Ticagrelor alone versus ticagrelor plus aspirin from month 1 to month 12 after percutaneous coronary intervention in patients with acute coronary syndromes (ULTIMATE-DAPT): a randomised, placebo-controlled, double-blind clinical trial.

BACKGROUND: Following percutaneous coronary intervention with stent placement to treat acute coronary syndromes, international clinical guidelines generally recommend dual antiplatelet therapy with aspirin plus a P2Y12 receptor inhibitor for 12 months to prevent myocardial infarction and stent thrombosis. However, data on single antiplatelet therapy with a potent P2Y12 inhibitor earlier than 12 months after percutaneous coronary intervention for patients with an acute coronary syndrome are scarce. The aim of this trial was to assess whether the use of ticagrelor alone, compared with ticagrelor plus aspirin, could reduce the incidence of clinically relevant bleeding events without an accompanying increase in major adverse cardiovascular or cerebrovascular events (MACCE). METHODS: In this randomised, placebo-controlled, double-blind clinical trial, patients aged 18 years or older with an acute coronary syndrome who completed the IVUS-ACS study and who had no major ischaemic or bleeding events after 1-month treatment with dual antiplatelet therapy were randomly assigned to receive oral ticagrelor (90 mg twice daily) plus oral aspirin (100 mg once daily) or oral ticagrelor (90 mg twice daily) plus a matching oral placebo, beginning 1 month and ending at 12 months after percutaneous coronary intervention (11 months in total). Recruitment took place at 58 centres in China, Italy, Pakistan, and the UK. Patients were required to remain event-free for 1 month on dual antiplatelet therapy following percutaneous coronary intervention with contemporary drug-eluting stents. Randomisation was done using a web-based system, stratified by acute coronary syndrome type, diabetes, IVUS-ACS randomisation, and site, using dynamic minimisation. The primary superiority endpoint was clinically relevant bleeding (Bleeding Academic Research Consortium [known as BARC] types 2, 3, or 5). The primary non-inferiority endpoint was MACCE (defined as the composite of cardiac death, myocardial infarction, ischaemic stroke, definite stent thrombosis, or clinically driven target vessel revascularisation), with an expected event rate of 6·2% in the ticagrelor plus aspirin group and an absolute non-inferiority margin of 2·5 percentage points between 1 month and 12 months after percutaneous coronary intervention. The two co-primary endpoints were tested sequentially; the primary superiority endpoint had to be met for hypothesis testing of the MACCE outcome to proceed. All principal analyses were assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT03971500, and is completed. FINDINGS: Between Sept 21, 2019, and Oct 27, 2022, 3400 (97·0%) of the 3505 participants in the IVUS-ACS study were randomly assigned (1700 patients to ticagrelor plus aspirin and 1700 patients to ticagrelor plus placebo). 12-month follow-up was completed by 3399 (>99·9%) patients. Between month 1 and month 12 after percutaneous coronary intervention, clinically relevant bleeding occurred in 35 patients (2·1%) in the ticagrelor plus placebo group and in 78 patients (4·6%) in the ticagrelor plus aspirin group (hazard ratio [HR] 0·45 [95% CI 0·30 to 0·66]; p<0·0001). MACCE occurred in 61 patients (3·6%) in the ticagrelor plus placebo group and in 63 patients (3·7%) in the ticagrelor plus aspirin group (absolute difference -0·1% [95% CI -1·4% to 1·2%]; HR 0·98 [95% CI 0·69 to 1·39]; pnon-inferiority<0·0001, psuperiority=0·89). INTERPRETATION: In patients with an acute coronary syndrome who had percutaneous coronary intervention with contemporary drug-eluting stents and remained event-free for 1 month on dual antiplatelet therapy, treatment with ticagrelor alone between month 1 and month 12 after the intervention resulted in a lower rate of clinically relevant bleeding and a similar rate of MACCE compared with ticagrelor plus aspirin. Along with the results from previous studies, these findings show that most patients in this population can benefit from superior clinical outcomes with aspirin discontinuation and maintenance on ticagrelor monotherapy after 1 month of dual antiplatelet therapy. FUNDING: The Chinese Society of Cardiology, the National Natural Scientific Foundation of China, and the Jiangsu Provincial & Nanjing Municipal Clinical Trial Project. TRANSLATION: For the Mandarin translation of the abstract see Supplementary Materials section.

A Visualized Nomogram for Predicting Prognosis in Elderly Patients after Percutaneous Coronary Intervention.

