cardiovascular-agents and Vascular-Calcification

Cardiovascular calcification (CVC) is associated with increased morbidity and mortality. It develops in several diseases and locations, such as in the tunica intima in atherosclerosis plaques, in the tunica media in type 2 diabetes and chronic kidney disease, and in aortic valves. In spite of the wide occurrence of CVC and its detrimental effects on cardiovascular diseases (CVD), no treatment is yet available. Most of CVC involve mechanisms similar to those occurring during endochondral and/or intramembranous ossification. Logically, since tissue-nonspecific alkaline phosphatase (TNAP) is the key-enzyme responsible for skeletal/dental mineralization, it is a promising target to limit CVC. Tools have recently been developed to inhibit its activity and preclinical studies conducted in animal models of vascular calcification already provided promising results. Nevertheless, as its name indicates, TNAP is ubiquitous and recent data indicate that it dephosphorylates different substrates in vivo to participate in other important physiological functions besides mineralization. For instance, TNAP is involved in the metabolism of pyridoxal phosphate and the production of neurotransmitters. TNAP has also been described as an anti-inflammatory enzyme able to dephosphorylate adenosine nucleotides and lipopolysaccharide. A better understanding of the full spectrum of TNAP's functions is needed to better characterize the effects of TNAP inhibition in diseases associated with CVC. In this review, after a brief description of the different types of CVC, we describe the newly uncovered additional functions of TNAP and discuss the expected consequences of its systemic inhibition in vivo.

Topics: Alkaline Phosphatase; Animals; Arteries; Cardiovascular Agents; Enzyme Inhibitors; Humans; Phosphorylation; Signal Transduction; Substrate Specificity; Vascular Calcification

This review summarizes current understanding of generalized arterial calcification of infancy (GACI), emphasizing pathophysiology, clinical presentation, and approaches and controversies in management.. Identification of causative ENPP1 mutations revealed that GACI arises from deficiencies in inorganic pyrophosphate (leading to calcifications) and adenosine monophosphate (leading to intimal proliferation). Identification of genotypic and phenotypic overlap with pseudoxanthoma elasticum and autosomal recessive hypophosphatemic rickets further advanced understanding of GACI as a complex, multisystemic disease. Clinical data is limited to small, retrospective samples; it is therefore unknown whether commonly used medications, such as bisphosphonates and hypophosphatemia treatment, are therapeutic or potentially harmful. ENPP1-Fc replacement represents a promising approach warranting further study. Knowledge gaps in natural history place clinicians at high risk of assigning causality to interventions that are correlated with changes in clinical status. There is thus a critical need for improved natural history studies to develop and test targeted therapies.

Topics: Adenosine Monophosphate; Bone Density Conservation Agents; Calcinosis; Cardiovascular Agents; Chelating Agents; Diphosphates; Diphosphonates; Familial Hypophosphatemic Rickets; Genotype; Hearing Loss; Humans; Multidrug Resistance-Associated Proteins; Phenotype; Phosphoric Diester Hydrolases; Pseudoxanthoma Elasticum; Pyrophosphatases; Thiosulfates; Tooth Diseases; Vascular Calcification; Vitamin D

Life expectancy in patients with all stages of chronic kidney disease (CKD) falls far short of that in the general population. Cardiovascular disease is the leading cause of mortality in pediatric patients with CKD. In contrast to the intimal atherosclerotic lesions that characterize cardiovascular disease in the general population, vascular endothelial dysfunction, medial arterial calcification, and cardiac dysfunction contribute to cardiovascular pathological conditions in CKD. The pathogenesis of these lesions, the origins of which can be identified in the absence of traditional cardiovascular risk factors, is incompletely understood. CKD-mediated vascular calcification in CKD is characterized by a transition of vascular smooth muscle cells to an osteoblast-like phenotype and altered bone and mineral metabolism are strongly linked to progressive cardiovascular disease in this population. Renal osteodystrophy therapies, including phosphate binders, vitamin D analogs, and calcimimetics, have an impact on the progression of cardiovascular disease. However, cardiovascular disease has its origins before the development of secondary hyperparathyroidism, and optimal therapeutic regimens that minimize cardiac dysfunction, vascular calcification, and early mortality remain to be defined.

Topics: Age Factors; Arteries; Bone and Bones; Calcimimetic Agents; Cardiovascular Agents; Cardiovascular Diseases; Chelating Agents; Child; Chronic Kidney Disease-Mineral and Bone Disorder; Disease Progression; Endothelium, Vascular; Humans; Kidney Transplantation; Minerals; Renal Insufficiency, Chronic; Tunica Media; Vascular Calcification; Vitamin D

Even in the drug-eluting stent era, ostial lesion of the right coronary artery (RCA) still remains therapeutic challenge for interventional cardiologists. Case Series Case 1 (76 y.o. male) with angina on effort underwent transradial stent-less percutaneous coronary intervention (PCI) using rotational atherectomy (RA) followed by drug-coated balloon (DCB) dilation alone (RA/DCB) against a calcified de novo RCA ostial lesion. Case 2 (86 y.o. female) with recurrent unstable angina and hemodialysis underwent transfemoral RA/DCB against a severe repeat in-stent restenosis probably due to calcified nodule in the RCA ostium. In the both patients, PCI was successfully completed under intravascular ultrasound imaging (IVUS) guidance without complications. Follow-up CAG performed 4-5 months after the procedure revealed no significant lumen narrowing in the both RCA ostial lesions.. The both cases suggest that stent-less PCI using RA/DCB under IVUS might be an alternative revascularization therapy of choice for calcified RCA ostial lesions.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Equipment Design; Female; Humans; Male; Treatment Outcome; Ultrasonography, Interventional; Vascular Calcification

Within the last years, many new endovascular treatment modalities have been invented for treatment of peripheral arterial disease. To leave nothing behind and to keep options for future treatment are key issues of these new revascularization procedures. Drug coated balloon technology (DCB) is one key element in this strategy but there are still limitations for this revascularization technology. Especially calcium rich lesions and long lesions are still challenging in terms of treatment success and long-term patency. Treatment of both calcified and long lesions continues to be a clinical challenge for every interventionalists. Therefore, a treatment combination of debulking procedure using atherectomy plus antirestenotic therapy using DCB seems to be promising to treat complex lesions.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Atherectomy; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Recurrence; Risk Factors; Treatment Outcome; Vascular Access Devices; Vascular Calcification; Vascular Patency

Coronary artery calcification is concomitant with the development of advanced atherosclerosis. Coronary artery calcification pathologically begins as microcalcifications (0.5 to 15.0 μm) and grows into larger calcium fragments, which eventually result in sheet-like deposits (>3 mm). This evolution is observed to occur concurrently with the progression of plaque. These fragments and sheets of calcification can be easily identified by radiography as well as by computed tomography and intravascular imaging. Many imaging modalities have proposed spotty calcification to be a predictor of unstable plaque and have suggested more extensive calcification to be associated with stable plaques and perhaps the use of statin therapy. We will review the pathology of coronary calcification in humans with a focus on risk factors, relationship with plaque progression, correlation with plaque (in)stability, and effect of pharmacologic interventions.

Topics: Adult; Aged; Aged, 80 and over; Animals; Biopsy; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Disease Progression; Female; Fibrosis; Humans; Male; Middle Aged; Necrosis; Plaque, Atherosclerotic; Prognosis; Risk Factors; Rupture, Spontaneous; Severity of Illness Index; Ultrasonography, Interventional; Vascular Calcification

The aim of this study was to assess the odds of initiation or continuation of pharmacological and lifestyle preventive therapies in patients with nonzero versus zero coronary artery calcium (CAC) score detected on cardiac computed tomography.. Detection of calcified coronary plaque could serve as a motivational tool for physicians and patients to intensify preventive therapies.. We searched PubMed, EMBASE (Excerpta Medica database), Web of Science, Cochrane CENTRAL (Cochrane central register of controlled trials), ClinicalTrials.gov, and the International Clinical Trials Registry Platform for studies evaluating the association of CAC scores with downstream pharmacological or lifestyle interventions for prevention of cardiovascular disease. Pooled odds ratios (ORs) of downstream interventions were obtained using the DerSimonian and Laird random effects model.. After a review of 6,256 citations and 54 full-text papers, 6 studies (11,256 participants, mean follow-up time: 1.6 to 6.0 years) were included. Pooled estimates of the odds of aspirin initiation (OR: 2.6; 95% confidence interval [CI]: 1.8 to 3.8), lipid-lowering medication initiation (OR: 2.9; 95% CI: 1.9 to 4.4), blood pressure-lowering medication initiation (OR: 1.9; 95% CI: 1.6 to 2.3), lipid-lowering medication continuation (OR: 2.3; 95% CI: 1.6 to 3.3), increase in exercise (OR: 1.8; 95% CI: 1.4 to 2.4), and dietary change (OR: 1.9; 95% CI: 1.5 to 2.5) were higher in individuals with nonzero CAC versus zero CAC scores, but not for aspirin or blood pressure-lowering medication continuation. When assessed within individual studies, these findings remained significant after adjustment for baseline patient characteristics and cardiovascular risk factors.. This systematic review and meta-analysis suggests that nonzero CAC score, identifying calcified coronary plaque, significantly increases the likelihood of initiation or continuation of pharmacological and lifestyle therapies for the prevention of cardiovascular disease.

