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Background: Xinyue capsule, a patented Chinese herbal medicine, has been used to manage coronary artery disease (CAD) for over a decade in China, but whether it can further reduce risk of cardiovascular events beyond conventional treatment is unknown., Methods: In this multicenter, randomized, placebo-controlled trial, we randomly assigned patients with stable CAD who underwent percutaneous coronary intervention (PCI) within the preceding 3-12 months to receive Xinyue capsule (100 mg panax quinquefolius saponins, three times a day) or placebo for 24 weeks in addition to conventional treatment. The primary endpoint was a composite that included cardiac death, nonfatal myocardial infarction and urgent revascularization with either PCI or coronary artery bypass grafting. The secondary composite endpoints included stroke, re-hospitalization due to acute coronary syndrome (ACS), pulmonary embolism, peripheral vascular events and all-cause mortality. Quality of life was assessed using a 36-item Short-Form Health Survey (SF-36)., Results: A total of 1054 participants were included in the analyses. The median follow up was 1 year. The primary endpoint events occurred in 16 patients (3.02%) in the Xinyue group and 34 patients (6.49%) in the placebo group (hazard ratio [HR] 0.455, 95% confidence interval [CI] 0.25 to 0.825; P = 0.009). Secondary end-point events occurred in 5.47% of patients in the Xinyue group and 10.31% in the placebo group (HR 0.515, 95% CI 0.328 to 0.809; P = 0.004). SF-36 subscale scores at 12 months were significantly higher in the Xinyue group than placebo group for general health (P = 0.048) and vitality (P = 0.008)., Conclusions: In patients with stable CAD after PCI within the preceding 3 to 12 months, Xinyue capsule added on conventional treatment reduced the incidence of primary composite endpoint (cardiac death, nonfatal myocardial infarction and urgent revascularization)., Competing Interests: Conflicts of Interest The authors declare no conflicts of interest., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

The aim of this study was to evaluate the capacity of the SYNTAX Score-II (SS-II) to predict long-term mortality in patients undergoing left main percutaneous coronary intervention (LM-PCI) treated with second-generation drug-eluting stents (DES).Data from 487 consecutive patients with de novo left main coronary artery disease undergoing PCI were retrospectively studied. The patients were divided into tertiles according to the SS-II: low SS-II tertile (SS-II ≤ 22), intermediate SS-II tertile (SS-II of 23 to 30), and high SS-II tertile (SS-II ≥ 30). The survival curves were estimated by the Kaplan-Meier method. Univariate and multivariate Cox proportional hazard regression analyses were performed to evaluate the possible associations between the SS-II and the rates of long-term mortality. The predictive ability of the SS-II for mortality was assessed and compared with the SYNTAX score (SS) alone by an area under the receiver operator curve (AUC).The overall SS-II was 27.3 ± 9.1. At a mean follow-up of 5.1 years, the long-term mortality was 6.0%. The rates of mortality were 2.4%, 3.4%, and 11.6%, respectively (P < 0.0001) in the low, intermediate, and high SS-II tertiles. The cardiac mortality rates were 1.8%, 1.4%, and 8.1%, respectively (P = 0.002) among patients in the 3 groups. By multivariate analysis, SS-II was an independent predictor of the long-term mortality (hazard ratio: 1.56, 95% confidence interval: 1.05 to 2.32; P = 0.03). The AUC demonstrated a substantially higher predictive accuracy of the SS-II for mortality compared with the SS alone (AUC was 0.689 and 0.596, respectively).In patients with LM-PCI treated with a second-generation DES, the SS-II is an independent predictor of long-term mortality and demonstrates a superior predictability compared with the SS alone.

Aims: To observe the influence of the peroxisome proliferator-activator receptor-G (PPAR-G) gene and cytochrome P4501A1 (CYP1A1) single-nucleotide polymorphisms (SNPs), and interactions among several SNPs on coronary artery disease (CAD) risk., Methods: A total of 1106 participants (including 583 males and 523 females) including 550 CAD patients and 556 control subjects were recruited in this study, and the mean age for these participants was 55.5 ± 11.8 years old. Logistic regression was used to observe association of SNP within PPARG and CYP1A1 with CAD risk and GMDR model was used to screen the best interaction combinations., Results: CAD susceptibility was higher in those with homozygous mutant of rs10865710, rs1805192 and rs4646903 than those with wild-type homozygotes, OR (95%CI) were 1.47 (1.15-1.92), 1.69 (1.27-2.09) and 1.72 (1.35-2.32), respectively. We also found a significant two-locus model involving rs1805192 and rs4646903 (p = 0.0107), and the cross-validation consistency of this locus model was 10 of 10, the testing accuracy of this model is 62.17%. Logistic regression shown that CAD risk was the highest in those with rs1805192- Pro/Ala or Ala/Ala and rs4646903- AG+GG genotype, and was lowest in those with rs1805192- Pro/ Pro and rs4646903- AA genotype, OR(95%CI) = 3.56 (1.91-5.42)., Conclusions: Polymorphism in rs10865710, rs1805192 and rs4646903 and interaction between rs1805192 and rs4646903 were related with increased CAD susceptibility.