Background: Revascularized patients still experience adverse cardiovascular events. This is particularly true for elderly patients over the age of 65, as they often have more co-morbid vascular conditions. It is important to develop a tool to assist clinicians in comprehensively assessing these patients' prognosis. The objective of this study is to create a comprehensive visual nomogram model combining clinical and physiological assessments to predict outcomes in elderly patients undergoing percutaneous coronary intervention (PCI). Methods: This study is a retrospective investigation of patients who underwent PCI between January 2016 and December 2017. A total of 691 patients with 1461 vessels were randomly divided into a training (n = 483) and a validation set (n = 208). A multivariate Cox regression model was employed using the training set to select variables for constructing a nomogram. The performance of the nomogram was assessed through the receiver operating characteristic curve (ROC) and calibration curves to evaluate its discrimination and predictive accuracy. To further assess the clinical usefulness, Kaplan-Meier curve analysis and landmark analysis were conducted. Results: Independent risk factors, including diabetes mellitus (DM), post-PCI quantitative flow ratio (QFR), previous myocardial infarction (MI), and previous PCI, were contained in the nomogram. The nomogram exhibited a good area under the curve (AUC) ranging from 0.742 to 0.789 in the training set, 0.783 to 0.837 in the validation set, and 0.764 to 0.786 in the entire population. Calibration curves demonstrated a well-fitted curve in all three sets. The Kaplan-Meier curves showed clear separation and the patients with higher scores in the nomogram model exhibited a higher incidence of target vessel revascularization (TVR) (7.99% vs. 1.24% for 2-year, p < 0.001 and 13.54% vs. 2.23% for 5-years, p < 0.001, respectively). Conclusions: This study has developed the visually intuitive nomogram to predict the 2-year and 5-year TVR rates for elderly patients who underwent PCI. This tool provides more accurate and comprehensive healthcare guidance for patients and their physicians.

2024 Statement from Asia expert operators on transcatheter pulmonary valve replacement.

Transcatheter pulmonary valve replacement (TPVR), also known as percutaneous pulmonary valve implantation, refers to a minimally invasive technique that replaces the pulmonary valve by delivering an artificial pulmonary prosthesis through a catheter into the diseased pulmonary valve under the guidance of X-ray and/or echocardiogram while the heart is still beating not arrested. In recent years, TPVR has achieved remarkable progress in device development, evidence-based medicine proof and clinical experience. To update the knowledge of TPVR in a timely fashion, and according to the latest research and further facilitate the standardized and healthy development of TPVR in Asia, we have updated this consensus statement. After systematical review of the relevant literature with an in-depth analysis of eight main issues, we finally established eight core viewpoints, including indication recommendation, device selection, perioperative evaluation, procedure precautions, and prevention and treatment of complications.

Endogenous electric field coupling Mxene sponge for diabetic wound management: haemostatic, antibacterial, and healing.

Improper management of diabetic wound effusion and disruption of the endogenous electric field can lead to passive healing of damaged tissue, affecting the process of tissue cascade repair. This study developed an extracellular matrix sponge scaffold (K1P6@Mxene) by incorporating Mxene into an acellular dermal stroma-hydroxypropyl chitosan interpenetrating network structure. This scaffold is designed to couple with the endogenous electric field and promote precise tissue remodelling in diabetic wounds. The fibrous structure of the sponge closely resembles that of a natural extracellular matrix, providing a conducive microenvironment for cells to adhere grow, and exchange oxygen. Additionally, the inclusion of Mxene enhances antibacterial activity(98.89%) and electrical conductivity within the scaffold. Simultaneously, K1P6@Mxene exhibits excellent water absorption (39 times) and porosity (91%). It actively interacts with the endogenous electric field to guide cell migration and growth on the wound surface upon absorbing wound exudate. In in vivo experiments, the K1P6@Mxene sponge reduced the inflammatory response in diabetic wounds, increased collagen deposition and arrangement, promoted microvascular regeneration, Facilitate expedited re-epithelialization of wounds, minimize scar formation, and accelerate the healing process of diabetic wounds by 7 days. Therefore, this extracellular matrix sponge scaffold, combined with an endogenous electric field, presents an appealing approach for the comprehensive repair of diabetic wounds.

Randomized Pilot Study to Compare DCB-Based versus DST-Based Strategies for the Treatment of True or Complex Coronary Bifurcation Lesions.

