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Investigating the prognostic value of the Murray law-based quantitative flow ratio (μQFR) on the clinical outcome after treatment of in-stent restenosis (ISR) with a drug-coated balloon (DCB).Patients participating in a previous randomized clinical trial for DCB-ISR were post-hoc analyzed. The primary endpoint was vessel-oriented composite endpoint (VOCE), defined as cardiac death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization. μQFRs at baseline and after DCB angioplasty was calculated, and its prognostic value as a predictor of VOCE was explored in Cox regression.A total of 169 lesions in 169 patients were analyzed. At one-year follow-up, 20 VOCEs occurred in 20 patients. Receiver-operating characteristic curve analysis identified a post-procedural μQFR of ≤ 0.89 as the best cut-off to predict VOCE (area under curve [AUC]: 0.74; 95% confidence interval [CI]: 0.67-0.80; p0.001), superior to post-procedural in-stent percent diameter stenosis (DS), which reported an AUC of 0.61 (95% CI: 0.53-0.68; p = 0.18). Post-procedural μQFR was significantly lower in patients with VOCE compared with those without (0.88 [interquartile range: 0.79-0.94] vs. 0.96 [interquartile range: 0.91-0.98], respectively; p0.001). After correction for potential confounders, post-procedural μQFR ≤ 0.89 was associated with a 6-fold higher risk of VOCE than lesions with μQFR0.89 (hazard ratio: 5.94; 95% CI: 2.33-15.09; p0.001).Post-procedural μQFR may become a promising predictor of clinical outcome after treatment of DES-ISR lesions by DCB angioplasty.

Background The optimal strategy of percutaneous coronary intervention (PCI) for isolated left anterior descending (LAD) ostial lesions remains debatable. This study aimed to compare clinical outcomes of patients with isolated LAD ostial stenosis treated by single-stent crossover versus accurate ostial stenting. Methods A total of 216 eligible consecutive patients with isolated de novo LAD ostial stenosis were enrolled, and were stratified according to the stenting techniques. Clinical follow-up was performed by review of medical charts or telephone contact with the patients, and repeat angiography was made at 9-12 months after the procedure. Major adverse cardiovascular events (MACE) including cardiac death, myocardial infarction, non-fatal stroke and target vessel revascularization (TVR) were recorded. Results Single-stent crossover and accurate ostial stenting were applied to 78 (36%) and 138 (64%) patients, respectively. During a mean of 13 ± 4.1 months of follow-up, the rate of composite MACE (19.6 vs. 8.9%; P = 0.040) was higher in LAD ostial stenosis patients treated with accurate ostial stenting than those treated with single-stent crossover technique, mainly driven by more frequent TVR (17.4 vs. 7.7%; P = 0.048). PCI strategy was an independent predictor of MACE (hazard ratio 2.561; 95% CI, 1.041-6.299; P = 0.021) in the multivariable Cox regression analysis. Conclusions Our retrospective study suggests that the single-stent crossover technique is associated with a better 1-year clinical outcome compared with accurate ostial stenting in patients with isolated LAD ostial stenosis.

Background Treatment of coronary in-stent restenosis (ISR) remains challenging in contemporary clinical applications. Drug-coated balloon (DCB) angioplasty offers an effective treatment for ISR. Shenqi is a novel iopromide-based paclitaxel-coated balloon and its clinical safety, effectiveness and angiographic efficacy in patients with ISR have not been investigated. Methods A total of 216 subjects with the first occurrence of ISR at 11 investigational sites in China were randomly allocated in a 1:1 fashion to treatment with DCB SeQuent Please or Shenqi. Clinical follow-up was planned at 1, 6, 9 and 12 months, and angiographic follow-up was planned at 9 months. The study was powered for the primary endpoint of 9-month in-segment late loss. Results At 9-month follow-up, the in-segment late loss was 0.29 ± 0.43 mm with Shenqi versus 0.30 ± 0.46 mm with SeQuent Please, and the one-sided 97.5% upper confidence limit of the difference was 0.14 mm, achieving noninferiority of Shenqi compared with SeQuent Please (P = 0.002). In total, 12 patients developed target lesion failure (TLF) in the Shenqi group compared with 16 patients in the SeQuent Please group (10.91% versus 15.09%; P = 0.42) within 1 year. TLF was mainly driven by target lesion revascularization (9.09%) followed by target vessel-related myocardial infarction (1.82%) and cardiovascular death (0.91%) in the Shenqi group. Conclusions Shenqi DCB was noninferior to SeQuent Please DCB for the primary endpoint of 9-month in-segment late loss. Shenqi DCB may become an attractive alternative treatment for patients with coronary ISR, withholding the need for additional stent implantation.

Diabetes mellitus (DM) plays an important role in restenosis and late in-stent thrombosis (ST). The current study using optical coherence tomography (OCT) aims to compare target lesion neointima in patients with or without diabetes after zotarolimus-eluting stent (ZES) treatment. OCT images of 90,212 struts and quantitative coronary angiography (QCA) in 62 patients (32 with DM and 30 without DM) with 69 de novo coronary lesions (34 DM and 35 non-DM) both after ZES implantation and 12 ± 1 month angiographic follow-up were recorded. Patient characteristics, lesion characteristics, clinical outcomes, and OCT findings including neointimal thickness, coverage, malapposition, and intimal morphology were analyzed. Baseline patient characteristics and lesion characteristics data were similar between the two groups. Higher neointimal thickness (0.14 ± 0.09 mm vs. 0.09 ± 0.04 mm, p = 0.021), more neovascularization (3.03 ± 6.24 vs. 0.52 ± 1.87, p = 0.017) and higher incidence of layered signal pattern (12.19 ± 19.91% vs. 4.28 ± 9.02%, p = 0.049) were observed in diabetic lesions comparing with non-diabetic lesions. No differences were found in malapposition, uncovered percentage, and thrombus between the two groups (all p > 0.05). Occurrence of clinical adverse events was also similar during the follow-up period (p > 0.05). Although more neointimal proliferation and more neovascularization were found in diabetic coronary lesions when compared with non-diabetic lesions, treatment with ZES showed similar stent malapposition rate at 1-year follow-up. The data indicated that ZES treatment could possibly be effective in treating diabetic coronary lesions. ClinicalTrials.gov identifier, NCT01747356.

Background: Due to advances in medical treatments, a substantial proportion of heart failure (HF) patients with reduced left ventricular ejection fraction (LVEF, HFrEF) have experienced partial or complete recovery of LVEF, termed HFrecEF, and markedly improved clinical outcomes. In the present study, we sought to investigate the relationship between glycemic control and the incidence of HFrecEF in patients with type 2 diabetes mellitus (T2DM).Methods: A total of 310 age- and sex-matched T2DM patients with HFrecEF and persistent HFrEF were retrospectively enrolled based on 12-month repeat echocardiograms. HFrecEF was defined as follow-up LVEF > 40% and absolute LVEF improvement ≥ 10% compared to the baseline. The relationship between HFrecEF and HbA1c levels was analyzed. Results: During the 12-month follow-up, LVEF recovered from 35.93% ± 5.62% to 51.11% ± 8.53% in the HFrecEF group (PP=0.238) in the HFrEF group. T2DM patients with HFrecEF had significantly lower HbA1c level than those with persistent HFrEF (6.4% [IQR 5.8%~7.1%] vs. 6.8% [IQR 6.3%~7.4%], PConclusions: This study demonstrates that HFrEF patients with T2DM are more likely to develop HFrecEF under optimal glycemic control valued by lower HbA1c level.

