Safety of the Deferral of Coronary Revascularization on the Basis of Instantaneous Wave-Free Ratio and Fractional Flow Reserve Measurements in Stable Coronary Artery Disease and Acute Coronary Syndromes

OBJECTIVES The aim of this study was to investigate the clinical outcomes of patients deferred from coronary revascularization on the basis of instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR) measurements in stable angina pectoris (SAP) and acute coronary syndromes (ACS). BACKGROUND Assessment of coronary stenosis severity with pressure guidewires is recommended to determine the need for myocardial revascularization. METHODS The safety of deferral of coronary revascularization in the pooled per-protocol population (n = 4,486) of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) and iFR-SWEDEHEART (Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve in Patients With Stable Angina Pectoris or Acute Coronary Syndrome) randomized clinical trials was investigated. Patients were stratified according to revascularization decision making on the basis of iFR or FFR and to clinical presentation (SAP or ACS). The primary endpoint was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year. RESULTS Coronary revascularization was deferred in 2,130 patients. Deferral was performed in 1,117 patients (50%) in the iFR group and 1,013 patients (45%) in the FFR group (p <0.01). At 1 year, the MACE rate in the deferred population was similar between the iFR and FFR groups (4.12% vs. 4.05%; fully adjusted hazard ratio: 1.13; 95% confidence interval: 0.72 to 1.79; p = 0.60). A clinical presentation with ACS was associated with a higher MACE rate compared with SAP in deferred patients (5.91% vs. 3.64% in ACS and SAP, respectively; fully adjusted hazard ratio: 0.61 in favor of SAP; 95% confidence interval: 0.38 to 0.99; p = 0.04). CONCLUSIONS Overall, deferral of revascularization is equally safe with both iFR and FFR, with a low MACE rate of about 4%. Lesions were more frequently deferred when iFR was used to assess physiological significance. In deferred patients presenting with ACS, the event rate was significantly increased compared with SAP at 1 year. (C) 2018 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.Peer reviewe

Is the Hospital Anxiety and Depression Scale (HADS) a valid measure in a general population 65-80 years old? A psychometric evaluation study

Background: The HADS (Hospital Anxiety and Depression Scale) aims to measure symptoms of anxiety (HADS Anxiety) and depression (HADS Depression). The HADS is widely used but has shown ambiguous results both regarding the factor structure and sex differences in the prevalence of depressive symptoms. There is also a lack of psychometric evaluations of the HADS in non-clinical samples of older people. The aim of the study was to evaluate the factor structure of the HADS in a general population 65-80 years old and to exam possible presence of differential item functioning (DIF) with respect to sex. Methods: This study was based on data from a Swedish sample, randomized from the total population in the age group 65-80 years (n = 6659). Confirmatory factor analyses (CFA) were performed to examine the factor structure. Ordinal regression analyses were conducted to detect DIF for sex. Reliability was examined by both ordinal as well as traditional Cronbachs alpha. Results: The CFA showed a two-factor model with cross-loadings for two items (7 and 8) had excellent model fit. Internal consistency was good in both subscales, measured with ordinal and traditional alpha. Floor effects were presented for all items. No indication for meaningful DIF regarding sex was found for any of the subscales. Conclusions: HADS Anxiety and HADS Depression are unidimensional measures with acceptable internal consistency and are invariant with regard to sex. Despite pronounced ceiling effects and cross-loadings for item 7 and 8, the hypothesized two-factor model of HADS can be recommended to assess psychological distress among a general population 65-80 years old

Long-term safety and efficacy of drug-eluting and bare metal stents in saphenous vein grafts

