Rationale and design of EXPLORE: a randomized, prospective, multicenter trial investigating the impact of recanalization of a chronic total occlusion on left ventricular function in patients after primary percutaneous coronary intervention for acute ST-elevation myocardial infarction

<p>Abstract</p> <p>Background</p> <p>In the setting of primary percutaneous coronary intervention, patients with a chronic total occlusion in a non-infarct related artery were recently identified as a high-risk subgroup. It is unclear whether ST-elevation myocardial infarction patients with a chronic total occlusion in a non-infarct related artery should undergo additional percutaneous coronary intervention of the chronic total occlusion on top of optimal medical therapy shortly after primary percutaneous coronary intervention. Possible beneficial effects include reduction in adverse left ventricular remodeling and preservation of global left ventricular function and improved clinical outcome during future coronary events.</p> <p>Methods/Design</p> <p>The Evaluating Xience V and left ventricular function in Percutaneous coronary intervention on occLusiOns afteR ST-Elevation myocardial infarction (EXPLORE) trial is a randomized, prospective, multicenter, two-arm trial with blinded evaluation of endpoints. Three hundred patients after primary percutaneous coronary intervention for ST-elevation myocardial infarction with a chronic total occlusion in a non-infarct related artery are randomized to either elective percutaneous coronary intervention of the chronic total occlusion within seven days or standard medical treatment. When assigned to the invasive arm, an everolimus-eluting coronary stent is used. Primary endpoints are left ventricular ejection fraction and left ventricular end-diastolic volume assessed by cardiac Magnetic Resonance Imaging at four months. Clinical follow-up will continue until five years.</p> <p>Discussion</p> <p>The ongoing EXPLORE trial is the first randomized clinical trial powered to investigate whether recanalization of a chronic total occlusion in a non-infarct related artery after primary percutaneous coronary intervention for ST-elevation myocardial infarction results in a better preserved residual left ventricular ejection fraction, reduced end-diastolic volume and enhanced clinical outcome.</p> <p>Trial registration</p> <p>trialregister.nl NTR1108.</p

Histopathological Features of Aspirated Thrombi after Primary Percutaneous Coronary Intervention in Patients with ST-Elevation Myocardial Infarction

BACKGROUND: Plaque disruption with superimposed thrombus is the predominant mechanism responsible for the onset of acute coronary syndromes. Studies have shown that plaque disruption and thrombotic occlusion are frequently separated in time. We established the histopathological characteristics of material aspirated during primary percutaneous coronary intervention (PCI) in a large consecutive ST-elevation myocardial infarction (STEMI) population. METHODOLOGY/PRINCIPAL FINDINGS: Thrombus aspiration during primary PCI was performed in 1,362 STEMI patients. Thrombus age was classified as fresh (<1 day), lytic (1-5 days), or organized (>5 day). Further, the presence of plaque was documented. The histopathological findings were related to the clinical, angiographic, and procedural characteristics. Material could be aspirated in 1,009 patients (74%). Components of plaque were found in 395 of these patients (39%). Fresh thrombus was found in 577 of 959 patients (60%) compared to 382 patients (40%) with lytic or organized thrombi. Distal embolization was present in 21% of patients with lytic thrombus compared to 12% and 15% of patients with fresh or organized thrombus. CONCLUSIONS/SIGNIFICANCE: Material could be obtained in 74% of STEMI patients treated with thrombus aspiration during primary PCI. In 40% of patients thrombus age is older than 24 h, indicating that plaque disruption and thrombus formation occur significantly earlier than the onset of symptoms in many patients

Less bleeding by omitting aspirin in non-ST-segment elevation acute coronary syndrome patients: Rationale and design of the LEGACY study

BACKGROUND: Early aspirin withdrawal, also known as P2Y12-inhibitor monotherapy, following percutaneous coronary intervention (PCI) for non-ST-segment elevation acute coronary syndrome (NSTE-ACS) can reduce bleeding without a trade-off in efficacy. Still the average daily bleeding risk is highest during the first months and it remains unclear if aspirin can be omitted immediately following PCI. METHODS: The LEGACY study is an open-label, multicenter randomized controlled trial evaluating the safety and efficacy of immediate P2Y12-inhibitor monotherapy versus dual antiplatelet therapy (DAPT) for 12 months in 3,090 patients. Patients are randomized immediately following successful PCI for NSTE-ACS to 75-100 mg aspirin once daily versus no aspirin. The primary hypothesis is that immediately omitting aspirin is superior to DAPT with respect to major or minor bleeding defined as Bleeding Academic Research Consortium type 2, 3, or 5 bleeding, while maintaining noninferiority for the composite of all-cause mortality, myocardial infarction and stroke compared to DAPT. CONCLUSIONS: The LEGACY study is the first randomized study that is specifically designed to evaluate the impact of immediately omitting aspirin, and thus treating patients with P2Y12-inhibitor monotherapy, as compared to DAPT for 12 months on bleeding and ischemic events within 12 months following PCI for NSTE-ACS

