Prehospital and in-hospital use of healthcare resources in patients surviving acute coronary syndromes: an analysis of the EPICOR registry.

OBJECTIVE: The aim of this report is to provide insight into real-world healthcare resource use (HCRU) during the critical management of patients surviving acute coronary syndromes (ACS), using data from EPICOR (long-tErm follow-up of antithrombotic management Patterns In acute CORonary syndrome patients) (NCT01171404). METHODS: EPICOR was a prospective, multinational, observational study that enrolled 10 568 ACS survivors from 555 hospitals in 20 countries in Europe and Latin America, between September 2010 and March 2011. HCRU was evaluated in patients with ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation ACS (NSTE-ACS), with or without a history of cardiovascular disease (CVD). Multivariable analysis was performed to determine factors that affected resource use. RESULTS: Before hospitalisation, more patients with STEMI than with NSTE-ACS had their first ECG (44.1% vs 36.4%, p<0.0001) and received antithrombotic medication (26.6% vs 15.2%, p<0.0001). Patients with NSTE-ACS with prior CVD were less likely than those without to be catheterised (73.1% vs 82.8%, p<0.0001). More patients with STEMI than with NSTE-ACS had percutaneous coronary intervention (77.1% vs 54.9%, p<0.0001), but fewer underwent coronary artery bypass grafting (1.2% vs 3.7%, p<0.0001). Multivariable analysis showed that resource use, including length of hospital stay and coronary revascularisation, was significantly influenced by multiple factors, including ACS type, site characteristics and region (all p≤0.05). CONCLUSIONS: In this large-scale, real-life study, findings were generally in line with clinical logic, although site characteristics and region still significantly affected resource use. Moreover, and unexpectedly, resource use tended to be slightly higher in patients without a history of CVD. TRIAL REGISTRATION NUMBER: NCT01171404 (ClinicalTrials.gov)

Predictors of one-year mortality at hospital discharge after acute coronary syndromes: A new risk score from the EPICOR (long-tErm follow uP of antithrombotic management patterns In acute CORonary syndrome patients) study.

AIMS: A reliable prediction tool is needed to identify acute coronary syndrome (ACS) patients with high mortality risk after their initial hospitalization. METHODS: EPICOR (long-tErm follow uP of antithrombotic management patterns In acute CORonary syndrome patients: NCT01171404) is a prospective cohort study of 10,568 consecutive hospital survivors after an ACS event (4943 ST-segment elevation myocardial infarction (STEMI) and 5625 non-ST-elevation ACS (NSTE-ACS)). Of these cases, 65.1% underwent percutaneous coronary intervention (PCI) and 2.5% coronary artery bypass graft (CABG). Post-discharge mortality was recorded for up to two years. From over 50 potential predictor variables a new risk score for one-year mortality was developed using forward stepwise Cox regression, and examined for goodness-of-fit, discriminatory power, and external validation. RESULTS: A total of 407 patients (3.9%) died within one year of discharge. We identified 12 highly significant independent predictors of mortality (in order of predictive strength): age, lower ejection fraction, poorer EQ-5D quality of life, elevated serum creatinine, in-hospital cardiac complications, chronic obstructive pulmonary disease, elevated blood glucose, male gender, no PCI/CABG after NSTE-ACS, low hemoglobin, peripheral artery disease, on diuretics at discharge. When combined into a new risk score excellent discrimination was achieved (c-statistic=0.81) and this was also validated on a large similar cohort (9907 patients) in Asia (c=0.78). For both STEMI and NSTE-ACS there was a steep gradient in one-year mortality ranging from 0.5% in the lowest quintile to 18.2% in the highest decile. NSTE-ACS contributes over twice as many high-risk patients as STEMI. CONCLUSIONS: Post-discharge mortality for ACS patients remains of concern. Our new user-friendly risk score available on www.acsrisk.org can readily identify who is at high risk

Prehospital ticagrelor in ST-segment elevation myocardial infarction

Background:The direct-acting platelet P2Y receptor antagonist ticagrelor can reduce the incidence of major adverse cardiovascular events when administered at hospital admission to patients with ST-segment elevation myocardial infarction (STEMI). Whether prehospital administration of ticagrelor can improve coronary reperfusion and the clinical outcome is unknown. Methods: We conducted an international, multicenter, randomized, double-blind study involving 1862 patients with ongoing STEMI of less than 6 hours' duration, comparing prehospital (in the ambulance) versus in-hospital (in the catheterization laboratory) treatment with ticagrelor. The coprimary end points were the proportion of patients who did not have a 70% or greater resolution of ST-segment elevation before percutaneous coronary intervention (PCI) and the proportion of patients who did not have Thrombolysis in Myocardial Infarction flow grade 3 in the infarct-related artery at initial angiography. Secondary end points included the rates of major adverse cardiovascular events and definite stent thrombosis at 30 days. Results: The median time from randomization to angiography was 48 minutes, and the median time difference between the two treatment strategies was 31 minutes. The two coprimary end points did not differ significantly between the prehospital and in-hospital groups. The absence of ST-segment elevation resolution of 70% or greater after PCI (a secondary end point) was reported for 42.5% and 47.5% of the patients, respectively. The rates of major adverse cardiovascular events did not differ significantly between the two study groups. The rates of definite stent thrombosis were lower in the prehospital group than in the in-hospital group (0% vs. 0.8% in the first 24 hours; 0.2% vs. 1.2% at 30 days). Rates of major bleeding events were low and virtually identical in the two groups, regardless of the bleeding definition use

Treatment Characteristics and Real-World Progression-Free Survival in Patients With Unresectable Stage III NSCLC Who Received Durvalumab After Chemoradiotherapy: Findings From the PACIFIC-R Study.

