Clinical Outcome After DK Crush Versus Culotte Stenting of Distal Left Main Bifurcation Lesions: The 3-Year Follow-Up Results of the DKCRUSH-III Study.

OBJECTIVES: The present study aimed to investigate the difference in major adverse cardiac events (MACE) at 3 years after double-kissing (DK) crush versus culotte stenting for unprotected left main distal bifurcation lesions (LMDBLs). BACKGROUND: The multicenter and randomized DKCRUSH-III (Comparison of double kissing crush versus culotte stenting for unprotected distal left main bifurcation lesions: results from a multicenter, randomized, prospective study) showed that DK crush stenting was associated with fewer MACE at 1-year follow-up in patients with LMDBLs compared with culotte stenting. Here, we report the 3-year clinical outcome of the DKCRUSH-III study. METHODS: A total of 419 patients with LMDBLs who were randomly assigned to either the DK crush or culotte group in the DKCRUSH-III study were followed for 3 year. The primary endpoint was the occurrence of a MACE at 3 years. Stent thrombosis (ST) was the safety endpoint. Patients were classified by simple and complex LMDBLs according to the DEFINITION (Definition and Impact of Complex Bifurcation Lesions on Clinical Outcomes After Percutaneous Coronary Intervention Using Drug-Eluting Stents) study criteria. RESULTS: At 3 years, MACE occurred in 49 patients the culotte group and in 17 patients in the DK crush group (cumulative event rates of 23.7% and 8.2%, respectively; p < 0.001), mainly driven by increased myocardial infarction (8.2% vs. 3.4%, respectively; p = 0.037) and target-vessel revascularization (18.8% vs. 5.8%, respectively; p < 0.001) between groups. Definite ST rate was 3.4% in the culotte group and 0% in the DK crush group (p = 0.007). Complex LMDBLs were associated with a higher rate of MACE (35.3%) at 3 years compared with a rate of 8.1% in patients with simple LMDBLs (p < 0.001), with an extremely higher rate in the culotte group (51.5% vs. 15.1%, p < 0.001). CONCLUSIONS: Culotte stenting for LMDBLs was associated with significantly increased rates of MACE and ST. (Double Kissing [DK] Crush Versus Culotte Stenting for the Treatment of Unprotected Distal Left Main Bifurcation Lesions: DKCRUSH-III, a Multicenter Randomized Study Comparing Double-Stent Techniques; ChiCTR-TRC-11001877).

Comparison of reendothelialization and neointimal formation with stents coated with antibodies against endoglin and CD34 in a porcine model.

Anti-CD34 coated stents are the only commercialized antibody-coated stents currently used for coronary artery diseases with various limitations. Endoglin plays important roles in the proliferation of endothelial cells and vascular remodeling and could be an ideal target surface molecule. The objective of this study was to investigate the efficacy of stents coated with anti-endoglin antibodies (ENDs) in terms of endothelial recovery and the reduction of neointimal formation. The performance of ENDs was evaluated by comparing with stents coated with anti-CD34 antibodies (CD34s), sirolimus-eluting stents (SESs), and bare metal stents (BMSs). Stents were randomly assigned and placed in the coronary arteries of juvenile pigs. Histomorphometric analysis and scanning electron microscopy were performed after stent implantation. Our results showed at 14 days after stent implantation, the neointima area and percent area stenosis in ENDs and CD34s were remarkably decreased compared with those in BMSs and SESs (P<0.05). Moreover, the percentage of reendothelialization was significantly higher in ENDs and CD34s than that in SESs or BMSs at both 7 and 14 days (P<0.05). There was no difference in the neointima area, percent area stenosis, and percentage of reendothelialization in ENDs compared with CD34s. The artery injury and the inflammation scores were similar in all groups at both 7 and 14 days. Our results demonstrate that the performance of ENDs is similar to the commercial CD34s, without the disadvantages of CD34s, and both are better than SESs and BMSs. ENDs potentially offer an alternative approach to reduce restenotic process and enhance reendothelialization after stent implantation.

Plaque Thrombosis is Reduced by Attenuating Plaque Inflammation with Pioglitazone and is Evaluated by Fluorodeoxyglucose Positron Emission Tomography.

