Background Advances in coronary angioplasty and adjunct pharmacology have improved patient outcomes after primary percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI). ...However, several areas for improvement remain. Hemorrhagic complications, which are common in patients receiving intense anticoagulant and antiplatelet agents during primary PCI to suppress ischemia, have been strongly associated with early and late mortality. Moreover, restenosis after bare-metal stents (BMSs) frequently results in symptom recurrence and the need for repeat rehospitalization and revascularization procedures. Newer pharmacologic agents and drug-eluting stents may address both of these issues. Study Design In the HORIZONS-AMI trial, 3,602 patients with AMI undergoing primary PCI were prospectively randomized to unfractionated heparin plus routine use of glycoprotein (GP) IIb/IIIa inhibitors versus the direct thrombin inhibitor bivalirudin plus provisional use of GP IIb/IIIa inhibitors reserved for predefined thrombotic complications. In a second randomization, 3,011 eligible patients were randomly assigned to either a polymer-based paclitaxel-eluting stent or to an otherwise identical BMS. The study was powered for the assessment of sequential safety and efficacy end points for each specific randomization, with clinical end points assessed at 30 days, 1 year, and then annually for 5 years. Summary The ongoing HORIZONS-AMI trial will determine whether bivalirudin monotherapy reduces bleeding complications and improves overall event-free survival compared with unfractionated heparin plus the routine use of GP IIb/IIIa inhibitors in patients undergoing primary PCI for AMI. Furthermore, this study will determine whether paclitaxel-eluting stents safely reduce rates of ischemic target lesion revascularization compared with BMSs in the setting of primary PCI.
Background Both ST-segment resolution (STR) and myocardial blush grade (MBG) have prognostic utility after primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction. We ...sought to clarify how frequently MBG and STR provide discordant measures of reperfusion success and to determine the independent prognostic significance of each on long-term outcomes. Methods In HORIZONS-AMI, core laboratory measures of both MBG and STR were assessed in 2,367 patients undergoing primary PCI. Four groups were identified based on MBG (grades 2/3 vs 0/1) and STR (≥50% vs <50%). A multivariable model identified predictors of death and major adverse cardiac events at 3 years. Results Myocardial blush grade 2/3 was achieved in 77.7% of patients, and STR ≥50% was achieved in 75.1% of patients. Myocardial blush grade and STR were discordant in 765 patients (30.9%). By multivariable analysis, MBG 2/3 compared with 0/1 was an independent predictor of lower mortality at 3 years (4.4% vs 8.4%, adjusted hazard ratio HR = 0.57 0.39, 0.82, P = .003). In contrast, STR ≥50% compared with <50% was not associated with mortality (5.1% vs 5.9%, adjusted HR = 1.11 0.68, 1.56, P = .89). However, repeated revascularization at 3 years was less frequent when STR ≥50% (12.4% vs 17.6%, adjusted HR = 0.74 0.58, 0.95, P = .02). In contrast, MBG 2/3 vs 0/1 was not associated with reduced repeated revascularization (13.6% vs 14.1%, adjusted HR = 1.02 0.79, 1.33, P = .85). Conclusions In HORIZONS-AMI, MBG and STR after primary PCI were concordant in only 70% of patients and provided complementary prognostic information. Myocardial blush grade predicted long-term survival, whereas STR predicted freedom from repeated revascularization.
The aim of this study was to assess the impact of baseline anemia on the outcomes of patients with ST elevation myocardial infarctions who underwent primary percutaneous coronary intervention in ...relation to contemporary adjunctive antithrombotic therapy and gender. In the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, patients were randomized to bivalirudin alone or to unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor before primary percutaneous coronary intervention. Outcomes were assessed at 30 days and 1 year according to anemia and gender. Baseline anemia was present in 331 of 3,153 patients (10.5%). Patients with versus without baseline anemia had a more than twofold increase in major bleeding at 30 days (13.5% vs 6.7%, p <0.0001) and at 1 year (14.8% vs 7.2%, p <0.0001), an association that on multivariate analysis was independent of gender. Mortality was significantly higher in men with versus without baseline anemia (4.6% vs 1.8% at 30 days, p = 0.003; 8.9% vs 3.0% at 1 year, p <0.0001) but not in women (5.3% vs 3.6% at 30 days, p = 0.42; 7.5% vs 5.9% at 1 year, p = 0.54). On multivariate analysis, anemia independently predicted 1-year all-cause mortality in men but not in women. Bivalirudin compared with unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor resulted in twofold lower rates of all-cause and cardiac mortality and major bleeding in patients without but not in those with baseline anemia. In conclusion, baseline anemia was associated with increased major bleeding and death in patients with ST elevation myocardial infarctions who underwent primary PCI but was a stronger predictor of early and late mortality in men than in women. Paradoxically, in this post hoc analysis, the reductions in major bleeding and mortality in ST elevation myocardial infarction afforded by bivalirudin occurred primarily in patients without baseline anemia.