Background Chromogranin B (CgB) is a member of granin family that can be cleaved into a number of bioactive peptides. Previous studies showed that CgB is produced in cardiomyocytes and is increased in heart failure animals and patients in proportion to disease severity. Chronic total occlusion (CTO) of coronary artery leads to sustained myocardial ischemia which predisposes to adverse cardiovascular outcomes including heart failure. Purpose In this study, we sought to investigate the association between CgB and coronary collateralization formation and heart failure in patients with stable angina and CTO. Methods A total of 720 subjects with stable angina and CTO of at least one major coronary artery were enrolled in this study. CgB was assayed using an ELISA kit and the degree of coronary collaterals supplying the distal aspect of a total occlusion from the contralateral vessel was graded according to Rentrop classification. Results These was a stepwise decrease in levels of CgB with increasing Rentrop grades of coronary collateralization (P=0.001). Compared with the good collateralization (Rentrop grade 2–3) group, CgB was significantly higher in subjects with poor coronary collateralization (Rentrop grade 0–1; 1222.95 [IQR 506.24–2710.24] pg/mL vs. 776.17 [IQR 276.24–2209.39] pg/mL, P Conclusions CgB is an independent predictor of poor coronary collateralization and is related to worse heart function in patients with stable angina and CTO. Figure 1 Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): National Natural Science Foundation of China

Background Left ventricular aneurysm (LVA), a serious complication of transmural myocardial infarction, is generally related to poor cardiovascular outcomes. The formation of LVA is essentially an inflammatory remodeling process regulated by multiple systemic and local factors. Epicardial adipose tissue (EAT), a depot of visceral adipose tissue directly overlying the myocardium, is increasingly recognized as an important immune organ by secreting a variety of bioactive adipocytokines. However, the relation of EAT to the development of LVA is still unclear. Purpose In this study, we sought to investigate the association between EAT volume and the formation of LVA in subjects with previous myocardial infarction (MI). Methods A total of 55 subjects with previous MI and the presence of LVA, and age- and sex-matched 50 subjects with previous MI but without LVA were enrolled between October 2011 and June 2019. EAT was quantified and the presence of LVA was ascertained by cardiac magnetic resonance (CMR). EAT volume was indexed to body surface area. Results In the overall population, EAT volume index was correlated positively to log-transformed N-terminal pro-brain natriuretic peptide (NT-proBNP) levels (Pearson's r=0.332, P=0.002), and inversely to left ventricular ejection fraction (LVEF; Pearson's r=−0.240, P=0.031). The indexed EAT volume was significantly higher in subjects with than without LVA (41.10±11.73 vs. 33.25/11.70 mL/m2, P=0.003). In subjects with LVA, EAT volume index was further increased in those at older age (43.59±13.09 mL/m2 vs. 37.29±8.26 mL/m2, P=0.029) or with type 2 diabetes (43.38±12.32 mL/m2 vs. 35.20±7.67 mL/m2, P=0.013). After adjusting for sex, age and the presence of diabetes in the multivariate analysis, tertiles of EAT volume index remained significantly associated with the presence of LVA (P for trend=0. 003). Strikingly, compared to the lowest tertile (≤30.80 mL/m2), the intermediate (30.80–44.13 mL/m2) and highest (>44.13 mL/m2) tertiles of EAT volume index corresponded to 4.869– (95% CI 1.792–14.155, P=0.003) and 4.876– (95% CI, 1.787–14.206, P=0.003) increased risk for LVA. Conclusion Our study suggests that EAT volume is independently associated with the formation of LVA and reduced cardiac function after myocardial infarction. EAT in patients with or without LVA Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): National Natural Science Foundation of China

Background Patients with type 2 diabetes are under substantially higher risk of in-stent restenosis (ISR) after coronary stent implantation. We sought to investigate whether visit-to-visit HbA1c variability is a potential predictor of ISR in diabetic patients after stent implantation. Methods We consecutively enrolled type 2 diabetic patients who underwent successful elective percutaneous coronary intervention and performed follow-up coronary angiography after around 12 months. The incidence of ISR and its relationship with visit-to-visit HbA1c variability, expressed as coefficient of variation (CV), standard deviation (SD) and variability independent of the mean (VIM), were studied. Multivariable Cox proportional hazards models were constructed to analyze the predictive value of HbA1c variability for ISR. Results From September 2014 to July 2018 in Ruijin Hospital, a total of 420 diabetic patients (688 lesions) after stent implantation were included in the final analysis. During a mean follow-up of 12.8 ± 1.3 months, the incidence of ISR was 8.6%, which was significantly increased in patients with higher CV of HbA1c (P = 0.001). The mean diameter stenosis (DS), net luminal loss and net luminal gain were 22.9 ± 16.8%, 0.42 ± 0.88 mm and 1.66 ± 0.83 mm, respectively. Greater DS was observed in subjects with higher tertiles of CV of HbA1c (P 1c ≤ 7%) in the baseline. In multivariate analysis, HbA1c variability was independently associated with incidence of ISR after adjustment for traditional risk factors and mean HbA1c (HR: 3.00 [95% CI 1.14–7.92] for highest vs. lowest tertile). Inclusion of CV of HbA1c led to a better risk stratification accuracy. Assessing HbA1c variability by SD or VIM yielded similar findings. Conclusions This study suggests that visit-to-visit HbA1c variability is an independent predictor of incidence of ISR in patients with type 2 diabetes after stent implantation. Trial registration NCT02089360: NCT

Background Patients with type 2 diabetes mellitus (T2DM) are predisposed to poor cardiovascular outcomes after ST-segment elevation myocardial infarction (STEMI). Left ventricular adverse remodeling (LVAR) triggered upon myocardial infarction is recognized as the predominant pathological process in the development of heart failure. In the present study, we sought to investigate whether visit-to-visit fasting plasma glucose (FPG) variability is a potential predictor of LVAR in T2DM patients after STEMI. Methods From January 2014 to December 2018 in Ruijin Hospital, T2DM patients with STEMI who underwent primary percutaneous coronary intervention were consecutively enrolled and followed up for ~ 12 months. The changes in left ventricular geometric and functional parameters between baseline and 12-month follow-up were assessed by echocardiography. The incidence of LVAR, defined as 20% increase in indexed left ventricular end-diastolic volume (LVEDV), and its relationship with visit-to-visit FPG variability were analyzed. Multivariate regression models were constructed to test the predictive value of FPG variability for post-infarction LVAR. Results A total of 437 patients with type 2 diabetes and STEMI were included in the final analysis. During a mean follow-up of 12.4 ± 1.1 months, the incidence of LVAR was 20.6% and mean enlargement of indexed LVEDV was 3.31 ± 14.4 mL/m2, which was significantly increased in patients with higher coefficient variance (CV) of FPG (P = 0.002) irrespective of baseline glycemic levels. In multivariate analysis, FPG variability was independently associated with incidence of post-infarction LVAR after adjustment for traditional risk factors, baseline HbA1c as well as mean FPG during follow-up (OR: 3.021 [95% CI 1.081–8.764] for highest vs. lowest tertile of CV of FPG). Assessing FPG variability by other two measures, including standard deviation (SD) and variability independent of the mean (VIM), yielded similar findings. Conclusions This study suggests that visit-to-visit FPG variability is an independent predictor of incidence of LVAR in T2DM patients with STEMI. Trial registration Trials number, NCT02089360; registered on March 17,2014.

