Clinical features and long-term prognosis of diabetic patients with low or intermediate complexity coronary artery disease post percutaneous coronary intervention / 中华心血管病杂志

Objective: To investigate the clinical features and long-term prognostic factors of diabetic patients with low or intermediate complexity coronary artery disease (CAD) post percutaneous coronary intervention (PCI). Methods: This was a prospective, single-centre observational study. Consecutive diabetic patients with SYNTAX score (SS)≤32 undergoing PCI between January and December 2013 in Fuwai hospital were included in this analysis. The patients were divided into two groups based on SS, namely SS≤22 group and SS 23-32 group. Multivariate Cox regression analysis was performed to identify independent factors related to poor 5-year prognosis. The primary outcomes were cardiac death and recurrent myocardial infarction, the secondary outcomes were all cause death and revascularization. Results: Of the 3 899 patients included in the study, 2 888 were men (74.1%); mean age was 59.4±9.8 years. There were 3 450 patients in the SS≤22 group and 449 patients in the SS 23-32 group. Compared with SS≤22 group, the incidence of revascularization was higher in SS 23-32 group (18.9% (85/449) vs. 15.2% (524/3450), log-rank P=0.019). There was no significant difference in all-cause death, cardiac death and recurrent myocardial infarction between the two groups (log-rank P>0.05). Multivariate Cox regression analysis showed that age (HR=1.05, 95%CI 1.02-1.08, P<0.001), chronic obstructive pulmonary disease (HR=3.12, 95%CI 1.37-7.07, P=0.007) and creatinine clearance rate (CCr)<60 ml/min (HR=3.67, 95%CI 2.05-6.58, P<0.001) were independent risk factors for 5-year cardiac death, while left ventricular ejection fraction (HR=0.94, 95%CI 0.91-0.96, P<0.001) was a protective factor. Previous PCI (HR=2.04, 95%CI 1.38-3.00, P<0.001), blood glucose level≥11.1 mmol/L on admission (HR=2.49, 95%CI 1.32-4.70, P=0.005) and CCr<60 ml/min (HR=1.85, 95%CI 1.14-2.99, P=0.012) were independent risk factors for 5-year recurrent myocardial infarction. The SS of 23-32 was independently associated with risk of revascularization (HR=1.54, 95%CI 1.09-2.16, P=0.014), after adjusting for residual SS. Residual SS was not a risk factor for 5-year prognosis. Conclusions: In diabetic patients with low-or intermediate complexity CAD, SS 23-32 is associated with increased risk of 5-year revascularization; the clinical characteristics of the patients are associated with the long-term mortality and recurrent myocardial infarction, but not related to revascularization.

Impact of prolonging dual antiplatelet therapy on long-term prognosis of elderly patients with coronary heart disease complicated with diabetes mellitus undergoing drug-eluting stent implantation / 中华心血管病杂志

Objective: To explore and compare the effect of standard or prolonged dual antiplatelet therapy (DAPT) on the long-term prognosis of elderly patients with coronary heart disease complicated with diabetes mellitus after drug-eluting stent (DES) implantation. Methods: Consecutive patients with diabetes mellitus, ≥65 years old, underwent DES implantation, and had no adverse events within 1 year after operation underwent percutaneous coronary intervention (PCI) from January to December 2013 in Fuwai Hospital were enrolled in this prospective cohort study. These patients were divided into three groups according to DAPT duration: standard DAPT duration group (11 ≤ DAPT duration≤ 13 months) and prolonged DAPT duration group (13<DAPT duration≤ 24 months; DAPT duration>24 months). All the patients were followed up at 1, 6 months, 1, 2 and 5 years in order to collect the incidence of major adverse cardiovascular and cerebrovascular events (MACCE), and type 2 to 5 bleeding events defined by the Federation of Bleeding Academic Research (BARC). MACCE were consisted of all cause death, myocardial infarction, target vessel revascularization or stroke. The incidence of clinical adverse events were compared among 3 different DAPT duration groups, and Cox regression model were used to analyze the effect of different DAPT duration on 5-year long-term prognosis. Results: A total of 1 562 patients were enrolled, aged (70.8±4.5) years, with 398 female (25.5%). There were 467 cases in standard DAPT duration group, 684 cases in 13<DAPT duration≤ 24 months group and 411 cases in DAPT duration>24 months group. The patients in standard DAPT duration group and the prolonged DAPT duration groups accounted for 29.9% (467/1 562) and 70.1% (1 095/1 562), respectively. The 5-year follow-up results showed that the incidence of all-cause death in 13<DAPT duration≤ 24 months group (4.8%(33/684) vs. 8.6%(40/467),P=0.011) and DAPT duration>24 month group(4.1%(17/411) vs. 8.6%(40/467),P=0.008) were significantly lower than in standard DAPT group. The incidence of myocardial infarction in 13<DAPT duration≤ 24 months group was lower than in standard DAPT duration group (1.9%(13/684) vs. 5.1%(24/467),P=0.002). The incidence of MACCE in 13<DAPT duration≤ 24 months group was the lowest (standard DAPT duration group, 13<DAPT duration≤ 24 months group and DAPT duration>24 month group were 19.3% (90/467), 12.3% (84/684), 20.2% (83/411), respectively, P<0.001). There was no significant difference in the incidence of stroke and bleeding events among the three groups (all P>0.05). Multivariate Cox analysis showed that compared with the standard DAPT group, prolonged DAPT to 13-24 months was negatively correlated with MACCE (HR=0.601, 95%CI 0.446-0.811, P=0.001), all-cause death (HR=0.568, 95%CI 0.357-0.903, P=0.017) and myocardial infarction (HR=0.353, 95%CI 0.179-0.695, P=0.003). DAPT>24 months was negatively correlated with all-cause death (HR=0.687, 95%CI 0.516-0.913, P=0.010) and positively correlated with revascularization (HR=1.404, 95%CI 1.116-1.765, P=0.004). There was no correlation between prolonged DAPT and bleeding events. Conclusions: For elderly patients with coronary heart disease complicated with diabetes mellitus underwent DES implantation, and had no MACCE and bleeding events within 1 year after operation, appropriately prolonging of the DAPT duration is related to the reduction of the risk of cardiovascular adverse events. Patients may benefit the most from the DAPT between 13 to 24 months. In addition, prolonging DAPT duration does not increase the incidence of bleeding events in this patient cohort.

