BACKGROUND: Patients with severe aortic stenosis present frequently (∼50%) with concomitant obstructive coronary artery disease. Current guidelines recommend combined surgical aortic valve replacement (SAVR) and coronary artery bypass grafting (CABG) as the preferred treatment. Transcatheter aortic valve implantation (TAVI) and fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) represent a valid treatment alternative. We aimed to test the non-inferiority of FFR-guided PCI plus TAVI versus SAVR plus CABG in patients with severe aortic stenosis and complex coronary artery disease. METHODS: This international, multicentre, prospective, open-label, non-inferiority, randomised controlled trial was conducted at 18 tertiary medical centres across Europe. Patients (aged ≥70 years) with severe aortic stenosis and complex coronary artery disease, deemed feasible for percutaneous or surgical treatment according to the on-site Heart Team, were randomly assigned (1:1) to FFR-guided PCI plus TAVI or SAVR plus CABG according to a computer-generated sequence with random permuted blocks sizes stratified by site. The primary endpoint was a composite of all-cause mortality, myocardial infarction, disabling stroke, clinically driven target-vessel revascularisation, valve reintervention, and life-threatening or disabling bleeding at 1 year post-treatment. The trial was powered for non-inferiority (with a margin of 15%) and if met, for superiority. The primary and safety analyses were done per an intention-to-treat principle. This trial is registered with ClinicalTrials.gov (NCT03424941) and is closed. FINDINGS: Between May 31, 2018, and June 30, 2023, 172 patients were enrolled, of whom 91 were assigned to the FFR-guided PCI plus TAVI group and 81 to the SAVR plus CABG group. The mean age of patients was 76·5 years (SD 3·9). 118 (69%) of 172 patients were male and 54 (31%) patients were female. FFR-guided PCI plus TAVI resulted in favourable outcomes for the primary endpoint (four [4%] of 91 patients) versus SAVR plus CABG (17 [23%] of 77 patients; risk difference -18·5 [90% CI -27·8 to -9·7]), which was below the 15% prespecified non-inferiority margin (pnon-inferiority<0·001). FFR-guided PCI plus TAVI was superior to SAVR plus CABG (hazard ratio 0·17 [95% CI 0·06-0·51]; psuperiority<0·001), which was driven mainly by all-cause mortality (none [0%] of 91 patients vs seven (10%) of 77 patients; p=0·0025) and life-threatening bleeding (two [2%] vs nine [12%]; p=0·010). INTERPRETATION: The TCW trial is the first trial to compare percutaneous treatment versus surgical treatment in patients with severe aortic stenosis and complex coronary artery disease, showing favourable primary endpoint and mortality outcomes with percutaneous treatment. FUNDING: Isala Heart Centre and Medtronic.
- MeSH
- Aortic Valve Stenosis * surgery complications MeSH
- Heart Valve Prosthesis Implantation methods MeSH
- Fractional Flow Reserve, Myocardial * MeSH
- Percutaneous Coronary Intervention * methods MeSH
- Coronary Artery Bypass * methods MeSH
- Humans MeSH
- Coronary Artery Disease * surgery complications therapy MeSH
- Prospective Studies MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Transcatheter Aortic Valve Replacement * methods MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Equivalence Trial MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Comparative Study MeSH
BACKGROUND: This prospective randomized study compares the efficacy of novel intravascular lithotripsy (IVL) to the standard preparation of calcified coronary lesions based on rotational atherectomy (RA). METHODS: A total of 50 patients with 52 calcified lesions were enrolled in the study and randomized 1:1 to be treated with IVL or RA followed by drug-eluting stent (DES) implantation. The procedural success was chosen as a primary endpoint and the 12-month late lumen loss (LLL) as measured by quantitative coronarography, the incidence of binary in-stent restenosis (ISR), 12-month major adverse cardiac events (MACE) and target lesion failure (TLF) served as secondary angiographic and clinical endpoints. RESULTS: Procedural success was achieved in 21 patients (84.0%) in the IVL group and in 24 patients (96%) in the RA group (p = 0.349). The secondary endpoints, including 12-month LLL (0.12 mm [IQR: - 0.06; 0.68] vs. 0.61 mm [IQR: 0.22; 0.72]; p = 0.084), the incidence of 12-month binary ISR (11.1% vs. 8.0%; p >0.999), MACE (18.5% vs. 8.0%; p = 0.422), TLR (14.8% vs. 8.0%; p = 0.670) or TLF (18.5% vs. 8.0%; p = 0.422) did not show significant differences between the IVL and RA groups. CONCLUSION: Despite different approaches to the treatment of calcified coronary lesions, both therapeutic techniques achieved similar procedural, angiographic and clinical results. (ClinicalTrials.gov NCT04428177).