Topics: Adult; Attitude of Health Personnel; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Female; Health Knowledge, Attitudes, Practice; Humans; Linear Models; Male; Middle Aged; Odds Ratio; Patient Compliance; Plaque, Atherosclerotic; Predictive Value of Tests; Protective Factors; Risk Factors; Risk Reduction Behavior; Time Factors; Treatment Outcome; Vascular Calcification

Vascular calcification (VC), a disorder that causes blood vessel hardening and dysfunction, is a significant risk factor for type-2 diabetes mellitus (T2DM), which invariably manifests associated cardiovascular complications. Although the clinical effects of VC have been well-documented, the precise cellular events underlying the manifestation and progression of VC are only now coming to light. Current research models indicate that VC likely involves signalling pathways traditionally associated with bone remodelling, such as the OPG/RANKL/TRAIL signalling system. In this respect, receptor activator of NF-κB ligand (RANKL) promotes VC whilst osteoprotegerin (OPG) acts as a RANKL decoy receptor to block this effect, events that contrast with the known functional influence of these proteins during bone metabolism. Moreover, evidence suggests that tumour necrosis factor-related apoptosis-inducing ligand (TRAIL), an alternative decoy ligand for OPG, may exert an anti-calcific influence within the vasculature. In the current review, we conduct a timely examination of this complex VC pathology from both mechanistic and therapeutic perspectives. Our objectives are twofold: (i) to critically assess our current understanding of both osteogenic and vascular calcification pathways, with particular focus on the co-interactive roles of OPG, RANKL, and TRAIL. Extensive in vitro, in vivo, and clinical studies will therefore be reviewed and critical findings highlighted; and (ii) to examine a range of therapeutic approaches of potential relevance to VC pathology. In this regard, a clear focus on VC as it applies to T2DM and cardiovascular disease (and particularly atherosclerosis) will be maintained.

Topics: Animals; Arteries; Atherosclerosis; Cardiovascular Agents; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Humans; Osteoblasts; Osteoclasts; Osteogenesis; Osteoprotegerin; Plaque, Atherosclerotic; RANK Ligand; Signal Transduction; TNF-Related Apoptosis-Inducing Ligand; Vascular Calcification

Topics: Adult; Aged; Attitude of Health Personnel; Cardiovascular Agents; Coronary Artery Disease; Female; Health Knowledge, Attitudes, Practice; Humans; Male; Middle Aged; Myocardial Infarction; Patient Compliance; Predictive Value of Tests; Primary Prevention; Risk Assessment; Risk Factors; Risk Reduction Behavior; Treatment Outcome; Vascular Calcification

Topics: Aged; Amputation, Surgical; Cardiovascular Agents; Constriction, Pathologic; Drug-Eluting Stents; Endovascular Procedures; Europe; Female; Femoral Artery; Humans; Japan; Limb Salvage; Male; Middle Aged; New Zealand; Paclitaxel; Patient Safety; Peripheral Arterial Disease; Progression-Free Survival; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Time Factors; United States; Vascular Calcification; Vascular Patency

Balloon dilatation or debulking seems to be essential to allow successful stent implantation in calcified coronary lesions. Compared with standard balloon predilatation, debulking using high-speed rotational atherectomy (RA) is associated with higher initial procedural success albeit with higher in-stent late lumen loss at intermediate-term follow-up. Whether modified (scoring or cutting) balloons (MB) could achieve similar procedural success compared with RA is not known. In addition, whether new-generation drug-eluting stents could counterbalance the excessive neointimal proliferation triggered by RA remains to be determined.. We randomly assigned patients with documented myocardial ischemia and severely calcified native coronary lesions undergoing percutaneous coronary intervention to a strategy of lesion preparation using MB or RA followed by drug-eluting stent implantation. Stenting was performed using a third-generation sirolimus-eluting stent with a bioabsorbable polymer. The trial had 2 primary end points: strategy success (defined as successful stent delivery and expansion with attainment of <20% in-stent residual stenosis in the presence of TIMI [Thrombolysis in Myocardial Infarction] 3 flow without crossover or stent failure; powered for superiority) and in-stent late lumen loss at 9 months (powered for noninferiority). Two hundred patients were enrolled at 2 centers in Germany (n=100 in each treatment group). The mean age of the study population was 74.9±7.0 years; 76% were men, and 33.5% had diabetes mellitus. Strategy success was significantly more common in the RA group (81% versus 98%; relative risk of failure with an MB- versus RA-based strategy, 9.5; 95% CI, 2.3-39.7; P=0.0001), but mean fluoroscopy time was longer (19.6±13.4 versus 23.9±12.2 minutes; P=0.03). At 9 months, mean in-stent late lumen loss was 0.16±0.39 mm in the MB group and 0.22±0.40 mm in the RA group ( P=0.21, P=0.02 for noninferiority). Target lesion revascularization (7% versus 2%; P=0.17), definite or probable stent thrombosis (0% versus 0%; P=1.00), and target vessel failure (8% versus 6%; P=0.78) were low and not significantly different between the MB and RA groups.. Lesion preparation with upfront RA before drug-eluting stent implantation is feasible in nearly all patients with severely calcified coronary lesions, is more commonly successful as a primary strategy compared with MB, and is not associated with excessive late lumen loss. A strategy of provisional MB remains feasible, safe, and effective as long as bailout RA is readily available and may offer the advantages of compatibility with smaller sized catheters and less irradiation. Both strategies are associated with excellent clinical outcome at 9 months.. URL: https://www.clinicaltrials.gov . Unique identifier: NCT02502851.

Topics: Absorbable Implants; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Germany; Humans; Male; Neointima; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome; Vascular Calcification

The aim of this study was to investigate the impact of attenuated-signal plaque (ASP) observed by intravascular ultrasound (IVUS) on vessel response after drug-eluting stent implantation.. Data were derived from the IVUS cohort of the J-DESsERT trial comparing paclitaxel- and sirolimus-eluting stents. Serial IVUS analysis (pre- and post-intervention, and 8-month follow-up) was performed in 136 non-AMI lesions. ASP was defined as hypoechoic plaque with ultrasound attenuation without calcification. Calcified plaque (CP) was defined as brightly echoreflective plaque with acoustic shadowing. ASP and CP scores were calculated by grading their measured angle as 0 to 4 for 0°, <90°, 90-180°, 180-270° and >270°, respectively. The entire stented segment was analyzed at 1-mm intervals.. At pre-intervention, ASP was observed in 40.4% of lesions, and this group had greater % neointimal volume (%NIV) at follow-up than the no-ASP group (p = 0.011). ASP score at pre-intervention positively correlated with %NIV (p = 0.023). During the follow-up, ASP score significantly decreased (p < 0.001), and CP score significantly increased (p < 0.001), with a negative correlation between them (p < 0.001). A decrease in the ASP score was associated with less %NIV in PES (p = 0.031), but not in SES (p = 0.229).. The greater extent of plaque with IVUS-signal attenuation at pre-intervention and its persistence during follow-up were associated with neointimal proliferation, possibly representing sustained inflammatory status, depending on the type of DES used.