Effect of platelet reactivity on clinical events in patients using bivalirudin in selective percutaneous coronary intervention / 中华心血管病杂志

Objective: To investigate the effect of platelet reactivity and other clinical factors on the postoperative 1-year adverse clinical events in patients who underwent selective percutaneous coronary intervention (PCI) anticoagulated with bivalirudin. Methods: This is a multicenter, retrospective and observational study, enrolling 632 patients at high risk of bleeding adjudicated by operators who underwent selective PCI anticoagulated with bivalirudin and had preoperative thrombelastography (TEG) test results in Fuwai Hospital, Northern Theater General Hospital and Xinxiang Central Hospital between January 2017 and August 2018. Platelet reactivity was tested by TEG and adenosine-induced maximal amplitude (MAADP) was recorded. According to MAADP patients were divided into three groups: low on-treatment platelet reactivity (LTPR) group (MAADP<31 mm, n=229), normal on-treatment platelet reactivity (NTPR) group (31 mm≤MAADP≤47 mm, n=207) and high on-treatment platelet reactivity (HTPR) group (MAADP>47 mm, n=196). The endpoints consisted of major adverse cardiovascular and cerebrovascular events (MACCE) and bleeding events. The definition of MACCE was the composite of all-cause mortality, myocardial infarction, intrastent thrombosis, stroke and revascularization. Bleeding events were defined by bleeding academic research consortium (BARC) type 2, 3 and 5 bleeding. Using multivariate Cox regression to analyze the factors of MACCE and bleeding events in patients underwent selective PCI anticoagulated with bivalirudin. Results: A total of 632 patients were finally enrolled in the study with age of (68.3±10.0) years and there were 423 (66.9%) males. All of 632 patients finished one-year follow-up, and 48 (7.6%) patients occurred MACCE and 11 (1.7%) patients occurred bleeding events. There was not statistically significant difference in the incidence of MACCE (8.3% (19/229) vs. 6.3% (13/207) vs.8.2% (16/196), P=0.68) and bleeding events (1.8% (4/229) vs. 2.9% (6/207) vs. 0.5% (1/196), P=0.17) in LTPR, NTPR and HTPR group. Multivariate Cox regression showed that HTPR was not the independent factor of MACCE (HR=1.25, 95%CI 0.67-2.30, P=0.49), and the history of peripheral vessel disease was the independent risk factor of MACCE (HR=2.47, 95%CI 1.19-5.11, P=0.02). LTPR was not the independent factor of bleeding events (HR=1.35, 95%CI 0.39-4.66, P=0.64), and the independent factors of bleeding events were history of peripheral vessel disease (HR=3.95, 95%CI 1.03-15.22, P=0.05) and hemoglobin (HR=0.96, 95%CI 0.93-0.99, P=0.01). Conclusions: In patients undergoing selective PCI anticoagulated with bivalirudin, there is no significant association between platelet reactivity and postoperative 1-year MACCE or bleeding events. History of peripheral vessel disease is an independent risk factor of MACCE, and history of peripheral vessel disease and decreased hemoglobin are independent risk factors of bleeding events.

The safety and efficacy of Firesorb bioresorbable scaffold in first-in-man study for coronary artery disease: the four-year outcomes / 中华心血管病杂志

Objective: To evaluate the 4-year clinical outcomes of patients following Firesorb bioresorbable scaffold (BRS) implantation. Methods: The study reported the 4-year follow-up results of the FUTURE I study. FUTURE I was a prospective, single-center, open-label, first-in-man study which evaluated the feasibility, preliminary safety, and efficacy of Firesorb stent in the treatment of coronary artery stenosis. A total of 45 patients with single de novo lesions in native coronary arteries ,who hospitalized in Fuwai Hospital from January to March 2016 were enrolled. After successfully stent implantation these patients were randomized in a 2∶1 ratio into cohort 1 (n=30) or cohort 2 (n=15). The patients in cohort 1 underwent angiographic, IVUS or OCT examination at 6 months and 2 years; and cohort 2 underwent angiographic, IVUS or OCT at 1 and 3 years. All patients underwent clinical follow-up at 1, 6 months and 1 year and annually thereafter up to 5 years. The primary endpoint was target lesion failure (TLF, including cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization). Secondary endpoints included patient-oriented composite endpoint (PoCE, defined as composite of all death, all miocardial infarction, or any revascularization). Results: A total of 45 patients were enrolled and implanted with Firesorb BRS, including 35 males (77.8%), and the age was (54.4±9.3) years. At 4 years, 10 patients in cohort 1 were reexamined by coronary angiography and OCT examination. Among them, 2 patients' stents were completely degraded and absorbed. Compared with the OCT images of the other 8 patients in cohort 2 at 3 years, the degree of stent degradation was increased, and no stent adherence was found. The 4-year clinical follow-up rate was 100%. In 4-year clinical following up, 2 patients suffered PoCE (4.4%): 1 patient underwent non-target vessel revascularization the day after index procedure and target vessel revascularization (Non-target lesion revascularization) at 2-year imaging follow-up; the other patient underwent target lesion revascularization during imaging follow-up at 4 years but not due to ischemic driven. There was no scaffold thrombosis or TLF events through 4 years. Conclusions: Four years after the implantation, complete degradation and absorption of the Firsorb stent are evidenced in some patients. Firesorb stent is feasible and effective in the treatment of patients with non-complex coronary lesions.