Background: Dual stenting technique (DST) is still mandatory for some true bifurcation lesions (BLs), but drug-coated balloon (DCB) alone may offer a new optional treatment with the potential benefits of fewer implants. However, procedural safety presents a concern when using DCB-only to treat true BLs. This study sought to explore the safety and efficacy of the DCB-only strategy for the treatment of true BLs. Methods: Sixty patients with TBLs were randomly assigned to be treated by a DCB-based strategy or DST-based strategy. All patients received angiographic follow-up scheduled after one-year and staged clinical follow-up. The primary endpoint was the one-year late lumen loss (LLL) and cumulative major cardiac adverse events (MACEs) composed of cardiac death (CD), target vessel myocardial infarction (TVMI), target lesion thrombosis (TVT), or target vessel/lesion revascularization (TLR/TVR). The secondary endpoint was the one-year minimal lumen diameter (MLD), diameter stenosis percentage (DSP) or binary restenosis (BRS), and each MACE component. Results: The baseline clinical and lesioncharacteristics were comparable with similar proportions (20.0% vs. 23.3%, p = 1.000) of the complex BLs between the two groups. At the one-year follow-up, LLL was significantly lower in the DCB-based group (main-vessel: 0.05 ± 0.24 mm vs. 0.25 ± 0.35 mm, p = 0.013; side-branch: -0.02 ± 0.19 mm vs. 0.11 ± 0.15 mm, p = 0.005). MLD, DSP and TLR/TVR were comparable between the groups. The one-year cumulative MACE, all driven by TLR/TVR (6.7% vs. 13.3%, p = 0.667), was low and similar without CD, TVMI or TVT in both groups. Conclusions: Compared to the DST strategy, the DCB- based strategy may be safe and effective in treatment of the selected true BLs. Clinical Trial Registration: Clinical registration number is ChiCTR1900024914.

Mid-Term Outcomes of Novel Covered Stent with Biodegradable Membrane in Porcine Coronary Artery Perforation.

Background: Currently, commercially covered stents are the main treatment for coronary artery perforation (CAP), but without satisfied late-term outcomes when compared to drug-eluting stents (DES). This study seeks to report a new covered stent to treat porcine CAP, which is manufactured with DES and a biodegradable membrane fabricated by poly-L-lactic acid (PLLA) polymer. Methods: Experimental swines experienced CAP in proximal-middle of right coronary artery (RCA) by non-compliant balloon burst, and covered stent was deployed in breach segment. Meanwhile, coronary angiography (CAG), optical coherence tomography (OCT), histological light microscopy and scan electron microscopy were performed to characterize the performance of covered stent. Results: Seven swines were used for this study. Two swines were euthanasia at 14 days and 28 days after procedure, respectively. The remaining 5 kept alive until sacrifice at six months. CAG at six months showed total occlusion at the stented segment of RCA in all swines. The interventional revascularization of occlusion lesion was instituted in two swines. After recanalizing occlusion lesion, OCT examination visualized diffuse heterogeneous fibrous plaques, as well as organized thrombosis, lipid deposits and several neoatherosclerosis in the occluded segment. Serial histopathologic and electron microscopies at 14 days, 28 days and six months revealed gradual occlusive vessel lumen with diffuse heterogeneous fibroplasia, smooth muscle proliferation, inflammation response and local neoatherosclerosis, moreover with identification of PLLA polymer membrane degradability. Conclusions: The new covered stent with biodegradable membrane could seal urgent coronary breach and prevent experimental swines death, but with all stent occlusion in mid-term (six months) follow-up, which might be attributed to diffuse heterogeneous fibroplasia, smooth muscle proliferation, inflammation response and local neoatherosclerosis with the degradation of PLLA membrane.

Triglyceride-glucose index on risk of adverse events after drug-coated balloon angioplasty.

BACKGROUND: The pathogenetic mechanism of atherosclerotic cardiovascular diseases is associated with insulin resistance (IR), which serves as a metabolic risk factor. As a novel indication for IR, triglyceride-glucose (TyG) index may predict cardiovascular disease outcomes. METHODS: In current study, a cohort of 157 individuals with newly developed de novo lesions who received DCB angioplasty between January 2017 and May 2021 were included. The midterm follow-up clinical results consisted of the presence of vessel-oriented composite endpoint (VOCE). The baseline TyG index was divided into three groups by tertiles. This study compared various clinical characteristics and parameters among different groups during DCB angioplasty. A multivariate Cox regression model was built to investigate the potential predictors. RESULTS: Higher TyG index indicated an increased risk of VOCE according to the adjusted model (HR = 4.0, 95%Cl: 1.0-15.4, P = 0.047). A non-linear correlation was uncovered between the index and VOCE from the smooth curve. Based on Kaplan-Meier curve, individuals in the highest TyG index group were more likely to develop VOCE (P < 0.05 for log-rank). CONCLUSIONS: The incidence of VOCE was shown to be independently and positively correlated with an elevated TyG index in individuals with de novo coronary lesions who received DCB angioplasty.

