[Clinical features and long-term prognosis of diabetic patients with low or intermediate complexity coronary artery disease post percutaneous coronary intervention].

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].

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 (1324 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 1324 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 1324 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 1324 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].

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].

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.

[The impact of metabolic syndrome and its individual components on long-term prognosis of patients undergoing percutaneous coronary intervention].

Objective: To investigate the impact of metabolic syndrome (MS) and its individual components on long-term prognosis of patients undergoing percutaneous coronary intervention(PCI). Methods: Patients who underwent PCI in Fuwai Hospital in 2013 were enrolled and divided to two groups: with MS and without MS. The primary endpoint of 2-year follow-up was major adverse cardiovascular events (MACE), including death, myocardial infarction, and repeat revascularization. Results: Of the 10 422 PCI patients, there were 5 656 (54.27%) without MS and 4 766 (45.73%) with MS. Patients in the MS group were younger, tended to be male and had more comorbidities. There were no significant differences between the two groups in the proportion of drug-coated stents and the success rate of interventional therapy. The 2-year follow-up showed that the incidence of MACE in the MS group was significantly higher than that in the MS-free group (12.0% vs 10.0%, P<0.001), which was mainly due to the significantly higher revascularization rate in the MS group than in the non-MS group (9.5% vs 7.9%, P=0.003). Cox's regression analysis showed that MS was an independent risk factor for MACE. In MS component analysis, abnormal glucose metabolism was an independent risk factor for MACE events. Conclusions: Among the patients undergoing PCI, the incidence of MACE in patients with MS is significantly higher than that in patients without MS, and MS was an independent risk factor for MACE. In addition, hyperglycemia is an independent predictor for MACE.

[Long-term prognostic value of mean platelet volume in patients with stable coronary artery disease undergoing elective percutaneous coronary intervention].

Objective: To evaluate the relationship between admission mean platelet volume (MPV) and 2-year cardiac mortality in patients with stable coronary artery disease (CAD) undergoing elective percutaneous coronary intervention (PCI), and explored the consistence of this relationship in diabetes mellitus (DM) and non-DM subgroups. Method: A total of 4 293 patients who underwent PCI in Fuwai Hospital in 2013 were enrolled and divided into two groups according to MPV as follows: lower MPV (n=2 219, MPV≤10.5fL) and higher MPV (n=2 074, MPV>10.5fL). Result: Patients with high MPV had a higher rate of DM (30.4%(674/2 219) vs 34.5%(715/2 074)), smoking (53.3%(1 183/2219) vs 57.0%(1 182/2 074)), and previous coronary artery bypass grafting (CABG) (4.0%(88/2 219) vs 5.4%(112/2 074)), while left ventricular ejection fraction (LVEF) (64±7 vs 63±7), and glomerular filtration rate (eGFR) (92±14 vs 91±15) were lower compared with patients in the low MPV group (all P<0.05). In the laboratory examination, patients with high MPV had higher glycosylated hemoglobin, and lower platelet count (all P<0.05). In coronary angiography, there was no significant difference in SYNTAX scores, left main/three-vessel lesions, stent type, success rate of operation, and total stent length (all P>0.05). Compared with low MPV group, patients with high MPV had ahigher cardiac mortality [18 (0.9%) vs 5 (0.2%), P=0.004]. Kaplan-Meier analysis showed that compared to low MPV group, cardiac mortality in high MPV group was significantly higher (Log-rank P=0.004). Multivariate Cox regression analysis showed that high MPV was independently associated with 2-year cardiac mortality (HR 4.127, 95%CI 1.373 to 12.405, P=0.012). Receiver operating characteristic curve (ROC) analysis also showed that MPV had a good diagnostic value in predicting 2-year cardiac mortality (area under the curve=0.624, 95%CI: 0.511-0.738, P=0.04). Subgroup analysis showed that in patients with DM (HR 2.090, 95%CI 1.217-3.589, P=0.008) and male (HR 1.561, 95%CI 1.007-2.421, P=0.047), MPV was significantly related with cardiac mortality. Conclusion: In patients with stable CAD who underwent elective PCI, high MPV was independently associated with an increase in 2-year cardiac mortality, especially in patients with DM and male gender.

[Related factors and the long-term outcome after percutaneous coronary intervention of premature acute myocardial infarction].

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.

[Association between plasma HDL-C levels and coronary artery severity and impact on outcomes of patients underwent percutaneous coronary intervention].