Clinical characteristics of early and late drug-eluting stent in-stent restenosis and mid-term prognosis after repeated percutaneous coronary intervention / 中华医学杂志(英文版)

BACKGROUND@#The mechanism and characteristics of early and late drug-eluting stent in-stent restenosis (DES-ISR) have not been fully clarified. Whether there are different outcomes among those patients being irrespective of their repeated treatments remain a knowledge gap.@*METHODS@#A total of 250 patients who underwent initial stent implantation in our hospital, and then were readmitted to receive treatment for the reason of recurrent significant DES-ISR in 2016 were involved. The patients were categorized as early ISR (<12 months; E-ISR; n = 32) and late ISR (≥12 months; L-ISR; n = 218). Associations between patient characteristics and clinical performance, as well as clinical outcomes after a repeated percutaneous coronary intervention (PCI) were evaluated. Primary composite endpoint of major adverse cardiac events (MACEs) included cardiac death, non-fatal myocardial infarction (MI), or target lesion revascularization (TLR).@*RESULTS@#Most baseline characteristics are similar in both groups, except for the period of ISR, initial pre-procedure thrombolysis in myocardial infarction, and some serum biochemical indicators. The incidence of MACE (37.5% vs. 5.5%; P < 0.001) and TLR (37.5% vs. 5.0%; P < 0.001) is higher in the E-ISR group. After multivariate analysis, E-ISR (odds ratio [OR], 13.267; [95% CI 4.984-35.311]; P < 0.001) and left ventricular systolic dysfunction (odds ratio [OR], 6.317; [95% CI 1.145-34.843]; P = 0.034) are the independent predictors for MACE among DES-ISR patients in the mid-term follow-up of 12 months.@*CONCLUSIONS@#Early ISR and left ventricular systolic dysfunction are associated with MACE during the mid-term follow-up period for DES-ISR patients. The results may benefit the risk stratification and secondary prevention for DES-ISR patients in clinical practice.

Risk or Beneficial Factors Associated with Unplanned Revascularization Risk Following Percutaneous Coronary Intervention: A Large Single-Center Data / 生物医学与环境科学（英文）

Objective@#To analyze factors associated with unplanned revascularization (UR) risk in patients with coronary artery disease (CAD) who underwent percutaneous coronary intervention (PCI).@*Methods@#A total of 10,640 cases with CAD who underwent PCI were analyzed. Multivariate COX regressions and competing risk regressions were applied.@*Results@#The patients who underwent UR following PCI in 30 days, 1, and 2 years accounted for 0.3%, 6.5%, and 8.7%, respectively. After multivariate adjustment, the number of target lesions [hazard ratio ( ) = 2.320; 95% confidence interval ( ): 1.643-3.277; < 0.001], time of procedure ( = 1.006; 95% : 1.001-1.010; = 0.014), body mass index ( = 1.104; 95% : 1.006-1.210; = 0.036), incomplete revascularization (ICR) ( = 2.476; 95% : 1.030-5.952; = 0.043), and age ( 1.037; 95% : 1.000-1.075; = 0.048) were determined as independent risk factors of 30-day UR. Factors, including low-molecular-weight heparin or fondaparinux ( = 0.618; 95% : 0.531-0.719; < 0.001), second-generation durable polymer drug-eluting stent ( 0.713; 95% : 0.624-0.814; < 0.001), left anterior descending artery involvement ( = 0.654; 95% : 0.530-0.807; < 0.001), and age ( = 0.992; 95% : 0.985-0.998; = 0.014), were independently associated with decreased two-year UR risk. While, Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery score ( = 1.024; 95% : 1.014-1.033; < 0.001) and ICR ( = 1.549; 95% : 1.290-1.860; < 0.001) were negatively associated with two-year UR risk.@*Conclusion@#Specific factors were positively or negatively associated with short- and medium-long-term UR following PCI.

Association between plasma HDL-C levels and coronary artery severity and impact on outcomes of patients underwent percutaneous coronary intervention / 中华心血管病杂志

Objective: To analyze the association between plasma high-density lipoprotein cholesterol (HDL-C) levels and the severity of coronary artery disease, and to evaluate the impact of HDL-C levels on long-term outcomes in patients underwent percutaneous coronary intervention (PCI). Methods: A total of 10 458 consecutive patients underwent PCI from January 2013 to December 2013 at Fuwai hospital were enrolled in this study. Patients were divided into three groups according to HDL-C tertiles: low HDL-C group (HDL-C≤0.89 mmol/L, n=3 525), median HDL-C group (HDL-C>0.89-1.11 mmol/L, n=3 570) and high HDL-C group (HDL-C>1.11 mmol/L, n=3 363). SYNTAX score was used to evaluate the severity of coronary artery disease, linear regression was used to analyze the relationship of HDL-C and SYNTAX score. Kaplan-Meier survival analysis was used to compare the outcomes among the three groups. Multivariate Cox regression was used to define the potential associations of HDL-C and outcomes. Results: The HDL-C level was (1.03±0.28) mmol/L and the SYNTAX score was 11.7±8.1. Patients were older, proportion of female, stable angina pectoris, successful PCI and left ventricular eject fraction value were higher, while incidence of diabetes mellitus was lower, hyperlipidemia, old myocardial infraction, smoking history and left main and three vessels disease were lower in high HDL-C group (all P<0.05). Patients in high HDL-C group also had the lowest SYNTAX score (12.2±8.4 vs. 11.7±8.1 vs. 11.2±7.8, P<0.001). Both univariate and multivariate linear regression analysis showed that HDL-C was negatively associated with SYNTAX score, e.g. Univariate analysis: β=-0.046, P<0.001; Multivariate analysis: β=-0.058, P=0.001. And 10 400 (99.4%) patients completed 2-year follow up. At 2-year follow-up, there were no difference in all-cause death, cardiac death, myocardial infarction, revascularization, stroke, major adverse cardiovascular and cerebral events (MACCE) and stent thrombosis among three groups (P for trend>0.05), while patient in high HDL-C group experienced the highest BARC type 2 bleeding events (P for trend=0.018). Multivariate Cox regression analysis showed that HDL-C level was not an independent risk factor of 2-year adverse ischemia events (P>0.05) and 2-year bleeding events (P>0.05). Conclusion: In patients underwent PCI, plasma HDL-C level is negatively associated with SYNTAX score, but not an independent risk factor of ischemic and bleeding events post PCI.

