Occurrence Of Primary Outcome Research Articles

Prognostic significance of cardiorenal dysfunction within 1year after atrial fibrillation ablation in patients with systolic dysfunction.

Atrial fibrillation (AF) ablation can improve left ventricular ejection fraction (LVEF) and renal function and can even reduce mortality in patients with impaired LVEF. However, the effect of post-ablation cardiorenal dysfunction on the prognosis of patients with impaired LVEF who underwent AF ablation remains unclear. Of the 1243 consecutive patients undergoing AF ablation, the prognosis of 163 non-dialysis patients who underwent AF ablation with < 50% LVEF was evaluated. The primary outcome was a composite of all-cause mortality, heart failure hospitalization, and a need for modification of the treatment for heart failure. During the median follow-up of 4.2years after the first AF ablation procedure, the primary outcome occurred in 30 of 163 patients (18%). The receiver operating characteristic curve analysis demonstrated that the post-LVEF (LVEF within 1year after the procedure, and before the occurrence of primary outcome) had larger areas under the curve (0.70) than the pre-LVEF (LVEF before the procedure), and the most optimal cutoff value was LVEF ≤ 42%. Multivariate analysis demonstrated that patients with post-LVEF ≤ 42% and worsening renal function (WRF; an absolute increase in serum creatinine [SCr] ≥ 0.3mg/dL compared with the SCr at baseline within 1year after the procedure and before the occurrence of primary outcome) had a 3.4- to 4.3-fold and 3.4- to 3.7-fold higher risk of the primary outcome compared with those without these predictors, respectively. Patients were categorized using post-LVEF ≤ 42% and WRF as follows: group 1 (post-LVEF > 42% without WRF), group 2 (post-LVEF ≤ 42% without WRF), group 3 (post-LVEF > 42% with WRF), and group 4 (post-LVEF ≤ 42% with WRF). Group 4 had a 15.8-fold (P = 0.0001) higher risk of the primary outcome compared with group 1 after adjusting for pre-procedural factors. In patients with impaired LVEF undergoing AF ablation, post-LVEF ≤ 42% and WRF were independent predictors of poor prognosis. The combination of post-LVEF ≤ 42% and WRF is strongly associated with a poor prognosis in patients with AF undergoing ablation, who with these post-ablation cardiorenal dysfunction may have to be treated more intensively after AF ablation.

Patients With LDLR and PCSK9 Gene Variants Experienced Higher Incidence of Cardiovascular Outcomes in Heterozygous Familial Hypercholesterolemia.

BackgroundPatients with familial hypercholesterolemia who harbored both low‐density lipoprotein receptor (LDLR) and PCSK9 (proprotein convertase subtilisin/kexin type 9) gene variants exhibit severe phenotype associated with substantially high levels of low‐density lipoprotein cholesterol. In this study, we investigated the cardiovascular outcomes in patients with both LDLR and PCSK9 gene variants.Methods and ResultsA total of 232 unrelated patients with LDLR and/or PCSK9 gene variants were stratified as follows: patients with LDLR and PCSK9 (LDLR/PCSK9) gene variants, patients with LDLR gene variant, and patients with PCSK9 gene variant. Clinical demographics and the occurrence of primary outcome (nonfatal myocardial infarction) were compared. The observation period of primary outcome started at the time of birth and ended at the time of the first cardiac event or the last visit. Patients with LDLR/PCSK9 gene variants were identified in 6% of study patients. They had higher levels of low‐density lipoprotein cholesterol (P=0.04) than those with LDLR gene variants. On multivariate Cox regression model, they experienced a higher incidence of nonfatal myocardial infarction (hazard ratio, 4.62; 95% CI, 1.66–11.0; P=0.003 versus patients with LDLR gene variant). Of note, risk for nonfatal myocardial infarction was greatest in male patients with LDLR/PCSK9 gene variants compared with those with LDLR gene variant (86% versus 24%; P<0.001).ConclusionsPatients with LDLR/PCSK9 gene variants were high‐risk genotype associated with atherogenic lipid profiles and worse cardiovascular outcomes. These findings underscore the importance of genetic testing to identify patients with LDLR/PCSK9 gene variants, who require more stringent antiatherosclerotic management.