Topics: Aged; Cardiovascular Agents; Cell Proliferation; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Japan; Male; Neointima; Paclitaxel; Percutaneous Coronary Intervention; Plaque, Atherosclerotic; Predictive Value of Tests; Prospective Studies; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Vascular Calcification

Studies assessing drug-coated balloons (DCB) for the treatment of femoropopliteal artery disease are encouraging. However, challenging lesions, such as severely calcified, remain difficult to treat with DCB alone. Vessel preparation with directional atherectomy (DA) potentially improves outcomes of DCB.. DA+DCB treatment was effective and safe, but the study was not powered to show significant differences between the 2 methods of revascularization in 1-year follow-up. An adequately powered randomized trial is warranted.. http://www.clinicaltrials.gov. Unique Identifier: NCT01366482.

Topics: Aged; Angioplasty, Balloon; Atherectomy; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Europe; Female; Humans; Intermittent Claudication; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Pilot Projects; Prospective Studies; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Calcification; Vascular Patency

We aimed to investigate the impact of lesion calcification on angiographic outcomes after Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) implantation in comparison with those after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation.. The present post hoc analysis of the ABSORB Japan randomised trial compared post-procedure and 13-month angiographic outcomes between patients implanted with BVS and CoCr-EES based on the presence or absence of calcification, excluding extremely heavily calcified lesions or lesions requiring rotational atherectomy. The study population comprised 384 patients with 384 lesions (including 114 lesions [29.7%] with moderate or severe calcification), classified into two subgroups: calcification, 114 (BVS: n=72 and CoCr-EES: n=42) and non-calcification, 270 (BVS: n=181 and CoCr-EES: n=89). Follow-up angiography was performed in 94.8% of patients. Both post-procedure and follow-up in-device minimal lumen diameters were comparable in both the BVS arm (calcification vs. non-calcification: 2.43±0.32 mm vs. 2.43±0.39 mm, p=0.91 and 2.17±0.49 mm vs. 2.27±0.47 mm, p=0.17) and in the CoCr-EES arm (2.68±0.34 mm vs. 2.65±0.42 mm, p=0.62 and 2.57±0.52 mm vs. 2.47±0.53 mm, p=0.36).. Moderate or severe lesion calcification (excluding patients with extremely heavily calcified lesions or lesions requiring rotational atherectomy) does not negatively affect angiographic outcomes at both post-procedure and 13-month follow-up after BVS implantation.

Topics: Absorbable Implants; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Japan; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Sirolimus; Treatment Outcome; Vascular Calcification

In the randomized ROTAXUS trial, routine lesion preparation of complex calcified coronary lesions using rotational atherectomy (RA) prior to paclitaxel-eluting stent implantation did not reduce the primary endpoint of angiographic late lumen loss at 9 months compared to stenting without RA. So far, no long-term data of prospective head-to-head comparisons between both treatment strategies have been reported.. ROTAXUS randomly assigned patients with complex calcified coronary lesions to RA followed by stenting (n = 120) or stenting without RA (n = 120). The primary endpoint of the current analysis was the occurrence of major adverse cardiac events (MACE) at 2-year follow-up defined as the composite of death, myocardial infarction, and target vessel revascularization (TVR). At 2 years, MACE occurred in 32 patients in the RA group and 37 patients in the standard therapy group (29.4% vs. 34.3%, P = 0.47). The rates of death (8.3% vs. 7.4%, P = 1.00), myocardial infarction (8.3% vs. 6.5%, P = 0.80), target lesion revascularization (TLR, 13.8% vs. 16.7%, P = 0.58), and TVR (19.3% vs. 22.2%, P = 0.62) were similar in both groups.. Despite high rates of initial angiographic success, nearly one third of patients enrolled in ROTAXUS experienced MACE within 2-year follow-up, with no differences between patients treated with or without RA.

Topics: Aged; Atherectomy, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Time Factors; Treatment Outcome; Vascular Calcification

This study sought to determine the effect of rotational atherectomy (RA) on drug-eluting stent (DES) effectiveness.. DES are frequently used in complex lesions, including calcified stenoses, which may challenge DES delivery, expansion, and effectiveness. RA can adequately modify calcified plaques and facilitate stent delivery and expansion. Its impact on DES effectiveness is widely unknown.. The ROTAXUS (Rotational Atherectomy Prior to TAXUS Stent Treatment for Complex Native Coronary Artery Disease) study randomly assigned 240 patients with complex calcified native coronary lesions to RA followed by stenting (n = 120) or stenting without RA (n = 120, standard therapy group). Stenting was performed using a polymer-based slow-release paclitaxel-eluting stent. The primary endpoint was in-stent late lumen loss at 9 months. Secondary endpoints included angiographic and strategy success, binary restenosis, definite stent thrombosis, and major adverse cardiac events at 9 months.. Despite similar baseline characteristics, significantly more patients in the standard therapy group were crossed over (12.5% vs. 4.2%, p = 0.02), resulting in higher strategy success in the rotablation group (92.5% vs. 83.3%, p = 0.03). At 9 months, in-stent late lumen loss was higher in the rotablation group (0.44 ± 0.58 vs. 0.31 ± 0.52, p = 0.04), despite an initially higher acute lumen gain (1.56 ± 0.43 vs. 1.44 ± 0.49 mm, p = 0.01). In-stent binary restenosis (11.4% vs. 10.6%, p = 0.71), target lesion revascularization (11.7% vs. 12.5%, p = 0.84), definite stent thrombosis (0.8% vs. 0%, p = 1.0), and major adverse cardiac events (24.2% vs. 28.3%, p = 0.46) were similar in both groups.. Routine lesion preparation using RA did not reduce late lumen loss of DES at 9 months. Balloon dilation with only provisional rotablation remains the default strategy for complex calcified lesions before DES implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Disease-Free Survival; Drug-Eluting Stents; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prospective Studies; Prosthesis Design; Time Factors; Treatment Outcome; Vascular Calcification

This study sought to investigate in vivo the vascular response at the proximal and distal edges of the second-generation ABSORB everolimus-eluting bioresorbable vascular scaffold (BVS).. The edge vascular response after implantation of the BVS has not been previously investigated.. The ABSORB Cohort B trial enrolled 101 patients and was divided into B(1) (n = 45) and B(2) (n = 56) subgroups. The adjacent (5-mm) proximal and distal vessel segments to the implanted ABSORB BVS were investigated at either 6 months (B(1)) or 1 year (B(2)) with virtual histology intravascular ultrasound (VH-IVUS) imaging.. At the 5-mm proximal edge, the only significant change was modest constrictive remodeling at 6 months (Δ vessel cross-sectional area: -1.80% [-3.18; 1.30], p < 0.05), with a tendency to regress at 1 year (Δ vessel cross-sectional area: -1.53% [-7.74; 2.48], p = 0.06). The relative change of the fibrotic and fibrofatty (FF) tissue areas at this segment were not statistically significant at either time point. At the 5-mm distal edge, a significant increase in the FF tissue of 43.32% [-19.90; 244.28], (p < 0.05) 1-year post-implantation was evident. The changes in dense calcium need to be interpreted with caution since the polymeric struts are detected as "pseudo" dense calcium structures with the VH-IVUS imaging modality.. The vascular response up to 1 year after implantation of the ABSORB BVS demonstrated some degree of proximal edge constrictive remodeling and distal edge increase in FF tissue resulting in nonsignificant plaque progression with adaptive expansive remodeling. This morphological and tissue composition behavior appears to not significantly differ from the behavior of metallic drug-eluting stents at the same observational time points.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Fibrosis; Humans; Male; Middle Aged; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Tissue Scaffolds; Treatment Outcome; Ultrasonography, Interventional; Vascular Calcification

Given the multimodal medical and interventional treatment options in coronary artery disease (CAD), the current value of intensified lifestyle modification remains unclear. No randomized studies have so far assessed the impact of lifestyle modification on coronary artery calcium (CAC). We examined the long-term effects of a one-year comprehensive lifestyle modification on risk factors and CAC by means of a randomized clinical trial.. 96 participants (age range 35-75 years, 22 women) of the SAFE-LIFE randomized trial in patients with established CAD completed 3-year follow-up. The active treatment was a one-year lifestyle modification and stress reduction intervention (LG), while the control group received written advice only (AG). CAC (derived from electron beam tomography), blood lipids, heart rate, blood pressure, anginal symptoms and quality-of-life were assessed on entry and at 3-year follow-up.. Lifestyle modification had no impact on change of CAC after three years (median progression factor [25th,75th percentile] 1.46 [1.16,2.19] in LG and 1.41 [1.20,1.79] in AG; p=0.68), but led to reductions of blood pressure, heart rate and to dose-reductions in anti-ischemic medications as compared to AG. Multiple regression analysis indicated that in the pooled study population increase of CAC was related to psychosocial factors and heart rate.. In the presence of modern treatments, complementary prescription of comprehensive lifestyle modification has no impact on CAC progression but sustainable benefit for blood pressure, heart rate and the need of anti-ischemic medication is demonstrated. A possible influence of stress reduction measures on CAC progression should be further evaluated.

