Rate Of Major Adverse Events Research Articles

Dapagliflozin versus empagliflozin and major adverse cardiovascular events in type 2 diabetes: a nationwide cohort study

Abstract Background Large randomized clinical trials have shown that sodium-glucose co-transporter-2 (SGLT2) inhibitors reduce the risk of adverse kidney and cardiovascular outcomes in patients with heart failure, chronic kidney disease, or type 2 diabetes mellitus (T2DM) at high risk of atherosclerotic cardiovascular disease. Whether these effects might differ between individual SGLT2-inhbitors remain unclear given the lack of head-to-head comparisons. Purpose To examine the association between treatment with dapagliflozin versus empagliflozin and the long-term rate of major adverse cardiovascular events (MACE) in patients with T2DM. Methods Using nationwide registries, all Danish residents with T2DM, who initiated treatment with dapagliflozin or empagliflozin from 2015 to 2020, were identified. Only treatment with dapagliflozin or empagliflozin was considered in the present analysis, since approximately 3% initiated treatment with other SGLT2-inhibitors (i.e., canagliflozin and ertugliflozin). Patients were followed from date of the first claimed prescription of dapagliflozin or empagliflozin until the outcome of interest, emigration, death, or end of study (December 31, 2021). The primary outcome was a composite endpoint of major adverse cardiovascular events (i.e., time to first heart failure hospitalisation, acute myocardial infarction (AMI), stroke, or all-cause mortality). The primary outcome was compared between the dapagliflozin and empagliflozin group, overall and in prespecified subgroups of interest, with multivariable Cox proportional hazards regression models. Results In total, 61,031 patients with T2DM initiated treatment with dapagliflozin (N=21,028; 34.5%) or empagliflozin (N=40,003; 65.5%). The median age of study population was 62.6 years (25th-75th percentile, 54.2-70.8 years), and 62.6% were men. There were no clinically significant differences between the dapagliflozin and empagliflozin group with respect to age, sex, and clinical characteristics. The median follow-up was 3.1 years (25th-75th percentile, 1.9-4.5 years). The adjusted long-term hazard ratios of the primary outcome, overall and in prespecified subgroups of interest, are displayed in the Figure. Compared with empagliflozin, treatment with dapagliflozin was not associated with a significantly different rate of the primary outcome (HR 1.02 [95% CI, 0.97-1.07]). The observed association was consistent across clinically relevant subgroups, including in patients with and without heart failure, chronic kidney disease, and atherosclerotic cardiovascular disease. Conclusion In a large, nationwide cohort of patients with T2DM, treatment with dapagliflozin was associated with a similar rate of major adverse cardiovascular outcomes compared with empagliflozin, and this association was consistent across clinically relevant subgroups. These findings suggest that the benefits of SGLT2-inhibitors can be characterized as a class-effect.

Prevalence of high-risk plaque features on cardiac computed tomography scans in patients with a coronary artery calcium score of zero

Abstract Introduction Coronary artery calcium (CAC) score of zero (so-called "power of zero") is associated with a very low rate of major adverse cardiac events (MACE), especially during short and midterm follow-up. However, a CAC score of zero does not definitively exclude the presence of atherosclerotic plaques or obstructive coronary artery disease (CAD). The composition of atherosclerotic plaques and the frequency of high-risk plaque features in this population are not well described. Purpose We sought to characterize the composition of atherosclerotic plaques and assess the frequency of high-risk plaque features on contrast-enhanced computed tomography (CT) images in patients with a zero CAC score. Methods The study enrolled patients with stable chest pain suspected of CAD referred for coronary CT imaging and having a CAC score of zero. Coronary CT angiography images were assessed by an expert reader to identify atherosclerotic plaques and high-risk plaque features in all coronary arteries with a diameter ≥1.5mm. The coronary artery lumen and plaques were manually segmented, and the degree of stenosis was evaluated following the Coronary Artery Disease Reporting and Data System (CAD-RADS) criteria. The presence of four high-risk plaque features was identified: positive remodeling, spotty calcification, low-attenuation plaque, and napkin ring sign. Total plaque volume, percent atheroma volume, and plaque composition were quantified using dedicated software (Figure 1). Results A total of 145 patients (mean age 54.2±12.1 years, 35.9% males) were included in the analysis. At least one coronary artery plaque was identified in 30 individuals (20.7%). 22 (15.2%), 7 (4.8%), and 1 (0.7%) patients were categorized into CAD-RADS 1, CAD-RADS 2, and CAD-RADS 3 categories, respectively. Among 30 patients with any coronary artery plaque, at least one high-risk feature was found in 10 individuals (33.3%), while 3 individuals (10.0%) had two features. Positive remodeling was found in 7 (23.3%), spotty calcification in 3 (10.0%), low-attenuation plaque in 3 (10.0%), and napkin ring sign in 0 patients, respectively (Figure 1). The mean total plaque volume was 48.2±54.3mm³, and the mean percent atheroma volume was 1.2±0.8%. Total plaque volume comprised low-attenuation (0.4%), fibro-fatty (58.9%), fibrous (39.4%), and calcified (1.3%) plaque volumes. Notably, in 3 (10.0%) individuals, the presence of calcified plaque was identified, which on non-contrast CT images did not meet the Agatston criteria for the CAC score. Conclusions Our study demonstrates a significant prevalence of atherosclerotic plaques and high-risk plaque features in patients with a CAC score of zero. Specifically, one in every five study participants had identifiable atherosclerotic plaque, with one in every three of those exhibiting one or more high-risk plaque features. The prognostic significance of these findings warrants further evaluation in studies with longitudinal follow-up.