High-Density Lipoprotein Cholesterol and Cardiovascular Events in Patients with Stable Coronary Artery Disease Treated with Statins: An Observation from the REAL-CAD Study.

Aim: The association between high-density lipoprotein cholesterol (HDL-C) level after statin therapy and cardiovascular events in patients with stable coronary artery disease (CAD) remains unclear. Thus, in this study, we sought to determine how HDL-C level after statin therapy is associated with cardiovascular events in stable CAD patients. Methods: From the REAL-CAD study which had shown the favorable prognostic effect of high-dose pitavastatin in stable CAD patients with low-density lipoprotein cholesterol (LDL-C) ＜120 mg/dL, 9,221 patients with HDL-C data at baseline and 6 months, no occurrence of primary outcome at 6 months, and reported non-adherence for pitavastatin, were examined. The primary outcome was a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, or unstable angina requiring emergent admission after 6 months of randomization. Absolute difference and ratio of HDL-C levels were defined as (those at 6 months–at baseline) and (absolute difference/baseline)×100, respectively. Results: During a median follow-up period of 4.0 (IQR 3.2–4.7) years, the primary outcome occurred in 417 (4.5%) patients. The adjusted risk of all HDL-C-related variables (baseline value, 6-month value, absolute, and relative changes) for the primary outcome was not significant (hazard ratio [HR] 0.99, 95% confidence interval [CI] 0.91–1.08, HR 1.03, 95% CI 0.94–1.12, HR 1.05, 95% CI 0.98–1.12, and HR 1.08, 95% CI 0.94–1.24, respectively). Furthermore, adjusted HRs of all HDL-C-related variables remained non-significant for the primary outcome regardless of on-treatment LDL-C level at 6 months. Conclusions: After statin therapy with modestly controlled LDL-C, HDL-C level has little prognostic value in patients with stable CAD.

Prognostic value of estimated plasma volume in patients with chronic systolic heart failure

Assessing congestion is challenging but important to patients with chronic heart failure (CHF). However, there are limited data regarding the association between estimated plasma volume status (ePVS) determined using hemoglobin/hematocrit...

Prognostic role of bronchial asthma in patients with heart failure.

There are few reports investigating the relationship between bronchial asthma (BA) and heart failure (HF). We hypothesized BA may have impact on prognosis in patients with HF. Among 323 consecutive outpatients with HF, 191 patients without chronic obstructive pulmonary disease were analyzed. Twenty patients had BA, most of whom (80.0%) had preserved left ventricular ejection fraction (LVEF ≥ 50%). The use of β-blockers was less frequent (55.0% vs 83.0%. p = 0.01), systolic blood pressure (133 ± 22 vs 120 ± 17mmHg, p = 0.003), and heart rate (83 ± 14 vs 74 ± 15bpm, p = 0.02) were higher in patients with BA than those without BA. During median follow up of 24months, 45 (23.6%) experienced primary outcome defined as a composite of all-cause death, nonfatal myocardial infarction, nonfatal ischemic stroke, and unexpected hospitalization due to HF. Multivariate Cox regression analysis revealed that the presence of BA was independently associated with the occurrence of primary outcome (hazard ratio 3.08, 95% CI 1.42-6.71, p = 0.004). In the subgroup analysis of patients with preserved LVEF, patients with BA exhibited worse outcomes (p = 0.03 by log-rank). Patients with HF complicated by BA, most of whom had preserved LVEF, exhibited worse outcomes than those without BA.

Chinese primary knee osteoarthritis progression cohort (CPKOPC) to evaluate the progression of knee osteoarthritis in the Beijing population: a prospective cohort study protocol

IntroductionMillions of patients are currently suffering from pain and dysfunction caused by osteoarthritis (OA), and billions of dollars have been invested into treatment. Because there is no effective treatment that...

Chinese observational prospective study of ageing population with chronic kidney disease (C-OPTION): a study protocol

IntroductionThe proportion of elderly people is steadily rising worldwide, especially in low-income and middle-income countries, including China. Chronic kidney disease (CKD) is a common disorder in older people. However, little...

Effects of Coronary Artery Revascularization with a Polymer-Free Biolimus A9-Coated BioFreedom Stent Versus Bypass Surgery before Noncardiac Surgery.