Canagliflozin ameliorates hypobaric hypoxia-induced pulmonary arterial hypertension by inhibiting pulmonary arterial smooth muscle cell proliferation.

Pulmonary arterial hypertension (PAH) is a disease with a high mortality and few treatment options to prevent the development of pulmonary vessel remodeling, pulmonary vascular resistance, and right ventricular failure. Canagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, is originally used in diabetes patients which could assist the glucose excretion and decrease blood glucose. Recently, a few studies have reported the protective effect of SGLT2 inhibitor on monocrotaline-induced PAH. However, the effects of canagliflozin on hypobaric hypoxia-induced PAH as well as its mechanism still unclear. In this study, we used hypobaric hypoxia-induced PAH mice model to demonstrate if canagliflozin could alleviate PAH and prevent pulmonary vessel remodeling. We found that daily canagliflozin administration significantly improved survival in mice with hypobaric hypoxia-induced PAH compared to vehicle control. Canagliflozin treatment significantly reduced right ventricular systolic pressure and increased pulmonary acceleration time determined by hemodynamic assessments. Canagliflozin significantly reduced medial wall thickening and decreased muscularization of pulmonary arterioles compared to vehicle treated mice. In addition, canagliflozin inhibited the proliferation and migration of pulmonary arterial smooth muscle cells through suppressing glycolysis and reactivating AMP-activated protein kinase signaling pathway under hypoxia condition. In summary, our findings suggest that canagliflozin is sufficient to inhibit pulmonary arterial remodeling which is a potential therapeutic strategy for PAH treatment.

Angiographic quantitative flow ratio-guided coronary intervention (FAVOR III China): a multicentre, randomised, sham-controlled trial.

BACKGROUND: Compared with visual angiographic assessment, pressure wire-based physiological measurement more accurately identifies flow-limiting lesions in patients with coronary artery disease. Nonetheless, angiography remains the most widely used method to guide percutaneous coronary intervention (PCI). In FAVOR III China, we aimed to establish whether clinical outcomes might be improved by lesion selection for PCI using the quantitative flow ratio (QFR), a novel angiography-based approach to estimate the fractional flow reserve. METHODS: FAVOR III China is a multicentre, blinded, randomised, sham-controlled trial done at 26 hospitals in China. Patients aged 18 years or older, with stable or unstable angina pectoris or patients who had a myocardial infarction at least 72 h before screening, who had at least one lesion with a diameter stenosis of 50-90% in a coronary artery with a reference vessel of at least 2·5 mm diameter by visual assessment were eligible. Patients were randomly assigned to a QFR-guided strategy (PCI performed only if QFR ≤0·80) or an angiography-guided strategy (PCI based on standard visual angiographic assessment). Participants and clinical assessors were masked to treatment allocation. The primary endpoint was the 1-year rate of major adverse cardiac events, a composite of death from any cause, myocardial infarction, or ischaemia-driven revascularisation. The primary analysis was done in the intention-to-treat population. The trial was registered with ClinicalTrials.gov (NCT03656848). FINDINGS: Between Dec 25, 2018, and Jan 19, 2020, 3847 patients were enrolled. After exclusion of 22 patients who elected not to undergo PCI or who were withdrawn by their physicians, 3825 participants were included in the intention-to-treat population (1913 in the QFR-guided group and 1912 in the angiography-guided group). The mean age was 62·7 years (SD 10·1), 2699 (70·6%) were men and 1126 (29·4%) were women, 1295 (33·9%) had diabetes, and 2428 (63·5%) presented with an acute coronary syndrome. The 1-year primary endpoint occurred in 110 (Kaplan-Meier estimated rate 5·8%) participants in the QFR-guided group and in 167 (8·8%) participants in the angiography-guided group (difference, -3·0% [95% CI -4·7 to -1·4]; hazard ratio 0·65 [95% CI 0·51 to 0·83]; p=0·0004), driven by fewer myocardial infarctions and ischaemia-driven revascularisations in the QFR-guided group than in the angiography-guided group. INTERPRETATION: In FAVOR III China, among patients undergoing PCI, a QFR-guided strategy of lesion selection improved 1-year clinical outcomes compared with standard angiography guidance. FUNDING: Beijing Municipal Science and Technology Commission, Chinese Academy of Medical Sciences, and the National Clinical Research Centre for Cardiovascular Diseases, Fuwai Hospital.

Simple Stenting Strategy with or without Branch Ostial Optimization Technique for Treatment of Coronary Bifurcation Lesions.

