiology and Cardiovascular Medicine - Published
- 2023
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44. Periprocedural myocardial infarction: multiple definitions and still a quest for consensus
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Johny Nicolas, Gennaro Giustino, and George Dangas
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Cardiology and Cardiovascular Medicine - Published
- 2021
45. Impact of target vessel choice on outcomes following percutaneous coronary intervention in patients with a prior coronary artery bypass graft
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Anton Camaj, Samin K. Sharma, Mauro Chiarito, Annapoorna Kini, Usman Baber, Matteo Nardin, Joseph Sweeny, Clayton Snyder, David A. Power, Samantha Sartori, Bimmer E. Claessen, Ranbir Singh, Prakash Krishnan, Carlo Andrea Pivato, George Dangas, Davis Jones, Anne H. Tavenier, Victor Razuk, Roxana Mehran, Nitin Barman, Davide Cao, Gennaro Giustino, Johny Nicolas, Frans Beerkens, Cardiology, and ACS - Atherosclerosis & ischemic syndromes
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medicine.medical_specialty ,Time Factors ,saphenous vein graft interventions ,medicine.medical_treatment ,Target vessel ,Coronary Artery Disease ,law.invention ,saphenous vein bypass graft ,Randomized controlled trial ,law ,Risk Factors ,Internal medicine ,complex PCI ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,In patient ,Myocardial infarction ,cardiovascular diseases ,Coronary Artery Bypass ,business.industry ,percutaneous coronary intervention ,Percutaneous coronary intervention ,General Medicine ,medicine.disease ,medicine.anatomical_structure ,Treatment Outcome ,surgical procedures, operative ,coronary bypass grafts ,Conventional PCI ,Cardiology ,no reflow ,Cardiology and Cardiovascular Medicine ,business ,Mace ,Artery - Abstract
Objectives: To evaluate and compare characteristics and clinical outcomes of percutaneous coronary intervention (PCI) among target vessel types in patients with a prior coronary artery bypass graft (CABG) surgery. Background: Patients with a prior CABG often require repeat revascularization with PCI. Graft PCI has been associated with worse outcomes compared to native vessel PCI, yet the optimal PCI strategy in prior CABG patients remains unknown. Methods: We stratified prior CABG patients who underwent PCI at a tertiary-care center between 2009 and 2017 by target vessel type: native vessel, venous graft, and arterial graft. The primary outcome of major adverse cardiac events (MACE) was a composite of all-cause death, myocardial infarction, stent thrombosis, or target vessel revascularization up to 1 year post-PCI. Results: Prior CABG patients (n = 3983) represented 19.5% of all PCI interventions during the study period. PCI was most frequently performed on native vessels (n = 2928, 73.5%) followed by venous (n = 883, 22.2%) and arterial grafts (n = 172, 4.3%). Procedural success and complications were similar among the groups; however, slow- and no-reflow phenomenon was more common in venous graft PCI compared to native vessel PCI (OR 4.78; 95% CI 2.56–8.95; p < 0.001). At 1 year, there were no significant differences in MACE or in its individual components. Conclusions: Target vessel choice did not appear to affect MACE at 1 year in a large cohort of patients with prior CABG undergoing PCI. Whether PCI of surgical grafts versus native arteries truly results in similar outcomes warrants further investigation in randomized controlled trials.
