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Objective@#To analyze the association between plasma high-density lipoprotein cholesterol (HDL-C) levels and the severity of coronary artery disease, and to evaluate the impact of HDL-C levels on long-term outcomes in patients underwent percutaneous coronary intervention (PCI).@*Methods@#A total of 10 458 consecutive patients underwent PCI from January 2013 to December 2013 at Fuwai hospital were enrolled in this study. Patients were divided into three groups according to HDL-C tertiles: low HDL-C group (HDL-C≤0.89 mmol/L, n=3 525), median HDL-C group (HDL-C>0.89-1.11 mmol/L, n=3 570) and high HDL-C group (HDL-C>1.11 mmol/L, n=3 363). SYNTAX score was used to evaluate the severity of coronary artery disease, linear regression was used to analyze the relationship of HDL-C and SYNTAX score. Kaplan-Meier survival analysis was used to compare the outcomes among the three groups. Multivariate Cox regression was used to define the potential associations of HDL-C and outcomes.@*Results@#The HDL-C level was (1.03±0.28) mmol/L and the SYNTAX score was 11.7±8.1. Patients were older, proportion of female, stable angina pectoris, successful PCI and left ventricular eject fraction value were higher, while incidence of diabetes mellitus was lower, hyperlipidemia, old myocardial infraction, smoking history and left main and three vessels disease were lower in high HDL-C group (all P<0.05). Patients in high HDL-C group also had the lowest SYNTAX score (12.2±8.4 vs. 11.7±8.1 vs. 11.2±7.8, P<0.001). Both univariate and multivariate linear regression analysis showed that HDL-C was negatively associated with SYNTAX score, e.g. Univariate analysis: β=-0.046, P<0.001; Multivariate analysis: β=-0.058, P=0.001. And 10 400 (99.4%) patients completed 2-year follow up. At 2-year follow-up, there were no difference in all-cause death, cardiac death, myocardial infarction, revascularization, stroke, major adverse cardiovascular and cerebral events (MACCE) and stent thrombosis among three groups (P for trend>0.05), while patient in high HDL-C group experienced the highest BARC type 2 bleeding events (P for trend=0.018). Multivariate Cox regression analysis showed that HDL-C level was not an independent risk factor of 2-year adverse ischemia events (P>0.05) and 2-year bleeding events (P>0.05).@*Conclusion@#In patients underwent PCI, plasma HDL-C level is negatively associated with SYNTAX score, but not an independent risk factor of ischemic and bleeding events post PCI.
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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.
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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.
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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/m2, 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.
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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.
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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.
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Objective@#To compare the effectiveness of percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) or medical therapy (MT) alone for real-world stable coronary artery disease (SCAD) patients with three-vessel disease (TVD) in mainland China.@*Methods@#A total of 8 943 consecutive cases with TVD hospitalized in our center from April 2004 to February 2011 were screened for this study. In this cohort, 3 435 cases diagnosed as SCAD were analyzed. PCI, CABG, MT alone were performed in 1 313 (38.2%), 1 259 (36.7%) and 863 (25.1%) patients, respectively. Propensity score matching (PSM) analysis using nearest neighbor matching with a 1∶1 ratio was applied, and 758 pairs of CABG and PCI groups, 552 pairs of PCI and MT groups, 639 pairs of CABG and MT groups were selected, respectively. 1- and 2-year clinical outcomes were evaluated among PCI, CABG and MT group. Kaplan-Meier curves and multivariable Cox regression method were used for survival analysis.