Quantitative flow ratio versus fractional flow reserve for guiding percutaneous coronary intervention: design and rationale of the randomised FAVOR III Europe Japan trial.

Quantitative flow ratio (QFR) is a computation of fractional flow reserve (FFR) based on invasive coronary angiographic images. Calculating QFR is less invasive than measuring FFR and may be associated with lower costs. Current evidence supports the call for an adequately powered randomised comparison of QFR and FFR for the evaluation of intermediate coronary stenosis. The aim of the FAVOR III Europe Japan trial is to investigate if a QFR-based diagnostic strategy yields a non-inferior 12-month clinical outcome compared with a standard FFR-guided strategy in the evaluation of patients with intermediary coronary stenosis. FAVOR III Europe Japan is an investigator-initiated, randomised, clinical outcome, non-inferiority trial scheduled to randomise 2,000 patients with either 1) stable angina pectoris and intermediate coronary stenosis, or 2) indications for functional assessment of at least 1 non-culprit lesion after acute myocardial infarction. Up to 40 international centres will randomise patients to either a QFR-based or a standard FFR-based diagnostic strategy. The primary endpoint of major adverse cardiovascular events is a composite of all-cause mortality, any myocardial infarction, and any unplanned coronary revascularisation at 12 months. QFR could emerge as an adenosine- and wire-free alternative to FFR, making the functional evaluation of intermediary coronary stenosis less invasive and more cost-effective.

The impact of first wave of the SARS-CoV-2 2019 pandemic in Poland on characteristics and outcomes of patients hospitalized due to stable coronary artery disease.

BACKGROUND: An investigation of baseline characteristics, treatment, and outcomes in patients with stable coronary disease after the first wave of the severe acute respiratory syndrome coronavirus 2 (SARS- -CoV-2) pandemic may provide valuable data and is beneficial for public health strategy in upcoming years. METHODS: A multi-institutional registry, including 10 cardiology departments, was searched for patients admitted from June 2020 to October 2020. The baseline characteristics (age, gender, symptoms, comorbidities), treatment (non-invasive, invasive, surgical), and hospitalization outcome (mortality, myocardial infarction, stroke, composite endpoint - major adverse cardiac and cerebrovascular events [MACCE]) were evaluated. The comparison was made to parameters presented by patients from the same timeframe in 2019 (June-October). Multivariable analysis was performed. RESULTS: Number of hospitalized stable patients following lockdown was lower (2498 vs. 1903; p < 0.0001). They were younger (68.0 vs. 69.0; p < 0.019), more likely to present with hypertension (88.5% vs. 77.5%; p < 0.0001), diabetes (35.7% vs. 31.5%; p = 0.003), hyperlipidemia (67.9% vs. 55.4%; p < 0.0001), obesity (35.8% vs. 31.3%; p = 0.002), and more pronounced symptoms (Canadian Cardiovascular Society [CCS] III and CCS class IV angina: 30.4% vs. 26.5%; p = 0.005). They underwent percutaneous treatment more often (35.0% vs. 25.9%; p < 0.0001) and were less likely to be referred for surgery (3.7% vs. 4.9%; p = 0.0001). There were no significant differences in hospitalization outcome. New York Heart Association (NYHA) class IV for heart failure was a risk factor for both mortality and MACCE in multivariate analysis. CONCLUSIONS: The SARS-CoV-2 2019 pandemic affected the characteristics and hospitalization course of stable angina patients hospitalized following the first wave. The hospitalization outcome was similar in the analyzed time intervals. The higher prevalence of comorbidities raises concern regarding upcoming years.

Incidence and course of acute coronary syndrome cases after the first wave of the COVID-19 pandemic.

