Evidence-based Care In Heart Disease Research Articles

ABO blood type and risk of porcine bioprosthetic aortic valve degeneration: SWEDEHEART observational cohort study

ObjectiveBlood type A antigen on porcine aortic bioprostheses might initiate an immune reaction leading to an increased frequency of structural valve deterioration in patients with blood type B or O....

Cardiac Troponin Elevation in Patients Without a Specific Diagnosis

BackgroundCardiac troponin (cTn) elevation is a common finding in acutely admitted patients, even in the absence of acute coronary syndrome. In some of these patients, no etiology of cTn elevation can be identified. The term troponinemia is sometimes used to describe this scenario. ObjectivesThis study aimed to investigate the associations of cTn levels with clinical findings and long-term outcome in acutely admitted patients with suspected acute coronary syndrome who had been discharged without a specified diagnosis. MethodsRetrospective registry-based cohort study investigating 48,872 patients (SWEDEHEART [Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies] registry). Patients were stratified into cohorts with cTn levels less than or equal to the assay-specific 99th percentile and separated by assay-specific cTn tertiles in case of higher levels. ResultsA cTn level >99th percentile was noted in 9,800 (20.1%) patients. The prevalence of cardiovascular risk factors as well as cardiovascular and noncardiovascular comorbidities increased across higher cTn strata. In total, 7,529 (15.4%) patients had a major adverse event (MAE), defined as the composite of all-cause mortality, myocardial infarction, readmission for heart failure, or stroke (median follow-up 4.9 years). MAE risk was associated with higher cTn strata (hazard ratio for highest assay-specific cTn tertile: 2.59; 95% confidence interval: 2.39 to 2.80; hazard ratio in patients without cardiovascular comorbidities, renal dysfunction, left ventricular dysfunction, or significant coronary stenosis: 3.57; 95% confidence interval: 2.30 to 5.54). ConclusionscTn elevation is associated with cardiovascular and noncardiovascular comorbidities and predicts major adverse events in acutely admitted patients, in whom no definite diagnosis could have been established. The term troponinemia is trivializing and should be avoided. Instead, careful work-up is required in these patients.

Association of Weather With Day-to-Day Incidence of Myocardial Infarction

Whether certain weather conditions modulate the onset of myocardial infarction (MI) is of great interest to clinicians because it could be used to prevent MIs as well as guide allocation of health care resources. To determine if weather is associated with day-to-day incidence of MI. In this prospective, population-based and nationwide setting, daily weather data from the Swedish Meteorological and Hydrological Institute were extracted for all MIs reported to the Swedish nationwide coronary care unit registry, Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART), during 1998 to 2013 and then merged with each MI on date of symptom onset and coronary care unit. All patients admitted to any coronary care unit in Sweden owing to MI were included. A total of 280 873 patients were included, of whom 92 044 were diagnosed as having ST-elevation MI. Weather data were available for 274 029 patients (97.6%), which composed the final study population. Data were analyzed between February 2017 and April 2018. The nationwide daily mean air temperature, minimum air temperature, maximum air temperature, wind velocity, sunshine duration, atmospheric air pressure, air humidity, snow precipitation, rain precipitation, and change in air temperature. The nationwide daily counts of MI as outcome. In 274 029 patients, mean (SD) age was 71.7 (12) years. Incidence of MI increased with lower air temperature, lower atmospheric air pressure, higher wind velocity, and shorter sunshine duration. The most pronounced association was observed for air temperature, where a 1-SD increase in air temperature (7.4°C) was associated with a 2.8% reduction in risk of MI (unadjusted incidence ratio, 0.972; 95% CI, 0.967-0.977; P <.001). Results were consistent for non-ST-elevation MI as well as ST-elevation MI and across a large range of subgroups and health care regions. In this large, nationwide study, low air temperature, low atmospheric air pressure, high wind velocity, and shorter sunshine duration were associated with risk of MI with the most evident association observed for air temperature.

