Rate Of Major Adverse Cardiac Events Research Articles

Prognostic Value of Microvascular Resistance Reserve Measured Immediately After PCI in Stable Coronary Artery Disease.

Microvascular resistance reserve (MRR) has been proposed as a specific metric to quantify coronary microvascular function. The long-term prognostic value of MRR measured in stable patients immediately after percutaneous coronary intervention (PCI) is unknown. This study sought to determine the prognostic value of MRR measured immediately after PCI in patients with stable coronary artery disease. This study included 502 patients with stable coronary artery disease who underwent elective PCI and coronary physiological measurements, including pressure and flow estimation using a bolus thermodilution method after PCI. MRR was calculated as coronary flow reserve divided by fractional flow reserve times the ratio of mean aortic pressure at rest to that at maximal hyperemia induced by hyperemic agents. An abnormal MRR was defined as ≤2.5. Major adverse cardiac events (MACEs) were defined as a composite of all-cause mortality, any myocardial infarction, and target-vessel revascularization. During a median follow-up of 3.4 years, the cumulative MACE rate was significantly higher in the abnormal MRR group (12.5 versus 8.3 per 100 patient-years; hazard ratio 1.53 [95% CI, 1.10-2.11]; P<0.001). A higher all-cause mortality rate primarily drove this difference. On multivariable analysis, a higher MRR value was independently associated with lower MACE and lower mortality. When comparing 4 subgroups according to MRR and the index of microcirculatory resistance, patients with both abnormal MRR and index of microcirculatory resistance (≥25) had the highest MACE rate. An abnormal MRR measured immediately after PCI in patients with stable coronary artery disease is an independent predictor of MACE, particularly all-cause mortality.

Long-term lipoprotein apheresis reduces cardiovascular events in high-risk patients with isolated lipoprotein(a) elevation

BACKGROUNDElevated lipoprotein(a) (Lp(a)) is an established risk factor for cardiovascular disease (CVD). To date, the only approved treatment to lower Lp(a) is lipoprotein apheresis (LA). Previous studies have demonstrated that LA is effective in reducing cardiovascular (CV) risk in patients with elevated low-density lipoprotein cholesterol (LDL-C) and/or Lp(a). Here we report our long-term experience with LA and its effectiveness in reducing CVD events in patients with elevated Lp(a). METHODSThis retrospective open-label, single-center study included 25 individuals with Lp(a) elevation >60 mg/dL and LDL-C <2.59 mmol/L who had indication for LA. The primary endpoint of this study was the incidence of any CV event (determined by medical records) after initiation of LA. RESULTSMean LA treatment duration was 7.1 years (min-max: 1-19 years). Median Lp(a) was reduced from 95.0 to 31.1 mg/dL after LA (-67.3%, p<0.0001). Mean LDL-C was reduced from 1.85 to 0.76 mmol/L after LA (-58.9%, p<0.0001). Prior LA, 81 CV events occurred in total (0.87 events/patient/year). During LA, 49 CV events occurred in total (0.24 events/patient/year; -0.63, p=0.001). Yearly major adverse cardiac event (MACE) rate was reduced from 0.34 to 0.006 (-0.33, p=0.0002). Similar results were obtained when considering only individuals with baseline LDL-C below 1.42 mmol/L. CONCLUSIONIn this observational study of a heterogeneous CV high-risk cohort with elevated Lp(a), LA reduced Lp(a) levels and was paralleled by a decrease in CV events and MACE. We recommend LA for patients with high Lp(a) who still have CV events despite optimal lipid-lowering medication and lifestyle changes.

Comparing long-term outcomes of septal myectomy and mitral valve replacement in hypertrophic cardiomyopathy patients: A retrospective cohort study in Iran.

Hypertrophic cardiomyopathy (HCM) affects millions of individuals worldwide. In severe cases, it can cause life-threatening conditions such as left ventricular outflow tract (LVOT) obstruction, mitral regurgitation (MR), and sudden cardiac death, making surgical treatment necessary. This study aimed to report the long-term outcomes of HCM patients undergoing septal myectomy or mitral valve replacement (MVR) and compare the results between different types of surgeries. This was a retrospective cohort study on HCM patients who underwent surgical treatment in an Iranian referral center between 2005 and 2021. Patients were divided into three groups according to the type of surgery received: septal myectomy, MVR, or a combination of both surgeries. Patient characteristics, surgical and echocardiographic features, and in-hospital and long-term outcomes were reported and compared between the three groups. A total of 102 patients with an average age of 53.3 ± 16.9 were included. Twenty-six patients had septal myectomy, 23 had MVR, and 53 had combined septal myectomy and MVR surgery. All surgeries were associated with a significant reduction in interventricular septum thickness and LVOT gradients. After a median of 6.8-year follow-up time, patients with an isolated septal myectomy had significantly lower mortality and major adverse cardiac and cerebrovascular events rates than the other groups. Isolated septal myectomy showed better long-term survival rates and can correct HCM-related MR, while MVR should be preserved only for intrinsic valve defects. More extensive studies are needed to confirm these findings and achieve a comprehensive guideline on surgical treatment of HCM.