Plaque characteristics and long-term outcome of non-culprit plaque rupture in AMI patients

Abstract Background Non-culprit plaque rupture (PR) had widespread nature in patients with acute coronary syndrome, indicating generalized acute destabilization. However, morphological features and long-term outcomes of non-culprit PR in acute myocardial infarction (AMI) patients have not been systemically investigated. Objectives We aimed to investigate the pancoronary picture (plaque characteristics and location) and long-term outcomes of non-culprit PR in AMI patients. Methods From January 2017 to May 2019, 3757 non-culprit plaques were analyzed in 883 AMI patients treated by 3-vessel optical coherence tomography. Patients and lesions were divided into two groups based on the presence or absence of non-culprit PR. All patients enrolled were followed for up to four years. Results Non-culprit PR was found in 178 patients (20.2%) and 200 lesions (5.3%). Patients with non-culprit PR had a more non-culprit lesions (NCLs) (p < 0.001), diseased arteries (p < 0.001) and multi-vessel disease (p < 0.001) compared with patients without non-culprit PR, both in angiography and OCT analyses. In vulnerable plaque feature, non-culprit PR group had higher incidence of thin-cap fibroatheroma (TCFA) (p < 0.001; p < 0.001), minimal lumen area (MLA) < 3.5mm² (p = 0.004; p = 0.012), CLIMA-defined high-risk plaque (p < 0.001; p < 0.001), thrombus (p < 0.001; p < 0.001), lipid rich plaque (p < 0.001; p < 0.001), calcification (p < 0.001; p < 0.001), macrophage (p < 0.001; p < 0.001), microchannel (p < 0.001; p < 0.001), cholesterol crystals (p < 0.001; p < 0.001), and layered tissue (p < 0.001; p < 0.001) compared with the other group, in patient and lesion level. In addition, non-culprit PR was highly populated at "hot spots" in the right coronary artery (56.5% vs. 40.2%; p < 0.001), and the originally treated culprit artery (33.5% vs. 25.2%; p = 0.008), and tended to cluster proximal to the coronary ostium [26.1 (15.5-38.0) vs. 29.4 (15.8-44.5); p = 0.009]. Multivariate analysis identified the NCL in the initially treated culprit artery (odds ratio [OR]: 1.874, 95% confidence interval [CI]: 1.230–2.857, p = 0.003), distance from coronary ostium to MLA site (OR: 0.987, 95% CI: 0.978–0.997, p = 0.008), mean lipid arc (OR: 1.006, 95% CI: 1.003–1.010, p = 0.001), TCFA (OR: 15.870, 95% CI: 10.259–24.551, p < 0.001), thrombus (OR: 4.333, 95% CI: 2.346–8.003, p < 0.001), and microchannel (OR: 1.679, 95% CI: 1.136–2.482, p = 0.009) were independent predictors of non-culprit PR. Non-culprit PR showed higher 4-year rates of NCL-related major adverse cardiac events in the patient (14.0% vs. 5.1%; p = 0.001) and lesion (6.5% vs. 0.9%; p < 0.001) levels. Conclusions NCLs with non-culprit PR had a unique pancoronary picture (pancoronary vulnerability and "hot spots") and worse long-term outcomes in AMI patients.

Comparison of 600 mg VS 300 mg clopidogrel loading dose for patients with ischemic heart disease: a meta-analysis of randomized controlled trials

Abstract Background While a 600-mg loading dose (LD) of clopidogrel has demonstrated superior inhibition of platelet function compared to 300-mg LD, the clinical evidence supporting this superiority is limited. The debate centers on whether a higher clopidogrel LD regimen in primary percutaneous coronary intervention outperforms the standard 300 mg LD, with potential benefits being more pronounced in higher-risk patients. Balancing enhanced platelet inhibition to reduce ischemic events against the associated risk of increased bleeding remains a critical consideration in determining the optimal loading dose of clopidogrel for patients with ischemic heart disease. Purpose The objective of this meta-analysis is to validate current randomized trials that investigate the efficacy and safety of two clopidogrel loading regimens (600 mg vs 300 mg) in patients with ischemic heart disease treated with primary percutaneous coronary intervention. Method A systematic literature search for randomized controlled trials was performed comparing 600 mg with 300 mg LD of clopidogrel using PubMed, MEDLINE, Embase, Cochrane, Clinicaltrials.gov. and Herdin PH. Studies included those between 2010 - 2023 involving human subjects. The primary efficacy endpoint was a 1-month rate of major adverse cardiac event (MACE) and the primary safety outcome was bleeding adverse effects. Result Nine randomized control studies involving 29,827 patients were included in the efficacy analysis. Mean duration of follow-up was 30 days. Only 8 studies were eligible for safety analysis. Compared with standard LD clopidogrel, high LD significantly reduced incidence of overall MACE (OR:0.82, 95% CI:0.74-0.91, p=0.0002), nonfatal myocardial infarction (OR:0.56; 95% CI:0.32-0.99, p = 0.15) and target vessel revascularization (OR 0.63; 95% CI 0.41 to 0.95, p = 0.03 ), without significant difference in terms of cardiac death (OR:0.89; 95% CI:0.76-1.04, p=0.15) and stroke (OR 0.92; 95% CI 0.67 to 1.26, p = 0.61). However, major bleeding risk was higher in the 600 mg LD (1.9%; 261/13288) compared with 300 mg LD (2.4%; 328/13242) [OR:1.27; 95% CI:1.08-1.49, p=0.005] without significant difference in minor bleeding (OR:1.05; 95% CI:0.94-1.17, p=0.35). Conclusion The administration of 600 mg of clopidogrel LD reduces the overall risk of MACE with an associated increased risk of major bleeding in patients with ischemic heart disease undergoing primary percutaneous coronary intervention.MACE OUTCOMES