Potassium levels and risk of in-hospital arrhythmias and mortality in patients admitted with suspected acute coronary syndrome

BackgroundIn acute coronary syndrome (ACS), potassium imbalance at admission has been associated with in-hospital arrhythmias, cardiac arrest, and mortality. However, several important presentation characteristics and subtype of ACS have not been considered. MethodsConsecutive patients (n = 32,955) admitted with suspected ACS between 2006 and 2011, registered in the Swedish Web-System for Enhancement and Development of Evidence-Based care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART) and the Stockholm CREAtinine Measurements (SCREAM) project were included. Associations between admission plasma potassium categories (reference 3.5–<4.0 mmol/L) and in-hospital outcomes including mortality, cardiac arrest, new-onset atrial fibrillation, and second- or third-degree atrioventricular block were assessed with logistic regression models. Covariates included demographics, presentation characteristics, comorbidities, estimated glomerular filtration rate (eGFR), main diagnosis, and medication on admission. ResultsU-shaped associations between admission potassium, mortality and cardiac arrest were observed. However, in fully adjusted models, only hyperkalemia (5.0–<5.5 [OR 1.83; 95% CI, 1.34–2.49] and ≥5.5 mmol/L [OR 2.27; 95% CI, 1.57–3.27]) was associated with mortality, while only hypokalemia (3.0–<3.5 [OR 1.63; 95% CI, 1.21–2.19] and <3.0 mmol/L [OR 2.72; 95% CI, 1.56–4.74]) was associated with cardiac arrest. Potassium <3.0 mmol/L (OR 1.93; 95% CI, 1.00–3.76) was associated with new-onset atrial fibrillation. After multivariable adjustment, no association was observed between potassium and second- or third-degree atrioventricular block. Results were not modified by main diagnosis (ACS subtype or non-ACS diagnosis) or eGFR. ConclusionsHyperkalemia at admission is associated with in-hospital mortality and hypokalemia with cardiac arrest and new-onset atrial fibrillation in patients admitted with suspected ACS.

Relations between implementation of new treatments and improved outcomes in patients with non-ST-elevation myocardial infarction during the last 20 years: experiences from SWEDEHEART registry 1995 to 2014.

We assessed the changes in short- and long-term outcomes and their relation to implementation of new evidence-based treatments in all patients with non-ST-elevation myocardial infarction (NSTEMI) in Sweden over 20 years. Cases with NSTEMI (n = 205 693) between 1995 and 2014 were included from the nationwide Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART) registry. During 20 years in-hospital invasive procedures increased from 1.9% to 73.2%, percutaneous coronary intervention or coronary artery bypass grafting 6.5% to 58.1%, dual antiplatelet medication 0% to 72.7%, statins 13.3% to 85.6%, and angiotensin-converting enzyme inhibitors/angiotensin II receptor blocker 36.8% to 75.5%. The standardized 1-year mortality ratio compared with a control population decreased from 5.53 [95% confidence interval (CI) 5.30-5.75] to 3.03 (95% CI 2.89-3.19). If patients admitted the first 2 years were modelled to receive the same invasive treatments as the last 2 years the expected mortality/myocardial infarction (MI) rate would be reduced from 33.0% to 25.0%. After adjusting for differences in baseline characteristics, the change of 1-year cardiovascular death/MI corresponded to a linearly decreasing odds ratio trend of 0.930 (95% CI 0.926-0.935) per 2-year period. This trend was substantially attenuated [0.970 (95% CI 0.964-0.975)] after adjusting for changes in coronary interventions, and almost eliminated [0.988 (95% CI 0.982-0.994)] after also adjusting for changes in discharge medications. In NSTEMI patients during the last 20 years, there has been a substantial improvement in long-term survival and reduction in the risk of new cardiovascular events. These improvements seem mainly explained by the gradual uptake and widespread use of in-hospital coronary interventions and evidence-based long-term medications.

Myocardial Infarction with Nonobstructive Coronary Arteries: The Importance of Achieving Secondary Prevention Targets

