1-year Major Cardiovascular Events Research Articles

European cardiovascular registries as reliable data sources to assess implants safety and performances across the implant lifecycle

Abstract Introduction Cardiovascular device registries could be important data sources for manufacturers to provide data required by the recently implemented Medical Device Regulation. However, quality and reliability of device registries for regulatory purposes has not been reported. Purpose To assess European cardiovascular registries on their design and methodology used, to gain insight into the quality of the evidence provided. Methods Seven medical literature libraries were searched to identify regional/national/multi-country European cardiovascular registries capturing data on coronary stents and/or valve repair and/or replacement, following the International Medical Device Regulators Forum definition of a medical device registry. Registries’ annual reports, peer-reviewed publications, and websites were reviewed to extract information on 32 variables in 6 different domains: identification (e.g., geographical representativeness); maturity (e.g., starting year); governance (e.g., funding); coverage, design & organisation (e.g., hospital coverage); data quality (e.g., completeness of procedures); safety & performance (e.g., outlier procedures). Additionally, reported outcomes with their definition and follow-up duration were collected. An active registry was defined as supplying recent data (2018 or beyond). Results 20 registries were identified, of which 11 registries capturing data solely on valve repair and/or replacement, 2 solely on coronary stents, and 7 capturing data on both valves and coronary stents (Table 1). The majority (55%) of included registries were active. Overall, registries reported on a median of 33% of variables (IQR 14-67%), varying from 0% (IQR 0-4%) for the domain safety & performance to 83% (IQR 67-100%) for the domain identification (Figure 1). 6 (30%) registries published annual reports, but most registries publish papers for which selected patient groups are included, so that the total number of patients receiving an implant were reported by only 4 (20%) registries. No registry reported procedure completeness or outlier procedures. The most frequently reported outcome was mortality, reported by 18 (90%) registries, but using 70 different time-points ranging from in-hospital mortality to mortality at 21-years. Most registries (80%) reported 30-day mortality. Major cardiovascular events (MACE) were reported as combined end-points by 8 registries (40%), but with 17 different combinations of complications included and 7 different time intervals; most (33%) registries reported 1-year MACE. This large heterogeneity in outcomes, definitions, and follow-up durations makes comparing outcomes, pooling data, and/or benchmarking implants across registries impossible. Conclusion European cardiovascular registries need better reporting on variables related to the design and methods used as well as agreement on definitions and outcomes used, to achieve their potential as a reliable data source for regulatory purposes.Recent activity of included registriesReported items by registries

Prognostic utility of a multibiomarker panel in patients with suspected myocardial infarction

Abstract Introduction Rapid and accurate evaluation of patients presenting with suspected myocardial infarction (MI) to the emergency department (ED) is crucial due to strongly varying outcomes in these patients. Despite the routine use of circulating biomarkers, among which high-sensitivity cardiac troponin currently dictates diagnostic protocols in chest pain patients, it still remains unclear which biomarkers are of highest utility for prognostic purposes in this patient collective. Purpose We sought to investigate the prognostic utility of a multibiomarker panel with 29 different biomarkers in a contemporary cohort of patients with suspected MI by applying a dual analytical approach. Methods The multibiomarker panel was measured in stored blood samples that were collected directly at admission from 748 prospectively enrolled patients who presented with symptoms suggestive of MI to the ED of a German tertiary center between 2013 and 2017. The final diagnosis of all patients was adjudicated according to the 4th Universal Definition of MI. The investigated endpoint comprised incident major cardiovascular events (MACE) within 1 year after admission. MACE was defined as the composite of cardiovascular death, non-fatal MI (excluding index events), revascularization and cardiac rehospitalization. Log-transformed biomarkers were entered individually into an age-and sex-adjusted Cox regression model to explore the hazard ratio (HR) per one standard deviation increase (SD) for 1-year MACE in the overall cohort. The selection of optimal multimarker models, adjusted for age and sex, was performed using 1) stepwise backward selection via Akaike information criterion as the stopping rule, and 2) Least Absolute Shrinkage and Selection Operator (LASSO) with 5-fold cross-validation. Results Out of 748 patients with available multibiomarker panel, 138 (18.4%) were diagnosed with MI. Median age at admission was 64 (interquartile range [IQR] 50–75) years in the overall cohort, 63.1% were male. At 1 year of follow-up, 160 cases of incident MACE were documented. 16 of the investigated 29 biomarkers were significantly associated with 1-year MACE, amongst which NT-proBNP was the strongest predictor (HR per SD 1.74, 95% confidence interval [CI] 1.44–2.09, p<0.0001; Table 1). Using stepwise backward selection, three biomarkers including NT-proBNP, Apo A-I and Apo C-III remained in the final multivariable model (Figure 1). The LASSO approach confirmed NT-proBNP (HR per SD 1.24) and Apo A-I (HR per SD 0.98) as strong and independent predictors of 1-year MACE while Apo C-III was replaced with KIM-1 (HR per SD 1.06). Conclusions Among 29 biomarkers, numerous provide prognostic utility while NT-proBNP and Apo A-I emerged as the strongest independent predictors of 1-year MACE. Their routine assessment and integration into risk prediction models may improve personalized risk stratification in patients with symptoms suggestive of MI. Funding Acknowledgement Type of funding sources: Foundation. Main funding source(s): The BACC study was supported by the German Center for Cardiovascular Research, an unrestricted grant by Abbott Diagnostics, and Prevencio, which also partly covered the biomarker measurements.

