Publications by authors named "Roxana Mehran"

Background: Limited data exist on the impact of polyvascular disease (PolyVD) on clinical outcomes in female patients undergoing transcatheter aortic valve replacement (TAVR). We therefore sought to investigate clinical outcomes in women with versus without PolyVD undergoing TAVR.

Methods: Female participants from the multicentre Women's International Transcatheter Aortic Valve Implantation (WIN-TAVI) registry were categorized based on the presence or absence of PolyVD.

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Background: The role of direct oral anticoagulants (DOACs) in the treatment of left ventricular thrombus (LVT) after ST-elevation myocardial infarction (STEMI) remains uncertain.

Aims: We aimed to compare the effect of rivaroxaban versus warfarin in patients with STEMI complicated by LVT.

Methods: Adult patients with STEMI and two-dimensional transthoracic echocardiography showing LVT were assigned to rivaroxaban (15 mg once daily) or warfarin (international normalised ratio goal of 2.

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In-stent restenosis (ISR) remains the predominant cause of stent failure and the most common indication for repeat revascularization. Despite technological advances in stent design, ISR continues to pose significant challenges, contributing to increased morbidity and mortality among patients undergoing percutaneous coronary interventions. In the last decade, intravascular imaging has emerged as an important method for identifying the mechanisms behind ISR and guiding its treatment.

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Background: Whether the high bleeding risk (HBR) criteria of the Academic Research Consortium (ARC) have a consistent predictive ability across different categories of body mass index (BMI) remains unclear.

Methods: Consecutive patients undergoing percutaneous coronary intervention (PCI) between 2012 and 2019 at Mount Sinai Hospital (New York, USA) were stratified into five BMI categories (18.5-24.

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Importance: Drug-coated balloon (DCB) angioplasty has emerged as an alternative to drug-eluting stent (DES) implantation for percutaneous coronary intervention (PCI) in patients with coronary in-stent restenosis (ISR) as well as de novo coronary artery disease.

Observations: DCBs are balloons coated with antiproliferative agents and excipients, whose aim is to foster favorable vessel healing after appropriate lesion preparation. By providing homogeneous antiproliferative drug delivery in the absence of permanent foreign body implantation, DCBs offer multiple advantages over DES, including preservation of vessel anatomy and function and positive vessel remodeling.

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Aim: Due to the absence of validated bleeding risk tools in cancer patients undergoing percutaneous coronary intervention (PCI), we aimed to validate an adapted version of the Academic Research Consortium (ARC) High Bleeding Risk (HBR) criteria.

Methods: Consecutive patients with active or remission cancer undergoing PCI between 2012 and 2022 at Mount Sinai Hospital (New York, USA) were included. Patients were considered at HBR if they met at least one of the major ARC-HBR criteria, other than cancer, or two minor criteria.

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Article Synopsis
  • The COMPLETE trial showed that complete revascularization in STEMI patients with multivessel disease leads to better health outcomes than treating only the culprit lesion.
  • This subanalysis focused on whether having a nonculprit lesion (NCL) in the proximal/mid left anterior descending artery (LAD) affects outcomes compared to NCLs in other locations.
  • Results indicated that while the presence of a proximal/mid-LAD NCL did not significantly alter treatment benefits, complete revascularization consistently reduced major cardiovascular events across both groups.
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Current evidence indicates that dual antiplatelet therapy with aspirin plus a P2Y inhibitor is essential for the prevention of thrombotic events after percutaneous coronary interventions. However, dual antiplatelet therapy is associated with increased bleeding which may outweigh the benefits. This has set the foundations for customizing antiplatelet treatments to the individual patient.

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Article Synopsis
  • Traditional analyses in clinical trials for antithrombotic agents evaluate bleeding and ischemic events separately, which have limitations; this study proposes using days alive and out of hospital (DAOH) as an alternative endpoint.
  • The AUGUSTUS trial involving 4614 patients compared two treatments (apixaban vs. warfarin and aspirin vs. placebo) and measured DAOH, finding no significant differences between treatment groups.
  • Despite apixaban showing lower rates of major bleeding and hospitalization, the study concludes that DAOH may not effectively capture the impact of antithrombotic therapies for patients with atrial fibrillation and acute coronary syndrome.
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Limited evidence exists concerning the prognostic impact of baseline left ventricular ejection fraction (LVEF) on outcomes among women undergoing transcatheter aortic valve implantation (TAVI), which we aimed to investigate in the present analysis. Patients from the Women's International Transcatheter Aortic Valve Implantation (WIN-TAVI) registry were categorized according to baseline LVEF into 3 groups: reduced (LVEF ≤40%), mildly reduced (LVEF between 41% and 49%), and preserved (LVEF ≥50%) LVEF. The primary (Valve Academic Research Consortium 2 [VARC-2]) efficacy point was defined as a composite of mortality, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure, or valve-related dysfunction at 1 year.

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Cardiovascular diseases are the leading cause of death among women, and the incidence among younger women has shown the greatest increase over the last decades, in particular for acute myocardial infarction (AMI). Moreover, the prognosis of women post-AMI is poor when compared with men of similar ages. Since the 1990s, an abundant literature has highlighted the existing differences between sexes with regard to presentation, burden, and impact of traditional risk factors and of risk factors pertaining predominantly to women, the perception of risk by women and men, and the pathophysiological causations, their treatment, and prognosis.