BACKGROUND: The collateral damage caused by the COVID-19 pandemic affected cardiovascular disease patients, mainly acute coronary syndrome (ACS) cases. Additionally, lockdown caused treatment-related concerns and reluctance to seek medical help, factors that can delay treatment. AIM: We aimed to analyze the incidence and course of ACS after the first COVID-19 wave. METHODS: The report is based on a multi-institutional registry of 10 interventional cardiology departments. ACS patient data were gathered from June to October 2020, i.e. in the period following the first lockdown in Poland (March 30-May 31, 2020) and compared with the corresponding 2019 timeframe. RESULTS: Patients (2801 and 2620) hospitalized for ACS in 2019 and 2020 (June-October) represented 52.8% and 57.9% of coronary artery disease admissions, respectively. In 2020 vs. 2019, more cases of arterial hypertension (80.2% vs. 71.5%; P <0.001), diabetes (32.7% vs. 28.2%; P <0.001) hyperlipidemia (53.2% vs. 49.8%; P = 0.01), and smoking history (29.5% vs. 25.8%; P = 0.003) were detected. Median troponin and cholesterol values, as well as glycemia, were higher in 2020. Patients were more likely to undergo percutaneous treatment (91.2% vs. 87.5%; P <0.001) and were less often referred for surgery (3.7% vs. 4.9%; P = 0.03). No differences in deaths from repeat myocardial infarction, stroke, and/or composite endpoint (major adverse cardiac and cerebrovascular events [MACCE]) were noted. However, suffering from ACS in 2020 (June-October) was a risk factor for mortality based on multivariable analysis. CONCLUSIONS: The COVID-19 pandemic affected ACS patient profile, course of treatment, and increased risk for mortality.

Active screening for COPD among hospitalized smokers - a feasibility study.

BACKGROUND: Spirometry is a primary tool for early chronic obstructive pulmonary disease (COPD) detection in patients with risk factors, for example, cigarette smoking. The aim of this study was to evaluate the strategy of an active screening for COPD among smokers admitted to the pulmonary and cardiology department. METHODS: This prospective study was conducted between February and March 2019. All hospitalized smokers aged 40 years and older completed an original questionnaire and had spirometry measurement with a bronchial reversibility test (if applicable) performed by medical students using a portable spirometer. RESULTS: One hundred and eighty-eight patients were eligible to participate in the study. Seventy (37%) subjects refused to participate. Eventually, 116 (62%) patients were included in the final analysis and 94 (81%) performed spirometry correctly. In total, 32 (34 %) patients were found to have COPD. Nine (28%) of these patients were newly diagnosed, 89% of them had mild-to-moderate airway obstruction. Patients with newly diagnosed COPD were significantly younger [age 63 (56-64) versus 69 (64-78) years], had a longer smoking-free period [17 (13-20) versus 9 (2-12) years], had fewer symptoms and had a better lung function compared with patients with a previous diagnosis of COPD (p < 0.05 for all comparisons). CONCLUSION: The proposed diagnostic strategy can be successfully used to improve COPD detection in the inpatient setting. The majority of the newly diagnosed COPD patients had mild-to-moderate airway obstruction. Patients who should be particularly screened for COPD include ex-smokers with less pronounced respiratory symptoms.

Smoking and outcomes following guided de-escalation of antiplatelet treatment in acute coronary syndrome patients: a substudy from the randomized TROPICAL-ACS trial.