PurposeThe present study aimed to evaluate the efficacy and safety of polymer-free drug-coated BioFreedom stent implantation in comparison to coronary artery bypass graft (CABG) before major noncardiac surgery.Materials and MethodsIn a multicenter registry, 55 patients required revascularization before major noncardiac surgery that should not be delayed >6 months. Of them, 27 underwent BioFreedom stent implantation and 28 underwent CABG. Primary outcomes included rate of noncardiac surgery, time from revascularization to noncardiac surgery, and occurrence of composite outcomes (all-cause death, myocardial infarction, stent thrombosis, stroke, repeat revascularization, or major bleeding).ResultsThe rate of major noncardiac surgery was significantly higher in the BioFreedom group (92.6%) than in the CABG group (64.3%; p=0.027). Time from revascularization to noncardiac surgery was significantly shorter in the BioFreedom group (38.0 days) than in the CABG group (73.0 days; p=0.042). During the hospitalization for revascularization period, the occurrence of primary outcomes did not differ between the groups. However, the BioFreedom group showed a shorter hospitalization period and lower total treatment cost than the CABG group. During the hospital stay for noncardiac surgery, the occurrence of composite outcome was not significantly different between groups (4% vs. 0%; p>0.999): stroke occurred in only 1 case, and there were no cases of death or stent thrombosis in the BioFreedom group.ConclusionThis study demonstrated that BioFreedom stenting as a revascularization strategy before major noncardiac surgery might be feasible and safe in selected patients with less severe coronary artery diseases.

Abstract 21008: Effects of Coronary Artery Revascularization With Biofreedom Stent Before Elective Surgery

Introduction: The role of Biofreedom (polymer-free drug coated) stenting compared to coronary artery bypass graft (CABG) for coronary artery revascularization before elective surgery is unclear. Hypothesis: Biofreedom stent might be associated with better outcomes than CABG. Methods: Between January 2016 and Mar 2017, a total of 21 patients underwent percutaneous coronary intervention with Biofreedom stents before elective surgery (Biofreedom group) and 19 patients underwent CABG in the retrospective, multicenter cohort and we compared clinical outcomes between the Biofreedom group and CABG group. Primary outcomes were the period of planned operation after revascularization and the occurrence of the composite clinical endpoints (including death from any causes, myocardial infarction, stent thrombosis, stroke, any revascularization, or major bleeding). Results: During follow-up (mean 276.2± 134.3 days), all patients of Biofreedom group underwent planned surgery without delay, but 73.7% of patients in CABG group underwent surgery (p=0.04). Comparing the time to planned surgery, the Biofreedom group showed a greater incidence of performing surgery within 45 days than with CABG (72.7 vs. 31.6%, p=0.02). The Biofreedom group maintained a shorter duration of dual antiplatelet therapy (DAPT) (32.0 ± 10.0 vs 97.8 ± 88.3, p=0.005). During the entire treatment period, incidence of major bleeding after revascularization was significantly lower in Biofreedom group than CABG group (0% vs. 36.8%, p=0.007). There were no occurrence of death or stent thrombosis in the Biofreedom group. The Biofreedom group showed a significantly lower occurrence of primary outcome (7.2% versus 54.8%, HR 0.11, 95% CI 0.01 to 0.93, p=0.01, mainly due to the lower incidence of major bleeding after intervention). However, the statistical significance was not reached when only the perioperative period was observed. Conclusions: Biofreedom stent was associated with higher rate of performing planned surgery, shorter DAPT duration and lower incidence of major bleeding without increasing the risks of major cardiac event after surgery. In patients requiring coronary artery revascularization prior to elective surgery, Biofreedom stent might be a good treatment option.

A Randomized, Controlled Trial of Oral Intestinal Sorbent AST-120 on Renal Function Deterioration in Patients with Advanced Renal Dysfunction.