Related factors and the long-term outcome after percutaneous coronary intervention of premature acute myocardial infarction / 中华心血管病杂志

Objective: To explore the related factors of premature acute myocardial infarction(AMI), and to compare the the long-term outcomes in patients with and without premature AMI after percutaneous coronary intervention (PCI). Methods: This study was a prospective cohort study.From January 2013 to December 2013, 10 724 consecutive patients with coronary heart disease undergoing PCI in Fuwai Hospital were enrolled. Among them 1 920 patients with the diagnosis of AMI were divided into two groups: premature AMI (man≤50 years old, woman≤60 years old) and non-premature AMI. The baseline characteristics were collected, and multivariate logistic regression was uesed to analysis the related factors of premature AMI. The clinical outcomes, including the major adverse cardiovascular and cerebrovascular events(MACCE) which was the composite of cardiac death, myocardial infarction, revascularization, stroke and stent thrombosis, as well as bleeding events, during hospitalization, at 2 years and 5 years follow-up were analyzed. Results: A total of 1 920 AMI patiens were included(age was (56.5±11.3) years old)，with 1 612(84.0%) males. There were statistically significant differences between the two groups in gender, body mass index, blood lipid, complications, inflammatory markers, etc (all P<0.05). Multivariate logistic regression analysis showed body mass index(OR=1.06, 95%CI 1.01-1.10, P<0.01), triglyceride(OR=1.47, 95%CI 1.14-1.90, P<0.01), serum uric acid level(OR=1.02, 95%CI 1.01-1.04, P<0.01), high density lipoprotein cholesterol level(OR=0.33, 95%CI 0.14-0.78, P=0.01) and history of hypertension(OR=0.72, 95%CI 0.56-0.93, P=0.01) were independent related factors of premature AMI. The incidence of all-cause death and cardiac death were lower during hospitalization, at 2 years and 5 years follow-up in the premature AMI group than in non-premature AMI group(all P<0.05). In the premature AMI group, the incidence of MACCE and stroke was lower, with more bleeding events in 5 years follow-up(all P<0.05). Conclusions: Metabolic abnormalities, including high BMI, high triglyceride level and high serum uric acid, low high-density lipoprotein cholesterol level are the related factor of premature AMI. The incidence of ischemic events in patients with premature AMI is lower, while the incidence of bleeding events is higher than non-premature AMI patients.

Relationship between fibrinogen levels and cardiovascular events in patients receiving percutaneous coronary intervention: a large single-center study / 中华医学杂志(英文版)

BACKGROUND@#It is currently unclear if fibrinogen is a risk factor for adverse events in patients receiving percutaneous coronary intervention (PCI) or merely serves as a marker of pre-existing comorbidities and other causal factors. We therefore investigated the association between fibrinogen levels and 2-year all-cause mortality, and compared the additional predictive value of adding fibrinogen to a basic model including traditional risk factors in patients receiving contemporary PCI.@*METHODS@#A total of 6293 patients undergoing PCI with measured baseline fibrinogen levels were enrolled from January to December 2013 in Fuwai Hospital. Patients were divided into three groups according to tertiles of baseline fibrinogen levels: low fibrinogen, <2.98 g/L; medium fibrinogen, 2.98 to 3.58 g/L; and high fibrinogen, ≥3.58 g/L. Independent predictors of 2-year clinical outcomes were determined by multivariate Cox proportional hazards regression modeling. The increased discriminative value of fibrinogen for predicting all-cause mortality was assessed using the C-statistic and integrated discrimination improvement (IDI).@*RESULTS@#The 2-year all-cause mortality rate was 1.2%. It was significantly higher in the high fibrinogen compared with the low and medium fibrinogen groups according to Kaplan-Meier analyses (1.7% vs. 0.9% and 1.7% vs. 1.0%, respectively; log-rank, P = 0.022). Fibrinogen was significantly associated with all-cause mortality according to multivariate Cox regression (hazard ratio 1.339, 95% confidence interval: 1.109-1.763, P = 0.005), together with traditional risk factors including age, sex, diabetes mellitus, left ventricular ejection fraction, creatinine clearance, and low-density lipoprotein cholesterol. The area under the curve for all-cause mortality in the basic model including traditional risk factors was 0.776, and this value increased to 0.787 when fibrinogen was added to the model (IDI = 0.003, Z = 0.140, P = 0.889).@*CONCLUSIONS@#Fibrinogen is associated with 2-year all-cause mortality in patients receiving PCI, but provides no additional information over a model including traditional risk factors.

