Incidence Of Secondary End Point Research Articles

Comparison of Various Regimens of Antithrombotic Therapy in Patients With Valvular Heart Disease and Coronary Artery Disease After Surgical and Interventional Interventions

To evaluate the postoperative incidence of bleeding, incidence of thromboembolic complications, and all-cause mortality in patients with valvular heart disease and ischemic heart disease (IHD) associated with various regimens of the antithrombotic treatment during one year after surgery. This study included 271 patients with valvular heart disease and IHD after heart valve replacement and myocardial revascularization from 2009 through 2018. However, during the follow-up period (12 months), contact with 12 patients was lost, and therefore these patients were excluded from the study. Further analysis included 259 patients. Coronary artery bypass grafting (CABG) in combination with heart valve intervention was performed in 217 (83.8 %) patients, and percutaneous coronary interventions (PCIs) were performed in 42 (16.2 %) patients. There were 197 (72.7 %) male participants; median age was 64.0 [58.0; 67.5] years. The patients were divided into two groups. Group 1 consisted of 113 patients who received postoperative dual antithrombotic therapy (DAT) with acetylsalicylic acid (ASA)/clopidogrel+vitamin K antagonist (VKA). Group 2 included 146 patients receiving postoperative triple antithrombotic therapy (TAT) with ASA+clopidogrel+VKA. Follow-up duration was 12 months after surgery. Due to significant intergroup differences in major clinical anamnestic data, the data were adjusted using pseudo-randomization (Propensity Score Matching, PSM). In result, 109 patients were selected for each group. The incidence of adverse hemorrhagic outcomes was significantly higher in the group treated with TAT than with DAT. Minor bleedings were observed in 19 (17.4 %) vs. 8 (7.3 %) cases; moderate, clinically significant bleedings in 16 (14.7 %) vs. 6 (5.5 %) cases; and the total number of bleedings was 35 (32.1 %) vs. 14 (12.8 %; p=0.02, p=0.02, and р=0.001, respectively). Comparing the incidence of major bleedings did not show and significant intergroup differences (p=1.000). The incidence rate of any bleeding during the follow-up period was 32.1 % in patients treated with TAT (n=109) and 12.8 % in patients treated with DAT (n=109; p=0.005). The incidence of no bleeding during one year after surgery was 87 % in the DAT treatment group and 67 % in the TAT treatment group (p=0.005). The incidence of secondary endpoints, including ischemic stroke, myocardial infarction, prosthetic valve thrombosis, and death, was statistically non-significant. Administration of DAT vs. TAT after heart valve replacement and myocardial revascularization significantly decreases the incidence of any bleedings in the absence of significant differences in the incidence of thromboembolic events and mortality.

Effect of Perindopril on Atrial Fibrillation Recurrence and Burden: Results of the Canadian Trial of Atrial Fibrillation (CTAF)-2

BackgroundHypertension is a risk factor for the development and exacerbation of atrial fibrillation (AF). Angiotensin-converting enzyme inhibitors are a standard-of-care treatment option for patients with hypertension; however, there is conflicting evidence about their effects on AF recurrence. Therefore, our objective was to assess the efficacy of perindopril, compared with placebo, to reduce AF recurrence in patients with hypertension and AF. MethodsIn a multicenter, double-blind, placebo-controlled trial, patients with hypertension and symptomatic AF were randomly assigned (1:1) to perindopril or placebo based on a stratification factor of antiarrhythmic drug use. Patients with terminated AF were followed up from 30 days after randomization to 7 to 13 months. The primary endpoint was AF recurrence. Secondary endpoints included AF hospitalization, cardioversion, and blood pressure control. Recurrent events, AF burden, and safety endpoints were also investigated. ResultsA total of 315 patients were randomly assigned, and 301 patients were included in the modified intent-to-treat analysis (155 vs 146 patients in the perindopril and placebo groups, respectively). The mean follow-up was 336 ± 70 days, and 91.1% of patients were compliant to the treatment medication throughout the study. After adjustment for baseline antiarrhythmic drugs, there was no statistically significant difference in the hazards of AF recurrence (hazard ratio, 1.22; 95% confidence interval, 0.92-1.61), with similar blood pressure. The incidence of secondary endpoints and adverse events also did not differ between treatment arms. ConclusionsPerindopril does not reduce recurrence or the number of AF episodes in patients with hypertension and AF.

