The residual risk of inflammation and remnant cholesterol in acute coronary syndrome patients on statin treatment undergoing percutaneous coronary intervention.

BACKGROUND: Residual risk assessment for acute coronary syndrome (ACS) patients after sufficient medical management remains challenging. The usefulness of measuring high-sensitivity C-reactive protein (hsCRP) and remnant cholesterol (RC) in assessing the level of residual inflammation risk (RIR) and residual cholesterol risk (RCR) for risk stratification in these patients needs to be evaluated. METHODS: Patients admitted for ACS on statin treatment who underwent percutaneous coronary intervention (PCI) between March 2016 and March 2019 were enrolled in the analysis. The included patients were stratified based on the levels of hsCRP and RC during hospitalization. The primary outcome was ischemic events at 12 months, defined as a composite of cardiac death, myocardial infarction, or stroke. The secondary outcomes included 12-month all-cause death and cardiac death. RESULTS: Among the 5778 patients, the median hsCRP concentration was 2.60 mg/L and the median RC concentration was 24.98 mg/dL. The RIR was significantly associated with ischemic events (highest hsCRP tertile vs. lowest hsCRP tertile, adjusted hazard ratio [aHR]: 1.52, 95% confidence interval [CI]: 1.01-2.30, P = 0.046), cardiac death (aHR: 1.77, 95% CI:1.02-3.07, P = 0.0418) and all-cause death (aHR: 2.00, 95% CI: 1.24-3.24, P = 0.0048). The RCR was also significantly associated with these outcomes, with corresponding values for the highest tertile of RC were 1.81 (1.21-2.73, P = 0.0043), 2.76 (1.57-4.86, P = 0.0004), and 1.72 (1.09-2.73, P = 0.0208), respectively. The risks of ischemic events (aHR: 2.80, 95% CI: 1.75-4.49, P < 0.0001), cardiac death (aHR: 4.10, 95% CI: 2.18-7.70, P < 0.0001), and all-cause death (aHR: 3.00, 95% CI, 1.73-5.19, P < 0.0001) were significantly greater in patients with both RIR and RCR (highest hsCRP and RC tertile) than in patients with neither RIR nor RCR (lowest hsCRP and RC tertile). Notably, the RIR and RCR was associated with an increased risk of ischemic events especially in patients with adequate low-density lipoprotein cholesterol (LDL-C) control (LDL-C < 70 mg/dl) (Pinteraction=0.04). Furthermore, the RIR and RCR provide more accurate evaluations of risk in addition to the GRACE score in these patients [areas under the curve (AUC) for ischemic events: 0.64 vs. 0.66, P = 0.003]. CONCLUSION: Among ACS patients receiving contemporary statin treatment who underwent PCI, high risks of both residual inflammation and cholesterol, as assessed by hsCRP and RC, were strongly associated with increased risks of ischemic events, cardiac death, and all-cause death.

Application of Antithrombotic Drugs in Patients with Acute Type B Aortic Dissection Underwent Thoracic Endovascular Aortic Repair.

This study aimed to evaluate the safety and necessity of antithrombotic drugs for acute type B aortic dissection (TBAD) treated with thoracic endovascular aortic repair (TEVAR).The patients of acute TBAD treated with TEVAR were retrospectively enrolled from January 2007 to October 2022 in General Hospital of Northern Theater Command. The primary outcomes such as mortality and aortic adverse events [stroke, paraplegia, limb ischemia, organ failure (renal and intestinal tract), endoleak, redissection, aortic rupture, reintervention, and mortality] were recorded and evaluated at 1 month (early term) and 18 months (late term).The 697 patients of TBAD treated with TEVAR were divided into the antithrombotic (AT) group (n = 208) and nonantithrombotic (NAT) group (n = 489). The incidence of early mortality, early aortic adverse events, and the 18 months of cumulative freedom from all-cause mortality and aortic adverse events were not significantly different between the AT and NAT groups (2.4% versus 1.4%, 2.9% versus 4.5%, 94.7% versus 96.5% and 88.4% versus 89.9%, respectively). Log-rank tests also indicated that there were no significant differences. In multivariate Cox regression models, only pleural effusion, partially thrombosed of false lumen, maximum diameter of false lumen, and branch involvement were independent predictors of mortality, whereas the systolic blood pressure (SBP), pleural effusion, partially thrombosed of false lumen, true lumen compression, maximum diameter of false lumen, branch involvement were independent predictors of adverse aortic events.The antithrombotic drug for acute TBAD treated with TEVAR does not influence the mortality and aortic events in the early and late terms.

Three-year clinical outcomes of the novel sirolimus-eluting bioresorbable scaffold for the treatment of de novo coronary artery disease: A prospective patient-level pooled analysis of NeoVas trials.