Background To assess the prognostic role of coronary collaterals in patients with type 2 diabetes mellitus (T2DM) after successful percutaneous coronary intervention (PCI) for chronic total occlusion (CTO). Methods Coronary collateralization was graded according to Rentrop scoring system in 198 type 2 diabetic patients and 335 non-diabetics with stable angina undergoing PCI for at least one CTO lesion. Left ventricular ejection fraction (LVEF) was determined and major adverse cardio-cerebral events (MACCE) were recorded during follow-up. Results Poor collateralization was more common in patients with T2DM than in non-diabetics (40% vs 29%, p = 0.008). At 13.5 ± 4.1 months, the rate of composite MACCE (17.3% vs 27.6%, p = 0.034) and repeat revascularization (15.2% vs 25.5%, p = 0.026) was lower and the increase in LVEF (3.10% vs 1.80%, p = 0.024) was greater in patients with good collaterals than in those with poor collaterals for non-diabetic group. The associations were in the same direction for T2DM group (35% vs 44%; 30% vs 36%; 2.14% vs 1.65%, respectively) with a higher all-cause mortality in diabetic patients with poor collaterals (p = 0.034). Multivariable Cox proportional hazards analysis showed that coronary collateralization was an independent factor for time to MACCE (HR 2.155,95% CI 1.290–3.599, p = 0.003) and repeat revascularization (HR 2.326, 95% CI 1.357–3.986, p = 0.002) in non-diabetic patients, but did not enter the model in those with T2DM. Conclusions T2DM is associated with reduced coronary collateralization. The effects of the status of coronary collateralization on long-term clinical outcomes and left ventricular function appear to be similar in size in type 2 diabetic patients and non-diabetics after successful recanalization of CTO.

Background Adverse cardiac remodeling after ST-segment elevation myocardial infarction (STEMI) is a major cause for poor cardiovascular outcomes such as heart failure. The predisposing factors and underlying mechanisms remain not fully understood. This study investigates the association of insulin resistance and dysglycemia with left ventricular (LV) remodeling after STEMI in non-diabetic patients. Methods A total of 485 non-diabetic subjects with STEMI who underwent primary percutaneous coronary intervention were consecutively enrolled and followed up for 12 months. Relation of homeostasis model assessment-estimated insulin resistance (HOMA-IR) and glucose levels to changes in echocardiography parameters was studied. Results Left ventricular dilation was detected in 49.1% of subjects at 12-month follow-up after STEMI, and was more severe in subjects with impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and high HOMA-IR levels. HOMA-IR remained correlated to changes in LV dimensions after adjusting for confounding risk factors. Multivariate regression analysis demonstrated that higher HOMA-IR was independently associated with greater LV dilation after STEMI. A significant interaction term was present between HOMA-IR and IGT in the model (P = 0.001). Conclusions Our study reveals that insulin resistance and dysglycemia are prevalent in non-diabetic patients with STEMI and are predictors of the post-infarction LV dilation. Trial registration Trials number, NCT02089360; registered on March 17, 2014

Background We investigated whether or to what extent the interaction of lipoprotein (a) [Lp(a)] with cholesterol-containing lipids was associated with angiographic coronary collateralization in type 2 diabetic patients with chronic total occlusion. Methods Serum levels of Lp(a), total cholesterol, low-density lipoprotein–cholesterol (LDL-C), high-density lipoprotein–cholesterol (HDL-C), and triglyceride were determined and non-HDL-C was calculated in 706 type 2 diabetic and 578 non-diabetic patients with stable coronary artery disease and angiographic total occlusion of at least one major coronary artery. The degree of collaterals supplying the distal aspect of a total occlusion from the contra-lateral vessel was graded as poor (Rentrop score of 0 or 1) or good coronary collateralization (Rentrop score of 2 or 3). Results For diabetic and non-diabetic patients, Lp(a), total cholesterol, LDL-C, and non-HDL-C levels were higher in patients with poor coronary collateralization than in those with good collateralization, whereas HDL-C and triglyceride levels were similar. After adjustment for potential confounding factors, tertiles of Lp(a), total cholesterol, LDL-C and non-HDL-C remained independent determinants for poor collateralization. A significant interaction between Lp(a) and total cholesterol, LDL-C or non-HDL-C was observed in diabetic patients (all P interaction

Objective This study aimed to evaluate the relationship between coronary collateralization and in-stent restenosis (ISR) in stable coronary artery disease patients with chronic total occlusion (CTO) after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation. Methods The degree of coronary collaterals supplying the distal aspect of a total occlusion from the contra-lateral vessel was graded according to Rentrop classification in 216 patients with stable angina undergoing successful DES based PCI for CTO. Univariable and multivariable logistic regression analyses were performed to assess the potential factors related to angiographic ISR during follow-up. Results Despite similar number of diseased coronary arteries, good collateralization (Rentrop score 2 or 3) was more frequently associated with right coronary artery occlusion (60%), whereas poor collaterals (Rentrop score 0 or 1) occurred more often in left anterior descending artery occlusion (40%). Despite similar number of CTO intervened, stent length was longer in patients with good collateralization (59±27mm vs 47±23mm, p =0.001). At mean 18months, the rate of ISR did not significantly differ between patients with good collateralization and those with poor collateralization (12.7% vs 20.2%, p =0.148). At multivariable analysis, age (OR 1.058, 95%CI 1.015–1.104, p =0.008), history of diabetes mellitus (OR 2.382, 95%CI 1.109–5.116, p =0.026) and reference CTO vessel diameter (OR 0.219, 95% CI 0.051–0.951, p =0.043) were independent risk factors for ISR while Rentrop collateral grade (OR 0.795, 95% CI 0.365–1.732, p =0.414) was not associated with ISR. Conclusions The occurrence of ISR after successful DES based PCI for CTO may be not influenced by coronary collateralization.

The present study aimed to investigate the relationship between serum levels of secretory vimentin and coronary artery disease (CAD). The biological effect of secretory vimentin was ascertained by experiments.We analysed serum levels of secretory vimentin in CAD patients (n = 288) and non-CAD controls (n = 195) by ELISA. To evaluate the pro-inflammatory effects of secreted vimentin, the human aortic endothelial cells (HAECs) and human peripheral blood mononuclear cells (PBMCs) were treated with recombinant vimentin or saline. Intraperitoneal injection of vimentin (1 μg/each) or saline was performed every other day for 12 weeks in ApoESerum levels of secretory vimentin were significantly increased in CAD patients than in health controls (p 0.05), and correlated with the number of diseased coronary arteries, Syntax and Gensini score (for all comparison, p 0.01). Logistic regression analysis showed that vimentin level is an independent determinant of CAD. In experiments, recombinant vimentin protein enhanced the expression of adhesion molecules and inflammatory cytokines in both endothelial cells and macrophages. This protein also promoted macrophage-endothelial cells adhesion in vitro and the recruitment of leukocytes to mesenteric venules in C57BL/6 mice. Compared with saline, intraperitoneal injection of recombinant vimentin (1 μg/each) every other day induced atherogenesis in ApoESerum vimentin levels are associated with the presence and the severity of CAD. Vimentin protein promotes atherogenesis in ApoE