Exploring the long-term effects of dapagliflozin in patients with stable acute myocardial infarction and preserved ejection fraction through a propensity score matching study

Abstract Background and Aims The recent Emmy trial underscored notable improvements in cardiac structure and function among post-acute myocardial infarction (AMI) patients treated with Empagliflozin, compared to those receiving a placebo. However, limitations such as a small sample size and a short follow-up period hindered the assessment of potential differences in actual clinical events between the groups. Consequently, our study aimed to evaluate the long-term outcomes, survival rates, rates of major adverse cardiovascular events (MACE), and heart failure (HF) incidence in patients with preserved ejection fraction (EF) who experienced AMI and underwent successful percutaneous coronary intervention (PCI), comparing those who received early initiation of Dapagliflozin with those who did not. Methods Data from the Taipei Medical University Research Database in Taiwan identified 7,081 inpatients who met the criteria of AMI status post successful PCI, with a left ventricular ejection fraction (LVEF) greater than 50% and absence of clinical symptoms indicative of heart failure. Exclusion criteria included individuals with a pre-existing diagnosis of heart failure before the index AMI episode and those with an LVEF below 50%, resulting in the exclusion of 357 patients from our study. The study subjects were then divided into two groups: those treated with Dapagliflozin and those not treated with Dapagliflozin, with matching for age, diabetes mellitus, and chronic kidney disease in a 1:2 ratio. Results The cohort study included of 756 patients who met the criteria of this study, among whom 252 were Dapagliflozin users and 504 were not. Over a 7-year follow-up period, Kaplan-Meier survival analyses revealed a significant reduction in cardiovascular mortality and all-cause mortality among Dapagliflozin users compared to non-users (p < 0.01). However, no significant differences were observed in heart failure, recurrent AMI, or stroke during the follow-up. Multivariate Cox analysis indicated the use of Dapagliflozin (hazard ratio = 0.310, 95% confidence interval = 0.188-0.510, p < 0.001) and age of diagnosis (hazard ratio = 1.063, 95% confidence interval =1.045-1.081, p < 0.001) were both independent predictors of all cause death. Conclusions In patients with stabilized AMI, the use of Dapagliflozin was associated with a decreased risk of all-cause death, especially cardiovascular mortality. However, there were no significant differences observed in the rates of heart failure, recurrent AMI, or stroke over the seven-year follow-up period.Baseline characteristicsKaplan–Meier curves of all cause death

1-year outcomes of patients presenting with acute coronary syndromes in Western Cape, South Africa: findings from the PERFUSION ACS registry

Abstract Background Cardiovascular disease(CVD), particularly acute myocardial infarction(MI), has emerged as a public health challenge in South Africa(SA), however, there is a paucity of data regarding long-term clinical outcomes such as CVD mortality, heart failure, stroke and recurrence of MI in this region. Purpose To determine 1-year major adverse cardiac outcomes among individuals discharged alive following admission for troponin-positive Acute Coronary Syndromes(ACS) in Western Cape, SA. Methods Between February 2021 and May 2022, 838 adults(≥18 years) with a diagnosis of ACS were prospectively enrolled into the investigator-initiated, multi-center PrEsentation, Rationale, and impact of reperFUSION for Acute Coronary Syndromes (PERFUSION ACS) registry. Participants were enrolled at a tertiary-care referral center and four secondary-level healthcare facilities. Key data elements were measured at index admission, including baseline demographics, risk factors, clinical presentation, complications, laboratory tests, revascularization strategies, and discharge medication. Survivors at discharge provided consent for 30-day and 12-month telephonic evaluations for major adverse cardiovascular events(MACE), which were captured on a web-based system that was centrally managed and analyzed. Results Of 838 participants, 39% were female, one-third were <55 years of age, 76% had a history of smoking, 74% had hypertension, 58% had dyslipidemia, and 56% were obese. STEMI accounted for 51% of cases, with NSTEMI in 49%. Baseline data for the cohort, stratified into two categories of MI, are provided in Table 1. Median duration from symptom onset to hospital presentation was 10.42 (±15.26) hours, with a majority(80%) presenting first to a non-PCI-capable facility. Among STEMI cases, two-thirds received thrombolysis(65%), primarily with Streptokinase; 49% underwent angiography via a pharmacoinvasive strategy, and 3% received primary percutaneous coronary intervention(PCI). Overall, 57% of patients with NSTEMI were treated with an invasive approach. The one-year all-cause mortality was 21%, with 88% attributable to cardiovascular disease-related death. Cumulative MACE rate at one year was 57%. Event rates for the individual MACE components were 32% for heart failure, 19% for non-fatal MI, and 6% for non-fatal stroke. 6% of participants died in-hospital, while 30-day mortality was 9%. There were no significant differences in all-cause mortality between STEMI and NSTEMI at 1 year. Conclusion Troponin-positive ACS are associated with a high rate of 12-month mortality and non-fatal major adverse cardiac events in Western Cape, SA. The concerning registry findings emphasize the need to prioritize ischemic heart disease prevention and management, and highlight important gaps in care which can serve as targets for improvement throughout the country.PERFUSION: Table 1PERFUSION: All-cause mortality and MACE

A retrospective study on real world, 2-stent left main bifurcation PCI using DK crush technique with IVUS guidance - a single center experience

