[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.

[Feasibility of radiofrequency ablation for cancer patients with atrial fibrillation].

Objective: To analyze the impact of cancer on the recurrence rate of atrial fibrillation (AF) after AF radiofrequency ablation and further evaluate the feasibility of radiofrequency ablation therapy in cancer patients with AF. Methods: This study was a single-center, retrospective study. Cancer patients with AF undergoing radiofrequency ablation for the first time in the First Affiliated Hospital of Dalian Medical University from May 30, 2008 to September 30, 2018 were included (cancer group). AF patients without cancer undergoing radiofrequency ablation for the first time during the same period served as non-cancer group. Clinical data including age, gender, past history, cancer and AF-related parameters, etc. were analyzed. Patients were followed up after radiofrequency ablation. The primary endpoints were AF recurrence or all-cause death. Kaplan-Meier survival analysis was used to analyze the effect of cancers on the recurrence after AF ablation. The multivariate cox regression analysis was further applied to correct for other confounding factors to analyze whether the impact of cancers on the recurrence of atrial fibrillation was statistically significant. Results: A total of 90 patients were enrolled, there were 30 patients in the cancer group (mean age (64.8±6.6) years, 16 (53.3%) males) and 60 patients in the non-cancer group (mean age (63.6±6.2) years, 32 (53.3%) males). Clinical data, such as age, gender, and cancer treatment, were similar between the two groups. During an average follow-up period of (328.7±110.2) days, there were 6 AF recurrences (recurrence rate 20.0%) in the cancer group, and 17 AF recurrences (recurrence rate 28.3%) in the control group. AF recurrence rate was similar between the two groups (P>0.05). During the follow-up period, there was no all-cause death in the two groups. Kaplan-Meier survival analysis showed that cancer was not related to AF recurrence after radiofrequency ablation (P = 0.383). After adjusting for other confounding factors, the multivariate Cox regression analysis showed that cancer was not an independent predictor of AF recurrence after radiofrequency ablation (HR=0.508, 95%CI: 0.192-1.342, P = 0.172). Conclusions: The combination of cancer has no impact on the recurrence of AF after radiofrequency ablation. For cancer patients with AF, radiofrequency ablation therapy can be considered as a feasible heart rhythm control treatment strategy.

[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.

[Impact of type 2 diabetes mellitus on the progression and revascularization of coronary non-target lesions in patients with coronary heart disease].

Objective: To investigate the impact of type 2 diabetes mellitus on progression and revascularization of coronary non-target lesions in patients with coronary heart disease. Methods: From January 2010 to September 2014, we retrospectively analyzed the clinical data of patients with coronary heart disease who underwent two consecutive coronary angiographies at Fuwai Hospital. At least one coronary non-target lesion was recorded at the first procedure in these patients. Patients were grouped according to the diagnose of type 2 diabetes mellitus. Demographic features, risk factors of coronary heart disease, laboratory results as well as characteristics of coronary non-target lesions were collected at baseline (first coronary angiography) and follow-up (second coronary angiography). Lesion progression was defined by quantitative coronary angiography analysis. Lesions revascularization was recorded. Multivariable Cox regression analysis was used to define the impacts of diabetes mellitus on progression and revascularization of non-target lesions. Subgroup analysis in diabetic and non-diabetic groups were further performed. Receiver operating characteristics curve was used to identify the predictive value of HbA1c. Results: A total of 1 255 patients were included, and 1 003(79.9%) were male, age was(58.0±9.7) years old. And 486 patients were diagnosed with type 2 diabetes mellitus. Follow-up time was (14.8±4.5) months. Compared with non-diabetic group, diabetic group were older with less male and had higher BMI index as well as higher prevalence of hypertension, dyslipidemia, prior myocardial infarction and prior percutaneous coronary intervention(all P<0.05). Diabetic patients also had higher level of white blood cells, erythrocyte sedimentation rate, C-reactive protein, endothelin and HbA1c at both baseline and follow-up compared with non-diabetic patients (all P<0.01). There was no significant difference on progression of non-target lesions (20.0%(97/486) vs. 18.5%(142/769), P=0.512), revascularization of non-target lesions (13.2%(64/486) vs. 15.9%(122/769), P=0.190) and non-target lesion related myocardial infarction(1.9%(9/486) vs. 1.3%(10/769), P=0.436) between diabetic and non-diabetic patients. Multivariable Cox regression analysis revealed that diabetes mellitus was not an independent predictor for progression and revascularization of non-target lesions (Both P>0.05). Subgroup analysis in diabetic patients showed that baseline HbA1c level(HR=1.160, 95%CI 1.009-1.333, P=0.037) was an independent predictor for non-target lesion progression. Cut-off value of HbA1c was 6.5% (Area Under Curve(AUC) 0.57, specificity 88.7%; sensitivity 24.2%, P=0.046) by receiver operating characteristics curve. Patients with HbA1c level above 6.5% had 2.8 times higher risk of lesion progression compared with patients with HbA1c level below 6.5% (HR=2.838, 95%CI 1.505-5.349, P=0.001). Compared with non-diabetic patients, diabetic patients with HbA1c below 6.5% also had lower risk of lesion progression (HR=0.469, 95%CI 0.252-0.872, P=0.012). ST-segment elevated myocardial infarction was an independent predictor for revascularization of non-target lesions in diabetic patients. Conclusion: Type 2 diabetes mellitus is not an independent predictor for progression and revascularization of coronary non-target lesions in patients with coronary heart disease. However, elevated HbA1c level is a risk factor for progression of non-target lesion in patients with type 2 diabetes mellitus.