Background Negative coronary artery remodeling is frequent in patients with diabetes, but its mechanism remains unclear. We here evaluated the association of serum levels of glycated albumin (GA) and endogenous secretory receptor for advanced glycation end products (esRAGE) with coronary artery remodeling in type 2 diabetic patients. Methods Serum levels of GA and esRAGE were measured and intravascular ultrasound was performed in 136 consecutive diabetic patients with 143 coronary intermediate lesions. The remodeling index (RI) was calculated as the ratio between external elastic membrane (EEM) area at the lesion site and EEM area at the reference segment. Negative remodeling (NR) was defined as an RI

Background We investigated whether and to what extent stenosis of predominant collateral donor artery (PCDA) affects coronary collateral flow in relation to blood pressure (BP) in type 2 diabetic patients with chronic total occlusion (CTO). Methods Collateral flow index (CFI) as derived from intracoronary pressure distal to occluded segment and mean aortic pressure in 220 type 2 diabetic patients and 220 propensity score matched non-diabetic controls undergoing percutaneous coronary intervention for CTO. The severity of PCDA stenosis was graded according to lumen diameter narrowing. Results CFI decreased stepwise from mild to severe stenosis of the PCDA and was lower in diabetic patients with moderate or severe PCDA stenosis than in non-diabetic controls (0.36 ± 0.10 vs. 0.45 ± 0.08, P

Background There is increasing interest in percutaneous coronary intervention (PCI) for chronic total occlusions (CTO). Periprocedural myocardial injury (PMI) post CTO PCI is not uncommon, but true incidence and implications of PMI are not well understood. Objectives This study aimed to investigate risk factors for PMI post CTO PCI and its implications for the 1-year clinical outcome of a Chinese population. Methods Baseline characteristics, procedure features, and major adverse cardiac events (MACE) at 1 year were assessed in 629 consecutive patients who underwent CTO PCI. PMI was diagnosed as an elevation of creatine kinase MB ≥3 times ULN 12–24 hr post procedure. Multivariate analysis was performed to determine the correlates of PMI and MACE at 1-year follow-up. Results In total, PMI was detected in 115 patients (18.3%). Compared with patients without PMI, those with PMI had a higher percentage of previous coronary artery bypass grafting (CABG), right coronary occlusion and side branch occlusion, and technical success was lower in the PMI group (90.4% vs. 96.7%, P = 0.003). One-year MACE-free survival was reduced in the PMI group (87.8% vs. 95.9%, P = 0.001). The final TIMI flow 0–1 (OR 2.23, 95%CI 1.06–4.87, P = 0.02), side branch occlusion (OR 2.67, 95%CI 1.19–7.11, P = 0.009), retrograde PCI (OR 1.35, 95%CI 1.10–2.74, P = 0.04), and history of prior CABG (OR 2.41, 95%CI 1.38–5.91, P = 0.01) were independent risk factors for the occurrence of PMI. Conclusions In this unique Chinese cohort, PMI post CTO PCI was associated with several clinical and angiographic factors and exerts an adverse effect on 1-year clinical outcomes. © 2016 Wiley Periodicals, Inc.

Glycated albumin (GA) and the endogenous secretory receptor for advanced glycation endproducts (esRAGE) may modulate risk related to atherosclerosis. We tested the hypothesis that elevated GA and reduced esRAGE in serum are associated with adverse clinical outcomes in patients with type 2 diabetes and stable coronary artery disease (CAD).We determined GA and esRAGE serum levels in 576 consecutive patients with type 2 diabetes and stable CAD undergoing sirolimus-eluting stent (SES)-PCI. The primary endpoint was the incidence of major adverse cardio-cerebral events (MACCE) including cardiac death, non-fatal myocardial infarction, and non-fatal stroke during a 2-year follow-up. The secondary endpoint was the occurrence of clinically driven repeat revascularization during a 2-year follow-up. The prognostic value of GA and esRAGE was determined with the Cox-proportional hazard model after adjustment for covariates.A total 40 patients (6.9%) experienced MACCE, and 108 (18.8%) patients underwent repeat coronary revascularization during the follow-up. Serum GA (HR=1.22, 95% CI 1.16-1.28; HR=1.15, 95% CI 1.11-1.19, respectively; for both p0.001) and esRAGE (HR=0.60, 95% CI 0.40-0.87; HR=0.75, 95% CI 0.61-0.92, respectively; for both p0.01) levels remained independent predictors of the primary and secondary endpoints after adjustment for possible confounders.Serum GA and esRAGE are novel predictors of long-term clinical outcomes in patients with type 2 diabetes and stable CAD. Increased serum GA and decreased esRAGE are associated with a poor prognosis in such patients.

Objective: We investigated whether disturbance of calcium and phosphate metabolism is associated with the presence and severity of calcific aortic valve disease (CAVD) in patients with normal or mildly impaired renal function. Methods: We measured serum levels of calcium, phosphate, alkaline phosphatase (AKP), intact parathyroid hormone (iPTH), 25-hydroxyvitamin D (25-OHD), and biomarkers of bone turnover in 260 consecutive patients with normal or mildly impaired renal function and aortic valve sclerosis (AVSc) (n=164) or stenosis (AVS) (n=96) and in 164 age- and gender-matched controls. Logistic regression models were used to determine the association of mineral metabolism parameters with the presence and severity of CAVD. Results: Stepwise increases were observed in serum levels of calcium, phosphate, AKP, and iPTH from the control group to patients with AVS, and with reverse changes for 25-OHD levels (all P

Background and purpose:Patients are at risk of developing periprocedural myonecrosis after percutaneous coronary intervention (PCI). We investigated whether the use of the platelet glycoprotein (GP) IIb/IIIa receptor inhibitor tirofiban could reduce periprocedural myocardial infarction (PMI) in pati

Background Sirolimus-eluting stents (SES) with a biodegradable polymer coating have demonstrated promising results but have not been compared to SES with a durable polymer in high-risk patients. We compared the efficacy of these 2 stent types in patients with acute myocardial infarction (STEMI). Methods One thousand one hundred ninety-two STEMI patients were randomized to receive SES coated with biodegradable (n = 596) or durable polymer (n = 596). The study end-point was the composite of major adverse cardiac events (MACE) including all-cause death, recurrent myocardial infarction (MI), or target lesion revascularization (TLR) at 1-year follow-up. Secondary end-points included individual components of primary end-point and stent thrombosis. Results Compared with durable polymer SES, the noninferiority of SES with biodegradable polymer coating was established by an absolute risk difference of 0.9% in the primary end-point (12.4% vs. 13.3%, P = 0.67) and an upper limit of one-sided 95% confidence interval (CI) of 2.96% (P for noninferiority = 0.001). Rate of death, recurrent MI, and TLR were 7.9% and 8.6% (HR: 0.92; 95% CI: 0.61–1.38, P = 0.67), 2.9% and 3.5% (HR: 0.80; 95% CI: 0.42–1.54, P = 0.51), and 2.0% and 3.2% (HR: 0.62; 95% CI: 0.30–1.30, P = 0.20) in the biodegradable polymer SES and durable polymer SES group at 1-year clinical follow-up, respectively. Despite similar rates of 30-day ARC definite/probable stent thrombosis, late stent thrombosis (stent thrombosis occurring beyond 30 days) was lower with biodegradable polymer SES (0.7% vs. 2.2%, P = 0.028). Conclusions In patients undergoing primary PCI for STEMI, the use of biodegradable polymer SES was associated with noninferior 1-year rates of MACE compared with durable polymer SES. (J Interven Cardiol 2014;27:131–141)