Abstract Objectives The aim of this study is to investigate clinical outcome of the IVUS guided 2-stent bifurcation strategy using DK crush technique performed in a complex Left Main (LM) bifurcation lesions defined according to DEFINITION study in our local setting. We seek to assess the composite endpoint of target vessel failure (TVF) at 9-12 months. Methods All patients underwent IVUS guided 2-stent Bifurcation PCI with DK crush technique for complex LM bifurcation lesions defined by the DEFINITION criteria performed in a heart institute from 1.1.2019 to 31.7.2023 were included..Patient baseline characteristics, post-procedural and 12-months follow-up outcomes including cardiac death,myocardial infarction (MI),rate of target vessel failure (TVF),rate of stent thrombosis (ST) and major adverse coronary event (MACE) were analysed.Exclusion criteria are patients age <18 years and previous stenting in the target vessel Results A total of 50 patients were included in this analysis. Mean age was 64.3±9.1 years with predominant males (n= 38, 76%).Majority were hypertensive (n=37, 74%) and diabetes mellitus accounted for 32 (64%) cases.Patients with pre-existing coronary artery disease were 39 (78%) cases. 40% presented with history of recent myocardial infarction (MI), 12% had new onset angina and 6% had heart failure. Pre-existing chronic renal failure (18%) and history of CVA (2%). Among chronic renal failure cases, 50% had eGFR <50 during index procedure.Additionally, previous PCI was performed in 22 cases (44%) and 2 previous CABG cases included (4%).Majority of the cases were performed as staged elective procedure ( n=45, 90%) and others were indicated for ACS ( n=5, 10%). Radial approach was predominantly preferred with 25 cases (50%), where additional 5 cases (10%) were converted to femoral approach due to severe radial spasm. Among these 50 cases, 1 case required additional PCI to CTO LAD and mid LCX, while 7 cases (14%) had calcified lesions requiring scoring / cutting balloons and atherectomy device utilization for adequate lesion preparation prior to bifurcation stenting.All 50 patients received combination of both aspirin and a P2Y12 inhibitors for 12 months. Follow up done at at 30-day, 60-days and 1 year after the index procedure.Clinical follow-up were available in 46 (92%) patients only.4 cases were lost to follow up due to logistic reasons. At 1 year follow-up, cardiac death occurred in 5 (10.9%) patients, out of which 3 (6.5%) cases were cardiac related and 2 (4.4%) are non-cardiac. Major adverse cardiac events (MACE) and target vessel failure (TVF) occurred in total 4 (8.7%) cases, where 3 (6.5%) cases resulted in cardiac death and 1 (2.2%) case had MI and clinically driven target lesion revascularization. Conclusion Our experience demonstrates that IVUS guided, upfront 2-stent Bifurcation PCI using DK crush technique for complex bifurcation lesions is effective and safe with a low MACE and TLR rate at 1 year follow-up.

Prognostic implication of computational angiography-derived fractional flow reserve in patients with non-obstructive coronary artery disease

Abstract Background Non-obstructive coronary artery disease (NOCAD) is proved to have high association with rate of major adverse cardiovascular events (MACE) in recent studies, yet risk stratification of symptomatic Non-Obstructive Coronary Artery Disease (NOCAD) patients remains uncertain. Objectives Our study assessed clinical value of single-vessel, multi-vessel, and three-vessel computational angiography-derived fractional flow reserve (caFFR) measurement in NOCAD patients. Methods We enrolled patients with ≤ 50% stenosis with a caFFR value ≥ 0.8 in all three coronary arteries on coronary angiography. The sum of caFFR values in the three vessels was computed for each patient. Patient stratification was based on median value of the following criteria: single vessel analysis, multi-vessel analysis, 3-vessel (3V) analysis. The primary endpoint of this study was major adverse cardiac events (MACE) at 5 years, defined as a composite of cardiac death, myocardial infarction, and ischemia-driven revascularization. Results A total of 490 patients were included (mean age 64.39 ± 11.16, 55.5% male). The 5-year MACE rates in single-vessel analysis were statistically insignificant between low and high caFFR groups (Left anterior descending artery (P=0.163); Left circumflex artery (P=0.797); Right coronary artery (P=0.127)). In multi-vessel analysis, patients in multiple-vessel low-caFFR group (with 2-3 vessels lower than median value of all coronary arteries) show an increased risk of 5-year MACE than patients in single-vessel low-caFFR group (0-1 vessel) (hazard ratio [HR] 2.648, 95% confidence interval [CI] 1.141 - 6.145, P = 0.023). In 3-vessel analysis, patients in the low 3V-caFFR group demonstrated a greater 5-year MACE risk than the high 3V-caFFR group ([HR] 2.43, 95% 95%[CI] 1.087 - 5.433, P = 0.031). Conclusion In patients with NOCAD, the higher count of vessels exhibiting with low caFFR values and the low 3V-caFFR values have been found to be associated with increased rate of MACE over a 5-year period. We demonstrated that both multiple-vessel and 3V-caFFR measurements serve as valuable prognostic indicators for risk assessment in NOCAD patients.

Comparative characteristics and invasive management in patients with non-ST elevation acute coronary syndromes in two high-volume hospitals from Romania and Germany