- MeSH
- Time Factors MeSH
- Coronary Angiography MeSH
- Percutaneous Coronary Intervention * adverse effects instrumentation mortality MeSH
- Atherectomy, Coronary * adverse effects mortality MeSH
- Coronary Restenosis etiology MeSH
- Middle Aged MeSH
- Humans MeSH
- Lithotripsy * adverse effects mortality MeSH
- Coronary Artery Disease * therapy diagnostic imaging mortality MeSH
- Prospective Studies MeSH
- Risk Factors MeSH
- Aged MeSH
- Drug-Eluting Stents * MeSH
- Vascular Calcification * therapy diagnostic imaging mortality MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
There is a lack of reliable in vivo models that replicate limb-threatening ischemia in humans. To fill this gap, we developed and validated two novel porcine ischemic models: ischemic limb and dorsal flap models, both with and without streptozotocin-induced hyperglycemia (N = 3 per group, 12 in total). Hind limb ischemia model was induced via different arterial ligations, with two ischemic and three control wounds per animal. In the flap model, four full-thickness flaps were created on the dorsum with silicone sheets to block reperfusion, and excisional wounds were made on the top. One non-ischemic wound served as control. Transcutaneous oxygen pressure (TcPO2), wound area, and microvascular density were measured, with TcPO2 and wound area assessed longitudinally. Data analysis focused on detailed visualization and Bayesian hierarchical modelling to account for the small sample size. Developed models exhibited stable ischemia and prolonged wound healing, with TcPO2 remaining under 30 mmHg over 28 days, and wound healing extending beyond two weeks. The flap model showed slower TcPO2 recovery and greater chronicity compared to the limb model, without reliable effect of hyperglycemia. Thus, the porcine flap model shows the highest potential as a relevant model for chronic limb-threatening ischemia.
- Keywords
- Animal model, Bayesian modelling, Critical limb ischemia, Diabetes mellitus, In vivo model, Pig,
- MeSH
- Time Factors MeSH
- Surgical Flaps * MeSH
- Chronic Limb-Threatening Ischemia * physiopathology pathology blood MeSH
- Chronic Disease MeSH
- Diabetes Mellitus, Experimental complications blood chemically induced MeSH
- Neovascularization, Physiologic MeSH
- Wound Healing MeSH
- Hyperglycemia chemically induced complications blood MeSH
- Ischemia * physiopathology pathology blood etiology MeSH
- Blood Glucose metabolism MeSH
- Microvascular Density MeSH
- Disease Models, Animal MeSH
- Swine MeSH
- Regional Blood Flow MeSH
- Reproducibility of Results MeSH
- Sus scrofa MeSH
- Blood Gas Monitoring, Transcutaneous MeSH
- Hindlimb blood supply MeSH
- Animals MeSH
- Check Tag
- Male MeSH
- Animals MeSH
- Publication type
- Journal Article MeSH
- Validation Study MeSH
- Names of Substances
- Blood Glucose MeSH
AIMS: Data about long-term clinical outcomes of revascularization procedures, especially for autologous cell therapy (ACT), in diabetic patients with chronic limb-threatening ischaemia (CLTI) are lacking. The aim of our study was to compare the mortality and amputation rates in patients with diabetic foot ulcers (DFU) and CLTI treated by ACT with patients treated by repeated percutaneous transluminal angioplasty (re-PTA) and those treated conservatively. MATERIALS AND METHODS: One-hundred and thirty patients with DFU and CLTI (defined as transcutaneous oxygen pressure-TcPO2 <30 mmHg after unsuccessful standard revascularization) treated in our foot clinic over 9 years were enrolled in the study. Forty-five patients were treated by ACT, 43 patients underwent re-PTA, and 42 patients were treated conservatively and formed the control group. Overall survival, amputation-free survival (AFS) and major amputation rate were assessed over a 7-year follow-up period. RESULTS: Baseline demographic characteristics and comorbidities were similar between groups. However, patients in ACT and control groups had significantly worse baseline angiograms in accordance with Graziani and GLASS (infrapopliteal region) classifications than the re-PTA group (both p < 0.001), but there were no differences in baseline values of TcPO2 between groups. AFS in the ACT and re-PTA groups were significantly longer compared to control (both p < 0.001). The rate of major amputation was significantly lower in both active groups (both p < 0.001). The re-PTA group showed significantly longer overall survival compared to the control group (p < 0.001), but there was no significant difference between ACT and control groups (p = 0.063) and ACT and re-PTA groups (p = 0.081) in this parameter. CONCLUSIONS: Our study showed significantly longer AFS and lower major amputation rates in patients treated by ACT and re-PTA in contrast to patients treated conservatively. Overall survival was significantly longer only in the re-PTA group. ACT was shown to be effective in long-term limb salvage in people with no-option CLTI.
