Gersh, Bernard J.

Objectives Compare the effect of apixaban and warfarin on coagulation and primary haemostasis biomarkers in atrial fibrillation (AF). Methods The biomarker substudy from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial included 4850 patients with AF randomised to treatment with apixaban or warfarin. Sixty per cent of patients used vitamin K antagonist (VKA) within 7 days before randomisation. Prothrombin fragment 1+2 (F1+2), D-dimer, soluble CD40 ligand (sCD40L) and von Willebrand factor (vWF) antigen were analysed at randomisation and after 2 months of study treatment. Results In patients not on VKA treatment at randomisation, F1+2 and D-dimer levels were decreased by 25% and 23%, respectively, with apixaban, and by 59% and 38%, respectively, with warfarin (p<0.0001 for treatment differences for both). In patients on VKA at randomisation, F1+2 and D-dimer levels increased by 41% and 10%, respectively, with apixaban and decreased by 37% and 11%, respectively, with warfarin (p<0.0001 for treatment differences for both). sCD40L levels were slightly increased at 2 months, regardless of VKA or randomised treatment. Apixaban and warfarin also both reduced vWF antigen regardless of VKA treatment. The efficacy (stroke) and safety (bleeding) of apixaban compared with warfarin was similar irrespectively of biomarker levels at 2 months. Conclusions Treatment with apixaban compared with warfarin for stroke prevention in patients with AF was associated with less reduction in thrombin generation and fibrin turnover. This effect of apixaban could contribute to the clinical results where apixaban was superior to warfarin both in stroke prevention and in reducing bleeding risk. Trial registration number NCT00412984.

Introduction: Shared decision making (SDM) incorporates patient and physician values and preferences into treatment selection. While multiple therapeutic options are available for stroke prevention in atrial fibrillation (AF), few studies have examined factors associated with SDM regarding choice of antithrombotic strategy. Methods: We evaluated survey data from 1006 patients with new-onset AF enrolled at 56 sites participating in a substudy of the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT II), an outpatient AF registry in the US. Patients were asked: “When choosing your blood thinner(s), who made this treatment decision?”, and SDM was defined as a response of “equally me and my healthcare provider (HCP)”, “mostly me” or “entirely me”, while no SDM was defined as a response of “mostly my HCP” or “entirely my HCP”. Multivariable logistic regression models evaluated associations between 13 patient-level factors, self-reported understanding of treatment options, and SDM for antithrombotic therapy. Results: Most patients allowed their HCP to make the therapeutic decisions on antithrombotic strategy, with 246 (24.5%) reporting SDM. Patients reporting SDM were more often female (47.2% vs. 40.5%) and were more frequently insured by Medicare (40.2% vs. 34.5%) than patients reporting no SDM. Among patients taking warfarin, median time in therapeutic range was higher among patients reporting SDM than among those not reporting SDM. In multivariable models, chronic obstructive pulmonary disease was associated with lower odds of SDM while self-reported understanding of blood thinner options was associated with higher odds of SDM (Table). Conclusion: One in four patients in an outpatient AF registry reported that their current antithrombotic strategy was the result of a shared decision making process. Additional work is need to determine whether patient-reported SDM is associated with medication adherence and outcomes of therapy.

Abstract Objectives We sought to identify clinical, electrocardiographic (ECG), and angiographic characteristics that are predictive of 3‐year mortality after primary percutaneous coronary intervention (PCI) in patients with non‐anterior ST‐elevation myocardial infarction (NA‐STEMI) from the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS‐AMI) trial. Background Which patients with NA‐STEMI undergoing PCI have a poor prognosis is uncertain. Methods NA‐STEMI was defined as ST‐segment elevation in lateral (V5, V6, I, aVL), inferior (II, III, aVF), or inferolateral (I, II, III, aVF, and V5‐V6) ECG leads or posterior myocardial infarction with ST‐segment depression of ≥1 mm in ≥2 contiguous anterior leads. Cox regression was used to identify independent predictors of 3‐year mortality. Missing data were imputed using multiple imputation. Results In HORIZONS‐AMI, 2,578/3,602 patients had no prior coronary artery bypass grafting, underwent single‐vessel PCI, and had baseline ECG data assessed in an independent core laboratory. Among them, 1,495 (58.0%) had NA‐STEMI. Patients with NA‐STEMI had lower 3‐year mortality risk than those with anterior STEMI (4.5% versus 7.1%, P = 0.004). The independent predictors of increased 3‐year mortality in NA‐STEMI were older age (median > 59.0 years), diabetes, reduced LVEF (≤50%), Killip class ≥2, post‐procedure TIMI flow 0–2 versus 3, renal insufficiency, and ST‐resolution <30% at 60 min post‐PCI. Patients with 0, 1, 2, 3, and ≥4 of these risk factors had 3‐year mortality rates of 1.8%, 2.3%, 3.1%, 6.1%, and 36.3%, respectively ( P < 0.0001). Conclusions Although NA‐STEMI carries a better prognosis than anterior STEMI, high‐risk patient cohorts with NA‐STEMI may be identified who have substantial 3‐year mortality.