Background: A simple stenting strategy with provisional side-branch (SB) stenting or crossover stenting has been recommended as the default approach for most coronary bifurcation lesions (CBLs). The proximal optimization technique (POT) and POT-associated techniques (POTAs) were introduced to optimize the ostium of SB. However, these techniques are unable to remove the jailed struts or completely diminish vessel damage. In this study we developed a novel branch ostial optimization technique (BOOT) and assessed its efficacy and safety by a propensity score matching comparison (PSM) with POT-associated techniques (POTA). Methods: From June 2016 to March 2018, a total of 203 consecutive patients with true CBLs were treated with BOOT (50 patients) or POTA stenting (153 patients). We performed PSM to correct for confounders from clinical and lesion characteristics. The primary endpoint was cumulative major adverse cardiac events (MACE) at 12 months including cardiac death, non-fatal myocardial infarction, and target vessel/lesion revascularization (TVR/TLR) or target vessel/lesion thrombosis (ST). Results: After PSM, there were 43 patients in each group. Follow-up coronary angiography was performed in 77 (89.5%) patients. At 12 months, the angiographic restenosis rate was significantly different between the BOOT group and the POTA group after PSM (proximal main branch: 20.01 ± 11.33% vs. 26.81 ± 14.02%, p = 0.003; distal main branch: 18.07 ± 3.71% vs. 23.44 ± 10.78%, p = 0.006; side branch: 23.53 ± 10.12% vs. 39.01 ± 10.29%, p < 0.001, respectively). The incidence of MACE at 12 months was not different between the BOOT group before PSM (8.0% vs. 11.8%, p = 0.604), but less frequent after PSM (4.7% vs. 23.3%, p = 0.026) when compared with the POTA group, mainly due to TVR/TLR (2.3% vs. 20.9%, p = 0.015). Conclusions: In patients with CBLs, BOOT is feasible for optimization of the SB ostium and may be superior to POTAs in terms of the angiographic measurements and long-term clinical outcomes at 12 months follow-up.

MELD-XI score predict no-reflow phenomenon and short-term mortality in patient with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.

INTRODUCTION: No-reflow phenomenon (NRP) is one of the complications that mostly occur during percutaneous coronary intervention (PCI). In this study, we comprehensively examined the relationship between the model for end-stage liver disease-XI (MELD-XI) score and NRP. Moreover, we discussed whether the MELD-XI score could be considered as an accurate risk assessment score of patients with ST-segment elevation myocardial infarction (STEMI) who are candidates for PCI. METHODS: This retrospective study involved 693 patients with acute STEMI and who underwent an emergency PCI. They were divided into a normal reflow group or a no-reflow group on the basis of the flow rate of post-interventional thrombolysis in myocardial infarction. Univariate, multivariate logistic regression, and Cox regression analyses were performed to identify the independent predictors of NRP in both groups. Receiver operator characteristic (ROC) curves and Kaplan-Meier curves were plotted to estimate the predictive values of the MELD-XI score. RESULTS: MELD-XI score was found to be an independent indicator of NRP (odds ratio: 1.247, 95% CI: 1.144-1.360, P < 0.001). Multivariate Cox regression analysis also revealed that the MELD-XI score is an independent prognostic factor for 30-day all-cause mortality (hazard ratio: 1.155, 95% CI: 1.077-1.239, P < 0.001). Moreover, according to the ROC curves, the cutoff value of the MELD-XI score to predict NRP was 9.47 (area under ROC curve: 0.739, P < 0.001). The Kaplan-Meier curves for 30-day all-cause mortality revealed lower survival rate in the group with a MELD-XI score of > 9.78 (P < 0.001). CONCLUSION: The MELD-XI score can be used to predict NRP and the 30-day prognosis in patients with STEMI who are candidates for primary PCI. It could be adopted as an inexpensive and a readily available tool for risk stratification.

Exposure to maternal diabetes induces endothelial dysfunction and hypertension in adult male rat offspring.

The adverse environment in early life can modulate adult phenotype, including blood pressure. Our previous study shows, in a rat streptozotocin (STZ)-induced maternal diabetes model, fetal exposure to maternal diabetes is characterized by established hypertension in the offspring. However, the exact mechanisms are not known. Our present study found, as compared with male control mother offspring (CMO), male diabetic mother offspring (DMO) had higher blood pressure with arterial dysfunction, i.e., decreased acetylcholine (Ach)-induced vasodilation. But there is no difference in blood pressure between female CMO and DMO. The decreased Ach-induced vasodilation was related to decreased nitric oxide (NO) production in the endothelium, not NO sensitivity in vascular smooth muscle because sodium nitroprusside (SNP)-mediated vasodilation was preserved; there was decreased NO production and lower eNOS phosphorylation in male DMO. The reactive oxygen species (ROS) level was increased in male DMO than CMO; normalized ROS levels with tempol increased NO production, normalized Ach-mediated vasodilation, and lowered blood pressure in male DMO rats. It indicates that diabetic programming hypertension is related to arterial dysfunction; normalizing ROS might be a potential strategy for the prevention of hypertension in the offspring.