Peripheral Artery Disease Screening in the Community and 1-Year Mortality, Cardiovascular Events, and Adverse Limb Events

This study aimed to examine all-cause mortality, 1- and 2-year major cardiovascular events, and major adverse limb events in individuals aged ≥65 years who received an in-home health visit with peripheral artery disease screening. In addition, we compared 1-year healthcare utilization before and after peripheral artery disease screening for those who screened positive. Medicare Advantage beneficiaries aged ≥65 years participating in the Optum HouseCalls program in the U.S. between April 1, 2017 and February 1, 2019 were included. The intervention consisted of a peripheral artery disease screening program using a plethysmography system. One-year all-cause mortality as a landmark analysis, 1- and 2-year major cardiovascular events, and major adverse limb events after screening were compared by peripheral artery disease screen status using claims data. We compared cardiovascular medications and revascularization procedures between the year before and after the peripheral artery disease screening event for those with peripheral artery disease. Of 192,500 beneficiaries, 27.7% screened positive. One-year all-cause mortality rates for those who screened positive for peripheral artery disease versus those who screened negative were higher (1.51% vs 0.89%; p<0.001; adjusted hazard ratio=1.21; 95% CI=1.08, 1.36) as well as 1-year major cardiovascular events (5.54% vs 3.60%; adjusted hazard ratio= 1.22; 95% CI=1.15, 1.30) and major adverse limb events (0.23% vs 0.04%; adjusted hazard ratio=3.15; 95% CI=2.10, 4.73). Similar risks were observed for 2-year results. Before and after peripheral artery disease screening, medications remained stable for those who screened positive (e.g., statin therapy=54.2% vs 56.6%); rates of peripheral vascular interventions remained stable (0.0% vs 0.1%). A national peripheral artery disease screening effort is feasible. Detecting previously undiagnosed peripheral artery disease is a way to risk stratify a population that would benefit from further cardiovascular risk management.

Predictors of 1-Year Major Cardiovascular Events after ST-Elevation Myocardial Infarction in a Specialized Cardiovascular Center in Western Iran.