Physical Resilience in Daily Functioning Among Acutely Ill Hospitalized Older Adults: The Hospital-ADL Study

Objectives: Insight into older adults’ physical resilience is needed to predict functional recovery after hospitalization. We assessed functional trajectories in response to acute illness and subsequent hospitalization and investigated baseline variables and dynamic variables associated with these trajectories. Design: Prospective observational cohort study (Hospitalization-Associated Disability and impact on daily Life Study). Setting and Participants: This study included 207 older adults (aged 79.8 ± 6.9 years, 49% female, 57% frail) acutely hospitalized in 6 Dutch hospitals. Methods: Functional disability was assessed using the 15-item modified activities of daily living index retrospectively 2 weeks before admission, and prospectively from admission up to 3 months after discharge. Baseline variables including frailty, somatic, physical, and psychosocial factors were assessed at admission. Dynamic variables (step count, pain, fatigue, and fear of falling) were continuously or repeatedly assessed during hospitalization. We performed individual spline modeling using random effects. Baseline variables and within-person mean levels and variability in the dynamic variables were assessed as predictors of functional trajectories. Results: Functional disability significantly increased before admission and decreased from admission to 3 months post discharge. Frail participants had a significantly higher increase in functional disability before admission compared with nonfrail participants. Lower step count, higher pain scores, and higher within-person variability in fear of falling were significantly associated with higher increase in functional disability before admission. Higher within-person variability in fear of falling was associated with more recovery. Conclusions and Implications: Older adults increase in functional disability before hospitalization and start to recover from admission onward. Frailty and dynamic variables are associated with a higher increase in functional disability after acute illness. Our findings give more insight into older adults’ physical resilience, which may improve the prediction of functional recovery and may improve therapeutic decision-making and rehabilitation strategies to improve functional recovery after acute hospitalization

Distinguishing the right coronary artery from the left circumflex coronary artery as the infarct-related artery in patients undergoing primary percutaneous coronary intervention for acute inferior myocardial infarction

AIMS: Aim of this study was to investigate the diagnostic accuracy of the conventional electrocardiogram (ECG) algorithm [ST-segment elevation (STE) in lead III exceeding that in lead II combined with ST-segment depression in lead I or aVL] for identification of the infarct-related artery (IRA) in a large cohort of patients undergoing primary percutaneous coronary intervention (PCI) for inferior wall STE myocardial infarction (STEMI). METHODS AND RESULTS: We included 1131 patients with inferior STEMI, who underwent primary PCI between 2000 and 2007 and of whom a pre-procedural 12-lead ECG was available, recorded immediately prior to PCI. The IRA was determined during emergency angiography. Coronary angiography confirmed the right coronary artery (RCA) as the IRA in 895 patients (79%) with inferior wall STEMI. Application of the ECG algorithm resulted in 624 true positive cases of acute RCA obstruction (sensitivity: 70%, 95% CI: 67 -73%) and 170 cases with true negative result (specificity: 72%, 95% CI: 66-77%). Sensitivity of >90% was established in patients with cumulative ST-segment deviation above median (>18.5 mm). CONCLUSION: The conventional ECG algorithm showed a low sensitivity for the non-invasive diagnosis of RCA occlusion in an all-comer, inferior STEMI cohort undergoing primary PCI. Sensitivity was only sufficient in patients with extensive ST-segment deviatio

Creatinine clearance is independently associated with one year mortality in a primary PCI cohort with cardiogenic shock

Background: Acute ST-segment elevation myocardial infarction (STEMI) complicated with cardiogenic shock (CS) has still the highest in hospital mortality. Patients with STEMI and increasing creatinine levels within 24 h after admission have a poor prognosis. Data about STEMI complicated with CS and kidney function are sparse. We sought to assess the prognostic value of creatinine clearance on admission in patients with STEMI and CS treated with percutaneous coronary intervention (PCI). Methods and results: Between 1997 and 2005, a total of 3038 patients presented with STEMI and treated with PCI. On admission 292 patients presented with CS. Creatinine clearance (CrCl) could be calculated in 193 patients and classified in tertiles: group I>96.8 ml/min; Group II between 67.5 and 96.8 ml/min; Group III <67.5 ml/min. Overall one year mortality was 34%. In group I, II and III mortality was 24%, 30% and 45% respectively (P for trend 0.009). In multivariate logistic regression analysis, the odds for mortality increased with 96% for each tertile of admission CrCl (OR 1.961, 95%CI 1,135-3.385, P=0.016). Conclusion: Creatinine clearance on admission is strongly associated with one year mortality in STEMI patients with CS on admission and treated with PC