Differences In Baseline Risk Factors Research Articles

Abstract 92: Impacts of a Multidisciplinary Brain Heart Team on Patent Foramen Ovale Closure in Patients With Cryptogenic Stroke

Background: The AHA/ASA 2021 Secondary Stroke Prevention Guideline recommends a joint decision by neurology and cardiology for patent foramen ovale (PFO) closure. The impact of a Brain Heart Team (BHT) consisting of interventional cardiologists and vascular neurologists to evaluate PFO closure is unclear. We analyzed whether a BHT implementation led to more guideline recommended PFO closures based on Risk of Paradoxical Embolism (RoPE) score and PASCAL categories across a 15-hospital system. Methods: Data were collected retrospectively between 1/2016 - 2/2023. Baseline demographics, risk factors, method of shunt identification, high-risk shunt features, post PFO atrial fibrillation and stroke rates, RoPE score and PASCAL categorization were abstracted. Non-BHT was defined as absence of vascular neurology involvement. Appropriate PFO closure was defined as RoPE score > 7 and/or PASCAL categories of possible/probable. Chi-squared and t-test were used. Results: Of 174 patients, 108 (62%) were identified as BHT and 66 (38%) as non-BHT. There were no differences in baseline risk factors between BHT and non-BHT besides hyperlipidemia (28.7% vs 53% p < .002) and smoking history (12% vs 31.8% p < .003). BHT patients were younger at age of diagnosis and PFO closure (44.8 yrs ±1.7 vs 56 yrs ±1.2 p=0.003 and 44.7 yrs ±1.9 vs. 56 yrs ±1.3 p=0.004 respectively). There were differences in race/ethnicity (Table 1). More BHT patients had possible/probable PASCAL vs non-BHT (101 [93.5%] vs 44 [66.7%], p <0.001). Patients in BHT had higher mean RoPe scores (7.34 ± 1.55 vs 6.06 ± 2.02 p <0.001). More patients in BHT had a RoPE score > 7 (77 [71.3%] vs 26 [39.4%] p <0.001). There were no differences in atrial fibrillation (5 [4.6%] vs 5 [7.6%] p = 0.635) or stroke after PFO closure (2 [1.9%] vs 2 [3%] p = 1). Conclusion: Implementing a multi-disciplinary approach with a Brain Heart Team leads to more guideline based PFO closures in cryptogenic strokes based on PASCAL and RoPE scores.

Patient characteristics, management, and outcomes of acute myocardial infarction due to unprotected left main stem occlusion: insights from a real-world multicentre registry over a 12-year period

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Acute myocardial infarction (AMI) due to unprotected left main coronary artery (LMCA) occlusion is a potentially life-threatening disease. AMI management has evolved over the past two decades, and mortality has decreased considerably. Though, little information on patient characteristics, management, and mortality trends in the most recent years is available regarding acute unprotected LMCA occlusion. Purpose We aimed to assess trends in patient characteristics, management, and outcomes for acute myocardial infarction due to LMCA occlusion between 2008 and 2020. Methods We conducted a retrospective multicentre registry of patients with AMI with unprotected LMCA occlusion admitted in three tertiary hospitals between 2008 and 2020. Patients were divided according to timeline of presentation, and we sought to compare clinical characteristics, management, and outcomes between a past group (from January 2008 to December 2012) and a contemporary group (from January 2017 to December 2020). Results Of 128 patients with AMI from unprotected LMCA occlusion, 28 were included in the past group [from January 2008 to December 2012 (group 1)] and 48 were included in the contemporary group [from January 2017 to December 2020 (group 2)]. No statistically significant differences in baseline risk factors were found between the two groups, except for hypertension (50.0% in group 1 vs 75.0% in group 2, p=0.027). There was no difference regarding presentation with cardiogenic shock (57.1% vs 64.6%, p=0.520). Median symptom-to-balloon time was high but similar in both groups [180 min (120-300) vs 210 min (120-420), p=0.640]. Radial access was more frequent used in the contemporary group (33.0% vs 10.7%, p=0.028), as well as the administration of glycoprotein IIb/IIIa inhibitors (14.6% vs 12.0%, p=0.004) and the implantation of drug-eluting stents (100% vs 63.2%, p=0.010). The use of mechanical circulatory support device was surprisingly higher in group 1 (82% vs 46%, p=0.002), but the intra-aortic pump balloon (IABP) was the only device available in that group. In the contemporary group, the use of IABP, Impella device, and extracorporeal membrane oxygenation was 37.5%, 20.8%, and 2.1%, respectively. The second antiplatelet agent was also different between groups, with a higher percentage of ticagrelor loading in the contemporary group. In-hospital mortality (46.4% in group 1 vs. 54.2% in group 2, p=0.520) and 1-year cumulative mortality (60.7% vs 60.4%, p=0.741) were high in both groups, but no statistically significant difference was found in survival analysis (p=0.794; log-rank test). Conclusion In our real-world population, despite the use of newer drugs and more advanced devices being more common in the contemporary group, patients with AMI due to LMCA occlusion are still a subpopulation with poor prognosis. Innovative strategies are needed to make a difference.