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: ß=-0.046, P<0.001; Multivariate analysis: ß=-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.

[Effect of ABO blood groups on long-term outcome of stable coronary artery disease after percutaneous coronary intervention].

Objective: To evaluate the effect of ABO blood groups on long-term outcome of stable coronary artery disease (CAD) after percutaneous coronary intervention (PCI). Methods: A total of 4 272 patients with stable coronary artery disease and received PCI were consecutively enrolled from January to December 2013 and followed up for 2 years. Patients were divided into O group and non-O group according to their ABO groups. Multivariable COX regression was used to evaluated the relationship between ABO blood groups and prognosis of CAD. The endpoints included all-cause death, cardiac death, myocardial infarction(MI), revascularization, and stroke. Results: There were 1 302 patients in O group and 2 970 patients in non-O group. ABO blood group was not associated with age, sex and blood pressure (P>0.05). The comorbidity rate of hypertension, diabetes mellitus, smoking, family history, previous MI, previous cerebrovascular disease, previous PCI and left ventricular ejection fraction were similar between the two groups (P>0.05). Total cholesterol, low density lipid cholesterol level were significantly higher in non-O group compared with O group [(4.2±1.1)mmol/L vs (4.1±1.1)mmol/L, P=0.027; (2.5±0.9)mmol/L vs (2.4±0.9) mmol/L, P=0.025], while high density lipid cholesterol level was significantly lower[(1.04±0.26) mmol/L vs (1.06±0.28) mmol/L, P=0.035]. As to angiographic results, non-O blood group was not related to the severity of coronary atherosclerosis assessed by SYNTAX score(P=0.277). More cardiac death occurred in non-O group compared with that in O group [21 (0.7%) vs 2(0.1%)] during 2-year follow-up. After adjusted for confounding factors, multivariable COX regression revealed that non-O blood type was not associated with increased cardiac death [HR (95%CI)=7.30(0.97-55.09), P=0.054]. Conclusion: Non-O blood group is associated with 2-year cardiac death in patients with stable coronary artery disease who received PCI, but it is not an independent risk factor for cardiac death.

[Status of the clopidogrel use in ACS patients and related factors among county hospitals in China].

Objective: To observe the use of clopidogrel and related factors for patients with acute coronary syndrome (ACS) in terms of early use, loading dose, dual antiplatelet therapy (DAPT) and maintenance dose hospitalized in non-PCI country hospitals in China. Methods: Patients hospitalized for ACS from 101 non-PCI country hospitals across China were recruited prospectively from October 2011 to November 2014. In-hospital clopidogrel use rate, the proportions of early use (within 24 hours), loading dose use (≥300 mg), DAPT (early use combined with aspirin) and maintenance dose use (following dose≥75 mg/d) were analyzed. Generalized estimated equation (GEE) model was used to explore factors associated to in-hospital clopidogrel use and loading dose use in both univariate and multivariate analyses, adjusting for cluster effect. Results: A total of 14 809 ACS patients were included, with an average age of (64.1±11.6) years and 60% (8 888/14 809) were male. The in-hospital clopidogrel use rate was 66.4% (9 828/14 809), which varied across different regions, years and sub-types of ACS (all P<0.05). Among users, the proportions of patients with early use, DAPT and maintenance dose use were 91.3% (8 734/9 562), 89.2% (8 526/9 562) and 95.1% (9 094/9 562), respectively, but the proportion of patients received loading dose was only 41.8% (3 995/9 562). Multivariate analyses showed that patients who admitted to hospital in earlier years and with non-ST elevation ACS, ≥75 years old, female, non-smoking, illiterate, heart rate≥100 beats per minute, atrial fibrillation, not on ECG monitoring, and not using other anti-ACS drugs were less likely to receive clopidogrel (all P<0.05). And those clopidogrel users who with non-ST elevation ACS, ≥75 years old, non-smoking, illiterate, not using other anti-ACS drugs were less likely to receive loading dose (all P<0.05). Conclusion: The use rate of clopidogrel and the loading dose among in-hospital ACS patients are both low and remain to be improved in non-PCI county hospitals in China. Special attention should be paid on non-ST elevation ACS, ≥75 years old, female, and illiterate patients to increase the rational use of clopidogrel and the loading dose.

[Clinical characteristics and prognosis between male and female patients with premature coronary artery disease after intervention].