Background There are limited data on the role of temporary mechanical circulatory support ( MCS ) devices for cardiogenic shock before left ventricular assist device ( LVAD ) surgery. This study sought to evaluate the trends of use and outcomes of MCS in cardiogenic shock before LVAD surgery. Methods and Results This was a retrospective cohort study from 2005 to 2014 using the National Inpatient Sample (20% stratified sample of US hospitals). This study identified admissions undergoing LVAD surgery with preoperative cardiogenic shock. Admissions for other cardiac surgery and heart transplant were excluded. Temporary MCS was identified using administrative codes. The primary outcome was hospital mortality and secondary outcomes were hospital costs and lengths of stay in admissions with and without MCS use. In this 10‐year period, 9753 admissions were identified with 40.6% requiring pre‐ LVAD MCS . There was a temporal increase in the frequency of cardiogenic shock associated with an increase in non–intra‐aortic balloon pump MCS devices. The cohort receiving MCS had greater in‐hospital myocardial infarction, ventricular arrhythmias, and use of coronary angiography. On multivariable analysis, older age, myocardial infarction, and need for MCS devices were independently predictive of higher in‐hospital mortality. In 696 propensity‐matched pairs, use of MCS was predictive of higher in‐hospital mortality (odds ratio 1.4 [95% confidence interval 1.1–1.6]; P =0.02) and higher hospital costs, but similar lengths of stay. Conclusions In patients with cardiogenic shock bridged to LVAD therapy, there was a steady increase in preoperative MCS use. Use of MCS identified patients at higher risk for in‐hospital mortality and greater resource utilization.

Introduction: Recent trials using insertable cardiac monitors (ICMs) show high rates of atrial fibrillation (AF) in those at risk of developing AF based on demographics. Further identifying subsets who could benefit most from ICMs is desirable. We evaluated if the recently-developed HAVOC risk score which has predicted AF in cryptogenic stroke patients also predicts AF detection by ICMs in those without a recent stroke. Methods: Participants from the prospective REVEAL AF study, which reported frequent clinically unrecognized AF in patients at risk for AF (CHADS 2 scores ≥3 or =2 with ≥1 additional risk factor), with ICM data and not on anti-arrhythmic drugs were included. Ischemic stroke <1 year ago excluded participation. HAVOC scores were calculated using points for hypertension (2), age ≥75 (2), valvular disease (2), vascular disease (1), obesity (1), congestive heart failure (4), and coronary artery disease (2). Prior stroke, an AF outcome, generally not a cause, is not included. Score classification is: low (0-4), intermediate (5-9), or high (10-14). Corresponding AF detection rates were compared via the log-rank test. Results: Among 391 participants, 95 (24%), 241 (62%), and 55 (14%) had low, intermediate, and high HAVOC scores, respectively. At 18 months, AF incidence was significantly less for those with low (19.5%) vs intermediate (32.1%) or high (34.2%) scores (p=0.045, Figure). At 18 months, AF incidence was similar among those with (n=79) vs. without (n=312) a history of remote stroke (27.1% vs. 29.9%; p>0.05, median time from stroke to ICM insertion=4 years). Conclusions: The HAVOC risk score identified a subset of high risk individuals at greatest risk of developing AF. AF incidence rates were similar among those with and without prior remote stroke. Remote strokes may not be a strong predictor of AF in this population. HAVOC scores could be a useful approach to identify those at high likelihood of manifesting AF, as best documented by long-term monitoring.

It was a randomized trial, and 308 patients undergoing revascularization were randomly assigned: 155 to off-pump coronary artery bypass (OPCAB) and 153 to on-pump coronary artery bypass (ONCAB). End points were freedom from death, myocardial infarction, revascularization, and cerebrovascular accidents. The rates for 10-year, event-free survival for ONCAB versus OPCAB were 69.6% and 64%, (hazard ratio [HR]: 0.88; 95% confidence interval [CI] 0.86-1.02; P = .41), respectively. Adjusted Cox proportional hazard ratio was similar (HR: 0.92; 95% CI 0.61-1.38, P = .68). A difference occurred between the duration of OPCAB and ONCAB, respectively (4.9 ± 1.5 vs 6.6 ± 1.1 h, P < .001). Statistical differences occurred between OPCAB and ONCAB in the length of intensive care unit (ICU) stay (20 ± 2.5 vs 48 ± 10 hours, P < .001), time to extubation (5.5 ± 4.2 vs 10.2 ± 3.5 hours, P < .001), hospital stay (6.7 ± 1.4 vs 9.2 ± 1.3 days, P < .001), higher incidence of atrial fibrillation (AF; 33 vs 5 patients, P < .001), and blood requirements (46 vs 64 patients, P < .001). Grafts per patient was higher in ONCAB (3.15 vs 2.55 grafts, P < .001). No difference existed between the groups in primary composite end points at 10-year follow-up. Although OPCAB surgery was related to a lower number of grafts and higher incidence of AF, it had no effects related to long-term outcomes.