Sex-Related Differences in Long-Term Outcomes After Early-Onset Myocardial Infarction

ImportanceThere is growing awareness of sex-related differences in cardiovascular risk profiles, but less is known about whether these extend to pre-menopausal females experiencing an early-onset myocardial infarction (MI), who may benefit from the protective effects of estrogen exposure.MethodsA nationwide study involving 125 Italian Coronary Care Units recruited 2,000 patients between 1998 and 2002 hospitalized for a type I myocardial infarction before the age of 45 years (male, n = 1,778 (88.9%). Patients were followed up for a median of 19.9 years (IQR 18.1–22.6). The primary composite endpoint was the occurrence of cardiovascular death, non-fatal myocardial re-infarction or non-fatal stroke, and the secondary endpoint of hospitalization for revascularisation by means of a percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG).ResultsST-elevation MI was the most frequent presentation among both men and women (85.1 vs. 87.4%, p = ns), but the men had a greater baseline coronary atherosclerotic burden (median Duke Coronary Artery Disease Index: 48 vs. 23; median Syntax score 9 vs. 7; both p < 0.001). The primary composite endpoint occurred less frequently among women (25.7% vs. 37.0%; adjusted hazard ratio: 0.69, 95% CI 0.52–0.91; p = 0.01) despite being less likely to receive treatment with most secondary prevention medications during follow up.ConclusionsThere are significant sex-related differences in baseline risk factors and outcomes among patients with early-onset MI: women present with a lower atherosclerotic disease burden and, although they are less frequently prescribed secondary prevention measures, experience better long-term outcomes.Trial Registration4272/98 Ospedale Niguarda, Ca' Granda 03/09/1998.

Sex Differences in Baseline Risk Factors for Asthma Between Early Adolescence and Young Adulthood.

Several studies have shown sex differences in the prevalence of asthma and an association with age. The aim of the present study was to prospectively investigate the development of asthma, wheeze, rhinitis, and allergic symptoms in adolescence and adulthood. We also aimed to determine whether sex modifies the association between baseline risk factors and incidence of asthma in early adulthood. In the Screening Project Asthma in Schools (SPAIS) study, adolescents aged 12-15 years completed a standardized respiratory questionnaire (International Study of Asthma and Allergies in Childhood) and underwent measurements of fractional exhaled nitric oxide (FeNO) and lung function (FEV1) at baseline. Two follow-up assessments with similar questionnaires were performed after 4 and 16 years, with a total of 491 participants in all 3 examinations. The prevalence of asthma and wheeze were unchanged after 4 years but had increased after 16 years. However, the increase was significant only for females. The prevalence of rhinitis and allergy symptoms increased steadily, albeit with no differences between the sexes. The sex interaction analysis showed that higher FeNO (P=.01) and a family history of asthma (P=.02) increased the risk of incident asthma for males but not for females. An increased prevalence of respiratory symptoms was seen primarily between late adolescence and young adulthood; the difference was significant for females but not for males. Allergic risk factors in early adolescence for incident asthma in early adulthood were confirmed in males but not in females. Awareness of these sex differences in the development of symptoms and of the associated risk factors is important in clinical practice.

Casirivimab-Imdevimab (REGN-COV2) for Mild to Moderate SARS-CoV-2 Infection in Kidney Transplant Recipients

Casirivimab-Imdevimab (REGN-COV2) for Mild to Moderate SARS-CoV-2 Infection in Kidney Transplant Recipients

Community Risk Factors in the COVID-19 Incidence and Mortality in Catalonia (Spain). A Population-Based Study.