BackgroundApproximately 5% to 10% of all patients with myocardial infarction have nonobstructive coronary arteries. Studies investigating the importance of follow-up and achievement of conventional secondary prevention targets in these patients are lacking. MethodsIn this analysis from the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART) registry, we investigated 5830 patients with myocardial infarction with nonobstructive coronary arteries (group 1) and 54,637 patients with myocardial infarction with significant coronary artery disease (≥50% stenosis; group 2). Multivariable- and propensity score–adjusted statistics were used to assess the reduction in the 1-year risk of major adverse events associated with prespecified secondary preventive measures: participation in follow-up at 6 to 10 weeks after the hospitalization and achievement of secondary prevention targets (blood pressure and low-density lipoprotein cholesterol levels in the target ranges, nonsmoking, and participation in exercise training). ResultsPatients in group 1 were less often followed up compared with patients in group 2 and less often achieved any of the secondary prevention targets. Participation in the 6- to 10-week follow-up was associated with a 3% to 20% risk reduction in group 1, similar as for group 2 according to interaction analysis. The improvement in outcome in group 1 was mainly mediated by achieving target range low-density lipoprotein cholesterol levels (24%-32% risk reduction) and, to a smaller extent, by participation in exercise training (10%-23% risk reduction). ConclusionsSelected secondary preventive measures are associated with prognostic benefit in patients with myocardial infarction with nonobstructive coronary arteries, in particular achieving target range low-density lipoprotein cholesterol levels. Our results indicate that these patients should receive similar follow-up as myocardial infarction patients with significant coronary stenoses.

A user-friendly risk-score for predicting in-hospital cardiac arrest among patients admitted with suspected non ST-elevation acute coronary syndrome – The SAFER-score

AimTo develop a simple risk-score model for predicting in-hospital cardiac arrest (CA) among patients hospitalized with suspected non-ST elevation acute coronary syndrome (NSTE-ACS). MethodsUsing the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART), we identified patients (n=242 303) admitted with suspected NSTE-ACS between 2008 and 2014. Logistic regression was used to assess the association between 26 candidate variables and in-hospital CA. A risk-score model was developed and validated using a temporal cohort (n=126 073) comprising patients from SWEDEHEART between 2005 and 2007 and an external cohort (n=276 109) comprising patients from the Myocardial Ischaemia National Audit Project (MINAP) between 2008 and 2013. ResultsThe incidence of in-hospital CA for NSTE-ACS and non-ACS was lower in the SWEDEHEART-derivation cohort than in MINAP (1.3% and 0.5% vs. 2.3% and 2.3%). A seven point, five variable risk score (age ≥60 years (1 point), ST-T abnormalities (2 points), Killip Class >1 (1 point), heart rate <50 or ≥100bpm (1 point), and systolic blood pressure <100mmHg (2 points) was developed. Model discrimination was good in the derivation cohort (c-statistic 0.72) and temporal validation cohort (c-statistic 0.74), and calibration was reasonable with a tendency towards overestimation of risk with a higher sum of score points. External validation showed moderate discrimination (c-statistic 0.65) and calibration showed a general underestimation of predicted risk. ConclusionsA simple points score containing five variables readily available on admission predicts in-hospital CA for patients with suspected NSTE-ACS.

No improvements in long-term outcome after coronary artery bypass grafting with arterial grafts as a second conduit: a Swedish nationwide registry study.

Coronary artery bypass grafting using saphenous vein grafts (SVGs) in addition to the left internal mammary artery (IMA) graft is vitiated by poor long-term patency of the vein grafts. Hypothetically, the increased use of arterial grafts could confer even better outcomes. Our goal was to evaluate results after coronary artery bypass grafting in Sweden, where arterial grafts were used as a second conduit. Within the Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART) registry, we identified patients who had coronary artery bypass grafting from 2001 to 2015 using the IMA and the SVG, the radial artery (RA) or the additional IMA [bilateral IMA (BIMA)] as a second conduit. Deaths, postoperative incidence of coronary angiography and need for reintervention were recorded, and multivariable adjusted hazard ratios were calculated for different types of grafts. The study population comprised 46 343 cases of IMA + SVG, 1036 cases of IMA + RA and 862 cases of BIMA. The mean follow-up time (SD) was 9.3 (4.2) years for IMA + SVG, 10.7 (4.1) years for IMA + RA grafts and 5.5 (5.0) years for the BIMA graft. The adjusted hazard ratio for death was (95% confidence interval) 1.01 (0.89-1.14) for IMA + RA and 0.87 (0.72-1.06) for BIMA grafts compared with IMA + SVG. The adjusted hazard ratio for the first angiographic examination was (95% confidence interval) 0.96 (0.84-1.10) for IMA + RA and 1.13 (0.95-1.35) for BIMA grafts. The adjusted hazard ratio for the need for reintervention was (95% confidence interval) 0.91 (0.75-1.09) for IMA + RA and 1.26 (1.00-1.58) for BIMA grafts. Patients who had arterial grafts as second conduits did not demonstrate a better outcome in any of the studied end-points. Radial artery grafts seem to be preferable to BIMA grafts as an alternative to an SVG.

