Virtual histology intravascular ultrasound (VH-IVUS) analyses were performed in the first 990 patients enrolled in the 3,000+ patient global VH-IVUS Registry to assess the impact of gender and age on ...in vivo VH-IVUS plaque characterization. The 990 patients were divided into 3 age group terciles (<58, 58 to 68, and >68 years) and again divided according to gender. In conclusion, (1) both women and men had an increase in plaque with increasing age; (2) at any age, men had more plaque than women; (3) percentages of dense calcium and necrotic core increased with increasing patient age in both men and women; and (4) gender differences were lowest in the oldest tercile (>68 years).
Background
Embedding Public and Patient Involvement (PPI) in postgraduate research has been recognized as an important component of post-graduate training, providing research scholars with an ...awareness and a skillset in an area which prepares them for future roles as healthcare researchers. Improving Pathways for Acute STroke And Rehabilitation (iPASTAR) is a structured PhD training program Collaborative Doctoral Award (CDA) which aims to design a person-centered stroke pathway throughout the trajectory of stroke care, to optimize post-stroke health and wellbeing. PPI is embedded at all stages.
Purpose
The iPASTAR research programme was strongly informed by a round-table PPI consultation process with individuals who experienced stroke and who provided broad representation across ages, gender, geographical locations (urban and rural) and the PhD themed areas of acute care, early supported discharge and lifestyle-based interventions after stroke. Four PhD scholars taking part in the CDA-iPASTAR now work collaboratively with four stroke champions, supported by a wider PPI advisory panel.
Methods
This study will evaluate the process and impact of embedding PPI during a PhD program. We will conduct a longitudinal mixed-methods evaluation, conducting focus groups at 24, 36, and 48 months to explore the experiences of the key stakeholders involved. The participants will include PhD scholars, PPI partners (PPI Advisory Group and PPI Champions), PhD supervisors and a PPI manager. An independent researcher will conduct the evaluation. We will include focus groups, individual interviews and participant reflections. Qualitative data will be analyzed using thematic and content analysis, quantitative data will be analyzed using descriptive statistics.
Discussion
PPI and patient voice initiatives bring together researchers, family, and people with health care issues into meaningful dialogue and allow the development of a patient-voice learning network. Embedding PPI training within a PhD program can build meaningful capacity in PPI partnerships in stroke research.
Objectives The purpose of this study was to assess the prognostic impact of intraprocedural thrombotic events (IPTE) during percutaneous coronary intervention (PCI). Background Ischemic complications ...of PCI are infrequent but prognostically important. How often these events are a consequence of intraprocedural complications is unknown, with only limited data assessing the occurrence and importance of IPTE. Methods A total of 3,428 patients who underwent PCI for non–ST-segment elevation acute coronary syndrome in the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial underwent detailed frame-by-frame core laboratory angiographic analysis. An IPTE, defined as the development of new or increasing thrombus, abrupt vessel closure, no reflow, slow reflow, or distal embolization at any time during the procedure, occurred in 121 patients (3.5%). Results Patients with IPTE had higher in-hospital, 30-day, and 1-year major adverse cardiac event rates than patients without IPTE (25.6% vs. 6.3% in-hospital, 30.6% vs. 9.3% at 30 days, and 37.0% vs. 20.5% at 1 year; p < 0.0001 for each). An IPTE was strongly associated with Q-wave myocardial infarction and out-of-laboratory definite/probable stent thrombosis (in-hospital 3.3% vs. 0.5%, p = 0.006; 30 days 5.8% vs. 1.3%, p < 0.0001; and 1 year 6.7% vs. 2.0%, p = 0.0002). Unplanned revascularization, target vessel revascularization, and major bleeding not associated with coronary artery bypass graft surgery were also increased among patients with IPTE, as was overall 30-day mortality (3.3% vs. 0.7%, p = 0.002). Moreover, IPTE was an independent predictor of 30-day and 1-year composite death/myocardial infarction, stent thrombosis, and major adverse cardiac events. Conclusions Although infrequent among patients undergoing early PCI for moderate and high-risk non–ST-segment elevation acute coronary syndrome, IPTE was strongly associated with subsequent adverse outcomes including death, myocardial infarction, and stent thrombosis.
Regression to the Mean in SYMPLICITY HTN-3 Pocock, Stuart J., PhD; Bakris, George, MD; Bhatt, Deepak L., MD, MPH ...