Prognostic Values of Serum Chloride and Sodium Levels in Patients with Three-vessel Disease / 生物医学与环境科学（英文）

OBJECTIVE@#Identification of new risk factors is needed to improve prediction of adverse outcomes in patients with three-vessel disease (TVD). The present study aimed to evaluate the prognostic values of serum chloride and sodium levels in patients with TVD.@*METHODS@#We used data from a prospective cohort of consecutive patients with angiographically confirmed TVD. The primary endpoint was all-cause death. Cox proportional hazard regression was used to analyze the relationship of serum chloride and sodium levels with long-term outcomes of TVD patients.@*RESULTS@#A total of 8,318 participants with available serum chloride and sodium data were included in this analysis. At baseline, patients in the low tertiles group of serum chloride level (⪕ 102.0 mmol/L) or serum sodium level (⪕ 139.0 mmol/L) had more severe disease conditions. During a median follow-up of 7.5-year, both low serum chloride level and low serum sodium level were found to be associated with an increased risk for mortality in univariate analysis. However, when both parameters were incorporated into a multivariate model, only low serum sodium level remained to be an independent predictor of all-cause death (hazard ratio: 1.16, 95% confidence interval: 1.01-1.34, P = 0.041). Modest but significant improvement of discrimination was observed after incorporating serum sodium level into the Synergy between percutaneous coronary intervention (PCI) with Taxus and Cardiac Surgery score.@*CONCLUSION@#Serum sodium level is more strongly associated with long-term outcomes of TVD patients compared with serum chloride level. Low serum sodium level is an independent risk factor for mortality, but only provides modest prognostic information beyond an established risk model.

Comparison of Long-term Outcomes in Patients with Premature Triple-vessel Coronary Disease Undergoing Three Different Treatment Strategies: A Prospective Cohort Study / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Patients with premature triple-vessel disease (PTVD) have a higher risk of recurrent coronary events and repeat revascularization; however, the long-term outcome of coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), and medical therapy (MT) alone for PTVD patients is controversial. The aim of this study is to evaluate the long-term outcome of PTVD patients among these three treatment strategies, to find out the most appropriate treatment methods for these patients.</p><p><b>METHODS</b>One thousand seven hundred and ninety-two patients with PTVD (age: men ≤50 years and women ≤60 years) were enrolled between 2004 and 2011. The primary end point was all-cause death. The secondary end points were cardiac death, myocardial infarction, stroke, or repeat revascularization.</p><p><b>RESULTS</b>PCI, CABG, and MT alone were performed in 933 (52.1%), 459 (25.6%), and 400 (22.3%) patients. Both PCI and CABG were associated with lower all-cause death (4.6% vs. 4.1% vs. 15.5%, respectively, P < 0.01) and cardiac death (2.8% vs. 2.0% vs. 9.8%, respectively, P < 0.01) versus MT alone. The rate of repeat revascularization in the CABG group was significantly lower than those in the PCI and MT groups. After adjusting for baseline factors, PCI and CABG were still associated with similar lower risk of all-cause death and cardiac death versus MT alone (all-cause death: hazard ratio [HR]: 0.35, 95% confidence interval [CI]: 0.23-0.53, P < 0.01 and HR: 0.35, 95% CI: 0.18-0.70, P = 0.003, respectively, and cardiac death: HR: 0.32, 95% CI: 0.19-0.54, P < 0.01 and HR: 0.36, 95% CI: 0.14-0.93, P = 0.03, respectively).</p><p><b>CONCLUSIONS</b>PCI and CABG provided equal long-term benefits for all-cause death and cardiac death for PTVD patients. Patients undergoing MT alone had the worst long-term clinical outcomes.</p><p><b>TRIAL REGISTRATION</b>ClinicalTrials.gov; Identifier: NCT02634086. https://www.clinicaltrials.gov/ct2/show/record/NCT02634086?term=NCT02634086&rank=1.</p>

Comparison of Efficacy and Safety between First- and Second-Generation Drug-Eluting Stents in Patients with Acute Coronary Syndrome / 中华医学杂志(英文版)

Background@#It remains undetermined whether second-generation drug-eluting stents (G2-DESs) outperform first-generation DESs (G1-DESs) in patients with acute coronary syndrome (ACS). We aimed to compare the efficacy and safety of G1-DES and G2-DES in ACS patients in a high-volume cardiovascular center.@*Methods@#In 2013, 10,724 consecutive patients underwent percutaneous coronary intervention in our institution. We included 4037 patients with ACS who underwent exclusively G1-DES or G2-DES implantation (n = 364 and n = 3673, respectively). We used propensity score matching to minimize the imbalance between the G1-DES and G2-DES groups and followed patients for 2 years. The efficacy endpoints were major adverse cardiac events (MACEs) and its components including target vessel-related myocardial infarction (TV-MI), target vessel revascularization/target lesion revascularization (TVR/TLR), and cardiac death. The safety endpoint was stent thrombosis. Continuous variables were compared by Mann-Whitney U-test, and categorical variables were compared using Pearson's Chi-square or Fisher's exact test. Kaplan-Meier curves were constructed to compare the event-free survival rates, and multivariate Cox proportional hazards regression analysis was used to assess whether stent type was an independent risk factor for the efficacy and safety endpoints.@*Results@#At the 2-year follow-up, the results for MACE and it components, as well as stent thrombosis, were similar for G1-DES and G2-DES (MACE, 5.2% vs. 4.3%, χ = 0.514, P = 0.474; TV-MI, 0.8% vs. 0.4%, P = 0.407; TVR, 4.9% vs. 3.7%, χ = 0.939, P = 0.333; TLR, 3.8% vs. 2.5%, χ = 1.610, P = 0.205; cardiac death, 0.3% vs. 0.5%, P = 0.670; and stent thrombosis, 0.5% vs. 0.4%, P > 0.999). Kaplan-Meier analysis indicated similar event-free survival rates between G1-DES and G2-DES after propensity score matching (all: log-rank P > 0.05). Multivariate analysis demonstrated that stent type was not an independent risk factor for the efficacy and safety endpoints (MACE, hazard ratio [HR] = 0.805, 95% confidence interval [CI]: 0.455-1.424, P = 0.456; TV-MI, HR = 0.500, 95% CI: 0.101-2.475, P = 0.395; TVR, HR = 0.732, 95% CI: 0.403-1.330, P = 0.306; TLR, HR = 0.629, 95% CI: 0.313-1.264, P = 0.193; cardiac death, HR = 1.991, 95% CI: 0.223-17.814, P = 0.538; and stent thrombosis, HR = 0.746, 95% CI: 0.125-4.467, P = 0.749).@*Conclusion@#G1-DES and G2-DES have similar efficacy and safety profiles in ACS patients at the 2-year follow-up.