PCI Versus CABG in Patients With Type 1 Diabetes and Multivessel Disease

BackgroundIt is unknown if coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) may offer a survival benefit in patients with type 1 diabetes (T1D) in need of multivessel revascularization. ObjectivesThis study sought to determine if patients with T1D and multivessel disease may benefit from CABG compared with PCI. MethodsIn an observational cohort study, the authors included all patients with T1D who underwent a first multivessel revascularization in Sweden from 1995 to 2013. The authors used the SWEDEHEART (Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies) register, the Swedish National Diabetes Register, and the Swedish National Patient Register to retrieve information about patient characteristics and outcomes. They estimated hazard ratios (HRs) adjusted for confounders with 95% confidence intervals (CIs) for all-cause and coronary heart disease mortality, myocardial infarction, repeat revascularization, stroke, and heart failure using inverse probability of treatment weighting based on propensity scores. ResultsIn total, 683 patients who underwent CABG and 1,863 patients who underwent PCI were included. During a mean follow-up of 10.6 years, 53% of patients in the CABG group and 45% in the PCI group died. PCI, compared with CABG, was associated with a similar risk of all-cause mortality (HR: 1.14; 95% CI: 0.99 to 1.32), but higher risks of death from coronary heart disease (HR: 1.45; 95% CI: 1.21 to 1.74), myocardial infarction (HR: 1.47; 95% CI: 1.23 to 1.78), and repeat revascularization (HR: 5.64; 95% CI: 4.67 to 6.82). No differences in risks of stroke or heart failure were found. ConclusionsNotwithstanding the inclusion of patients with T1D who might not have been able to undergo CABG in the PCI group we found that PCI, compared with CABG, was associated with higher rates and risks of coronary heart disease mortality, myocardial infarction, and repeat revascularizations. Our findings indicate that CABG may be the preferred strategy in patients with T1D in need of multivessel revascularization.

Temporal changes in myocardial infarction incidence rates are associated with periods of perceived psychosocial stress: A SWEDEHEART national registry study

Psychosocial stress might trigger myocardial infarction (MI). Increased MI incidence coincides with recurrent time periods during the year perceived as particularly stressful in the population. A stress-triggering hypothesis on the risk of MI onset was investigated with Swedish population data on MI hospital admission date and symptom onset date (N=156,690; 148,176) as registered from 2006 through 2013 in the national quality registry database Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART). Poisson regression was applied to analyze daily MI rates during days belonging to the Christmas and New Year holidays, turns of the month, Mondays, weekends, and summer vacation in July compared with remaining control days. Adjusted incidence rate ratios (IRRs) for MI rates were higher during Christmas and New Year holidays (IRR=1.07 [1.04-1.09], P<.001) and on Mondays (IRR=1.11 [1.09-1.13], P<.001) and lower in July (IRR=0.92 [0.90-0.94], P<.001) and over weekends (IRR=0.88 [0.87-0.89], P<.001), yet not during the turns of the month (IRR=1.01 [1.00-1.02], P=.891). These findings were also predominantly robust with symptom onset as alternative outcome, when adjusting for both established and some suggested-but-untested confounders, and in 8 subgroups. Fluctuations in daily MI incidence rates are systematically related to time periods of presumed psychosocial stress. Further research might clarify mechanisms that are amenable to clinical alteration.

Intravenous beta-blocker therapy in ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention is not associated with benefit regarding short-term mortality: a Swedish nationwide observational study.