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- 2021
46. TCT-346 The Mega COMBO Collaboration:An Individual Patient Data Pooled Analysis of Patients Undergoing PCI With COMBO Stent
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Carlo Andrea Pivato, Roxana Mehran, Ulf Landmesser, George Dangas, Davide Cao, Robbert J. de Winter, Harry Suryapranata, Lisette Okkels Jensen, Hanbo Qiu, Shigeru Saito, Lars Jakobsen, Mauro Chiarito, Zhongjie Zhang, Antonio Colombo, Alexandre Abizaid, Johny Nicolas, Giuseppe De Luca, Michael Haude, Evald Høj Christiansen, Matteo Nardin, and Samantha Sartori
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medicine.medical_specialty ,Pooled analysis ,business.industry ,medicine.medical_treatment ,Conventional PCI ,Medicine ,Stent ,Patient data ,Radiology ,Cardiology and Cardiovascular Medicine ,business ,Mega - Published
- 2021
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47. Ticagrelor monotherapy in patients at high bleeding risk undergoing percutaneous coronary intervention: TWILIGHT-HBR
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Kurt Huber, Roxana Mehran, Davide Cao, Zhongjie Zhang, Samin K. Sharma, Gennaro Sardella, Upendra Kaul, Mitchell W. Krucoff, Robert J. Gil, Richard Shlofmitz, Keith G. Oldroyd, Johny Nicolas, Ran Kornowski, Timothy Collier, Dariusz Dudek, Stuart J. Pocock, Dominick J. Angiolillo, Javier Escaned, Samantha Sartori, David J. Moliterno, Bernhard Witzenbichler, Giora Weisz, Carlo Briguori, Vijay Kunadian, Usman Baber, E. Magnus Ohman, Michael C. Gibson, George Dangas, David Cohen, and Shamir R. Mehta
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medicine.medical_specialty ,Ticagrelor ,medicine.medical_treatment ,Population ,Fast Track Clinical Research ,Hemorrhage ,030204 cardiovascular system & hematology ,03 medical and health sciences ,0302 clinical medicine ,Percutaneous Coronary Intervention ,Internal medicine ,medicine ,Humans ,AcademicSubjects/MED00200 ,030212 general & internal medicine ,education ,Stroke ,education.field_of_study ,Aspirin ,business.industry ,Absolute risk reduction ,Percutaneous coronary intervention ,medicine.disease ,3. Good health ,Discontinuation ,Treatment Outcome ,Editorial ,Conventional PCI ,Drug Therapy, Combination ,Cardiology and Cardiovascular Medicine ,business ,Platelet Aggregation Inhibitors ,medicine.drug - Abstract
Aims Patients at high bleeding risk (HBR) represent a prevalent subgroup among those undergoing percutaneous coronary intervention (PCI). Early aspirin discontinuation after a short course of dual antiplatelet therapy (DAPT) has emerged as a bleeding avoidance strategy. The aim of this study was to assess the effects of ticagrelor monotherapy after 3-month DAPT in a contemporary HBR population. Methods and results This prespecified analysis of the TWILIGHT trial evaluated the treatment effects of early aspirin withdrawal followed by ticagrelor monotherapy in HBR patients undergoing PCI with drug-eluting stents. After 3 months of ticagrelor plus aspirin, event-free patients were randomized to 12 months of aspirin or placebo in addition to ticagrelor. A total of 1064 (17.2%) met the Academic Research Consortium definition for HBR. Ticagrelor monotherapy reduced the incidence of the primary endpoint of Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding compared with ticagrelor plus aspirin in HBR (6.3% vs. 11.4%; hazard ratio (HR) 0.53, 95% confidence interval (CI) 0.35–0.82) and non-HBR patients (3.5% vs. 5.9%; HR 0.59, 95% CI 0.46–0.77) with similar relative (P interaction = 0.67) but a trend towards greater absolute risk reduction in the former [−5.1% vs. −2.3%; difference in absolute risk differences (ARDs) −2.8%, 95% CI −6.4% to 0.8%, P = 0.130]. A similar pattern was observed for more severe BARC 3 or 5 bleeding with a larger absolute risk reduction in HBR patients (−3.5% vs. −0.5%; difference in ARDs −3.0%, 95% CI −5.2% to −0.8%, P = 0.008). There was no significant difference in the key secondary endpoint of death, myocardial infarction, or stroke between treatment arms, irrespective of HBR status. Conclusions Among HBR patients undergoing PCI who completed 3-month DAPT without experiencing major adverse events, aspirin discontinuation followed by ticagrelor monotherapy significantly reduced bleeding without increasing ischaemic events, compared with ticagrelor plus aspirin. The absolute risk reduction in major bleeding was larger in HBR than non-HBR patients.