Objective: To compare the clinical characteristics and long-term prognosis between male and female patients with premature coronary artery disease (PCAD) post coronary intervention, and analyse the risk factors of major adverse cardio-cerebrovascular events (MACCE) and bleeding events. Methods: This was a prospective single-center observational study. From January 2013 to December 2013, 4 744 patients diagnosed as PCAD and treated with percutaneous coronary intervention (PCI) in Fuwai Hospital were enrolled. The general clinical data, laboratory results and interventional treatment data of all patients were collected, and patients were followed up for 2 years after PCI and the incidence of events including MACCE and bleeding was analyzed. The baseline data and clinical events of PCAD patients of different genders were compared. Survival curves were estimated by Kaplan-Meier method. Univariate and multivariate Cox regression were used to analyze whether gender was an influencing factor of different clinical events of PCAD patients within 2 years after PCI, and other relevant influencing factors of MACCE and bleeding events. Results: Among the 4 744 PCAD patients included, there were 3 390 (71.5%) male aged (47.0±5.4) years old and 1 354 (28.5%) female aged (57.0±5.8) years old. Compared with female patients, male patients had higher body mass index, higher proportion of hyperlipidemia, smoking, myocardial infarction, previous PCI, preoperative estimated glomerular filtration rate, ST-segment elevation myocardial infarction, radial artery approach, intravenous ultrasound use and chronic occlusive lesions (all P<0.05). Age, left ventricular ejection fraction, prevalence of hypertension, diabetes mellitus, past stroke history, non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and the use of calcium channel blockers were lower in male patients than in female patients (all P<0.05). The 2-year follow-up results showed that the incidence of BARC type 1 hemorrhage was significantly higher in female patients than in male patients (6.9%(92/1 343) vs. 3.7%(126/3 378), P<0.001); however, the incidence of MACCE, all-cause death, cardiac death, recurrent myocardial infarction, revascularization (target vessel revascularization and target lesion revascularization), stent thrombosis, stroke and BARC type 2-5 hemorrhage were similar between the two groups (all P>0.05). Multivariate Cox regression analysis showed that gender was an independent risk factor for BARC type 1 bleeding in PCAD patients (HR=2.180, 95%CI 1.392-3.416, P<0.001), but it was not an independent risk factor for MACCE and BARC type 2-5 bleeding(all P>0.05). Hyperlipidemia, preoperative SYNTAX score, multivessel lesions and NSTE-ACS were the independent risk factors for MACCE in PCAD patients with PCI (the HRs(95%CI) were 1.289(1.052-1.580), 1.030(1.019-1.042), 1.758(1.365-2.264), 1.264(1.040-1.537), respectively); gender (HR=1.579, 95%CI 1.085-2.297, P=0.017), hyperlipidemia (HR=1.305, 95%CI 1.005-1.695, P=0.046), anticoagulant drugs including low molecular weight heparin (HR=1.321, 95%CI 1.002-1.741, P=0.048) or sulfonate(HR=1.659, 95%CI 1.198-2.298, P=0.002) were the independent risk factors for bleeding events. Conclusions: There are differences in clinical and coronary artery lesion characteristics between different genders in patients with PCAD. The incidence of minor bleeding is significantly higher in female PCAD patients than in male PCAD patients. Hyperlipidemia, preoperative SYNTAX score, multivessel lesions and NSTE-ACS are the independent risk factors for MACCE, and gender, hyperlipidemia, anticoagulant drugs including low molecular weight heparin or sulfonate are the independent risk factors for bleeding events in patients with PCAD.

[Impact of coronary artery lesion calcification on the long-term outcome of patients with coronary heart disease after percutaneous coronary intervention].