Our aim was to investigate the impact of intravenous (IV) beta-blocker therapy on short-term mortality and other in-hospital events in patients with ST-segment elevation myocardial infarction (STEMI) treated with dual antiplatelet therapy (DAPT) and primary percutaneous coronary intervention (PCI). Using the nationwide Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART) registry, we identified all patients with STEMI undergoing PCI between 2006 and 2013. Patients with cardiogenic shock and cardiac arrest at presentation were excluded. The primary endpoint was mortality within 30 days. Secondary endpoints were in-hospital events (mortality, cardiogenic shock and left ventricular ejection fraction [LVEF] <40% at discharge). We adjusted for confounders with a multivariable model and propensity score matching. Out of 16,909 patients, 2,876 (17.0%) were treated with an IV beta-blocker. After adjusting for confounders, the IV beta-blocker group had higher 30-day all-cause mortality (HR: 1.44, 95% CI: 1.14-1.83), more in-hospital cardiogenic shock (OR: 1.53, 95% CI: 1.09-2.16) and were more often discharged with an LVEF <40% (OR: 1.70, 95% CI: 1.51-1.92). In this large nationwide observational study, the use of IV beta-blockers in patients with STEMI treated with primary PCI was associated with higher short-term mortality, lower LVEF at discharge, as well as a higher risk of in-hospital cardiogenic shock.

Medical Therapy for Secondary Prevention and Long-Term Outcome in Patients With Myocardial Infarction With Nonobstructive Coronary Artery Disease.

Myocardial infarction with nonobstructive coronary arteries (MINOCA) occurs in 5% to 10% of all patients with myocardial infarction. Clinical trials of secondary prevention treatment in MINOCA patients are lacking. Therefore, the aim of this study was to examine the associations between treatment with statins, renin-angiotensin system blockers, β-blockers, dual antiplatelet therapy, and long-term cardiovascular events. This is an observational study of MINOCA patients recorded in the SWEDEHEART registry (the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapy) between July 2003 and June 2013 and followed until December 2013 for outcome events in the Swedish Cause of Death Register and National Patient Register. Of 199 162 myocardial infarction admissions, 9466 consecutive unique patients with MINOCA were identified. Among those, the 9136 patients surviving the first 30 days after discharge constituted the study population. Mean age was 65.3 years, and 61% were women. No patient was lost to follow-up. A stratified propensity score analysis was performed to match treated and untreated groups. The association between treatment and outcome was estimated by comparing between treated and untreated groups by using Cox proportional hazards models. The exposures were treatment at discharge with statins, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, β-blockers, and dual antiplatelet therapy. The primary end point was major adverse cardiac events defined as all-cause mortality, hospitalization for myocardial infarction, ischemic stroke, and heart failure. At discharge, 84.5%, 64.1%, 83.4%, and 66.4% of the patients were on statins, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, β-blockers, and dual antiplatelet therapy, respectively. During the follow-up of a mean of 4.1 years, 2183 (23.9%) patients experienced a major adverse cardiac event. The hazard ratios (95% confidence intervals) for major adverse cardiac events were 0.77 (0.68-0.87), 0.82 (0.73-0.93), and 0.86 (0.74-1.01) in patients on statins, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, and β-blockers, respectively. For patients on dual antiplatelet therapy followed for 1 year, the hazard ratio was 0.90 (0.74-1.08). The results indicate long-term beneficial effects of treatment with statins and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers on outcome in patients with MINOCA, a trend toward a positive effect of β-blocker treatment, and a neutral effect of dual antiplatelet therapy. Properly powered randomized clinical trials to confirm these results are warranted.

Sex-Discordant Blood Transfusions and Survival After Cardiac Surgery

Patients who are transfused in conjunction with cardiac surgery have been found to have an increased risk of death. Several possible mechanisms behind this observation have been proposed. Among these, 2 recent cohort studies have reported increased mortality in recipients of sex-discordant transfusions.1,2 Because such effects, if true, would have important clinical and logistical implications, we investigated the association between sex-discordant blood transfusions and mortality in a nationwide cohort study. We identified all patients who underwent cardiac surgery in Sweden from the SWEDEHEART registry (Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies), which records details on all patients undergoing cardiac surgery in Sweden since 1992.3 Transfusion data were obtained through linkage with the SCANDAT2 database (Scandinavian Donations and Transfusions),4 which has recorded computerized data from all transfusion medicine clinics in Sweden since the 1960s. The linked database has previously been used to study the effects of red blood cell storage.5 The analyses were restricted to adult patients who had undergone isolated coronary artery bypass grafting or isolated valve repair/replacement surgery or a combination of coronary artery bypass grafting and valve repair/replacement surgery between 1997 and 2012, …

Abstract 13206: Culprit and Non-Culprit Recurrent Ischemic Events in Post-Myocardial Infarction Patients: Data From SWEDEHEART