Background: Identifying the long-term predictors of recurrent cardiovascular events may help improve the quality of care and prevent subsequent events. We aimed to investigate the predictors of 1-year major cardiovascular events (MACE) in patients discharged after ST-elevation myocardial infarction (STEMI) in a tertiary hospital in Iran. Methods: This registry-based cohort study included consecutive STEMI patients between 2016 and 2019 in Imam-Ali Hospital, Kermanshah, Iran. All patients discharged alive from STEMI hospitalization were followed up for 1 year for MACE, consisting of all-cause mortality, nonfatal MI, and nonfatal stroke. We estimated the hazard ratio (HR) and the 95% confidence interval (95% CI) using Cox proportional-hazard models to evaluate potential predictors, including demographic characteristics, medical history, cardiovascular risk factors, laboratory tests, reperfusion therapy, and medications. Results: During 2187.2 person-years, 21 patients were lost to follow-up (success rate =99.1%). Of 2274 post-discharge STEMI patients (mean age =60.26 y; 21.9% female), 151 (6.6%) experienced MACE, including, all-cause mortality (n=115, 5.1%), nonfatal MI (n=20, 0.9%), and nonfatal stroke (n=16, 0.7%). Independent predictors of MACE were age (HR:1.02; 95% CI: 1.00-1.04), no education vs ≥12 years of formal schooling (HR: 2.07; 95% CI: 1.17-3.67), stroke history (HR: 2.37; 95% CI: 1.48-3.81), the glomerular filtration rate (HR: 0.98; 95% CI: 0.97-1.00), the body mass index (HR: 0.94; 95% CI:, 0.89-0.99), peak creatine kinase-MB (HR: 1.00; 95% CI: 1.00-1.002), thrombolysis vs primary percutaneous coronary intervention (HR: 1.85; 95% CI: 1.21-2.81), and left ventricular ejection fraction <35% vs ≥50% (HR: 2.82; 95% CI: 1.46-5.47). Conclusion: Age, education, stroke history, the glomerular filtration rate, the body mass index, peak creatine kinase-MB, reperfusion therapy, and left ventricular function can be independently associated with 1-year MACE.

Impact of active and stable cancer on survival in patients undergoing percutaneous coronary intervention

Abstract Background With advances in treatment of ischemic heart disease and cancer treatment, use of percutaneous coronary intervention (PCI) in cancer survivors and patients with active cancer (AC) is expanding. Objectives The purpose of this study was to determine the impact of cancer on survival and major cardiovascular events (MACE) in a long-term, single-center cohort of patients treated with PCI. Methods Patients treated with PCI between January 2010 and December 2017 were grouped as follows: controls (patients without cancer), stable cancer (SC), and AC. AC was included patients with cancer diagnosed within the past 6 months, patients who had cancer-related therapy within the past 6 months, active metastatic disease, or active recurrence of the cancer. The primary endpoints were 5-year survival and a secondary endpoint was 5-year MACE. Results A total of 6,743 patients (age 66±12 years, 68.4% men) treated with PCI were included: 6,404 (95.0%) controls, 245 (3.6%) SC, and 94 (1.4%) AC. Predominant malignancies were gastrointestinal (37.4%), lung (22.7%), and genitourinary cancer (14.7%). No differences were observed between patients with AC, SC and controls regarding 5-year MACE (total MACE, 33.2% vs. 28.1% vs. 17.5%, p=0.072; cardiac death, 13.6% vs. 9.1% vs. 6.7%, p=0.066; non-fatal myocardial infarction, 2.9% vs. 7.5% vs. 7.8%, p=0.820; revascularization, 17.9% vs. 17.6% vs. 11.6%, p=0.794, respectively). Patients with AC and SC had reduced 5-year survival compared with controls (62.0% vs. 81.5% vs. 89.8%, p&amp;lt;0.001) (Figure). AC was associated with a 1.76 (95% CI 1.22 to 2.54, p=0.002) fold increased risk of all-cause 5-year mortality in multivariable adjusted models. Conclusions Cumulative incidence of 5-year survival was discriminated by concurrent status of cancer following PCI. Individualized decision making is needed in the routine practice of PCI regarding concurrent cancer-specific treatment and prognosis. Funding Acknowledgement Type of funding sources: None.