Objective: To investigate the impact of coronary lesion calcification on the long-term outcome of patients with coronary heart disease after percutaneous coronary intervention. Methods: In this prospective observational study, a total of 10 119 consecutive patients with coronary heart disease undergoing percutaneous coronary intervention from January 1 to December 31, 2 103 in our hospital were enrolled. The patients were divided into non/mild calcification group (8 268 cases) and moderate/severe calcification group (1 851 cases) according to the angiographic results. The primary endpoint was one-year major adverse cardiovascular events (MACE), including all-cause death, myocardial infarction, and target vessel revascularization. Results: The patients were (58.3±10.3) years old, and there were 2 355 females (23.3%). Compared with non/mild calcification group, patients in the moderate/severe calcification group were older ((60.0±10.6) years vs. (57.9±10.2) years, P<0.01), and had higher proportion of female (25.4% (470/1 851) vs. 22.8% (1 885/8 268), P=0.02), debates (33.9% (628/1 851) vs. 29.0% (2 399/8 268), P<0.01), hypertension (68.0% (1 259/1 851) vs. 63.7% (5 264/8 268), P<0.01), coronary artery bypass grafting (4.6% (85/1 851) vs. 3.2% (268/8 268), P<0.01), stroke (12.6% (233/1 851) vs. 10.4% (861/8 268), P=0.01), and renal dysfunction (6.2% (115/1 851) vs. 3.7% (303/8 268), P<0.01). Compared with non/mild calcification group, patients in themoderate/severe calcification group experienced longer procedure time (37 (24, 61) min vs. 27 (17,40) min, P<0.01) and stent length was longer (32 (23,48) mm vs. 27 (18,38) mm, P<0.01), and percent of rotational atherectomy was higher (2.56%(57/2 229) vs. 0.03% (3/11 930), P<0.01). One-year follow-up results showed that MACE (7.5% (139/1 846) vs. 4.9% (402/8 243), P<0.01), all-cause death (1.0% (19/1 846) vs. 0.6% (49/8 243), P=0.04), myocardial infarction (2.2% (41/1 846) vs. 1.4% (114/8 243), P=0.01), and target vessel revascularization (5.0% (92/1 846) vs. 3.2% (266/8 243), P<0.01) were all significantly higher in moderate/severe calcification group than in non/mild group. Multivariate Cox regression analysis showed that moderate/severe calcification was an independent predictor of MACE at one-year after the procedure (HR=1.41, 95%CI 1.16-1.72, P<0.01). Conclusion: Moderate/severe calcification in coronary lesion is an independent predictor of long-term poor prognosis in coronary heart disease patients undergoing percutaneous coronary intervention.

[Predictive value of neutrophil to lymphocyte ratio on long-term outcomes of acute myocardial infarction patients with multivessel disease].

Objective: Patients with acute coronary syndrome due to multivessel disease (MVD) were at the highest risk of adverse cardiovascular events. Neutrophil to lymphocyte ratio (NLR) was proposed as a marker of cardiovascular risk. Present study evaluated the independent predictive value of NLR for acute myocardial infarction (AMI) patients with MVD. Methods: AMI patients with MVD (n=1 433) underwent percutaneous coronary intervention (PCI) between January 2013 and December 2013 were followed up for 2 years. Patients were divided into 2 sub-groups based on an optimal cut off value of NLR to predict 2-year all-cause mortality. The primary endpoint was all-cause death. The secondary endpoint was long-term major adverse cardiovascular and cerebrovascular events (MACCE). Results: By receiver operating characteristics curve analysis, the optimal cut-off value of admission NLR to predict 2-year all-cause mortality was 3.39 (area under the curve 0.765, sensitivity 71%, specificity 73%). The high NLR group(n=396) had higher prevalence of prior myocardial infarction, prior PCI and intra-aortic balloon pump use (IABP)(P<0.01). Compared to the low NLR group (n=1 037), patients in the high NLR group were older, had higher level of neutrophil count and high-sensitivity C-reactive protein (hs-CRP) (P<0.001), but lower level of lymphocyte count, estimated glomerular filtration rate (eGFR) and ejection fraction (P<0.001). During the follow-up period, rate of long-term all-cause death was significantly higher in the high NLR group than in the low NLR group (5.1% (20/396) vs. 0.8% (8/1 037), P<0.001). Cardiac death (4.0% (16/396) vs. 0.7% (7/1 037), P<0.001) and MACCE (21.7% (86/396) vs. 12.6% (131/1 037), P<0.001) were also significantly higher in the high NLR group than in the low NLR group. Multivariate Cox analysis showed that NLR ≥ 3.39 was determined as an independent predictor of 2-year all-cause mortality (HR=3.23, 95%CI 1.38-7.54, P=0.007) and MACCE (HR=1.58, 95%CI 1.19-2.10, P=0.002) in this patient cohort after adjusting for other risk factors. Correlation analysis showed that the NLR was positively correlated with hs-CRP levels (r=0.241, P<0.001). Conclusion: Our study demonstrates that admission NLR ≥ 3.39 is an independent predictor of long term all cause death and MACCE in AMI patients with MVD post PCI.

[Impact of short-time anticoagulant therapy after selective percutaneous intervention on prognosis of patients with coronary artery disease].

