Long-Term Imaging Evolution and Clinical Prognosis Among Patients With Acute Penetrating Aortic Ulcers: A Retrospective Observational Study.

Background Acute penetrating aortic ulcers (PAUs) are reported to dynamically evolve into different clinical outcomes ranging from regression to aortic rupture, but no practice guidelines are available in China. Methods and Results All 109 patients with acute PAUs were monitored clinically. At 30 days follow-up, 31 patients (28.44%) suffered from aortic-related adverse events, a composite of aortic-related mortality, aortic dissection, or an enlarged ulcer. In addition, 7 (6.42%) patients had clinically related adverse events, including all-cause mortality, cerebral stroke, nonfatal myocardial infarction, acute heart failure alone or acute exacerbation of chronic heart failure, acute renal failure, arrhythmia, and bleeding events. In the present study, the intervention criteria for the Chinese PAU population included a PAU diameter of 12.5 mm and depth of 9.5 mm. The multivariate analysis showed that an ulcer diameter >12.5 mm (hazard ratio [HR], 3.846; 95% CI, 1.561-9.476; P=0.003) and an ulcer depth >9.5 mm (HR, 3.359; 95% CI, 1.505-7.494; P=0.003) were each independent predictors of aortic-related events. Conclusions Patients with acute PAUs were at high risk for aortic-related adverse events and clinically related adverse events within 30 days after onset. Patients with an ulcer diameter >12.5 mm or an ulcer depth >9.5 mm have a higher risk for disease progression, and early intervention may be recommended.

A drug-eluting Balloon for the trEatment of coronarY bifurcatiON lesions in the side branch: a prospective multicenter ranDomized (BEYOND) clinical trial in China.

BACKGROUND: Treatment of coronary bifurcation lesions remains challenging; a simple strategy has been preferred as of late, but the disadvantage is ostium stenosis or even occlusion of the side branch (SB). Only a few single-center studies investigating the combination of a drug-eluting stent in the main branch followed by a drug-eluting balloon in the SB have been reported. This prospective, multicenter, randomized study aimed to investigate the safety and efficacy of a paclitaxel-eluting balloon (PEB) compared with regular balloon angioplasty (BA) in the treatment of non-left main coronary artery bifurcation lesions. METHODS: Between December 2014 and November 2015, a total of 222 consecutive patients with bifurcation lesions were enrolled in this study at ten Chinese centers. Patients were randomly allocated at a 1:1 ratio to a PEB group (n = 113) and a BA group (n = 109). The primary efficacy endpoint was angiographic target lesion stenosis at 9 months. Secondary efficacy and safety endpoints included target lesion revascularization, target vessel revascularization, target lesion failure, major adverse cardiac and cerebral events (MACCEs), all-cause death, cardiac death, non-fatal myocardial infarction, and thrombosis in target lesions. The main analyses performed in this clinical trial included case shedding analysis, base-value equilibrium analysis, effectiveness analysis, and safety analysis. SAS version 9.4 was used for the statistical analyses. RESULTS: At the 9-month angiographic follow-up, the difference in the primary efficacy endpoint of target lesion stenosis between the PEB (28.7% ± 18.7%) and BA groups (40.0% ±â€Š19.0%) was -11.3% (95% confidence interval: -16.3% to -6.3%, Psuperiority <0.0001) in the intention-to-treat analysis, and similar results were recorded in the per-protocol analysis, demonstrating the superiority of PEB to BA. Late lumen loss was significantly lower in the PEB group than in the BA group (-0.06 ±â€Š0.32 vs. 0.18 ± 0.34 mm, P < 0.0001). For intention-to-treat, there were no significant differences between PEB and BA in the 9-month percentages of MACCEs (0.9% vs. 3.7%, P = 0.16) or non-fatal myocardial infarctions (0 vs. 0.9%, P = 0.49). There were no clinical events of target lesion revascularization, target vessel revascularization, target lesion failure, all-cause death, cardiac death or target lesion thrombosis in either group. CONCLUSIONS: In de novo non-left main coronary artery bifurcations treated with provisional T stenting, SB dilation with the PEB group demonstrated better angiographic results than treatment with regular BA at the 9-month follow-up in terms of reduced target lesion stenosis. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02325817; https://clinicaltrials.gov.