The heterogenous distribution of both COVID-19 incidence and mortality in Catalonia (Spain) during the firsts moths of the pandemic suggests that differences in baseline risk factors across regions might play a relevant role in modulating the outcome of the pandemic. This paper investigates the associations between both COVID-19 incidence and mortality and air pollutant concentration levels, and screens the potential effect of the type of agri-food industry and the overall land use and cover (LULC) at area level. We used a main model with demographic, socioeconomic and comorbidity covariates highlighted in previous research as important predictors. This allowed us to take a glimpse of the independent effect of the explanatory variables when controlled for the main model covariates. Our findings are aligned with previous research showing that the baseline features of the regions in terms of general health status, pollutant concentration levels (here NO2 and PM10), type of agri-food industry, and type of land use and land cover have modulated the impact of COVID-19 at a regional scale. This study is among the first to explore the associations between COVID-19 and the type of agri-food industry and LULC data using a population-based approach. The results of this paper might serve as the basis to develop new research hypotheses using a more comprehensive approach, highlighting the inequalities of regions in terms of risk factors and their response to COVID-19, as well as fostering public policies towards more resilient and safer environments.

Outcomes in Women and Men in the First Year After Acute Myocardial Infarction (AMI) in 2019

Previous audits have demonstrated improving in-hospital and longer-term outcomes after AMI. It is not known if outcomes are equivalent in women and men. Retrospective audit of consecutive patients admitted with AMI between 1 October 2019 and 31 December 2019. Baseline characteristics, in-hospital treatments, discharge medications and 12-month outcomes were compared in women and men using hospital records. 175 eligible patients were admitted. 56 were women and 119 were men. There were trends to older age (median 68 vs 65 years), more current smokers (27% vs 22%) more hypertension (54% vs 51%) and more diabetes (21% vs 17%) in women compared with men. 84% of women and 96% on men received coronary angiography, and 64% and 77% were revascularised. Mean hospital stay was 4.2 and 4.9 days, in-hospital death was 4% in both groups. Discharge medications were similar except for beta-blockers in 81% of women and 91% on men. Aspirin was prescribed in 94% of women and 98% of men, clopidogrel or ticagrelor in 96% and 96%, ACE inhibitor/ARB in 81% and 76%, and lipid modifier in 93% and 96%. At 12 months, freedom from death or AMI was 89.3% and 89.1%, freedom from death, AMI or repeat revascularisation was 85.7% and 87.4%, and freedom from death, AMI, revascularisation or cardiac readmission was 76.8% and 75.6% in women and men, respectively. We have documented very similar 12-month outcomes in women and men after AMI despite small differences in baseline risk factors and in-hospital treatments.

Clinical features and outcomes of COVID-19 in patients with solid tumors: Turkish National Registry Data.

We present demographic, clinical, laboratory characteristics and outcomes of the patients with solid malignancies and novel coronavirus disease (COVID-19) collected from the National COVID-19 Registry of Turkey. A total of 1523 patients with a current or past diagnosis of solid tumors and diagnosed with COVID-19 (confirmed with PCR) between 11 March and 20 May 2020 were included. The primary outcome was 30-day mortality. Median age was 61 (range: 18-94), and 752 (49%) were male. The most common types of cancers were breast (19.8%), prostate (10.9%) and colorectal cancer (10.8%). 65% of the patients had at least one comorbidity. At least one COVID-19-directed therapy was given in 73% of the patients.. Hospitalization rate of the patients was 56.6% and intensive care unit admission rate was 11.4%. Seventy-seven (5.1%) patients died within 30 days of diagnosis. The first multivariate model which included only the demographic and clinical characteristics showed older age, male gender and presence of diabetes and receipt of cytotoxic therapy to be associated with increased 30-day mortality, while breast and prostate cancer diagnoses were associated with lower 30-day mortality. In the second set, we further included laboratory parameters. The presence of leukocytosis (OR 6.7, 95% CI 3.3-13.7, P < .001), lymphocytopenia (OR 3,1, 95% CI 1,6-6,1, P = .001) and thrombocytopenia (OR 3,4 95% CI 1,5-8,1, P = .005) were found to be associated with increased 30-day mortality. Relatively lower mortality compared to Western countries and China mainly results from differences in baseline risk factors but may also implicate the importance of intensive supportive care.

Racial Differences in Cause-Specific Mortality Between Community-Dwelling Older Black and White Adults.