Journal of the American College of Cardiology,
11/2016, Letnik:
68, Številka:
18
Journal Article
Recenzirano
Odprti dostop
Abstract Regression to the mean (RTM) describes the tendency for an extreme measurement on 1 occasion to become less extreme when measured again. RTM may affect clinical trial data interpretation ...when the outcome measure has high variability. We investigated RTM in the SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) trial of renal denervation versus a sham procedure. Analysis of covariance was performed on the 6-month change in systolic blood pressure, estimating a mean treatment difference of −4.11 mm Hg (95% confidence interval: −8.44 to 0.22 mm Hg; p = 0.064), which was similar to the unadjusted difference but with a smaller confidence interval. RTM occurred in both arms, but it had a negligible effect on the observed treatment difference. A second example concerns changes in hemoglobin A1c in a nonrandomized study. These findings emphasize the importance of incorporating RTM and analysis of covariance into the design and reporting of clinical studies of how treatments affect time changes in quantitative outcomes. (Renal Denervation in Patients With Uncontrolled Hypertension SYMPLICITY HTN-3; NCT01418261 )
The SPYRAL HTN-OFF MED Pivotal trial demonstrated that RDN was efficacious compared to a sham control. The underlying model was an extension of the analysis of covariance (ANCOVA) model, adjusted for ...baseline blood pressure (BP), and allowed borrowing of information from the previously reported feasibility study using a novel Bayesian method. Fundamental to the estimation of a treatment effect for efficacy are a multitude of statistical modelling assumptions, including the role of outliers, linearity of the association between baseline BP and outcome, and parallelism of the treatment effect difference over the baseline BP range. In this report, we examine the validity of these assumptions to verify the robustness of the treatment effect measured.
We examined the requisite modelling assumptions of the ANCOVA model fitted to the SPYRAL HTN-OFF MED Pivotal trial using Bayesian methods. To address outliers, we fit a robust regression model (with heavy tailed errors) to the data with diffuse weakly informative prior distributions on the parameters. To address linearity, we replaced the linear baseline term by a natural spline term with 4 degrees of freedom. To address parallelism, we refit the ANCOVA model with an interaction term for treatment arm and baseline BP.
ANCOVA models were fitted to the trial data (pooled across the feasibility and pivotal cohorts) using Bayesian methodology with diffuse (non-informative) prior distributions. The modelling assumptions inherent to the ANCOVA models were shown to be broadly satisfied. A robust ANCOVA model yielded a posterior treatment effect of -4.1 mmHg (95% credible interval: -6.3 to -1.9) indicating the influence of outlier values was small. There was moderate evidence of an interaction term effect between baseline BP and treatment, but no evidence of gross violation of linearity in baseline BP.
The posterior treatment effect estimate is shown to be robust to underlying model assumptions, thus further supporting the evidence of RDN to be an efficacious treatment for resistant hypertension.
Myocardial salvage is often suboptimal after percutaneous coronary intervention in ST-segment elevation myocardial infarction. Posthoc subgroup analysis from a previous trial (AMIHOT I) suggested ...that intracoronary delivery of supersaturated oxygen (SSO(2)) may reduce infarct size in patients with large ST-segment elevation myocardial infarction treated early.
A prospective, multicenter trial was performed in which 301 patients with anterior ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention within 6 hours of symptom onset were randomized to a 90-minute intracoronary SSO(2) infusion in the left anterior descending artery infarct territory (n=222) or control (n=79). The primary efficacy measure was infarct size in the intention-to-treat population (powered for superiority), and the primary safety measure was composite major adverse cardiovascular events at 30 days in the intention-to-treat and per-protocol populations (powered for noninferiority), with Bayesian hierarchical modeling used to allow partial pooling of evidence from AMIHOT I. Among 281 randomized patients with tc-99m-sestamibi single-photon emission computed tomography data in AMIHOT II, median (interquartile range) infarct size was 26.5% (8.5%, 44%) with control compared with 20% (6%, 37%) after SSO(2). The pooled adjusted infarct size was 25% (7%, 42%) with control compared with 18.5% (3.5%, 34.5%) after SSO(2) (P(Wilcoxon)=0.02; Bayesian posterior probability of superiority, 96.9%). The Bayesian pooled 30-day mean (+/-SE) rates of major adverse cardiovascular events were 5.0+/-1.4% for control and 5.9+/-1.4% for SSO(2) by intention-to-treat, and 5.1+/-1.5% for control and 4.7+/-1.5% for SSO(2) by per-protocol analysis (posterior probability of noninferiority, 99.5% and 99.9%, respectively).
Among patients with anterior ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention within 6 hours of symptom onset, infusion of SSO(2) into the left anterior descending artery infarct territory results in a significant reduction in infarct size with noninferior rates of major adverse cardiovascular events at 30 days. Clinical Trial Registration- clinicaltrials.gov Identifier: NCT00175058.