Predictors of contrast-induced acute kidney injury in patients with coronary artery disease receiving contrast agents twice within 30 days.

BACKGROUND: None of study mentioned about contrast-induced acute kidney injury (CI-AKI) in people who have received contrast agents twice within in a short period of time. This study is trying to identify the predictors. METHODS: We enrolled 607 patients between Oct. 2010 and Jul. 2015 who received contrast agents twice within 30 days in the Department of Cardiology of the General Hospital of Shenyang Military Region. The primary outcome was CI-AKI within 72 h after contrast agent exposure. Patients were divided into groups A (n = 559) and group B (n = 48) according to whether CI-AKI occurred after the second agent. RESULTS: Patients in group B (CI-AKI occurred after the second agent) had a more rapid heart rate and more usage of diuretics and digitalis. In group B, CI-AKI occurred more frequently after the first agent. Multivariate logistic regression showed that diuretic (P = 0.006) and intra-aortic balloon pump (IABP) usage (P = 0.012) were independent predictors of CI-AKI after the first agent. Angiotensin-converting enzyme inhibitor/Angiotensin II receptor antagonist (ACEI/ARB) usage (P = 0.039), IABP usage (P = 0.040) and CI-AKI occurring after administration of the first agent (P = 0.015) were independent predictors of CI-AKI after the second. Furthermore, dividing the patients into tertiles of the time interval between the two agents showed that CI-AKI occurred more frequently when the second agent was administered within 1-3 days after the first exposure than within 4-6 days (12.4% vs. 5.0%, P = 0.008) or ≥ 7 days (12.4% vs. 6.4%, P = 0.039). CONCLUSIONS: Diuretic and IABP usage are independent predictors of CI-AKI following exposure to a first contrast agent. The major predictors of CI-AKI after exposure to a second agent are time since the first contrast exposure, ACEI/ARB usage, and IABP usage. More importantly, a three-day interval between the two agents is associated with a higher incidence of CI-AKI following the second administration.

Analysis of failure factors in retrograde wire-guided intervention for chronic total occlusion.

OBJECTIVE: This study aims to investigate failure factors in retrograde wire-guided cannulation (retrograde approach) for the treatment of coronary chronic total occlusion (CTO). METHODS: Data of 285 patients treated for CTO using retrograde approach in the General Hospital of Shenyang Military Region from August 2004 to May 2016 were collected. RESULTS: The average age of the 285 patients was 63.89 ± 11.3 years old. Multivariate analysis revealed that the operation risk factors include the number of diseased vessels, collateral circulation, as well as whether anterograde intervention for CTO target vessels was previously performed (OR = 0.875, 95% CI = 0.779-0.940, P= 0.026) and whether other vessels were intervened (OR = 22.372, 95% CI = 2.059-243.031, P= 0.011). CONCLUSION: Based on the present study, the success rate of retrograde approach for CTO was negatively correlated with the number of diseased vessels and collateral circulation. It was furthermore of importance whether anterograde intervention for CTO target vessels was previously performed and whether other vessels beside CTO vessels were intervened, which were also risk factors.

Photothermal-assisted surface-mediated gene delivery for enhancing transfection efficiency.