Assessment of fitness for open repair in patients with infrarenal abdominal aortic aneurysms

Endovascular aortic repair (EVAR) was originally designed as a treatment modality for patients with abdominal aortic aneurysms (AAAs) deemed unfit for open repair. However, the definition of "unfit for open repair" is largely subjective and heterogenous. The purpose of this study was to compare patients deemed unfit for open repair who underwent EVAR to a matched cohort who underwent open repair for infrarenal AAAs. The Vascular Quality Initiative (VQI) of the Society for Vascular Surgery (SVS) was queried for patients who underwent EVAR and open infrarenal AAA repair from 2003-2022. Patients that underwent EVAR were included if they were deemed unfit for open repair by the operating surgeon. EVAR patients deemed unfit because of a hostile abdomen were excluded. Patients in both the open and EVAR datasets were excluded if their repair was deemed non-elective or if they had prior aortic surgery. EVAR patients were matched to a cohort of open patients. The primary outcome for this study was one-year mortality. Secondary outcomes included 30-day mortality, major adverse cardiac events (MACE), pulmonary complications, non-home discharge, re-interventions, and 5-year survival. A total of 5,310 EVAR patients were identified who were deemed unfit for open repair. Of those, 3,028 (57.0%) EVAR patients were able to be matched 1:1 to a cohort of open patients. Open patients had higher rates of MACE (20.2% versus 4.4%, P<.001), pulmonary complications (12.8% versus 1.6%, P<.001), non-home discharges (28.5% versus 7.9%, P<.001), and 30-day mortality (4.5% versus 1.4%, P<.001). There were no differences in early survival but open repair had better middle and late survival compared to EVAR over the course of 5 years. A total of 74 (2.4%) EVAR patients had reinterventions during the study period. EVAR patients that required interventions had higher 1-year (40.5%% versus 7.3%, P<.001) and 5-year mortality (43.2% versus 14.1%, P<.001) compared to those that did not require re-interventions. EVAR patients who had reinterventions had higher 1-year (40.5% versus 6.3%, P<.001) and 5-year (43.2% versus 20.3%, P=.006) mortality compared to their matched open cohort. Patients undergoing EVAR for AAAs who are deemed unfit for open repair have better perioperative morbidity and mortality compared to open. However, patients who had an open repair had better middle and late survival over the course of 5 years. The categorization of unfitness for open surgery may be inaccurate and re-evaluation of this terminology/concept should be undertaken.

Prognostic Value of Mitral Annular Calcification in Liver Transplant Patients: Implication in Posttransplant Outcomes.

With the rise of metabolic diseases and aging in liver transplant (LT) candidates, mitral annular calcification (MAC) is more recognizable. Despite cardiovascular risk becoming a leading cause of mortality in LT recipients, the influence of MAC remains unexamined. This study investigates the prevalence, related factors, and impact of MAC on LT outcomes. We explored 4148 consecutive LT patients who underwent routine pretransplant echocardiography from 2008 to 2019. Multivariate logistic analysis and the tree-based Shapley additive explanation scores in machine learning were used to evaluate the significant and important related factors. The primary outcome was 30-d major adverse cardiac events (MACE), and the secondary outcome was a median of 5-y cumulative all-cause mortality. MAC was found in 123 (3.0%) patients. Significant and important related factors included age, alcoholic liver disease, chronic kidney disease, hyperuricemia, hypertension, and coronary artery disease. The MACE rate was higher in patients with MAC compared with those without MAC at 30 d (P < 0.001, adjusted hazard ratio 1.67; 95% confidence interval, 1.08-2.57). Patients with MAC had poorer cumulative overall survival probability compared with those without MAC (P = 0.0016; adjusted hazard ratio 1.47; 95% confidence interval, 1.01-2.15). Specifically, women with MAC had a poorer survival probability compared with men without MAC (65.0% versus 80.7%, P < 0.001) >10 y post-LT. The presence of MAC before LT was linked to increased 30-d MACE and lower long-term survival rates, especially in women. Identification and management of MAC and potential risk factors are crucial for improving post-LT survival.