Background Long-term safety and efficacy data of drug-eluting stents (DESs) in saphenous vein grafts (SVGs) are lacking. This study sought to compare the clinical outcomes of DES versus bare metal stents (BMS) in SVGs. Methods We studied all stent implantations in SVGs in Sweden during 74 months between 2005 and 2011 registered in the Swedish Coronary Angiography and Angioplasty Registry. We evaluated outcome in patients who received DES compared with those who received BMS after adjustments for differences in clinical, vessel, and lesion characteristics. Results Mean follow-up time was 3 years and 4 months. A total of 4,576 stents, implanted at 3,063 procedures, were included in the analysis of which 2,499 stents (54.6 %) were BMS and 2,077 (45.4%) were DES. The outcome analysis was based on 190 stent thromboses, 898 restenoses, and 523 deaths. The incidence of stent thrombosis did not differ between groups. When adjusted for baseline characteristics, including a propensity score for receiving DES, the incidence of restenosis was significantly lower with DES as compared with BMS (risk ratio 0.83, 95% CI 0.70-0.97, P = .019). There was a difference in mortality in the crude analysis between DES and BMS, and after multivariable adjustment, this difference remained statistically significant (risk ratio 0.80, CI 0.65-0.99, P = .038). Conclusions The use of DES compared with BMS in SVGs was associated with a significantly lower adjusted incidence of restenosis and death in this large, national, all-encompassing propensity adjusted observational study. (Am Heart J 2012;164:87-93.

Stent Thrombosis in Sweden A Report From the Swedish Coronary Angiography and Angioplasty Registry

Background-The objective was to evaluate the role of risk factors and stent type for stent thrombosis (ST) using a large real world registry. Methods and Results-We evaluated all consecutive coronary stent implantations in Sweden from May 1, 2005, to June 30, 2007. All cases of ST, documented in the Swedish coronary angiography and angioplasty registry until September 21, 2008, were analyzed. ST was registered in 882 of 73 798 stents. Acute coronary syndromes, insulin-treated diabetes mellitus, smoking, previous coronary intervention, warfarin treatment, small stent diameter, and stenting in restenotic, complex, or bypass graft lesions had the strongest association with ST in the multivariable statistical model. There were considerable differences in the frequency of ST between different stent brands. The overall risk of ST was lower in drug-eluting stents compared with bare metal stents (adjusted risk ratio, 0.79; 99% CI, 0.63 to 0.99). However, from 6 months after stent implantation and onward, the risk for ST was higher in drug-eluting stents compared with bare metal stents (adjusted risk ratio, 2.02; 99% CI, 1.30 to 3.14). Conclusions-ST is a multifactor disease, and the incidence varies considerably between patients based on clinical, vessel, and stent characteristics. For drug-eluting stents compared with bare metal stents, the risk pattern was biphasic; initially, bare metal stents demonstrated a higher risk of ST; whereas after the first months, ST risk was higher with drug-eluting stents. Our findings highlight the need for prospective randomized studies with head-to-head comparisons between different stents. (Circ Cardiovasc Intervent. 2009;2:401-408.

Safety and efficacy of drug-eluting vs. bare metal stents in patients with diabetes mellitus: long-term follow-up in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)

Patients with diabetes mellitus have more extensive coronary artery disease, more disease progression, and restenosis. The use of drug-eluting stents (DES) in these patients is widespread, despite uncertain long-term safety and efficacy. All consecutive patients with diabetes mellitus in Sweden who underwent percutaneous coronary intervention were entered into the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) during 2003-06 with complete follow-up for 1-4 years (median 2.5). Patients who received at least one DES (n = 4754) were compared with those who received only bare metal stents (BMS) (n = 4956) at the index procedure. Combined outcome of death or myocardial infarction (MI) showed no difference for DES vs. BMS, relative risk (RR), 0.91 [95% confidence interval (CI), 0.77-1.06]. Myocardial infarction was significantly less common with DES in patients who received only one stent RR, 0.80 (95% CI, 0.66-0.96). The restenosis rate was 50% lower in DES-treated patients RR, 0.50 (95% CI, 0.35-0.70) and was associated with a higher adjusted RR of MI, RR, 5.03 (95% CI, 4.25-5.97). DES was associated with reduced restenosis rates in all subgroups of diabetic patients with the greatest benefit in stent diameters 20 mm. The number of lesions treated with DES to prevent one restenosis ranged from 11 to 47 in various subgroups. This real-life registry study shows that restenosis was halved by DES in diabetic patients with stable or unstable coronary disease, with similar risk of death or MI up to 4 years compared with BMS