[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.

[A nationwide online questionnaire survey of the understanding and implementation of pulmonary rehabilitation at all levels of medical institutions in China in 2017].

Objective: To analyze the implementation and understanding of pulmonary rehabilitation in medical personnel at all levels of medical institutions nationwide. Methods: We used WeChat and e-channels to disseminate e-questionnaires including personal basic information and the implementation of hospital pulmonary rehabilitation (including the setting up of hospital rehabilitation, pulmonary rehabilitation-related treatment, and the composition of pulmonary rehabilitation teams), and awareness of pulmonary rehabilitation (including doctors' understanding of lung rehabilitation status, pathways, prospects, and obstacle factors). Finally, the analysis of the data was performed using SPSS 20.0 for statistical analysis. The frequency distribution and composition ratio were used to describe the distribution of each question item. Comparison among groups according to the unit level of the respondents was performed by chi-square test. P<0.05 was considered statistically significant. Results: A total of 921 medical staff from all over the country completed the survey, covering the entire country including Taiwan Province and a total of 32 provinces, municipalities, autonomous regions, and municipalities directly under the Central Government. 88.1% of medical personnel reported that their hospitals had rehabilitation departments, the difference being statistically significant (P=0.001). Doctors could understand that the most important ways of pulmonary rehabilitation knowledge were the following: expert lectures (559, 60.69%), professional literature (541, 58.74%), professional books (442, 47.99%), pulmonary rehabilitation conference (392, 42.56%), the difference being statistically significant (all P<0.05).Among the factors that impeded the implementation of pulmonary rehabilitation, the top four were lack of talent (690, 74.92%), lack of education (645, 70.03%), lack of policy support (603, 65.47%), and lack of related equipments (578, 62.76%). Conclusions: The lower the level of the hospitals, the poor the implementation and cognitive status of pulmonary rehabilitation. Promoting the training of pulmonary rehabilitation personnel and strengthening the academic exchange of pulmonary rehabilitation were good ways to strengthen the implementation of pulmonary rehabilitation and improve the understanding of pulmonary rehabilitation.

[Impact of different anticoagulation therapies on heparin dosage applied to atrial fibrillation patients undergoing atrial fibrillation catheter ablation].