The development of gene therapy puts forward the requirements for efficient delivery of genetic information into diverse cells. However, in some cases of transfection, especially those for transfecting some primary cells and for delivering large size plasmid DNA (pDNA), the existing conventional transfection methods show poor efficiency. How to further improve transfection efficiency in these hard-to-achieve issues remains a crucial challenge. Here, we report a photothermal-assisted surface-mediated gene delivery based on a polydopamine-polyethylenimine (PDA-PEI) surface. The PDA-PEI surface was prepared through PEI-accelerated dopamine polymerization, which showed efficiency in the immobilization of PEI/pDNA polyplexes and remarkable photothermal properties. Upon IR irradiation, we observed improved transfection efficiencies of two important hard-to-achieve transfection issues, namely the transfection of primary endothelial cells, which are kinds of typical hard-to-transfect cells, and the transfection of cells with large-size pDNA. We demonstrate that the increases of transfection efficiency were due to the hyperthermia-induced pDNA release, the local cell membrane disturbance, and the polyplex internalization. This work highlights the importance of local immobilization and release of pDNA to gene deliveries, showing great potential applications in medical devices in the field of gene therapy.

Optimal use of fielder XT guidewire enhances the success rate of chronic total occlusion percutaneous coronary intervention.

BACKGROUND: Chronic total occlusion (CTO) is found in 18-31% of patients who undergo coronary angiography. Successful recanalization of CTOs is associated with reduced recurrent angina pectoris rates and increased long-term survival. Although the success rate of CTO percutaneous coronary intervention (CTO-PCI) has improved, CTO-PCI remains technically challenging. The Fielder XT guidewire was designed for CTO lesions. To validate whether the use of the guidewire increases the success rate, we compared the results of CTO-PCI with or without the guidewire. We hypothesized that the use of Fielder XT guidewire can increase the success rate of CTO-PCI. AIM: To investigate whether the use of Fielder XT guidewire increases the final procedural success of CTO-PCI via the anterograde approach. METHODS: Between January 2013 and December 2015, a retrospective study was conducted on 1230 consecutive patients with CTO who received PCI via the anterograde approach at the General Hospital of Northern Theater Command. The patients were divided into an XT Group (n = 686) and a no-XT Group (n = 544) depending on whether Fielder XT guidewire was used. Both groups were compared for clinical parameters, lesion-related characteristics, procedural outcomes and in-hospital complications. The data were statistically analyzed using Pearson's χ 2 test for categorical variables, and Students' t test was used to compare the quantitative data. Significant independent factors and a risk ratio with 95% confidence interval (CI) were assessed by multivariate logistic regression analysis. RESULTS: In total, 1230 patients were recruited; 75.4% of the patients were male, and 55.8% of the patients were in the XT group. The overall success rate was 83.9%, with 87.8% in the XT group. Based on multivariate logistic regression analysis, factors positively associated with procedural success were the use of Fielder XT guidewire (P = 0.005, 95%CI: 1.172-2.380) and systolic blood pressure (P = 0.011, 95%CI: 1.003-1.022), while factors negatively associated with procedural success were blunt stump (P = 0.013, 95%CI: 1.341-11.862), male sex (P = 0.016, 95%CI: 0.363-0.902), New York Heart Association (NYHA) class (P = 0.035, 95%CI: 0.553-0.979), contrast amount (P = 0.018, 95%CI: 0.983-0.998) and occlusion time (P = 0.009, 95%CI: 0.994-0.999). No significant differences were found between the XT group and the no-XT group with respect to clinical parameters, lesion-related characteristics, coronary artery rupture [3 (0.4%) vs 8 (1.5%), P = 0.056], in-hospital death [2 (0.3%) vs 6 (1.1%), P = 0.079] or in-hospital target lesion revascularization [3 (0.4%) vs 7 (1.3%), P < 0.099]. However, there were significant differences between the groups with respect to success rate [602 (87.8%) vs 430 (79.0%), P < 0.001], procedure time [(74 ± 23) vs (83 ± 21), P < 0.001], stent length [(32.0 ± 15.8) vs (37.3 ± 17.6), P < 0.001], contrast amount [(148 ± 46) vs (166 ± 43), P < 0.001], post-PCI myocardial infarction [43 (6.3%) vs 59 (10.8%), P = 0.004], major adverse cardiovascular event [44 (6.4%) vs 57 (10.7%), P = 0.007], side branch loss [31 (4.5%) vs 44 (8.1%), P = 0.009], contrast-induced nephropathy [29 (4.2%) vs 40 (7.4%), P = 0.018] and no reflow [8 (1.2%) vs 14 (2.9%), P = 0.034]. CONCLUSION: The use of Fielder XT guidewire shortens the Procedure and increases the success rate of CTO-PCI, and is also associated with reduced complication rates.