Whether the effect of diabetes on patients with unprotected left main coronary artery (ULMCA) disease differs according to different strategies of revascularization was unknown. This study was conducted to evaluate the impact of diabetes on patients with ULMCA disease treated with either percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG).A total of 922 patients with ULMCA disease who received drug-eluting stent (DES) (n = 465) implantation or underwent CABG (n = 457) were retrospectively analyzed. We compared the effects of these 2 treatments on clinical outcomes (death, myocardial infarction, stroke, repeat revascularization, and the composite of death, myocardial infarction, or stroke), according to diabetic status.During the median follow-up of 7.1 years (interquartile range, 5.3 to 8.2 years), no difference was found between PCI and CABG in the adjusted occurrence of death (P = 0.112) and the composite endpoints of death, myocardial infarction, and stroke (P = 0.235). Significantly higher incidence of repeat revascularization (P < 0.001) was observed in the DES group, whereas the CABG group had a significantly higher rate of stroke (P = 0.001). These trends were consistent in both diabetic and nondiabetic patients. We did not observe significant interactions between treatment outcomes and the presence or absence of diabetes after adjustment for covariates (P(interaction) = 0.580 for the composite of death, MI and stroke, P(interaction) = 0.685 for death, P(interaction) = 0.416 for MI, P(interaction) = 0.470 for stroke, and P(interaction) = 0.502 for repeat revascularization).Presence of diabetes was not important for decision-making between CABG and PCI in patients with ULMCA disease.

Objectives: Matrix metalloproteinase-9 (MMP-9), tissue inhibitor of matrix metalloproteinase-1 (TIMP-1) and their ratio (MMP-9/TIMP-1) are involved in multiple processes that are associated with coronary heart disease and are especially associated with cardiovascular events. However, few long-term population-based clinical studies have evaluated the role of these factors in cardiovascular events in a Chinese population., Methods: A prospective study was performed on 560 patients with mild to moderate coronary artery lesions. MMP-9, TIMP-1 and their ratio were determined., Results: A total of 522 of patients completed the follow-up. The median follow-up time was 64 months. Kaplan-Meier analysis demonstrated a clear increase of the incidence of major adverse cardiac events (MACEs) during the follow-up period in subjects with above-median levels of TIMP-1 (p = 0.033), whereas there was no association with either MMP-9 (p = 0.199) or MMP-9/TIMP-1 (p = 0.631). Multivariate Cox proportional hazards analysis showed the same results after further adjustment for covariates. Patients with above-median levels of TIMP-1 were more likely to suffer from adverse outcomes than patients with below-median levels of TIMP-1. However, the lack of relationship of MACEs with MMP-9 and MMP-9/TIMP-1 remained., Conclusions: Higher circulating TIMP-1 concentrations were associated with cardiovascular events during long-term follow-up of Chinese patients with mild to moderate coronary artery lesions., (© 2015 S. Karger AG, Basel.)

Background: The effects of revascularization extent (RE) on the long-term prognosis of patients with stable angina pectoris and 3-vessel disease who underwent percutaneous coronary intervention were unknown., Hypothesis: The study was aimed at evaluating whether there was an effect of RE on patients presenting with stable angina pectoris and 3-vessel disease., Methods: RE, which was calculated by baseline SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score minus residue SYNTAX score divided by baseline SYNTAX score, was initially used in our study. Five hundred fifty-eight patients presenting with stable angina pectoris and 3-vessel disease were assigned to and compared among tertiles according to RE and clinical outcomes. The primary end point was the major adverse cardiovascular event (MACE), a composite of cardiac death, nonfatal myocardial infarction (MI), and any repeat revascularization., Results: The median follow-up period was 56.9 months (interquartile range, 52.1-63.6). The incidence of MACE increased significantly as RE increased (13.3%, 31.4%, and 44.1%, log-rank P < 0.001). The same tendency was observed in occurrences of target-vessel failure (TVF) (a composite of cardiac death, MI, or target-vessel revascularization) (8.8%, 20.3%, and 28.4%, log-rank P < 0.001), repeat revascularization (11.8%, 26.2%, and 35.6%, log-rank P < 0.001), and MI (1.1%, 2.9%, and 12.6%, log-rank P < 0.001). Multivariate analysis confirmed the tendencies mentioned above., Conclusions: For patients presenting with stable angina pectoris and 3-vessel disease, the increasing extent of revascularization resulted in a less favorable prognosis., (© 2014 Wiley Periodicals, Inc.)

