There are limited head-to-head randomized data on patient-related versus stent-related outcomes for everolimus-eluting stents (EES) and sirolimus-eluting stents (SES).
In the SORT OUT IV (Scandinavian Organization for Randomized Trials With Clinical Outcome IV) trial, comparing the EES with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months.
The primary endpoint was a composite: cardiac death, myocardial infarction (MI), definite stent thrombosis, or target vessel revascularization. Safety and efficacy outcomes at 2 years were further assessed with specific focus on patient-related composite (all death, all MI, or any revascularization) and stent-related composite outcomes (cardiac death, target vessel MI, or symptom-driven target lesion revascularization). A total of 1,390 patients were assigned to receive the EES, and 1,384 patients were assigned to receive the SES.
At 2 years, the composite primary endpoint occurred in 8.3% in the EES group and in 8.7% in the SES group (hazard ratio [HR]: 0.94, 95% confidence interval [CI]: 0.73 to 1.22). The patient-related outcome: 15.0% in the EES group versus 15.6% in the SES group, (HR: 0.95, 95% CI: 0.78 to 1.15), and the stent-related outcome: 5.2% in the EES group versus 5.3% in the SES group (HR: 0.97, 95% CI: 0.70 to 1.35) did not differ between groups. Rate of definite stent thrombosis was lower in the EES group (0.2% vs. 0.9%, (HR: 0.23, 95% CI: 0.07 to 0.80).
At 2-year follow-up, the EES was found to be noninferior to the SES with regard to both patient-related and stent-related clinical outcomes.
We aimed to compare angiographic and clinical outcomes after the implantation of everolimus-eluting (EES) and sirolimus-eluting (SES) stents in patients with diabetes.
There are limited data on long-term outcome after EES vs SES implantation in diabetic patients.
We randomized 213 patients with diabetes and coronary artery disease to EES (n?=?108) or SES (n?=?105) implantation. Angiographic follow-up was performed 10 months after the index procedure and all patients were followed clinically for 4 years. The primary endpoint was angiographic in-stent late luminal loss at 10-month follow-up. Secondary endpoints included angiographic restenosis rate, the need for target lesion revascularization (TLR) and major adverse cardiac events (MACE; defined as cardiac death, myocardial infarction, definite stent thrombosis, or TLR) at 4-year follow-up.
At 10-month angiographic follow-up, in-stent late lumen loss was 0.20?±?0.53 mm and 0.11?±?0.49 mm (P?=?0.28), and angiographic restenosis rate was 3.8% and 5.2% (P?=?0.72) in the EES and SES groups, respectively. At 4-year clinical follow-up, MACE had occurred in 22 (20.4%) patients in the EES group and 25 (23.8%) patients in SES group (HR 0.84, 95% CI 0.47-1.49; P?=?0.55), with TLR performed in 6 (5.6%) and 10 (9.5%) patients in the two groups (HR 0.57, 95% CI 0.21-1-58; P?=?0.28).
EES and SES had comparable 10-month angiographic and 4-year clinical outcomes in patients with diabetes mellitus and coronary artery disease.
OBJECTIVES: To investigate the diagnostic approach in Nordic hospitals receiving patients suspected of acute myocardial infarction (MI), especially focusing on implementation of the recently proposed criteria by the European Society of Cardiology (ESC) and the American College of Cardiology (ACC) for the definition of MI. DESIGN: A survey with questionnaires of the diagnostic approach was conducted among all relevant departments (220) in the Nordic countries. RESULTS: Seventy-six percent (167) of hospitals responded. Troponins I and T (TnI and TnT) and creatinine kinase monobasic fraction (mass concentration) (CKMB(mass)) covered 93 and 65% of hospitals, respectively. Of troponin users, 34% indicated use of TnI vs 66% using TnT. Sporadic use of AST, CK, LD and myoglobin was reported. There was a tendency to lower cut-off levels in Sweden and Finland. Among troponin assays, there was considerable heterogeneity regarding cut-off levels. CONCLUSIONS: The Nordic countries are approaching ESC/ACC consensus on cardiac markers. Compared with previous national surveys (1995-1999), there is a shift towards the use of troponins. However, differences in cut-off levels of troponin emphasize the need for harmonization of assays.
The aim of the study was to compare long-term follow-up results of crush versus culotte stent techniques in coronary bifurcation lesions.
The randomized Nordic Stent Technique Study showed similar 6-month clinical and 8-month angiographic results with the crush and culotte stent techniques of de novo coronary artery bifurcation lesions using sirolimus-eluting stents. Here, we report the 36-month efficacy and safety of the Nordic Stent Technique Study.
A total of 424 patients with a bifurcation lesion were randomized to stenting of both main vessel and side branch with the crush or the culotte technique and followed for 36 months. Major adverse cardiac events-the composite of cardiac death, myocardial infarction, stent thrombosis, or target vessel revascularization-were the primary endpoint.