The prognostic importance of renal insufficiency (RI) in patients undergoing primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) has not been well characterized.
...PCI was performed in 2082 AMI patients without shock presenting within 12 hours of symptom onset in a prospective, multicenter randomized trial. RI was defined as a calculated (Cockroft-Gault) creatinine clearance (CrCl) < or =60 mL/min. RI at baseline was present in 18% of patients. Compared with patients without RI, patients with RI were older and were more likely to be female; to have hypertension, peripheral vascular disease, or cerebrovascular disease; and to present in heart failure. Mortality was markedly increased in patients with versus without baseline RI both at 30 days (7.5% versus 0.8%, P<0.0001) and at 1 year (12.7% versus 2.4%, P<0.0001). Mortality rates increased incrementally for every 10-mL/min decrease in baseline CrCl. By multivariate analysis, reduced baseline CrCl was a powerful independent predictor of 30-day mortality (hazard ratio, 5.77; P<0.0001) and remained associated with reduced survival at 1 year (hazard ratio, 1.98; P=0.08). Hemorrhagic complications and transfusion requirements were also increased more than 2-fold in patients with RI, as were severe restenosis (diameter stenosis > or =70%; 20.6% versus 11.8%, P=0.024) and infarct artery reocclusion (14.7% versus 7.3%, P=0.02).
Baseline RI in patients with AMI undergoing primary PCI is associated with a markedly increased risk of mortality, as well as bleeding and restenosis. Novel approaches are needed to improve the otherwise poor prognosis of patients with RI and AMI.
Objectives This study sought to evaluate the impact of chronic kidney disease (CKD) on coronary atherosclerotic plaque composition, morphology, and outcomes in patients with acute coronary syndromes ...(ACS). Background CKD patients presenting with ACS are at increased risk for adverse events. Whether or not this increased risk reflects differences in coronary plaque composition remains unknown. Methods In the PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree) study, patients presenting with ACS in whom percutaneous coronary intervention was successful underwent 3-vessel grayscale and radiofrequency intravascular ultrasound imaging. Lesions were prospectively characterized, and patients were followed for a median of 3.4 years. We conducted a patient-level and lesion-level analysis of study participants by comparing intravascular ultrasound parameters of untreated nonculprit lesions in patients with and without CKD. Results Patients with CKD (n = 73, 11.3%) were older, more often female and diabetic compared to those without CKD (n = 573). Nonculprit lesions in patients with (n = 280) versus without (n = 2,390) CKD were more likely to have plaque burden ≥70% (11.8% vs. 8.5%, p = 0.05) and minimal luminal area ≤4.0 mm2 (25.9% vs. 19.2%, p = 0.005). The percentage of plaque comprised of necrotic core (15.0% vs. 13.0%, p = 0.0001) and dense calcium (8.2% vs. 6.4%, p < 0.0001) was higher while fibrous tissue (57.7% vs. 59.8%, p < 0.0001) was lower in CKD versus non-CKD lesions. The 3-year composite rate of cardiac death, cardiac arrest, or myocardial infarction (15.1% vs. 3.3%, p < 0.0001) was significantly higher in patients with than in those without CKD, although there were no differences in the rates of events adjudicated to nonculprit lesions. Conclusions Following percutaneous coronary intervention of all culprit lesions in ACS, patients with versus without CKD have more extensive and severe atherosclerosis remaining in their coronary tree with plaque composed of greater necrotic core and less fibrous tissue. These influences resulted in nonsignificantly different rates of non-culprit lesion–related adverse events, although cardiac death, arrest, or myocardial infarction were more common in patients with CKD.