Objective: The goals of this study were to establish a new model for predicting in-hospital mortality of percutaneous coronary intervention (PCI), and to compare the predictive accuracy of the new model with the European System for Cardiac Operative Risk Evaluation (EuroSCORE) model., Methods: We retrospectively analyzed 18206 Chinese patients undergoing PCI in our hospital between January 2002 and December 2008. Univariate and multivariate logistic regression analysis were performed to determine the preoperative risk factors that predicted in-hospital mortality. The EuroSCORE model was used to predict in-hospital mortality. To improve the predictive value of the EuroSCORE, we proposed a modified EuroSCORE that included some PCI-specific factors., Results: Multivariate logistic regression analysis indicated that left main trunk lesions, type C lesions, preoperative high-risk state, emergency PCI, and severe reduction of ejection fraction (<30%) were independent predictors of PCI mortality. Receiver operating characteristic (ROC) curve analysis showed that the area under the ROC curve for the modified EuroSCORE was larger than that for the EuroSCORE, however, there was no significant difference between the actual mortality rate and the mortality rate predicted by the two models. The modified EuroSCORE more accurately predicted the mortality rate in patients with a EuroSCORE score of 7-9 points, whereas it was no better than the standard EuroSCORE in patients with EuroSCORE scores of 1-3 or 4-6 points., Conclusion: The modified EuroSCORE improves acute risk assessment in PCI patients compared with the EuroSCORE, and the mortality rate predicted by the modified EuroSCORE in high-risk patients was close to the actual mortality rate.

Objective: This study was carried out to determine the effect of the use of dual antiplatelet therapy (DAPT) for more than 12 months on long-term clinical outcomes in patients who had undergone a percutaneous coronary intervention with the first and second generations of drug-eluting stents (DES)., Background: The potential benefits of the use of DAPT beyond a 12-month period in patients receiving DES have not been established clearly. Moreover, it is also unclear whether the optimal duration of DAPT is similar for all DES types., Methods: A total of 2141 patients with coronary artery disease treated exclusively with Cypher sirolimus-eluting stents (SES) or Endeavor zotarolimus-eluting stents (ZES) were considered for retrospective analysis. The primary endpoint [a composite of all-cause mortality, nonfatal myocardial infarction (MI), and stroke] was compared between the 12-month DAPT and the >12-month DAPT group., Results: A total of 1870 event-free patients on DAPT at 12 months were identified. The average follow-up was 28.2±7.4 months. The primary outcomes were similar between the two groups (4.1% 12-month DAPT vs. 1.9% >12-month DAPT; P=0.090). Incidences of death, MI, stroke, and target vessel revascularization did not differ significantly between the two groups. Subgroup analysis showed that in the patients with hypertension, >12-month DAPT significantly reduced the occurrence of death/MI/stroke compared with that in the 12-month DAPT group (P=0.04). In patients implanted with SES, the primary outcome was significantly lower with the >12-month DAPT group (5.2% 12-month DAPT vs. 1.6% >12-month DAPT; P=0.016), whereas in patients with ZES, the primary outcome was comparable between the two groups (2.3% 12-month DAPT vs. 2.0% >12-month DAPT; P=0.99)., Conclusion: In our study, for all patients, >12-month DAPT in patients who had received DES was not significantly more effective than 12-month DAPT in reducing the rate of death/MI/stroke. Our findings, that patients who received SES benefit from >12-month DAPT whereas extended use of DAPT was not significantly more effective in those implanted with ZES, implied that the optimal duration of DAPT was different depending on different types of DES.

Aims: This study sought to evaluate the safety and efficacy of the NOYA stent which is a cobalt chromium-based sirolimus-eluting stent (SES) with DL-polylactide biodegradable polymer (Medfavour Medical, Beijing, China) in treating de novo coronary artery lesions., Methods and Results: The NOYA I trial was designed to compare the NOYA stent with the FIREBIRD2™ stent, a durable polymer SES widely used in China (MicroPort Medical, Shanghai, China); the trial was a non-inferiority trial with a primary angiographic endpoint of the in-stent late lumen loss (LLL) at nine-month follow-up. The secondary endpoints were binary restenosis rates within nine months, major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction (MI) or target lesion revascularisation (TLR), and definite/probable stent thrombosis (ST) at 24-month follow-up. A total of 300 patients (n=150 in each group) were enrolled in the study from 16 Chinese centres. The LLL in the NOYA group at nine-month follow-up was similar to the FIREBIRD2 group (0.11±0.18 mm vs. 0.14±0.23 mm, p=0.16; non-inferiority p<0.001). The rates of MACE, death, MI and TLR at 24-month follow-up were comparable between these two devices (p>0.05, respectively)., Conclusions: The biodegradable polymer NOYA stent was non-inferior to the FIREBIRD2 durable polymer stent with respect to the primary non-inferiority endpoint of in-stent LLL at nine-month follow-up. Clinical outcomes at 24-month follow-up were comparable between the two stents. (ClinicalTrials.gov number, NCT01226355).