AIMS: Prior analyses disclosed variations in antiplatelet drug response and clinical outcomes between smokers and non-smokers, thus the safety and efficacy of any dual antiplatelet therapy (DAPT) de-escalation strategy may differ in relation to smoking status. Hence, we assessed the impact of smoking on clinical outcomes and adenosine diphosphate-induced platelet aggregation following guided de-escalation of DAPT in invasively managed acute coronary syndrome (ACS) patients. METHODS AND RESULTS: The multicentre TROPICAL-ACS trial randomized 2610 biomarker-positive ACS patients 1:1 to standard treatment with prasugrel for 12 months (control group) or a platelet function testing guided de-escalation of DAPT. Current smokers (n = 1182) showed comparable event rates between study groups [6.6% vs. 6.6%; hazard ratio (HR) 1.0, 95% confidence interval (CI) 0.64-1.56, P > 0.99]. In non-smokers (n = 1428), a guided DAPT de-escalation was associated with a lower 1-year incidence of the primary endpoint [cardiovascular death, myocardial infarction, stroke, or bleeding ≥ Grade 2 according to Bleeding Academic Research Consortium (BARC) criteria] compared with control group patients (7.9% vs. 11.0%; HR 0.71, 95% CI 0.50-0.99, P = 0.048). This reduction was mainly driven by a lower rate of BARC ≥ Grade 2 bleedings (5.2% vs. 7.7%; HR 0.68, 95% CI 0.45-1.03, P = 0.066). There was no significant interaction of smoking status with treatment effects of guided DAPT de-escalation (Pint = 0.23). Adenosine diphosphate-induced platelet aggregation values were higher in current smokers [median 28 U, interquartile range (IQR: 20-40)] vs. non-smoker [median 24 U (16-25), P < 0.0001] in the control group and in current smokers [median 42 U, IQR (27-68)] vs. non-smoker [median 37 U, IQR (25-55), P < 0.001] in the monitoring group. CONCLUSION: Guided DAPT de-escalation appears to be equally safe and effective in smokers and non-smokers. Regardless of smoking status and especially for those patients deemed unsuitable for 1 year of potent platelet inhibition this DAPT strategy might be used as an alternative antiplatelet treatment regimen.

Clinical characteristics and thromboembolic risk of atrial fibrillation patients with and without congestive heart failure. Results from the CRATF study.

Congestive heart failure (CHF) and atrial fibrillation (AF) frequently coexist and are associated with increased risk of cardiovascular events.To compare baseline characteristics, comorbidities and pharmacotherapy in AF patients with concomitant CHF to those without CHF.The study included 3506 real-life AF patients with (37.1%) and without CHF - participants of the multicentre, retrospective MultiCenter expeRience in AFib patients Treated with OAC (CRAFT) trial (NCT02987062).All patients were treated with non-vitamin K antagonist oral anticoagulants (NOAC) or vitamin K antagonists (VKA). The frequency of NOAC among patients with and without CHF was 45.6% and 43.2%, respectively (P = .17). Patients with CHF were older (73.3 vs 64.7 years, P <.001), less likely to be women (37.4% vs 42%, P = .007), had higher CHA2DS2-VASc score (3.8 ±â€Š1.7 vs 2.6 ±â€Š1.8, P <.001), more often had permanent AF (53.0% vs 13.4%, P <.001), chronic obstructive pulmonary disease (16.7% vs 4.9%, P <.001), coronary artery disease (64.3% vs 29.8%, P <.001), peripheral vascular disease (65.3% vs 31.4%, P <.001), chronic kidney disease (43.1% vs 10.0%, P <.001), liver fibrosis (5.7% vs 2.6%, P <.001), neoplasm (9.6% vs 7.3%, P = .05), history of composite of stroke, transient ischemic attack or systemic embolization (16.2% vs 10.7%, P <.001), pacemaker (27.4% vs 22.1%, P = .004), implantable cardioverter-defibrillator (22.7% vs 0.8%, P <.001) or transaortic valve implantation (4.0% vs 0.8%, P <.001), cardiac resynchronization therapy (8.7% vs 0.3%, P <.001), composite of kidney transplantation, hemodialysis or creatinine level > 2.26 mg/dL (3.6% vs 0.8%, P <.001) and had less often hypertension (69.4% vs 72.5%, P = .05).Patients with AF and CHF had a higher thromboembolic risk and had more concomitant diseases.

A randomised trial on platelet function-guided de-escalation of antiplatelet treatment in ACS patients undergoing PCI. Rationale and design of the Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment for Acute Coronary Syndromes (TROPICAL-ACS) Trial.