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.

Correlation between Sex and Prognosis of Acute Aortic Dissection in the Chinese Population.

BACKGROUND: The prevalence, presentation, management, and prognosis of coronary heart disease differ according to sex. Greater understanding on the differences between men and women with acute aortic dissection (AAD) is needed. We aimed to investigate whether sex disparities are found in patients with AAD, and to study sex differences in complications, mortality in-hospital, and long-term. METHODS: We included 884 patients enrolled in our institute between June 2002 and May 2016. Considering psychosocial factors, treatments, and the outcomes in men versus those in women with AAD, we explored the association of sex with psychosocial characteristics and mortality risk. For categorical variables, significant differences between groups were assessed with the Chi-square test or Fisher's exact test, and continuous parameters were assessed with Student's t-test. Univariate and stratified survival statistics were computed using Kaplan-Meier analysis. RESULTS: A total of 884 patients (76.1% male, mean age 51.4 ± 11.8 years) were included in this study. There were fewer current smokers in female compared with male (17.5% vs. 67.2%, χ2 = 160.06, P < 0.05). The percentage of men who reported regular alcohol consumption was significantly higher than that in women (40.6% vs. 3.8%, χ2 = 100.18, P < 0.05). About 6.2% (55 of 884) of patients with AAD died before vascular or endovascular surgery was performed, 34.4% (304 of 884) of patients underwent surgical procedures, and 52.7% (466 of 884) and 12.8% (113 of 884) of patients received endovascular treatment and medication. Postoperative mortality similar (6.0% vs. 5.6%, respectively, χ2 = 0.03, P = 0.91) between men and women. Follow-up was completed in 653 of 829 patients (78.8%). Adjustment for age, history of coronary disease, hypertension, smoking and drinking, Type A and use of beta-blocker, angiotensin II receptor blockers, angiotensin converting enzyme (ACE) inhibitor, calcium-channel blockers and statins by multivariate logistic regression analysis suggested that age (odds ratios [OR s], 1.04; 95% confidence interval [CI], 1.01-1.07; P < 0.05), using of calcium-channel blockers (OR, 0.37; 95% CI, 0.18-0.74; P < 0.05), at discharge were independent predictors of late mortality, ACE inhibitors (OR, 1.91; 95% CI, 1.03-3.54; P = 0.04) was independent risk factor of late mortality. CONCLUSIONS: In Chinese with AAD, sex is not independently associated with long-term clinical outcomes. Age, the intake of calcium-channel blockers at discharge might help to improve long-term outcomes.

A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Study of the Effects of Tongxinluo Capsules in Acute Coronary Syndrome Patients with High On-Treatment Platelet Reactivity.

BACKGROUND: High platelet reactivity (HPR) during clopidogrel treatment predicts postpercutaneous coronary intervention (PCI) ischemic events strongly and independently. Tongxinluo capsules (TCs) are a traditional Chinese medicine formulation used as antiplatelet treatment. However, its efficacy against HPR is not known. The aim of the present study was to evaluate the effects of TCs in acute coronary syndrome (ACS) patients with HPR. METHODS: This multicenter, randomized, double-blind, placebo-controlled study prospectively analyzed 136 ACS patients with HPR who underwent PCI. The patients were enrolled from November 2013 to May 2014 and randomized to receive placebo or TCs in addition to standard dual antiplatelet therapy (DAPT) with aspirin and clopidogrel. The primary end points were the prevalence of HPR at 30 days and the mean change in P2Y12reaction units (PRUs) between baseline and 30 days. Survival curves were constructed with Kaplan-Meier estimates and compared by log-rank tests between the two groups. RESULTS: Both groups had a significantly reduced prevalence of HPR at 30 days versus baseline, but the TC group, compared with the placebo group, had greater reduction (15.8% vs. 24.8%, P = 0.013), especially among patients with one cytochrome P450 2C19 loss of function (LOF) allele (χ2 = 2.931, P = 0.047). The TC group also had a lower prevalence of HPR (33.3% vs. 54.2%, t = 5.284, P = 0.022) and superior performance in light transmittance aggregometry and higher levels of high-sensitivity C-reactive protein (hsCRP), but the composite prevalence of ischemic events did not differ significantly (χ2 = 1.587, P = 0.208). CONCLUSIONS: In addition to standard DAPT with aspirin and clopidogrel, TCs further reduce PRU and hsCRP levels, especially in patients carrying only one LOF allele. The data suggest that TCs could be used in combination therapy for ACS patients with HPR undergoing PCI.

