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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% ± 19.0%) 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 ± 0.32 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.
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Osteoprotegerin (OPG), as a member of the tumor necrosis factor (TNF) superfamily, is a soluble secretary glycoprotein, which is accompanied with NF-κB receptor activator (RANK), NF-κB receptor activator ligand (RANKL) and tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) to form osteoprotegerin system. A large number of clinical and experimental studies have confirmed that osteoprotegerin system participates in physiological processes such as endothelial function, inflammatory reaction, oxidative stress and apoptosis, which is expected to be a biomarker for the occurrence, development, severity and long-term prognosis of coronary heart disease. In this paper, we summarized the biological effects and mechanism of the osteoprotegerin system in the occurrence and development of coronary heart disease and its future clinical application.
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<p><b>OBJECTIVE</b>To investigate cholesteryl ester transfer protein (CETP) gene polymorphism -629C/A among Han Chinese patients with coronary heart disease (CHD) in Tianjin region, and to assess the influence of genetic factors on therapeutic effect of atorvastatin and clinical outcome in order to provide a pharmacogenomic basis for personalized treatment.</p><p><b>METHODS</b>From October 2010 to July 2011, 232 patients with angiographically confirmed CHD were recruited. Polymorphism of position -629 of CETP gene promoter was determined with polymerase chain reaction - restricted fragment length polymorphism (PCR-RFLP) method. Serum level of CETP was determined with enzyme-linked immunosorbent assay (ELISA). Lipid level in all patients was determined at baseline and after 12 months of treatment with 20 mg/d atorvastatin. Clinical follow-up was carried out for more than a year (12-23 months). Major adverse cardiac events including death, non-fatal infarction, revascularization and stroke (MACE) were recorded. A Kaplan-Meier log-rank test was used to compare MACE-free survival for individuals with various genotypes.</p><p><b>RESULTS</b>The frequency of -629A allele was 0.408. Compared with CC or CA genotypes, individuals with AA genotype had lower CETP levels and higher high-density lipoprotein cholesterol (HDL-C) levels, albeit without statistical significance (F = 0.893, P = 0.411 and F = 1.279, P = 0.282, respectively). There also appeared to be a negative correlation between serum HDL-C and CETP levels, though no statistical significance was detected (r = -0.151, P = 0.081). After 12 months atorvastatin therapy, individuals with CC genotype had greater reduction of low-density lipoprotein cholesterol (LDL-C), reduced LP(a) and elevated HDL-C compared with CA or AA genotypes. LDL-C level has decreased by 35.41% in CC homozygotes, 18.84% in CA heterozygotes and 8.15% in AA homozygotes (P = 0.001). HDL-C level has increased by 14.37% in CC homozygotes, 10.48% in CA heterozygotes and 6.64% in AA homozygotes, respectively. However, above changes did not reach statistical significance (P = 0.470). The incidence of MACE after a mean follow-up of (18.66 ± 5.99) months was 7.76%, which included 2 (0.86%) deaths, 5 (2.16%) non-fatal infarctions, 9 (3.88%) revascularizations and 2 (0.86%) strokes. The cumulative MACE-free survival rates were 92.4%, 85.3% and 65.0% for CC, CA and AA genotypes, respectively (Log-rank P = 0.444).</p><p><b>CONCLUSION</b>Our results suggested that AA variant for the -629A allele of CETP gene had higher HDL-C levels and reduced CETP levels, though patients with CC genotype appeared to have better benefited from statin therapy with reduction in LDL-C and LP(a) levels. Long-term clinical prognosis was however not affected by the 3 genotypes.</p>
Subject(s)
Adult , Aged , Female , Humans , Male , Middle Aged , Atorvastatin , Cholesterol Ester Transfer Proteins , Blood , Genetics , Cholesterol, HDL , Blood , Cholesterol, LDL , Blood , Coronary Artery Disease , Blood , Drug Therapy , Genetics , Heptanoic Acids , Therapeutic Uses , Mutation, Missense , Polymorphism, Single Nucleotide , Pyrroles , Therapeutic Uses , Treatment OutcomeABSTRACT