The long-term safety and efficiency of sirolimus-eluting stent (SES) treatment in unprotected left main coronary artery (ULMCA) have not yet been ascertained.From 2003 to 2006, 126 consecutive patients with de novo lesions in ULMCA who underwent SES were retrospectively analyzed in a single center in China. During 4-year follow-up, major adverse cardiovascular event (MACE)-free survival was 74.6%. Cardiac death occurred in 5 (4.0%), and target lesion revascularization (TLR) and target vessel revascularization (TVR) occurred in 15 (11.9%) and 24 (19.0%) patients, respectively. One (0.8%) experienced probable stent thrombosis while 1 (0.8%) presented possible stent thrombosis. Impaired LVEF (< 40%) and high surgical risk (Euro score > 6) were the independent predictors of MACEs.PCI with SES for de novo lesions in ULMCA is feasible with a low procedural risk. However, SES was associated with a relatively higher rate of TLR and TVR. Impaired LVEF and high surgical risk were important predictors of MACEs.

Background: Studies comparing coronary artery bypass grafting (CABG) with drug-eluting stent (DES) for the treatment of diabetic patients with multivessel disease are relatively scarce although controversies exist concerning the relative efficacy of CABG versus DES., Hypothesis: The aim of this study was to evaluate the effect of drug-eluting stent (DES) implantation in diabetic patients with multivessel disease compared with CABG., Methods: We included 645 consecutive diabetic patients who underwent either CABG (n = 282) or DES implantation (n = 363) in our institution from July 2003 to December 2005., Results: At 12 mo after index revascularization procedure, the total mortality rate was similar in the CABG and DES group (3.2% versus 3.0%, hazard ratio [HR] of CABG versus percutaneous coronary intervention [PCI] 0.58, 95% confidence interval [CI]: 0.14 to 2.45, p = 0.460), but the rate of major adverse cardiac cerebrovascular events was lower in the CABG group (7.8% versus 17.9%, HR: 0.15, 95% CI: 0.06 to 0.37, p < 0.001) mainly due to less repeat revascularization with CABG (1.4% versus 11.6%, HR: 0.02, 95% CI: 0.01 to 0.13, p < 0.001). Age, 3-vessel disease, and serum creatinine > or =1.5 mg/dl were positive independent predictors of 12 mo death., Conclusions: At 12 mo, CABG was associated with less adverse events primarily due to less repeat revascularization compared with DES although there was no significant difference in mortality and myocardial infarction (MI) rates between the 2 groups; high repeat revascularization rate related to DES resulted from high restenosis rate in diabetic patients and lower rate of complete revascularization offered by PCI.

Background: The best strategy for ST-segment elevation myocardial infarction (STEMI) patients with multivessel disease (MVD), who underwent primary percutaneous coronary intervention (PCI) in the acute phase, is not well established. Objectives: Our goal was to conduct a meta-analysis comparing culprit vessel only percutaneous coronary intervention (culprit PCI) with multivessel percutaneous coronary intervention (MV-PCI) for treatment of patients with STEMI and MVD. Methods: Pubmed, Elsevier, Embase, and China National Knowledge Infrastructure (CNKI) databases were systematically searched for randomized and nonrandomized studies comparing culprit PCI and MV-PCI strategies during the index procedure. A meta-analysis was performed using Review Manager 5.1 (Cochrane Center, Denmark). Results: Four randomized and fourteen nonrandomized studies involving 39,390 patients were included. MV-PCI strategy is associated with an increased short-term mortality (OR: 0.50, 95% CI: 0.32 to 0.77, p = 0.002), long-term mortality (OR: 0.52, 95% CI: 0.36 to 0.74, p<0.001), and risk of renal dysfunction (OR: 0.77, 95% CI: 0.61 to 0.97, p = 0.03) compared with culprit PCI strategy, while it reduced the incidence of revascularization (OR: 2.65, 95% CI: 1.80 to 3.90, p<0.001). Conclusions: This meta-analysis supports current guidelines which indicate that the non-culprit vessel should not be treated during the index procedure. [ABSTRACT FROM AUTHOR]