Follow-up was complete for all patients. At 36 months, the rates of the primary endpoint were 20.6% versus 16.7% (p = 0.32), index lesion restenosis 11.5% versus 6.5% (p = 0.09), and definite stent thrombosis 1.4% versus 4.7% (p = 0.09) in the crush and the culotte groups, respectively.
At 36-month follow-up, the clinical outcomes were similar for patients with coronary bifurcation lesions treated with the culotte or the crush stent technique. (Nordic Bifurcation Study. How to Use Drug Eluting Stents [DES] in Bifurcation Lesions? NCT00376571).
Diabetes is associated with increased risk of major adverse cardiac events (MACEs) after percutaneous coronary intervention. The purpose of this substudy of the SORT OUT IV trial was to compare clinical outcomes in patients with and without diabetes mellitus treated with everolimus-eluting stents (EESs) or sirolimus-eluting stents (SESs). In total 2,774 patients (390 with diabetes, 14.1%) were randomized to stent implantation with EESs (n = 1,390, diabetes in 14.0%) or SESs (n = 1,384, diabetes in 14.2%). Randomization was stratified by presence/absence of diabetes. The primary end point was MACEs, a composite of cardiac death, myocardial infarction, definite stent thrombosis, or target vessel revascularization within 18 months. MACEs were higher in diabetic than in nondiabetic patients (13.1% vs 6.4%, hazard ratio [HR] 2.08, 95% confidence interval [CI] 1.51 to 2.86). In diabetic patients, MACEs were seen in 10.3% of those treated with EESs and in 15.8% of those treated with SESs (HR 0.63, 95% CI 0.36 to 1.11). In nondiabetic patients, MACEs occurred in 6.6% of EES-treated and in 6.3% SES-treated patients (HR 1.06, 95% CI 0.77 to 1.46). In diabetics, cardiac death occurred in 3.1% of EES-treated and in 4.6% of SES-treated patients (HR 0.67, 95% CI 0.24 to 1.89), myocardial infarction occurred in 0.5% of EES-treated and in 3.6% of SES-treated patients (HR 0.14, 95% CI 0.02 to 1.16), and clinically driven target lesion revascularization was needed in 3.1% of EES-treated and in 7.7% of SES-treated patients (HR 0.40, 95% CI 0.15 to 1.02). No interaction between diabetes status and type of drug-eluting stent was found for the end points. In conclusion, patients with diabetes have higher MACE rates than nondiabetics. No significant differences in safety or efficacy outcomes after EES or SES implantation were present in nondiabetic or diabetic patients.
Comparison of outcomes of patients = 80 years of age having percutaneous coronary intervention according to presentation (stable vs unstable angina pectoris/non-ST-segment elevation myocardial infarction vs ST-segment elevation myocardial infarction).
Patients = 80 years old with coronary artery disease constitute a particular risk group in relation to percutaneous coronary intervention (PCI). From 2002 through 2008 we examined the annual proportion of patients = 80 years old undergoing PCI in western Denmark, their indications for PCI, and prognosis. From 2002 through 2009 all elderly patients treated with PCI were identified in a population of 3.0 million based on the Western Denmark Heart Registry. Cox regression analysis was used to compare mortality rates according to clinical indications controlling for potential confounding. In total 3,792 elderly patients (= 80 years old) were treated with PCI and the annual proportion increased from 224 (5.4%) in 2002 to 588 (10.2%) in 2009. The clinical indication was stable angina pectoris (SAP) in 30.2%, ST-segment elevation myocardial infarction (STEMI) in 35.0%, UAP/non-STEMI in 29.7%, and "ventricular arrhythmia or congestive heart failure" in 5.1%. Overall 30-day and 1-year mortality rates were 9.2% and 18.1%, respectively. Compared to patients with SAP the adjusted 1-year mortality risk was significantly higher for patients presenting with STEMI (hazard ratio 3.86, 95% confidence interval 3.08 to 4.85), UAP/non-STEMI (hazard ratio 1.95, 95% confidence interval 1.53 to 2.50), and ventricular arrhythmia or congestive heart failure (hazard ratio 2.75, 95% confidence interval 1.92 to 3.92). In patients with SAP target vessel revascularization decreased from 7.1% in 2002 to 2.5% in 2008. In conclusion, the proportion of patients = 80 years old treated with PCI increased significantly over an 8-year period. Patients with SAP had the lowest mortality rates and rates of clinically driven target vessel revascularization decreased over time.