Objective: To observe the safety and impact of short-term anticoagulant therapy on prognosis after selective percutaneous coronary intervention (PCI) in patients with coronary artery disease. Methods: From January 2013 to December 2013, 9 769 consecutive patients underwent selective PCI in Fuwai Hospital were retrospectively included in this study. Patients were divided into two groups, including non-post-PCI anticoagulant therapy group and low-dose and short-time post-PCI anticoagulant therapy group (enoxaparin 0.4 ml/12 h or fondaparinux 2.5 mg/day by subcutaneous injection for 2-3 days after PCI). All patients were evaluated at 30 days, 180 days and 12 months for major adverse coronary and cerebral events (MACCE) including all-cause death, myocardial infarction, revascularization and stroke as well as in-stent thrombosis and bleeding events. Data from 1 755 pairs of patients were analysis after propensity score matching. The clinical outcomes were compared between groups by using Kaplan-Meier survival analysis before and after propensity score matching. Multivariable Cox analysis was used to define the impact and determinants of post-PCI anticoagulation on clinical outcomes. Results: one thousand seven hundred and fifty-five (18.0%) patients didn't receive post-PCI anticoagulation and 8 014 (82.0%) patients received post-PCI anticoagulation, 5 666 (58.0%) patients received enoxaparin and 2 348 (24.0%) patients received fondaparinux. Patients were younger and incidence of female patients was less, incidence of renal dysfunction and acute coronary syndrome were higher in low-dose and short-time post-PCI anticoagulant therapy group than in non-post-PCI anticoagulation group (all P<0.05). Similarly, patients with post-PCI anticoagulation were associated with more left main coronary artery lesion and branch lesion (P<0.05). Post-PCI anticoagulation patients were associated with less trans-femoral process, more drug-eluting stents implantation and less simple balloon dilatation (all P<0.05). Nine thousand seven hundred and seventeen (99.5%) patients completed 2 years follow up. Post-PCI anticoagulation patients had significantly lower 30-day all-cause death (0.05% (4 cases) vs. 0.46% (8 cases), P<0.001) and stroke (0 vs. 0.11% (2 cases), P=0.003), lower 180-day all-cause death (0.17% (14 cases) vs. 0.57% (10 cases), P=0.002), revascularization (2.07% (166 cases) vs. 3.71% (65 cases), P<0.001) and MACCE (3.49% (280 cases) vs. 5.47% (96 cases), P<0.001), lower 2-year revascularization (7.61% (610 cases) vs. 12.84% (225 cases), P<0.001) and MACCE (10.92 (875 cases) vs. 16.01% (281 cases), P<0.001). Multivariable Cox regression analysis showed that post-PCI anticoagulant therapy was an independent protective factor of 30-day (HR=0.17, 95%CI 0.05-0.62, P=0.007), 180-day all-cause death (HR=0.37, 95%CI 0.16-0.87, P=0.023) and MACCE (HR=0.74, 95%CI 0.58-0.94, P=0.013), 2-year MACCE (HR=0.71, 95%CI 0.62-0.81, P<0.001). After propensity score matching, post-PCI anticoagulation therapy remained as an independent protective factor of 30-day all-cause death (HR=0.11, 95%CI 0.01-0.92, P=0.042) and 2-year MACCE (HR=0.81, 95%CI 0.68-0.96, P=0.015). Conclusions: Low-dose and short-time post-PCI anticoagulant therapy may decrease 30-day all-cause death, 180-day all-cause death and MACCE and 2-year MACCE, and meanwhile this option does not increase bleeding risk in patients underwent selective PCI.

[Predictive value of GRACE discharge score for long-term out-of-hospital death in acute coronary syndrome after percutaneous coronary intervention].