To understand which causes of death are higher in black than white community-dwelling older adults and determine whether differences in baseline risk factors explain racial differences in mortality. Longitudinal cohort study (Health, Aging, and Body Composition Study). Pittsburgh, Pennsylvania; and Memphis, Tennessee. Black and white men and women aged 70 to 79 during recruitment (N=3,075; 48% men, 42% black) followed for a median of 13 years. A committee of physicians adjudicated cause of death, which was categorized as cardiovascular disease (CVD), stroke, cancer, dementia, pulmonary, infection, kidney, or other causes. Using competing risks regression, we examined whether known risk factors at baseline (demographic characteristics, smoking, body mass index, chronic diseases, physical function, cognition) could explain racial differences in cause-specific mortality risk. During follow-up, 1,991 (65%) participants died. Black participants died at higher rates from cancer (hazard ratio (HR)=1.36, 95% confidence interval (CI)=1.14-1.63), kidney disease (HR=2.09, 95% CI=1.16-3.74), stroke (HR=1.31, 95% CI=0.98-1.76); and CVD (HR=1.16, 95% CI=0.98-1.37). Poorer physical and cognitive performance at baseline among black participants explained most of the racial difference in risks of dying from kidney disease, stroke, and CVD but not cancer. When examining types of cancer deaths, black participants died at higher rates from multiple myeloma, pancreatic cancer, and prostate cancer, which baseline risk factors did not explain either. Factors contributing to poorer physical and cognitive performance in similarly aged black men and women could be targets to reduce excess mortality from CVD, stroke, and kidney disease. More work is needed to identify factors contributing to cancer mortality disparities.

The association between intraoperative dexmedetomidine and 1 year morbidity and mortality after cardiac surgery: A propensity matched analysis of over 1400 patients

Study objectiveDexmedetomidine is widely used during surgery. Recent studies have demonstrated that dexmedetomidine administered perioperatively is associated with lower postoperative mortality and complications in patients undergoing cardiac surgery. DesignThis study was designed to investigate the effects of dexmedetomidine during cardiac surgery in Chinese patients. Patients/InterventionsWe conducted a retrospective review of 1477 consecutive patients who underwent cardiac surgery at our institution. Of these patients, 1077 received dexmedetomidine during their surgery (dexmedetomidine group) and 400 did not (control group). All patients were followed for 1 year. Their short- and long-term outcomes were compared by the inverse-probability of treatment weighted adjustment to reduce treatment selectmen bias. Propensity-score matching yielded two well-matched groups for further comparison. Main resultsAfter adjusting for differences in baseline risk factors with the inverse probability of treatment weighting, the risk of perioperative mortality (Odds ratio [OR]:1.02; 95% confidence interval [CI]:0.32 to 3.28, P = 0.97) and cardiovascular complications were not significantly different between the two groups. After 1 year of follow-up, the two groups showed no differences in mortality (hazard ratio [HR]:0.70; 95% CI 0.28 to 1.73, P = 0.44) and major adverse cardiovascular and cerebrovascular events (MACCE) (HR 1.08; 95% CI 0.69 to 1.68, P = 0.74).However, postoperative atrial fibrillation was lower in the dexmedetomidine group (OR: 0.53; 95% CI: 0.31 to 0.90, P = 0.02). ConclusionsDexmedetomidine administered perioperatively reduced postoperative atrial fibrillation, but was not effective in decreasing short and long-term mortality or cardiovascular complications in a Chinese population.

Examining variation in interstage mortality rates across the National Pediatric Cardiology Quality Improvement Collaborative: do lower-mortality centres have lower-risk patients?

Although interstage mortality for infants with hypoplastic left heart syndrome has declined within the National Pediatric Cardiology Quality Improvement Collaborative, variation across centres persists. It remains unclear whether centres with lower interstage mortality have lower-risk patients or whether differences in care may explain this variation. We examined previously established risk factors across National Pediatric Cardiology Quality Improvement Collaborative centres with lower and higher interstage mortality rates. Lower-mortality centres were defined as those with >25 consecutive interstage survivors. Higher-mortality centres were defined as those with cumulative interstage mortality rates >10%, which is a collaborative historic baseline rate. Baseline risk factors and perioperative characteristics were compared. Seven lower-mortality centres were identified (n=331 patients) and had an interstage mortality rate of 2.7%, as compared with 13.3% in the four higher-mortality centres (n=173 patients, p<0.0001). Of all baseline risk factors examined, the only factor that differed between the lower- and higher-mortality centres was postnatal diagnosis (18.4 versus 31.8%, p=0.001). In multivariable analysis, there remained a significant mortality difference between the two groups of centres after adjusting for this variable: adjusted mortality rate was 2.8% in lower-mortality centres compared with 12.6% in higher-mortality centres, p=0.003. Secondary analyses identified multiple differences between groups in perioperative practices and other variables. Variation in interstage mortality rates between these two groups of centres does not appear to be explained by differences in baseline risk factors. Further study is necessary to evaluate variation in care practices to identify targets for improvement efforts.