Background Glycated albumin (GA) has been shown to be a better indicator than glycosylated hemoglobin A1c (HbA1c) in terms of severity of renal impairment in patients with type 2 diabetes mellitus (T2DM). This study aimed to determine whether elevated serum GA levels are associated with an increased risk for contrast-induced acute kidney injury (CI-AKI) and worse clinical outcome in patients with T2DM and at least moderate renal insufficiency (RI) undergoing coronary angiography. Methods Serum levels of fasting blood glucose (FBG), HbA1c and GA were measured in 1030 patients with T2DM and moderate to severe RI (eGFR 15–59mL/min/1.73m 2 ). CI-AKI was defined as ≥25% increase in serum creatinine within 72h after the procedure. Receiver-operating characteristic curve was constructed to assess the predictive value of GA, HbA1c and FBG for CI-AKI. Multivariable logistic regression model was developed to identify risk factors for CI-AKI, and Kaplan–Meier curve analysis was used to compare the rates of dialysis and major adverse cardiac events (MACE) during one-year follow-up. Results The overall rate of CI-AKI was 11.1%. GA was significantly higher in patients with CI-AKI than in those without, and correlated positively with changes of renal function after the procedure. After adjusting for age, sex, left ventricular ejection fraction, multi-vessel disease, type and volume of contrast media, FBG, and HbA1c, GA remained an independent risk factor for CI-AKI. GA≥21% was associated with increased rates of dialysis and MACE during one-year follow-up in patients with or without CI-AKI. Conclusions Increased GA level serves as a valuable risk factor for CI-AKI and indicates poor one-year clinical outcome in patients with T2DM and moderate to severe RI.

Background We investigated whether an additional intracoronary tirofiban bolus administration following upstream intravenous treatment could further improve myocardial reperfusion and clinical outcome in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Methods A total of 453 eligible STEMI patients were randomly allocated to intracoronary bolus administration of tirofiban (10μg/kg; n=229) or saline (10mL; n=224) during primary PCI, followed by intravenous tirofiban infusion (0.15μg/kg/min) for 24–36h. Serum levels of P-selectin, vWF, CD40L and serum amyloid A (SAA) in the coronary sinus were measured before and after intracoronary bolus administration. The primary endpoint was ST-segment resolution (STR) at 90min after the procedure. Second endpoints included corrected TIMI frame count (cTFC), left ventricular volumes and ejection fraction (EF), and major adverse cardiac events (MACE) at 30-day and 6-month follow-up. Results Intracoronary tirofiban administration resulted in a higher rate of completed STR (59.0% vs. 44.6%, P=0.002), lower cTFC (21.6±5.4 vs. 23.7±7.8, P=0.048), and significantly reduced coronary sinus levels of P-selectin, vWF, CD40L and SAA. Patients treated with intracoronary tirofiban had a trend toward less MACE at 30days (3.1% vs. 6.7%, P=0.072). At 6months, left ventricular end-systolic volume was smaller, EF was higher and MACE-free survival was improved (96.1% vs. 90.6%, P=0.020) in the intracoronary tirofiban group. Conclusions An additional intracoronary tirofiban bolus administration following upstream intravenous treatment reduces coronary circulatory platelet activation and inflammatory process, and significantly improves myocardial reperfusion and left ventricular function as well as 6-month MACE-free survival for STEMI patients undergoing primary PCI.

Objectives We investigated whether α2-adrenergic receptor (AR) polymorphisms (α2A-AR, α2B-AR and α2C-AR gene) affected silent myocardial ischemia (SMI) in patients with type 2 diabetes mellitus (T2DM). Design and methods Genetic polymorphisms were determined in 321 patients with T2DM and coronary artery disease (CAD). Among them, 129 patients experienced transient asymptomatic ST-depression during 24-hour ambulatory electrocardiogram (SMI group), and the remaining 192 patients who had ambulatory electrocardiogram-symptom matching angina were categorized as angina group. Results The genotype distribution and allele frequencies of α2B-AR gene polymorphism (insertion [I]/deletion[D]) exhibited significant difference between SMI group and angina group (both P

OBJECTIVES This study aimed to evaluate the impact of angiographic and intravascular ultrasound (IVUS) features on clinical outcome in nondiabetic and type 2 diabetic patients after percutaneous coronary intervention (PCI) with sirolimus-eluting stent (SES) implantation. METHODS Repeat coronary angiography with IVUS imaging was performed after SES-based PCI for de-novo lesions in 128 diabetic and 327 nondiabetic patients (189 lesions and 504 lesions, respectively). The rate of major adverse cardiac events including cardiac death, non fatal myocardial infarction (MI), and target lesion revascularization during clinical follow-up was recorded. RESULTS In-stent and in-segment late loss, intimal hyperplasia volume, and percentage volumetric obstruction were similar, but stented external elastic membrane cross-sectional area and reference/stented segment ratio were lower in diabetic than in nondiabetic patients. Incomplete stent apposition (ISA) was less frequent, but occurrence of new coronary lesions was higher in diabetic than in nondiabetic patients. Despite similar target lesion revascularization, cumulative survival rates freedom from composite cardiac death and nonfatal MI or major adverse cardiac events were reduced in diabetic patients. Cox proportional hazards model identified diabetes, left ventricular ejection fraction, minimal stent CSA, maximal ISA area, atherosclerotic progression and lesion length as independent predictors of non fatal MI or mortality at follow-up. CONCLUSION In diabetic patients, PCI with SES implantation neutralizes the excess risk of intimal hyperplasia and decreases occurrence of ISA, but could not modify the propensity of increased adverse clinical outcomes at follow-up.

Bosentan has an established role in the management of pulmonary arterial hypertension (PAH). This clinical trial assessed the benefits of bosentan in the Chinese population.We investigated the efficacy and safety of bosentan in 92 Chinese citizens (mean +/- standard deviation age, 29.0 +/- 3.8 years) with PAH for a minimum of 12 weeks. All received bosentan (62.5 mg twice daily) for 4 weeks; then, patients who weighed40 kg received 62.5 mg bosentan twice daily and patients who weighed40 kg received 125 mg twice daily. All patients were eligible to continue bosentan beyond 12 weeks. The primary end point was a change in exercise capacity from baseline to 12 and 24 weeks. Secondary end points included a change in World Health Organization (WHO) functional class and changes in cardiopulmonary hemodynamics.At baseline, 66 patients (72%) were in WHO functional class III; presentation was 37 (40%) with idiopathic PAH (iPAH), 34 (37%) with PAH related to congenital heart disease (CHD), and 21 (23%) with PAH related to connective tissue disease (CTD). Exercise capacity increased to 67.8 m after 12 weeks and 92.6 m after 24 weeks (p0.001). After 24 weeks, WHO functional class decreased (-0.8 +/- 0.6; p0.001), mean pulmonary artery pressure and pulmonary vascular resistance decreased (p0.01), and cardiac output increased (p0.001). Twelve patients (13%) experienced at least 1 adverse event.Bosentan improved exercise capacity, functional class, and cardiopulmonary hemodynamics in this patient cohort and was well tolerated.