<p><b>OBJECTIVE</b>To investigate the impact of depression on clinical outcome of patients undergoing revascularization.</p><p><b>METHODS</b>Self-rating depression scale (SDS) assessment was made before and after coronary artery bypass grafting (CABG, n = 345) and percutaneous coronary intervention (PCI, n = 308) procedure. Patients were divided into depression and non-depression group. All patients were followed up for 12 months after procedure for the occurrence of rehospitalization and major adverse cardiovascular events (MACE) including all-cause mortality, nonfatal myocardial infarction or target lesion revascularization.</p><p><b>RESULTS</b>Depression was present in 40.9% (n = 141) of patients after CABG, which was significantly higher than before procedure (24.3%, P < 0.01). The MACE rate was significantly higher in patients with post-procedure depression [8.5% (12/141)] than in patients without depression [2.9% (6/204), P < 0.05] and the incidences of target lesion revascularization and rehospitalization were also significantly higher in depression patients than in non-depression patients during the 12 months follow-up (all P < 0.05). Depression was present in 36.4% (n = 112) of patients after PCI, which was significantly higher than that before procedure (28.6%, P < 0.05). The MACE rate [8.0% (9/112) vs. 2.0% (4/196)] and rehospitalization rate [12.5% (14/112) vs. 4.6% (9/196)] were significantly higher in depression patients than in patients without depression during the 12 months follow-up (P < 0.05). There was no significant difference on SDS score between the PCI and CABG before the procedure. However, after the procedure, the SDS score for patients undergoing CABG was significantly higher than in patients undergoing PCI (48.9 ± 9.8 vs. 45.7 ± 10.5 P = 0.01). The level of serum IL-6 was significantly higher in depression patients than in patients without depression (P < 0.05).</p><p><b>CONCLUSION</b>Prevalence of depression is high in patients treated with revascularization procedures and is linked with poor post-procedure prognosis.</p>
Subject(s)
Aged , Female , Humans , Male , Middle Aged , Angioplasty, Balloon, Coronary , Coronary Artery Bypass , Coronary Disease , Diagnosis , Psychology , Therapeutics , Coronary Stenosis , Depression , Prognosis , Treatment OutcomeABSTRACT
<p><b>BACKGROUND</b>The role of angiotensin-converting enzyme inhibitors (ACEI) in contrast-induced acute kidney injury (CI-AKI) is controversial. Some studies pointed out that it was effective in the prevention of CI-AKI, while some concluded that it was one risk for CI-AKI, especially for patients with pre-existing renal impairment. The purpose of this study was to assess the influence of benazepril administration on the development of CI-AKI in patients with mild to moderate renal insufficiency undergoing coronary intervention.</p><p><b>METHODS</b>One hundred and fourteen patients with mild to moderate impairment of renal function were enrolled before coronary angioplasty, who were randomly assigned to benazepril group (n = 52) and control group (n = 62). In the benazepril group, the patients received benazepril tablets 10 mg per day at least for 3 days before procedure. CI-AKI was defined as an increase of ≥ 25% in creatinine over the baseline value or increase of 0.5 mg/L within 72 hours of angioplasty.</p><p><b>RESULTS</b>Patients were well matched with no significant differences at baseline in all measured parameters between two groups. The incidence of CI-AKI was lower by 64% in the benazepril group compared with control group but without statistical significance (3.45% vs. 9.68%, P = 0.506). Compared with benazepril group, estimated glomerular filtration rate (eGFR) level significantly decreased from (70.64 ± 16.38) ml · min⁻¹·1.73 m⁻² to (67.30 ± 11.99) ml · min⁻¹·1.73 m⁻² in control group (P = 0.038). There was no significant difference for the post-procedure decreased eGFR from baseline (ΔeGFR) between two groups (benazepril group (0.67 ± 12.67) ml · min⁻¹·1.73 m⁻² vs. control group (-3.33 ± 12.39) ml · min⁻¹·1.73 m⁻², P = 0.092). In diabetic subgroup analysis, ΔeGFR in benazepril group was slightly lower than that in the control group, but the difference was not statistically significant.</p><p><b>CONCLUSIONS</b>Benazepril has a protective effect on mild to moderate impairment of renal function during coronary angioplasty. It is safe to use benazepril for treatment of patients with mild to moderate impairment of renal function before coronary intervention.</p>
Subject(s)
Aged , Female , Humans , Male , Middle Aged , Acute Kidney Injury , Angioplasty, Balloon, Coronary , Angiotensin-Converting Enzyme Inhibitors , Benzazepines , Therapeutic Uses , Contrast Media , Coronary Angiography , Renal InsufficiencyABSTRACT