Topics: Adult; Aged; Blood Pressure; Cardiovascular Agents; Chi-Square Distribution; Combined Modality Therapy; Coronary Angiography; Coronary Artery Disease; Diet, Mediterranean; Disease Progression; Female; Germany; Heart Rate; Humans; Linear Models; Lipids; Male; Middle Aged; Mind-Body Therapies; Quality of Life; Risk Assessment; Risk Factors; Risk Reduction Behavior; Severity of Illness Index; Stress, Psychological; Time Factors; Tomography, X-Ray Computed; Treatment Outcome; Vascular Calcification

Topics: Athletes; Cardiovascular Agents; Computed Tomography Angiography; Coronary Angiography; Coronary Artery Disease; Death, Sudden, Cardiac; Exercise; Humans; Predictive Value of Tests; Prognosis; Protective Factors; Risk Assessment; Risk Factors; Risk Reduction Behavior; Vascular Calcification

Atherosclerotic disease of the common femoral artery (CFA), commonly associated with multilevel disease affecting the femoropopliteal segment, can cause claudication or contribute to critical limb ischemia. Although endovascular therapy for the management of peripheral arterial disease (PAD) has been increasingly utilized, its role in CFA lesions remains controversial. The aim of this study was to investigate the safety and efficacy of drug (DCB) vs non drug coated balloon angioplasty (BA) at the CFA segment.. In this two-center study, we identified 154 patients treated either with DCB (n = 47) or BA (n = 107) for CFA lesions. Hazard ratios (HR) and the respective 95% confidence interval (CI) were synthesized to examine the association between the two groups in terms of target lesion revascularization (TLR), limb loss, and major adverse limb event (MALE) at 12 and 24 months of follow up.. This real-world population included a high percentage of patients with critical limb ischemia (43%) and moderate to severe lesion calcification (75%). Adjunctive atherectomy was performed in 97.9% of DCB cases (N = 46/47) and 44.7% of BA cases (N = 51/114). The overall procedural success rate was 95% without any differences between the two groups. Post-angioplasty dissections were observed in 15 cases [DCB: 8.5% (N = 4/47) vs BA: 9.7% (N = 11/113); p = .81], while distal embolization occurred in one patient in the DCB group and one in the BA group (p = .52). Provisional stenting was more commonly necessary in BA vs. DCB cases (12.3% vs 2.13%, p = .044). Physiologic assessment during follow up demonstrated a better mean 2-year ABI for the DCB group (mean: 0.9; SD: 0.2) vs BA group (mean: 0.6; SD: 0.4), although statistical significance was not reached (p = .06). No difference between the two groups was detected in terms of freedom from TLR (DCB: 75.5% vs BA: 86.8%; HR: 1.31; 95% CI: 0.46-3.67; p = .61), freedom from limb loss (DCB: 83.8% vs BA: 83.6%; HR: 1.04; 95% CI: 0.36-2.99; p = .94) or freedom from MALE (DCB: 83.5% vs BA: 78%; HR: 0.73; 95% CI: 0.26-1.99; p = .53) at 24 m of follow up. However, at the end of follow up more deaths were observed in patients treated with BA than DCB (DCB: 14.9% vs BA: 31.7%; p = .03). Patients who required provisional stenting were at higher risk for limb loss 2 years after the initial procedure (multivariate: HR: 4.54; 95% CI: 1.09-18.85; p = .04).. Both DCB and non-DCB strategies are effective modalities for revascularization of patients with CFA lesions. Larger prospective studies are necessary to determine the relative benefit, if any, of drug-eluting technologies for the treatment of common femoral artery disease.

Topics: Aged; Amputation, Surgical; Angioplasty, Balloon; Atherectomy; California; Cardiovascular Agents; Coated Materials, Biocompatible; Colorado; Comparative Effectiveness Research; Critical Illness; Female; Femoral Artery; Humans; Ischemia; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Retrospective Studies; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Calcification; Vascular Patency

Chronic second-generation drug-eluting stent recoil in severely calcified coronary lesions has not been studied. We aimed to evaluate chronic stent recoil by optical coherence tomography (OCT) in severely calcified lesions treated with thin strut stents after rotational atherectomy. In 28 lesions (26 patients with 23% on hemodialysis) treated with everolimus-eluting stents after rotational atherectomy, baseline and 8-month follow-up OCT were compared. Stent recoil was defined as >10% decrease in stent area from baseline to follow-up. Overall, there was no change in minimal stent area (6.0 mm

Topics: Aged; Atherectomy, Coronary; Cardiovascular Agents; Chronic Disease; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Neointima; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Severity of Illness Index; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Vascular Calcification

The ultrathin-strut bioresorbable-polymer sirolimus-eluting stent (BP-SES) demonstrated comparable performance to durable-polymer everolimus-eluting stent (DP-EES) in randomized controlled trials. The purpose of this study was to evaluate the performance of a BP-SES compared with a DP-EES in calcified or small vessel lesions, which represent higher risk of restenosis.. From the pooled BIOFLOW (BIOFLOW-II, IV, and V; BIOTRONIK - A Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions ) randomized controlled trials, a total of 1553 BP-SES and 784 DP-EES patients with valid 1-year follow-up data were available. Coronary lesions were assessed for the presence of moderate-to-severe calcification or small vessels (reference vessel diameter, ≤2.75 mm) by core laboratory analysis. One-year clinical outcomes were assessed with or without the lesion subsets between BP-SES and DP-EES.. Baseline characteristics were similar between the groups. Among patients with small vessel disease, target lesion failure (8.0% versus 12.4%;. Among patients with more complex disease representing a higher risk of target lesion failure, the effectiveness of an ultrathin-strut BP-SES compared with a thin-strut DP-EES was maintained through 1 year. Registration: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01356888, NCT01939249, NCT02389946.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Multicenter Studies as Topic; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Vascular Calcification

Long-term clinical outcomes of permanent polymer everolimus-eluting stent (PP-EES) implantation after rotational atherectomy (RA) have not been fully evaluated. We sought to investigate the long-term clinical outcomes of PP-EES implantation after RA and assess the impact of hemodialysis on this treatment strategy.. Patients who underwent percutaneous coronary intervention (PCI) with PP-EES at 22 institutions between January 2010 and December 2011 were enrolled in this multicenter, observational trial. From a total of 1918 registered patients, 113 patients with 115 de-novo lesions who underwent PCI with PP-EES following RA were retrospectively analyzed. The primary endpoint was a major adverse cardiac event (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinically driven target lesion revascularization (TLR).. Long-term follow-up was available for 112 patients (99.1%). The median follow-up period was 2.9 (interquartile range 1.9-3.6) years. The mean age of the patients was 72.3 ± 8.8 years and 64 patients (56.6%) had chronic kidney disease (≥stage 3, 42 on hemodialysis). The cumulative incidences of MACE, non-fatal MI, and TLR were 22.1%, 5.3%, and 10.6%, respectively. Cox's proportional hazards analysis showed that the independent predictors of TLR were hemodialysis and chronic total occlusion. (HR, 14.1; 95% CI, 1.74-155.5; p = 0.01, HR, 9.01; 95% CI, 1.34-62.5; p = 0.02).. PP-EES implantation after lesion modification by RA is considered to be a feasible treatment strategy for heavily calcified lesions. Hemodialysis and chronic total occlusion appeared to be associated with TLR.