Abstract Introduction Cardiovascular disease (CVD) carries the highest mortality burden across Europe, acute coronary syndromes (ACS) being responsible for most CVD-related deaths. However, significant regional differences in ACS management have been reported. Purpose To describe the characteristics and management of patients with higher-risk non-ST elevation ACS (NSTE-ACS) in 2 high-volume hospitals from 2 European countries with different prevalence of CVD and different income (Germany – GER and Romania – RO). Methods All consecutive invasively managed high and very-high risk NSTE-ACS patients admitted in 2022 in two high-volume hospitals from GER and RO were identified. Patient clinical profiles, coronary anatomy, revascularization strategies, and in-hospital outcomes were compared. Results were adjusted for age and gender. Results 707 patients (345 GER, 66.7% male; 362 RO, 71.5% male; p>0.05) were included. RO patients were younger (65.5 vs. 70.1 years), with higher rates of hypertension (88.7% vs. 82.0%), dyslipidemia (95.6% vs. 81.7%), diabetes (46.1% vs. 34.5%), and active smoking (37.3% vs. 23.5%) (all p<0.05); whereas GER patients had higher rates of atrial fibrillation (36.2% vs. 23.2%), chronic respiratory disease (24.6% vs. 10.5%), sleep apnoea (9.0% vs. 1.4%), thyroid disorders (24.1% vs. 6.4%), and prior revascularization by percutaneous coronary interventions (PCI) (36.5% vs. 20.2%) or coronary artery bypass grafting (CABG) (15.7% vs. 3.0%) (all p<0.05). Mean left ventricular ejection fraction (LVEF) was lower in the RO cohort (43.4% vs. 48%, p<0.001). Rates of myocardial infarction diagnosed by high-sensitivity troponin I assays (88.7% GER, 87.6% RO), and median diagnosis-to-cathlab intervals (12.8 hours GER, 15.5 hours RO) were similar (all p>0.05). In the obstructive coronary artery disease (CAD) group (80.3% GER, 84.3% RO), no differences were found in multivessel disease rates (67.1% GER, 69.8% RO) or mean SYNTAX score (18.6 GER, 16.9 RO) (all p>0.05). For type 1 NSTE-ACS (67% GER vs. 79% RO, p<0.001), PCI represented the main revascularization method (88.3% GER vs. 78.3% RO, p<0.05). Excluding patients with prior CABG undergoing PCI, complete revascularization (residual SYNTAX score ≤8), was reported in 77.1% GER and 84.4% RO of the PCI cases (p>0.05). Intravascular imaging was used in 28.4% of PCIs in GER, and in none in RO. In-hospital mortality (7.0% GER, 6.8% RO), and rates of major adverse cardiovascular events, defined as a composite of death, myocardial infarction, and stroke (8.1% GER, 9.1% RO), were similar (all p>0.05). Conclusions Higher-risk NSTE-ACS patient profiles mirror overall country CVD risk patterns. Compared to Germany, patients in Romania are younger, with a higher CVD risk factor burden, lower LVEF, underdiagnosis of major non-CVD comorbidities, and delayed CAD diagnosis. Despite similar guideline-directed management and in-hospital outcomes in both centres, these aspects may influence the long-term prognosis.

Primary Percutaneous Coronary Intervention in Multivessel Disease: Complete versus Culprit-only Revascularization

Objective: To compare the clinical outcomes of complete revascularization and culprit-only revascularization in patients with multivessel coronary artery disease (CAD) who presented with ST-segment elevation myocardial infarction (STEMI) at Hayatabad Medical Complex, Peshawar. Methodology: A prospective, randomized controlled trial was conducted, enrolling 400 patients with multivessel CAD. Patients were randomly assigned to either the complete revascularization group (n=200) or the culprit-only revascularization group (n=200). The primary outcomes assessed included cardiovascular death, reinfarction, and the need for repeat revascularization over a six-month follow-up period. Statistical analysis was performed using chi-square tests and Kaplan-Meier survival analysis. Results: Complete revascularization significantly reduced the rates of major adverse cardiovascular events compared to culprit-only revascularization. Cardiovascular death was lower in the complete revascularization group (4% vs 9%, p = 0.02), as was reinfarction (5% vs 11%, p = 0.01), and repeat revascularization (7% vs 15%, p = 0.004). Kaplan-Meier analysis showed a significant improvement in event-free survival in the complete revascularization group. Conclusion: Complete revascularization significantly improves clinical outcomes in patients with multivessel CAD presenting with STEMI, reducing cardiovascular death, reinfarction, and repeat revascularization. This study supports complete revascularization as a preferred treatment strategy in such patients to improve long-term outcomes. Keywords: coronary artery disease, STEMI, complete revascularization, culprit-only PCI, cardiovascular outcomes

The Use of Short Dilator Tip in Endovascular Branched Arch Repair: A Case Series.

The aim of the study was to investigate the safety and feasibility of branched endovascular arch repair (b-TEVAR) with a custom-made double or triple inner branched arch endograft using a short dilator tip (35 mm) in patients with aortic arch pathologies. Retrospective analysis of all consecutive patients undergoing b-TEVAR with a short dilator tip for the treatment of aortic arch pathologies in a high-volume tertiary center between January 2019 and July 2023. The combined primary endpoint was technical success and perioperative complications caused by the endograft, including tip-induced cardiac injury and trackability issues. Secondary endpoints were major adverse events (MAE), including morbidity, mortality, and reinterventions within 30 days. During a 4-year period, 22 patients (median age 72 years, 16 males) were treated with a custom-made double or triple inner-branched TEVAR for different aortic arch pathologies using a short dilator tip (35 mm). After initial exclusive treatment of patients with previous valve replacement, the use of a short dilator tip became standard. Eighteen patients received a triple- and 4 patients received a double-branched endograft. Seventeen patients (77.3%) underwent elective treatment, while 5 patients underwent urgent repair due to contained rupture or symptomatic aneurysms. The technical success was 100%. No tip-induced cardiac mortality and morbidity occurred perioperatively. The trackability of the device was in no case affected by the short tip. Within 30 days, the MAE rate was 45%, including one death. No re-intervention had to be performed. Endovascular aortic arch repair with inner-branched arch endografts using a short dilator tip (35 mm) appears to be safe and technically feasible and could potentially reduce the risk of fatal myocardial injuries. Due to safe and stable maneuverability and deployment of endograft in zone 0 the use of short dilator tip might have the potential to become standard in endovascular branched arch repair. This is one of the first reports on the use of short dilator tip and associated complications in endovascular branched arch repair.

Technical aspects of the new BYCROSSTM atherectomy device - preliminary results after 28 patients.