Objective: To evaluate the prognostic value of Global Registry of Acute Coronary Events(GRACE) discharge score for long-term out-of-hospital death in acute coronary syndrome (ACS) after drug-eluting stents (DES) and with Dual-antiplatelet Therapy (DAPT). Methods: Our study was a prospective, observational, single center (Fuwai Hospital of China) study.A total of 6 431consecutive ACS patients underwent percutaneous coronary intervention(PCI)between January 2013 and December 2013 were involved.The primary endpoint was all-cause death and second endpoint was major adverse cardiovascular and cerebrovascular events (MACCE) as a composite of all-cause death, myocardial infarction, revascularization, stent thrombosis or stroke. Results: Finally, 5 867 ACS patients who were received DES with DAPT and had no in-hospital event included in this study, and 59 (1.01%) death and 608 (10.36%) MACCE were reported during 2-year follow-up after discharge.GRACE score was significantly higher among death patients than those survivalpatients (94± 28 vs 78± 24, P<0.001). According to risk stratification of GRACE discharge score, as compared to the low-risk group, death risk in high-risk group was 6.73 times (HR=6.73, 95%CI 3.53-12.84; P<0.001) higher, but could not distinguish between the moderate and low risk group (HR=1.61, 95%CI 0.88-2.95; P=0.124). The GRACE score showed predictive value in ACS patients after DESand with DAPT (area under the receiver operating characteristic curve (AUROC)=0.661; 95%CI 0.586-0.736, P<0.001). In subgroup analysis, GRACE score also showed predictive value both in unstable angina pectoris (UAP)(AUROC=0.660, 95%CI 0.576-0.744; P<0.001) and acute myocardial infarction(AMI)subgroup (AUROC=0.748, 95%CI 0.631-0.864; P=0.001). Conclusion: GRACE discharge score shows prognostic value for long-term out-of-hospital death in ACS patients undergoing PCI with DES and DAPT, and demonstrates good risk stratification of high and low-risk of death.

[Long-term prognosis of coronary artery disease with atrial fibrillation after percutaneous coronary intervention].

Objective: To investigate the long-term prognosis of coronary artery disease with atrial fibrillation (AF) after percutaneous coronary intervention (PCI). Methods: A total of 10 724 patients with PCI were enrolled in 2013, and 2-year clinical outcomes in patients with AF (AF group) and without AF (non-AF group) were compared. Results: A total of 113 patients were with AF (1.1%), and 8 out of them were on triple antithrombotic therapy (9.5%), and AF group patients were with more complications. The 2-year follow-up results showed that the all-cause mortality in AF group was significantly higher than that in non-AF group (9.7% vs 1.1%; P<0.001). The incidence of cardiac death, stent thrombosis and stroke was also significantly higher in patients with AF. The incidence of major adverse cardiac and cerebrovascular events (MACCE) was also significantly higher in AF group compared with non-AF group (17.7% vs 8.8%; P<0.001), whereas the incidence of revascularization was significantly lower in the AF group than in the non-AF group (2.7% vs 8.7%; P=0.023). The incidence of myocardial infarction and bleeding had no significant difference between the two groups, and the adverse events between the two groups had no significant difference after propensity score (PS) either. Conclusions: The 2-year clinical follow-up of single-center, large-sample PCI patients shows poor prognosis in patients with AF compared with the non-AF patients. But there is no difference in the prognosis between the two groups after PS, however, this conclusion still needs to be confirmed by randomized controlled studies.

[Clinical outcomes with beta-blockers in stable patients undergoing percutaneous coronary intervention with adequate left ventricular ejection function].

Objective: To investigate the impact of beta-blockers on long-term outcomes in patients who underwent percutaneous coronary intervention (PCI) for stable coronary artery disease (SCAD) with adequate left ventricular ejection function (LVEF). Methods: A total of 3 946 consecutive SCAD patiens who underwent PCI with adequate LVEF between January and December 2013 in Fuwai Hospital were prospectively included in this study. According to beta-blocker use at discharge, patients were divided into no-beta-blocker group (n=309) and beta-blocker group (n=3 637). Major adverse cardiovascular and cerebrovascular events (MACCE) including all-cause death, myocardial infarction, revascularization, stroke and stent thrombosis at 2 years were compared between the two groups. Multivariate Cox regression analysis and Propensity-score matched analysis were used to identify independent risk factors of poor prognosis. Results: Compared with those in the beta-blocker group, patients of no-beta-blocker group were more likely to have lower body mass index, less complex comorbidities, slower heart rate either on admission or at discharge. There was no significant association of beta-blocker use with 2-year mortality (0.8% versus 1.3%, hazard ratio (HR) 0.65, 95% confidence interval (CI) 0.23 to 1.86, P=0.421), myocardial infarction ( HR 0.66, 95% CI 0.24 to 2.64, P=0.718) or MACCE (HR 0.70, 95% CI 0.65 to 1.32, P=0.674). Results were similar in propensity score-matched analysis. Conclusions: In this large, prospective, single-center study, patients with beta-blocker prescription appear to have more risk factors. No beta-blockers at discharge is not an independent risk factor of poor prognosis at up to 2 years among stable patients who underwent PCI with adequate LVEF.