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.

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.

Five-year outcomes of ST-elevation myocardial infarction versus non-ST-elevation acute coronary syndrome treated with biodegradable polymer-coated sirolimus-eluting stents: Insights from the CREATE trial.

BACKGROUND: Long-term outcome of drug-eluting stents (DES) for ST-elevation myocardial infarction (STEMI) versus non-ST-elevation acute coronary syndrome (NSTE-ACS) remains unclear. This study sought to compare the long-term outcomes of biodegradable polymer-coated DES in patients with STEMI versus NSTE-ACS. METHODS: We explored a post hoc analysis of the 5-year outcome of the CREATE trial in the subgroup of patients with STEMI (n=318) versus NSTE-ACS (n=1223) who were implanted with biodegradable polymer-coated DES. The primary outcome was the rate of major adverse cardiac events (MACE) at 5 years. Clopidogrel and aspirin for 6 months followed by chronic aspirin therapy were recommended. RESULTS: STEMI patients showed a trend of increase in MACE (8.7% vs. 6.8%, log rank p=0.289) compared to NSTE-ACS patients at 5 years, and a greater risk of cardiac death (5.4% vs. 2.1%, log rank p=0.003), mainly driven by the higher cardiac death rate within the first month after stent placement (log rank p=0.003) and the last year of follow-up (log rank p=0.001). No significant difference in stent thrombosis was found between them (3.1% vs. 2.5%, log rank p=0.653). Prolonged clopidogrel therapy (>6 months) showed no effect on risk of MACE or stent thrombosis between the two groups (both p for interaction >0.1). CONCLUSIONS: STEMI patients have a higher risk of cardiac mortality compared with NSTE-ACS patients after biodegradable polymer-coated DES placement, primarily attribute to more cardiac deaths that happened within the first month after the event and the last year of follow-up.

Clinical and multimodality imaging results at 6 months of a bioresorbable sirolimus-eluting scaffold for patients with single de novo coronary artery lesions: the NeoVas first-in-man trial.

AIMS: The study sought to investigate clinical and multimodality imaging assessment of a bioresorbable sirolimus-eluting scaffold (NeoVas, Lepu Medical, Beijing, China) for patients with single de novo coronary artery lesions. METHODS AND RESULTS: The NeoVas first-in-man study was a prospective, open-label study which enrolled 31 patients with single de novo lesions treated with a bioresorbable sirolimus-eluting scaffold. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation (TLR). Angiography, intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging were performed at baseline and six months. Procedural success and device success were 100% (31/31 patients). At six months, the rate of TLF was 3.2%, with only one patient having clinically indicated TLR. No scaffold thrombosis was observed. The angiographic six-month in-scaffold late loss was 0.26±0.32 mm. The minimal scaffold area decreased from 7.11±1.56 mm2 post procedure to 6.74±1.38 mm2 at six months, as measured by IVUS. The OCT results showed that the neointimal hyperplasia area was low (1.56±0.46 mm2), with a high proportion of scaffold strut coverage (95.7%). CONCLUSIONS: This first-in-man study shows feasibility, promising clinical and multimodality imaging results up to six months for the NeoVas bioresorbable sirolimus-eluting scaffold in the treatment of patients with simple de novo lesions, with an acceptable in-scaffold late loss, low neointimal hyperplasia, and a high percentage of scaffold strut coverage.

