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"Vascular Calcification - diagnostic imaging"
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Impact of provision of abdominal aortic calcification results on fruit and vegetable intake: 12-week randomized phase 2 controlled trial
by
Radavelli-Bagatini, Simone
,
Gebre, Abadi K.
,
Mullin, Shelby
in
692/699/75/593/2193
,
692/700/1719
,
692/700/2814
2024
Provision of non-invasive vascular imaging results to individuals has been shown to improve cardiovascular disease risk factor control: its impact on diet remains uncertain. In this two-arm, single-blind, parallel, 12-week randomized controlled trial, 240 participants, 57.5% females aged 60–80 y had abdominal aortic calcification and clinical assessments performed at a hospital clinic. Participants were randomized 1:1 to receive (intervention
n
= 121) or not (control
n
= 119) their calcification results. Both groups received educational resources on cardiovascular disease risk control and were unblinded to the intervention. Outcome measures were performed at baseline and 12 weeks. The primary outcomes of the study were changes in fruit and vegetable intake measures over 12 weeks assessed using plasma carotenoid concentrations (biomarkers of FV intake) and a food frequency questionnaire. Secondary outcomes included 12-week changes in other aspects of the diet, physical activity, body weight, blood pressure, heart rate, lipid profile, glucose concentrations, estimated cardiovascular disease risk score, and medication use. Between-group differences were tested using linear mixed-effects regression. There were no between-group differences in the primary outcomes at 12 weeks: plasma carotenoids (mean difference +0.03 µg/mL [95%CI −0.06, 0.13]) and fruit and vegetable intakes (+18 g/d [−37, 72]). However, the provision of calcification results led to between-group differences in serum total (−0.22 mmol/L [−0.41, −0.04]) and non-HDL (−0.19 mmol/L [−0.35, −0.03]) cholesterol, and estimated cardiovascular disease risk score (−0.24% [−0.47, −0.02]). No between-group differences were seen for other secondary outcomes. In this work, providing vascular imaging results did not improve diet but did improve some cardiovascular disease risk factors (Australian and New Zealand Clinical Trials Registry ACTRN12618001087246).
It is unclear whether providing the results of abdominal aortic calcification imaging to patients improves diet parameters. This randomized trial shows that this intervention does not lead to improvements in fruit and vegetable intake, while showing an effect on some cardiovascular disease risk factors used as secondary outcomes.
Journal Article
Randomized evaluation of vessel preparation with orbital atherectomy prior to drug-eluting stent implantation in severely calcified coronary artery lesions: Design and rationale of the ECLIPSE trial
by
Redfors, Björn
,
Généreux, Philippe
,
Armstrong, Ehrin J.
in
Acute coronary syndromes
,
Angioplasty
,
Atherectomy
2022
Severe coronary artery calcification has been associated with stent underexpansion, procedural complications, and increased rates of early and late adverse clinical events in patients undergoing percutaneous coronary intervention. To date, no lesion preparation strategy has been shown to definitively improve outcomes of percutaneous coronary intervention for calcified coronary artery lesions.
ECLIPSE (NCT03108456) is a prospective, randomized, multicenter trial designed to evaluate two different vessel preparation strategies in severely calcified coronary artery lesions. The routine use of the Diamondback 360 Coronary Orbital Atherectomy System is compared with conventional balloon angioplasty prior to drug-eluting stent implantation. The trial aims to enroll approximately 2000 subjects with a primary clinical endpoint of target vessel failure, defined as the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target vessel revascularization assessed at 1 year. The co-primary endpoint is the acute post-procedural in-stent minimal cross-sectional area as assessed by optical coherence tomography in a 500-subject cohort. Enrollment is anticipated to complete in 2022 with total clinical follow-up planned for 2 years.
ECLIPSE is a large-scale, prospective randomized trial powered to demonstrate whether a vessel preparation strategy of routine orbital atherectomy system is superior to conventional balloon angioplasty prior to implantation of drug-eluting stents in severely calcified coronary artery lesions.
Journal Article
Cardiac (82)Rb PET/CT for fast and non-invasive assessment of microvascular function and structure in asymptomatic patients with type 2 diabetes
2016
Coronary flow reserve (CFR) and coronary artery calcium (CAC) represent functional and structural aspects of atherosclerosis. We examined the prevalence of reduced CFR and high CAC scores in three predefined groups of participants without known cardiovascular disease: (1) patients with type 2 diabetes and albuminuria; (2) patients with type 2 diabetes and normoalbuminuria; and (3) non-diabetic controls.