Background
Despite advances in the quality of acute stroke management, there are gaps in knowledge about effective support interventions to better manage the transition of care to home for patients ...with this complex condition. The goal of this systematic review is to explore the literature around support interventions available for patients as they navigate from acute hospital, rehabilitation or early supported discharge (ESD) services to independent living at home; and to establish if, in comparison with usual care or other comparative active interventions, support services offered to patients as they transition from acute hospital, inpatient rehabilitation/ESD to home, can achieve better patient and / or process outcomes.
Protocol
In June 2021, we will carry out, on electronic peer-reviewed databases, a comprehensive literature search based on a pre-defined search strategy, developed and conducted in collaboration with an Information Specialist. In an effort to identify all published trials we will perform citation tracking of included studies, check reference lists of relevant articles, review grey literature, and extend our search to google scholar.
We will include randomised controlled trials (including cluster and quasi-randomisation) recruiting stroke patients transitioning to home, to receive either usual care or any support intervention designed to improve outcomes after stroke.
The primary clinical outcome will be functional status. Two review authors will scrutinise trials, categorise them on their eligibility, and extract data. We will analyse the results for all trials and perform meta-analyses where possible. We will assess risk of bias for the included trials and use GRADE to assess the quality of the body of evidence.
Patient and public involvement (PPI) engaged in the development of the research questions, and will participate in co-design of a strategy for dissemination of findings.
Conclusions:
The findings from this review will be used to identify knowledge gaps to direct future research.
Distal embolization after percutaneous coronary intervention occurs in 15% to 70% of patients, depending on the sensitivity of the diagnostic modality used, and is associated with a poor prognosis ...after elective and primary percutaneous coronary intervention. It has been hypothesized that imaging of the plaque composition can identify coronary artery lesions that are predisposed to causing distal embolization. This review report aims to summarize all currently available published data on the use of assessment of atherosclerotic plaque composition by virtual histology intravascular ultrasound (VH-IVUS) to predict the occurrence of distal embolization. A systematic review of the literature was performed. We searched Medline, ISI Web of Knowledge, and the Cochrane Library from January 2002 until March 2011. When a study was found to be relevant, the manuscript was obtained and reviewed. A total of 11 studies were identified investigating the relationship between plaque composition assessed by VH-IVUS and distal embolization. Although all studies used the same equipment to perform and analyze VH-IVUS, there was considerable heterogeneity in patient characteristics, outcome definitions, and reporting of VH-IVUS findings. Nevertheless, the necrotic core plaque component—either by itself or as a constituent of a VH thin cap fibroatheroma—was associated with distal embolization in all but 2 of the 11 reviewed studies. Therefore, identification of lesions with large amounts of necrotic core on VH-IVUS could identify lesions that might benefit from the selective use of embolic protection devices.
Background Despite advances in the quality of acute stroke management, there are gaps in knowledge about effective support interventions to better manage the transition of care to home for patients ...with this complex condition. The goal of this systematic review is to explore the literature around support interventions available for patients as they navigate from acute hospital, rehabilitation or early supported discharge (ESD) services to independent living at home; and to establish if, in comparison with usual care or other comparative active interventions, support services offered to patients as they transition from acute hospital, inpatient rehabilitation/ESD to home, can achieve better patient and / or process outcomes. Protocol In June 2021, we will carry out, on electronic peer-reviewed databases, a comprehensive literature search based on a pre-defined search strategy, developed and conducted in collaboration with an Information Specialist. In an effort to identify all published trials we will perform citation tracking of included studies, check reference lists of relevant articles, review grey literature, and extend our search to google scholar. We will include randomised controlled trials (including cluster and quasi-randomisation) recruiting stroke patients transitioning to home, to receive either usual care or any support intervention designed to improve outcomes after stroke. The primary clinical outcome will be functional status. Two review authors will scrutinise trials, categorise them on their eligibility, and extract data. We will analyse the results for all trials and perform meta-analyses where possible. We will assess risk of bias for the included trials and use GRADE to assess the quality of the body of evidence. Patient and public involvement (PPI) engaged in the development of the research questions, and will participate in co-design of a strategy for dissemination of findings.
The findings from this review will be used to identify knowledge gaps to direct future research.
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.
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