Recovery Dynamics and Prognosis After Dialysis for Acute Kidney Injury

The interplay among baseline kidney function, severity of acute kidney disease (AKD), and post-AKD kidney function has significant associations with patient outcomes. However, a comprehensive understanding of how these factors are collectively associated with mortality, major adverse cardiac events (MACEs), and end-stage kidney disease (ESKD) in patients with dialysis-requiring acute kidney injury (AKI-D) is yet to be fully explored. To investigate the associations of baseline kidney function, AKD severity, and post-AKD kidney function with mortality, MACEs, and ESKD in patients with AKI-D. This nationwide, population-based cohort study of patients with AKI-D was conducted between January 1, 2015, and December 31, 2018, using data from various health care settings included in the Taiwan nationwide population-based cohort database. Data analysis was conducted from April 28, 2022, to June 30, 2023. Exposure to severe AKI and baseline and post-AKD kidney function. The primary outcomes were all-cause mortality and incident MACEs, and secondary outcomes were risks of permanent dialysis and readmission. A total of 6703 of 22 232 patients (mean [SD] age, 68.0 [14.7] years; 3846 [57.4%] male) with AKI-D with post-AKD kidney function follow-up and AKD stage data were enrolled. During a mean (SD) 1.2 (0.9) years of follow-up, the all-cause mortality rate was 28.3% (n = 1899), while the incidence rates of MACEs and ESKD were 11.1% (n = 746) and 16.7% (n = 1119), respectively. After adjusting for known covariates, both post-AKD kidney function and baseline kidney function, but not AKD severity, were independently associated with all-cause mortality, MACEs, ESKD, and readmission. Moreover, worse post-AKD kidney function correlated with progressive and significant increases in the risk of adverse outcomes. In this cohort study of patients with AKI-D, more than one-quarter of patients died after 1.2 years of follow-up. Baseline and post-AKD kidney functions serve as important factors associated with the long-term prognosis of patients with AKI-D. Therefore, concerted efforts to understand the transition from post-AKD to chronic kidney disease are crucial.

SYNERGY—Everolimus-Eluting Stent With a Bioabsorbable Polymer in ST-Elevation Myocardial Infarction: CLEAR SYNERGY OASIS-9 Registry

Our objective was to evaluate the clinical effectiveness of the SYNERGY stent in patients with ST elevation myocardial infarction (STEMI). The only drug eluting stent approved for treatment of STEMI by the FDA is the Taxus stent which is no longer commercially available, so further data are needed. The CLEAR SYNERGY stent registry was embedded into a larger randomized trial of patients with STEMI (N=7000), comparing colchicine vs. placebo and spironolactone vs. placebo. The primary outcome for the SYNERGY stent registry is major adverse cardiac events (MACE) as defined by cardiovascular death, recurrent MI, or unplanned ischemia driven target vessel revascularization (TVR) within 12 months. We estimated a MACE rate of 6.3% at 12 months after primary percutaneous coronary intervention (PPCI) for STEMI based on the TOTAL trial. Success was defined as upper bound of confidence interval (CI) to be less than the performance goal of 9.45%.Overall, 733 patients were enrolled from 8 countries with a mean age 60.2 years, 19% diabetes, 41.3% anterior MI and median door to balloon time of 72 minutes. The MACE rate was 4.8% (95% CI 3.2-6.3%) at 12 months which met the success criteria against performance goal of 9.45%. The rates of cardiovascular death, recurrent MI or TVR were 2.7%, 1.9%, 1.0% respectively. The rates of acute definite stent thrombosis were 0.3%, subacute 0.4%, late 0.4% and cumulative stent thrombosis of 1.1% at 12 months. In conclusion, the SYNERGY stent in STEMI performed well and was successful compared to the performance goal based on prior trials.Trial Registration: ClinicalTrials.gov Identifier: NCT03048825

Impact of atrial fibrillation on 1-year outcome in patients with implantable cardioverter defibrillator or cardiac resynchronization therapy with defibrillator: results from the German DEVICE Registry.