Prognostic value of noninvasive combined anatomic/functional assessment by cardiac CT in patients with suspected coronary artery disease — Comparison with invasive coronary angiography and nuclear myocardial perfusion imaging for the five-year-follow up of the CORE320 multicenter study

BackgroundFew data exist on long-term outcome in patients undergoing combined coronary CT angiography (CTA) and myocardial CT perfusion imaging (CTP) as well as invasive coronary angiography (ICA) and single photon emission tomography (SPECT). MethodsAt 16 centers, 381 patients were followed for major adverse cardiac events (MACE) for the CORE320 study. All patients underwent coronary CTA, CTP, and SPECT before ICA within 60 days. Prognostic performance according binary results (normal/abnormal) was assessed by 5-year major cardiovascular events (MACE) free survival and area under the receiver-operating-characteristic curve (AUC). ResultsFollow up beyond 2-years was available in 323 patients. MACE-free survival rate was greater among patients with normal combined CTA-CTP findings compared to ICA-SPECT: 85 vs. 80% (95% confidence interval [CI] for difference 0.1, 11.3) though event-free survival time was similar (4.54 vs. 4.37 years, 95% CI for difference: -0.03, 0.36). Abnormal results by combined CTA-CTP was associated with 3.83 years event-free survival vs. 3.66 years after abnormal combined ICA-SPECT (95% CI for difference: -0.05, 0.39). Predicting MACE by AUC also was similar: 65 vs. 65 (difference 0.1; 95% CI -4.6, 4.9). When MACE was restricted to cardiovascular death, myocardial infarction, or stroke, AUC for CTA-CTP was 71 vs. 60 by ICA-SPECT (difference 11.2; 95% CI -1.0, 19.7). ConclusionsCombined CTA-CTP evaluation yields at least equal 5-year prognostic information as combined ICA-SPECT assessment in patients presenting with suspected coronary artery disease. Noninvasive cardiac CT assessment may eliminate the need for diagnostic cardiac catheterization in many patients. Clinical trial registrationNCT00934037.

Impact of compliance with lifestyle recommendations and medication adherence on 1-year prevention of major cardiovascular events in diabetic patients undergoing partial foot amputation

Abstract Funding Acknowledgements Type of funding sources: None. Background Partial foot amputation (PFA) is generally not considered a high-risk surgery. However, 3 years survival rate is less than 50-60%. The purpose of the study was to evaluate the impact of compliance with lifestyle recommendations and medication adherence on 1-year prevention of major cardiovascular events (MACE) in patients with type 2 diabetes mellitus (T2DM) after PFA. Methods In this prospective single-center interventional cohort study, 785 consecutive T2DM patients after PFA were included in the 1-year follow-up. Physical examination and laboratory tests were performed at baseline and every month after PFA for 1 year. Patients were considered as compliant with lifestyle recommendations if they followed a healthy diet, smoking cessation, and at least ≥30 min/day physical exercise. Patients were defined as adherent to medication if they followed ≥80% prescribed medication intake. MACE was defined as a composite endpoint including cardiovascular death, myocardial infarction (MI), stent thrombosis, acute stroke, or unstable arrhythmia. Results During 1-year follow-up MACE occurred in 63/535 patients who were medication adherent compared to 137/249 non-adherent patients (Chi square = 167,2, p &amp;lt; 0,001). Among lifestyle compliant patients, 55/498 had MACE compare with 145/286 non-compliant patients (Chi square = 150.3, p &amp;lt; 0,001). The COX regression analysis was conducted to present the adjusted effect of compliance and adherence to the incidence of MACE (B = 0.989, p &amp;lt; 0.001, and B= 1.096, p &amp;lt; 0.001, respectively) (Table). The potential confounders such as age and previous MI were statistically significant (Table). Gender, smoking, diabetes severity, HbA1c, hypertension, symptomatic coronary artery disease, history of ischemic events, heart revascularization were not statistically significant. Conclusion. Failure to follow lifestyle recommendations in T2DM patients after PFA increases the OR of the incidence of MACE 2.7 fold, non-adherence to medication 3 fold. Our results indicate that optimizing preventive interventions is of outmost importance for patients with diabetes undergoing PFA Cox Regression Results for predictors of Indicator Odds ratio B Standard error P-value Age 1.031 0.031 0.009 0.007 History of myocardial infarction 4.017 1.391 0.184 &amp;lt;0.001 Non-compliance to lifestyle changes 2.688 0.989 0.198 &amp;lt;0.001 Medication non-adherence 2.992 1.096 0.186 &amp;lt;0.001

Association between acute heart failure and major cardiovascular events in atrial fibrillation patients presenting at the emergency department: an EMERG-AF ancillary study.