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- 2021
48. Prasugrel or clopidogrel in patients with acute coronary syndromes at high thrombotic risk: results from the PROMETHEUS study
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Matteo Nardin, Z Zhongjie, Carlo Andrea Pivato, Timothy D. Henry, Prometheus Investigators, George Dangas, Mauro Chiarito, A. Kini, Johny Nicolas, Davide Cao, Usman Baber, Sunil V. Rao, Samantha Sartori, Stuart J. Pocock, R Mehran, and Anne H. Tavenier
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Thrombotic risk ,medicine.medical_specialty ,Prasugrel ,business.industry ,medicine.medical_treatment ,medicine.disease ,Clopidogrel ,Revascularization ,Pharmacotherapy ,Internal medicine ,Cardiology ,Medicine ,In patient ,Thrombus ,Cardiology and Cardiovascular Medicine ,business ,Fibrinolytic agent ,medicine.drug - Abstract
Background Potent P2Y12 inhibitors are recommended on top of aspirin in patients presenting with acute coronary syndrome (ACS). However, guideline recommendations suggest that the optimal antithrombotic strategy should be tailored based on patients thrombotic and hemorrhagic risk profile. Purpose It is poorly investigated if the benefits derived from potent P2Y12 inhibition in patients with ACS depend on the individual thrombotic risk profile. Our aim was to evaluate if the benefits associated with prasugrel vs. clopidogrel in patients with ACS undergoing percutaneous coronary intervention (PCI) are similar in case of different thrombotic risk profiles. Methods PROMETHEUS was a multicenter observational study comparing prasugrel vs. clopidogrel in ACS patients undergoing PCI. According to the 2020 ESC guidelines for non-ST elevation-ACS, patients are defined at high thrombotic risk if presenting with a clinical (diabetes mellitus requiring medication, history of recurrent myocardial infarction [MI], multivessel coronary artery disease [CAD], polyvascular [coronary and peripheral] disease, premature (60 mm, complex revascularization [left main PCI, bifurcation or chronic total occlusion]) risk features. The primary endpoint was major adverse cardiac events (MACE), a composite of death, MI, stroke or unplanned revascularization. Hazard ratio (HR) and 95% confidence intervals (CI) were calculated using propensity-stratified analysis to assess the effect of prasugrel vs. clopidogrel and with multivariable Cox regression to evaluate the impact of thrombotic risk. Results Among 16065 patients, 4293 were defined at high thrombotic risk and 11772 at low-to-moderate thrombotic risk. Patients treated with prasugrel had less comorbidities and risk factors than those treated with clopidogrel, both in the high and low-to-moderate thrombotic risk strata. Patients at high thrombotic risk had higher rates of both ischemic and bleeding events at 90 days and at 1 year. Patients treated with prasugrel had a lower adjusted risk of MACE at 1 year (HR 0.86, 95% CI 0.77–0.96), with no significant interaction between effect estimates and thrombotic risk. However, after stratifying the study population by the number of risk factors, there was a significant interaction for a greater reduction in MACE with prasugrel in patients with ≤1 thrombotic risk factor. Conversely, there were no differences in major bleeding among patients treated with prasugrel and clopidogrel. Conclusions Patients with ACS at high thrombotic risk who undergo PCI are at increased risk of adverse events. Prasugrel, although mainly reserved to patients with lower burden of comorbidities, reduced the risk of ischemic events both in patients at high and low-to-moderate thrombotic risk as compared with clopidogrel. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Daiichi Sankyo and Eli Lilly and Company Clinical outcomes at 1 year.Impact of number of risk factors
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- 2021
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49. A contemporary simple risk score for prediction of contrast-associated acute kidney injury after percutaneous coronary intervention: derivation and validation from an observational registry
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Mauro Chiarito, Samin K. Sharma, Samantha Sartori, Prakash Krishnan, Carlo Andrea Pivato, George Dangas, Johny Nicolas, Stuart J. Pocock, Usman Baber, Matteo Nardin, Roxana Mehran, Davide Cao, Annapoorna Kini, and Ruth Owen
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Adult ,Male ,medicine.medical_specialty ,medicine.medical_treatment ,Renal function ,Contrast Media ,Risk Assessment ,Tertiary Care Centers ,Percutaneous Coronary Intervention ,Internal medicine ,Diabetes mellitus ,Medicine ,Humans ,Prospective Studies ,Aged ,Aged, 80 and over ,Framingham Risk Score ,business.industry ,Hazard ratio ,Acute kidney injury ,Percutaneous coronary intervention ,General Medicine ,Acute Kidney Injury ,Middle Aged ,medicine.disease ,Creatinine ,Conventional PCI ,Cohort ,Female ,business - Abstract