In a cross-sectional design, cardiac (82)Rb positron emission tomography/computed tomography was conducted in 60 patients with type 2 diabetes who were free of overt cardiovascular disease and who were stratified by normoalbuminuria (<30 mg/24 h) (n = 30; age [mean ± SD] 60.9 ± 10.1 years) and albuminuria (≥ 30 mg/24 h) (n = 30; age 65.6 ± 4.8 years), and in 30 healthy, non-diabetic controls (age 59.8 ± 9.9 years).
In controls, normoalbuminuric and albuminuric patients, CFR was 3.0 ± 0.8, 2.6 ± 0.8 and 2.0 ± 0.5, respectively. Reduced CFR (<2.5) was observed in 16.7%, 40.0% and 83.3% of participants, respectively, and median (interquartile range) CAC scores were 0 (0-81), 36 (1-325) and 370 (152-1,025), respectively (p for trend <0.01). After adjustment, the difference in CFR and CAC between albuminuric patients and controls remained significant (p ≤ 0.001). There were trends towards lower CFR and higher CAC scores in normoalbuminuric patients vs controls (p ≤ 0.023) and towards higher CAC scores in albuminuric vs normoalbuminuric patients (p = 0.026). In multivariate regression analysis, a higher urinary albumin excretion rate (UAER) tended to predict reduced CFR in the total population (p = 0.045). When the CAC score was added, there was also a trend (p = 0.032) towards an inverse association with reduced CFR.
Type 2 diabetic patients who were free of overt cardiovascular disease had a high prevalence of coronary microvascular dysfunction, especially with concomitant albuminuria, suggesting a common microvascular impairment occurring in multiple microvascular beds. Prospective studies are needed to show the prognostic significance of this finding.
Journal Article
Coronary Plaque Characteristics in Hemodialysis-Dependent Patients as Assessed by Optical Coherence Tomography
by
Shlofmitz, Richard A.
,
Matsumura, Mitsuaki
,
Ben-Yehuda, Ori
in
Acute coronary syndromes
,
Aged
,
Angina, Stable - complications
2017
Coronary arteries in patients with chronic kidney disease (CKD) have been shown to exhibit more extensive atherosclerosis and calcium. We aimed to assess characteristics of coronary plaque in hemodialysis (HD)-dependent patients using optical coherence tomography (OCT). This was a multicenter, retrospective study of 124 patients with stable angina who underwent OCT imaging. Sixty-two HD-dependent patients who underwent pre-intervention OCT for coronary artery disease were compared 1:1 with a cohort of patients without CKD, matched for age, diabetes mellitus, gender, and culprit vessel. Baseline characteristics were comparable. Pre-intervention OCT imaging identified 62 paired culprit, 53 paired non-culprit, and 19 paired distal vessel lesions. Lesion length, minimum lumen area, and area stenosis were similar between groups. The HD-dependent group had greater mean calcium arcs in culprit (54.3° vs 26.4°, p = 0.004) and non-culprit lesions (34.3° vs 24.5°, p = 0.02) and greater maximum calcium arc in distal vessel segments (101.6° vs 0°, p = 0.03). There were no differences in lipid arcs between groups. There was a higher prevalence of thin intimal calcium, defined as an arc of calcium >30° within intima <0.5 mm thick, in patients in the HD-dependent group (41.9% vs 4.8%, p <0.001). There was a higher prevalence of calcified nodules in the HD-dependent group (24.2% vs 9.7%, p = 0.049) but no differences in medial calcification or thin-cap fibroatheroma. In conclusion, in this OCT study, HD-dependent patients, compared with matched patients without CKD, had more extensively distributed coronary calcium and uniquely, a higher prevalence of non-atherosclerotic thin intimal calcium. This thin intimal calcium may cause an overestimation of calcium burden by intravascular ultrasound and may contribute to the lack of correlation between increased coronary artery calcification scores with long-term outcomes in patients with CKD.