There is little evidence concerning the impact of acute heart failure (AHF) on the prognosis of atrial fibrillation patients attending the emergency department (ED). To know the influence of AHF on adverse long-term outcomes in patients presenting with atrial fibrillation in ED. Secondary analysis of a prospective, multicenter, observational cohort of consecutive atrial fibrillation patients, performed in 62 Spanish EDs. Patients presenting with atrial fibrillation in ED were divided by the presence or absence of AHF at arrival. Primary outcome: combination of 1-year all-cause mortality, major bleeding, stroke and other major cardiovascular events (MACE). Secondary outcomes: each of these events analyzed separately. Cox and logistic regression were used to investigate adjusted significant associations between AHF and outcomes. Totally, 1107 consecutive ED patients with atrial fibrillation attending ED were analyzed, 262 (23.7%) with AHF. The primary outcome occurred in 433 patients (39.1%), 1-year all-cause mortality in 151 patients (13.6%), major bleeding in 47 patients (4.2 %), stroke in 31 patients (2.8 %) and other MACE in 333 patients (30.1%). AHF was independently related to the primary outcome [odds ratio (OR), 1.422; 95% confidence interval (CI), 1.020-1.981; P = 0.037)] and 1-year MACE (OR, 1.797; 95% CI, 1.285-2.512; P = 0.001), but not to 1-year all-cause mortality, stroke or bleeding. The coexistence of AHF in patients presenting with atrial fibrillation in ED is associated to a worse 1-year outcome mainly due to MACE, but does not impact in overall mortality.

Prognostic value of noninvasive combined anatomic/functional assessment by cardiac ct in patients with suspected coronary heart disease

Abstract Background Noninvasive evaluation of patients with stable angina is preferable over invasive testing if it leads to similar patient outcome. The combination of coronary angiography and vasodilator challenge myocardial perfusion imaging by computed tomography allows fast, comprehensive assessment of patients with suspected coronary heart disease. Purpose To compare the long-term prognostic value of combined computed tomography angiography (CTA) and myocardial CT perfusion imaging (CTP) with invasive coronary angiography (ICA) and single photon emission tomography (SPECT) in patients with suspected hemodynamically significant coronary heart disease. Methods At 16 centres, 381 patients were followed for major adverse cardiac events (MACE) for the CORE320 study. All patients underwent coronary CTA, CTP, and SPECT before ICA. Prognostic performance according binary results (normal/abnormal) was assessed by 5-year major cardiovascular events (MACE) free survival and area under the receiver-operating-characteristic curve (AUC). Results Follow up beyond 2-years was available in 323 patients. MACE-free survival rate was greater among patients with normal combined CTA/CTP findings compared to ICA/SPECT: 85 vs. 80% (95% confidence interval [CI] for difference 0.1, 11.3) though event-free survival time was similar (4.54 vs. 4.37 years, 95% CI for difference: 0.03, 0.36). Abnormal results by combined CTA/CTP was associated with 3.83 years event-free survival vs. 3.66 years after abnormal combined ICA/SPECT (95% CI for difference: 0.05, 0.39, CI −1.0, 11.1) (Figure). Predicting MACE by AUC also was similar: 65 vs. 65 (difference 0.1; 95% CI: −4.6, 4.9). When MACE was restricted to death, myocardial infarction, or stroke, AUC for CTA/CTP was 66 vs. 61 by ICA/SPECT (difference 5.1; 95% CI: −7.1, 12.9). Conclusions Combined CTA/CTP yield similar 5-year prognostic performance as joined ICA/SPECT assessment in patients presenting with suspected coronary heart disease and thus may represent a fast, non-invasive alternative to the traditional diagnostic approach. Figure 1. 5-year event-free survival Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): National Institutes of Health

Beta blockers versus calcium channel blockers for provocation of vasospastic angina after drug-eluting stent implantation: a multicentre prospective randomised trial

BackgroundDrug-eluting stent-induced vasospastic angina (DES-VSA) has emerged as a novel complication in the modern era of percutaneous coronary intervention (PCI). Although beta blockers (BBs) are generally recommended for coronary heart...