@*Results@#Significant differences were found at baseline between PCI, CABG and MT group, including age, gender, body mass index, family history of coronary artery disease, hyperlipidemia, diabetes mellitus, previous myocardial infarction, stroke, previous revascularization, peripheral vascular disease, SNYTAX score, left ventricular ejection fraction, hemoglobin, serum creatinine, high-sensitivity C-reactive protein, triglyceride and medication (all P<0.05) . All-cause death rates of 1- and 2-year follow-up of PCI, CABG and MT group were 0.6% (8/1 313), 1.1% (14/1 259), 3.4% (29/863) (P<0.001) and 1.1%(14/1 313), 1.5%(19/1 259), 7.3%(63/863) (P<0.001), respectively. Multivariate Cox regression analysis showed that 1-year MACCE rate (HR=0.51, 95%CI 0.33-0.77, P=0.001) was significantly reduced, due to the significant decrease of myocardial infarction (MI) rate (HR=0.09, 95%CI 0.01-0.76, P=0.027) and repeat revascularization rate (HR=0.21, 95%CI 0.10-0.41, P<0.001) in CABG group compared to PCI group, while all-cause death (HR=1.21, 95%CI 0.48-3.00, P=0.69) and stroke rate (HR=2.31, 95%CI 0.82-6.47, P=0.112) were similar between 2 groups. 2-year outcome showed CABG was associated with higher stroke rate (HR=2.20, 95%CI 1.06-4.55, P=0.034) and lower MI (HR=0.19, 95%CI 0.06-0.59, P=0.004) and repeat revascularization rate (HR=0.22, 95%CI 0.13-0.37, P<0.001), and lower MACCE rate (HR=0.49, 95%CI 0.36-0.68, P<0.001). Compared to MT group, 2-year all-cause death (HR=0.22, 95%CI 0.12-0.42, P<0.001) and MACCE rate (HR=0.63, 95%CI 0.47-0.83, P=0.001) were lower in PCI group, while 2-year all-cause death (HR=0.21, 95%CI 0.13-0.37, P<0.001), MACCE (HR=0.31, 95%CI 0.23-0.42, P<0.001), MI (HR=0.19, 95%CI 0.06-0.60, P=0.004) and repeat revascularization rate (HR=0.24, 95%CI 0.13-0.41, P<0.001) were lower in CABG group. Results of multivariate Cox regression analysis after PSM were consistent with above results.@*Conclusion@#For SCAD patients with TVD, CABG shows better effectiveness by reducing MI and revascularization risk as compared to PCI, even though stroke risk is somehow higher in CABG patients. Patients received MT alone are associated with worse outcomes than those undergoing revascularization strategies.
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Objective@#To investigate the impact of previous coronary artery bypass grafting(CABG) on long-term outcomes in patients undergoing percutaneous coronary intervention(PCI).@*Methods@#A total of 10 724 consecutive coronary heart disease patients undergoing PCI between January and December 2013 in Fuwai hospital were prospectively included in this research. According to CABG history, the patients were divided into CABG group(437 cases) and without CABG group(10 287 cases). The patients were followed up for 2 years. Major adverse cardiovascular and cerebrovascular events(MACCE) including death, myocardial infarction, revascularization and stroke, and in-stent thrombosis following PCI were compared between the 2 groups. Multivariate Cox regression analysis was used to identify independent risk factors of poor prognosis.@*Results@#Compared with without CABG group, CABG group were older((61±10)years vs.(58±10)years, P<0.001), and more often had diabetes(35.7%(156/437) vs. 30.0%(3 082/10 287), P=0.012), hyperlipoidemia(73.9%(323/437) vs. 67.0%(6 888/10 287), P=0.003), previous myocardial infarction(31.1%(136/437) vs. 18.7%(1 925/10 287), P<0.001), PCI history(61.6%(269/437) vs. 23.0%(2 371/10 287), P<0.001), and cerebrovascular disease(7.1%(31/437) vs. 10.9%(1 119/10 287), P=0.013). After 2 years follow-up, rates of cardiac death(1.8%(8/437) vs. 0.6%(66/10 287), P=0.010), revascularization(11.2%(49/437) vs. 8.5%(877/10 287), P=0.049) and MACCE(15.1%(66/437) vs. 12.0%(1 231/10 287), P=0.049) were significantly higher in CABG patients than in without CABG group. There were no significant difference in all cause death(2.1%(9/437) vs. 1.2%(122/10 287), P=0.114), recurrence of myocardial infarction(2.3%(10/437) vs. 2.0%(204/10 287), P=0.600), stroke(1.1%(5/437) vs. 1.4%(140/10 287), P=0.701), and in-stent thrombosis(1.1%(5/437) vs. 0.6%(61/10 287), P=0.194). Multivariate Cox regression analysis showed that previous CABG was an independent risk factor of cardiac death(HR=2.13, 95%CI 1.02-4.46, P=0.045)and revascularization(HR=1.35, 95%CI 1.01-1.81, P=0.040). However, after propensity score matched analyses(429 pairs), previous CABG was no longer an independent risk factor of cardiac mortality (HR=0.97, 95% CI 0.37-2.54, P=0.954)and revascularization(HR=1.74, 95%CI 0.94-3.21, P=0.753).@*Conclusion@#Previous CABG is not an independent risk factor of poor prognosis in coronary heart disease patients undergoing PCI.