Introduction: Long-term disease progression post myocardial infarction (MI) is inadequately understood and recurrences appear at the stented lesion or in untreated progressive lesions. Hypothesis: We studied the pattern and angiographic properties (culprit/non-culprit) of recurrent-MI (re-MI) in a large real-world patient population. Methods: We performed a prospective cohort study in 99,546 first-occurrence MI patients enrolled in Swedish Web system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART) between 1 Jan 2006 and 31 Dec 2014. Results: A culprit lesion could be identified in 41,006 patients who underwent coronary angiography. Of those, 2,361 patients suffered a re-MI where the angiography could detect the infarct origin: 587 originated from the culprit lesion- and 1,774 from the non-culprit lesion. The cumulative event probability for re-MI within 8 years (estimated by Kaplan-Meier) related to the culprit lesion was 0.027 (0.023-0.030) as compared with 0.080 (0.075-0.085) for a non-culprit lesion (Figure). At the index infarction, patients with subsequent culprit vs. non-culprit re-MIs were overall similar according to baseline characteristics: gender (men: 69% vs. 72%), age (66 vs. 65 years), infarction type (STEMI: 54% vs. 52%), diabetic status (22% vs. 21%), current smoking (32 % vs. 30 %), hyperlipidemia (statin treatment: 20 vs. 23 %) and hypertension (44.1% vs. 47.5%). Patients with culprit re-MIs were somewhat less likely to have 3-vessel disease at index (12% vs 17%) but procedural characteristics such as number of stents, total stent length and mean stent diameter were similar between groups. Conclusions: In a large cohort of first-occurrence MI patients undergoing PCI, the risk of reinfarction not originating from a previously stented lesion was three times higher than the risk of lesions originating from a previously stented lesion.

Incidence and risk factors for thromboembolism and major bleeding in patients with mechanical valve prosthesis: A nationwide population-based study

Risk factors of stroke/thromboembolism (TE) and major bleeding, and incidence of these events in specific age categories in warfarin-treated patients with mechanical heart valves (MHV) are uncertain. Our objective was to calculate event rates in specific age categories and identify risk factors for adverse events. We identified 4,810 treatment periods with MHV between January 2006 and December 2011 in the Auricula and Swedish Web system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies registries. There were 3,751 treatment periods with aortic valve replacements (AVR) and 866 with mitral valve replacements (MVR). Median follow-up time was 4.5 years (IQR, 1.5-6.0). Time in therapeutic range with warfarin for patients with AVR was 74.2% for international normalized ratio of 2.0 to 3.0, with 72% of the patients having this target range. Rate of stroke/TE for AVR and MVR was 1.3 and 1.6 per 100 patient years, respectively (P=.20). The rate of first major bleeding was 2.6 and 3.9 per 100 patient years with AVR and MVR, respectively (P<.001). By multivariate analysis for AVR, age (hazard ratio [HR], 1.02; 95% confidence interval [CI], 1.01-1.03 per year) and previous stroke (HR, 2.4; 95% CI, 1.7-3.5) emerged as independent risk factors for stroke/TE. Heart failure (HR, 0.9; 95% CI, 0.6-1.4) and atrial fibrillation (HR, 1.0; 95% CI, 0.7-1.4) were not associated to stroke/TE. For major bleeding events, age (HR, 1.02; 95% CI, 1.01-1.03 per year) and previous major bleeding (HR, 2.5; 95% CI, 1.9-3.3) emerged as independent risk factors for AVR. In a nationwide cohort study with MHV and high time in therapeutic range, heart failure and atrial fibrillation did not appear as risk factors of stroke/TE.

Survival After Coronary Artery Bypass Grafting in Patients With Preoperative Heart Failure and Preserved vs Reduced Ejection Fraction.