Design and rationale of a randomized control trial testing the effectiveness of combined therapy with STAtin plus FENOfibrate and statin alone in non-diabetic, combined dyslipidemia patients with non-intervened intermediate coronary artery disease - STAFENO study

BackgroundDespite the chronicled success of low-density lipoprotein cholesterol (LDLc)-lowering statin therapy, substantial residual cardiovascular (CV) disease risk remains a problem worldwide, highlighting the need to for combination therapies targeting non-LDLc factors, such as with fenofibrate.Methods/designThe STAFENO trial is a prospective, randomized, open-label, multi-center trial to compare the effect of statin plus fenofibrate with statin alone on the reduction and stabilization of plaque in non-diabetic, combined dyslipidemia patients with non-intervened, intermediate coronary artery disease (CAD) using virtual histology-intravascular ultrasound at 12 months. A total of 106 eligible patients are planned to be randomized to receive either a combination therapy (rosuvastatin 10 mg plus fenofibrate 160 mg/day) or monotherapy (rosuvastatin 10 mg/day) for 12 months. The primary endpoint of this study is the percentage change in the necrotic core volume. Secondary endpoints include changes in tissue characteristics and 1-year major CV events, including all-cause mortality, CV mortality, nonfatal myocardial infarction, stroke, and revascularization of the intervened and non-intervened lesions.DiscussionThe STAFENO trial will address whether combination treatment of statin and fenofibrate has an additive beneficial effect compared to statin alone on the reduction and stabilization of plaque and CV events in non-diabetic, combined dyslipidemia patients with non-intervened intermediate CAD.Trial registrationClinicalTrials.gov, NCT02232360. Registered 9 February 2014.https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0004ULE&selectaction=Edit&uid=U00023SZ&ts=2&cx=juppd2

Ankle-Brachial Index in Addition to Stress Testing in Patients Who Presented With Chest Pain and 1-Year Major Cardiovascular Events

Chest pain is a common presentation to the emergency department, and the best approach for risk stratification with long-term outcomes is limited. Our goal was to assess the utility of ankle-brachial index (ABI) in addition to stress testing among patients (males >40 and females >50 years old) who presented with chest pain, undetectable biomarkers, and unchanged electrocardiogram. A total of 348 consecutive patients were enrolled in a prospective cohort study and completed an ABI and cardiovascular stress test. Patients with an abnormal ABI were twice as likely to have an abnormal stress test (odds ratio = 2.03; 95% confidence interval [CI], 1.11-3.70). At 1 year, the incidence of adjusted major cardiovascular events (MCE) was lowest (8.2%) among those with a normal ABI and normal stress test. When compared with this low-risk group, the adjusted risk of 1-year MCE was 8.4% higher (95% CI, -1.0% to 17.8%; P = 0.080) in the normal ABI with abnormal stress test group; 5.3% higher (95% CI, -4.5% to 15.1%; P = 0.291) in the abnormal ABI with normal stress test group; and finally, 12.1% higher (95% CI, -2.5% to 26.6%; P = 0.105) in the abnormal ABI with abnormal stress test group. Although additional research needs to be conducted, either an abnormal stress test or abnormal ABI suggested an increase of MCE at 1 year with abnormal stress test and ABI demonstrating the highest risk. The addition of ABI to patients undergoing stress testing may enhance risk stratification in patients who present with chest pain.

Long-Term Outcomes of Coronary and Carotid Artery Disease Revascularization in the FRIENDS Study.