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Background: In the AUGUSTUS trial (An Open-Label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs Vitamin K Antagonist and Aspirin vs Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention), the combination of dual antiplatelet therapy plus oral anticoagulation increased the risk of bleeding without reducing ischemic events compared with a P2Y12 inhibitor plus oral anticoagulation among patients with atrial fibrillation and acute coronary syndrome or elective percutaneous coronary intervention. However, AUGUSTUS enrolled patients up to 14 days after acute coronary syndrome or percutaneous coronary intervention, and there may be a benefit to dual antiplatelet therapy plus oral anticoagulation early after an ischemic event.

Methods: In this secondary analysis of AUGUSTUS, we divided patients into groups based on whether they were enrolled <6 days (early) or ≥6 days (later) after their index acute coronary syndrome or percutaneous coronary intervention, and tested the interaction between time from the index event to enrollment and randomized treatment (apixaban versus vitamin K antagonist and aspirin versus placebo) on 30-day and 6-month clinical outcomes using Cox proportional hazards models.

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Article Synopsis
  • * The AUGUSTUS trial compared the safety of antithrombotic treatments (apixaban vs vitamin K antagonists and aspirin vs placebo) in patients categorized by the number of comorbidities.
  • * Results showed that higher comorbidity levels increased bleeding risks, but no significant differences in outcomes between the antithrombotic regimens were observed, supporting the use of apixaban plus a P2Y inhibitor.
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Over the past decades, there have been great advancements in the antithrombotic management of patients undergoing percutaneous interventions, but most of the available evidence derives from studies conducted in the setting of cardiac interventions. Antithrombotic treatment regimens used in patients undergoing percutaneous cardiac interventions, in particular coronary, are frequently extrapolated to patients undergoing noncardiac interventions. However, the differences in risk profile of the population treated and the types of interventions performed may translate into differences is the safety and efficacy associated with antithrombotic therapy.

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The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) has recently introduced a consensus document that outlines risk factors to identify high bleeding risk (HBR) in patients undergoing transcatheter aortic valve replacement (TAVR). The objective of the present study was to evaluate the prevalence and predictive value of the VARC-HBR definition in a contemporary, large-scale TAVR population. Multicenter study including 10,449 patients undergoing TAVR.

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Background: Accurate bleeding risk stratification after percutaneous coronary intervention (PCI) is important for treatment individualization. However, there is still an unmet need for a more precise and standardized identification of high bleeding risk patients. We derived and validated a novel bleeding risk score by augmenting the PRECISE-DAPT score with the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria.

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Data on percutaneous coronary intervention (PCI) for left main coronary artery (LMCA) disease in patients of diverse race/ethnicity are scant. This study aimed to assess the impact of race/ethnicity on clinical outcomes at 12-month follow-up of patients with LMCA disease who underwent PCI with drug-eluting stent implantation. All patients who underwent PCI for LMCA disease between 2010 and 2019 at a tertiary care center were prospectively enrolled.

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Article Synopsis
  • The study evaluates the impact of early discontinuation of aspirin in favor of ticagrelor monotherapy on bleeding and ischemic events in patients who underwent percutaneous coronary intervention (PCI).
  • Results show that while ticagrelor monotherapy led to significantly fewer bleeding events compared to ticagrelor plus aspirin, the total ischemic events remained similar between the two groups.
  • Overall, among high-risk PCI patients, ticagrelor alone was associated with reduced bleeding without increasing the risk of ischemic complications.
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Antithrombotic therapy after cardiac percutaneous interventions is key for the prevention of thrombotic events but is inevitably associated with increased bleeding, proportional to the number, duration, and potency of the antithrombotic agents used. Bleeding complications have important clinical implications, which in some cases may outweigh the expected benefit of reducing thrombotic events. Because the response to antithrombotic agents varies widely among patients, there has been a relentless effort toward the identification of patients at high bleeding risk (HBR), in whom modulation of antithrombotic therapy may be needed to optimize the balance between safety and efficacy.

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Article Synopsis
  • Patients who need oral anticoagulation and undergo coronary intervention can use a special stent (COBRA PzF) that may lower the need for long-term dual antiplatelet therapy (DAPT) while maintaining safety against blood clots.
  • In a study, 996 patients were randomized to receive either the COBRA PzF stent with a short 14-day DAPT or a regular stent with longer DAPT durations of 3 to 6 months.
  • Results showed that the COBRA stent did not significantly reduce bleeding compared to the control group and was not proven to maintain equivalent safety for thromboembolic events, indicating further investigation is needed.
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Article Synopsis
  • - The BRIGHT-4 study showed that using bivalirudin with a high-dose infusion after PCI led to lower overall mortality and bleeding risks compared to heparin, without raising rates of reinfarction or stent thrombosis in STEMI patients.
  • - A meta-analysis of six trials involving over 15,000 patients found that while bivalirudin reduced overall and cardiac mortality and major bleeding, it was associated with higher rates of reinfarction and stent thrombosis compared to heparin.
  • - When specifically looking at a subset of trials similar to the BRIGHT-4 approach, bivalirudin also showed a decrease in 30-day mortality and major bleeding, with comparable rates of reinfar
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