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.

Comparison of the efficacy of drug-eluting stents versus bare-metal stents for the treatment of left main coronary artery disease.

BACKGROUND: Recent studies reported that percutaneous coronary intervention with stent implantation was safe and feasible for the treatment of left main coronary artery (LMCA) disease in select patients. However, it is unclear whether drug-eluting stents (DESs) have better outcomes in patients with LMCA disease compared with bare-metal stent (BMS) during long-term follow-up in Chinese populations. METHODS: From a perspective multicenter registry, 1136 consecutive patients, who underwent BMS or DES implantation for unprotected LMCA stenosis, were divided into two groups: 1007 underwent DES implantation, and 129 underwent BMS implantation. The primary outcome was the rate of major adverse cardiac events (MACEs), including cardiovascular (CV) death, myocardial infarction (MI), and target lesion revascularization (TLR) at 5 years postimplantation. RESULTS: Patients in the DES group were older and more likely to have hyperlipidemia and bifurcation lesions. They had smaller vessels and longer lesions than patients in the BMS group. In the adjusted cohort of patients, the DES group had significantly lower 5 years rates of MACE (19.4% vs. 31.8%, P = 0.022), CV death (7.0% vs. 14.7%, P = 0.045), and MI (5.4% vs. 12.4%, P = 0.049) than the BMS group. There were no significant differences in the rate of TLR (10.9% vs. 17.8%, P = 0.110) and stent thrombosis (4.7% vs. 3.9%, P = 0.758). The rates of MACE (80.6% vs. 68.2%, P = 0.023), CV death (93.0% vs. 85.3%, P = 0.045), TLR (84.5% vs. 72.1%, P = 0.014), and MI (89.9% vs. 80.6%, P = 0.029) free survival were significantly higher in the DES group than in the BMS group. When the propensity score was included as a covariate in the Cox model, the adjusted hazard ratios for the risk of CV death and MI were 0.41 (95% confidence interval [CI]: 0.21-0.63, P = 0.029) and 0.29 (95% CI: 0.08-0.92, P = 0.037), respectively. CONCLUSIONS: DES implantation was associated with more favorable clinical outcomes than BMS implantation for the treatment of LMCA disease even though there was no significant difference in the rate of TLR between the two groups.

Short-term rosuvastatin treatment for the prevention of contrast-induced acute kidney injury in patients receiving moderate or high volumes of contrast media: a sub-analysis of the TRACK-D study.

BACKGROUND: Current randomized trials have demonstrated the effects of short-term rosuvastatin therapy in preventing contrast-induced acute kidney injury (CIAKI). However, the consistency of these effects on patients administered different volumes of contrast media is unknown. METHODS: In the TRACK-D trial, 2998 patients with type 2 diabetes and concomitant chronic kidney disease (CKD) who underwent coronary/peripheral arterial angiography with or without percutaneous intervention were randomized to short-term (2 days before and 3 days after procedure) rosuvastatin therapy or standard-of-care. This prespecified analysis compared the effects of rosuvastatin versus standard therapy in patients exposed to (moderate contrast volume [MCV], 200-300 ml, n = 712) or (high contrast volume [HCV], ≥ 300 ml, n = 220). The primary outcome was the incidence of CIAKI. The secondary outcome was a composite of death, dialysis/hemofiltration or worsened heart failure at 30 days. RESULTS: Rosuvastatin treatment was associated with a significant reduction in CIAKI compared with the controls (2.1% vs. 4.4%, P = 0.050) in the overall cohort and in patients with MCV (1.7% vs. 4.5%, P = 0.029), whereas no benefit was observed in patients with HCV (3.4% vs. 3.9%, P = 0.834). The incidence of secondary outcomes was significantly lower in the rosuvastatin group compared with control group (2.7% vs. 5.3%, P = 0.049) in the overall cohort, but it was similar between the patients with MCV (2.0% vs. 4.2%, P = 0.081) or HCV (5.1% vs. 8.8%, P = 0.273). CONCLUSIONS: Periprocedural short-term rosuvastatin treatment is effective in reducing CIAKI and adverse clinical events for patients with diabetes and CKD after their exposure to a moderate volume of contrast medium.