Data on the prognostic consequence of heart failure (HF) with preserved ejection fraction in patients undergoing coronary artery bypass grafting (CABG) are limited and inconclusive. To investigate the survival after CABG in patients with preoperative HF and preserved ejection fraction (pEF) vs reduced ejection fraction (rEF). Swedish nationwide population-based cohort study that included all patients who underwent primary isolated CABG between January 1, 2001, and December 31, 2013, from the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART) register, with follow-up for all-cause mortality in March 2014. Information regarding baseline characteristics, all-cause mortality, and readmissions for HF was obtained from national health data registers. Preserved EF was defined as at least 50%. The primary outcome was all-cause mortality. A secondary outcome measure was a combination of all-cause mortality and readmission for HF. The study included 41 906 patients, 37 234 without known HF (27 165 with pEF and 10 069 with rEF) and 4672 with HF (1216 with pEF and 3456 with rEF). Their mean (SD) age was 67.4 (9.3) years, and 21.0% were female. During a mean (SD) follow-up time of 6.0 (3.3) years, 19.0% (7943 of 41 906) of patients died, including 13.2% (3574 of 27 165) with no HF and pEF, 24.6% (2476 of 10 069) with no HF and rEF, 33.9% (412 of 1216) with HFpEF, and 42.9% (1481 of 3456) with HFrEF. The multivariable-adjusted hazard ratios for death were 1.47 (95% CI, 1.40-1.56), 1.62 (95% CI, 1.46-1.80), and 2.29 (95% CI, 2.14-2.44) in patients with no HF and rEF, patients with HFpEF, and patients with HFrEF compared with patients with no HF and pEF. The findings were similar for the combined outcome of all-cause mortality and readmission for HF. The multivariable-adjusted hazard ratios for death within 30 days of surgery were 2.25 (95% CI, 1.86-2.73), 1.83 (95% CI, 1.26-2.66), and 2.52 (95% CI, 1.99-3.19) in patients with no HF and rEF, patients with HFpEF, and patients with HFrEF. A history of HF was an important risk factor for poor short-term and long-term outcomes after CABG regardless of preoperative EF. Reduced EF more than doubled the risk of early death after CABG.

Outcomes in patients treated with ticagrelor or clopidogrel after acute myocardial infarction: experiences from SWEDEHEART registry.

Ticagrelor reduces ischaemic events and mortality in acute coronary syndrome (ACS) vs. clopidogrel. We wished to study clinical outcomes in a large real-world population post-ACS. We performed a prospective cohort study in 45 073 ACS patients enrolled into Swedish Web system for Enhancement and Development of Evidence-based care in Heart Disease Evaluated According to Recommended Therapies who were discharged on ticagrelor (N = 11 954) or clopidogrel (N = 33 119) between 1 January 2010 and 31 December 2013. The primary outcome was a composite of all-cause death, re-admission with myocardial infarction (MI) or stroke, secondary outcomes as the individual components of the primary outcome, and re-admission with bleeding. The risk of the primary outcome with ticagrelor vs. clopidogrel was 11.7 vs. 22.3% (adjusted hazard ratio (HR) 0.85 [95% confidence interval: 0.78-0.93]), risk of death 5.8 vs. 12.9% (adjusted HR 0.83 [0.75-0.92]), and risk of MI 6.1 vs. 10.8% (adjusted HR 0.89 [0.78-1.01]) at 24 months. Re-admission with bleeding with ticagrelor vs. clopidogrel occurred in 5.5 vs. 5.2% (adjusted HR 1.20 [1.04-1.40]). In a subset of patients undergoing percutaneous coronary intervention (PCI) on ticagrelor vs. clopidogrel the PCI-related in-hospital bleeding was 3.7 vs. 2.7% (adjusted odds ratio, OR, 1.57 [1.30-1.90]). Ticagrelor vs. clopidogrel post-ACS was associated with a lower risk of death, MI, or stroke, as well as death alone. Risk of bleeding was higher with ticagrelor. These real-world outcomes are consistent with randomized trial results.

Bivalirudin versus heparin in non-ST and ST-segment elevation myocardial infarction—a registry-based randomized clinical trial in the SWEDEHEART registry (the VALIDATE-SWEDEHEART trial)