Comparison of standard versus modified stenting technique for treatment of tapered coronary artery lesions.

Tapered coronary artery lesions (TCALs) are often seen clinically, optimal stenting of TCALs remains challengeable. This study sought to compare clinical outcomes between the modified single stenting (MSS) and conventional overlapped stenting (COS) in treatment of TCALs. 150 patients were treated with MSS (MSS group), another 150 patients were matched with propensity score matching from 5055 patients treated with COS (COS group). Quantitative coronary angiography was performed to measure minimal lumen diameter (MLD), late lumen loss (LLL). The primary endpoint was immediate angiographic success, one-year cumulative major cardiac adverse events (MACEs) composing cardiac death, target vessel myocardial infarction (TVMI), target lesion/vessel revascularization (TLR/TVR) or stent thrombosis (ST). Post-procedural in-stent MLD (2.96 ± 0.34 versus 3.08 ± 0.33, P = 0.004) was smaller and diameter stenosis (11.7 ± 4.0% versus 9.0 ± 4.8%, P = 0.003) was higher in MSS group than COS group. At 1-year follow-up, in-stent MLD (2.76 ± 0.38 mm versus 2.65 ± 0.60 mm, P = 0.003) was reduced, LLL (0.20 ± 0.26 mm versus 0.42 ± 0.48 mm, P = 0.001), diameter stenosis (24.02 ± 20.94% versus 19.68 ± 11.75%, P = 0.028) and binary restenosis (18.7% versus 10.0%, P = 0.047) were increased in COS group. Angiographic success (96.7% versus 98.0%, P = 0.723) was similar between MSS group and COS group. At 1-year, the cumulative MACEs (12.0% versus 22.7%, P = 0.022) and TLR/TVR (10.0% versus 18.7%, P = 0.047) were reduced in MSS group as compared to COS group, there was no difference in cardiac death, TVMI and ST between the groups. Compared to conventional overlapped stenting, modified single stenting for TCALs is associated with similar angiographic success, fewer one-year cumulative MACEs and less treatment cost.

Prevention of Contrast-Induced Nephropathy by Inferior Vena Cava Ultrasonography-Guided Hydration in Chronic Heart Failure Patients.

INTRODUCTION: Contrast-induced nephropathy (CIN) is a common complication resulting from the administration of contrast media. This study was designed to determine whether inferior vena cava (IVC) ultrasonography (IVCU)-guided hydration can reduce the risk of CIN in chronic heart failure patients undergoing coronary angiography or coronary angiography with percutaneous coronary intervention compared with standard hydration. METHODS: This prospective clinical trial enrolled 207 chronic heart failure patients from February 2016 to November 2017, who were randomly assigned to either the IVCU-guided hydration group (n = 104) or the routine hydration group (n = 103). In the IVCU-guided group, the hydration infusion rate was set according to the IVC diameter determined by IVCU, while the control group received intravenous infusion of 0.9% saline at 0.5 mL/(kg·h). Serum Cr was measured before and 48-72 h after the procedure. All patients were followed up for 18 months. The incidence of nephropathy and major adverse cardiovascular or cerebrovascular events (MACCEs) was also compared between the 2 groups. RESULTS: Statistically significant difference between the 2 groups regarding the occurrence of CIN was observed (12.5 vs. 29.1%, p = 0.004). The hydration volume of the IVCU-guided group was significantly higher than that of the routine group (p < 0.001). In addition, patients receiving IVCU-guided hydration had significantly lower risk of developing MACCEs than patients in the control group during the 18-month follow-up (14.4 vs. 27.2%, p = 0.027). CONCLUSION: Our findings support that IVCU-guided hydration is superior to standard hydration in prevention of CIN and may substantially reduce longtime composite major adverse events.

Low Serum Calcitonin Gene-Related Peptide Level is Associated with Severity of Coronary Stenosis.