- Keywords
- cellular research, clinical trial, diabetes complications, effectiveness,
- MeSH
- Amputation, Surgical statistics & numerical data MeSH
- Angioplasty * MeSH
- Transplantation, Autologous MeSH
- Cell- and Tissue-Based Therapy * MeSH
- Chronic Limb-Threatening Ischemia * therapy mortality MeSH
- Diabetic Foot * therapy mortality complications surgery MeSH
- Ischemia * therapy mortality MeSH
- Conservative Treatment * MeSH
- Middle Aged MeSH
- Humans MeSH
- Aged MeSH
- Treatment Outcome MeSH
- Limb Salvage statistics & numerical data MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Comparative Study MeSH
The aim of study was to confirm the hypothesis that advanced medial arterial calcification (MAC)/ small artery disease (SAD), much like the progression of peripheral arterial disease (PAD) stages can adversely impact the outcomes in DFU patients, even after successful endovascular procedures. In retrospective study, we enrolled 54 patients with DFUs who underwent percutaneous transluminal angioplasty (PTA). MAC was quantified using a three-level scoring system based on radiographs. Patients were categorized based on their MAC score into three groups. Study groups were compared in terms of primary DFU outcomes (healing, amputations) and secondary DFU outcomes (mortality, changes in transcutaneous oxygen pressure (TcPO2)) three and six months after PTA. The MAC/SAD score increased significantly with age (p = 0.014). The MAC/SAD score was't associated with the risk of amputation or the healing of DFUs up to three months after revascularization. However, a significant association was observed after six months (p = 0.043). The MAC/SAD score correlated significantly with severity of PAD, as classified by the Global Limb Anatomic Staging System (p = 0.042) and the Graziani system (p = 0.019). We found a negative correlation between the MAC/SAD score and absolute levels of TcPO2 after PTA. MAC/SAD score was significantly associated with long-term unhealed DFUs and the risk of lower limb amputations.