Abstract 14484: The Association of Pre-operative Glycemic Control With Long-term Survival in Diabetic Patients After Coronary Artery Bypass Grafting

Introduction: We analyzed the national Veteran Affairs (VA) data to evaluate the association of preoperative glycated Hemoglobin (HbA1c) and long-term outcome after isolated coronary artery bypass grafting (CABG). Methods: Between January 2007 - December 2014, Veterans with diabetes mellitus (DM) that underwent isolated CABG were divided on into three groups (I: HbA1c < 8%, II: HbA1c 8 - 10% and III: HbA1c > 10%). Demographic and clinical differences between groups were evaluated with the t-test or chi-square test. The relationship of preoperative HbA1c and long-term survival was evaluated with a multivariable proportional hazards model; restricted cubic splines were used to model non-linear effects. The cumulative incidence of secondary end-points (myocardial infarction, urgent revascularization) for each group was modeled as a competing-risk analysis. Results: Overall, 3,210 patients (mean age 64.6 years, male 98.8%; insulin dependent - 53%) with DM underwent isolated CABG. Group III patients were younger (61 vs 65 years in group I). Median HbA1c levels were similar between races (white - 7.3% and blacks - 7.35%). Insulin dependence was higher in group III (79.3%) vs groups I (43.5%) and II (69.9%). In groups I,II and III, 5 and 10 year survival was 76.2%, 74.4%, 75.4% and 38.9%, 36.9% and 30.2% respectively. HbA1c was observed to have a J-shaped association with mortality with values < 6% and > 9% at higher risk of death. Left ventricular systolic dysfunction [HR 1.5 (1.3 - 1.7)], prior myocardial infarction [HR 1.3 (1.2 - 1.5)] and insulin dependence [HR 1.4 (1.2 - 1.5)] were also associated with lower survival. Myocardial infarction was observed in 9.8% , 13.4% and 12.8% patients in groups I, II and III respectively. Conclusions: Pre-operative HbA1c impacts long-term survival among diabetic patients undergoing CABG. We observed a J-shaped relationship between HbA1c and survival with values < 6% and > 9% associated with increased mortality.

Safety and efficacy of frequency-domain optical coherence tomography in evaluating and treating intermediate coronary lesions.

AIMTo establish whether frequency-domain optical coherence tomography (FD-OCT) is safe and effective in the evaluation and treatment of angiographically-intermediate coronary lesions (ICL)METHODSSixty-four patients with 2-dimensional quantitative coronary angiography (2D-QCA) demonstrating ICL were included. OCT imaging was performed. According to predetermined OCT criteria, patients were assigned to either of 2 groups: OCT-guided percutaneous coronary intervention (PCI) or OCT-guided optimal medical therapy (OMT). The primary efficacy endpoint was to demonstrate the superiority and higher accuracy of FD-OCT compared to 2D-QCA in evaluating stenosis severity in patients with ICL. The primary safety endpoint was the incidence of 30-d major adverse cardiac events (MACE). Secondary endpoints included MACE at 12 mo and other clinical events.RESULTSAnalysis of the primary efficacy endpoint demonstrates that 2D-QCA overestimates the stenosis severity of ICL in both the OCT-guided PCI and OMT groups, proving FD-OCT to be superior to and more precise than 2D-QCA in treating this subset of lesions. The primary safety endpoint was fully met with the incidence of 30-d MACE being nil in both the OCT-guided PCI and OCT-guided OMT groups. Incidences of secondary endpoints were found to be low in both arms, the only exception being the relatively high incidence of recurrent episodes of angina which was, however, very similar in the 2 groups.CONCLUSIONFD-OCT is safe and effective in the evaluation and treatment of ICL. Larger studies are needed to firmly establish the efficacy and safety of FD-OCT in treating ICL across all coronary artery disease population subgroups.