Summary Background Contrast-associated acute kidney injury can occur after percutaneous coronary intervention (PCI). Prediction of the contrast-associated acute kidney injury risk is important for a tailored prevention and mitigation strategy. We sought to develop a simple risk score to estimate contrast-associated acute kidney injury risk based on a large contemporary PCI cohort. Methods Consecutive patients undergoing PCI at a large tertiary care centre between Jan 1, 2012, and Dec 31, 2020, with available creatinine measurements both before and within 48 h after the procedure, were included; only patients on chronic dialysis were excluded. Patients treated between 2012 and 2017 comprised the derivation cohort and those treated between 2018 and 2020 formed the validation cohort. The primary endpoint was contrast-associated acute kidney injury, defined according to the Acute Kidney Injury Network. Independent predictors of contrast-associated acute kidney injury were derived from multivariate logistic regression analysis. Model 1 included only pre-procedural variables, whereas Model 2 also included procedural variables. A weighted integer score based on the effect estimate of each independent variable was used to calculate the final risk score for each patient. The impact of contrast-associated acute kidney injury on 1-year deaths was also evaluated. Findings 32 378 PCI procedures were performed and screened for inclusion in the present analysis. After the exclusion of patients without paired creatinine measurements, patients on chronic dialysis, and multiple procedures, 14 616 patients were included in the derivation cohort (mean age 66·2 years, 29·2% female) and 5606 were included in the validation cohort (mean age 67·0 years, 26·4% female). Contrast-associated acute kidney injury occurred in 860 (4·3%) patients. Independent predictors of contrast-associated acute kidney injury included in Model 1 were: clinical presentation, estimated glomerular filtration rate, left ventricular ejection fraction, diabetes, haemoglobin, basal glucose, congestive heart failure, and age. Additional independent predictors in Model 2 were: contrast volume, peri-procedural bleeding, no flow or slow flow post procedure, and complex PCI anatomy. The occurrence of contrast-associated acute kidney injury in the derivation cohort increased gradually from the lowest to the highest of the four risk score groups in both models (2·3% to 34·9% in Model 1, and 2·0% to 38·8% in Model 2). Inclusion of procedural variables in the model only slightly improved the discrimination of the risk score (C-statistic in the derivation cohort: 0·72 for Model 1 and 0·74 for model 2; in the validation cohort: 0·84 for Model 1 and 0·86 for Model 2). The risk of 1-year deaths significantly increased in patients with contrast-associated acute kidney injury (10·2% vs 2·5%; adjusted hazard ratio 1·76, 95% CI 1·31–2·36; p=0·0002), which was mainly due to excess 30-day deaths. Interpretation A contemporary simple risk score based on readily available variables from patients undergoing PCI can accurately discriminate the risk of contrast-associated acute kidney injury, the occurrence of which is strongly associated with subsequent death. Funding None.
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- 2021
50. Sex-Related Differences in the Prevalence and Prognostic Value of the Academic Research Consortium for High Bleeding Risk Criteria
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Samin K. Sharma, Joseph Sweeny, Hanbo Qiu, Roxana Mehran, Davide Cao, Rishi Chandiramani, Usman Baber, Giuseppe De Luca, Matteo Nardin, Mauro Chiarito, Samantha Sartori, George Dangas, Giulio G. Stefanini, Johny Nicolas, Zhongjie Zhang, Ekta Golani, and Annapoorna Kini
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medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Percutaneous coronary intervention ,Sex related ,Hemorrhage ,Prognosis ,Risk Assessment ,Percutaneous Coronary Intervention ,Risk Factors ,Internal medicine ,Female patient ,medicine ,Prevalence ,Humans ,Cardiology and Cardiovascular Medicine ,business ,Value (mathematics) ,Risk criteria - Abstract
Background: Bleeding events after percutaneous coronary intervention are associated with substantial morbidity and mortality. Female patients undergoing percutaneous coronary intervention are often older and present with a higher burden of comorbidities, which in turn increases their risk of adverse events, including bleeding complications. The Academic Research Consortium (ARC) have proposed a list of clinical criteria to define high bleeding risk (HBR). Our aim was to evaluate the prevalence and predictive value of the ARC-HBR criteria according to sex in a contemporary cohort of patients undergoing percutaneous coronary intervention. Methods: All consecutive patients receiving coronary stenting between 2014 and 2017 at a tertiary-care center were defined as HBR if they fulfilled at least 1 major or 2 minor ARC-HBR criteria. The primary bleeding end point was the composite of periprocedural in-hospital or postdischarge bleeding up to 1 year. Individual components of the primary bleeding end point, all-cause mortality, and myocardial infarction were also evaluated. Results: Of the total 9623 patients, 6979 (72.5%) were male and 2644 (27.5%) female. The prevalence of HBR was significantly higher in females compared with males (56.5% versus 39.9%, P P P interaction =0.344). The ARC-HBR criteria associated with the highest bleeding risk at 1 year were severe/end-stage chronic kidney disease and thrombocytopenia in females, and moderate/severe anemia in males. Conclusions: In a real-world cohort of percutaneous coronary intervention patients, females were more often at HBR than males. The prognostic value of the ARC-HBR definition was consistent between female and male patients, despite sex-related differences in the prevalence and bleeding risk associated with individual ARC-HBR criteria.
- Published
- 2021
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