Atrial fibrillation (AF) is a cardiac arrhythmia frequently documented in patients requiring implantable cardioverter defibrillators (ICDs) and/or cardiac resynchronization therapy with defibrillator (CRT-D). Patients with diagnosed AF at the point of ICD or CRT-D implantation may have an impaired follow-up outcome. The German DEVICE I-II registry is a nationwide prospective multicentre database of patients implanted with ICD and CRT-D with clinical follow-up data. We analysed a 1-year follow up of implanted patients with AF and with sinus rhythm (SR). A total of 4,929 ICD/CRT patients are included in the present analysis: 946 (19.2%) were in AF and 3,983 (80.8%) were SR at time of device implantation. AF patients had a significantly more comorbid profile including older age {72 [interquartile range (IQR), 66-77] vs. 66 (IQR, 56-73) years; P<0.001}, and higher rate of patients with left ventricular ejection fraction <30% (68.2% vs. 61.0%; P<0.001), peripheral artery disease (4.5% vs. 2.7%; P=0.002), diabetes (33.6% vs. 25.5%; P<0.001), hypertension (58.4% vs. 51.1%; P<0.001) and renal failure (22.6% vs. 15.3%; P<0.001). The intra-hospital complication rate was 4.3% in the AF and 3.6% in the SR group (P=0.38). In 1-year follow-up AF patients experienced a significantly higher rate of defibrillator shocks (25% vs. 15.3%; P<0.001). One-year estimated mortality was 10.8% in the AF and 5.9% in the SR group (P<0.001), while estimated 1-year major adverse cardiac and cerebrovascular events (MACCE) rate was 11.2% vs. 7.0% (P<0.001). The effects of AF on electrical shocks and mortality persisted after adjusting for age, sex, advanced New York Heart Association (NYHA) class, severely impaired left ventricular ejection fraction (LVEF), coronary artery disease (CAD), chronic obstructive pulmonary disease (COPD), diabetes mellitus (DM), chronic renal failure (CRF), QRS duration, and type of indication for electronic device implantation. Our clinical data on an extended cohort of contemporary patients confirm the significant impact of AF, and its associated comorbidities, upon mortality and major adverse events after implantation of ICD/CRT.

Clinical outcomes with biodegradable versus durable polymer drug-eluting stents in patients with ST-elevation myocardial infarction

BackgroundCoronary drug-eluting stents (DES) built with either durable (DP) or biodegradable (BP) polymeric coatings have been largely tested and are extensively available for routine use. However, their comparative performance remains an open question, particularly in more complex subsets of patients. AimsWe evaluated the outcomes of patients with ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI) using DP-DES versus BP-DES in a large multicenter real-world registry. MethodsThe population comprised patients with STEMI treated with pPCI within 12 h of symptoms onset. Those treated with more than one DES who received different polymer types were excluded. The final cohort for analysis was selected after propensity score matching (PSM), computed to generate similar groups of DP DES versus BP DES. Primary endpoint was the incidence of major adverse cardiac events (MACE), defined as the composite of total death, myocardial infarction and target lesion revascularization at 2 years. ResultsFrom January 2017 to April 2022, a total of 1527 STEMI patients underwent pPCI with a single DES type (587 DP-DES; 940 BP-DES). After PSM, 836 patients (418 patients in the DP-DES and 418 patients in the BP-DES groups), comprised the final study population. Both study groups had a similar baseline profile. Patients treated with BP-DES group had similar rates of MACE (15.3 % vs. 19.4 %, HR 0.69, 95 % CI 0.50–0.94, p = 0.022). Rates of target lesion revascularization was lower in BP DES group (0.7 % vs. 3.8 %, HR 0.17, 95 % CI 0.05–0.51, p = 0.006). ConclusionIn a cohort of STEMI patients submitted to pPCI, BP and DP DES had similar rates of the primary outcome. Patients treated with BP DES, however, had a decreased incidence of TLR at after 2-year follow-up.

Racial disparities in chronic total occlusion percutaneous coronary interventions: insights from the PROGRESS-CTO registry.

There is limited data on race and outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). The authors sought to evaluate CTO PCI techniques and outcomes in different racial groups. We examined the baseline characteristics and procedural outcomes of 11 806 CTO PCIs performed at 44 US and non-US centers between 2012 and March 2023. In-hospital major adverse cardiac events (MACE) included death, myocardial infarction, repeat target-vessel revascularization, pericardiocentesis, cardiac surgery, and stroke prior to discharge. The most common racial group was White (84.5%), followed by Black (5.7%), "Other" (3.9%), Hispanic (2.9%), Asian (2.4%), and Native American (0.7%). There were significant differences in the baseline characteristics between different racial groups. When compared with non-White patients, the retrograde approach and antegrade dissection re-entry were more likely to be the successful crossing strategies in White patients without any significant differences in technical success (86.4% vs 86.4%; P = .93), procedural success (84.8% vs 85.0%; P = .79), and in-hospital MACE (2.0% vs 1.5%; P = .15) between the 2 groups. The technical success rate was significantly higher in the "Other" racial group (91.0% vs 86.4% in White, 86.9% in Asian, 84.5% in Black, 84.5% in Hispanic, and 83.3% in Native American; P = .03) without any significant differences in procedural success or in-hospital MACE rates between the groups. Despite differences in baseline characteristics and procedural techniques, the procedural success and in-hospital MACE of CTO PCI were not significantly different between most racial groups.