Journal Article
The Effect of Eicosapentaenoic and Docosahexaenoic Acid Supplementation on Coronary Artery Calcium Progression in Subjects With Diabetes and Coronary Artery Disease: A Secondary Analysis of a Randomized Trial
2024
Higher coronary artery calcium (CAC) scores and progression of CAC are associated with higher mortality. We previously reported that subjects with coronary artery disease randomly allocated to eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) supplementation or none had similar significant increases in CAC score over 30 months. Whether these findings are influenced by diabetes status is unknown. A total of 242 subjects with coronary artery disease who were on statin therapy were randomly allocated to to 1.86 g EPA and 1.5 g DHA daily or none (control). The CAC score was measured at baseline and 30-month follow-up using noncontrast, cardiac computed tomography. A significant interaction term between diabetes status and treatment arm was noted in the prediction of the CAC score (p <0.001). A total of 176 subjects (85.8% men) had no diabetes and 66 subjects (80.3% men) had diabetes. The mean age was 62.9 ± 7.9 versus 63.2 ± 7.1 years, respectively. The mean low-density lipoprotein cholesterol and median triglyceride levels were not significantly different between those without and with diabetes: 77.7 ± 25.9 versus 77.1 ± 30.2 mg/100 ml, respectively, and 117.0 (78.0 to 158.0) versus 119.0 (84.5 to 201.5) mg/100 ml, respectively. Subjects with diabetes on EPA+DHA had a greater increase in CAC score than subjects with diabetes in the control group (median 380.7 vs 183.5, respectively, p = 0.021). In contrast, no difference occurred between the EPA+DHA and control groups in subjects without diabetes (175.7 vs 201.1, respectively, p = 0.41). In conclusion, EPA+DHA supplementation was associated with greater CAC progression in subjects with diabetes than subjects with diabetes in the control group over a 30-month period; whether this indicates progression of the disease burden or plaque stabilization requires further study.
•A total of 242 patients with coronary artery disease on statin were randomly allocated to eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) or none for 30 months.•The coronary artery calcium (CAC) score was measured at baseline and 30 months using computed tomography.•Subjects without diabetes on EPA+DHA had a similar increase in CAC compared with the control group.•Subjects with diabetes on EPA+DHA had a greater increase in CAC than the control group.•Whether this is disease progression or plaque stabilization requires further study.
Journal Article
Abdominal aortic calcification in patients with CKD
by
Blankestijn, Peter J.
,
van den Brand, Jan AJG
,
Koster, Yelka
in
Adult
,
Aged
,
Aorta, Abdominal
2017
Background
Abdominal aortic calcification (AAC) is independently associated with cardiovascular events in dialysis patients and in the general population. However, data in non-dialysis chronic kidney disease (CKD) patients are limited. We analyzed determinants and prognostic value of AAC in non-dialysis CKD patients.
Methods
We included patients with CKD not receiving renal replacement therapy from the MASTERPLAN study, a randomized controlled trial that started in 2004. In the period 2008–2009, an X-ray to evaluate AAC was performed in a subgroup of patients. We studied AAC using a semi-quantitative scoring system by lateral lumbar X-ray. We used baseline and 2-year data to find determinants of AAC. We used a composite cardiovascular endpoint and propensity score matching to evaluate the prognostic value of AAC.
Results
In 280 patients an X-ray was performed. In 79 patients (28 %) the X-ray showed no calcification, in 62 patients (22 %) calcification was minor (<4), while 139 patients (50 %) had moderate or heavy calcification (≥4). Older age, prior cardiovascular disease, higher triglyceride levels, and higher phosphate levels were independent determinants of a calcification score ≥4. AAC score ≥4 was independently associated with cardiovascular events, with a hazard ratio of 5.5 (95 % confidence interval 1.2–24.8).
Conclusions
Assessment of AAC can identify CKD patients at higher cardiovascular risk, and may provide important information for personalized treatment. Whether this approach will ultimately translate into better outcomes remains to be answered.
Journal Article
The PROPHECI trial: a phase II, double-blind, placebo-controlled, randomized clinical trial for the treatment of pseudoxanthoma elasticum with oral pyrophosphate
by
Chamorey, Emmanuel
,
Chiaverini, Christine
,
Baillif, Stéphanie
in
Administration, Oral
,
Adult
,
Arterial calcification
2025
Background
/aims.
Pseudoxanthoma Elasticum (PXE, OMIM 264800) is an autosomal, recessive, metabolic disorder characterized by progressive ectopic calcification in the skin, the vasculature and Bruch’s membrane. Variants in the
ABCC6
gene are associated with low plasma pyrophosphate (PPi) concentration. There is currently no reference treatment for this chronic debilitating disease.
Methods
PROPHECI (PyROphosPHate supplementation to fight ECtopIc calcification in PseudoXanthoma Elasticum) is the first phase II, randomized, double-blind, placebo-controlled clinical trial (NTC 04868578) to evaluate the efficacy and safety of a daily oral PPi salt supplementation to attenuate and/or stabilize the progression of ectopic calcification in PXE patients. The primary endpoint is the change in arterial calcification volume quantified by non-contrast CT scan between baseline and 12 months of treatment. Secondary endpoints include the safety and efficacy of daily oral PPi administration on ocular and skin lesions and the evaluation of patients’ quality of life.