Predictive Value of Combining the Ankle-Brachial Index and SYNTAX Score for the Outcome in STEMI Patients Undergoing Primary Percutaneous Coronary Intervention

AbstractBackground: The Synergy between PCI with TAXUS and Cardiac Surgery (SYNTAX) score is effective for prediction of clinical outcome after Percutaneous Coronary Intervention (PCI). However, its predictive ability is low because it reflects only the coronary characterization.Objective: Evaluation of predictive value of combining the Ankle-Brachial Index (ABI) and SYNTAX score for the outcome in STEMI patients undergoing primary percutaneous coronary intervention.Methods: A prospective observational cohort study con-ducted from June 2016 to May 2017 at Cardiovascular Med-icine Department, Tanta University Hospitals in Gharbia Governorate, Egypt. The study enrolled 90 consecutive adult patients of both genders who were diagnosed with definite ST-segment elevation myocardial infarction within 12 hours from the time of symptoms onset, and were treated by primary percutaneous coronary intervention. SYNTAX score was calculated based on its results. ABI-SYNTAX score was calculated by first reclassifying the ABI and SYNTAX scores and then adding them. ABI 0.9 to 1.3 as 0 points; and SYNTAX score 33 as 2 points. The resulting scores were added. Patients were classified into 3 groups: ABI-SYNTAX score low (0), ABI-SYNTAX score moderate (1 or 2), and ABI-SYNTAX score high (3 or 4).Results: Incidence of MACEs was higher among patients with high ABI-SYNTAX score. From the total incidence of MACEs in the study population (n=17), 12 were present in group III (70.6%), 4 in group II (23.5%) and 1 in group I (5.9%). ABI-SYNATX score was more sensitive than SYNTAX score alone for detection of occurrence of MACEs in patients with high score (group III). Incidence of secondary endpoints, defined as stent thrombosis, in stent restenosis, re-hospitalization with acute coronary syndrome and target lesion revascularization, was higher in group III.Conclusion: ABI- SYNTAX score is an independent prognostic factor for both in-hospital adverse outcomes, as well as, short-term adverse outcomes among STEMI patients who underwent primary PCI. It improved the ability of the SYNTAX score which assesses the angiographic characteristics and complexity of coronary artery lesions by combining the SYNTAX score with ABI. The predictive value of ABI-Syntax score with respect to MACEs was superior to Syntax score alone.

Effects of Bisoprolol Are Comparable with Carvedilol in Secondary Prevention of Acute Myocardial Infarction in Patients Undergoing Percutaneous Coronary Intervention.

Although the benefits of carvedilol have been demonstrated in the era of percutaneous coronary intervention (PCI), very few studies have evaluated the efficacy of bisoprolol in the secondary prevention of acute myocardial infarction (MI) in patients treated with PCI. We hypothesized that the effect of bisoprolol would not be different from carvedilol in post-MI patients. A total of 13,813 patients who underwent PCI were treated either with carvedilol or bisoprolol at the time of discharge. They were enrolled from the Korean Acute MI Registry (KAMIR). After 1:2 propensity score matching, 1,806 patients were enrolled in the bisoprolol group and 3,612 patients in the carvedilol group. The primary end point was the composite of major adverse cardiac events (MACEs), which was defined as cardiac death, nonfatal MI, target vessel revascularization, and coronary artery bypass surgery. The secondary end point was defined as all-cause mortality, cardiac death, nonfatal MI, any revascularization, or target vessel revascularization. After adjustment for differences in baseline characteristics by propensity score matching, the MACE-free survival rate was not different between the groups (HR=0.815, 95% CI:0.614–1.081, p=0.156). In the subgroup analysis, the cumulative incidence of MACEs was lower in the bisoprolol group in patients having a Killip class of III or IV than in the carvedilol group (HR=0.512, 95% CI: 0.263–0.998, p=0.049). The incidence of secondary end points was similar between the two beta-blocker groups. In conclusion, the benefits of bisoprolol were comparable with those of carvedilol in the secondary prevention of acute MI.

Long-term follow-up of Chinese herbal medicines combined with conventional treatment in patients with acute coronary syndrome after percutaneous coronary intervention: A multicenter randomized controlled trial.