Intravascular Ultrasound Guidance Improves the Long-term Prognosis in Patients with Unprotected Left Main Coronary Artery Disease Undergoing Percutaneous Coronary Intervention

This study compared the long term outcomes in patients with unprotected left main coronary artery (LMCA) disease who underwent stenting under the guidance of intravascular ultrasound (IVUS) or conventional angiography at a large single center. The primary outcome was the composite of all-cause death and myocardial infarction (MI) at 3 years. Target vessel revascularization (TVR) at 3 years was one of the secondary outcomes. Between January 2004 and December 2011, a total of 1,899 patients who underwent IVUS-guided (n = 713, 37.5%) or conventional angiography-guided (n = 1186, 62.5%) stenting were included. At 3 years, the unadjusted primary outcome trended lower in the IVUS-guided group versus the angiography-guided (6.9% vs. 8.4%, p = 0.22) although the TVR was similar between two groups (6.0% vs. 6.0%, p = 0.97). However, after adjustment for differences in baseline risk factors, IVUS-guidance was associated with significantly lower incidence of the composite of all-cause death and MI (hazard ratio [HR]: 0.65; 95% confidence interval [CI]: 0.50 to 0.84; p = 0.001), although there was still no significant difference in TVR between the two groups (HR: 1.09; 95% CI: 0.84 to 1.42; p = 0.53). IVUS guidance has benefits in improving the long-term prognosis for unprotected LMCA stenting.

Abstract P5-08-06: Impact of a decision-support tool on the utilization of colony-stimulating factors and incidence of febrile neutropenia among patients with breast cancer

Abstract Background: Following the 2012 American Society of Clinical Oncology's Choosing Wisely campaign recommendation against the routine use of colony-stimulating factors (CSFs) for the primary prevention of febrile neutropenia (FN) in patients with ≤ 20% risk, an evidence-based clinical decision-support tool (CSF decision tool) was implemented to promote risk-appropriate CSF use in breast cancer patients receiving chemotherapy by a national payer in the United States (US). We hypothesized that there should be no change in pre- and post-implementation FN rates if the CSF decision tool had promoted appropriate FN risk stratification among breast cancer patients. Methods: A retrospective observational cohort study design was used to analyze data from a national payer administrative claims database of nearly 40 million lives geographically spread across the US. The CSF decision tool was first implemented in 2014, with a staggered implementation across states (July 1, 2014 - November 1, 2014). Study subjects were female patients, aged ≥ 18 years, who initiated chemotherapy for breast cancer in the time periods before or after the implementation of the decision tool (July 1, 2014 through March 30, 2015). Patients were assigned to case (defined as patients in the states where the CSF decision tool had been implemented) or control (defined as patients in states where the CSF decision tool had yet to be implemented) cohort. Patients in each cohort were followed up to 6 months after the first chemotherapy dose in the pre- and post-implementation periods. The outcomes were changes in the incidence of FN and CSF use rates, respectively. Rates of FN and CSF use were compared between the cohorts using difference-in-differences models; generalized estimating equations were used to adjust for differences in baseline risk factors including age, history of neutropenia or infections. Results: The final study population comprised 7,224 patients: 4,001 and 3,223 in the case and control cohorts, respectively. There was a higher proportion of patients who were 65 years or older in the case cohort compared to the control (22% vs 18%, p: &amp;lt;0.001). Otherwise, the cohorts were comparable in FN risk factors at baseline in pre- and post-implementation periods. In adjusted regression results, pre- and post-implementation FN rates were not significantly different for both case (5.38% to 5.65%) and control (5.07% to 5.13%) cohorts, [p=0.778]. Use of CSF in the pre- and post-implementation periods decreased from 75% to 69% in the case cohort compared with a reduction from 72% to 71% in the control cohort: an absolute difference of 5.4% decrease in CSF use associated with the implementation of the decision support tool [p= 0.006]. Conclusion: Despite a modest reduction in CSF use, we found no evidence of an increase in FN rates after the implementation of the CSF decision tool. Given the lack of impact of the Choosing Wisely campaign on inappropriate CSF use; our findings suggest that beyond the educational efforts and media campaigns, a greater reduction in unnecessary CSF use can be achieved through the use of clinical decision algorithms to reduce practice variation and improve adherence to national guideline recommendations. Citation Format: Adeboyeje G, Agiro A, Goodwin A, DeVries A, Malin J. Impact of a decision-support tool on the utilization of colony-stimulating factors and incidence of febrile neutropenia among patients with breast cancer [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P5-08-06.