Purpose: Technical aspects are crucial for the planning and performing of the atherectomy to treat peripheral arterial disease. This report illustrates the use of a novel atherectomy device and investigates the feasibility, efficacy, and safety procedures involved in performing the atherectomy on 28 patients. We performed a prospective analysis of patients who underwent an atherectomy with the BYCROSSTM Atherectomy device between August 2022 and September 2023 at a tertiary referral centre. Patients with a lesion below the aortic bifurcation (vessel diameter ≥ 3mm) having a de novo or restenotic (stent-included) present were recruited. Major adverse events (MAE) are defined as amputation, death, myocardial infarction, or angiographic distal embolization that require a separate intervention. Of the 28 patients treated with the BYCROSS device, 23 were men with a mean age of 65.6 ± 9,6 years and a mean BMI of 24,6 ± 3.9 kg/m2. Most patients had a typical atherogenic risk profile as well as multiple preexisting comorbidities. In all patients, a symptomatic peripheral arterial disease (PAD) was the main reason for an intervention. The most common Rutherford category was 5 (12/28). The most common lesion region was the femoropopliteal segment (25/28) with 23 de novo stenosis. Mean lesion length was 218,0 ± 93,7 mm. The mean PACCS Score was 3,0 ± 1,0. Stenosis grade was by mean 99,3 ± 3,7%. Ankle Brachial Index (ABI) increased significantly after BYCROSS atherectomy (pre- 0,44 ± 0,43 vs. post-procedure 0,84 ± 0,30 P<0,001. Target lesion/vessel revascularization (TLR/TVR) within the first 30 days was 3,6% (1/28). 30-day MAE rate was 14,3% (vessel perforation in 3/28 patients, embolism in 1/28). There were no deaths, index limb amputations, or myocardial infarctions. The BYCROSSTM atherectomy system is a new device with numerous advantages in treating high-grade, calcifying stenosis and occlusion processes in PAD. Based on the above findings, the BYCROSSTM Atherectomy device represents a feasible, safe, and effective method for endovascular treatment of peripheral arterial disease.

Effects of Chronic Obstructive Pulmonary Disease on the Outcomes of Fenestrated-Branched Endovascular Aortic Aneurysm Repair.

Chronic obstructive pulmonary disease (COPD) is common in patients with aortic aneurysms. Severe COPD is associated with an increased risk of aneurysm rupture and perioperative complications. This study assesses the outcomes of COPD and non-COPD patients after fenestrated-branched endovascular aortic aneurysm repair (FBEVAR). A single institution, retrospective study of FBEVAR patients between 2011 and 2020 compared outcomes between COPD and non-COPD patients. COPD patients were stratified by Global Initiative for Chronic Obstructive Lung Disease criteria and oxygen dependence. Outcome measures included 30-day mortality, pulmonary complications, major adverse events (MAE), and mid-term survival. 387 patients (71% male, age 72 years, interquartile range [68-79]) underwent FBEVAR. 181 patients (47%) had COPD. Smoking history was more frequent in COPD patients (P = .022). Among COPD patients, 20.4% were oxygen-dependent. Technical success, defined as successful delivery of the main aortic endograft and all intended side branches, was 98.4%. 30-day mortality (P = .83) and MAE rates (P = .87) were similar between groups. While not statistically significant, COPD patients had more frequent pulmonary complications (6.1% vs. 2.4%, P = .13) and were more frequently discharged on oxygen (P = .002). There were no differences in intensive care unit or hospital length of stay between groups (P = .29; P = .85, respectively). 5-year survival was similar between groups (P = .10). Oxygen-dependent COPD and severe-very severe COPD were associated with decreased mid-term survival (Hazard Ratio 2.39, P = .048). FBEVAR is safe and effective for treating complex aortic pathology in COPD patients, including oxygen-dependent patients. Patients with more severe COPD were more frequently discharged on oxygen. Mid-term survival was slightly reduced in patients with oxygen-dependent and severe-very severe COPD. Level 3, non-randomized controlled cohort/follow-up study.

Outcome study of the Pipeline Vantage Embolization Device (second version) in unruptured (and ruptured) aneurysms (PEDVU(R) study)

BackgroundThe Pipeline Vantage Embolization Device (PEDV) is the fourth-generation pipeline flow diverter for intracranial aneurysm treatment. There are no outcome studies for the second PEDV version. We aimed to evaluate...

Low-Profile Minos TM Stent Graft System for Endovascular Abdominal Aorta Aneurysm Repair—Early and Late Outcomes in Elective and Emergent Situations

BackgroundThe aim of the study was to present the results of a novel abdominal stent graft for patients with Abdominal aortic aneurysm (AAA), through 2 years follow-up. MethodsA single-center retrospective review with prospectively collected data was performed to assess the safety and effectiveness of the Minos Abdominal stent device for treating abdominal aortic aneurysms. We estimated technical success rate, in-hospital and 30-day mortality, and mortality at the end of follow-up as well as complication and reintervention rate in our study cohort. Follow-up imaging assessments consisted of computed tomography angiography (CTA) at 1 and 6 months and yearly thereafter. ResultsA total of 52 patients (92% males; mean age, 74±6 years) were enrolled with Minos Abdominal stent device from July 2020 until September 2023. Thirty one (60%) patients were asymptomatic while 21 (40%) were symptomatic. The technical success of the endovascular aortic repair (EVAR) was 95% (49/52 patients). In 5% (3/52) of the cases, cannulation of the contralateral limb was unsuccessful and was converted to aorto-uni-iliac graft (AIU). Two (4%) aortic related death were recorded during the 30-day period. The major adverse event rate was 3.8%. The overall mean follow-up was 30±6 months; no aorta-related deaths or graft related complications were observed. Sac shrinkage (>5mm) has been observed in 70% of patients. ConclusionsMinos endoprosthesis seems to be safe, effective and durable for treating AAA either in elective or emergent situations.