To evaluate the prognosis effect of Chinese herbal medicines (CHMs) for benefiting qi and activating blood circulation adjunctive to conventional treatment in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI). A total of 702 patients with ACS who underwent PCI were enrolled and randomly assigned to receive conventional treatment plus CHMs for benefiting qi and activating blood circulation (treatment group, 351 cases) or conventional treatment alone (control group, 351 cases) for 6 months. Six months later, all patients received conventional treatment alone. Follow-ups were scheduled at 6th, 12th, 18th, 24th month after enrollment in April 2008, and the final follow-up visit was during September 2011 and November 2011. The primary endpoint was the composite of cardiac death, nonfatal myocardial infarction or revascularization (PCI or coronary artery bypass grafting); and the secondary endpoint was the composite of re-admission for ACS, congestive heart failure, nonfatal stroke or other thrombus events. A total of 621 (88.59%) patients completed 35.4±3.8 months follow-up, while 80 (11.41%) patients withdrew from the trial (41 in the treatment group and 39 in the control group). The incidence of primary endpoint was 5.7% (20 patients) in the treatment group versus 10.86% (38 patients) in the control group [relative risk (RR): 0.53; 95% confidence interval (CI): 0.30, 0.88; P=0.013; absolute risk reduction (ARR):-0.052, 95% CI: -0.06, 0.01]. The incidence of secondary endpoint was 5.98% (21 patients) in the treatment group versus 10.28% (36 patients) in control group (RR: 0.58, 95% CI: 0.33, 0.97, P=0.037; ARR: -0.043, 95% CI: 0.06, 0.01). Most of the primary and secondary endpoints were occurred in 18 months (84.50% in the treatment group versus 78.10% in the control group). CHMs for benefiting qi and activating blood circulation adjunctive to conventional treatment improved clinical outcomes for patients with ACS after PCI in long-term follow-up.

Abstract 17155: Complications with Cardiac Perforation and Lead Dislodgement of the 5086 MRI Pacing Lead

As the MR-conditional Medtronic 5086 lead has been implanted, there were some reports that the 5086 lead demonstrated higher lead dislodgement and cardiac perforation compared with the 5076 lead. However, little is known regarding the rates of complications between the 5086 lead and the 5076 lead especially in asian populations. The purpose of this study was to describe the incidence of lead-related complications including cardiac perforation and lead dislodgement of the 5086 lead compared to the 5076 lead and to investigate the clinical factors associated with development of cardiac perforation or lead dislodgement. This study was a retrospective single center study. Consecutive 292 patients who underwent dual chamber pacemaker implantation using either 5076 (N=121) or 5086 lead (N=171) between January 2008 and March 2014 were enrolled in this study. Primary endpoint was incidence of cardiac perforation with pericardial effusion or cardiac tamponade within 30 days of implant. Secondary endpoint was combined incidence of cardiac perforation or lead dislodgement. Primary outcome occurred in 3 patients with the 5806 lead (1.8%) and no patient with the 5076 lead (0.0%) (p=0.269). Lead dislodgement occurred in 9 patients with the 5806 lead (5.3%) and 5 patient with the 5076 lead (4.1%) (p=0.784) (Table1). There was no difference in the incidence of secondary endpoint between groups (7.0 vs 4.1%, p=0.447). On logistic regression analysis after multivariate adjustment, factors associated with an increased risk for dislodgement and cardiac perforation included heart failure, taking a rivaroxaban, and location of atrial lead other than right atrial appendage (Table2). Compared with the 5076 lead, the rate of cardiac perforation and lead dislodgement was not significantly higher with the 5086 MRI lead in asian population. Cardiac perforation and lead dislodgements occured more often in patient with heart failure, taking a rivaroxaban, and unusual location of atrial lead.

Propensity-matched lesion-based comparison of midterm outcomes of TAXUS Express and TAXUS Liberté stents for de novo native coronary stenosis

BackgroundWe examined the implication of the revised platform of TAXUS Liberté (TAXUS-Lib; Boston Scientific, Natick, MA, USA) from TAXUS Express (TAXUS-Exp; Boston Scientific) stents, after stent placements in a daily practice environment, on midterm clinical and angiographic outcomes. Methods and resultsBy adjusting historically different baselines with propensity score matching analysis in 1358 de novo native coronary stenoses, the incidence of the clinical safety endpoint (700-day cardiac death, nonfatal recurrent myocardial infarction, and definite stent thrombosis) after placement of TAXUS-Lib (0.60%; mean follow-up, 683±64 days) was not significantly different from that in the TAXUS-Exp group (1.20%; 677±96 days, p=0.182). Cardiac dysfunction (ejection fraction of left ventricle less than 40%) was the predictor of primary endpoint [odds ratio (OR), 17.8; 95% CI, 4.39–71.9; p<0.001]. In the baseline-adjusted angiographic followed-up lesions (n=443 in each arm), the incidence of secondary endpoint [binary in-stent restenosis: percent diameter stenosis (%DS) >50% at the follow-up angiography] in the TAXUS-Lib group (11.3%) was not significantly different from that in the TAXUS-Exp group (13.5%, p=0.368). TAXUS-Exp was not the predictor of secondary endpoint (OR, 1.20; 95% CI, 0.77–1.85; p=0.424). ConclusionsThe midterm clinical and angiographic outcomes after placement of the new TAXUS-Lib stent for de novo coronary stenosis in a daily practice environment were statistically equivalent compared to the former TAXUS-Exp.