Abstract WP169: Racial Disparities n Risk of Stroke and Mortality Among Patients Undergoing Rhythm Control of Atrial Fibrillation

Introduction: Racial disparities in cardiovascular therapies and outcomes have been previously reported. We sought to investigate the risks of stroke and death in African American (AA) and white patients undergoing rhythm control of atrial fibrillation (AF). Hypothesis: AA patients have greater risk of stroke and death compared to white patients. Methods: We collected data on 5632 white and 241 AA patients that initiated rhythm control therapy for AF at our institution from 2006-2013. Cox proportional-hazards models were used to assess risk factors for stroke and mortality by race. Results: Patients were followed for a median of 40 months (range 1-101). AA patients had higher risk of stroke (6.6% vs. 3.9%, p=0.01) and all-cause mortality (16.2% vs. 13.1%, p=0.03) than white patients. Multivariate modeling confirmed the higher risk of stroke (HR=1.98, 95% CI [1.18-3.31], p=0.01) and mortality (HR=1.49, 95% CI [1.04-2.06], p=0.02) in AA patients after adjusting for baseline differences between race groups (age, HTN, DM, heart failure, and chronic kidney disease). AA patients with DM had an especially high risk of stroke (see Figure). Conclusions: African-American patients treated with a rhythm management strategy had significantly greater risk of stroke and all-cause mortality compared to white patients. AA patients with DM had an especially high risk, but the difference between AA patients vs. white patients was not explained by differences in baseline risk factors. Further investigation is required to determine the root causes of these racial disparities.

Abstract 19136: Association of Smoking With Myocardial Injury and Clinical Outcome in Patients Undergoing Mechanical Reperfusion for ST-Elevation Myocardial Infarction: Insights From Cardiovascular Magnetic Resonance Imaging

Introduction: There is evidence suggesting a positive effect of cigarette smoking on myocardial tissue reperfusion and clinical outcomes in patients with myocardial infarction (“smoker’s paradox”). Hypothesis/Aim: We aimed to evaluate the relationship of smoking status with cardiac magnetic resonance (CMR)-determined myocardial salvage and damage as well as clinical outcome in patients undergoing primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI). Methods: This multicenter study included 727 consecutive STEMI patients reperfused within 12 hours after symptom onset. CMR imaging parameters (area-at-risk [AAR], infarct size [IS], myocardial salvage index [MSI], and microvascular obstruction [MVO]) were compared according to admission smoking status. Major adverse cardiac events (MACE) rates at 12 months after infarction were compared between groups. Results: In our study cohort 339 (46.6%) patients were current smokers. There was no difference in the extent of AAR (35[24-47] vs. 37[27-49] %LV, p=0.10), IS (16[8-25] vs. 17[10-26] %LV, p=0.21), MSI (53[29-70] vs. 52[34-71], p=0.47) or MVO (0[0-1.7] vs. 0[0-1.6] %LV, p=0.91) between smokers and non-smokers. Smokers had lower MACE (3.8% vs. 8.2%, p=0.01) and mortality (0.9% vs. 3.9%, p=0.01) rates. However, after adjustment for differences in baseline risk factors, smoking was no longer associated with MACE (HR=0.72, 95% CI 0.37 to 1.41, p=0.34) or mortality (HR=0.49, 95% CI 0.14 to 1.76, p=0.27). Conclusion: Smoking is not associated with PPCI efficacy (myocardial salvage) or irreversible myocardial damage in patients with acute STEMI. The lower MACE and mortality rates of smokers were entirely explained by differences in baseline risk characteristics, thus challenging the existence of a “smoker’s paradox”.