Background: The efficacy of partial vs full coverage for tandem lesions in the culprit vessel during primary percutaneous coronary intervention (PCI) after ST-elevation myocardial infarction (STEMI) was compared in the present study. Methods and Results: The 76 patients with STEMI and tandem lesions in the culprit vessel were randomized to receive stent implantation for an occluded/culprit lesion only (partial group) or complete coverage of lesions (full group). After PCI, patients in the partial group had more complete ST-segment resolution (STR) at 90 min (60.5% vs 28.9%, P=0.006), Thrombosis In Myocardial Infarction (TIMI) flow grade 3 (68.4% vs 28.9%, P=0.001), and myocardial blush grade 3 (42.1% vs 15.8%, P=0.04) than those in the full group. At 6 months, the major adverse cardiac events-free survival rate did not differ significantly between groups, but left ventricular (LV) ejection fraction was improved in the partial group. Multivariate analysis revealed pre-procedural TIMI flow grade >1 and door-to-balloon time

Objective: The RIFT study aimed to observe the impact of renal insufficiency (RI) on the incidence of stent thrombosis (ST) after percutaneous coronary intervention. Methods: The RIFT study enrolled 1,174 patients undergoing revascularization exclusively with sirolimus-eluting stents. The occurrence of ST and major adverse cardiac events were compared between patients with (n = 309) and without (n = 865) RI, and independent predictors of ST were also identified. Results: During follow-up (mean 18.9 ± 9.2 months), the rate of ST was significantly higher in patients with than without RI [5.5% (n = 17) vs. 1.7% (n = 15), p < 0.001], and the presence of severe RI (estimated glomerular filtration rate 2) was an independent predictor of ST (odds ratio = 4.5, 95% confidence interval 1.4–15, p = 0.011). In patients with RI and diabetes or left ventricular ejection fraction (LVEF) Conclusions: These findings substantiate the importance of long-term antiplatelet therapy for patients with RI after drug-eluting stent implantation.

BACKGROUND Drug-eluting stent (DES) has been used widely for the treatment of patients with acute coronary syndrome with or without diabetes mellitus during percutaneous coronary intervention (PCI), but its long-term safety and efficacy in diabetic patients with acute ST elevation myocardial infarction (STEMI) remain uncertain. This study aimed to investigate the clinical outcomes after primary coronary intervention with DES implantation for diabetic patients with acute STEMI, compared with non-diabetic counterparts. METHODS From December 2004 to March 2006, 56 consecutive diabetic patients (diabetic group) and 170 non-diabetic patients (non-diabetic group) with acute STEMI who underwent primary PCI with DES implantation in 3 hospitals were enrolled. Baseline clinical, angiographic, and procedural characteristics, as well as occurrence of major adverse cardiac event (MACE) including cardiac death, non-fatal recurrent myocardial infarction (re-MI) and target vessel revascularization (TVR) during hospitalization and one-year clinical follow-up were compared between the two groups. RESULTS Patients in diabetic group were more hyperlipidemic (69.6% and 51.8%, P = 0.03) and had longer time delay from symptom onset to admission ((364 +/- 219) minutes and (309 +/- 223) minutes, P = 0.02) than those in non-diabetic group. The culprit vessel distribution, reference vessel diameter, and baseline TIMI flow grade were similar between the two groups, but multi-vessel disease was more common in diabetic than in non-diabetic group (82.1% and 51.2%, P < 0.001). Despite similar TIMI flow grades between the two groups after stenting, the occurrence of TIMI myocardial perfusion grade (TMPG) = 2 was lower in diabetic group (75.0% vs 88.8% in non-diabetic groups, P = 0.02). The MACE rate was similar during hospitalization between the two groups (5.4% vs 3.5%, P = 0.72), but it was significantly higher in diabetic group (16.1%) during one-year follow-up, as compared with non-diabetic group (6.5%, P = 0.03). The cumulative one-year MACE-free survival rate was significantly lower in diabetic than in non-diabetic group (78.6% vs 90.0%, P = 0.02). Angiographic stent thrombosis occurred in 5.4% and 1.2% of the patients in diabetic and non-diabetic group, respectively (P = 0.19). All of these patients experienced non-fatal myocardial infarction. CONCLUSIONS Although the early clinical outcomes were similar in diabetic and non-diabetic patients with acute STEMI treated with DES implantation, the cumulative MACE-free survival at one-year follow-up was worse in diabetic than in non-diabetic patients. More effective diabetes-related managements may further improve the clinical outcomes of diabetic cohort suffering STEMI.

AIMS To evaluate the efficacy and safety of a 5-in-6 double catheter (DC) technique during transradial complex PCI compared to a conventional buddy-wire or balloon-anchoring approach. METHODS AND RESULTS One hundred and eighty-seven patients who failed in stent or balloon delivery after successful wiring of the target vessel were prospectively randomised to further treatment with a 5-in-6 DC technique (DC group, n=94) or by a conventional buddy-wire or balloon-anchoring approach (control group, n=93). Baseline clinical and lesion features were comparable between the two groups. The primary endpoint of technical success was significantly higher in the DC than in the control group (97.9% and 39.8%, p

This study aimed to evaluate the impact of vascular response assessed by intravascular ultrasound (IVUS) imaging on clinical outcomes in elderly patients (≥ 75 years) undergoing percutaneous coronary intervention (PCI) for de novo lesions with sirolimus-eluting stent (SES) implantation. Repeat coronary angiography with IVUS was performed 1 year after SES-based PCI for de novo lesions in 136 elderly patients (≥ 75 years) and 427 younger counterparts (75 years) (219 lesions and 635 lesions, respectively). Major adverse cardiac events (MACE) including cardiac death, non-fatal myocardial infarction, and target lesion revascularization (TLR) during 2-year follow-up were recorded. Despite similar angiographic in-stent restenosis and TLR and IVUS-detected incomplete stent apposition (ISA), absolute intimal hyperplasia and percentage of volumetric obstruction were lower in elderly than in younger patients. At 2-year follow-up, cumulative survival freedom from composite death and myocardial infarction or MACE was significantly reduced in elderly patients, but very late stent thrombosis was similar in the two groups. Cox proportional hazards model identified age, diabetes, left ventricular ejection fraction, lesion length,minimal stent cross-sectional area and plaque progression as independent predictors of non-fatal myocardial infarction or mortality. In elderly patients undergoing SES-based PCI, despite similar TLR, neointimal hyperplasia was significantly lower than in younger patients. IVUS measurements except for minimal stent cross-sectional area did not correlate with stent thrombosis and clinical outcomes at 2 years.

Background Recently, a chronic total occlusion (CTO) in the non-infarct-related artery (non-IRA) was reported as an independent predictor of clinical outcome in patients with acute ST-segment elevation myocardial infarction (STEMI). The aim of this study was to investigate the clinical significance of staged revascularization for a CTO in the non-IRA for patients with STEMI. Methods A total of 136 patients with acute STEMI undergoing primary percutaneous coronary intervention (PCI) received staged revascularization (ranging 7–10days) for a CTO in the non-IRA. Cardiac mortality and major adverse cardiac events (MACE) including death, recurrent myocardial infarction, repeat revascularization, and re-hospitalization because of heart failure during 2-year follow-up were recorded. Results Recanalization of totally occluded lesions in the non-IRA was successful in 87 (64%) patients for 93 lesions but failed in 49 (36%) patients. During 2-year follow-up, cardiac mortality was lower (8.0% vs. 20.4%, p=0.036) and MACE-free survival was higher (78.2% vs. 61.2%, p=0.042) in patients with successful than in those with failed revascularization of a CTO in the non-IRA. Multivariable analysis showed that after adjustment for possible confounders, successful recanalization of a CTO in the non-IRA was an independent predictor for 2-year cardiac mortality (HR=0.145, 95% CI 0.047–0.446, P=0.001) and MACE-free survival (HR=0.430, 95%CI 0.220–0.838, P=0.013). Conclusion Successful revascularization of a CTO in the non-IRA is associated with improved clinical outcomes in patients with STEMI undergoing primary PCI.