Validation of Predictive Value of Patterns of Nonadherence to Antiplatelet Regimen in Stented Patients Thrombotic Risk Score in Chinese Population Undergoing Percutaneous Coronary Intervention: A Prospective Observational Study / 中华医学杂志(英文版)

Background@#The patterns of nonadherence to antiplatelet regimen in stented patients (PARIS) thrombotic risk score are a novel score for predicting the risk of coronary thrombotic events (CTEs) after percutaneous coronary intervention (PCI) with drug-eluting stents. However, the prognostic value of this score has not been fully evaluated in non-Euro-American PCI populations.@*Methods@#We performed a prospective, observational study of 10,724 patients who underwent PCI in Fuwai hospital, China and evaluated the PARIS thrombotic risk score's predictive value of CTEs in the PCI population. The area under the receiver operating characteristic curve (AUROC) was used to assess the predictive value of the PARIS score for CTE.@*Results@#Among 9782 patients without in-hospital events, a total of 95 CTEs occurred during the 2-year follow-up. The PARIS score was significantly higher in patients with CTEs (3.38 ± 2.04) compared with patients without events (2.53 ± 1.70, P < 0.001). According to the risk stratification of the PARIS thrombotic score, the risk of CTEs in the high-risk group was 3.14 times higher than that in the low-risk group (hazard ratio [HR], 3.14; 95% confidence interval [CI], 1.92-5.13; P < 0.001). However, the risk of CTEs in the intermediate-risk and low-risk groups was not significant (HR, 1.39; 95% CI, [0.86-2.24]; P = 0.184). The PARIS score showed prognostic value in evaluating CTEs in the overall population (AUROC, 0.621; 95% CI, 0.561-0.681), the acute coronary syndrome (ACS) population (AUROC, 0.617; 95% CI, 0.534-0.700; P = 0.003), and the non-ACS population (AUROC, 0.647; 95% CI, 0.558-0.736; P = 0.001).@*Conclusions@#In a real-world Chinese population, the PARIS thrombotic risk score shows a modest prognostic value for CTEs in patients after PCI. This score also has a predictive value for CTEs in the ACS and non-ACS subgroup populations.

Association of CDKN2B-AS1 Polymorphisms with Premature Triple-vessel Coronary Disease and Their Sex Specificity in the Chinese Population / 生物医学与环境科学（英文）

OBJECTIVE@#The aim of this study is to establish whether cyclin-dependent kinase inhibitor 2B antisense RNA 1 (CDKN2B-AS1) gene polymorphisms are associated with premature triple-vessel disease (PTVD).@*METHODS@#Nine single-nucleotide polymorphisms (rs1063192, rs10757274, rs1333042, rs1333049, rs2285327, rs3217986, rs3217992, rs4977574, and rs9632884) were genotyped in 884 PTVD patients and 907 control subjects (males ⪕ 50 years old and females ⪕ 60 years old) using the improved multiplex ligase detection reaction method.@*RESULTS@#The allele frequencies of rs10757274 G, rs1333049 C, rs4977574 G (all P < 0.001), and rs3217986 G (P = 0.040) were significantly higher in the PTVD group than in the control group, but those of rs1063192 A, rs1333042 G, and rs9632884 C (all P < 0.001) were significantly lower in the former than in the latter. Logistic regression analysis revealed that homozygote AA of rs1333042 is associated with decreased risk for PTVD (OR = 0.42, 95% CI: 0.22-0.82, P = 0.011). In addition, the allele frequencies observed differed between genders. The G allele of rs3217986 was associated with increased risk for PTVD in male patients only (OR = 2.94, 95% CI: 1.27-6.80, P = 0.012) in the dominant model, and no positively mutated allele was found in female patients.@*CONCLUSION@#Polymorphisms of the CDKN2B-AS1 gene are associated with the incidence of PTVD in the Chinese population. Furthermore, the frequencies of mutated alleles differed between genders.

Prognostic Value of NT-proBNP in Stable Coronary Artery Disease in Chinese Patients after Percutaneous Coronary Intervention in the Drug-eluting Stent Era / 生物医学与环境科学（英文）

OBJECTIVE@#The predictive value of N-terminal pro-brain natriuretic peptide (NT-proBNP) in patients with stable coronary artery disease (SCAD) in the drug-eluting stent era is not yet clear. We aimed to evaluate the prognostic value of NT-proBNP in SCAD patients after percutaneous coronary intervention (PCI).@*METHODS@#We examined 4,293 consecutive SCAD patients who underwent PCI between January 2013 and December 2013 in Fuwai Hospital, China. The primary endpoint was all-cause death. NT-proBNP levels were measured before PCI using Elisa kits (Biomedica, Austria). The indication for PCI was based on the degree of coronary stenosis and evidence of ischemia.@*RESULTS@#Among 3,187 SCAD patients with NT-proBNP data, after a 2-year follow-up, NT-proBNP levels were predictive for all-cause death in the SCAD population [area under the receiver operating characteristic curve, 0.768; 95% confidence interval (CI), 0.687-0.849; P < 0.001]. At the optimum cutoff point of 732 pg/mL, the sensitivity and specificity of death was 75.0% and 72.3%, respectively. In a multivariable Cox regression model, the death hazard ratio was 6.43 (95% CI, 2.99-13.82; P < 0.001) for patients with NT-proBNP levels ⪖ 732 pg/mL, compared with < 732 pg/mL.@*CONCLUSION@#NT-proBNP is a strong predictor of 2-year death with SCAD after PCI in the drug-eluting stent era.