Topics: Aged; Aged, 80 and over; Atherectomy, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Incidence; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Renal Dialysis; Retrospective Studies; Risk Assessment; Risk Factors; Severity of Illness Index; Time Factors; Tokyo; Treatment Outcome; Vascular Calcification

Topics: Aged; Aged, 80 and over; Amputation, Surgical; Cardiovascular Agents; Cilostazol; Constriction, Pathologic; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Humans; Japan; Limb Salvage; Male; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Progression-Free Survival; Prosthesis Design; Recurrence; Retrospective Studies; Risk Assessment; Risk Factors; Time Factors; Vascular Calcification; Vascular Patency

Coronary calcification (CCA) is one of the independent predictors for major adverse cardiac events (MACEs) in coronary intervention. Post-marketing surveillance study Japan is a prospective registry designed to evaluate the safety and efficacy of the everolimus-eluting stent (EES, XIENCE V/PROMUS Stent) in routine clinical practice at 47 centers. In this study, 1848 lesions (1546 patients) were assessed using quantitative coronary angiography. In these 1546 patients, renal function data were unknown in 26 patients. Three patients in 70 patients with dialysis and 56 patients in 1450 patients with no dialysis were excluded, because they had multiple lesions with mixed calcification lesions. We evaluated the effects of CCA on 8-month angiographic and 3-year clinical outcomes in dialysis and non-dialysis patients. Moderate-to-severe (Ca group) and none-to-mild CCA (non-Ca group) were observed in 33 lesions (30 patients) and 48 lesions (37 patients) in dialysis patients, and these were observed in 306 lesions (286 patients) and 1303 lesions (1108 patients) in non-dialysis patients, respectively. In non-dialysis patients, the ischemic-driven target lesion revascularization (ID-TLR) and MACE rate over the 3 years were significantly higher in the Ca group than in the non-Ca group (5.8 vs. 3.1%, p = 0.025 and 10.0 vs. 5.0%, p = 0.0011). In dialysis patients, ID-TLR and MACE rates were high in both groups (14.3 vs. 17.9%, p = 0.85 and 17.5 vs. 36.1%, p = 0.16). In non-dialysis patients, 8-month angiographic and 3-year clinical outcomes were worse in the Ca group. However, in dialysis patients, both outcomes were worse regardless of CCA.Clinical Trial registration https://clinicaltrials.gov/ct2/show/NCT01086228 .

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Percutaneous Coronary Intervention; Product Surveillance, Postmarketing; Prospective Studies; Registries; Renal Dialysis; Treatment Outcome; Vascular Calcification

Topics: Aortic Valve; Atherectomy, Coronary; Bicuspid Aortic Valve Disease; Cardiovascular Agents; Coronary Artery Disease; Coronary Vessel Anomalies; Heart Defects, Congenital; Heart Failure; Heart Valve Diseases; Humans; Stroke Volume; Treatment Outcome; Vascular Calcification; Ventricular Function, Left

This study evaluated angiographic success and in-hospital outcomes of percutaneous coronary intervention (PCI) with rotational atherectomy (RA) in patients with low left ventricular ejection fraction (LVEF).. Between January 2010 and March 2014, 272 consecutive patients with heavily calcified lesions underwent elective PCI with RA. Of these, 33 patients had LVEF ≤35% (low LVEF group), whereas 237 patients had LVEF >35% (preserved LVEF group). The primary endpoint was angiographic success and in-hospital major adverse cardiac events (MACE). MACE included death from any cause, postprocedure onset MI, emergency coronary artery bypass grafting, and target vessel revascularization. The secondary endpoints were MACE and the components within 30days after PCI. The components of MACE were evaluated.. Angiographic success, defined as <30% residual stenosis with thrombolysis in myocardial infarction flow 3 at final angiography, was achieved in all patients without fatal complications. Intra-aortic ballon pumping (IABP) was used significantly more frequently in the low LVEF group compared with the preserved LVEF group (15.2% vs. 2.1%, p = .003). There were no significant differences between groups regarding in-hospital and clinical outcomes within 30 days following PCI.. If medications and mechanical support were appropriately performed, the angiographic success rate and in-hospital MACE rate of PCI with RA in patients with low LVEF could be expected to have good outcomes similar to those for patients with preserved LVEF.

Topics: Aged; Atherectomy, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Female; Hospital Mortality; Humans; Intra-Aortic Balloon Pumping; Male; Middle Aged; Retrospective Studies; Risk Factors; Severity of Illness Index; Stents; Stroke Volume; Time Factors; Treatment Outcome; Vascular Calcification; Ventricular Function, Left

Hypomagnesemia was identified as a strong risk factor for cardiovascular disease in patients with chronic renal failure (CRF). However, the effects of magnesium (Mg) on vascular calcification (VC) have not been fully elucidated. Thus, we aim to determine the effects of Mg citrate (MgCit) on VC in CRF rats.. Rats were divided into 5 groups: group 1 (normal diet), group 2 (normal diet with MgCit), group 3 (the VC model of CRF induced by 0.75% adenine and 0.9% phosphorus diet from day 1 to day 28), group 4 (group 3 treated with low-dose MgCit from day 1 to day 42), and group 5 (same as group 3 except the high-dose MgCit). All rats were killed at day 43 with collection of blood and aortas. Then, serum biochemical parameters, VC-related staining, calcium and P contents, alkaline phosphatase contents and activity, expression of alpha smooth muscle actin, and runt-related transcription factor 2 (RUNX2) in aortas were assessed.. Group 3 had extensive VC. The VC degree decreased in groups 4 and 5 in a dose-depended manner with reduced calcium content, P levels, alkaline phosphatase content and activity, and protein levels of RUNX2 and increased protein levels of alpha smooth muscle actin in aortas.. MgCit exerted a protective role in VC in adenine-induced CRF rats; thus, it may be a potential drug for the prevention of VC in patients with CRF.

Topics: Actins; Adenine; Alkaline Phosphatase; Animals; Aorta; Aortic Diseases; Calcium; Cardiovascular Agents; Citric Acid; Core Binding Factor Alpha 1 Subunit; Disease Models, Animal; Kidney Failure, Chronic; Male; Organometallic Compounds; Phosphorus, Dietary; Rats, Sprague-Dawley; Vascular Calcification

The aim of this study was to assess the performance of the fluoropolymer-based paclitaxel-eluting stent (PES) in long femoropopliteal lesions.. The new-generation fluoropolymer-based PES showed promising outcomes in short femoropopliteal lesions. The main feature of the stent is its controlled and sustained paclitaxel release over 12 months. However, the safety and efficacy of this technology in longer femoropopliteal lesions remain unclear.. Between March 2016 and March 2017, 62 patients were included in this analysis. Indications for fluoropolymer-based PES deployment were insufficient luminal gain or flow-limiting dissection after plain old balloon angioplasty in a femoropopliteal lesion. Primary patency, freedom from target lesion revascularization, amputation-free survival, and paclitaxel-related adverse events were retrospectively analyzed for up to 1 year of follow-up.. Lesions were de novo in 84% of patients. Mean lesion length was 20 ± 12 cm, and 79% of the lesions (n = 49) were chronic total occlusions. Moderate or severe calcification was present in 42% of the lesions (n = 26). Stent implantation involved the distal superficial femoral artery and the proximal popliteal artery in 76% (n = 47) and 44% (n = 27) of patients, respectively. The Kaplan-Meier estimate of primary patency and freedom from target lesion revascularization was 87%. Amputation-free survival was 100% for patients with claudication (n = 32 [52%]) and 87% in patients with critical limb ischemia (n = 30 [48%]) (hazard ratio: 6.3; 95% confidence interval: 1.25 to 31.54; p = 0.052). Five aneurysm formations of the treated segments (8%) were thought to be attributable to paclitaxel.. The fluoropolymer-based PES showed promising 1-year clinical and angiographic outcomes in real-world long femoropopliteal lesions. The long-term impact of aneurysm formation remains to be further investigated.