Efficacy and safety of individually tailored antiplatelet therapy in patients with acute coronary syndrome after coronary stenting: a single center, randomized, feasibility study.

BACKGROUND: Low responsiveness to clopidogrel (LRC) is associated with increased risk of ischemic events. This study was aimed to explore the feasibility of tailored antiplatelet therapy according to the responsiveness to clopidogrel. METHODS: A total of 305 clopidogrel naïve patients with acute coronary syndromes (ACS) undergoing coronary stenting were randomly assigned to receive standard (n = 151) or tailored (n = 154) antiplatelet therapy. The ADP-induced platelet aggregation tests by light transmission aggregometry were performed to identify LRC patients assigned to the tailored group. The standard antiplatelet regimen was dual antiplatelet therapy with aspirin and clopidogrel. The tailored antiplatelet therapy was standard regimen for non-LRC patients and an additional 6-month cilostazol treatment for LRC patients. The primary efficacy outcome was the composite of cardiovascular death, myocardial infarction or stroke at one year. RESULTS: LCR was present in 26.6% (41/154) of patients in the tailored group. The percentage platelet aggregation for LCR patients was significantly decreased at three days after adjunctive cilostazol treatment (77.5% ± 12.1% vs. 64.5% ± 12.1%, P < 0.001). At one year follow-up, a non-significant 37% relative risk reduction of primary events were observed in the tailored group as compared to the standard group (5.8% vs. 9.3%, P = 0.257). There were no differences in the rates of stent thrombosis and hemorrhagic events between the two groups. CONCLUSIONS: Tailored antiplatelet therapy for ACS patients after coronary stenting according to responsiveness to clopidogrel is feasible. However, its efficacy and safety need further confirmation by clinical trials with larger sample sizes.

Long-term follow-up study of elderly patients with covered stent implantation after coronary perforation.

OBJECTIVE: To evaluate the long-term efficacy of covered stent implantation in the treatment of elderly patients with coronary perforation while undergoing percutaneous coronary intervention (PCI). METHODS: From June 2004 to June 2012, our center has followed ten elderly patients (age ≥ 60 years) who sustained coronary perforation during PCI. The major adverse cardiac events (MACE) were observed as well. The patients were advised to take 75 mg/day Clopidogrel for two years, and indefinite use of 100 mg/day enteric-coated aspirin. RESULTS: Six out of the 10 patients aged from 60 to 76 years old (mean 68.6 ± 5.2 years) were male, four were female. The average diameter of the implanted stents was 3.3 ± 0.3 mm, and the average length was 22.1 ± 3.7 mm. All the ruptures were successfully sealed without intra-procedural death. The follow-up duration ranged from 0.6 to 67 months (mean 31.7 ± 24.5 months). One patient died of multiple organ failure due to lung infection in 19 days after PCI; one died of cardiac sudden death in 13 months after PCI; one had angina pectoris in 53 months after PCI; one underwent multi-slice CT examination in six months after PCI, and no in-stent restenosis was found. The other four patients received angiography follow-up, and the results showed that three patients had no intra-stent restenosis, while one had left anterior descending (LAD) restenosis in the covered stent in 67 months after PCI. The in-hospital mortality was 10% (1/10). The MACE rate in 12 months after PCI was 10% (1/10). During the entire followed-up period, the restenosis rate in target vessels was 20% (1/5), mortality was 20% (2/10), and the MACE rate was 40% (4/10). CONCLUSION: Treatment of coronary perforation by using covered stents can achieve favorable long-term results; a two-year dual antiplatelet therapy (DAPT) after PCI can effectively prevent intra-stent thrombosis.