Objectives The aim of this study is to assess long-term-outcomes of patients with concomitant CAD and COD treated with different revascularization strategies. Background Multisite artery disease is common and patients with combined disease have poor prognosis. The best therapeutic strategy for patients with concomitant carotid obstructive disease (COD) and coronary artery disease (CAD) remains controversial. Methods This observational registry enrolled, between January 2006 and December 2012, 1022 consecutive patients from high volume institutions with concomitant CAD and COD suitable for endovascular, surgical, or hybrid revascularization in both territories selected by consensus of a multidisciplinary team. Results The cumulative incidence of 5-year major cardiovascular events (MACCE) including cardiovascular death, myocardial infarction (MI), or stroke in the overall population was 12%. The incidence of 5-year MACCE was not statistically different in the surgical, endovascular, or hybrid patients group (10.1% vs. 13.0% vs. 13.2%, P = .257, respectively). However, the hybrid group exhibited rates of myocardial infarction, chronic kidney disease, and cumulative incidence of all clinical events higher than the surgical group. After propensity score matching, the incidence of 5-year MACCE was similar in the three groups (13.0% vs. 15.0% vs. 16.0%, p = .947, respectively). Conclusions An individualized revascularization approach of patients with combined CAD and COD yields very good results at long-term follow-up, despite the high risk of this multilevel population even when the baseline clinical features are equalized.

Plasma angiopoietin-1 level, left ventricular ejection fraction, and multivessel disease predict development of 1-year major adverse cardiovascular events in patients with acute ST elevation myocardial infarction — A pilot study

ObjectivesPatients with acute myocardial infarction (AMI) are frequently complicated with major cardiovascular events (MACEs). Endothelial dysfunction has been found to be involved in pathogenesis of AMI, but its role in development of MACEs after AMI is not clearly investigated. This study aimed to determine whether the plasma markers of endothelial dysfunction could serve as independent predictors for MACEs in patients with AMI. MethodsThis prospective study was conducted from March 2010 to July 2012 and enrolled consecutive 132 patients with acute ST elevation myocardial infarction (STEMI) receiving primary percutaneous coronary intervention (PCI). Plasma levels of thrombomodulin (TM), von Willebrand factor (vWF), angiopoietin (Ang)-1, Ang-2, Tie-2, and vascular endothelial growth factor (VEGF) were measured on day 1 of AMI. The development of MACEs at 1-year follow-up was recorded. ResultPatients with STEMI who developed MACEs had increased heart rate on admission (86±24 vs. 74±20bpm, p=0.006), lower left ventricular ejection fraction (LVEF) (49.0±12.4 vs. 57.2±12.4%, p=0.002), and higher incidence of multivessel disease (66.7% vs. 42.2%, p=0.018) comparing with those without MACEs. Plasma level of Ang-1 was lower in patients with MACEs than in those without (21,165±16,281 vs. 31,411±21,593pg/mL, p=0.018). In multivariate analysis, Ang-1 level<median value (OR 2.977, 95% CI 1.16–7.63, p=0.023), LVEF (OR 0.958, 95% CI 0.92–0.99, p=0.022) and multivessel disease (OR 3.013, 95% CI 1.19–7.60, p=0.019) independently predicted 1-year MACEs. ConclusionDecreased plasma Ang-1 levels on admission, LVEF and multivessel disease independently predicted the development of 1-year MACEs in patients with STEMI. These results suggest that endothelial dysfunction may play an important role in mediating MACEs in patients with STEMI.

Sex difference in clinical outcomes after percutaneous coronary intervention in Korean population

Conflicting data on sex-based differences in outcomes after percutaneous coronary intervention (PCI) among Western population exist. Little is known about the nature of sex-specific PCI outcomes in an Asian population. We performed a pooled analysis using 23,604 patients from 11 prospective PCI clinical studies performed in Korea. The primary outcome was a major cardiovascular event, defined as composite of cardiovascular death, myocardial infarction, stent thrombosis, or stroke. Secondary outcomes were all-cause mortality and target vessel revascularization. Thirty-day and 2-year rates of major cardiovascular events were more frequent in women than in men, mainly because of a higher incidence of periprocedural myocardial infarction in women (30-day: 9.2% vs 7.1%; 2-year: 11.2% vs 8.9%). After multivariable adjustment, women had significantly higher risks of 30-day (hazard ratio [HR] 1.27, 95% CI 1.19-1.36) and 2-year major cardiovascular events (HR 1.21, 95% CI 1.13-1.30). Unadjusted 30-day and 2-year all-cause mortality was similar between women and men (30-day: 0.5% vs 0.4%; 2-year: 2.8% vs 2.8%). However, after multivariable adjustment, women had a lower adjusted risk of 2-year death (HR 0.82, 95% CI 0.77-0.87). No sex-based difference was observed for target vessel revascularization (HR 1.07, 95% CI 0.91-1.25). Overall, sex-specific findings for outcomes were consistent across multiple patient subgroups. Among Korean population undergoing contemporary PCI, women have a significantly higher risk of short- and long-term major cardiovascular events than do men but have better long-term survival.