- Keywords
- diabetic foot, peripheral arterial disease, small artery disease, wound healing,
- MeSH
- Amputation, Surgical statistics & numerical data MeSH
- Angioplasty * methods MeSH
- Diabetic Foot * surgery diagnosis physiopathology MeSH
- Wound Healing * physiology MeSH
- Middle Aged MeSH
- Humans MeSH
- Peripheral Arterial Disease * diagnosis surgery physiopathology complications MeSH
- Retrospective Studies MeSH
- Aged MeSH
- Severity of Illness Index MeSH
- Vascular Calcification * diagnosis MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
BACKGROUND: A considerable number of symptomatic patients leave the cardiac catheterization lab without a definitive diagnosis for their symptoms because no epicardial stenoses are found. The significance of disorders of coronary microvasculature and vasomotion as the cause of symptoms and signs of ischemia has only recently been appreciated. Today we have a wide spectrum of invasive coronary physiology tools but little is known about when and how these tools are used in clinical practice. STUDY DESIGN AND METHODOLOGY: SoutheAsTern eUrope microciRculATION (SATURATION) registry will study the regional practice of patient selection for coronary function testing, indications, non-invasive ischemia testing, medications, procedural aspects of invasive physiology evaluation, and treatment changes after testing. The registry is expected to include 1600 patients in participating centers in Southeastern Europe from 2024 to 2029, using the thermodilution technique for evaluation of microcirculation. Major adverse cardiovascular events as well as patient-centered outcomes such as burden of angina and quality of life using Seattle Angina Questionnaire (SAQ) and EQ-5D-5L will be recorded. The study will include patients with different stages of coronary artery disease (presence of disease or degree of stenosis) to elucidate the effect of coronary microcirculation on the outcomes in this broad group. CONCLUSION: The registry will provide information regarding the current practice of invasive coronary physiology assessment in populations at high cardiovascular risk in Southeastern Europe. This could lead to a better understanding of coronary microvascular dysfunction and its relationship to various degrees of coronary atherosclerosis together with potential interventions that can be beneficial.
- Keywords
- Coronary flow reserve, Coronary thermodilution, INOCA, Index of microvascular resistance, Microvascular angina, Vasospastic angina,
- MeSH
- Coronary Circulation * MeSH
- Quality of Life MeSH
- Humans MeSH
- Microcirculation * MeSH
- Multicenter Studies as Topic MeSH
- Coronary Artery Disease * physiopathology therapy diagnosis MeSH
- Predictive Value of Tests MeSH
- Prognosis MeSH
- Registries * MeSH
- Patient Selection MeSH
- Research Design MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Geographicals
- Europe MeSH
Atherosclerosis leading to cardiovascular diseases remains a dominant medical problem. In the early stages of this disease, the interaction between circulating monocytes and the endothelium is crucial. Monocytes and macrophages express scavenger receptor A (SR-A), which mediates cell adhesion and subsequently uptake of oxidized low-density lipoproteins (LDL). High iron stores in monocytes or macrophages are known to predispose individuals to atherosclerosis, however the reasons remain poorly understood. We hypothesized that a combination of iron and LDL may induce proatherogenic changes in circulating monocytes. Here, we treated a human monocytic cell line THP-1 with isolated LDL and/or iron. A limited uptake of native LDL, but not iron or oxidized LDL, markedly induced expression of SR-A in these cells. Both SR-AI and SR-AII isoforms were upregulated. The increased SR-A was also seen at the protein level, and LDL treatment increased cellular adhesion. The induction of SR-A by LDL was inhibited by the lysosomotropic thiol WR-1065 and by the chain-breaking lipophilic antioxidant butylated hydroxytoluene (BHT). The fluorescent probe BODIPY C11 exhibited increased lipid peroxidation inside lysosomes after LDL administration. The induction of SR-A by LDL was blocked by two silencing RNAs directed against the nuclear coactivator receptor NCOA4, the cargo receptor necessary for the autophagy of ferritin. These results may point to a new pathogenetic mechanism of early-stage atherosclerosis, in which high iron stores in circulating monocytes, through increased lysosomal lipid peroxidation, may lead to an upregulated expression of SR-A, which makes the cells more adhesive and hence more atherogenic.