Cardiac rupture is an uncommon but catastrophic mechanical complication after acute myocardial infarction associated with an exceedingly high mortality. We report the case of a 64-year-old man who presented with a subacute biventricular rupture after acute inferior ST segment elevation myocardial infarction.

There is continued debate as to whether a combined reperfusion regimen with platelet glycoprotein IIb/IIIa inhibitor-tirofiban provides additional benefit in optimal myocardial reperfusion for patients with acute ST-segment elevation myocardial infarction (STEMI). This study was conducted to investigate the clinical benefits of adjunctive tirofiban therapy combined with primary percutaneous coronary intervention (PCI) in patients with STEMI.One hundred and seventy-two consecutive patients with STEMI presented within 12 h of symptoms were randomly allocated to primary PCI combined with early (upstream group, n=57) or late administration of tirofiban (downstream group, n=57) or primary PCI treatment alone (control group, n=58). Clinical characteristics, angiographic findings, and in-hospital outcomes were compared between groups, as well as left ventricular ejection fraction (LVEF) and major adverse cardiac events (MACE, including death, reinfarction and target vessel revascularization) at 30-day and 6-month clinical follow-up.Despite comparable baseline clinical features among three groups, angiographic and procedural characteristics and outcomes differed significantly between patients receiving tirofiban treatment and controls, with respect to preprocedural (upstream: 28.1%, downstream: 7.0%, control: 5.2%, P0.001) and postprocedural thrombolysis in myocardial infarction (TIMI) grade 3 flow of infarct-related artery (98.2, 94.7, 86.2%, P=0.03), TIMI myocardial perfusion grade 3 (75.4, 70.2, 53.4%, P=0.03), corrected TIMI frame count (20.4+/-5.0, 23.1+/-5.3, 32.2+/-6.7, P0.001), resolution of the sum of ST-segment elevation (6.16+/-1.21, 6.02+/-1.09, 4.53+/-2.65 mm, P0.001), peak value of creatine kinase-MB (218.0+/-72.5, 224.2+/-69.4, 255.3+/-77.0 ng/ml, P=0.02) and troponin I (76.0+/-21.5, 79.8+/-18.7, 86.4+/-11.0 ng/ml, P=0.007), and average hospital stay (10.6+/-5.4, 12.6+/-4.7, 14.5+/-6.5 days, P=0.001). The MACE rate at 30 days (3.5, 5.3, 15.5%, P=0.04) was reduced and LVEF (0.51+/-0.07, 0.50+/-0.07, 0.47+/-0.08, P=0.008) was higher in upstream and downstream groups than in controls. At 6-month follow-up, the MACE rate was not significantly different among groups (7.0, 8.8, 17.2%, P=0.17), but LVEF in upstream and downstream groups was significantly improved (0.59+/-0.06, 0.57+/-0.07, 0.54+/-0.07, P0.001). Subgroup analysis demonstrated a statistically significant difference between upstream and downstream groups in preprocedural TIMI grade 3 flow (P=0.003) and postprocedural corrected TIMI frame count (P=0.007), which resulted in a shortened hospital stay (P=0.04), reduction of MACE rate at 30-day and 6-month follow-up by 34 and 20%, respectively. Multivariate logistic analysis revealed that age more than 65 years [odds ratio (OR)=3.42, P0.01], tirofiban therapy (OR=0.56, P0.05) and LVEF less than 0.5 during hospitalization (OR=2.56, P0.01) were major independent predictors of MACE at 6-month clinical follow-up. No significant difference in hemorrhagic complications among three groups was noted (upstream: 10.5%, downstream: 12.3%, control: 6.9%, P=0.61).This prospective study indicates that adjunctive tirofiban therapy for patients with STEMI who undergo primary PCI can significantly improve reperfusion level in the infarct area, clinical outcomes at 30-day and 6-month follow-up, especially with upstream tirofiban therapy, and is safe.

We sought to examine the impact of moderate or severe renal insufficiency (RI) on long-term clinical outcomes after successful percutaneous coronary intervention (PCI) with drug-eluting stent implantation.All-cause mortality and major adverse cardiac events were prospectively determined for 1174 patients after successful PCI with drug-eluting stent implantation. Based on estimated creatinine clearance (CrCl) levels, long-term outcomes were compared between patients with CrCl60 ml/min (RI group; n=460) and those with CrClor =60 ml/min (control group; n=714). Hazard ratio for mortality and myocardial infarction was further evaluated for patients with severe (CrCl30 ml/min), moderate (CrCl 30-59 ml/min), mild RI (CrCl 60-89 ml/min) and normal renal function (CrClor =90 ml/min).Patients in RI group were older, lower body weight and hemoglobin, more female gender, and less cigarette smokers than those in control group. During follow-up (averaged 19.2 months) after successful PCI, all-cause death (8.3% vs. 1.5%, P0.001), cardiac death (5.7% vs. 1.1%, P0.001) and occurrence of non-fatal myocardial infarction (2.2% vs. 0.4%, P=0.005) were significantly higher, but rate of target vessel revascularization (TVR) was lower (5.7% vs. 9.6%, P=0.017) in RI group than in control group. Multivariate analysis revealed that CrCl60 ml/min, diabetes, left ventricular ejection fraction0.50 and anemia were independent risk factors for mortality and non-fatal myocardial infarction. Compared with patients with normal renal function, hazard ratio for a composite of mortality and myocardial infarction was 1.079 (P=0.907), 5.067 (P=0.007) and 8.828 (P=0.002) in patents with mild, moderate and severe RI, respectively.Irrespective of whether drug-eluting stent implantation reduces TVR, the presence of moderate or severe RI is still associated with unfavorable long-term outcomes.

Background: Drug-eluting stents (DES) constitute a major breakthrough in restenosis prevention after percutaneous coronary intervention (PCI). This study compared the clinical outcomes of PCI using DES versus coronary artery bypass graft (CABG) in patients with multivessel coronary artery disease (MVD) in real-world. Methods: From January 2003 to December 2004, 466 consecutive patients with MVD underwent revascularization, 235 by PCI with DES and 231 by CABG. The study end-point was the incidence of major adverse cardiovascular events (MACEs) at the first 30 days after procedure and during follow-up. Results: Most preoperative characteristics were similar in the two groups, but left main disease (24.7% vs 2.6%, P

Background The optimal reperfusion strategy in elderly patients with ST-elevation myocardial infarction (STEMI) remains unclear. The purpose of this study was to evaluate the safety, in-hospital and one-year clinical outcomes for patients 75 years of age with STEMI receiving primary percutaneous coronary intervention (PCI), compared with those treated by conservative approach. Methods One hundred and two patients 75 years of age with STEMI presented 12 hours were randomly allocated to primary PCI (n=50) or conservative therapy only (n=52). The baseline characteristics, in-hospital outcome and major adverse cardiac events (MACE), including death, non-fatal myocardial infarction and target vessel revascularization at one-year clinical follow-up were compared between the two groups. Results Age, gender distribution, risk factors for coronary artery disease, infarct site and clinical functional status were similar between the two groups, but the patients in primary PCI group received less low-molecular-weight heparin during hospitalization. Compared with conservative group, the patients in primary PCI group had significantly lower occurrence rate of re-infarction and death and shortened hospital stay. The composite endpoint for in-hospital survivals at 30-day follow-up was similar between the two groups, but one-year MACE rate was significantly lower in the primary PCI group (21.3% and 45.2%, P=0.029). Left ventricular ejection fraction was not significantly changed in both groups during follow-up. Multivariate analysis revealed that primary PCI (OR=0.34,95% CI: 0.21-0.69, P =0.03) improved MACE-free survival rate for STEMI patients aged 75 years. Conclusion Our results indicated that primary PCI was safe and effective in reducing in-hospital mortality and one-year MACE rate for elderly patients with STEMI.