Objective: Differences in the activated coagulation time (ACT) during ablation and adequate heparin dosing were observed among atrial fibrillation (AF) patients undergoing AF catheter ablation receiving different anticoagulation therapies and the suitable heparin dosing during ablation among patients treated with different anticoagulation therapies was explored. Methods: Patients who received warfarin (n=100), low-molecular-weight heparin (n=100), dabigatran etexilate (n=98, 110 mg, Bid) and rivaroxaban (n=48, 20 mg, Qd) were included. All of them underwent the first AF ablation during January 2016 to December 2017 and patients with hepatic and renal dysfunction were excluded. Initial bolus heparin (100 U/kg, intravenous) was applied to all patients. Additional heparin dosage was added according to the ACT, which was measured in 15-minute interval to maintain the ACT within 250-350 seconds until the end of ablation. Patient characteristics, ACT and complications were compared among various groups. Results: The baseline general characteristics among patients were similar. The baseline ACTs in the dabigatran groups were significantly longer than those in the rivaroxaban group ((133±36) seconds vs. (113±22) seconds, P<0.05). The 15 min ACT in the warfarin group was longer than in the dabigatran group ((259±56) seconds vs. (243±43) seconds, P<0.05). The 15-minute ACTs were significantly longer in the warfarin ((259±56) seconds) and dabigatran ((243±43) seconds) groups compare with low-molecular-weight heparin group ((224±40) seconds) and rivaroxaban group ((226±32) seconds) (all P<0.05). The same trend was also observed in the rate of reaching ACT goal after initial-standard-dosage of heparin (warfarin (53%, 53/100), dabigatran (45%,44/98), low-molecular-weight heparin (28%,28/100), rivaroxaban (23%,11/48), P<0.05). The 1 hour ACT in the warfarin group ((254±49) seconds) was significantly longer than the other three groups (dabigatran (233±33) seconds, low-molecular-weight heparin (226±34) seconds, rivaroxaban (231±30) seconds, all P<0.01). The rate of reaching ACT goal at 1 hour were significantly higher in the warfarin group (66%,35/53) than in the dabigatran group (41%,18/44), and rivaroxaban group (27%,3/11) (all P<0.05). The total heparin required was significantly higher in rivaroxaban group than in the dabigatran and warfarin groups (all P<0.05). During the perioperative period, no patient exhibited any thromboembolic complications, and only a few minor bleeding complications was observed among patients, which was similar between the four groups (P>0.05). Conclusion: Higher dosage of heparin is required during AF ablation to achieve the satisfactory anticoagulant intensity for AF patients under dabigatran etexilate (110 mg, Bid), low-molecular-weight heparin and rivaroxaban (20 mg, Qd) anticoagulation therapy before AF ablation.

[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.

[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.

[The clinic experience of implantable diaphragm pacer in a patient with high cervical spinal cord injury and literature review].

Objective: To report the use of implantable diaphragm pacer (IDP) in a patient with high cervical spinal cord injury(HCSCI). Methods: A 14-year-old male patient, who suffered from a HCSCI at C2 neurological level and had been on a ventilator for 2 years, received IDP in August 2017 at China Rehabilitation Research Center. A systematic literature review was performed on IDP in patients with HCSCI in Pubmed, CNKI, and Wanfang databases, using the keywords: phrenic nerve and electrical stimulation and spinal cord injury; IDP and spinal cord injury; breathing pacemaker system and spinal cord injury. All fields were covered from 1970/01/01 to 2018/01/01 in Pubmed, from 1981/01/01 to 2018/01/01 in CNKI, and from 1900/01/01to 2018/01/01 in Wanfang. Results: No spontaneous breathing was observed preoperatively in the patient. The electrical response of phrenic nerves was intact on the right, but unresponsive on the left. We got started with the IDP at 4 weeks after surgery. The threshold voltage of the right hemidiaphragm pacing was 0.1 V and at the level of 0.7 V with an optimal effect. No significant diaphragmatic contraction was found at left side with the extent up till 0.7 V. The maximum tidal volume was 840 ml when electrical stimulation was given at an intensity of 0.7 V bilaterally. The bilateral stimulation voltage at 0.1-0.2 V, pacing frequencies at 9 beats/min in bed, or at 12 beats/min on wheelchair, were set to maintain the tidal volume at the level of (435±32) ml. After 2-week adaptive training, the patient could wean from the ventilator for 12 hours and had a normal blood gas analysis. At 6 week after surgery, with the aid of IDP, the patient could get out in wheelchair for outdoor activities. By literature review, we found 78 English papers, including 6 clinical trials, 10 reviews, and 11 Chinese papers, consisting of 8 reviews, 1 study in animal, and 2 news reports. Extensive contents, such as preoperative evaluation, preoperative preparation, surgical procedures, complications, surgical outcomes, and animal model studies of IDP were involved. The indications of IDP reported by literature were: (1) central alveolar hypoventilation; (2) Sleep apnea syndrome (Biot's respiration); (3) Respiratory failure induced by brainstem injury or disease; (4) Respiratory failure induced by spinal cord injury or disease above C3 level. Conclusion: Our case study confirmed the therapeutic effect of IDP on patients with respiratory failure caused by HCSCI.

[Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: 5-year results of the TARGET â ¡ trial].

Objective: This study sought to evaluate the safety and efficacy of FIREHAWK, a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent (SES) in patients with moderate-complex coronary lesions (including patients with small vessel disease, long lesion and multi vessel disease), and to validate the ability of the SYNTAX score (SS) to predict clinical outcomes in patients treated with FIREHAWK stent. Methods: TARGETⅡ was a prospective, multicenter, single-arm clinical trial, a total of 730 patients who underwent percutaneous coronary intervention (PCI) of de novo lesions in native coronary arteries in 24 medical centers in China from August 2011 to February 2012 were enrolled in this study. All patients were exclusively treated with the FIREHAWK stent. Clinical data including patients with diabetes, small vessel disease, long lesion and multi vessel disease were analyzed. The primary composite endpoint was the target lesion failure (TLF) of cardiac death, target vessel-related myocardial infarction (TV-MI), or target lesion revascularization (TLR). The secondary composite endpoint was patient-oriented endpoint (PoCE), a composite of all death, all myocardial in farction (MI), or any repeat revascularization; definite/probable stent thrombosis (ST) (including acute, late, and very late thrombosis) . SS was calculated in lesions with stenosis more than 50% with coronary artery diameter greater than 1.5 mm. Patients were grouped by tertiles of SS (≤7, >7 to ≤12, >12). Follow-up was performed up to 5 years. Results: A total of 730 patients were enrolled in the TARGET Ⅱ trial. The average SS was 10.9±6.9. 683 (93.6%) patients completed 5-year clinical follow-up. The 5-year incidence of TLF was 8.5%(58/683). The incidence of TLF components was as follows: cardiac death 2.0%(14/683), TV-MI 4.4%(30/683), TLR 3.4%(23/683). The incidence of PoCE was 16.4%(112/683). The incidence of definite/probable stent thrombosis was 0.7%(5/683).Multivariable Cox regression analysis showed that the diabetes subgroup (HR=1.123, 95%CI 0.623-2.026, P=0.699), the small vessel disease subgroup (HR=0.909, 95%CI 0.526-1.570, P=0.732), the long lesion subgroup (HR=1.561, 95%CI 0.922-2.640, P=0.097), and the multi vessel disease subgroup (HR=1.062, 95%CI 0.611-1.846, P=0.830) did not increase the HR of TLF compared with the counterpart subgroups. Multivariable Cox regression analysis showed that the hazard of TLF was not increased in the middle and high SS groups as compared with the low SS group (HR=1.203,95%CI 0.607-2.385,P=0.597;HR=1.548,95%CI 0.829-2.892,P=0.171). Conclusions: The 5 years follow-up results of TARGET Ⅱ trial shows that the biodegradable polymer of FIREHAWK stents have long-lasting safety and efficacy for patients with moderate-complex coronary lesions. SS is not the predicting factor for the occurrence of TLF in FIREHAWK treated patients with moderate-complex coronary lesions. Trial Registration Clinical Trials.gov, NCT0141264.

[Relationship between thrombolysis in myocardial infarction risk index and the severity of coronary artery lesions and long-term outcome in acute myocardial infarction patients undergoing percutaneous coronary intervention].