OBJECTIVES: We aimed to evaluate the long-term outcomes of the novel NeoVas sirolimus-eluting bioresorbable scaffold (BRS) for the treatment of de novo coronary artery disease. BACKGROUND: The long-term safety and efficacy of the novel NeoVas BRS are still needed to be elucidated. METHODS: A total of 1103 patients with de novo native coronary lesions for coronary stenting were enrolled. The primary endpoint of target lesion failure (TLF) was defined as a composite of cardiac death (CD), target vessel myocardial infarction (TV-MI), or ischemia-driven-target lesion revascularization (ID-TLR). RESULTS: A three-year clinical follow-up period was available for 1,091 (98.9%) patients. The cumulative TLF rate was 7.2% with 0.8% for CD, 2.6% for TV-MI, and 5.1% for ID-TLR. Additionally, 128 (11.8%) patient-oriented composite endpoint and 11 definite/probable stent thromboses (1.0%) were recorded. CONCLUSIONS: The extended outcomes of the NeoVas objective performance criterion trial demonstrated a promising 3-year efficacy and safety of the NeoVas BRS in low-risk patients with low complexity in terms of lesions and comorbidities.

Safety and Efficacy of Ticagrelor versus Clopidogrel in East Asian Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention Treated with Dual Antiplatelet Therapy: A Meta-Analysis of Randomized Controlled Trials.

INTRODUCTION: The treatment strategy for dual antiplatelet therapy (DAPT) with ticagrelor has been controversial in East Asian patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). Our meta-analysis aimed to demonstrate whether intensified antithrombotic regimens with ticagrelor plus aspirin have more beneficial effects and fewer adverse events compared to those of clopidogrel plus aspirin in East Asian patients with ACS undergoing PCI. METHODS: We searched PubMed, Embase, Web of Science, ScienceDirect, Clinical Trials, Cochrane Library, and Chinese Clinical Trial Registry for randomized controlled trials (RCTs) comparing the efficacy of DAPT with ticagrelor or clopidogrel plus aspirin for secondary prevention of ACS in East Asian patients undergoing PCI. Risk ratios (RRs) and 95% confidence intervals (CIs) were used as the metrics of choice for assessing treatment effects. The primary endpoint was bleeding events, and the secondary endpoints were major adverse cardiovascular and cerebrovascular events (MACCEs, including cardiovascular death, nonfatal myocardial infarction [MI], and stroke), all-cause death, and definite/probable/possible stent thrombosis. The I2 index was used to assess heterogeneity. RESULTS: Six RCTs involving a total of 2,725 patients met the inclusion criteria. The incidence of all bleeding events with ticagrelor was higher than that with clopidogrel (RR, 1.65; 95% CI, 1.31-2.07), but the incidence of MACCE was not significantly different between the two groups (RR, 1.08; 95% CI, 0.54-2.16). All-cause death (RR, 1.10; 95% CI, 0.67-1.79), cardiovascular death (RR, 1.42; 95% CI, 0.68-2.98), nonfatal MI (RR, 0.92; 95% CI, 0.48-1.78), stroke (RR, 1.00; 95% CI, 0.40-2.50), and stent thrombosis (RR, 0.76; 95% CI, 0.19-2.98) were not statistically different between the two groups. CONCLUSION: Ticagrelor increased the risk of bleeding and did not increase treatment efficacy compared to that of clopidogrel in the East Asian population who have ACS treated with PCI.

Analysis of Short-Term Clinical Outcomes and Influencing Factors in Patients with Acute Type B Aortic Intramural Hematoma Treated with Optimal Medical Therapy.

This study aimed to investigate the short-term predictors of aortic-related adverse events in patients with acute type B aortic intramural hematoma (IMH) initially treated with optimized medical therapy.A total of 157 patients with acute type B IMH were included in this study. These patients were divided into worsening group (n = 45) and stable group (n = 112) based on the incidence of aortic-related adverse events. The clinical data and imaging features of the two groups were compared. Multivariate logistic regression analysis of predictors of aortic-related adverse events in type B IMH was performed. Receiver operating characteristic (ROC) curve was applied to determine the optimal cutoff value for maximum descending aorta diameter (MDAD). Kaplan-Meier survival curve was used to analyze the incidence of aortic-related adverse events.Worsening and stable groups were statistically significant in diuretics, abnormal D-dimer level, observation endpoint systolic blood pressure (SBP), MDAD, aortic atherosclerosis, ulcer-like projection (ULP), and thickness of hematoma (P < 0.05). Multivariate logistic regression showed that abnormal D-dimer level (OR = 12.464, P = 0.025), MDAD (OR = 1.113, P = 0.030), and ULP (OR = 5.849, P = 0.022) were powerful independent risk factors for predicting aortic-related adverse events in type B IMH, and observation endpoint SBP within 100-120 mmHg (OR = 0.225, P = 0.014) was a protective factor for predicting aortic-related adverse events in type B IMH. The cutoff value of MDAD was 35.2 mm.Short-term imaging is recommended for type B IMH patients with abnormal D-dimer level, MDAD > 35.2 mm, and ULP. Blood pressure should also be strictly monitored and controlled during the acute phase of IMH.

Rhythm of Acute Aortic Syndrome in Northeastern China.

Acute aortic syndromes (AAS) are a series of life-threatening conditions of the aorta. To improve predictability and prevention, we investigated the daily, weekly, monthly, and seasonal variations in the onset of AAS in Liaoning Province, Northeast China.We collected the clinical data of 1,197 patients treated for AAS at the General Hospital of Northern Theater Command between June 2002 and June 2021. Chi-square goodness-of-fit testing was used to determine whether AAS uniformly occurred.The average age was 54.93 ± 12.32 years, and 614 patients (51.29%) aged below or equal to 55 years. Nine-hundred-and-five patients (75.61%) were male. The proportions of patients comorbid with hypertension and diabetes were 80.37% and 4.09%, respectively. The peak time of the day for the onset of AAS was between 12:00 and 17:59 (P < 0.001). Furthermore, we found that patients with hypertension had obvious circadian rhythm. AAS had a weekly distribution (P = 0.032), with Sunday and Monday being two troughs. The incidence rate of AAS was low in warmer periods, such as July and August in summer (P < 0.001). The correlation analysis revealed a negative association between the incidence of AAS and the monthly average temperature (P < 0.05).Our results revealed that AAS displayed circadian and seasonal rhythms in northeast China. AAS peaked between 12:00 and 17:59. Patients with AAS with hypertension had obvious circadian rhythm. Summer was trough season for the onset of AAS. The incidence rate of AAS was negatively correlated with the monthly average temperature.

A Comparison of the Clinical Outcomes of Thoracic Endovascular Repair for Acute Type B Aortic Dissection with Multichanneled and Double-Channeled Morphology.

In this study, we aim to investigate the clinical features and outcomes of multichanneled aortic dissection (MCAD) and double-channeled aortic dissection (DCAD) in acute type B aortic dissection (TBAD) patients who underwent thoracic endovascular aortic repair (TEVAR).In total, 479 consecutive acute TBAD patients treated with TEVAR from April 2002 to May 2020 were retrospectively enrolled in this study. The MCAD group was defined as those of multichanneled morphology by initial computed tomography angiography (CTA) (n = 61), whereas the DCAD group was defined as those with double-channeled morphology by initial CTA (n = 418). The clinical and morphological characteristics and short-term and long-term adverse events (30-day and > 30 days) were recorded and evaluated.No significant differences were noted between the 2 groups as regards demographics, comorbidity profiles, or initial feature of CTA. The incidence of true lumen compression was found to be significantly lower in the MCAD group compared with the DCAD group (8.2% versus 20.8%, P < 0.05). During the 65.37 ± 40.06 months of follow-up, there were no statistically significant differences in terms of 30-day mortality or the incidence of early adverse events between the 2 groups. The incidence rates of 5-year cumulative freedom from all-cause mortality and 5-year cumulative freedom from AD-related mortality were not significantly different between the MCAD and DCAD groups, whereas the 5-year cumulative freedom from adverse events were lower in the MCAD group compared to DCAD group (51.1% versus 72.5%, P < 0.05). In multivariate Cox regression models, only age > 60 years, pleural effusion, branch involvement, and length of the stent were independent predictors of mortality, whereas age > 60 years, pulse, pleural effusion, true lumen compression, widest diameter of the descending aorta, branch involvement, and length of stent were independent predictors of adverse aortic events.No significant difference was noted between the MCAD and DCAD groups in the 5-year mortality following, whereas patients with MCAD were found to have significantly lower AD-related events than patients with DCAD in long-term follow-up.

Impact of extended dual antiplatelet therapy on long-term prognosis in patients with acute coronary syndrome complicated with anemia: A sub-analysis of the real-world OPT-CAD study.

OBJECTIVES: To evaluate the impact of extended dual antiplatelet therapy (DAPT) beyond 12 months on long-term prognosis in acute coronary syndrome (ACS) patients complicated with anemia undergoing percutaneous coronary intervention (PCI). BACKGROUND: Anemia is frequent among ACS patients and is associated with increased risk of adverse clinical outcomes. METHODS: A total of 6,953 patients were enrolled from the Optimal anti Platelet Therapy for Chinese patients with Coronary Artery Disease (OPT-CAD) study. A landmark analysis comparing extended DAPT versus single antiplatelet therapy (SAPT) at 12-24 months were performed in anemia patients without premature discontinuation of DAPT before 9 months and major clinical adverse events within 12 months. The primary outcome was major adverse cardiovascular and cerebrovascular events (MACCE), defined as a composite of all-cause death, myocardial infarction, and stroke. RESULTS: Patients with anemia (n = 1,728) had higher rates of MACCE, all-cause mortality, and BARC type 2, 3, 5 bleeding (p < .05) compared to those without anemia (n = 5,225). Anemia patients received extended DAPT (n = 1,010) were associated with a lower risk of stroke (0.3% vs. 1.8%; HR, 0.14; 95% CI, 0.03-0.71; p = .018) compared to those received SAPT (n = 342). The rates of MACCE and all revascularization were lower in patients with extended DAPT, but the differences were not statistically significant. Risk of all-cause mortality and bleeding were comparable between the two groups. CONCLUSIONS: Extended DAPT beyond 12 months may reduce the incidence of stroke without increasing the risk of bleeding in anemic ACS patients who tolerate 12-month DAPT.

Clinical significance of glycated hemoglobin in acute coronary syndrome patients from the CCC-ACS project : Findings from a multicenter retrospective observational study.

BACKGROUND: Blood glucose levels are associated with the prognosis of patients with acute coronary syndrome (ACS). Glycated hemoglobin (HbA1c) reflects the average blood glucose level. The purpose of the study was to evaluate HbA1c as a prognostic indicator for ACS. METHODS: In total, 27,337 ACS patients from the CCC-ACS (Improving Care for Cardiovascular Disease in China - Acute Coronary Syndrome) project were enrolled in this study and divided into three groups according to HbA1c level: Group I, HbA1c level <5.7%; Group II, HbA1c level 5.7-6.4%; Group III, HbA1c level ≥6.5%. The primary outcome was an in-hospital major adverse cardiovascular event (MACE), such as all-cause death, recurrent myocardial infarction, acute or subacute stent thrombosis, heart failure, cardiogenic shock, or cardiac arrest. Baseline data and effectiveness outcome were compared among patients in the three groups. RESULTS: Group III had the highest MACE incidence (13.4% [Group III] vs. 8.7% [Group I] and 10.5% [Group II], p < 0.001). In the logistic regression, there was a statistically significant difference in HbA1c level between the groups (odds ratio [OR]: 1.110, 95% confidence interval [CI]: 1.008-1.133, p < 0.001). In the receiver operating characteristic curve, the area under the curve for MACE was 0.560 (95% CI: 0.550-0.571, p < 0.001); the cut-off value for the HbA1c level was 6.38%. CONCLUSION: The HbA1c level was associated with the risk of MACEs in ACS patients with or without diabetes. Trial Registration clinicaltrials.gov, NCT02306616. Registered 3 December 2014-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02306616 .

Long noncoding RNA PR11-387H17.6 as a potential novel diagnostic biomarker of atherosclerotic renal artery stenosis.

BACKGROUND: Atherosclerotic renal artery stenosis (ARAS) is frequently related to ischemic nephropathy, secondary hypertension, and end-stage renal failure. Thus, this study aimed to explore whether certain circulating long noncoding RNAs (lncRNAs) may be used as potential specific ARAS biomarkers. METHODS: In the present study, a microarray analysis was performed to screen for lncRNAs in renal artery tissue from four ARAS patients and four non-ARAS individuals. To identify specific lncRNAs as candidate potential biomarkers of ARAS, we used the following criteria: the fold change was set to >3.0 (compared with non-ARAS tissues), and p value cutoff was set at .05. According to these criteria, six lncRNAs were identified from 1150 lncRNAs. After validation by quantitative PCR (qPCR), these lncRNAs were independently validated in blood from groups of 18 ARAS patients, 18 non-ARAS individuals, and 18 healthy volunteers, furthermore, the predictive value of lncRNA PR11-387H17.6 was further assessed using blood from groups of 99 ARAS patients, 49 non-ARAS individuals, and 50 healthy volunteers. A receiver operating characteristic (ROC) curve analysis was performed to assess the performance of these lncRNAs as biomarkers. RESULTS: In the ROC analysis, the area under the curve (AUC) of PR11-387H17.6 was 0.733, with 52.5% sensitivity and 84.8% specificity in predicting the occurrence of ARAS. After considering the risk factors, the AUC of PR11-387H17.6 was 0.844, and the optimal sensitivity increased from 52.5% to 74.5%, although the specificity decreased from 84.8% to 81.9%. In the multivariable logistic analysis, PR11-387H17.6 was an independent predictor of major adverse events (OR: 3.039; 95% CI: 1.388-6.654; p= .006). CONCLUSIONS: PR11-387H17.6 is a potential diagnostic biomarker of ARAS. The lncRNA levels in blood cells are regulated in ARAS. Thus, further investigations of the role of lncRNAs in ARAS are warranted.

Extended antiplatelet therapy with clopidogrel alone versus clopidogrel plus aspirin after completion of 9- to 12-month dual antiplatelet therapy for acute coronary syndrome patients with both high bleeding and ischemic risk. Rationale and design of the OPT-BIRISK double-blinded, placebo-controlled randomized trial.

BACKGROUND: Dual antiplatelet therapy with aspirin and a P2Y12 inhibitor is the cornerstone for prevention ischemic events in patients with acute coronary syndromes (ACS) and undergoing percutaneous coronary intervention. However, the optimal antiplatelet strategy for ACS patients with both high bleeding and high ischemic risks is unclear. STUDY DESIGN: The OPT-BIRISK trial is a multicenter, double-blinded, placebo-controlled randomized study designed to test the superiority of extended antiplatelet therapy with clopidogrel monotherapy compared with aspirin and clopidogrel for reduction of bleeding events in ACS patients with both high bleeding and high ischemic risks ("bi-risk"). A total of 7,700 patients who completed 9- to 12-month dual antiplatelet therapy after new-generation drug-eluting stent implantation for the treatment of ACS will be randomized to receive clopidogrel monotherapy or aspirin plus clopidogrel for 9 months followed by aspirin monotherapy for 3 months. The primary end point is Bleeding Academic Research Consortium type 2, 3, or 5 bleedings at 9 months after randomization. The key secondary end point is major adverse cardiac and cerebral events at 9 months after randomization, defined as a composite of all-cause death, myocardial infarction, stroke, or coronary artery revascularization. CONCLUSIONS: OPT-BIRISK is the first large-scale randomized trial aimed to explore the optimal antiplatelet strategy for bi-risk ACS patients after percutaneous coronary intervention in current clinical practice. The results will add evidence regarding de-escalation antiplatelet therapy for patients at special risk.

Optimal antiplatelet therapy for prevention of gastrointestinal injury evaluated by ANKON magnetically controlled capsule endoscopy: Rationale and design of the OPT-PEACE trial.

BACKGROUND: Gastrointestinal injury is a common complication in patients treated with antiplatelet agents after percutaneous coronary intervention (PCI). However, the effects of different antiplatelet regimens on the incidence and severity of gastrointestinal injury have not been well studied, principally due to the lack of a low-risk sensitive and accurate detection system. TRIAL DESIGN: OPT-PEACE is a multicenter, randomized, double-blind, placebo-controlled trial. Gastrointestinal injury will be evaluated with the ANKON magnetically controlled capsule endoscopy system (AMCE), a minimally invasive approach for detecting mucosal lesions in the stomach, duodenum and small intestine. Patients without AMCE-detected gastrointestinal erosions, ulceration or bleeding after drug-eluting stent implantation are enrolled and treated with open-label aspirin (100 mg/d) plus clopidogrel (75 mg/d) for 6 months. Thereafter, 480 event-free patients will undergo repeat AMCE and are randomly assigned in a 1:1:1 ratio to receive aspirin plus clopidogrel, aspirin plus placebo or clopidogrel plus placebo for an additional 6 months. A final AMCE is performed at 12 months. The primary endpoint is the incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding) within 12 months after enrollment. CONCLUSIONS: OPT-PEACE is the first study to investigate the incidence and severity of gastrointestinal injury in patients receiving different antiplatelet therapy regimens after stent implantation. This trial will inform clinical decision-making for personalized antiplatelet therapy post-PCI.

Impact of dual antiplatelet therapy duration on 1-year clinical outcomes in diabetic patients with acute coronary syndrome undergoing percutaneous coronary intervention: Insights from the real-world OPT-CAD study.

OBJECTIVES: To investigate the optimal dual antiplatelet therapy (DAPT) duration for diabetic patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI). BACKGROUND: Diabetic patients are at high risk for ischemic and bleeding events when treated with antithrombotic agents after an ACS episode. METHODS: This post hoc study analyzed DAPT duration and clinical outcomes in diabetic patients with ACS who underwent PCI in the Optimal antiPlatelet Therapy for Chinese patients with Coronary Artery Disease (OPT-CAD) registry. The primary outcome was patient-oriented composite endpoints (PoCE) at 12 months; it was defined as a composite of all-cause mortality, all myocardial infarction (MI), stroke, or any revascularization. The safety outcome was bleeding events. RESULTS: In total, 1,773 diabetic patients with ACS were enrolled and treated with PCI in the OPT-CAD study. Premature DAPT discontinuation before 12 months was an independent PoCE predictor in diabetic patients (hazard ratio = 1.33, 95% confidence interval: 1.02-1.74, p = .006). It was associated with a significantly higher risk of PoCE (17.3 vs. 11.2%, p = .014) in diabetic patients with high risk factors (age ≥ 65 years or history of cardiovascular events including MI, stroke, or peripheral artery disease), but this association was not observed in those without high risk factors (10.4 vs. 9.1, p = .554). No excess bleeding risk was found in patients who received 12-month DAPT compared with those who discontinued DAPT prematurely. CONCLUSIONS: Premature DAPT discontinuation before 12 months was associated with increased risk of clinical events in diabetic patients with ACS after PCI, particularly in those with high-risk profiles.

Safety and efficacy of the novel sirolimus-eluting bioresorbable scaffold for the treatment of de novo coronary artery disease: One-year results from a prospective patient-level pooled analysis of NeoVas trials.

OBJECTIVES: This prospective, patient-level analysis assessed the safety and efficacy of NeoVas sirolimus-eluting bioresorbable scaffold (BRS) in patients with coronary lesions. Furthermore, to meet China Food and Drug Administration requirements, we conducted an objective performance criterion study by pooling all patients implanted with the NeoVas BRS in a previous randomized controlled trial (RCT) and registry trial. BACKGROUND: Drug-eluting stent-related permanent vessel caging by metallic struts may lead to several complications associated with percutaneous coronary intervention. BRSs reportedly result in more stent thromboses (ST) in comparison to everolimus-eluting stents. The NeoVas (Lepu Medical, Beijing, China) is a novel sirolimus-eluting poly-l-lactic acid (PLLA)-based BRS whose safety and efficacy remains to be fully elucidated. METHODS: Patient-level data derived from 1,103 patients with de novo native coronary lesions in the NeoVas RCT (n = 278) and NeoVas registry (n = 825) were prospectively collected, pooled, and analyzed. The primary outcome was 12-month target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven-target lesion revascularization. The patient-oriented composite endpoint (PoCE) of all-cause death, all MI, or any revascularization was also analyzed. RESULTS: The 12-month rate of TLF in 1,103 patients (follow-up rate, 99.8%) was 3.0%, significantly lower than the performance goal of 8.5% (P < 0.0001). Furthermore, 50 (5.4%) PoCEs and five definite/probable ST (0.5%) were recorded. CONCLUSIONS: This pooled, patient-level analysis indicates that the NeoVas BRS has promising 1-year efficacy and safety profiles.

Efficacy and safety of oral Guanxinshutong capsules in patients with stable angina pectoris in China: a prospective, multicenter, double-blind, placebo-controlled, randomized clinical trial.

BACKGROUND: To assess the efficacy and safety of oral Guanxinshutong (GXST) capsules in Chinese patients with stable angina pectoris (SAP) in a prospective, multicenter, double-Blind, placebo-controlled, randomized clinical trial (clinicaltrials.gov Identifier: NCT02280850). METHODS: Eligible patients were randomized 1:1 to the GXST or placebo group. Current standard antianginal treatment except for nitrate drugs was continued in both groups, who received an additional 4-week treatment of GXST capsule or placebo. Primary endpoint was the change from baseline in angina attack frequency after the 4-week treatment. Secondary endpoints included the reduction of nitroglycerin dose, score of Seatntle Agina Questionnaire, exercise tolerance test defined as time to onset of chest pain and ST-segment depression at least 1 mm greater than the resting one. RESULTS: A total of 300 SAP patients from 12 centers in China were enrolled between January 2013 and October 2015, and they were randomly divided into the GXST group and the placebo group (150 patients in each group). Of whom, 287 patients completed the study (143 patients in the GXST group, 144 patients in the placebo group). The baseline characteristics of the two groups were comparable. After 4-week treatment with GXST capsules, the number of angina attacks and the consumption of short-acting nitrates were significantly reduced. In addition, the quality of life of patients were also substantially improved in the GXST group. No significant differences in the time of onset of angina and 1-mm ST segment depression were noted between the two groups. 7 patients (4.1%) in the GXST group and 3 patients (2.1%) in the placebo group reported at least one adverse event, respectively. CONCLUSIONS: GXST capsules are beneficial for the treatment of SAP patients.

One-year clinical outcomes and multislice computed tomography angiographic results following implantation of the NeoVas bioresorbable sirolimus-eluting scaffold in patients with single de novo coronary artery lesions.

BACKGROUND: Tremendous efforts have been made to establish the concept of vascular restoration therapy with a fully bioresorbable scaffold for coronary artery disease. With an improved scaffold design and technologies, the novel NeoVas scaffold has shown promising clinical performance at 6 months follow-up. OBJECTIVE: The aim of this study was to investigate the 1 year clinical outcomes and multislice computed tomography (MSCT) angiographic results after implantation of the NeoVas scaffold in patients with single de novo coronary artery lesions. METHODS: The NeoVas first-in-man study was a prospective, two-center, single-arm study enrolling 31 patients who were eligible for the treatment. The composite endpoint of target lesion failure (TLF)-defined as cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization (TLR)-was assessed. Of the 31 patients scheduled for 1 year clinical follow-up, 29 patients received MSCT examinations. RESULTS: At 1 year follow-up, there was only 1 (3.2%) TLF, attributed to 1 patient who suffered ischemia-driven TLR at 181 days postprocedure. No cardiac deaths or scaffold thrombosis were observed. MSCT analysis demonstrated excellent vessel patency, with a median in-scaffold lumen area of 10.6 mm2 (interquartile range [IQR]: 8.2-11.7 mm2 ) and a minimal lumen diameter of 2.7 mm (IQR: 2.4-3.0 mm). CONCLUSIONS: This study demonstrated the safety and efficacy of the NeoVas scaffold for patients with single de novo coronary artery lesions at 1 year of follow-up. Noninvasive MSCT data confirmed vessel patency and the maintenance of vessel dimensions following implantation of the NeoVas bioresorbable sirolimus-eluting scaffold.

Prognostic value of the age, creatinine, and ejection fraction score for non-infarct-related chronic total occlusion revascularization after primary percutaneous intervention in acute ST-elevation myocardial infarction patients: A retrospective study.

OBJECTIVE: It is not known if ACEF scores could evaluate the prognosis of recanalization of non-infarct-related coronary arteries (non-IRA) with chronic total occlusions (CTO) in patients who successfully underwent primary PCI. The objective of the current study was to assess the prognostic value of ACEF scores in acute ST-segment elevation myocardial infarction (STEMI) patients with non-IRA CTO after successful primary PCI. METHODS: There were 2952 STEMI patients who underwent successful primary PCI from January 2006 to December 2014 in our hospital, among them 377 patients had a non-IRA CTO lesion. The patients were divided into successful CTO-PCI group (n = 221) and failed/non-attempted CTO-PCI group (n = 156). Patients were stratified based on the ACEF tertiles. Primary end points measured in the current study were major adverse cardiac events (MACE) defined as the composite of all-cause death, nonfatal myocardial infarction, ischemia-driven coronary revascularization and hospitalization for heart failure at 1 year. RESULTS: The incidence of MACE, all-cause death and cardiac death were higher in the failed/non-attempted CTO-PCI group (P < 0.001). In the successful CTO-PCI group, the cumulative 1-year incidences of MACE and all-cause death were decreased compared to those in the failed/non-attempted CTO-PCI group (log-rank P < 0.001). The risk for MACE was reduced in the successful CTO-PCI group compared to the failed/non-attempted CTO-PCI group in patients with low and intermediate ACEF scores (log-rank P = 0.02). CONCLUSIONS: Successfully staged CTO-PCI could gain advantageous clinical outcomes in those patients with low or intermediate ACEF scores.

Influence of distal extension of false lumen on adverse aortic events after TEVAR in patients with acute type B aortic dissection.

OBJECTIVE: To investigate the clinical outcomes influenced by distal extension of false lumen in acute type B aortic dissection (TBAD) patients following thoracic endovascular aortic repair (TEVAR). METHODS: From April 2002 to January 2013, 264 TBAD patients treated with TEVAR were retrospectively enrolled. The IIIa group exhibited a distal false lumen above the diaphragm (n = 70), and the IIIb group exhibited a distal false lumen under the diaphragm (n = 194). The morphological characteristics and adverse events (30-day and >30 days) were recorded and evaluated. RESULTS: There were no significant differences between the two groups regarding the demographics, comorbidity profiles, or initial feature of computed tomography angiography. The incidence of true lumen compression and branch involvement were significantly increased in the IIIb group compared with the IIIa group (8.6% vs. 25.3%, respectively; 15.7% vs. 36.1%, respectively, both P < 0.05). The 30-day mortality rate was 1.0% (2/194) in the IIIb group, whereas the IIIa group was zero. The incidence of early adverse events, the 5-year cumulative freedom from adverse events, and the 5-year cumulative freedom from all-cause mortality rate were not significantly different between the IIIa and IIIb groups (2.9% vs. 6.7%, 81.4%, and 80.4%, and 95.7% vs. 93.8%, respectively, all P > 0.05). Log-rank tests also indicated there was no significant difference. CONCLUSIONS: There was no significant difference between the IIIa and IIIb groups in the 5-year morality and adverse aortic events following TEVAR. The distal extension of false lumen prior to TEVAR does not influence the long-term morality and adverse aortic events in acute TBAD.

First-in-man study evaluating the safety and efficacy of a second generation biodegradable polymer sirolimus-eluting stent in the treatment of patients with de novo coronary lesions: clinical, Angiographic, and OCT outcomes of CREDIT-1.

OBJECTIVE: To evaluate the preliminary safety and efficacy of the EXCEL II stent system. BACKGROUND: Although the first biodegradable polymer drug-eluting stent (BP-DES), EXCEL, was launched nearly a decade ago, in-stent restenosis and stent thrombosis remain pertinent clinical problems in practice. A new cobalt-chromium BP-DES EXCEL II has been developed with the aim of improving stent safety and efficacy. METHODS: Forty-five patients with single de novo native coronary lesions were enrolled and randomized to two groups in a 2:1 ratio, the 4-month follow-up group (n = 30) and the 12-month follow-up group (n = 15). All patients underwent percutaneous coronary intervention (PCI) with the EXCEL II stent system. Quantitative coronary angiography (QCA) and optical coherence tomography (OCT) were used to assess coronary vasculature at the designated 4- or 12-month follow-up. The primary outcome was major adverse cardiac events (MACE) at 30 days post-PCI. RESULTS: No MACE, thrombotic events, or target lesion failure was found in the 45 patients during the 12-month follow-up. There was no significant difference (P > 0.05) between the two groups in terms of in-stent and in-segment late lumen loss (LLL). No in-stent and in-segment restenosis was found in either group. At follow-up, the ratio of >10% uncovered struts per lesion was 26.67% in the 4-month group and 0% in the 12-month group (P < 0.05). Neointimal coverage in the 12-month group was significantly better than in the 4-month group (98.58% vs. 93.51%, P < 0.01). CONCLUSIONS: This first-in-man study demonstrates promising feasibility, safety, and efficacy of EXCEL II stents. These stents were found to have rapid endothelialization and low LLL rates at 4 and 12 months after implantation.

Dual antiplatelet therapy over 6 months increases the risk of bleeding after biodegradable polymer-coated sirolimus eluting stents implantation: insights from the CREATE study.

BACKGROUND: The optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation remains controversial. The primary aim of our study was to evaluate the impact of optimal DAPT duration on bleeding events between 6 and 12 months after biodegradable polymer-coated DES implantation. The secondary aim is to determine the predictors and prognostic implications of bleeding. METHODS: This study is a post hoc analysis of the Multi-Center Registry of EXCEL Biodegradable Polymer Drug Eluting Stents (CREATE) study population. A total of 2,040 patients surviving at 6 months were studied, including 1,639 (80.3%) who had received 6-month DAPT and 401 (19.7%) who had received DAPT greater than 6 months. Bleeding events were defined according to the bleeding academic research consortium (BARC) definitions as described previously and were classified as major/minor (BARC 2-5) and minimal (BARC 1). A left censored method with a landmark at 6 months was used to determine the incidence, predictors, and impact of bleeding on clinical prognosis between 6 and 12 months. RESULTS: At 1-year follow-up, patients who received prolonged DAPT longer than 6 months had a significantly higher incidence of overall (3.0% vs. 5.5%, P = 0.021) and major/minor bleeding (1.1% vs. 2.5%, P = 0.050) compared to the patients who received 6-month DAPT. Multivariate analysis showed that being elderly (OR = 1.882, 95% CI: 1.109-3.193, P = 0.019), having diabetes (OR = 1.735, 95% CI: 1.020-2.952, P = 0.042), having a history of coronary artery disease (OR = 2.163, 95% CI: 1.097-4.266, P = 0.026), and duration of DAPT longer than 6 months (OR = 1.814, 95% CI: 1.064-3.091, P = 0.029) were independent predictors of bleeding. Patients with bleeding events had a significantly higher incidence of cardiac death, myocardial infarction, target lesion revascularization, and stent thrombosis. CONCLUSIONS: Prolonged DAPT (greater than 6 months) after biodegradable polymer-coated DES increases the risk of bleeding, and is associated with adverse cardiac events at 1-year follow-up. (J Interven Cardiol 2014;27:119-126).