Topics: Aged; Angioplasty; Cardiovascular Agents; Chronic Disease; Constriction, Pathologic; Drug-Eluting Stents; Female; Femoral Artery; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Recurrence; Retrospective Studies; Time Factors; Treatment Outcome; Vascular Calcification; Vascular Patency

A 79-year-old male who had a history of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) received coronary angiography (CAG), because of angina pectoris. CAG showed in-stent restenosis of the paclitaxel-eluting stent (PES). Since the devices could not pass the lesion, we performed rotational atherectomy. Although we could not identify the calcified lesion by the optical frequency domain imaging (OFDI) findings because of strong attenuation, the intravascular ultrasound (IVUS) image showed the superficial calcification. On the other hand, strong attenuation in OFDI suggested the presence of foamy macrophage, which was essential for the diagnosis of neoatherosclerosis. We could obtain a favorable result by deploying another drug-eluting stent. While an earlier report showed the calcified neoatherosclerosis following bare-metal stent implantation, we clearly showed the calcified neoatherosclerosis following PES implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Male; Paclitaxel; Treatment Outcome; Vascular Calcification

Kawasaki disease (KD) is the most common cause of acquired heart disease in children in Japan, North America and Europe. Undiagnosed and untreated KD can have clinically significant consequences later in life. The clinical spectrum of missed childhood KD is frequently being recognized during adulthood. We report four adult cases of acute coronary events, in which coronary angiography was suggestive of sequelae of KD.. Four adults who presented with acute coronary events, had coronary angiography for evaluation. Indoor-admission files were analyzed for the clinical details of individual cases.. Two cases were below 40 years of age. None of the patients had any known conventional risk factors for atherosclerosis. Case 4 had a clinical history of childhood KD. Coronary angiography revealed ectasia of multiple coronary arteries and stenosis in distal segments in the first three cases and large thrombosed aneurysm with calcified walls in the fourth case.. We hereby report four adult cases with acute coronary events, who had markedly dilated coronary artery segments suggestive of possible sequelae of childhood KD.

Topics: Adult; Aged; Anterior Wall Myocardial Infarction; Cardiovascular Agents; Coronary Aneurysm; Coronary Angiography; Coronary Artery Bypass; Coronary Artery Disease; Coronary Stenosis; Coronary Thrombosis; Delayed Diagnosis; Humans; India; Male; Mucocutaneous Lymph Node Syndrome; Myocardial Infarction; Predictive Value of Tests; Tertiary Care Centers; Treatment Outcome; Vascular Calcification

This analysis compared the angiographic outcomes of patients treated with orbital atherectomy for calcified common femoral artery (CFA) and superficial femoral artery (SFA) disease. The ideal revascularization strategy for CFA disease is unknown. Endarterectomy has been considered the standard of care for CFA disease for over 50 years. Endovascular intervention is becoming more commonly used to revascularize the CFA given the advances in technology and the less invasive nature of the procedure. Patient demographics, lesion characteristics, and procedure data for all CONFIRM patients with at least one CFA lesion location ( n=147 patients; n=200 lesions) were compared to patients with at least one SFA lesion location ( n=1508 patients; n=2367 lesions). The primary endpoint was angiographic complication, defined as the composite of dissection, perforation, slow flow, closure, spasm, embolism, or thrombosis. The CFA group had more patients with Rutherford class 4 and shorter lesion length. The CFA group had a higher final residual stenosis, shorter total run time, and shorter total inflation time. The primary endpoint was lower in the CFA group compared with the SFA group (17% vs 24%, p=0.02), driven by a lower dissection rate (10% vs 15%, p=0.04). Plaque modification of the CFA with orbital atherectomy was safe and compared favorably with SFA disease. The need for bail-out stenting was low. A randomized trial is needed to determine the ideal treatment strategy for calcified CFA disease.

Topics: Aged; Aged, 80 and over; Angiography; Angioplasty, Balloon; Atherectomy; Cardiovascular Agents; Coated Materials, Biocompatible; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Registries; Retrospective Studies; Time Factors; Treatment Outcome; United States; Vascular Access Devices; Vascular Calcification; Vascular Patency

Limited data are currently available on the performance of everolimus eluting bioresorbable vascular scaffold (BVS) for treatment of complex coronary lesions representative of daily practice.. This is a prospective, mono-center, single-arm study, reporting data after BVS implantation in patients presenting with stable, unstable angina, or non-ST segment elevation myocardial infarction caused by de novo stenotic lesions in native coronary arteries. No restrictions were applied to lesion complexity. Procedural results and 12-month clinical outcomes were reported.. A total of 180 patients have been evaluated in the present study, with 249 treated coronary lesions. Device Success per lesion was 99.2%. A total of 119 calcified lesions were treated. Comparable results were observed among severe, moderate and noncalcified lesions in term of %diameter stenosis (%DS) (20.3 ± 10.5%, 17.8 ± 7.7%, 16.8 ± 8.6%; P = 0.112) and acute gain (1.36 ± 0.41 mm, 1.48 ± 0.44 mm, 1.56 ± 0.54 mm; P = 0.109). In bifurcations (54 lesions), side-branch ballooning after main vessel treatment was often performed (33.3%) with low rate of side-branch impairment (9.3%). A total of 29 cases with coronary total occlusions were treated. After BVS implantation %DS was not different from other lesion types (17.2 ± 9.4%, vs. 17.7 ± 8.6%; P = 0.780). At one year, all-cause mortality was reported in three cases. The rate of target lesion revascularization and target vessel revascularization was 3.3%. The rate of definite scaffold thrombosis was 2.6%.. The implantation of the everolimus eluting bioresorbable vascular scaffold in an expanded range of coronary lesion types and clinical presentations was observed to be feasible with promising angiographic results and mid-term clinical outcomes. © 2016 Wiley Periodicals, Inc.

Topics: Absorbable Implants; Aged; Angina, Stable; Angina, Unstable; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clinical Decision-Making; Coronary Angiography; Coronary Stenosis; Everolimus; Feasibility Studies; Female; Humans; Male; Middle Aged; Netherlands; Non-ST Elevated Myocardial Infarction; Patient Selection; Product Surveillance, Postmarketing; Prospective Studies; Prosthesis Design; Risk Factors; Severity of Illness Index; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Vascular Calcification

The present study was aimed to determine the efficacy of nicorandil in treating cardiac reperfusion injury with an underlying co-morbidity of vascular calcification (VC). Adenine diet was used to induce VC in Wistar rat and the heart was isolated to induce global ischemia reperfusion (IR) by Langendorff method, with and without the nicorandil (7.5mg/kg) pre-treatment and compared with those fed on normal diet. The adenine-treated rats displayed abnormal ECG changes and altered mitochondrial integrity compared to a normal rat heart. These hearts, when subjected to IR increased the infarct size, cardiac injury (measured by lactate dehydrogenase and creatine kinase activity in the coronary perfusate) and significantly altered the hemodynamics compared to the normal perfused heart. Nicorandil pretreatment in rat fed on normal diet enhanced the hemodynamics significantly (P<0.05) along with a substantial reduction in the mitochondrial dysfunction (measured by high ADP to oxygen consumption ratio, respiratory control ratio, enzyme activities and less swelling behavior) when subjected to IR. However, this cardio-protective effect of nicorandil was absent in rat heart with underlying calcification. Our results suggest that, the protective effect of nicorandil, a known mitochondrial ATP linked K

Topics: Animals; Biomarkers; Cardiovascular Agents; Cytoprotection; Disease Models, Animal; Energy Metabolism; Hemodynamics; Isolated Heart Preparation; Lipid Peroxidation; Male; Mitochondria, Heart; Myocardial Infarction; Myocardial Reperfusion Injury; Myocytes, Cardiac; Nicorandil; Oxidative Stress; Potassium Channels; Rats, Wistar; Vascular Calcification

The aim of this study was to appraise 1-year outcomes after percutaneous treatment of long femoropopliteal artery disease using paclitaxel-coated balloons.. Percutaneous transluminal angioplasty with paclitaxel-coated balloons for TransAtlantic Inter-Society Consensus types A and B femoropopliteal artery disease has provided favorable results.. Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions >15 cm long and with 4- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency at 12 months. Secondary endpoints included major adverse events (the composite of death, major target limb amputation, thrombosis at the target lesion site, or clinically driven non-target lesion target vessel revascularization), changes in Rutherford class, ankle-brachial index, and quality of life up to 24 months post-procedure.. A total of 105 patients (mean age 68 ± 9 years, 81.9% men) treated with paclitaxel-coated balloons and provisional stenting were enrolled, and final procedural success was obtained in all. The mean treated lesion length was 251 ± 71 mm, including 63.4% moderate to severely calcified lesions and 49.5% total occlusions. The bailout stent rate was 10.9%. Follow-up after 12 months was obtained in 101 patients (96.2%), showing that primary patency was maintained in 84 (83.2%), and major adverse events had occurred in 7 (6.2%), with persistently significant clinical benefits in Rutherford class.. Paclitaxel-coated balloons are associated with favorable functional and clinical outcomes at 1 year in patients with long femoropopliteal artery disease requiring percutaneous revascularization. (Drug Eluting Balloon [DEB] and Long Lesions of Superficial Femoral Artery [SFA] Ischemic Vascular Disease [DEB-SFA-LONG]; NCT01658540).