Evaluation of CRUSADE and ACUITY-HORIZONS Scores for Predicting Long-term Out-of-Hospital Bleeding after Percutaneous Coronary Interventions / 中华医学杂志(英文版)

BACKGROUND@#There is scanty evidence concerning the ability of Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines (CRUSADE) and Acute Catheterization and Urgent Intervention Triage Strategy and Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (ACUITY-HORIZONS) scores to predict out-of-hospital bleeding risk after percutaneous coronary interventions (PCIs) with drug-eluting stents (DES) in patients receiving dual antiplatelet therapy. We aimed to assess and compare the long-term prognostic value of these scores regarding out-of-hospital bleeding risk in such patients.@*METHODS@#We performed a prospective observational study of 10,724 patients undergoing PCI between January and December 2013 in Fuwai Hospital, China. All patients were followed up for 2 years and evaluated through the Fuwai Hospital Follow-up Center. Major bleeding was defined as Types 2, 3, and 5 according to Bleeding Academic Research Consortium Definition criteria.@*RESULTS@#During a 2-year follow-up, 245 of 9782 patients (2.5%) had major bleeding (MB). CRUSADE (21.00 [12.00, 29.75] vs. 18.00 [11.00, 26.00], P 0.05). The value of CRUSADE and ACUITY-HORIZONS scores did not differ significantly (P > 0.05) in the whole cohort, ACS subgroup, or non-ACS subgroup.@*CONCLUSIONS@#CRUSADE and ACUITY-HORIZONS scores showed statistically significant but relatively limited long-term prognostic value for out-of-hospital MB after PCI with DES in a cohort of Chinese patients. The value of CRUSADE and ACUITY-HORIZONS scores did not differ significantly (P > 0.05) in the whole cohort, ACS subgroup, or non-ACS subgroup.

Relationship between High Level of Estimated Glomerular Filtration Rate and Contrast-Induced Acute Kidney Injury in Patients who Underwent an Emergency Percutaneous Coronary Intervention / 中华医学杂志(英文版)

Background@#Mounts of studies have shown that low estimated glomerular filtration rate (eGFR) is associated with increased risk of adverse outcomes in patients with coronary artery disease. However, high level of eGFR was less reported. In the study, we aimed to explore the relationship between the baseline eGFR, especially the high level, and contrast-induced acute kidney injury (CI-AKI) in a Chinese population who underwent an emergency percutaneous coronary intervention (PCI).@*Methods@#Patients who underwent an emergency PCI from 2013 to 2015 were enrolled and divided into five groups as eGFR decreasing. Baseline characteristics were collected and analyzed. The rates of CI-AKI and the composite endpoint (including nonfatal myocardial infarction, revascularization, stroke, and all-cause death) at 6- and 12-month follow-up were compared. Logistic analysis for CI-AKI was performed.@*Results@#A total of 1061 patients were included and the overall CI-AKI rate was 22.7% (241/1061). The separate rates were 77.8% (7/9) in Group 1 (eGFR ≥120 ml·min·1.73 m), 26.0% (118/454) in Group 2 (120 ml·min·1.73 m> eGFR ≥90 ml·min·1.73m), 18.3% (86/469) in Group 3 (90 ml·min·1.73 m> eGFR ≥60 ml·min·1.73 m), 21.8% (26/119) in Group 4 (60 ml·min·1.73 m> eGFR ≥30 ml·min·1.73 m), and 40.0% (4/10) in Group 5 (eGFR <30 ml·min·1.73 m), with statistical significance (χ = 25.19, P < 0.001). The rates of CI-AKI in five groups were 77.8%, 26.0%, 18.3%, 21.8%, and 40.0%, respectively, showing a U-typed curve as eGFR decreasing (the higher the level of eGFR, the higher the CI-AKI occurrence in case of eGFR ≥60 ml·min·1.73 m). The composite endpoint rates in five groups were 0, 0.9%, 2.1%, 6.7%, and 0 at 6-month follow-up, respectively, and 0, 3.3%, 3.4%, 16.0%, and 30.0% at 12-month follow-up, respectively, both with significant differences (χ = 16.26, P = 0.009 at 6-month follow-up, and χ = 49.05, P < 0.001 at 12-month follow-up). The logistic analysis confirmed that eGFR was one of independent risk factors of CI-AKI in emergency PCI patients.@*Conclusions@#High level of eGFR might be associated with increased risk of CI-AKI in patients with emergency PCI, implying for future studies and risk stratification in clinical practice.