Fitness for Entering a Simple Exercise Program and Mortality: A Study Corollary to the Exercise Introduction to Enhance Performance in Dialysis (Excite) Trial

Background/Aims: In this corollary analysis of the EXCITE study, we looked at possible differences in baseline risk factors and mortality between subjects excluded from the trial because non-eligible (n=216) or because eligible but refusing to participate (n=116). Methods: Baseline characteristics and mortality data were recorded. Survival and independent predictors of mortality were assessed by Kaplan-Meier and Cox regression analyses. Results: The incidence rate of mortality was higher in non-eligible vs. eligible non-randomized patients (21.0 vs. 10.9 deaths/100 persons-year; P<0.001). The crude excess risk of death in non-eligible patients (HR 1.96; 95% CI 1.36 to 2.77; P<0.001) was reduced after adjustment for risk factors which differed in the two cohorts including age, blood pressure, phosphate, CRP, smoking, diabetes, triglycerides, cardiovascular comorbidities and history of neoplasia (HR 1.60; 95% CI 1.10 to 2.35; P=0.017) and almost nullified after including in the same model also information on deambulation impairment (HR 1.16; 95% CI 0.75 to 1.80; P=0.513). Conclusions: Deambulation ability mostly explains the difference in survival rate in non-eligible and eligible non-randomized patients in the EXCITE trial. Extending data analyses and outcome reporting also to subjects not taking part in a trial may be helpful to assess the representability of the study population.

Remote Ischemic Preconditioning

Cardioprotective and Prognostic Effects of Remote Ischemic Preconditioning in Patients Undergoing Coronary Artery Bypass Surgery: A Single-Center Randomized, Double-Blind Trial Thielmann et al Lancet . 2013;382:597–604. During the past 3 decades, several experimental studies have shown that ischemic conditioning reduces myocardial damage by modifying ischemia-reperfusion injury. A recent study in the Lancet indicates that remote ischemic preconditioning translates into clinical benefit in patients undergoing coronary artery bypass surgery. The implications of the study extend to patients undergoing elective and acute coronary angioplasty and beyond. Adjunctive therapies to reduce myocardial ischemia- reperfusion injury related to cardiac surgery and percutaneous coronary interventions have yet to find their way into clinical practice, mainly because no pharmacological or mechanical cardioprotective strategy has convincingly shown clinically relevant benefit to the patient.1 That may be about to change. In a recent study by Thielmann et al,2 329 low-risk patients undergoing elective isolated on-pump first-time coronary artery bypass grafting (CABG) were randomized to either standard CABG or CABG preceded by remote ischemic preconditioning (RIPC), achieved by 3 cycles of 5-minute upper limb ischemia through inflation of a blood pressure cuff followed by 5-minute deflation. The results indicate that RIPC confers a prognostic benefit to the patient. The study was conducted as a single-center, double-blind, randomized, controlled trial. The primary end point was perioperative myocardial injury assessed by troponin I release measured at 6, 12, 24, 48, and 72 hours after surgery. The secondary end points comprised all-cause mortality, major adverse cardiac and cerebrovascular events (MACCE), and repeat revascularization at 30 days, 1 year, and at completion of follow-up, ranging from 1 to >4 years with a mean of 1.54 years. The group demographics were well-matched, and there were no significant differences in baseline risk factors. The authors demonstrated acutely reduced myocardial injury (assessed by troponin …

Long-term results of multivessel and left main coronary artery stenting in comparison with surgical revascularisation in patients with NSTE-ACS: the MILESTONE registry