Topics: Aged; Angioplasty, Balloon; Ankle Brachial Index; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Equipment Design; Female; Femoral Artery; Humans; Italy; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Quality of Life; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Calcification; Vascular Patency

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Humans; Predictive Value of Tests; Prosthesis Design; Risk Factors; Severity of Illness Index; Tomography, Optical Coherence; Ultrasonography, Interventional; Vascular Calcification

Topics: Aged; Angioscopy; Autopsy; Biopsy; Cardiovascular Agents; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Fatal Outcome; Female; Humans; Percutaneous Coronary Intervention; Sirolimus; Treatment Outcome; Ultrasonography, Interventional; Vascular Calcification

To assess the association of patient, lesion, and procedure variables, including calcification, with late lumen loss (LLL) after use of drug-eluting balloon (DEB) therapy in patients with femoropopliteal arterial disease.. In this retrospective study, 91 patients (mean age 72.0±8.62 years; 50 men) were analyzed at 6 months after DEB treatment. Lesions were located in the superficial femoral artery (SFA, n=68) and popliteal artery (n=23). Lesion calcification was graded by a core laboratory using 2 published scoring indices: the peripheral artery calcification scoring system and a grading system based on circumference (arc) and length of calcium.. The median LLL after 6 months was 0.2 mm (interquartile range -0.5, 1.14) overall and varied significantly across lesions with differing severity of calcification (p=0.042). However, LLL did not differ based on calcium location (intimal, medial, or mixed) or calcium length (p=0.351 and p=0.258, respectively). Additional predictors of LLL after DEB treatment included diabetes (p=0.034), coronary artery disease (p=0.024), and prior intervention (p=0.013). Interestingly, the severity of residual stenosis after the intervention did not have any impact on the LLL during follow-up (Spearman r = -0.238).. Severity of lesion calcification is associated with LLL after treatment with DEB. One possible approach to overcome this limitation might be plaque modification or removal prior to DEB usage. Nevertheless, clinical data that support this hypothesis are currently lacking.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Cardiovascular Agents; Chi-Square Distribution; Coated Materials, Biocompatible; Constriction, Pathologic; Equipment Design; Female; Femoral Artery; Germany; Humans; Male; Middle Aged; Multivariate Analysis; Peripheral Arterial Disease; Popliteal Artery; Retrospective Studies; Risk Factors; Severity of Illness Index; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Calcification

We report the case of a 77-year-old male patient who was admitted to our institution for non-ST segment elevation myocardial infarction. Coronary angiography showed a sub-occlusive lesion of the distal left anterior descending artery (LAD) in the context of a diffuse atherosclerotic disease involving a very long segment of the vessel (about 80mm in length by visual estimation). Pre-dilatation was performed in the mid calcified segment of the LAD with a non-compliant balloon inducing vessel dissection. An everolimus-eluting bioresorbable vascular scaffold (EEBVS) was then advanced in the LAD but the first delivery attempt at the distal site failed because of friction between the EEBVS struts and the calcified vessel wall. In order to facilitate EEBVS delivery, a 5Fr catheter system (Heart Rail II, Terumo, Tokyo, Japan) was advanced in the mid LAD within a standard 6Fr guiding catheter facilitating a non-traumatic deep intubation up to the mid LAD. This strategy increased back-up support facilitating the delivery, beyond the site of resistance, of four EEBVS implanted in overlap. This case demonstrated the successful use of a guide catheter extension system to deliver multiple EEBVS in a patient with a long, calcified LAD lesion.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiac Catheterization; Cardiac Catheters; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Male; Myocardial Infarction; Prosthesis Design; Tissue Scaffolds; Treatment Outcome; Vascular Calcification

Topics: Acute Disease; Age Factors; Aneurysm, False; Aorta, Abdominal; Aorta, Thoracic; Aortic Diseases; Aortic Dissection; Aortic Valve; Atherosclerosis; Bicuspid Aortic Valve Disease; Cardiovascular Agents; Clinical Laboratory Techniques; Diagnostic Imaging; Early Diagnosis; Endovascular Procedures; Female; Genetic Diseases, Inborn; Heart Defects, Congenital; Heart Valve Diseases; Hematoma; Humans; Long-Term Care; Male; Neoplasms, Vascular Tissue; Physical Examination; Risk Factors; Vascular Calcification; Vascular Stiffness; Vascular Surgical Procedures

Topics: Atherectomy, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Paclitaxel; Percutaneous Coronary Intervention; Sirolimus; Vascular Calcification

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Humans; Male; Middle Aged; Plaque, Atherosclerotic; Predictive Value of Tests; Prosthesis Design; Prosthesis Failure; Radiography; Sirolimus; Time Factors; Tomography, Optical Coherence; Vascular Calcification

To assess long-term outcome after rotational atherectomy (RA) is followed by drug-eluting stent (DES) implantation in complex calcified coronary lesions.. RA can favorably modify heavily calcified coronary lesions, but long-term outcome is poor when it is used as a stand-alone therapy or combined with bare-metal stents. DES have reduced rates of restenosis in a wide range of patient and lesion subsets, but little information is available on long-term clinical outcome when RA is followed by DES implantation (Rota-DES) in complex calcified lesions.. Two hundred and five patients with de novo complex calcified coronary lesions treated with Rota-DES were analyzed. Mean age was 69.7 ± 9.3 years, 63 patients (31%) had diabetes mellitus and 21 patients (10%) had chronic renal failure. Total stent length/patient was 32 mm. The majority of patients were treated with paclitaxel-eluting stents (64%) or sirolimus-eluting stents (30%). Angiographic success rate was 98%. The incidence of in-hospital major adverse cardiac events (MACE), defined as death, myocardial infarction (MI), and target vessel revascularization (TVR), was 4.4%. Long-term follow-up was available for 188 patients (92%). At a median follow-up period of 15 months (range, 1-84), the cumulative incidence of MACE (Kaplan-Meier estimate) was 17.7%. Death occurred in 4.4%, MI in 3.4%, TVR in 9.9%, and target lesion revascularization (TLR) in 6.8%. One definite (0.5%) and one probable (0.5%) stent thrombosis were observed. In a multivariate analysis, low ejection fraction (<40%) was the only independent predictor of MACE, and both age and diabetes were independent predictors of TLR.. This study represents the largest European data set of patients treated with RA in the DES era. RA followed by DES implantation in calcified coronary lesions appears to be feasible and effective, with a high rate of procedural success and low incidence of TLR and MACE at long term considering this complex patient and lesion subset.

Topics: Aged; Aged, 80 and over; Atherectomy, Coronary; Cardiovascular Agents; Comorbidity; Coronary Angiography; Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Female; Hospital Mortality; Humans; Incidence; Kaplan-Meier Estimate; Kidney Failure, Chronic; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Registries; Retrospective Studies; Risk Factors; Sirolimus; Stroke; Thrombosis; Time Factors; Treatment Outcome; Vascular Calcification

Although Virtual Histology intravascular ultrasound (VH-IVUS) is increasingly used in clinical research, the reproducibility of plaque composition remains unexplored in significant coronary artery and stented lesions. The purpose of this study was to assess the reproducibility of necrotic core and calcium content in atherosclerotic coronary lesions that were treated with a bioresorbable everolimus-eluting vascular scaffold (BVS) using a new measurement method (Shin's method) by VH-IVUS. Eight patients treated with a BVS (Abbott Vascular, Santa Clara, CA, USA) were analyzed with serial VH-IVUS assessments, i.e., pre- and post-stenting, and at 6 months and 2 years follow-up. A total of 32 coronary segments were imaged to evaluate the reproducibility of volumetric VH-IVUS measurements. In Shin's method, contours are drawn around the IVUS catheter (instead of the lumen) and vessel. Overall, in the imaged coronary segment, for necrotic core and dense calcium volumes, the relative intra-observer differences were 0.30 ± 0.22, 0.19 ± 0.16% for observer 1 and 0.45 ± 0.41, 0.36 ± 0.47% for observer 2, respectively. The inter-observer relative differences of necrotic core and dense calcium volumes were 0.51 ± 0.79 and 0.56 ± 1.01%, respectively. The present study demonstrates a good reproducibility for both, intra-observer and inter-observer measurements using Shin's method. This method is suitable for the measurement of necrotic core and dense calcium using VH-IVUS in longitudinal studies, especially studies on bioresorbable scaffolds, because the degradation process will be fully captured independently of the location of the struts and their greyscale appearance.

Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Atherosclerosis; Cardiovascular Agents; Cohort Studies; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Image Processing, Computer-Assisted; Male; Middle Aged; Necrosis; Observer Variation; Prosthesis Design; Reproducibility of Results; Sirolimus; Treatment Outcome; Ultrasonography, Interventional; Vascular Calcification

The aim was to examine and compare the impact of HeartScore and coronary artery calcification (CAC) score on subsequent changes in the use of medication.. A total of 1156 healthy men and women, aged 50 or 60, had a baseline medical examination and a coronary artery CT-scan as a part of a screening programme. Using the European HeartScore, the total 10-year cardiovascular mortality risk was estimated (≥5% risk was considered as high). Risk factors and CAC scores were reported to both the patients and their general practitioner. Six months after the screening, follow-up questionnaires addressing current medication were mailed to the participants.. A completed questionnaire was returned by 1075 (93%) subjects. At follow up, the overall use of prophylactic medication was significantly increased. Of those with CAC (n = 462) or high HeartScore (n = 233), 21 and 19%, respectively, received lipid-lowering treatment, while 25 and 32%, respectively, received antihypertensive treatment. In multivariate logistic regression analyses, the presence of CAC was associated with an increased use of lipid-lowering treatment (OR 2.2; 95% CI 1.2-4.0), while the presence of a high HeartScore was associated with an increased use of lipid-lowering (OR 2.9; 95% CI 1.6-5.5) and antihypertensive medication (OR 3.4; 95% CI 1.9-6.0).. Knowledge of present cardiovascular risk factors like high HeartScore and/or CAC leads to beneficial changes in medication. However, at follow up only a minority of high-risk subjects did received prophylactic treatment. CAC score was not superior to HeartScore regarding these motivational outcomes.

Topics: Antihypertensive Agents; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Denmark; Female; Humans; Hypolipidemic Agents; Logistic Models; Male; Mass Screening; Middle Aged; Multivariate Analysis; Odds Ratio; Predictive Value of Tests; Prognosis; Risk Assessment; Risk Factors; Severity of Illness Index; Surveys and Questionnaires; Time Factors; Tomography, X-Ray Computed; Vascular Calcification

The expression of bone morphogenetic proteins (BMPs) is enhanced in human atherosclerotic and calcific vascular lesions. Although genetic gain- and loss-of-function experiments in mice have supported a causal role of BMP signaling in atherosclerosis and vascular calcification, it remains uncertain whether BMP signaling might be targeted pharmacologically to ameliorate both of these processes.. We tested the impact of pharmacological BMP inhibition on atherosclerosis and calcification in LDL receptor-deficient (LDLR-/-) mice. LDLR-/- mice fed a high-fat diet developed abundant vascular calcification within 20 weeks. Prolonged treatment of LDLR-/- mice with the small molecule BMP inhibitor LDN-193189 was well-tolerated and potently inhibited development of atheroma, as well as associated vascular inflammation, osteogenic activity, and calcification. Administration of recombinant BMP antagonist ALK3-Fc replicated the antiatherosclerotic and anti-inflammatory effects of LDN-193189. Treatment of human aortic endothelial cells with LDN-193189 or ALK3-Fc abrogated the production of reactive oxygen species induced by oxidized LDL, a known early event in atherogenesis. Unexpectedly, treatment of mice with LDN-193189 lowered LDL serum cholesterol by 35% and markedly decreased hepatosteatosis without inhibiting HMG-CoA reductase activity. Treatment with BMP2 increased, whereas LDN-193189 or ALK3-Fc inhibited apolipoprotein B100 secretion in HepG2 cells, suggesting that BMP signaling contributes to the regulation of cholesterol biosynthesis.. These results definitively implicate BMP signaling in atherosclerosis and calcification, while uncovering a previously unidentified role for BMP signaling in LDL cholesterol metabolism. BMP inhibition may be helpful in the treatment of atherosclerosis and associated vascular calcification.

Topics: Animals; Anti-Inflammatory Agents; Antioxidants; Atherosclerosis; Bone Morphogenetic Protein Receptors, Type I; Bone Morphogenetic Proteins; Cardiovascular Agents; Cholesterol, LDL; Diet, High-Fat; Disease Models, Animal; Endothelial Cells; Fatty Liver; Female; Hep G2 Cells; Humans; Lipoproteins, LDL; Liver; Mice; Mice, Inbred C57BL; Mice, Knockout; Pyrazoles; Pyrimidines; Reactive Oxygen Species; Receptors, LDL; Recombinant Fusion Proteins; Signal Transduction; Time Factors; Vascular Calcification

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Stenosis; Drug-Eluting Stents; Humans; Male; Microscopy, Electron, Scanning; Polymers; Prosthesis Design; Severity of Illness Index; Sirolimus; Treatment Outcome; Vascular Calcification

Stent fracture (SF) after drug-eluting stent implantation has recently become an important concern because of its potential association with in-stent restenosis and stent thrombosis. However, the incidence and clinical impact of SF after everolimus-eluting stent implantation remain unclear.. A total of 1035 patients with 1339 lesions undergoing everolimus-eluting stent implantation and follow-up angiography 6 to 9 months after index procedure were analyzed. SF was defined as complete or partial separation of the stent, as assessed by plain fluoroscopy or intravascular ultrasound during follow-up. We assessed the rates of SF and major adverse cardiac events, defined as cardiac death, myocardial infarction, stent thrombosis, and clinically driven target lesion revascularization within 9 months. SF was observed in 39 of 1339 lesions (2.9%) and in 39 of 1035 patients (3.8%). Ostial stent location and lesions with hinge motion, tortuosity, or calcification were independent predictors of SF. The rate of myocardial infarction and target lesion revascularization were significantly higher in the SF group than in the non-SF group (5.1% versus 0.4%; P=0.018 and 25.6% versus 2.0%; P<0.001, respectively). Stent thrombosis was more frequently observed in the SF group than in the non-SF group (5.1% versus 0.4%; P=0.018). Major adverse cardiac events within 9 months were significantly higher in the SF group than in the non-SF group (25.6% versus 2.3%; P<0.001).. SF after everolimus-eluting stent implantation occurs in 2.9% of lesions and is associated with higher rate of major adverse cardiac events, driven by higher target lesion revascularization and stent thrombosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Incidence; Japan; Logistic Models; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Odds Ratio; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Prosthesis Failure; Risk Factors; Sirolimus; Time Factors; Ultrasonography, Interventional; Vascular Calcification

Although serial changes in necrotic core and calcium are regarded as surrogates for the bioresorption process in patients treated with the bioresorbable everolimus-eluting vascular scaffolds (BVS), these temporal changes have not yet been fully investigated. Shin's method may be offer a more suitable technique for this analysis because it includes all the contents of both the lumen and vessel wall. The purpose of this study was to assess the serial changes of necrotic core and dense calcium content in coronary lesions that were treated with a BVS implant using Virtual Histology intravascular ultrasound (VH-IVUS) analyzed using Shin's method. A total of 29 patients (92 coronary segments) were imaged to evaluate the serial changes in necrotic core and dense calcium using Shin's method. Lesions treated with a BVS implant were analyzed with serial VH-IVUS assessments, i.e., pre- and post-stenting, and at 6 months and 2 years follow-up. In Shin's method contours are drawn around the IVUS catheter (instead of delineating the lumen) and the vessel. The mean necrotic core area decreased by 6.9% from post-stenting to 6 months (1.71 ± 1.03 mm² vs. 1.36 ± 0.91 mm², P = 0.027), and by 20.5% (1.71 ± 1.03 mm² vs. 1.20 ± 0.70 mm², P = 0.003) from post-steting to 2 years; while the mean dense calcium areas decreased by 27.2% (1.07 ± 0.55 mm² vs. 0.78 ± 0.64 mm², P = 0.039) from post-stenting and 2 years. At 2 years, absolute necrotic core and dense calcium content were significantly decreased as compared to post-stenting values. The present study demonstrates that the bioresorption process in patients who undergoing BVS device implantation can be assessed using VH-IVUS analysed using Shin's method.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Animals; Calcium; Cardiovascular Agents; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Image Processing, Computer-Assisted; Male; Middle Aged; Models, Animal; Necrosis; Predictive Value of Tests; Prosthesis Design; Sirolimus; Swine; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Vascular Calcification