Background Patients with end-stage renal disease have a high mortality from coronary artery disease, but the impact of moderate renal insufficiency on clinical outcomes after percutaneous coronary intervention (PCI) and the effect of drug-eluting stent implantation in these patients remain unclear. This study determined the long-term effect of moderate renal insufficiency on death and major adverse cardiac events (MACE) after stent based PCI and examined whether drug-eluting stent implantation could favourably influence clinical outcome. Methods Major adverse cardiac events and causes of mortality were determined for 1012 patients undergoing percutaneous intervention from January 1, 2002 to December 31, 2004 at Shanghai Ruijin Hospital. Based on estimated creatinine clearance levels, long term outcomes were compared between patients with estimated creatinine clearance

Background: Sirolimus-eluting stents (SES) with biodegradable polymer coating showed promising results in registry studies. We investigated whether their efficacy and safety were noninferior to those of durable polymer-coated SES in primary percutaneous coronary intervention (PCI) for patients with acute ST-segment elevation myocardial infarction (STEMI). Methods: A total of 1192 STEMI patients within 12 hours of symptom-onset were randomly assigned, in an open-label fashion with 1:1 ratio, to receive SES coated with biodegradable (n=596) or durable polymer (n=596) during primary PCI. Primary endpoint was composite major adverse cardiac events (MACE) at one-year follow-up, including all-cause mortality, recurrent myocardial infarction, and target lesion revascularization. Secondary endpoint included individual components of primary endpoint and stent thrombosis according to the ARC definition. Results: Compared with durable polymer coated SES, the non-inferiority of SES with biodegradable polymer coating was established by an absolute risk difference of -0.9% in primary endpoint (12.4% vs. 13.3%, p=0.67) and an upper limit of one-sided 95% CI at 2.96% (one-sided p value for non-inferiority=0.001). And the finding of non-inferiority of SES with biodegradable polymer coating was consistent across the subgroups of patients with left ventricular dysfunction, door-to-balloon time 65 years in age. Despite similar occurrence of acute and subacute stent thrombosis (definite or probable), late stent thrombosis was lower after implantation of biodegradable polymer coated SES (0.7% vs. 2.2%, p=0.03). Conclusions: Our results indicate that a stent eluting sirolimus from a biodegradable polymer represents an effective and safer alternative to a stent eluting sirolimus from a durable polymer in STEMI patients treated by primary PCI.

Background: We investigated whether periprocedural intensive rosuvastatin therapy, compared with atorvastatin treatment, could lead to a further improvement of myocardial reperfusion among patients with ST-Elevation Myocardial Infarction (STEMI) undergoing primary PCI. Methods: In total, 435 patients with acute STEMI undergoing primary PCI were randomly assigned to receive no statin (Group I, n=149) or a loading dose of 80mg atorvastatin (Group II, n=144) or 40mg rosuvastatin (Group III, n=142) before the procedure. After PCI, Group I patients were treated with atorvastatin 20mg/day. For those in Group II or Group III, atorvastatin 40mg/day or rosuvastatin 20mg/day was given for 5 days, followed by atorvastatin 20mg/day or rosuvastatin 10mg/day, respectively, until the end of study. The primary endpoint was the corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) of Infarct-Related Artery (IRA) immediately after revascularization. Secondary endpoints included mean ST-segment Resolution (STR), enzymatic infarct size, Left Ventricular (LV) function, and Major Adverse Cardiac Event (MACE) free survival at 30-day follow-up. Results: The primary endpoint was significantly improved in statin-pretreatment groups after stent implantation (Group I: 26.4±14.2; Group II: 22.3±10.2; Group III 22.8±9.4, p=0.004). Striking differences were detected when comparisons using Fisher's Least Significant Difference (LSD) method were made between Group I and Group II (p=0.002) or Group III (p=0.007), respectively, while not between Group II and Group III (P=0.74). Similar differences were also achieved in mean STR (p=0.009), but not in enzymatic infarct size, LV Ejection Fraction (EF) and MACE free survival at 30-day follow-up among groups. The serum level of high-sensitivity C-reactive protein (hsCRP) 24h to 72h after primary PCI was dramatically lower in Groups II and III than in Group I (p

Background Observational clinical studies have shown that patients with diabetes have less favorable results after percutaneous coronary intervention compared with the non-diabetic counterparts, but its mechanism remains unclear. The aim of this study was to examine the changes of neointimal hyperplasia after sirolimus-eluting stent (SES) implantation in a diabetic porcine model, and to evaluate the impact of aortic inflammation on this proliferative process. Methods Diabetic porcine model was created with an intravenous administration of a single dose of streptozotocin in 15 Chinese Guizhou minipigs (diabetic group); each of them received 2 SES (Firebird, Microport Co, China) implanted into 2 separated major epicardial coronary arteries. Fifteen non-diabetic minipigs with SES implantation served as controls (control group). At 6 months, the degree of neointimal hyperplasia was determined by repeat coronary angiography, intravascular ultrasound (IVUS) and histological examination. Tumor necrosis factor (TNF)-α protein level in the aortic intima was evaluated by Western blotting, and TNF-α, interleukin (IL)-1β and IL-6 mRNA levels were assayed by reverse transcription and polymerase chain reaction. Results The distribution of stented vessels, diameter of reference vessels, and post-procedural minimal lumen diameter were comparable between the two groups. At 6-month follow-up, the degree of in-stent restenosis (40.4 ± 24.0% vs. 20.2 ± 17.7%, p < 0.05), late lumen loss (0.33 ± 0.19 mm vs. 0.10 ± 0.09 mm, p < 0.001) by quantitative angiography, percentage of intimal hyperplasia in the stented area (26.7 ± 19.2% vs. 7.3 ± 6.1%, p < 0.001) by IVUS, and neointimal area (1.59 ± 0.76 mm2 vs. 0.41 ± 0.18 mm2, p < 0.05) by histological examination were significantly exacerbated in the diabetic group than those in the controls. Significant increases in TNF-α protein and TNF-α, IL-1β and IL-6 mRNA levels were observed in aortic intima in the diabetic group. Conclusion Neointimal hyperplasia persisted at least up to 6 months after SES implantation in diabetic porcine, which may be partly related to an exaggerated inflammatory response within the blood vessel wall. Our results provide theoretical support for potential direct beneficial effects of anti-diabetic and anti-inflammation medications in reducing the risk of restenosis after stenting.