Free-Cell Area Impact on Stroke Prevention in Asymptomatic Patients Undergoing Carotid Artery Stenting: The "Carotid Artery sTenting And CeLl-area Impact on Stroke and Major Adverse events" (CATACLISMA) Multicenter Registry.

The study investigated the association between cell-stent area and cerebrovascular events incidence in asymptomatic patients undergoing carotid artery stenting (CAS). This is an observational, retrospective, multicenter, cohort study. Between 2012 and 2022, all patients undergoing primary CAS for severe asymptomatic carotid artery stenosis were evaluated. Three groups were defined on the basis of the cell area (open cell, OC; closed cell, CC; double layer, DL). Periprocedural primary outcomes were 30-day stroke, mortality, myocardial infarction (MI), and major adverse event (MAE, stroke/mortality composite outcome) rates. Follow-up primary outcomes included overall survival, stroke-free survival (SFS), freedom from ipsilateral stroke (FFiS), and freedom from stroke-related mortality (FF-SRM). Data were analyzed at short-term (1 year) and mid-term (2.5 years) period. A total of 1096 CAS were considered (787 men, 71.8%, median age = 74 years). Technical success was achieved in 99.5% procedures. Periprocedural 30-day stroke rate was 1.5% (OC: 1.1%, CC: 2.3%, DL: 1%, p=0.27), mortality was 0.7% (OC: 1.1%, CC: 0.3%, DL: 0.5%, p=0.35), and no MI was recorded. The MAE rate was 2.1% (OC: 2%, CC: 2.6%, DL: 1.5%, p=0.66). Median follow-up was 46 months. At 1 and 2.5 years, estimated overall survival was 96.1% and 91% (p=0.41), SFS was 99.1% and 98.2% (p=0.007, CC stroke rates 2.9% and 4.2% at timepoints), FFiS was 99.4% and 99% (p=0.014, CC FFiS rates 1.7% and 2.6% at timepoints) and FF-SRM was 99.5% and 99% (p=0.28). During follow-up, no stroke events occurred in DL group. CC design showed higher rates of any (4.2%) and ipsilateral stroke (2.6%) within 2.5 years. In asymptomatic patients undergoing CAS, the contemporary overall stroke incidence is 1.5%. No statistical differences were observed in terms of 30-day stroke incidence among groups. The closed free-cell area showed higher rates of any and ipsilateral stroke within 2.5 years. The DL stents may offer the best available performances in terms of mid-term stroke prevention. The study analyzed the contemporary results of carotid artery stenting (CAS) focusing on the impact of cell-stent area on peri- and post-operative cerebrovascular events in a multicenter real-world experience. In asymptomatic patients undergoing CAS the contemporary overall stroke incidence is 1.5%. No statistical differences were observed in terms of 30-day stroke incidence among groups. The closed free-cell area showed higher rates of any and ipsilateral stroke within 2.5 years. DL stents may offer the best available performances in terms of mid-term stroke prevention.

Safety and efficacy assessment of the Inno-Xmart venous stent system in managing symptomatic iliofemoral venous obstruction: a 12-month outcome analysis.

This study aims to evaluate the safety and efficacy of the dedicated Inno-Xmart braided venous stent system (Suzhou Innomed Medical Device Co., Ltd., Jiangsu, China) in treating symptomatic iliofemoral venous obstruction. This clinical study followed a prospective, multicentre, single-arm design with the application of an objective performance goal. Patients diagnosed with symptomatic iliofemoral venous obstruction who met the eligibility criteria of this study were enrolled and treated with the Inno-Xmart venous stent system. The safety endpoints included the assessment of stent fracture, satisfaction of delivery system and 12-month incidence rate of major adverse events (MAEs). The primary efficacy endpoint focused on evaluating the 12-month primary patency rate through venography as determined by core laboratory. Secondary efficacy endpoints included surgical success rate, 6-month primary patency rate and the changes in quality of life from baseline to 6- and 12-month follow-up intervals. Between September 18, 2019, and April 26, 2021, 193 patients were successfully enrolled across 18 research institutions. The surgical success rate was 95.3% (184/193), the 12-month MAE rate was 5.1% (9/178) with no stent fractures or migrations. The 12-month primary patency rate for the participants was 96.1%, significantly surpassing the literature-derived objective performance of 80% (95% confidence interval [CI], 92.1-98.4; P < 0.0001). In addition, the mean venous clinical severity score (VCSS) and Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) scores at the 6- and 12-month follow-ups were significantly lower than the preoperative scores (P < 0.001). The innovative, dedicated braided venous stent designed to address symptomatic iliofemoral venous obstruction demonstrates a high technical success rate, low complication rates, and impressive mid-term (12-month) patency. It effectively enhanced the quality of life for patients and holds promising prospects for a wide range of applications. The clinical study was officially registered in the "Chinese Clinical Trial Registry" (Registration number: ChiCTR2000040216, date of registration: November 25th, 2020).

Transarterial Chemoembolization Combined with Microwave Ablation in Elderly Patients with Recurrent Medium or Large Hepatocellular Carcinoma.