Background Several prognostic risk scores have been developed for patients with coronary artery disease, but their comparative use in patients with non–ST-segment elevation acute coronary syndromes ...(NSTEACS) undergoing percutaneous coronary intervention (PCI) has not been examined. We therefore investigated the accuracy of the Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) score, Clinical Synergy Between PCI With Taxus and Cardiac Surgery score (CSS), New Risk Stratification (NERS) score (NERS), Age, Creatinine, Ejection Fraction (ACEF) score, Global Registry for Acute Coronary Events (GRACE) score, and Thrombolysis in Myocardial Infarction (TIMI) score for risk assessment of 1-year mortality, cardiac mortality, myocardial infarction, target vessel revascularization, and stent thrombosis in patients with NSTEACS undergoing PCI. Methods The 6 scores were determined in 2,094 patients with NSTEACS treated with PCI enrolled in the angiographic substudy of the ACUITY trial. The prognostic accuracy of the 6 scores was assessed using the c statistic for discrimination and the Hosmer-Lemeshow test for calibration. The index of separation and net reclassification improvement (NRI) were also determined. Results Scores incorporating clinical and angiographic variables (CSS and NERS) showed the best tradeoff between discrimination and calibration for most end points, with the best discrimination for all end points and good calibration for most of them. The CSS had the best index of separation for most ischemic endpoints and displayed an NRI for cardiac death and myocardial infarction (MI) compared to the other scores, whereas NERS displayed an NRI for all-cause death and target vessel revascularization. The 3 scores—CSS, NERS, and SYNTAX—were the only scores to have both good discrimination and calibration for cardiac mortality. Conclusions In patients with NSTEACS undergoing PCI, risk scores incorporating clinical and angiographic variables had the highest predictive accuracy for a broad spectrum of ischemic end points.
Background: It is unclear whether renal denervation (RDN) can safely result in blood pressure (BP) reductions in Asian hypertensive patients and whether such reductions would be sustainable. The ...study is to assess the safety and efficacy of RDN achieved by either main renal artery ablation using the Symplicity Flex^(TM) catheter or main plus branch renal artery ablations using the Symplicity Spyral^(TM) catheter in Taiwanese uncontrolled hypertensive patients enrolled in the Global SYMPLICITY Registry (GSR) with 3 years of follow-up. Methods: The GSR is a prospective, open-label, and all-comer registry to evaluate the safety and effectiveness of RDN in patients with uncontrolled hypertension worldwide. Results: Among 26 patients enrolled (mean age, 59.1 ± 13.8 years), 8 were treated with the Symplicity Flex^(TM) catheter, and 18 were treated with the Symplicity Spyral^(TM) catheter. Baseline office systolic BP was 168.2 ± 19.8 mmHg and diastolic BP was 89.0 ± 14.3 mmHg. Office BP reductions following RDN were sustained throughout the follow-up periods of up to 3 years in the Symplicity Flex^(TM) group and 2 years in the Symplicity Spyral^(TM) group. In the Symplicity Flex^(TM) group, the office systolic BP reductions were 14.9 ± 14.7 mmHg and 29.7 ± 25.9 mmHg at 3 months and 3 years, respectively (both p ＜ 0.05 from baseline). In the Symplicity Spyral^(TM) group, the office systolic BP reductions were 21.2 ± 28.7 mmHg and 42.4 ± 10.7 mmHg at 3 months and 2 years, respectively (both p ＜ 0.05 from baseline). There were no significant changes in heart rate or antihypertensive medication classes. Three protocol-defined adverse events occurred in 2 patients, including new-onset end-stage renal disease, stroke, and hospitalization for new-onset heart failure. Conclusions: Given the susceptibility of Asian populations to hypertension, RDN, as a safe antihypertensive procedure with long-lasting BP-lowering effects, could reliably serve as an alternative or complementary BP-lowering strategy for patients with uncontrolled hypertension in Taiwan and other Asian countries.
Objective This study aimed to compare infarct size and clinical outcomes in patients with proximal versus mid left anterior descending (mLAD) infarction. Background The extent of myocardium at risk ...is an important prognostic determinate in patients with ST-segment elevation myocardial infarction. Methods The INFUSE-AMI trial randomized patients with anterior ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with bivalirudin anticoagulation to intracoronary (IC) bolus abciximab versus no abciximab and to thrombus aspiration versus no aspiration. The primary end point was magnetic resonance imaging infarct size (% of left ventricular mass) at 30 days. Lesion location was independently assessed and was defined as proximal (pLAD) if present before or at first significant septal perforator branch, or mLAD if beyond. Results Among 452 patients, 292 (64.7%) had pLAD and 159 (35.3%) had mLAD occlusions. Patients with pLAD infarcts were significantly more likely to have Killip class >1 heart failure and ejection fraction <40% and to present earlier to the hospital. Proximal LAD infarcts had significantly lower rates of final Thrombolysis In Myocardial Infarction flow 3 and procedural success but similar rates of myocardial blush grade 2/3 and ST-segment resolution compared with mLAD infarcts. Infarct size at 30 days was significantly greater in the pLAD group (19.3% 9.2-25.9 vs 14.3% 6.2-18.9, P < .0001). Mortality at 30 days was also higher in the pLAD group (4.2% vs 0.6%, P = .04). The effect of IC abciximab on reducing infarct size was comparable in both groups. Conclusion ST-segment elevation myocardial infarction caused by pLAD compared with mLAD occlusion results in larger infarcts and greater mortality even with contemporary reperfusion therapy.
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