IntroductionThe phase 3 PACIFIC trial established consolidation therapy with durvalumab as standard of care for patients with unresectable, stage III NSCLC and no disease progression after definitive chemoradiotherapy (CRT). The observational PACIFIC-R study assesses the real-world effectiveness of durvalumab in patients from an early access program. Here, we report treatment characteristics and a preplanned analysis of real-world progression-free survival (rwPFS).MethodsPACIFIC-R (NCT03798535) is an ongoing, international, retrospective study of patients who started durvalumab (intravenously; 10 mg/kg every 2 wk) within an early access program between September 2017 and December 2018. The primary end points are investigator-assessed rwPFS and overall survival (analyzed by Kaplan-Meier method).ResultsAs of November 30, 2020, the full analysis set comprised 1399 patients from 11 countries (median follow-up duration, 23.5 mo). Patients received durvalumab for a median of 11.0 months. Median rwPFS was 21.7 months (95% confidence interval: 19.1-24.5). RwPFS was numerically longer among patients who received concurrent versus sequential CRT (median, 23.7 versus 19.3 mo) and among patients with programmed cell death-ligand 1 expression greater than or equal to 1% versus less than 1% (22.4 versus 15.6 mo). Overall, 16.5% of the patients had adverse events leading to treatment discontinuation; 9.5% of all patients discontinued because of pneumonitis or interstitial lung disease.ConclusionsConsolidation durvalumab after definitive CRT was well tolerated and effective in this large, real-world cohort study of patients with unresectable, stage III NSCLC. As expected, rwPFS was longer among patients who received concurrent versus sequential CRT and patients with higher programmed cell death-ligand 1 expression. Nevertheless, favorable rwPFS outcomes were observed regardless of these factors

Vandetanib in locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 2 trial.

No effective standard treatment exists for patients with radioiodine-refractory, advanced differentiated thyroid carcinoma. We aimed to assess efficacy and safety of vandetanib, a tyrosine kinase inhibitor of RET, VEGFR and EGFR signalling, in this setting.Clinical Trial, Phase IIJournal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov'tSCOPUS: ar.jinfo:eu-repo/semantics/publishe

Contemporary inter-hospital transfer patterns for the management of acute coronary syndrome patients: findings from the EPICOR study.

AIM: The EPICOR observational study was designed to describe antithrombotic strategies in a broad acute coronary syndrome (ACS) population; it also included information on inter-hospital transfers and institutional resources. METHODS AND RESULTS: EPICOR enrolled 10,568 consecutively discharged patients with ST-elevation (STE) or non-STE (NSTE) ACS in 555 centres in 20 countries across Europe and Latin America. Patients were categorized as non-transferred, transferred in from another hospital and then discharged, or transferred out to a second hospital but discharged from their initial hospital after transfer back. Two-thirds of ACS patients were non-transferred, of which only 14% were hospitalized at a centre without a catheterization laboratory, and one-third were transferred in or transferred out. Almost all transferred out patients were transferred out to a hospital with catheterization facilities, most often for primary/urgent/rescue (78%) or planned catheterization (18%) in STE myocardial infarction (STEMI), and primary/urgent/rescue (44%) or planned (43%) catheterization in NSTE-ACS. Transferred in patients were more likely to have a STEMI (60%) than non-transferred (44%) and transferred out patients (36%). In STEMI patients, time from symptom onset to catheterization was shorter in non-transferred patients (median 3.5 h vs. 5.9 h for transferred in and 6.3 h for transferred out). In NSTE-ACS, cardiac markers were positive in 66% of non-transferred patients versus 78% and 82% in transferred in and transferred out, respectively. CONCLUSIONS: The lack of on-site 24/7 facilities or the availability of more advanced care are frequent reasons for inter-hospital transfer in ACS. Further follow-up of these patients will help to determine whether these practice patterns affect outcome

Opportunities for improvement in anti-thrombotic therapy and other strategies for the management of acute coronary syndromes: Insights from EPICOR, an international study of current practice patterns.

AIMS: To describe international patterns and opportunities for improvement of pre- and in-hospital care of patients hospitalized for acute coronary syndromes (ACS), with special focus on anti-thrombotic therapy. METHODS AND RESULTS: EPICOR (long-tErm follow-uP of anti-thrombotic management patterns In acute CORonary syndrome patients), an international, cohort study, which enrolled 10,568 consecutive ACS survivors from 555 hospitals in 20 countries across Europe and Latin America (September 2010 to March 2011), prospectively registered detailed information on pre- and in-hospital management. Globally, 4738 (44.8%) were attended before hospitalization, 4241 (40.1%) had an ECG, 2119 (20%) received anti-platelet therapy and 101 STEMI patients (2%) fibrinolysis. In-hospital, 7944 patients (75.2%) received dual anti-platelet therapy, most often with clopidogrel (69.7%), and less with prasugrel (5.4%); 1705 (16.1%) had triple anti-platelet therapy, and 849 (8%) single anti-platelet therapy. STEMI patients more often received pre-hospital anti-thrombotics, and prasugrel, GP IIb/IIIa inhibitors and UFH in-hospital (all p < 0.001). More NSTE-ACS patients received clopidogrel, single anti-platelet therapy, and fondaparinux (all p < 0.001). As many as 33% of ACS patients were medically managed. A significant decreasing gradient was found between Northern, Southern and Eastern Europe and Latin America in use of more potent patterns of anti-platelet therapy, reperfusion therapy and invasive strategy. CONCLUSION: This large international study shows room for improvement in use of anti-thrombotic drugs and other strategies for optimal management of ACS, including pre-hospital ECG and anti-thrombotic therapy. Regional practice differences not based on evidence or conditioned by economic constraints should be reduced