The Impact of the Neutrophil-to-Lymphocyte Ratio on In-Hospital Outcomes in Patients With Acute ST-Segment Elevation Myocardial Infarction.

Introduction The neutrophil-to-lymphocyte ratio (NLR) is a significant predictor of cardiovascular diseases, influencing their progression and prognosis. The exact role of the NLR in acute ST-segment elevation myocardial infarction (STEMI) is unclear. We investigated the possible association between peak NLR values within the first three days after STEMI onset and in-hospital outcomes in patients undergoing primary percutaneous coronary intervention (PCI). Methods This retrospective study included 641 patients who were diagnosed with acute STEMI and treated with primary PCI for 18 months at Dr. Siyami Ersek Hospital. The NLR was calculated using the maximum values obtained during the first three days after admission. The patients were divided into quartiles according to their NLR values for further analysis of potential complications during and after hospitalization, up to a follow-up period of three months. Results Significant differences were found in factors such as age, body mass index (BMI), and length of hospital stay among these groups. Specifically, we found that in-hospital mortality rates were significantly higher in the Q4 group, and there were variations in target vessel revascularization (TVR) rates, major adverse cardiac events (MACE) rates, and other clinical outcomes. Some parameters, such as reinfarction rates and certain procedural outcomes, did not show significant differences among the groups. However, despite the differences, most of the patients achieved successful outcomes after PCI, with the best results in the low NLR group and the worst results in the high NLR group. Conclusion Higher NLR values were associated with a higher risk of unfavorable outcomes during hospitalization.

Early and Long-Term Clinical Outcomes of Ductal Stenting Versus Surgical Aortopulmonary Shunt Among Young Infants with Duct-Dependent Pulmonary Circulation.

Surgical aortopulmonary shunting (SAPS) and ductal stenting (DS) are the main palliations in infants with cyanotic congenital heart diseases (CHD). We aimed to study the safety and efficacy of DS and to compare it with SAPS as a palliative procedure in infants with CHD and duct-dependent pulmonary circulation. Retrospective institutional clinical data review of consecutive infants aged < 3months who underwent DS or SAPS over 5years. The primary outcome was procedural success which was defined as event-free survival (mortality, need for re-intervention, procedural failure) at 30days post-procedure. The secondary outcome was defined by a composite of death, major adverse cardiovascular events, or need for re-intervention at 6months and on long-term follow-up. We included 102 infants (DS, n = 53 and SAPS, n = 49). The median age at DS and SAPS was 4days (IQR 2.0-8.5) and 8days (IQR 4.0-39.0), respectively. The median weight at intervention was 3.0kg (IQR 3.0-3.0) and 3.0kg (IQR 2.5-3.0) in the two respective arms. Tetralogy of Fallot with pulmonary atresia was the most common indication for DS and SAPS. The 30-day mortality was significantly higher in SAPS group as compared with DS group (p < 0.05). However, 30-day major adverse cardiac events (MACE) rates were similar in both groups (p = 0.29). DS was associated with shorter duration of mechanical ventilation, duration of stay in the intensive care and hospital stay than with SAPS. At 6months, there was no significant difference in terms of mortality or event-free survival. Long-term MACE-free survival was also comparable (p = 0.13). DS is an effective and safer alternative to SAPS in infants with duct-dependent pulmonary circulation, offering reduced procedure-related mortality and morbidity than SAPS. Careful study of ductal anatomy is crucial to procedural success. However, long-term outcomes are similar in both procedures.

Impact of diabetes mellitus on clinical outcomes after first episode in-stent restenosis PCI: Results from a large registry

BackgroundDiabetes mellitus (DM) is associated with a high rate of major adverse cardiac events (MACE) after de novo coronary artery percutaneous coronary intervention (PCI). Whether patients with DM undergoing PCI for in-stent restenosis (ISR) experience a similar heightened risk of MACE is not known. Hence, we sought to compare the clinical outcomes of patients with and without DM undergoing PCI for ISR. MethodsPatients undergoing first episode ISR PCI between January 2015 and December 2021 were included. The primary outcome of interest was MACE (all-cause death, myocardial infarction [MI], and target lesion revascularization [TVR]) at 1-year. ResultsA total of 3156 patients (56.7% with DM) underwent PCI for ISR during the study period. Patients with DM were younger, more likely to be female, and had a higher prevalence of comorbidities.At 1-year follow-up, DM was associated with a higher rate of MACE (22.4% vs. 18.7%, unadjusted HR 2.03, 95%CI(1.27–3.25), p = 0.003). All-cause mortality and MI were significantly more frequent among people with DM at 1-year follow-up. The rate of TVR was similar in both groups (17.9% vs. 16.0%, unadjusted HR 1.14, 95%CI (0.94–1.37), p = 0.180). On adjusted analysis, there was no significant difference in the rate of MACE (AHR 1.07, 95%CI(0.90 ‐ –1.29), p = 0.444), all-cause death (AHR 1.54, 95%CI(0.93–2.54), p = 0.095) or MI (AHR 1.10, 95%CI(0.74–1.63), p = 0.652). ConclusionISR PCI in patients with DM was associated with a higher rate of MACE at 1-year follow-up. However, this increased risk was no longer significant after adjusting for baseline characteristics.