Discussion
The PROPHECI trial aims to provide safety and efficacy data on the use of daily oral PPi to reduce or stabilize ectopic calcification in PXE. It also aims to validate the best markers to include in the design of future trials for the treatment of PXE and other parent diseases.
Trial registration
Trial registration number: NCT 04868578.
References can be found on the ClinicalTrials.gov website:
https://clinicaltrials.gov/study/NCT04868578?cond=Pseudoxanthoma%20Elasticum&intr=pyrophosphate&rank=2
Journal Article
Comparison of the efficacy of intravascular lithotripsy and rotational atherectomy as adjunctive therapy before drug-eluting stent implantation in calcified coronary lesions (CCS– Coronary Calcification Study)
2025
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).
Journal Article
Effect of vitamin K1 supplementation on coronary calcifications in hemodialysis patients: a randomized controlled trial
by
Escalante-Gutiérrez, Sergio Edgardo
,
Hinojosa-Gutiérrez, Luis Ricardo
,
Baron-Manzo, Miguel
in
Aged
,
Angina pectoris
,
Atherosclerosis
2025
Background
Chronic kidney disease (CKD) is associated with several adverse cardiovascular outcomes, including coronary heart disease, heart failure, and arrhythmias. The severity of arterial calcifications predicts the risk of coronary heart disease and increases the risk of premature cardiovascular death. In experimental models, vitamin K1 supplementation appears to reduce coronary artery calcifications.
Methods
In this single-center clinical trial (NCT04247087 on 07/09/2019), we randomized 60 Mexican patients on chronic hemodialysis and a coronary calcification score > 10 Agatston units to receive 10 mg intravenous vitamin K1 or placebo at the end of the hemodialysis session thrice weekly for 12 months. The primary outcome was the progression of coronary artery calcifications as assessed by the absolute change in Agatston and coronary calcium volume scores.
Results
The baseline coronary calcium score was 112.50 (14-2027) Agatston units in the vitamin K1 group and 177 (10-2843); Agatston units in the placebo group (p = 0.71), and after 12 months, the coronary calcium score in the vitamin K1 group was 78.50 (10-1915) Agatston units in the vitamin K1 group versus 344 (10-3323); Agatston units (p = 0.05) in the placebo group. Progression of coronary calcification was 20.8% in the vitamin K1 group versus 44% in the placebo group, with a relative risk (RR) of 0.45 (CI 95% 0.18–1.15).
Conclusions
In the Mexican hemodialysis cohort enrolled in this study intravenous vitamin K1 supplementation reduced the progression of coronary artery calcifications by 55% compared with placebo over a 12-month follow-up period.
Graphical abstract
Journal Article
Rivaroxaban versus vitamin K antagonist treatment on the progression of coronary calcification: the IRIVASC-trial
2024
Vitamin K antagonists (VKA) remain the only option of anticoagulation for people with mechanical valve replacement and due to their wider availability and lower acquisition costs, VKA’s remain widely used in low- and middle-income countries. It has been suggested that prolonged use of VKAs can increase the development of vascular and valvular calcification, though this effect has not been examined in larger randomized prospective trials. This investigator-initiated multicenter, prospective, randomized, open-label interventional trial randomized patients with baseline coronary or valvular calcification and an indication for prolonged oral anticoagulation therapy to Marcumar or Rivaroxaban. Patients were followed-up through repeat coronary computed tomographies to measure the progression of coronary and valvular calcification for up to 24 months. 192 patients were randomized between 2013 and 2018 to receive either Rivaroxaban or Marcumar and followed for up to 24 months. Coronary calcification significantly increased over time although there was no significant difference in progression between the groups after 12 and 24 months as measured by the Agatston score [360.7 (90.2; 1075.3) vs 380.4 (136.4; 1546.9) p = 0.69], the volume score [295.8 (93.0; 995.3) vs 335.5 (128.7; 1316.9) p = 0.95] and the mass score [58.5 (15.9; 172.0) vs 71.1 (24.8; 257.3) p = 0.5]. Dephosphorylated, uncarboxylated matrix Gla Protein (Dp-ucMGP) significantly decreased in the VKA group [Δ dp-uc MGP – 95.2 (− 554.1; 156.0) vs 231.3 (− 59.7; 388.1) p < 0.001]. There does not appear to be a relevant effect of vitamin K inhibition by the vitamin K antagonist marcumar upon coronary calcification.
Journal Article