PURPOSE: To evaluate the relationship between the serum calcitonin gene-related peptide (CGRP) level and severity of coronary stenosis. METHODS: A total of 233 eligible patients who underwent coronary angiography were divided into two groups: a control and a coronary heart disease (CHD) group. The angiographic severity of coronary stenosis was evaluated by SYNTAX and Gensini scores. The incidence of major adverse cardiovascular events within two years was collected. RESULTS: A negative correlation between serum CGRP levels and Gensini scores was observed in all patients (r=-0.352, p<0.001), the control group (r=-0.422, p<0.001) and the CHD group (r=-0.393, p<0.001). Serum CGRP levels were negatively associated with SYNTAX scores in the CHD group (r=-0.522, p<0.001). The area under the curve of CGRP for identifying high SYNTAX scores (>22) was 0.772 [95% confidence interval (CI): 0.673-0.870, p<0.001], and for identifying high Gensini scores was 0.744 (95% CI: 0.646-0.842, p<0.001). A CGRP concentration of 25.05 pg/ml was selected as the cutoff point. A low CGRP level (<25.05 pg/ml) was an independent predictor of severe coronary stenosis, a SYNTAX score >22 [odds ratio (OR) =5.819, 95% CI: 2.240-15.116; p<0.001] and a high Gensini score (>64) (OR=4.943, 95% CI: 2.020-12.095; p<0.001). The low CGRP group had a higher incidence of major adverse cardiovascular events within two years (11.1 vs. 3.1%, p=0.031). CONCLUSION: In coronary atherosclerosis patients without acute myocardial injury, serum CGRP levels were negatively associated with the severity of coronary stenosis.

Multicentre, randomized comparison of two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: the DEFINITION II trial.

AIM: The present study aimed to assess the benefits of two-stent techniques for patients with DEFINITION criteria-defined complex coronary bifurcation lesions. METHODS AND RESULTS: In total, 653 patients with complex bifurcation lesions at 49 international centres were randomly assigned to undergo the systematic two-stent technique (two-stent group) or provisional stenting (provisional group). The primary endpoint was the composite of target lesion failure (TLF) at the 1-year follow-up, including cardiac death, target vessel myocardial infarction (TVMI), and clinically driven target lesion revascularization (TLR). The safety endpoint was definite or probable stent thrombosis. At the 1-year follow-up, TLF occurred in 37 (11.4%) and 20 (6.1%) patients in the provisional and two-stent groups, respectively [77.8%: double-kissing crush; hazard ratio (HR) 0.52, 95% confidence interval (CI) 0.30-0.90; P = 0.019], largely driven by increased TVMI (7.1%, HR 0.43, 95% CI 0.20-0.90; P = 0.025) and clinically driven TLR (5.5%, HR 0.43, 95% CI 0.19-1.00; P = 0.049) in the provisional group. At the 1 year after indexed procedures, the incidence of cardiac death was 2.5% in the provisional group, non-significant to 2.1% in the two-stent group (HR 0.86, 95% CI 0.31-2.37; P = 0.772). CONCLUSION: For DEFINITION criteria-defined complex coronary bifurcation lesions, the systematic two-stent approach was associated with a significant improvement in clinical outcomes compared with the provisional stenting approach. Further study is urgently warranted to identify the mechanisms contributing to the increased rate of TVMI after provisional stenting. STUDY REGISTRATION: http://www.clinicaltrials.com; Identifier: NCT02284750.

Erratum: Erratum.

[This corrects the article DOI: 10.6515/ACS.201907_35(4).20181122A.].

Effect of remote ischemic preconditioning in patients with STEMI during primary percutaneous coronary intervention: a meta-analysis of randomized controlled trials.

Remote ischemic conditioning is usually associated with cardioprotective intervention against ischemia-reperfusion. However, the effect of remote ischemic preconditioning (RIC-pre) completed before myocardial reperfusion with intermittent limb ischemia-reperfusion in patients with STEMI undergoing primary percutaneous coronary intervention (PPCI) is unclear. PubMed, EMBASE, and the Cochrane Library were fully searched from the beginning of each database up to September 2019 to find seven RCTs, a total of 2796 patients with STEMI undergoing PPCI with RIC-pre and 2818 patients with STEMI undergoing PPCI alone. No significant discrepancy in cardiac death was observed between RIC-pre and control groups (RR 1.03, 95% CI [0.76-1.41], P = 0.83, I2 = 40%). The incidences of hospitalization for heart failure (RR 1.03, 95% CI [0.85-1.25], P = 0.77, I2 = 0%), myocardial infarction (RR 0.86, 95% CI [0.59-1.26], P = 0.44, I2 = 0%), and stroke (RR 1.04, 95% CI [0.62-1.77], P = 0.87, I2 = 0%) were not decreased in RIC-pre group when compared with control group. Subgroup analysis revealed similar risk in clinical adverse events at long- and short-term follow-up between two groups. However, peak of creatine kinase-myocardial band (CK-MB) was reduced in RIC-pre group (SWD -0.42, 95% CI [-0.77, -0.07], P = 0.02, I2 = 34%). RIC-pre tended to a low peak of CK-MB in patients with STEMI undergoing PPCI, but lacked significant beneficial effects on improving clinical outcomes at long- and short-term follow-up.