Persistent platelet reactivity in patients with unprotected left main disease treated by percutaneous coronary intervention

Purpose: Angioplasty is emerging as an alternative technique for patients with unprotected left main disease (ULMD). Persistent platelet reactivity (PPR) under aspirin or thienopyridines is associated with acute events after angioplasty. We aimed to determine the rate and potential clinical impact of PPR in patients treated by angioplasty for ULMD. Methods: We prospectively included 125 patients referred for angioplasty for ULMD in a single-centre registry. For the first 64 patients (ALMA-1), angioplasty was performed under aspirin and clopidogrel treatment without previous platelet reactivity assessment. For the last 61 patients (ALMA-2), platelet reactivity was assessed (light transmission aggregometry triggered by arachidonic acid and ADP and VASP index) systematically before angioplasty: patients found to have aspirin-related PPR were administered aspirin twice daily and those with clopidogrel-related PPR had their daily clopidogrel dose doubled or replaced by prasugrel. Results: Overall, patients mean age was 69±13y.o., 37% were diabetic, 37% had NSTEMI and 62% had multivessel disease. The left main lesion was ostial in 23%, medial in 8% and distal or both in 69%. Mean SYNTAX score was 22.8±9.2. More than 30% of the patients have an additive EuroSCORE≥6. Procedural characteristics were similar in both groups. Follow-up was successful at 1 year in all patients. In ALMA-2, concerning aspirin pathway, mean maximal aggregation intensity (MAI) was 15.4±17.0%. The proportion of patients with aspirin-related PPR (MAI≥20%) was 28% and aspirin was switched twice a day in those patients. Concerning thienopyridines pathway, mean MAI triggered by ADP 20μmol was 53.6±18.5%, mean VASP index was 46±19% and considering both MAI>65% and VASP>50%, 26% of patients (n=16) had PPR under thienopyridines. Following these results, 31% of patients (n=19) were switched to prasugrel and 26% (n=16) were treated by high-dose clopidogrel. Finally, 8% of patients (n=5) had PPR under both, aspirin and thienopyridine treatment. Dual antiplatelet therapy at 1 year was continued in 86% of patients in ALMA-1 and 92% in ALMA-2 (p=NS). The rate of 1-year major cardiovascular events was significantly decreased in ALMA-2 vs. ALMA-1 (8.2% vs. 20.8%; p=0.04) as a composite endpoint of cardiovascular death and stent thrombosis (0.0% vs. 8.3%; p=0.02). Conclusion: In our real life study, PPR for dual antiplatelet therapy is frequent in patients undergoing angioplasty for ULMD and appears to be strongly associated with subsequent major events.

The impact of admission procalcitonin on prognosis in acute coronary syndromes: a pilot study

Background: Available evidence on the prognostic role of procalcitonin levels in acute coronary syndromes (ACS) is so far controversial.Aims: To evaluate the association between procalcitonin, major cardiovascular events (MACE) and total mortality in acute coronary syndromes.Methods: Procalcitonin levels were measured in 247 patients admitted to our Intensive Cardiac Care Unit (ICCU) with ACS. Three subgroups were considered according to procalcitonin levels.Results: At Cox regression analysis, procalcitonin levels were both an unadjusted and an adjusted predictor (corrected for diagnosis and TnI) of intra-ICCU mortality and of 1-year follow-up MACE and total mortality.Conclusions: In ACS, admission procalcitonin values identify a “higher risk” group of patients for short and long-term mortality.