Initial clinical experience with an everolimus eluting platinum chromium stent (Promus Element) in unselected patients from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)

Background: The safety and efficacy of the Promus Element stent have been recently demonstrated in a selected population from one randomized trial. The aim of this study was to describe the initial clinical experience with the everolimus eluting platinum chromium stent (Promus Element) in unselected patients from a real life nationwide registry. Methods: The Promus Element DES was compared to all other DES implanted in Sweden (with more than 500 implants) from November 2009 to March 2011. The results were assessed using Cox regression. Results: A total of 13,577 stents (Promus Element, n = 2724, Cypher, n = 782; Endeavor, n = 747; Taxus Liberte, n = 1393, Xience V/Promus, n = 4832, Resolute, n = 1566, Xience Prime, n = 4832) were implanted at 8375 procedures. At one year the restenosis rate in the Promus Element was not significantly different from the overall DES group (2.8% vs. 2.7%, adjusted HR: 1.17, 95% CI: 0.75-1.75). A significantly lower restenosis rate was observed in the Promus Element when compared with Endeavor (2.8% vs. 5.8%; adjusted HR: 0.44; 95% CI: 0.26-0.74). The stent thrombosis (ST) rate at one year was not significantly different in the Promus Element as compared with the overall DES group (0.2% vs. 0.5% adjusted HR: 0.59; 95% CI: 025-1.40). ST rate was significantly lower as compared with Endeavor stent (0.2% vs. 0.8%; HR: 0.24; 95% CI: 0.08-0.67). Conclusions: In a large unselected population the Promus Element stent appears to be safe and effective with a low risk of restenosis and ST. (C) 2011 Elsevier Ireland Ltd. All rights reserved

Computed tomography coronary angiography in patients with acute myocardial infarction and normal invasive coronary angiography

Background: Three to five percent of patients with acute myocardial infarction (AMI) have normal coronary arteries on invasive coronary angiography (ICA). The aim of this study was to assess the presence and characteristics of atherosclerotic plaques on computed tomography coronary angiography (CTCA) and describe the clinical characteristics of this group of patients. Methods: This was a multicentre, prospective, descriptive study on CTCA evaluation in thirty patients fulfilling criteria for AMI and without visible coronary plaques on ICA. CTCA evaluation was performed head to head in consensus by two experienced observers blinded to baseline patient characteristics and ICA results. Analysis of plaque characteristics and plaque effect on the arterial lumen was performed. Coronary segments were visually scored for the presence of plaque. Seventeen segments were differentiated, according to a modified American Heart Association classification. Echocardiography performed according to routine during the initial hospitalisation was retrieved for analysis of wall motion abnormalities and left ventricular systolic function in most patients. Results: Twenty-five patients presented with non ST-elevation myocardial infarction (NSTEMI) and five with ST-elevation myocardial infarction (STEMI). Mean age was 60.2 years and 23/30 were women. The prevalence of risk factors of coronary artery disease (CAD) was low. In total, 452 coronary segments were analysed. Eighty percent (24/30) had completely normal coronary arteries and twenty percent (6/30) had coronary atherosclerosis on CTCA. In patients with atherosclerotic plaques, the median number of segments with plaque per patient was one. Echocardiography was normal in 4/22 patients based on normal global longitudinal strain (GLS) and normal wall motion score index (WMSI); 4/22 patients had normal GLS with pathological WMSI; 3/22 patients had pathological GLS and normal WMSI; 11/22 patients had pathological GLS and WMSI and among them we could identify 5 patients with a Takotsubo pattern on echo. Conclusions: Despite a diagnosis of AMI, 80 % of patients with normal ICA showed no coronary plaques on CTCA. The remaining 20 % had only minimal non-obstructive atherosclerosis. Patients fulfilling clinical criteria for AMI but with completely normal ICA need further evaluation, suggestively with magnetic resonance imaging (MRI).Funding Agencies|Swedish Heart and Lung Foundation [20120449]; Region of Ostergotland [437491]; European Union FP 7 [223615]; Medical Research Council of Southeast Sweden [157921]</p