(327) Adverse Event Reporting in Testosterone Therapy Randomized Controlled Trials (RCT)

Abstract Introduction Testosterone (T) therapy (TTH) is associated with well recognized adverse events (AEs) such as: polycythemia (PCT), major adverse cardiac events (MACE), gynecomastia (GYN), worsening obstructive sleep apnea (OSA). Objective We aimed to critically analyze published TTH RCTs with regard to how well TTH AEs were reported. Methods A literature review was performed of all TTH RCTs listed on PUBMED that had been published between 1997-2021. We describe sample size, trial duration, industry funding, T assay used, baseline and on-treatment total and free T, TTH modality, and mean follow-up during the RCTs. We also describe the reporting of PCT, GYN, MACE, OSA and the definitions used in these RCTs. Results 29 trials were reviewed (Table 1), 55% reported on transdermal T, 41% intramuscular T, 7% enclomiphene, 7% human chorionic gonadotropin and 7% other oral treatments (aromatase inhibitor, tamoxifen). 17% compared two TTH modalities. Median sample size was 73 [41, 189]. Median age was 63 [58, 67] years. Median follow-up in the RCT reported was 8 [6, 12] months. 55% had the support of pharmaceutical companies. The total T (TT) assay used was immunoassay (IA 59%), LCMS (24%), other (10%), while 7% did not report on the assay type, and only 55% reported free T level (79% calculate by Vermeulen formula, and 21% equilibrium dialysis). Median baseline TT level was 248 [227, 320] ng/dL; on TTH it was 528 [460, 621] ng/dL. Median baseline free T level was 5.4 [5, 6.3] ng/dL, on TTH it was 11.1 [9.3, 15.5] ng/dL. 83% measured HCT levels at any point, only 21% reported baseline levels, 24% reported post treatment. Median baseline HCT 43 [42, 46]%, post-TTH median HCT increase of 2.4[-2.5, +3]%. 52% reported on PCT rates (45% defined HCT &amp;gt;52%, 7% HB &amp;gt;17 g/dL). Median PCT rate was 2%, none mentioned phlebotomy. 17% of RCTs reported on GYN, with a median rate of 1.5%, while none mentioned GYN grade or if mammography had been performed. 17% of trials mentioned MACE, but only 2 defined MACE. Median MACE rate was 2%. 10% reported OSA, but none mentioned the type of assessment; the median rate was OSA 2%. Conclusions This analysis showed that the majority TTH RCTs have sub-optimal reporting of TTH safety. Disclosure No.

Prognostic impact of peripheral artery disease in patients with and without high bleeding risk undergoing percutaneous coronary intervention.

Peripheral artery disease (PAD) is associated with worse outcomes after percutaneous coronary intervention (PCI). The aim of this study was to assess the prognostic impact of PAD according to high bleeding risk (HBR) status. Consecutive patients undergoing PCI with drug-eluting stent implantation at a tertiary-care center (Mount Sinai Hospital) between 2012 and 2019 were stratified according to HBR and PAD status. The primary outcome was major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI), and stroke 1 year after PCI. Secondary outcomes included major bleeding. Out of 16,750 patients, 43% were HBR and 57% were no-HBR. Within the two groups, PAD patients were 14% and 6%, respectively, and were more likely to have comorbidities and to undergo complex PCI than no-PAD patients. Within the HBR group, PAD was associated with an increased risk of MACE (11.4% vs. 7.3%, hazard ratio [HR]: 1.59, 95% confidence interval [CI]: 1.27-1.99, p < 0.001) and a numerical nonsignificant increase of major bleeding (8.5% vs. 6.9%, HR: 1.25, 95% CI: 0.98-1.59, p = 0.066) as compared with no-PAD. Among no-HBR patients, rates of MACE and major bleeding were numerically but not significantly higher in the PAD group. After multivariable adjustment, PAD was no longer a predictor of adverse outcomes, irrespective of HBR status. At 1-year after PCI, PAD was associated with increased 1-year risks of MACE in HBR patients. After adjustment for cardiovascular risk factors and comorbidities, the effect of PAD on adverse events was largely attenuated.