Impact of Residual SYNTAX Score and Its Derived Indexes on Clinical Outcomes after Percutaneous Coronary Intervention: Data from a Large Single Center / 中华医学杂志(英文版)

<p><b>Background</b>Residual SYNTAX score (rSS) and its derived indexes including SYNTAX revascularization index (SRI) and clinical rSS had been developed to quantify and describe the extent of incomplete revascularization. This study was conducted to explore the utility of the three scores among real-world patients after percutaneous coronary intervention (PCI).</p><p><b>Methods</b>From January 2013 to December 2013, patients underwent PCI treatment at Fuwai Hospital were included. The primary endpoints were all-cause death and major adverse cardiovascular and cerebrovascular events. The secondary endpoints were myocardial infarction, revascularization, stroke, and stent thrombosis. Kaplan-Meier methodology was used to determine the outcomes. Cox multivariable regression was to test the associations between scores and all-cause mortality.</p><p><b>Results</b>A total of 10,344 patients were finally analyzed in this study. Kaplan-Meier survival analysis indicated that greater residual coronary lesions quantified by rSS and its derived indexes were associated with increased risk of adverse cardiovascular events. However, after multivariate analysis, only clinical rSS was an independent predictor of 2-year all-cause death (hazard ratio: 1.02, 95% confidence interval: 1.01-1.03, P < 0.01). By receiver operating characteristic (ROC) curve analysis, clinical rSS had superior predictability of 2-year all-cause death than rSS and SRI (area under ROC curve [AUC]: 0.59 vs. 0.56 vs. 0.56, all P < 0.01), whereas rSS was superior in predicting repeat revascularization than clinical rSS and SRI (AUC: 0.62 vs. 0.61 vs. 0.61; all P < 0.01). When comparing the predictive capability of rSS ≥8 with SRI <70%, their predictabilities were not significantly different.</p><p><b>Conclusions</b>This study indicates that all three indexes (rSS, clinical rSS, and SRI) are able to risk-stratify patients and predict 2-year outcomes after PCI. However, their prognostic capabilities are different.</p>

Characteristics of Coronary Artery Lesions in Smokers With Coronary Heart Disease and Prognostic Evaluation After Percutaneous Coronary Intervention / 中国循环杂志

Objectives: To investigate the characteristics of coronary lesions and evaluate the prognosis post-percutaneous coronary intervention(PCI)in smokers with coronary heart disease. Methods: The data were derived from PANDA III, which was a perspective, multi-center, "all-comer", randomized controlled trial. Between Dec. 2013 and Aug. 2014, 2 348 patients from 46 centers were enrolled. Mean age was (61.2 ±10.6) years old, 1 658 patients (70.6%) were male. All the patients underwent PCI and biodegradable polymer drug eluting stents were implanted as indicated. Patients were divided into non-smoking group, quitter group and smoking-group based on the basis of smoking status at baseline. Primary endpoint was major adverse cardiac events (MACE), including all-cause mortality, myocardial infarction and repeated revascularization. Secondary endpoint were stent thrombosis and target lesion failure (TLF), including cardiac death, target vessel myocardial infarction and ischemia driven target lesion revascularization. Results: Smokers and quitters were more often males. Compared with non-smoking group and quitter group, patients in smoking group were significantly younger (P<0.0001), proportion of hypertension (P=0.0002), diabetes mellitus (P=0.0052) and previous PCI history (P<0.0001) was significantly lower. The incidence of acute myocardial infarction in the smoking group was as high as 41.3% (363/879), which was significantly higher than that of the quitter group and non-smoking group (P<0.0001). A total of 1 130 (96.7%), 286 (95.3%) and 846 (96.2%) patients in the non-smoking group, quitter group and smoking-group completed the 2-year follow-up, respectively. The results of 2-years follow-up showed that MACE rate of non-smoking group, quitter group and smoking-group was 11.23%, 13.64% and 12.21%(P=0.54), respectively. Multivariable cox regression analysis indicated that smoking status was not an independent predictor for all-cause mortality and TLF.

Impact of Diabetes Mellitus on Long-term Prognosis of Patients After Implantation of Biodegradable Polymer Drug Eluting Stent or Excel Stent / 中国循环杂志

Objectives:To evaluate the impact of diabetes mellitus on prognosis of coronary artery disease patients after implantation of the novel biodegradable polymer drug eluting stents. Methods:PANDA Ⅲ was a perspective, multi-center, "all-comer", randomized controlled trial. Between Dec. 2013 and Sep. 2014, 2 348 patients from 46 centers were enrolled. All the patients underwent percutaneous coronary intervention, among them 1 174 patients implanted with BuMA stent and 1 174 patients implanted with Excel stent. Mean age was 61.2 ±10.6, 1 658 patients (70.6%) were male, 570 (24.2%) patients presented with diabetes mellitus (DM) and 1 778 (75.7%) without DM. Patients were divided into DM and non-DM groups. Primary endpoint was target lesion failure (TLF), including cardiac death, target vessel myocardial infarction and ischemia driven target lesion revascularization. Secondary endpoints included stent thrombosis and major adverse cardiac events (MACE), defined as a composite of death, myocardial infarction and any revascularization. Results:A total of 558 (97.9%) and 1 704 (95.8%) patients completed 2-year follow-up in DM and non-DM groups. Incidence of TLF in the DM and non-DM group was 8.24% vs. 6.81%, P=0.25, and cardiac death rate was significantly higher in the DM group compared with non-DM group:2.87% vs. 1.12%, P=0.004. Incidence of MACE was similar between two group:13.98% vs. 11.38, P=0.10. Myocardial infarction and any revascularization events were numericallyhigher in the DM group compared with non-DM group, but without statistical significance:5.73% vs. 5.11%, P=0.56; 6.45% vs. 5.46%, P=0.38, respectively. Incidence of all-cause death was significantly higher in the DM group compared with non-DM group:4.30% vs. 2.46%, P=0.03. The results were similar after propensity match analysis. Multivariable analysis showed that DM and baseline SYNTAX score were independent factors for 2-year cardiac death. Conclusions:Two-year incidence of TLF is similar in coronary artery disease patients with or without DM post implantation of biodegradable polymer drug eluting stent or Excel stent, however, the rate of death especially cardiac death is significantly higher in the DM group than in the non-DM group.