Combination of Chinese Herbal Medicines and Conventional Treatment versus Conventional Treatment Alone in Patients with Acute Coronary Syndrome after Percutaneous Coronary Intervention (5C Trial): An Open-Label Randomized Controlled, Multicenter Study

Aims. To evaluate the efficacy of Chinese herbal medicines (CHMs) plus conventional treatment in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI). Methods and Results. Participants (n = 808) with ACS who underwent PCI from thirteen hospitals of mainland China were randomized into two groups: CHMs plus conventional treatment group (treatment group) or conventional treatment alone group (control group). All participants received conventional treatment, and participants in treatment group additionally received CHMs for six months. The primary endpoint was the composite of cardiac death, nonfatal recurrent MI, and ischemia-driven revascularization. Secondary endpoint was the composite of readmission for ACS, stroke, or congestive heart failure. The safety endpoint involved occurrence of major bleeding events. The incidence of primary endpoint was 2.7% in treatment group versus 6.2% in control group (HR, 0.43; 95% CI, 0.21 to 0.87; P = 0.015). The incidence of secondary endpoint was 3.5% in treatment group versus 8.7% in control group (HR, 0.39; 95% CI, 0.21 to 0.72; P = 0.002). No major bleeding events were observed in any participant. Conclusion. Treatment with CHMs plus conventional treatment further reduced the occurrence of cardiovascular events in patients with ACS after PCI without increasing risk of major bleeding.

Statins Reduce Incidence of Early Perioperative Complications and Length of in-Hospital Stay after Coronary Artery Bypass Graft Surgery

Background: Coronary artery bypass grafting (CABG) is associated with several perioperative complications that may significantly prolong length of in-hospital stay, increase costs and provide worse long term outcome. The 3-hydroxy-3-methylglutaryl-CoA (HMG-CoA) reductase inhibitors, or statins, exert anti-inflammatory and vascular protective effects. We hypothesized that pre-operatory statin therapy may reduce incidence of early perioperative complications and length of in-hospital stay following CABG.Methods: We retrospectively enrolled 103 patients (age 67±3; 18 females), who underwent CABG. Patients were allocated into 2 groups: 57 patients on statin therapy prior to CABG (St Group) and 46 patients not on statin therapy (n-St group). Demographic and clinical features, pre-operative medications use and the incidence of early adverse postoperative events were collected. Pre-operative risk of death using the European System for Cardiac Operative Risk Evaluation (EuroSCORE) was also calculated. The primary end-point was the composite of early complications occurring after surgery, including infections, bleedings, sustained ventricular and supra-ventricular tachyarrhythmias, cardiogenic shock, myocardial infarction and mortality. As secondary end-points single perioperative complications were considered. In-hospital stay length was also evaluated.Results: Clinical features, cholesterol levels and EuroSCORE were similar between two groups. Statin therapy and EuroSCORE emerged as predictors of the composite adverse outcome. n-St patients had a significant higher rate of early complications if compared with St patients: the primary endpoint occurred in 18 St patients (31%) versus 25 (54%) non-St patients (p=0.019). Multivariate analysis confirmed pre-operative statin therapy and EuroSCORE as independent predictors of the primary endpoint (OR=0.307, 95% CI=0.123-0.766, p=0.011 and OR= 2.114, 95% CI= 1.213- 4.407, p= 0.002 respectively) showing a protective role of the statin therapy.The incidence of secondary end-points did not differ significantly between the groups, while in-hospital stay was longer in n-St group if compared with St group (7.7±3,9 days vs 5,6±1,8 days; p=0,001).Conclusion: Our data suggest that statin therapy may reduce early perioperative complications after coronary artery bypass grafting. This effect is independent from cholesterol basal levels, thus supporting pre-operative statin use in patients undergoing CABG.