- Keywords
- atherosclerosis, ferritinophagy, lipid peroxidation, lysosome, redox‐active iron,
- MeSH
- Atherosclerosis metabolism MeSH
- Cell Adhesion MeSH
- Humans MeSH
- Lipoproteins, LDL * metabolism MeSH
- Lysosomes * metabolism MeSH
- Monocytes * metabolism MeSH
- Oxidation-Reduction MeSH
- Scavenger Receptors, Class A * metabolism genetics MeSH
- THP-1 Cells MeSH
- Iron * metabolism MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Names of Substances
- Lipoproteins, LDL * MeSH
- oxidized low density lipoprotein MeSH Browser
- Scavenger Receptors, Class A * MeSH
- Iron * MeSH
OBJECTIVES: INCORPORATE trial was designed to evaluate whether default coronary-angiography (CA) and ischemia-targeted revascularization is superior compared to a conservative approach for patients with treated critical limb ischemia (CLI). Registered at clinicaltrials.gov (NCT03712644) on October 19, 2018. BACKGROUND: Severe peripheral artery disease is associated with increased cardiovascular risk and poor outcomes. METHODS: INCORPORATE was an open-label, prospective 1:1 randomized multicentric trial that recruited patients who had undergone successful CLI treatment. Patients were randomized to either a conservative or invasive approach regarding potential coronary artery disease (CAD). The conservative group received optimal medical therapy alone, while the invasive group had routine CA and fractional flow reserve-guided revascularization. The primary endpoint was myocardial infarction (MI) and 12-month mortality. RESULTS: Due to COVID-19 pandemic burdens, recruitment was halted prematurely. One hundred eighty-five patients were enrolled. Baseline cardiac symptoms were scarce with 92% being asymptomatic. Eighty-nine patients were randomized to the invasive approach of whom 73 underwent CA. Thirty-four percent had functional single-vessel disease, 26% had functional multi-vessel disease, and 90% achieved complete revascularization. Conservative and invasive groups had similar incidences of death and MI at 1 year (11% vs 10%; hazard ratio 1.21 [0.49-2.98]). Major adverse cardiac and cerebrovascular events (MACCE) trended for hazard in the Conservative group (20 vs 10%; hazard ratio 1.94 [0.90-4.19]). In the per-protocol analysis, the primary endpoint remained insignificantly different (11% vs 7%; hazard ratio 2.01 [0.72-5.57]), but the conservative approach had a higher MACCE risk (20% vs 7%; hazard ratio 2.88 [1.24-6.68]). CONCLUSION: This trial found no significant difference in the primary endpoint but observed a trend of higher MACCE in the conservative arm.
- Keywords
- Coronary angiography, Coronary artery disease, Critical limb ischemia, Fractional flow reserve,
- MeSH
- Ischemia * therapy diagnosis MeSH
- Conservative Treatment * methods MeSH
- Coronary Angiography methods MeSH
- Middle Aged MeSH
- Humans MeSH
- Coronary Artery Disease * complications MeSH
- Peripheral Arterial Disease * therapy complications diagnosis MeSH
- Prospective Studies MeSH
- Aged MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
BACKGROUNDS: Autologous cell therapy (ACT) could be a treatment option for patients with chronic limb-threatening ischemia (CLTI) when standard vascular intervention is impossible. This study aimed to analyze risk factors affecting therapeutic success and identify patients with diabetes most responsive to ACT. METHODS: In this prospective study, 129 treatments were provided to 118 limbs in 107 no-option CLTI patients with diabetes. Bone marrow was obtained, and stem cells were processed and injected into the calf muscles of the affected limb. After 16 years, we analyzed the influence of baseline factors related to patients (diabetes parameters, comorbidities, medications), limb ischemia (TcPO2 value, Graziani and GLASS classifications), ulcer (descriptions according to Wagner, WIfI, SINBAD and Texas classifications), and infection (the value of CRP, the presence of the osteomyelitis, resistant bacteria and clinical signs of infections). Outcomes were limb salvage (LS) and amputation-free survival (AFS), which were assessed using Cox regression models. RESULTS: Major amputation was performed in 41 out of 118 limbs (31.8%). The use of immunosuppressive therapy (HR 2.48, CI 1.30-4.73), higher stages of GLASS FP (femoropopliteal) score (HR 1.58, CI 1.31-1.90) in the univariate model, and signs of clinical infection (HR 2.21, CI 1.01-4.839) in the multivariable model significantly impacted LS. Shorter AFS was associated with a higher GLASS FP score (HR 1.28, CI 1.13-1.46), dialysis (HR 2.05, CI 1.33 - 3.16 ), hypoalbuminemia (HR 0.93, CI 0.89-0.98), signs of clinical infection (HR 1.99, CI 1.26-3.15) in the univariable model, and immunosuppression (HR 2.31, CI 1.09-4.95) in the multivariable model. CONCLUSION: Decisions to manage patients with no-option CLTI should be based on involvement of the peripheral circulation, the presence of infection and co-morbidities. Those with minimal impairment of the FP segment, with the best possible nutritional status and without signs of infection would benefit the most. Furthermore, we should be careful with dialysis patients and those on immunosuppressive therapy.