The optimal anticoagulant for patients with acute coronary syndrome treated with percutaneous coronary intervention (PCI) has not been validated in current practice of radial approach and pretreatment with potent P2Y12 inhibitors. Several studies have indicated increased bleeding rate and, in some instances, even increased mortality by the routine use of heparin and glycoprotein IIb/IIIa inhibitors compared to bivalirudin. Direct comparison of bivalirudin versus heparin alone has yielded contradictory results depending on study designs. The VALIDATE-SWEDEHEART trial is a multicenter, prospective, randomized, registry-based, controlled, and open-label clinical trial in patients with ST-segment elevation myocardial infarction (STEMI) or non-STEMI undergoing PCI pretreated with ticagrelor, prasugrel, or cangrelor. We hypothesize that bivalirudin is superior to heparin alone in reducing death, myocardial infarction, and major bleeding events at 180 days (primary end point). The trial will enroll 3,000 patients with STEMI and 3,000 patients with non-STEMI undergoing PCI. The trial will use a hybrid registry-based randomized clinical trial design where inclusion, randomization, and baseline data collection are performed using The Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies registry. The primary composite end point (death, myocardial infarction, or major bleeding events at 180 days) will be identified through active screening after 7 and 180 days and adjudicated by a blinded central end point committee. Secondary end points and long-term outcomes will be recorded from national registries. The VALIDATE-SWEDEHEART trial is founded on a nationwide clinical registry and uses a hybrid registry-based randomized clinical trial (RRCT) design methodology to evaluate efficacy and safety of bivalirudin as compared to heparin alone for acute coronary syndrome, in a large population receiving contemporary recommended therapies including predominantly radial invasive approach and pretreatment with potent P2Y12 inhibitors.

Aortic valve replacement with mechanical vs. biological prostheses in patients aged 50–69 years

The objective was to investigate the long-term all-cause mortality in patients aged 50-69 years after aortic valve replacement (AVR) with bioprosthetic or mechanical valves. All patients aged 50-69 years who had undergone AVR in Sweden 1997-2013 were identified from the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies register. Subsequent patient-level record linkage with national health-data registers provided patient characteristics, vital status, and clinical outcomes. Of the 4545 patients, 60% (2713/4545) had received mechanical valves and 40% (1832/4545) bioprostheses. In 1099 propensity score-matched patient pairs, 16% (180/1099) had died in the mechanical valve group and 20% (217/1099) in the bioprosthetic group; mean follow-up 6.6 (maximum 17.2) years. Survival was higher in the mechanical than in the bioprosthetic group: 5-, 10-, and 15-year survival 92, 79, and 59% vs. 89, 75, and 50%; hazard ratio 1.34; 95% confidence interval (CI) 1.09-1.66; P = 0.006. There was no difference in stroke [subdistribution hazard ratio (sHR) 1.04; 95% CI 0.72-1.50, P = 0.848]; however, the risk for aortic valve reoperation was higher (sHR 2.36; 95% CI 1.42-3.94, P = 0.001), and for major bleeding lower (sHR 0.49; 95% CI 0.34-0.70, P < 0.001), in patients who had received bioprostheses than in those with mechanical valves. Patients aged 50-69 years who received mechanical valves had better long-term survival after AVR than those with bioprostheses. The risk of stroke was similar; however, patients with bioprostheses had a higher risk of aortic valve reoperation and a lower risk of major bleeding. http://clinicaltrials.gov/show/NCT02276950. NCT02276950.

Contemporary use of ticagrelor in patients with acute coronary syndrome: insights from Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART)

The platelet inhibitor ticagrelor is strongly recommended during 12 months post-acute coronary syndrome (ACS) in European guidelines. We analysed clinical characteristics of patients given ticagrelor for ACS in the real world. We studied the use of ticagrelor in patients admitted for ACS in Sweden between 1 January 2012 and 31 December 2013 who were enrolled in the Swedish Web system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART). Clinical characteristics were investigated for patients prescribed ticagrelor at discharge as well as for patients undergoing percutaneous coronary intervention who were prescribed ticagrelor. Independent factors associated with selecting ticagrelor were analysed in logistic regression. We found that 44.0% (n = 12 601) out of a total of 28 639 patients had been prescribed ticagrelor at discharge. After adjusting for age and sex, prior cardiovascular disease was less common in patients discharged on ticagrelor (myocardial infarction, ischaemic stroke, and peripheral vascular disease; P for all <0.001). The risk of death as predicted by GRACE score and the risk of major bleeding as predicted by CRUSADE score were both lower in ticagrelor-treated patients vs. others (median 99 vs. 126 and median 23 vs. 25, respectively; P for both < 0.001). The intended treatment duration at discharge was 12 months in 82.5% of patients and <12 months in 9.3%. Ticagrelor is preferentially being used in patients at lower risk. A minority of patients are recommended ticagrelor during <12 months.