Three-Year Cardiovascular Outcomes of Telmisartan in Patients with Hypertension: An Electronic Health Record-Based Cohort Study.

Telmisartan exhibits superior efficacy in controlling 24-hour blood pressure (BP) compared with other angiotensin receptor blockers (ARBs). However, data on its cardiovascular effects in patients with hypertension are limited. This study aimed to evaluate the cardiovascular outcomes in patients taking telmisartan compared to those taking other ARBs. This multicenter retrospective study used data from the Korea University Medical Center database, built from electronic health records. A total of 19,247 patients taking two or more antihypertensive medications were identified. Patients prescribed telmisartan (telmisartan users) were compared with those prescribed an ARB other than telmisartan (other ARB users). The primary outcome was major adverse cardiac events (MACE), a composite of cardiovascular death, myocardial infarction, stroke, and hospitalizations due to heart failure. The adjusted outcomes were compared using 1:1 propensity score (PS) matching. Overall, 3,437 (17.9%) patients were telmisartan users. These patients were more likely to be younger and male and less likely to have a history of chronic kidney disease, dialysis, or heart failure. In the PS-matched cohort, BP control was similar in both groups; however, telmisartan users exhibited significantly lower visit-to-visit BP variability. The adjusted 3-year MACE rate was similar between telmisartan users (4.6%) and other ARB users (4.7%, log-rank p = 0.75), with comparable safety profiles. In real-world practice, telmisartan showed cardiovascular outcomes similar to those of other ARBs in patients with hypertension taking two or more antihypertensive drugs.

Complete Coronary Revascularization and Outcomes in Patients Who Underwent Coronary Artery Bypass Grafting: Insights from The REGROUP Trial

There is growing evidence in support of coronary complete revascularization (CR). Nonetheless, there is no universally accepted definition of CR in patients who undergo coronary bypass grafting surgery (CABG). We sought to investigate the outcomes of CR, defined as surgical revascularization of any territory supplied by a suitable coronary artery with ≥50% stenosis. We performed a preplanned subanalysis in the Randomized Trial of Endoscopic or Open Saphenous Vein Graft Harvesting (REGROUP) clinical trial cohort. Of 1,147 patients who underwent CABG, 810 (70.6%) received CR. The primary outcome was a composite of major adverse cardiac events (MACEs), including death from any cause, nonfatal myocardial infarction, or repeat revascularization over a median 4.7 years of follow-up. MACE occurred in 175 patients (21.6%) in the CR group and 86 patients (25.5%) in the incomplete revascularization (IR) group (hazard ratio [HR] 0.87, 95% confidence interval [CI] 0.67 to 1.13, p = 0.29). A total of 97 patients (12.0%) in the CR group and 48 patients (14.2%) in the IR group died (HR 0.93, 95% CI 0.65 to 1.32, p = 0.67); nonfatal myocardial infarction occurred in 49 patients (6.0%) in the CR group and 30 patients (8.9%) in the IR group (HR 0.76, 95% CI 0.48 to 1.2, p = 0.24), and repeat revascularization occurred in 62 patients (7.7%) in the CR group and 39 patients (11.6%) in the IR group (HR 0.64; 95% CI 0.42 to 0.95, p = 0.027). In conclusion, in patients with a great burden of co-morbidities who underwent CABG in the REGROUP trial over a median follow-up period of a median 4.7 years, CR was associated with similar MACE rates but a reduced risk of repeat revascularization. Longer-term follow-up is warranted.

Long-term results of percutaneous coronary intervention in no-touch vein grafts are significantly better than in conventional vein grafts.

Conventional vein grafts have a high risk of thrombosis and early atherosclerosis. Percutaneous coronary intervention (PCI) in conventional vein grafts is associated with a higher incidence of late adverse cardiac events. The aim of this study was to evaluate the long-term results after PCI in saphenous vein grafts (SVG) harvested with the no-touch technique compared to the conventional technique. This was a single-center, retrospective, cohort study, based on data from the Swedeheart register. The inclusion criterion was individuals who underwent CABG using different vein graft techniques between January 1992 and July 2020, and who required a PCI in SVGs between January 2006 and July 2020. The primary end point was long-term in-stent restenosis. The secondary endpoints were long-term major adverse cardiac events (MACE) and 1-year re-hospitalization rates. The associations between the graft types and the endpoints were evaluated using the Fine and Gray competing-risk regression analysis. The study included 346 individuals (67 no-touch, 279 conventional). The mean clinical follow-up time was 6.4years with a standard deviation of 3.7years. The long-term in-stent restenosis rate for the no-touch grafts was 3.2% compared to 18.7% for the conventional grafts (p < .01), with a subdistribution hazard ratio (SHR) of 0.16 (p = .010). The long-term MACE rate was 27.0% in the no-touch group and 48.3% in the conventional group (p < .01) with a SHR of 0.53 (p = .017). The short-term results were similar in both groups. Percutaneous coronary intervention in a no-touch vein graft was associated with statistically significantly fewer in-stent restenoses and MACE at long-term follow-up compared to a conventional SVG.