<p><b>BACKGROUND</b>Early clinical trials with the Endeavor zotarolimus eluting stent (ZES) in western populations demonstrated low rates of target lesion revascularization with a favorable safety profile including low late stent thrombosis with up to 5 years of follow-up. The aim of this clinical registry study was to evaluate real world clinical performance of the ZES coronary system in Chinese patients.</p><p><b>METHODS</b>The China Endeavor Registry is a prospective, multicenter registry assessing the safety of the ZES system in a real world patient population. It was conducted at 46 centers in China in routine treatment of patients with coronary artery stenosis, including patients with clinical characteristics or lesion types that are often excluded from randomized controlled trials. The registry included 2210 adult patients who underwent single-vessel or multi-vessel percutaneous coronary intervention. The primary end point was the rate of major adverse cardiac events (MACE) at 12 months.</p><p><b>RESULTS</b>The 12-month rate of MACE for all patients in the registry was 3.03%. Cardiac death or myocardial infarction rate was 1.28% and target lesion revascularization rate was 1.66%, non-target lesion target vessel revascularization (TVR) was 0.52%, TVR was 2.18%, and target vessel failure was 3.22%. There was only one case of emergent cardiac bypass surgery. The 12-month overall incidence of all Academic Research Consortium (ARC)-defined stent thrombosis was 0.43%.</p><p><b>CONCLUSION</b>Mid-term results from the real-world China Endeavor Registry suggest that Endeavor ZES was safe and effective in Chinese patients.</p>
Subject(s)
Aged , Female , Humans , Male , Middle Aged , Angioplasty, Balloon, Coronary , Asian People , Drug-Eluting Stents , Prospective Studies , Sirolimus , Therapeutic UsesABSTRACT
<p><b>BACKGROUND</b>Off-label application of drug-eluting stents (DES) during percutaneous coronary intervention (PCI) was not uncommon in daily practice, however DES in treating Chinese patients with complex lesion subset was under-investigated. The primary objective of the FIREMAN registry was to evaluate the long term efficacy and safety of the Firebird sirolimus-eluting stent (SES) in treating patients with complex coronary lesions. Here we report the mid-term of one-year clinical outcomes and eight-month angiographic follow-up results of FIREMAN registry.</p><p><b>METHODS</b>The FIREMAN registry was a prospective multi-center registry, which included 1029 consecutive patients undergoing PCI with Firebird SES implantation between September 2006 and July 2007 in 45 centers in China. The clinical follow-up was designed to be performed at 1, 6, 12, 18, 24, 30 and 36 months post index procedure, and non-mandatory angiographic follow-up at 8 months was planned. One hundred percent site monitoring was conducted.</p><p><b>RESULTS</b>Long lesions (59.2%), multi-vessel disease (50.4%), and small vessel disease (31.6%) were mostly found in angiography. Major adverse cardiac events (MACE) occurred in 51 (5.1%) patients at 1 year clinical follow-up, including cardiac mortality in 6 (0.6%), non-fatal myocardial infarction in 11 (1.1%), and target lesion revascularization in 36 (3.5%) of the patients. Definite and probable stent thrombosis (ST) by Academic Research Consortium (ARC) definition occurred in 12 (1.36%) patients at one-year clinical follow-up. The 8-month binary restenosis rate was 5.7% in-segment and 4.3% in-stent, respectively. Late lumen loss was (0.21 ± 0.40) mm in-segment and (0.23 ± 0.36) mm in-stent, respectively. Furthermore, Cox regression analysis revealed that diabetes, small vessel diameter, and chronic total occlusion were independent predictors of ST.</p><p><b>CONCLUSIONS</b>The results showed that the Firebird SES was effective and safe in treating Chinese patients with complex coronary lesions and occurrence of ST rate at one-year clinical follow-up was acceptable, however further long-term follow-up was still necessary. (NCT00552656)</p>
Subject(s)
Aged , Female , Humans , Male , Middle Aged , Angioplasty, Balloon, Coronary , Methods , Asian People , Coronary Angiography , Coronary Disease , Diagnostic Imaging , Therapeutics , Drug-Eluting Stents , Prospective Studies , Sirolimus , Therapeutic Uses , Treatment OutcomeABSTRACT
<p><b>OBJECTIVE</b>To investigate the change of the mortality of AMI and influence factors within 20 years.</p><p><b>METHODS</b>Clinic data of 134 AMI patients from 1980 to 1983, 354 AMI patients from 1990 to 1993 and 817 AMI patients from 2000 to 2003 were comparably analyzed.</p><p><b>RESULTS</b>In hospital mortality of AMI was 22.4% from 1980 to 1983, 14.4% from 1990 to 1993 and 9.2% from 2000 to 2003, respectively (P < 0.01). The decrease of in-hospital mortality in male was more significant than in female (P < 0.01). The corresponding factors for decrease of mortality were younger than 60 years old, first onset of AMI, successful rescue of cardiac arrest and reperfusion management of infarction relative artery. The disadvantage factor was female.</p><p><b>CONCLUSIONS</b>Improvement of medical and reperfusion management of AMI conduced in significant decreases of hospital mortality.</p>