[Safety and efficacy of second generation drug eluting stents in diabetic and non-diabetic patients].

Objective: To investigate the long-term prognosis of Second generation drug-eluting stents(G2-DES) in diabetic mellitus(DM) and non-DM patients. Methods: Patients with coronary heart disease(CHD) in Fuwai Hospital from January 2013 to December 2013 who had exclusively G2-DES implantation, were consecutively included the follow-up period was 2 years. Results: A total of 6 094 patients with CHD were implanted with G2-DES, of which 1 862 patients with DM, and 4 232 patients without DM.The proportion of DM patients receiving G2-DES implantation with the following characteristics: advanced age, female, hypertension, hyperlipidemia, history of previous stroke, history of peripheral artery disease, previous history of PCI, and with triple vessel, high preoperative Syntax score, high number of target lesions, B2 or C type lesions, severe calcification lesions, and chronic occlusive disease were significantly higher than those of non-DM patients(P<0.05). The incidence of major adverse cardiac and cerebral vascular events(MACCE), target vascular revascularization(TVR) and target lesion revascularization(TLR) were higher in DM patients than in non-DM patients during 2 year's follow-up(P<0.05). The univariate COX regression analysis showed that diabetes was risk factor for MACCE in patients with CHD implanting G2-DES(HR=1.241, 95%CI: 1.053-1.463, P=0.010). However, multivariable COX analysis showed that DM was not an independent risk factor for MACCE in CHD patients with G2-DES(HR=1.125, 95%CI: 0.952-1.330, P=0.167). While age, female, preoperative Syntex score, triple vessel, B2 or C lesion were independent risk factors for poor clinical prognosis in CHD patients with G2-DES. Conclusions: (1) CHD patients with DM often accompany more clinical risk factors and complicated coronary lesions; (2) the incidence of MACCE, TVR and TLR in DM patients is significantly higher than non-DM patients with G2-DES during the 2 year's follow-up; (3) after multivariate adjustment, DM is not an independent risk factor for poor clinical prognosis in CHD patients with G2-DES, while traditional risk factors and complex coronary lesions are independent risk factors for poor clinical prognosis.

[Impact of high-sensitivity C-reactive protein on outcomes in patients with acute coronary syndrome undergoing drug-eluting stent implantation].

Objective: To investigate the association between high-sensitivity C-reactive protein (hs-CRP) and long-term outcomes in Chinese patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) after drug-eluting stent (DES) implantation. Methods: A total of 4 815 consecutive NSTE-ACS patients who treated with DESs were included.Patients were divided into three groups: <1.00 mg/L, 1.00 to 2.99 mg/L and ≥3.00 mg/L, based on the level of hs-CRP on admission.Major adverse cardiovascular and cerebrovascular events (MACCE, including all-cause death, myocardial infarction, revascularization, in-stent thrombosis and stroke) were compared among groups during 2-year follow-up. Results: Patients with higher hs-CRP had more risk factors of cardiovascular events such as concomitant morbidities and multi-vessel lesions(68.5% vs 73.6% vs 76.2%, P<0.001). Higher hs-CRP value was associated with increased rates of MACCE (8.8% vs 11.2% vs 12.6%, P=0.003) and revascularization (6.5% vs 8.5% vs 9.8%, P=0.003). However, the rates of all-cause death, myocardial infarction, stroke, and stent thrombosis were comparable among groups(all P>0.05). Ongoing divergences in MACCE and revascularization among three groups were significant on Kaplan-Meier curves (both Log-rank P=0.003). Multivariable Cox regression analysis indicated that compared to hs-CRP<1.00 mg/L group, MACCE in the >3.00 mg/L group was increased by 42% [HR 1.42 (1.13-1.78), P=0.002]. Meanwhile, multivessel leisions, ejection fraction<50%, elevated white blood cell counts were also independent risk factors.CRP≥3.00 mg/L(HR 1.56, 95%CI 1.16-2.08, P=0.003, compared to <1.00 mg/L) and multivessel leisions were independent predictors of revascularization. Conclusions: (1)Patients with higher hs-CRP on admission have more risk factors of cardiovascular events.(2)Higher hs-CRP value is associated with increased rates of MACCE and revascularization.(3)Pre-procedural hs-CRP is an independent predictor of 2-year outcomes for Chinese NSTE-ACS patients treated with DESs.