The notion that oral intestinal sorbent AST-120 slows renal disease progression has not been evaluated thoroughly. In this study, we investigated the long-term effect of AST-120 on renal disease progression (doubling of serum creatinine, eGFR decrease >50%, or initiation of RRT) in patients with advanced CKD. We prospectively recruited 579 patients (CKD stage 3 or 4) from 11 medical centers in Korea from March 4, 2009 to August 31, 2010 and randomized them into an AST-120 arm and a control arm. Patients in the AST-120 arm were given 6 g AST-120 in three divided doses per day, and those in the control arm received only standard conventional treatment (open-label design) for 36 months or until the occurrence of primary outcomes. Levels of serum and urine indoxyl sulfate and β2-microglobulin decreased throughout the study period in both treatment arms; however, there was not a significant difference in change in uremic toxins in the AST-120 and control arms. The two arms were not different in the occurrence of composite primary outcomes (100 events in 272 individuals in the AST-120 arm and 100 events in 266 individuals in the control arm; hazard ratio, 1.12; 95% confidence interval, 0.85 to 1.48; log-rank P=0.45). The decline in eGFR and change in proteinuria were similar in the two treatment arms over time (Prandomization-time=0.64 and Prandomization-time=0.16, respectively). There was no difference in mortality (nine deaths in the AST-120 arm and 11 deaths in the control arm; log-rank P=0.73) or unplanned hospitalizations (102 in the AST-120 arm and 109 in the control arm; log-rank P=0.76) in the two treatment arms. There was no significant difference of the health-related quality of life score between the two arms. Long-term use of AST-120 added to standard treatment did not change renal disease progression, proteinuria, mortality, and health-related quality of life in patients with advanced renal dysfunction.

A Comparative Evaluation of Early Stent Occlusion Among Biliary Conventional Versus Wing Stents

Conventional plastic stents with a lumen typically have limited patency. The lumenless wing stent was engineered to overcome this problem. The objective of this study was to compare the incidence of early stent occlusion (symptomatic occlusion/cholangitis necessitating re-insertion within 90 days) for wing stents and conventional plastic stents. Patients with biliary pathology treated with plastic biliary stenting during the period 2003-2009 comprised the study cohort. Patients who had at least one biliary wing stent placed comprised the wing stent group, whereas patients who underwent only conventional stent plastic placement comprised the conventional stent group. Patients were stratified by indication: benign biliary strictures (group 1), malignant biliary strictures (group 2), or benign biliary non-stricture pathology (group 3). The association of stent type with the occurrence of primary outcome by indication was analyzed by use of multivariable logistic regression. Three-hundred and forty-six patients underwent 612 ERCP procedures with placement of plastic biliary stent(s). On multivariate analysis, early stent occlusion did not differ between the wing and conventional groups in groups 1, 2, and 3. Among patients who achieved primary outcome in group 2, significantly fewer patients in the wing group had cholangitis (6.7% vs. 39.1%, P = 0.03). Among patients who achieved primary outcome in group 3, significantly fewer patients in the wing group had cholangitis (10% vs. 50%, P = 0.03). Early stent occlusion was similar for wing stents and conventional plastic stents. Wing stents, however, were associated with a lower incidence of cholangitis in patients with malignant biliary obstruction and benign non-stricturing biliary pathology.

Prognóstico em médio prazo da cintilografia de perfusão miocárdica de estresse na unidade de dor torácica

To evaluate the prognostic value of stress myocardial perfusion scintigraphy (MPS) applied to patients with suspected acute coronary syndrome (ACS). Retrospective study. Patients with suspected acute coronary syndrome (ACS) admitted into the chest pain unit (CPU) from December 2002 to April 2004, after exclusion of acute myocardial infarction (AMI) and high risk unstable angina they underwent stress MPS. Selected 301 patients, 65.3 +/- 12.5 years and 164 (54.5%) male gender. The test was performed 13 +/- 12 hours after admission. Myocardial ischemia (ISQ) was found in 142 patients (47.2%). Male gender (n=94, p=<0.0001), history of diabetes mellitus (n=31, p=0.033), past of AMI (n=52, p=<0.0001), past of surgical myocardial revascularization (n=46, p=<0.0001) and past of percutaneous revascularization (n=68, p=<0.0001) presented correlation with ISQ. The follow-up was 697.7 +/- 326.6 days. No MPS variable correlated with the occurrence of primary outcome. Abnormal scintigraphy (n=76, p < 0.0001), ISQ (n=73, p < 0.0001) and post-stress left ventricular ejection fraction below 45% (n=21, p=0.006) correlated with secondary outcome. The presence of ISQ was the major variable in the multivariate analysis for the prediction of secondary outcome (RR = 6.5; CI 95% = 0.009). Presence of ISQ was the major independent factor in prediction of adverse events for patients admitted into the CPU.