Interventional cardiology in Denmark has been carried out since the mid 1980s. Interventional cardiology is only performed at a few high-volume centres. Healthcare coverage is universal and is essentially free of charge. Hospitals are mostly publicly owned and financed by fixed budgets and, in part, an activity-based funding system. Approximately 30,000 coronary angiographies (CAG), 10,000 percutaneous coronary interventions (PCIs) of which approximately 25% are primary PCIs, and 500 transcatheter aortic valve implantations (TAVIs) are carried out each year. The numbers of CAG and PCI have reached a plateau in recent years, whereas structural heart interventions, in particular TAVI, are increasing. Around 90% of all patients treated with PCI have a stent implanted, with more than 95% of these being drug-eluting stents. There is a low but increasing use of bioabsorbable scaffolds and drug-eluting balloons.
INTRODUCTION: Ischemia-modified albumin (IMA) has been proposed as a useful rule-out marker for the diagnosis of acute coronary syndrome (ACS) in the emergency department. This study evaluated the ability of IMA to predict the acute myocardial infarction (AMI) diagnosis in a population of chest pain patients. METHODS: The study population comprised 107 subjects (men, 62%; women, 38%) admitted with suspected ACS. None of the patients had ST-segment elevations that qualified for immediate revascularization. Ischemia-modified albumin was determined from serum with albumin cobalt binding test (Inverness Medical Innovations Inc, Stirling, UK). Furthermore, cardiac troponin T, creatinine kinase MB mass, myoglobin, and heart-type fatty acid binding protein (H-FABP) were determined on arrival, after 6 to 9 hours, and after 12 to 24 hours. All patients had at least 2 blood samples taken to exclude/verify the AMI. AMI was defined by a cardiac troponin T level greater than 0.03 microg/L. RESULTS: Thirty-three percent of the patients (n = 35) had a final diagnosis of AMI. The sensitivity of admission IMA for a final diagnosis of ACS was 0.86 (95% confidence interval [95% CI], 0.69-0.95). Specificity was 0.49 (95% CI, 0.36-0.60). Negative predictive value was 0.88 (95% CI, 0.72-0.95). The optimal cutoff threshold derived from the receiver operating characteristics (ROC) curve (ROC analysis) was determined as 91 U/mL. The area under the ROC curve was 0.73. Ischemia-modified albumin did not, at any time, provide superior sensitivity or specificity compared with other biomarkers. We do not find the data supportive of IMA as a standard marker in the emergency department.
The association between low socioeconomic status (SES) and high mortality from coronary heart disease is well-known. However, the role of SES in relation to the clinical outcome after primary percutaneous coronary intervention remains poorly understood.
We studied 7385 patients treated with primary percutaneous coronary intervention. Participants were divided into high-SES and low-SES groups according to income, education, and employment status. The primary outcome was major adverse cardiac events (cardiac death, recurrent myocardial infarction, and target vessel revascularization) at maximum follow-up (mean, 3.7 years). Low-SES patients had more adverse baseline risk profiles than high-SES patients. The cumulative risk of major adverse cardiac events after maximum follow-up was higher among low-income patients and unemployed patients compared with their counterparts (income: hazard ratio, 1.68; 95% CI, 1.47-1.92; employment status: hazard ratio, 1.75; 95% CI, 1.46-2.10). After adjustment for patient characteristics, these differences were substantially attenuated (income: hazard ratio, 1.12; 95% CI, 0.93-1.33; employment status: hazard ratio, 1.27; 95% CI, 1.03-1.56). Further adjustment for admission findings, procedure-related data, and medical treatment during follow-up did not significantly affect the associations. With education as the SES indicator, no between-group differences were observed in the risk of the composite end point.
Even in a tax-financed healthcare system, low-SES patients treated with primary percutaneous coronary intervention face a worse prognosis than high-SES patients. The poor outcome seems to be largely explained by differences in baseline patient characteristics. Employment status and income (but not education level) were associated with clinical outcomes.
Extra corporeal life support (ECLS) with a mobile system is an option in the treatment of cardiac arrest often of unknown reason. After commencing ECLS the search for a provoking origin may include advanced radiologic examinations before deciding further treatment.
Fifty-eight patients with circulatory arrest were treated with ECLS. In 15 cases the patient went through CT scans of the cerebrum, thorax and abdomen, pulmonary angiography, and or invasive cardiologic examinations. Two patients were transported in ambulance and helicopter on ECLS before the examinations.
The underlying diagnosis in the 15 patients were: lung embolism (n = 6), accidental hypothermia (n = 2), myocardial infarction (n = 2), WPW syndrome (n = 1), sepsis (n = 1), disseminated intravascular coagulation (n = 2), high voltage accident (n = 1). Only in the last mentioned patient the CT scan was indicative of major brain damage, and further treatment was stopped. Five of the 15 examined patients survived. The diagnoses in the survivors were lung embolism (n = 2), myocardial infarction (n = 1), WPW syndrome (n = 1), and accidental hypothermia (n = 1). The results of the radiologic examinations had great influence on all treatments.
It is possible to make radiological examinations i.e., CT scans, pulmonary and coronary angiography in patients suffering heart arrest of unknown origin with the use of ECLS in order to improve patient treatment in this very high-risk population.