Objective: To investigate the relationship between thrombolysis in myocardial infarction risk index(TRI) and the severity of coronary artery lesions and long-term outcome in acute myocardial infarction(AMI) patients undergoing percutaneous coronary intervention(PCI). Methods: A total of 1 663 consecutive AMI patients undergoing PCI between January and December 2013 in Fuwai hospital were prospectively included in this study. The severity of coronary artery lesions was evaluated using the SYNTAX score. Receiver operating characteristic(ROC) curve was used to analyze the optimal cut-off value of TRI on predicting all-cause mortality at 2 years after PCI.The patients were divided into 2 groups based on the optimal cut-off value of TRI:high TRI group (TRI ≥ 23.05, 465 cases) and low TRI group(TRI<23.05, 1 198 cases). Multivariate logistic regression analyses were used for determining the relationship between TRI and SYNTAX scores≥33. A multivariate Cox regression analyses was used to identify the influence factors of long-term outcome after PCI. Results: SYNTAX score was higher in high TRI group than in low TRI group (13.00(7.00, 20.50) vs.10.25(7.00, 17.00), P<0.001). TRI was independently associated with SYNTAX score ≥ 33 (OR=1.09,95% CI 1.03-1.16, P=0.004). After the 2 years follow-up, rates of all-cause death (4.1% (19/465) vs. 0.3% (4/1 198) , P<0.001), cardiac death (2.6% (12/465) vs. 0.2% (2/1 198) , P< 0.001) and stent thrombosis (1.7% (8/465) vs. 0.5% (6/1 198) , P=0.015) were all significantly higher in high TRI group than in low TRI group. Multivariate Cox regression analyses showed that TRI≥ 23.05 was an independent risk factor of all-cause death (HR=5.22, 95%CI 1.63-16.72, P=0.005), cardiac death (HR=8.48, 95%CI 1.75-41.07, P=0.008) and stent thrombosis(HR=3.87, 95%CI 1.32-11.41, P=0.014) at 2 years after PCI in AMI patients, but which was not the independent risk factor of major adverse cardiovascular and cerebrovascular events (HR=0.96, 95%CI 0.69-1.36, P=0.834) .The area under ROC curve of TRI ≥ 23.05 on predicting 2 years all-cause mortality in AMI patients undergoing PCI was 0.803(95%CI 0.711-0.894, P<0.001). Conclusions: TRI is independently associated with SYNTAX score ≥ 33. TRI is also an independent risk factor of 2 years all-cause death, cardiac death and stent thrombosis in AMI patients undergoing PCI.

[Predictive value of the GRACE discharge score on the long-term out-of-hospital coronary thrombotic events after implantation of drug-eluting stents].

Objective: To evaluate the predictive value of GRACE discharge score on the long-term out-of-hospital coronary thrombotic events (CTE) after percutaneous coronary intervention (PCI) with drug-eluting stents. Methods: Present study was a prospective, observational, single center study. 10 724 consecutive patients underwent PCI in Fuwai Hospital between January and December 2013 were included, stents were implanted with conventional method. After PCI, patients were prescribed aspirin 100 mg once daily indefinitely, and either clopidogrel 75 mg once daily or ticagrelor 90 mg twice daily for at least 1 year. A total of 9 782 patients were included in the final analysis after excluding patients who did not undergo successful stent implantation, who were not discharged on dual anti-platelet therapy (DAPT), who only underwent bare-metal stents, who experienced in-hospital major bleeding, stent thrombosis, myocardial infarction (MI) or death,and who lost follow up. Clinical data were collected from all patients. 9 543 patients with complete baseline data were further analyzed for risk stratification and predictive value of GRACE discharge score. CTE was defined as stent thrombosis or spontaneous myocardial infarction. All patients were followed through Fuwai Hospital Follow-up Center, and evaluated either by phone, letter, or clinic visits or at 1, 6, 12 and 24 months after PCI. Risk stratification was performed according to the GRACE discharge score, and the predictive value of the GRACE discharge score was assessed using the receiver operating characteristic (ROC) curve. Results: After 2 years follow-up, there were 95 CTE among the 9 782 patients. The patients were divided into 2 groups according to the presence or absence of CTE: CTE group (95 cases) and no CTE group (9 687 cases). GRACE discharge score was significantly higher in CTE group than no CTE group (82.98±27.58 vs. 75.51±22.46, t=-2.57, P=0.012). According to risk stratification of GRACE discharge score, the patients were divided into low-risk (≤88) group (n=6 902), moderate-risk (89-118) (n=2 988) and high-risk (>118) (n=343) groups. As compared to the low-risk group, CTE risk in moderate- and high-risk groups was 1.59 times (HR 1.59, 95%CI 1.01-2.52, P=0.046) and 3.89 times higher (HR 3.89, 95%CI 1.98-7.65, P<0.001), respectively. Further analysis showed that the GRACE score had predictive value in the total cohort for CTE (area under the receiver operating characteristic (AUROC) 0.576, 95%CI 0.512-0.640, P=0.012) and in the acute coronary syndromes(ACS) subgroup for CTE: (AUROC 0.594, 95%CI 0.509-0.680, P=0.019), but not in the non-ACS subgroup: (AUROC 0.561, 95%CI 0.466-0.657, P=0.187). Conclusion: GRACE discharge score can predict the long-term out-of-hospital CTE in patients undergoing PCI with drug-eluting stents and treated with DAPT, and patients can be stratified into the low-, moderate- and high-risk groups of CTE by the GRACE discharge score.