Background: The optimal revascularization strategy in patients with multivessel coronary artery disease (MVD) and unprotected left main coronary artery stenosis (ULMCA) presenting with non-ST acute coronary syndrome (NSTE-ACS) is unspecified. Therefore, we aimed to compare long-term outcomes after percutaneous (PCI) and surgical (CABG) intervention in this cohort Methods: In this multicenter prospective registry, 4856 patients with non-ST elevation myocardial infarction (NSTEMI), unstable angina and MVD with or without ULMCA stenosis were included. Following cardiac team consensus 3033 patients underwent PCI with stent implantation (including 10.3% drug eluting stents) whereas 1338 were assigned for CABG. The follow up on mortality was obtained at 3 years from all patients. Results: In the general population, patients assigned for PCI were younger (64.4±10 vs. 65.2±9 y.o., p=0.03), more frequently presented with NSTEMI (32.0 vs. 14.5% p=0.01), cardiogenic shock (1.5 vs. 0.7% p<0.01) history of prior PCI (13.1 vs. 5.5%; p<0.01) and CABG (10.6 vs. 4.6%, p<0.01). The Euroscore and TIMI risk score were slightly higher in PCI patients (5.36±2.3 vs. 5.16±2.0and 3.87±1.0 vs. 3.79±0.9 respectively,p<0.01). Patients consigned to CABG more often presented with triple and left main disease (82.2 vs. 33.8% and 13.7 vs. 2.4%; p<0.01). Otherwise, proximal LAD was more often revascularized with stenting (21.5 vs. 11.1%; p<0.01). After adjustment for differences in baseline risk factors (stand. diff. 65, female gender, unstable angina, euroscore>5, TIMI risk score>4, DES and two vessel disease. Conclusions: Basing on this large, propensity matched registry data, in patients with NSTE - ACS and MVD with or without ULMCA stenosis, stenting was associated with lower risk of mortality at long term follow up. The subgroup analysis highlighted improved outcomes with PCI in high clinical risk cohorts.

Outcomes After Unrestricted Use of Everolimus-Eluting and Sirolimus-Eluting Stents in Routine Clinical Practice

It remains unclear whether there are differences in the safety and efficacy outcomes between everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) in contemporary practice. We prospectively enrolled 6166 consecutive patients who received EES (3081 patients) and SES (3085 patients) between April 2008 and June 2010, using data from the Interventional Cardiology Research In-Cooperation Society-Drug-Eluting Stents Registry. The primary end point was a composite of death, nonfatal myocardial infarction (MI), or target-vessel revascularization (TVR). At 2 years of follow-up, the 2 study groups did not differ significantly in crude risk of the primary end point (12.1% for EES versus 12.4% for SES; HR, 0.97; 95% CI, 0.84-1.12, P=0.66). After adjustment for differences in baseline risk factors, the adjusted risk for the primary end point remained similar for the 2 stent types (HR, 0.96; 95% CI, 0.82-1.12, P=0.60). There were also no differences between the stent groups in the adjusted risks of the individual component of death (HR, 0.93; 95% CI, 0.67-1.30, P=0.68), MI (HR, 0.97; 95% CI, 0.79-1.18, P=0.74), and TVR (HR, 1.10; 95% CI, 0.82-1.49, P=0.51). The adjusted risk of stent thrombosis also was similar (HR, 1.16; 95% CI, 0.47-2.84, P=0.75). In contemporary practice of percutaneous coronary intervention procedures, the unrestricted use of EES and SES showed similar rates of safety and efficacy outcomes with regard to death, MI, sent thrombosis, and TVR. Future longer-term follow-up is needed to better define the relative benefits of these drug-eluting stents. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01070420.

Mid-term Outcomes of Total Arterial Revascularization Versus Conventional Coronary Surgery in Isolated Three-Vessel Coronary Disease

Whether arterial conduits are superior to venous grafts in coronary artery bypassing has been debated. The aim of this study was to investigate clinical outcomes after total arterial revascularization versus conventional coronary bypassing using both arterial and venous conduits in isolated three-vessel coronary disease. Between 2003 and 2005, 503 patients who underwent isolated coronary artery bypass grafting for three-vessel coronary disease were enrolled. A total of 117 patients underwent total arterial revascularization (Artery group) whereas 386 patients were treated with arterial and venous conduits (Vein group). Major adverse outcomes (death, myocardial infarction, stroke and repeat revascularization) were compared. Clinical follow-up was complete in all patients with a mean duration of 6.1 ± 0.9 yr. After adjustment for differences in baseline risk factors, risks of death (hazard ratio [HR] 0.96; 95% confidence interval [CI] 0.51-1.82, P = 0.90), myocardial infarction (HR 0.20, 95% CI 0.02-2.63, P = 0.22), stroke (HR 1.29, 95% CI 0.35-4.72, P = 0.70), repeat revascularization (HR 0.64, 95% CI 0.26-1.55, P = 0.32) and the composite outcomes (HR 0.83, 95% CI 0.50-1.36, P = 0.45) were similar between two groups. Since the use of veins does not increase the risks of adverse outcomes compared with total arterial revascularization, a selection of the conduit should be more liberal.