Outcomes of acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) have been significantly improved with the use of potent P2Y12 receptor inhibitors like prasugrel. While most of the ischaemic risk reduction for prasugrel versus clopidogrel was demonstrated in the early treatment period, the risk of bleeding became particularly prominent during the chronic course of therapy. It may therefore be a valid approach to substitute prasugrel for clopidogrel in the early phase of chronic antiplatelet treatment after PCI. In the Testing Responsiveness To Platelet Inhibition On Chronic Antiplatelet Treatment For Acute Coronary Syndromes (TROPICAL-ACS) trial, we aim to compare standard prasugrel therapy with a de-escalating antiplatelet treatment approach guided by platelet function testing (PFT). The study is an investigator-initiated European multicentre, randomised clinical trial in biomarker-positive ACS patients after successful PCI. Two thousand six hundred patients will be randomised prior to hospital discharge in a 1:1 fashion to either receive standard prasugrel therapy (control group) or de-escalating therapy (one-week prasugrel followed by one-week clopidogrel and PFT-guided maintenance therapy from day 14 after hospital discharge, monitoring group). Patients of the monitoring group with high on-clopidogrel platelet reactivity (HPR) based on Multiplate analyzer testing (HPR: ≥ 46U per consensus definition) will be switched back to prasugrel, whereas those without HPR (<46 U) will continue clopidogrel treatment. The overall study treatment duration will be one year in both groups. The primary endpoint of the study is net clinical benefit (combined incidence of cardiovascular death, myocardial infarction, stroke and bleeding ≥ grade 2 according to BARC criteria) one-year after randomisation. TROPICAL-ACS is the first large-scale, randomised controlled trial assessing the clinical value of a PFT-guided de-escalation of antiplatelet treatment in biomarker positive ACS patients undergoing PCI.

Risk factors for carotid artery disease in patients scheduled for coronary artery bypass grafting.

BACKGROUND: Carotid artery disease is thought to be a risk factor for neurological complications after cardiac surgery. Routine ultrasonographic screening is still not performed in every patient scheduled for coronary artery bypass grafting (CABG). AIM: To assess factors which may facilitate the selection for elective carotid artery ultrasound examination in patients undergoing CABG. METHODS: 682 patients (mean age 63.2 +/- 8.7, range: 37-85 years) scheduled for CABG underwent preoperative duplex ultrasound examination of the carotid arteries. The following factors were collected and analysed: age, sex, LVEF, history of cerebrovascular accidents (stroke and/or TIA), myocardial infarction, and presence of hypertension, diabetes, unstable angina, chronic obstructive pulmonary disease, chronic kidney disease, left main stenosis > or = 50%, lower-extremity peripheral arterial disease, and obesity (BMI > 30 kg/m(2)). Logistic regression analysis was used to determine the risk factors for carotid artery stenosis. RESULTS: Internal or common carotid artery stenosis > or = 50% was detected in 123 (18%) patients. Bilateral stenosis occurred in 35 (5.1%) patients, of whom 29 (4.5%) presented at least a monolateral vessel diameter reduction of > or= 70%. History of cerebrovascular accidents, presence of lower-extremity peripheral arterial disease, and unstable angina were independent risk factors for at least monolateral vessel diameter reduction > or = 50%. Although older age was also an independent predictor (Exp(B) = 1.035, p < 0.05), the ROC curve analysis did not reveal an age threshold above which the probability of detecting carotid disease increases significantly with satisfying sensitivity and specificity. The predictors of bilateral stenosis (at least one of them > or = 70%) were a history of stroke, presence of left main disease, and lower-extremity peripheral arterial disease. CONCLUSIONS: Carotid disease is common in patients scheduled for CABG. Preoperative carotid artery ultrasound examination should be performed, regardless of age, in all patients with more advanced symptomatic atherosclerosis, such as a history of cerebrovascular accidents, presence of lower-extremity peripheral arterial disease, left main disease, or unstable angina.