There are insufficient data about the optimal treatment for older patients with recurring medium or large hepatocellular carcinoma (HCC). The study intended to assess the effect of transcatheter arterial chemoembolization combined with microwave ablation (TACE-MWA) in an elderly cohort through a retrospective analysis. From 2011 to 2018, a cohort of individuals (age ≥70 years) with recurrent HCC tumors ranging from 3.1 cm to 7 cm underwent either a combination treatment of TACE and MWA (n = 43) or surgical intervention (n = 33). Using the Inverse Probability of Treatment Weighting (IPTW) technique, factors of disease-free survival (DFS), overall survival (OS), and rates of major adverse events were analyzed, retrospectively. The group that underwent surgery had a greater history of alcohol use before treatment (P= 0.001), as well as a higher Barcelona Clinic Liver Cancer (BCLC) stage for the primary tumor before treatment (P= 0.014) and a higher primary tumor location before treatment (P= 0.045). The TACE-MWA group had DFS rates of 86.2%, 68.8%, and 60.4% at 1, 3, and 5 years, while the surgery group had rates of 53.0%, 42.2%, and 25.8% at the same time points. In the TACE-MWA treatment group, survival rates at 1 year, 3 years, and 5 years post-treatment were recorded as 93.0%, 80.8%, and 65.7%, respectively, while in the surgery group, they were 62.7%, 46.9%, and 42.6%. In the univariate analysis using IPTW, the type of treatment was found to have a significant correlation with disease progression (hazard ratio [HR] 0.41, 95% CI 0.20-0.86, P=0.017). IPTW multivariate analysis showed that treatment modality (HR, 0.35; 95% CI, 0.17 to 0.79; P= 0.011) was the only significant prognostic factor for OS. In elderly patients with recurrent 3.1 cm≤ HCC ≤ 7 cm, TACE-WMA was superior to surgery in the respects of DFS and OS.

Sarcopenia influences clinical outcome in hospitalized patients with peripheral artery disease aged 75 years and older

ObjectivesSarcopenia represents a relevant comorbidity in patients with peripheral artery disease (PAD). However, only few studies exist assessing the clinical burden of sarcopenia in PAD. MethodsAll hospitalizations of patients aged ≥75 years who were admitted due to PAD within 2005-2020 in Germany were included in the study and stratified for sarcopenia. Temporal trends and the impact of sarcopenia on treatment procedures as well as adverse in-hospital events were investigated. ResultsOverall, 1,166,848 hospitalization-cases of patients admitted due to PAD (median age 81.0 [78.0-85.0] years; 49.5% female sex) were included, of which 2109 (0.2%) were coded with sarcopenia. Prevalence of sarcopenia in these patients increased during the observational period from 0.05% in 2005 to 0.34% in 2020 (β 2.61 [95%CI 2.42 to 2.80], P<0.001). Sarcopenic PAD patients were more often female (52.1% vs. 49.5%, P=0.015), obese (6.6% vs. 5.5%, P=0.021) and revealed higher prevalences of comorbidities (Charlson comorbidity index, 7.00 [6.00-9.00] vs. 6.00 [5.00-7.00], P<0.001). Sarcopenia was associated with reduced usage of reperfusion treatments (endovascular intervention: OR 0.409 [95%CI 0.358-0.466], P<0.001; surgical revascularization: OR 0.705 [95%CI 0.617-0.805],P<0.001), but higher conduction of amputation (OR 1.365 [95%CI 1.231-1.514], P<0.001) and higher rates of major adverse cardiovascular and cerebrovascular events (OR 1.313 [95%CI 1.141-1.512], P<0.001) and in-hospital death (OR 1.229 [95%CI 1.052-1.436], P=0.009). ConclusionsSarcopenia is an under-recognized condition in PAD patients of high clinical relevance causing a crucial disease burden. Awareness of the ailment needs to be increased in daily clinical practice to identify sarcopenia and improve clinical outcome of this vulnerable patient group.

Geographical Differences in the Safety and Efficacy of Tofacitinib Versus TNFi: APost Hoc Analysis of ORAL Surveillance.

In ORAL Surveillance, incidence rates (IRs) of major adverse cardiovascular events (MACE) and malignancies (excluding non-melanoma skin cancer [NMSC]) in cardiovascular (CV)-risk-enriched patients with rheumatoid arthritis (RA) were numerically greater with tofacitinib in North America versus the rest of the world, due to underlying risk factors. Here, we evaluated the safety and efficacy of tofacitinib versus tumor necrosis factor inhibitors (TNFi) among patients with RA across geographical regions. Patients with RA in ORAL Surveillance (NCT02092467), who were aged ≥ 50years with ≥ 1additional CV risk factor, received tofacitinib 5 or 10mg twice daily or TNFi; 45.9% were from either Poland or North America. This post hoc analysis stratified patients by region (Poland, North America, Other countries). Efficacy endpoints included Clinical Disease Activity Index, Disease Activity Score in 28 joints, with C-reactive protein (DAS28-4[CRP]), and Health Assessment Questionnaire-Disability Index (HAQ-DI). IRs and hazard ratios for adverse events were reported. Of 4362 patients (Poland, N = 759; North America, N = 1243; Other countries, N = 2360), more patients from North America versus Poland/Other countries had CV risk factors such as body mass index ≥ 30kg/m2 and history of diabetes/hypertension; however, more patients from Poland versus other regions were ever smokers and more patients from Poland/North America versus Other countries had history of coronary artery disease. MACE IRs were similar in North America and Poland, and numerically higher versus Other countries. IRs for malignancies (excluding NMSC) were numerically higher in NorthAmerica versus Poland/Other countries with tofacitinib. Serious infections IRs werenumerically higher in North America versus Poland across treatments. Venousthromboembolism/all-cause mortality IRs were generally comparable across regions. DAS28-4(CRP)/HAQ-DI improvements were generally lowest in North America. Differences in safety outcomes were driven by the presence of baseline risk factors; North America and Poland demonstrated a higher proportion of patients with some baseline CV risk factors/comorbidities versus Other countries. NCT02092467 (ClinicalTrials.gov).