- Keywords
- Amputation, Amputation-free survival, Ischemia, Peripheral artery disease, Stem cell therapy,
- MeSH
- Amputation, Surgical MeSH
- Transplantation, Autologous MeSH
- Cell- and Tissue-Based Therapy * methods MeSH
- Chronic Limb-Threatening Ischemia * therapy MeSH
- Ischemia * therapy MeSH
- Middle Aged MeSH
- Humans MeSH
- Prospective Studies MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Limb Salvage * methods MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
IMPORTANCE: The effect of computed tomography (CT) vs invasive coronary angiography (ICA) on health status outcomes is unknown. OBJECTIVE: To evaluate CT and ICA first-test strategies on quality of life (QOL) and angina. DESIGN, SETTING, AND PARTICIPANTS: The Diagnostic Imaging Strategies for Patients With Stable Chest Pain and Intermediate Risk of Coronary Artery Disease (DISCHARGE) randomized clinical trial, conducted between October 2015 and April 2019 in 26 European centers, followed up patients with stable chest pain and intermediate probability of coronary artery disease for a median 3.5 years. Data analysis was from December 2023 to July 2024. INTERVENTIONS: Random assignment to CT or ICA. MAIN OUTCOMES AND MEASURES: Patient-reported Euro QOL 5-dimensions descriptive system (EQ-5D-3L) visual analog scale (EQ-5D-3L-VAS) and 12-item Short Form Health Survey (SF-12) physical component score (SF-12-PCS) were primary prespecified QOL outcomes. Angina was the primary prespecified chest pain outcome. The EQ-5D-3L-VAS, summary index (EQ-5D-3L-SI), mental component summary (SF-12-MCS), and Hospital Anxiety and Depression Scale-anxiety subscale (HADS-A) and Hospital Anxiety and Depression Scale-anxiety subscale (HADS-D) were also evaluated. RESULTS: Among 3561 patients (mean [SD] age, 60.1 [10.1] years; 2002 female [56.2%]), 1735 (96.0%) in the CT group and 1671 (95.3%) in the ICA group completed at least 1 health status assessment during 3.5 years of follow-up. Health status outcomes were similar between groups, with significant improvements in all QOL outcomes (eg, mean EQ-5D-3L-VAS 3.5 year minus baseline score: CT = 4.0; 95% CI, 3.1-4.9; P < .001; ICA = 4.6; 95% CI, 3.6-5.6; P =.002), except HADS-D, which improved only in the CT group (mean EQ-5D-3L-VAS 3.5 year minus baseline score: CT = -0.2; 95% CI, -0.4 to 0; P = .04; ICA = -0.2; 95% CI, -0.4 to 0; P = .12). Female patients had worse baseline and follow-up QOL than male patients (eg, baseline EQ-5D-3L-VAS difference between men and women = 5.2; 95% CI, 4.0-6.3; P <.001 and at 3.5 years = 3.1; 95% CI, 1.9-4.4; P < .001) but showed greater improvements in EQ-5D-3L-VAS (-1.9; 95% CI, -3.4 to -0.5; P = .009), SF-12-PCS (-1.4; -2.1 to -0.7; P < .001), and HADS-A (0.3; 0-0.7; P = .04). Angina outcomes were comparable between groups at 3.5 years, with similar 1-year rates in the CT group but higher rates in female than male patients in the ICA group (10.2% vs 6.2%; P = .007). CONCLUSIONS AND RELEVANCE: Results of this secondary analysis of the DISCHARGE randomized clinical trial reveal that there was no significant difference in QOL or chest pain outcomes with CT vs ICA at 3.5 years. Female patients had worse health status than male patients at baseline and follow-up, and CT or ICA did not affect these differences. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02400229.
- MeSH
- Chest Pain * diagnostic imaging MeSH
- Coronary Angiography * methods MeSH
- Quality of Life * MeSH
- Middle Aged MeSH
- Humans MeSH
- Coronary Artery Disease * diagnostic imaging complications MeSH
- Tomography, X-Ray Computed * methods MeSH
- Aged MeSH
- Health Status * MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH