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.

Rivaroxaban in patients with abdominal aortic aneurysm and high-sensitivity C-reactive protein elevation (BANBOO): study protocol for a randomized, controlled trial.

BACKGROUND: Abdominal aortic aneurysm (AAA) is a fatal disease due to the tendency to rupture. The drug treatment for small AAA without surgical indications has been controversial. Previous studies showed that high-sensitivity C-reactive protein (hs-CRP) had become a potential biomarker of the disease, and the anti-inflammatory effect of rivaroxaban for AAA had been well established. Thus, we hypothesized that rivaroxaban could control the progression of AAA in patients with hs-CRP elevation. METHODS: The study is a prospective, open-label, randomized, controlled clinical trial. Sixty subjects are recruited from the General Hospital of Northern Theatre Command of China. Subjects are randomly assigned (1:1) to the intervention arm (rivaroxaban) or control arm (aspirin). The primary efficacy outcome is the level of serum hs-CRP at 6 months. The secondary outcomes include imaging examination (the maximal diameter of AAA, the maximal thickness of mural thrombus, and the length of aneurysm), major adverse cardiovascular and cerebrovascular events (MACCE, including AAA transformation, non-fatal myocardial infarction, acute congestive heart failure, stent thrombosis, ischemia-driven target vessel revascularization, vascular amputation, stroke, cardiovascular death, and all-cause death), and other laboratory tests (troponin T, interleukin 6, D-dimer, and coagulation function). DISCUSSION: The BANBOO trial tested the effect of rivaroxaban on the progression of AAA in patients with elevated Hs-CRP for the first time. TRIAL REGISTRATION: ChiCTR2100051990, ClinicalTrials.gov, registered on 12 October 2021.

Comparison of population characteristics and clinical outcomes of patients with type B aortic dissection or aortic intramural hematoma underwent thoracic endovascular aortic repair: a propensity score-matched analysis.

BACKGROUNDS: Survival and aortic-related adverse events after thoracic endovascular aortic repair (TEVAR) for aortic intramural hematoma (IMH) and aortic dissection (AD) are controversial. We aimed to assess the preoperative characteristics and to evaluate TEVAR outcomes of acute type B IMH and AD. METHODS: Between June 2002 and May 2021, 83 patients with acute type B IMH and 755 patients with acute type B AD underwent TEVAR at the General Hospital of Northern Theater Command. We retrospectively analyzed data from these patients, including clinical characteristics and follow-up outcomes. RESULTS: The patients with IMH were significantly older than the ones with AD (P < 0.001). Diabetes mellitus (P = 0.035) and ischemic cerebrovascular disease (P = 0.017) were more common in the IMH group than in the AD group. The results demonstrated a less long-term aortic-related death-free survival rate in the IMH group than the AD group for all the patients (P = 0.014) and the matched patients (P = 0.027). It also presents a lower long-term overall survival rate (P = 0.047) and aortic-related event-free rate (P = 0.048) in the IMH group than in the matched patients. CONCLUSIONS: Compared with AD patients, patients with IMH who underwent TEVAR had a worse long-term outcome of aortic-related survival in all and matched patients.

Efficacy and safety of rivaroxaban plus clopidogrel versus aspirin plus clopidogrel in patients with coronary atherosclerotic heart disease and gastrointestinal disease undergoing percutaneous coronary intervention: study protocol for a non-inferiority randomized controlled trial.

BACKGROUND: Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is recommended for patients with coronary heart disease (CHD) undergoing percutaneous coronary intervention (PCI) to antithrombosis, meanwhile, increasing the risks of gastrointestinal bleeding. Rivaroxaban, a novel oral anticoagulant, combined with a P2Y12 receptor inhibitor reduces adverse events in patients with CHD and atrial fibrillation who underwent PCI. The effect of rivaroxaban plus P2Y12 inhibitor on reducing bleeding events in patients with CHD and gastrointestinal disease (GID) undergoing PCI remains unclear. METHOD: The study is a prospective, single-center, randomized controlled trial. A total of 1020 patients with CHD and GID undergoing PCI will be enrolled. Patients are randomized (1:1) to receive either rivaroxaban 10 mg plus clopidogrel 75 mg daily or aspirin 100 mg plus clopidogrel 75 mg daily; both treatments will last 6 months. The primary endpoint is Bleeding Academic Research Consortium (BARC) type 2-5 bleeding requiring medical intervention. The secondary endpoint is a composite of major adverse cardiovascular and cerebrovascular events (MACCE), including all-cause death, cardiac death, nonfatal myocardial infarction, stent thrombosis, ischemia-driven target vessel revascularization, and stroke. DISCUSSION: The objective of this study is to evaluate the efficacy and safety of rivaroxaban plus clopidogrel versus aspirin plus clopidogrel in patients with CHD and GID undergoing PCI. We aim to explore an optimized antithrombotic strategy, which achieves the same anti-ischemic effect as standard DAPT without increasing the risk of GIB, for patients with CHD and GID undergoing PCI. TRIAL REGISTRATION: This protocol is registered at the Chinese Clinical Trial Registry under the number ChiCTR2100044319. And this publication is based on version 1.4 of the trial protocol dated Sep 6, 2021.

Thoracic Endovascular Aortic Repair versus Optimal Medical Treatment in Patients with Type B Intramural Hematoma: A Meta-Analysis.

PURPOSE: We intended to study the effect of thoracic endovascular aortic repair (TEVAR) and optimal medical treatment (OMT) on type B intramural hematoma (BIMH). METHODS: We searched PubMed, EMbase, Cochrane Library, and China National Knowledge Infrastructure databases that compared TEVAR and OMT in patients with BIMH. Two authors independently assessed the risk of bias using the Newcastle-Ottawa Scale. The rate ratio (RR) and 95% confidence interval were used to calculate the outcome. The primary endpoints were aortic-related death and regression/resolution. Secondary endpoints were all-cause death, progression to dissection, and secondary intervention. RESULTS: Eight observational studies were included in the analysis. TEVAR reduced aortic-related death (RR 0.22, 95% CI 0.08-0.56, P = 0.002, I² = 24%) and promoted hematoma regression/resolution (RR 1.48, 95% CI 1.05-2.10, P <0.05, I² = 71%) compared to OMT. Moreover, TEVAR was associated with a reduction in progression to dissection (RR 0.32, 95% CI 0.13-0.81, P <0.02, I² = 39%) and secondary intervention (RR 0.18, 95% CI 0.09-0.37, P <0.00001, I² = 38%) compared to OMT. However, all-cause death has no significant difference between the two groups (RR 0.45, 95% CI 0.17-1.19, P = 0.11, I² = 58%). CONCLUSIONS: The results of this meta-analysis suggested that TEVAR is an effective treatment for BIMH, which can delay the progression of intramural hematoma and promotes regression/resolution. More research about indications of TEVAR is still needed.

Safety of Left Subclavian Artery Selective Coverage without Revascularization in Thoracic Endovascular Aortic Repair for Type B Aortic Dissections.

PURPOSE: Whether to proceed left subclavian artery (LSA) revascularization in patients with LSA coverage due to insufficient proximal landing zone (PLZ) during thoracic endovascular aortic repair (TEVAR) remains controversial. METHODS: A total of 903 patients who received TEVAR were retrospectively analyzed. LSA could be covered if the PLZ was less than 15 mm accompanied with 1) a dominant or balanced right vertebral artery, 2) a complete circle of Willis, and 3) a left vertebral artery with a diameter ≥3 mm and without severe stenosis. RESULTS: LSA selective coverage was necessary for 35.0% (316/903) of the patients to extend the PLZ. Patients presented with weakness, pain, cooling and discoloration of the left upper extremity (LUE), and pulselessness of the left brachial artery were more in the LSA-covered group. The ischemia of LUE occurred more often in patients with LSA covered completely than in those with LSA covered partially. Functional arm status showed no significant difference in the arm, shoulder, and hand questionnaire scores at 12 months postoperative between the LSA-covered group and LSA-uncovered group, or between the LSA-covered completely group and LSA-covered partially group. CONCLUSION: It was safe to cover the LSA origin without revascularization if the PLZ was less than 15 mm accompanied with careful evaluation (description in method).

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.

Efficacy and Safety of the Reduced Bivalirudin in Patients Undergoing Coronary Angiography or Percutaneous Coronary Intervention Stratified by Renal Function (REDUCE BOLUS): A Single-Blind, Stratified Randomized, Non-inferiority Trial.

Background: In clinical practice, some cases indicated that the loading dose of bivalirudin increased the bleeding risk, particularly in patients with renal insufficiency. Therefore, this study aimed to assess the efficacy and safety of the low-dose (80%) bolus injection of bivalirudin in patients undergoing cardiac catheterization stratified by renal function. Methods: A total of 204 individuals in the REDUCE BOLUS trial were stratified 1:1 to the estimated glomerular filtration rate (eGFR) ≥ 60 ml/min cohort or eGFR < 60 ml/min cohort, then randomized 1:1 to the reduced bolus bivalirudin group (i.e., the experimental group) or normal bolus bivalirudin group (i.e., the control group), respectively. The primary end point was to compare the differences of the area under the curve of activated clotting time (ACT) between the two groups. The secondary end points were the postoperative net adverse clinical events (NACEs) before discharge, defined as the all-cause mortality, recurrent myocardial infarction, ischemia-driven target vessel revascularization, stroke, and bleeding events. Results: Between January 3, 2020, and March 26, 2021, 204 patients undergoing coronary angiography were randomly assigned, including 102 (i.e., 51 in the control group and 51 in the experimental group) with normal eGFR and 102 (i.e., 51 control and 51 experimental) with abnormal eGFR. No difference was observed in the curve of ACT between the control group and the experimental group (0.55 ± 0.09 vs. 0.56 ± 0.08, P = 0.542 and 0.55 ± 0.06 vs. 0.57 ± 0.05, P = 0.075, respectively, for normal eGFR cohort and abnormal eGFR cohort). The one-sided 97.5% lower confidence bound for the difference in the area under the ACT curve was -0.017 and 0.0015 in eGFR ≥ 60 ml/min and eGFR<60 ml/min cohort, respectively, both above the preset non-inferiority criterion of -0.07, establishing the non-inferiority. There was no incidence of NACE and stent thrombosis before discharge in each group. Conclusion: In patients undergoing cardiac catheterization, the efficacy and safety of the reduced bolus of bivalirudin were non-inferior to the normal one, even in patients without chronic kidney disease. Clinical Trial Registration: [www.ClinicalTrials.gov], identifier [NCT03588611].

Optimal strategy of switching from clopidogrel to ticagrelor in Chinese acute coronary syndrome patients with complicated coronary artery disease: the switching from clopidogrel to ticagrelor (SHIFT-CACS) study.

BACKGROUND: The dose and time point for switching from clopidogrel to ticagrelor remain controversial, especially for Chinese acute coronary syndrome (ACS) patients with complicated coronary artery disease (CAD). Hence, the purpose of this study was to further explore the optimal dose and time point for the switching strategy to balance the increase in platelet inhibition and the decrease in adverse events in Chinese ACS patients with complicated CAD managed by percutaneous coronary intervention (PCI). METHODS: From July 2017 to December 2017, the prospective, randomized, open-label study (the SwitcHIng from clopidogrel to ticagrelor study) assigned the eligible Chinese ACS patients with complicated CAD managed by PCI (n = 102) for 90 mg of ticagrelor at 12 h (T-90 mg-12 h), 90 mg of ticagrelor at 24 h (T-90 mg-24h) or 180 mg ticagrelor at 24 h (T-180 mg-24 h) after the last dose of clopidogrel. The primary endpoint was the comparison of maximal platelet aggregation (MPA) values at 2 h after switching strategies among the three groups. In addition, the MPA values at baseline, 8 h and before discharge and the rates of high on-treatment platelet reactivity were evaluated, the incidences of bleeding episodes and dyspnea during hospitalization and at 30-day follow-up in our study were also recorded. The MPA was measured by light transmittance aggregometry in our study. A repeated-measures analysis of variance (ANOVA) model and one-way ANOVA were used to compare data for the primary endpoint. RESULTS: The MPA values were significantly decreased in the T-180 mg-24 h group compared with the T-90 mg-12 h group (P = 0.017) and decreased numerically compared with the T-90 mg-24 h group (P = 0.072) at 2 h. In particular, the MPA values were markedly reduced in the T-90 mg-24 h group compared with the T-90 mg-12 h group at 8 h after switching treatment (P = 0.002). There was no significant difference among the three groups in all bleedings and dyspnea events. CONCLUSIONS: The optimal treatment strategy recommended in this study for Chinese ACS patients with complicated CAD managed by PCI is 180 or 90 mg of ticagrelor at 24 h after the last dose of clopidogrel. In addition, a negative interaction was detected in this study between the overlap for clopidogrel and ticagrelor at 12 h after the last dose of clopidogrel. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03577652; http://clinicaltrials.gov/ct2/show/NCT03577652.

Sex-Related Differences in Short- and Long-Term Outcome among Young and Middle-Aged Patients for ST-Segment Elevation Myocardial Infarction Underwent Percutaneous Coronary Intervention.

BACKGROUND: Females with ST-segment elevation myocardial infarction (STEMI) have higher in-hospital and short-term mortality rates compared with males in China, suggesting that a sex disparity exists. The age of onset of STEMI is ahead of time and tends to be younger. However, there are relatively little data on the significance of sex on prognosis for long-term outcomes for adult patients with STEMI after percutaneous coronary intervention (PCI) in China. This study sought to analyze the sex differences in 30-day, 1-year, and long-term net adverse clinical events (NACEs) in Chinese adult patients with STEMI after PCI. METHODS: This study retrospectively analyzed 1920 consecutive STEMI patients (age ≤60 years) treated with PCI from January 01, 2006, to December 31, 2012. A propensity score analysis between males and females was performed to adjust for differences in baseline characteristics and comorbidities. The primary endpoint was the incidence of 3-year NACE. Survival curves were constructed with Kaplan-Meier estimates and compared by log-rank tests between the two groups. Multivariate analysis was performed using a Cox proportional hazards model for 3-year NACE. RESULTS: Compared with males, females had higher risk profiles associated with old age, longer prehospital delay at the onset of STEMI, hypertension, diabetes mellitus, and chronic kidney disease, and a higher Killip class (≥3), with more multivessel diseases (P < 0.05). The female group had a higher levels of low-density lipoprotein (2.72 [2.27, 3.29] vs. 2.53 [2.12, 3.00], P < 0.001), high-density lipoprotein (1.43 [1.23, 1.71] vs. 1.36 [1.11, 1.63], P = 0.003), total cholesterol (4.98 ± 1.10 vs. 4.70 ± 1.15, t = -3.508, P < 0.001), and estimated glomerular filtration rate (103.12 ± 22.22 vs. 87.55 ± 18.03, t = -11.834, P < 0.001) than the male group. In the propensity-matched analysis, being female was associated with a higher risk for 3-year NACE and major adverse cardiac or cerebral events compared with males. In the multivariate model, female gender (hazard ratio [HR]: 2.557, 95% confidence interval [CI]: 1.415-4.620, P = 0.002), hypertension (HR: 2.017, 95% CI: 1.138-3.576, P = 0.016), and family history of coronary heart disease (HR: 2.256, 95% CI: 1.115-4.566, P = 0.024) were independent risk factors for NACE. The number of stents (HR: 0.625, 95% CI: 0.437-0.894, P = 0.010) was independent protective factors of NACE. CONCLUSIONS: Females with STEMI undergoing PCI have a significantly higher risk for 3-year NACE compared with males in this population. Sex differences appear to be a risk factor and present diagnostic challenges for clinicians.

Safety and Necessity of Antiplatelet Therapy on Patients Underwent Endovascular Aortic Repair with Both Stanford Type B Aortic Dissection and Coronary Heart Disease.

BACKGROUND: Acute aortic dissection is known as the most dangerous aortic disease, with management and prognosis determined as the disruption of the medial layer provoked by intramural bleeding. The objective of this study was to evaluate the safety and necessity of antiplatelet therapy on patients with Stanford Type B aortic dissection (TBAD) who underwent endovascular aortic repair (EVAR). METHODS: The present study retrospectively analyzed 388 patients with TBAD who underwent EVAR and coronary angiography. The primary outcomes were hemorrhage, death, endoleak, recurrent dissection, myocardial infarction, and cerebral infarction in patients with and without aspirin antiplatelet therapy at 1 month and 12 months. RESULTS: Of those 388 patients, 139 (35.8%) patients were treated with aspirin and 249 (64.2%) patients were not treated with aspirin. Patients in the aspirin group were elderly (57.0 ± 10.3 years vs. 52.5 ± 11.9 years, respectively, χ2 = 3.812, P < 0.001) and had more hypertension (92.1% vs. 83.9%, respectively, χ2 = 5.191, P = 0.023) and diabetes (7.2% vs. 2.8%, respectively, χ2 = 4.090, P = 0.043) than in the no-aspirin group. Twelve patients (aspirin group vs. no-aspirin group; 3.6% vs. 2.8%, respectively, χ2 = 0.184, P = 0.668) died at 1-month follow-up, while the number was 18 (4.6% vs. 5.0%, respectively, χ2 = 0.027, P = 0.870) at 12-month follow-up. Hemorrhage occurred in 1 patient (Bleeding Academic Research Consortium [BARC] Type 2) of the aspirin group, and 3 patients (1 BARC Type 2 and 2 BARC Type 5) in the no-aspirin group at 1-month follow-up (χ2 = 0.005, P = 0.944). New hemorrhage occurred in five patients in the no-aspirin group at 12-month follow-up. Three patients in the aspirin group while five patients in the no-aspirin group had recurrent dissection for endoleak at 1-month follow-up (2.3% vs. 2.2%, respectively, χ2 = 0.074, P = 0.816). Four patients had new dissection in the no-aspirin group at 12-month follow-up (2.3% vs. 3.8%, respectively, χ2 = 0.194, P = 0.660). Each group had one patient with myocardial infarction at 1-month follow-up (0.8% vs. 0.4%, respectively, χ2 = 0.102, P = 0.749) and one more patient in the no-aspirin group at 12-month follow-up. No one had cerebral infarction in both groups during the 12-month follow-up. In the percutaneous coronary intervention (PCI) subgroup, 44 (31.7%) patients had taken dual-antiplatelet therapy (DAPT, aspirin + clopidogrel) and the other 95 (68.3%) patients had taken only aspirin. There was no significant difference in hemorrhage (0% vs. 1.1%, respectively, χ2 = 0.144, P = 0.704), death (4.8% vs. 4.5%, respectively, χ2 = 0.154, P = 0.695), myocardial infarction (2.4% vs. 0%, respectively, χ2 = 0.144, P = 0.704), endoleak, and recurrent dissection (0% vs. 3.4%, respectively, χ2 = 0.344, P = 0.558) between the two groups at 12-month follow-up. CONCLUSIONS: The present study indicated that long-term oral low-dose aspirin was safe for patients with both TBAD and coronary heart disease who underwent EVAR. For the patients who underwent both EVAR and PCI, DAPT also showed no increase in hemorrhage, endoleak, recurrent dissection, death, and myocardial infarction.

[Effects of chronic kidney disease on platelet response to antiplatelet therapy in acute myocardial infarction patients].

OBJECTIVE: To elucidate the effects of dual antiplatelet therapy on platelet response in acute myocardial infarction patients with chronic kidney disease. METHODS: From September 2011 to June 2012, a total of 195 acute myocardial infarction patients with drug eluting stent implanting were enrolled. Among them, 133 cases had normal renal function and 62 cases suffered chronic kidney disease (CKD). Platelet reactivity was examined after clopidogrel 300 mg and aspirin 300 mg treatment for 24 h. High on treatment platelet reactivity (HPR) was defined as>55% for light transmission aggreometry. RESULTS: The CKD patients had a higher incidence of diabetes mellitus (43.5% (27/62) vs 24.8% (33/133), P = 0.01), anemia (16.1% (10/62) vs 5.3% (7/133), P = 0.03) and high on treatment platelet reactivity (45.2% (28/62) vs 28.6% (38/133), P = 0.03) than those with normal kidney function. Logistic regression analyses showed that CKD and diabetes mellitus were independent predictors of HPR. Prevalence of HPR was higher in CKD patients than normal kidney function patients (65.1% ± 10.2% vs 45.3% ± 7.8%, P < 0.01). In subgroup analysis, testing was done before and after antiplatelet treatment. At baseline, no differences existed in platelet aggregation. However, absolute decrease in reactivity after antiplatelet treatment was significantly less in CKD patients than those with normal kidney function (63.2% ± 8.6% vs 43.2% ± 5.2%, P < 0.01). CONCLUSION: CKD is an important contributor to apparent HPR.