Over-expansion of second-generation drug-eluting stents, risk of restenosis, and relation to major adverse cardiac events.

The relationship between stent expansion conditions and clinical outcomes is not completely understood. This prospective cohort study included patients who were successfully implanted with second-generation drug-eluting stent in 2012 and received follow-up angiography in 9-12 months. Stent over-expansion was defined as ≥ 1.05 of the stented segment over the reference artery diameter. Imaging parameters were measured, and the follow-up period was 7 years. A total of 123 patients with 161 lesions were enrolled, and 75 (46.58%) stents were found to be over-expanded. The baseline clinical and procedural data were comparable. Stent over-expansion showed a markedly increased diameter stenosis percentage (DSP) at 1-year follow-up (24.12 ± 21.10% vs. 14.65 ± 16.75%, P = 0.002) and high late lumen loss (LLL) in-segment (0.54 ± 0.62 mm vs. 0.31 ± 0.55 mm, P = 0.014). Furthermore, 63 patients with ≥ 1 over-expanded stented lesions were classified into the over-expansion group. Cumulative major cardiac adverse event (MACE) was higher in the over-expansion group than the norm-expansion group (17.5% vs. 8.3%, P = 0.133). Target lesion revascularization/target vessel revascularization increased during the 7-year follow-up period in the over-expansion group compared with the norm-expansion group (11.1% vs. 3.3%, P = 0.098). The Kaplan-Meier cumulative MACE-free survival showed a better tendency for statistical differences in the norm-expansion group than in the over-expansion group (log-rank test; P = 0.083). Conclusion: Stent over-expansion is associated with a significant increase in LLL and DSP at 1-year angiographic follow-up and with the increasing trend of cumulative MACE during 7-year clinical follow-up period compared with stent norm-expansion. Stent over-expansion needs to be avoided.

A direct comparison of 3 T contrast-enhanced whole-heart coronary cardiovascular magnetic resonance angiography to dual-source computed tomography angiography for detection of coronary artery stenosis: a single-center experience.

BACKGROUND: In recent years, substantial advances have been made in noninvasive cardiac imaging, including cardiac computed tomography (CT) and cardiovascular magnetic resonance (CMR). The purpose of this study was to prospectively compare the diagnostic performance of contrast-enhanced whole heart coronary CMR angiography (CCMRA) to dual-source coronary CT angiography (CCTA) for the diagnosis of significant coronary stenoses (≥50%) in patients with known or suspected coronary artery disease (CAD) referred for conventional x-ray coronary angiography. METHODS: Our objective was to directly compare the diagnostic accuracy of contrast-enhanced whole-heart CCMRA (CE-CCMRA) to dual-source CCTA (DS-CCTA) for the detection of CAD. We prospectively studied 57 symptomatic patients with suspected or known CAD who were scheduled for conventional x-ray coronary angiography. Significant CAD was defined as an x-ray defined diameter reduction of ≥50% in a coronary artery with a reference diameter of ≥1.5 mm. RESULTS: CE-CCMRA and DS-CCTA were completed in 51 (89%) of 57 patients without complications. The acquisition times of CE-CCMRA and DS-CCTA, respectively, were 9.5 ± 3.1 min and 8.3 ± 1.4 s. On patient-based analysis, the sensitivity, specificity, positive and negative predictive value of CE-CCMRA and DS-CCTA were 93.5% versus 93.5%(P > 0.05), 85% versus 90%(P > 0.05), 90.6% versus 93.5%(P > 0.05), and 89.4% versus 90%(P > 0.05), respectively. The area under the curve (AUC) was 0.89 (95% CI: 0.79 to 0.99) for CE-CCMRA and 0.92 (95% CI: 0.83 to 1.00) for DS-CCTA. CONCLUSIONS: DS-CCTA was found to be superior to CE-CCMRA in the diagnosis of significant coronary stenoses (≥50%) in patients with suspected or known CAD scheduled for conventional x-ray coronary angiography, owing to shorter scanning times and higher spatial resolution. However, CE-CCMRA and DS-CCTA have similar diagnostic accuracies.