Off-pump minimally invasive coronary artery bypass grafting in patients with left ventricular dysfunction: the lampang experience.

The minimally invasive cardiac surgery off-pump coronary artery bypass (MICSOPCAB) is technically difficult; therefore, previous studies have indicated that MICSOPCAB should be contraindicated in patients with impaired left ventricular (LV) function. In this study, we investigated the feasibility of MICSOPCAB in patients with impaired LV function. The 226 patients underwent MICSOPCAB between August 2017 and September 2022. Our study defined impaired LV function as ejection fraction (EF) in echocardiography 40% or less. The patients were divided into Low EF group (n = 39) and Normal EF group (n = 187). The Low EF group was in a more critical preoperative condition than Normal EF group (41.0% in the Low EF group vs. 14.4% in the Normal EF group; p < 0.001). For preoperative transthoracic echocardiography, LV end-diastolic diameter (5.5 ± 0.9 cm in the Low EF group vs. 5.0 ± 0.8 cm in the Normal EF group; p < 0.001) and LV end-systolic diameter (4.4 ± 1.0 cm in the Low EF group vs. 3.4 ± 1.0 cm in the Normal EF group; p < 0.001) were significantly larger in the Low EF group. No differences were found in the operative time (180 [160-240] min in the Low EF group vs. 205 [165-253] min in the Normal EF group; p = 0.231) and the median number of distal anastomoses (2 [1-2] in the Low EF group vs. 2 [1-3] in the Normal EF group; p = 0.073). Intensive care unit stay was longer in the Low EF group than in the Normal EF group (2 [1-2] in the Low EF group vs. 1 [1-2] in the Normal EF group; p = 0.010). Perioperative transfusion was more common in the Low EF group than in the Normal EF group (69.7% vs. 49.2%; p = 0.023). There were no differences in major complications, hospital stay, and 30-day mortality. The Kaplan-Meier curve showed no significant difference in postoperative major adverse cardiac or cerebrovascular events rates between the two groups (p = 0.185). In this study, MICSOPCAB can be performed in patients with low EF having short- and mid-term outcomes similar to patients with normal EF. Therefore, low EF should not be contraindicated in MICSOPCAB.

Pre-hospital rule-out of non-ST-segment elevation acute coronary syndrome by a single troponin: final one-year outcomes of the ARTICA randomised trial.

The healthcare burden of acute chest pain is enormous. In the randomised ARTICA trial we showed that pre-hospital identification of low-risk patients and rule-out of non-ST-segment elevation acute coronary syndrome (NSTE-ACS) with point-of-care (POC) troponin measurement reduces 30-day healthcare costs with low major adverse cardiac events (MACE) incidence. Here we present the final one-year results of the ARTICA trial. Low-risk patients with suspected NSTE-ACS were randomised to pre-hospital rule-out with POC troponin measurement or emergency department (ED) transfer. Primary one-year outcome was healthcare costs. Secondary outcomes were safety, quality of life (QoL) and cost-effectiveness. Safety was defined as one-year MACE, consisting of ACS, unplanned revascularisation or all-cause death. QoL was measured with EuroQol-5D-5L questionnaires. Cost-effectiveness was defined as one-year healthcare costs difference per QoL difference. Follow-up was completed in all 863 patients. Healthcare costs were significantly lower in the pre-hospital strategy (€1932±€2784vs €2649±€2750), mean difference €717 (95% confidence interval [CI] €347 to €1087; P<0.001). In the total population, one-year MACE rate was comparable between groups (5.1% [22/434] in the pre-hospital strategy vs 4.2% [18/429] in the ED strategy; P=0.54). In the ruled-out ACS population, one-year MACE remained low (1.7% [7/419] vs 1.4% [6/417]), risk difference 0.2% (95% CI -1.4% to 1.9%; P=0.79). QoL showed no significant difference between strategies. Pre-hospital rule-out of NSTE-ACS with POC troponin testing in low-risk patients is cost-effective, expressed by a sustainable healthcare costs reduction and no significant effect on QoL. One-year MACE remained low for both strategies. Trial registration: Clinicaltrials.gov: NCT05466591, International Clinical Trials Registry Platform: NTR7346.