[Impact of direct bilirubin on the long-term outcome of patients with acute coronary syndrome post percutaneous coronary intervention].

Objective: To investigate the impact of direct bilirubin on long-term prognosis of acute coronary syndrome (ACS) patients post percutaneous coronary intervention(PCI). Methods: As a prospective and observational cohort study, a total of 6 431 consecutive ACS patients underwent PCI from January to December 2013 in Fuwai hospital were included. Patients were divided into 3 groups according to tertiles values of direct bilirubin as follows: low direct bilirubin group(<2.2 µmol/L, n=2 219), moderate direct bilirubin group(2.2-3.0 µmol/L, n=2 016), and high direct bilirubin group(>3 µmol/L, n=2 196). The clinical characteristics were compared among the 3 groups, and the impact of direct bilirubin on clinical adverse events (main adverse cardiovascular and cerebrovascular events included cardiogenic death, myocardial infarction, revascularization, stroke, and stent thrombosis) were analyzed at 2 years after PCI. Results: (1) Percent of male patients was 66.5%(1 475/2 219), 78.0%(1 572/2 016), and 86.2%(1 892/2 196), body mass index was(25.7±3.1), (26.0±3.3),and (26.0±3.2) kg/m(2), the ratio of the history of old myocardial infarction was 11.9%(264/2 219), 13.0%(263/2 016),and 14.9%(328/2 196), the ratio of the current smoker was 56.3%(1 249/2 219), 59.1%(1 192/2 016),and 60.0%(1 317/2 196) in low, moderate and high direct bilirubin groups respectively, and the differences were statistically significant (P<0.01 or 0.05). (2) Two years after PCI, the all-cause mortality was 0.8%(17/2 219), 1.8%(36/2 016), and 1.5%(33/2 196) (P=0.011),the cardiogenic mortality was 0.5%(12/2 219), 1.3%(26/2 016), and 0.6%(13/2 196) (P=0.010),the ratio of myocardial infarction was 2.2%(49/2 219), 2.4%(49/2 016), and 1.4%(31/2 196)(P=0.044),the ratio of revascularization was 8.8%(195/2 219), 8.3%(168/2 016),and 8.9%(196/2 196)(P=0.783),the ratio of stroke was 1.4%(30/2 219),1.1%(22/2 016), and 1.9%(42/2 196)(P=0.076),the ratio of stent thrombosis was 0.9%(19/2 219), 1.2%(24/2 016),and 0.7%(15/2 196)(P=0.210) in low, moderate and high direct bilirubin groups, respectively. (3) Multivariable Cox regression analysis showed that, patients in moderate direct bilirubin group faced increased the risk of all-cause mortality compared with patients in the low direct bilirubin group (HR=2.23, 95%CI 1.23-4.05, P= 0.009), and the risk of all-cause mortality was similar between high direct bilirubin group and low direct bilirubin group (HR=1.84, 95%CI 0.99-3.38, P= 0.051). There were no statistically significant difference in the risks of main adverse cardiovascular and cerebrovascular events,cardiogenic death, myocardial infarction, revascularization, stroke, and stent thrombosis in moderate and high direct bilirubin groups compared with low direct bilirubin group (all P>0.05). Conclusion: Moderate direct bilirubin level is associated with increased risk of all-cause death at 2 years after PCI compared with low level of direct bilirubin group.