INTRODUCTION: The relationship between the beneficial effects of pioglitazone in reducing clinical events and plaque inflammatory burden remains unknown. This study aimed to determine whether pioglitazone can reduce the number of plaque thrombosis incidences and whether decreasing plaque inflammation is the mechanism by which pioglitazone reduces plaque thromboses. METHODS AND RESULTS: therosclerotic rabbits were divided into two groups: the atherosclerosis group (n = 13) and pioglitazone group (n = 10). The rabbits underwent pharmacological triggering to induce thrombosis. Serum inflammatory markers, FDG uptake, macrophage, and neovessel staining detected arterial inflammation. PET/CT scans were performed twice (baseline and posttreatment scans). Plaque area, macrophages, and neovessels were measured and the histologic sections were matched with the PET/CT scans. Serum MMP-9 and hsCRP were lower in the pioglitazone group compared to the atherosclerosis group. The SUVmean significantly decreased in the pioglitazone group (0.62 ± 0.21 vs. 0.55 ± 0.19, P = 0.008), but increased in the atherosclerosis group (0.61 ± 0.15 vs. 0.91 ± 0.20, P < 0.000). The incidence rate of plaque rupture, plaque area, macrophage density, and neovessel density was significantly lower in rabbits with pioglitazone than without (15% vs. 38%, P < 0.001; 18.00 ± 2.30 vs. 27.00 ± 1.60; P < 0.001; 8.80 ± 3.94 vs. 28.26 ± 2.49; P < 0.001; 16.50 ± 3.09 vs. 29.00 ± 2.11; P < 0.001, respectively). Moreover, plaque area and macrophage density were positively correlated with SUV values. CONCLUSIONS: Our study suggests that pioglitazone can reduce the number of plaque thrombosis incidences by decreasing plaque inflammation. (18)F-FDG-PET/CT can detect plaque inflammation and assess the effects of antiatherosclerotic drugs.

Impact of the complexity of bifurcation lesions treated with drug-eluting stents: the DEFINITION study (Definitions and impact of complEx biFurcation lesIons on clinical outcomes after percutaNeous coronary IntervenTIOn using drug-eluting steNts).

OBJECTIVES: The present study established criteria to differentiate simple from complex bifurcation lesions and compared 1-year outcomes stratified by lesion complexity after provisional stenting (PS) and 2-stent techniques using drug-eluting stents. BACKGROUND: Currently, no criterion can distinguish between simple and complex coronary bifurcation lesions. Comparisons of PS and 2-stent strategies stratified by lesion complexity have also not been reported previously. METHODS: Criteria of bifurcation complexity in 1,500 patients were externally tested in another 3,660 true bifurcation lesions after placement of drug-eluting stents. The primary endpoint was the occurrence of a major adverse cardiac event (MACE) at 12 months. The secondary endpoint was the rate of stent thrombosis (ST). RESULTS: Complex (n = 1,108) bifurcation lesions were associated with a higher 1-year rate of MACE (16.8%) compared with simple (n = 2,552) bifurcation lesions (8.9%) (p < 0.001). The in-hospital ST and 1-year target lesion revascularization rates after 2-stent techniques in the simple group (1.0% and 5.6%, respectively) were significantly different from those after PS (0.2% [p = 0.007] and 3.2% [p = 0.009], respectively); however, 1-year MACE rates were not significantly different between the 2 groups. For complex bifurcation lesions, 2-stent techniques had lower rates of 1-year cardiac death (2.8%) and in-hospital MACE (5.0%) compared with PS (5.3%, p = 0.047; 8.4%, p = 0.031). CONCLUSIONS: Complex bifurcation lesions had higher rates of 1-year MACE and ST. The 2-stent and PS techniques were overall equivalent in 1-year MACE. However, 2-stent techniques for complex lesions elicited a lower rate of cardiac death and in-hospital MACE but higher rates of in-hospital ST and revascularization at 1 year for simple lesions.

Effect of pioglitazone on in-stent restenosis after coronary drug-eluting stent implantation: a meta-analysis of randomized controlled trials.

BACKGROUND: In-stent restenosis (ISR) remains a common life-threatening complication and some studies have shown that pioglitazone can reduce the incidence of ISR in patients with drug-eluting stents (DES) implantation. We conducted a meta-analysis to assess the effect of pioglitazone in preventing ISR after DES implantation. METHODS: Randomized controlled trials (RCTs) investigating the effects of pioglitazone for ISR after DES implantation were identified by systematic searches of multiple online databases and manual searches of related reference lists of identified trials through May 2014. The primary endpoint was the rate of ISR. Secondary endpoints included minimum lumen diameter, percentage stenosis of stented vessels, late loss, in-stent neointimal volume, target vessel revascularization (TVR), target lesion revascularization, myocardial infarction, stent thrombosis and death. RESULTS: Five studies, comprising 255 pioglitazone-treated patients and 245 controls, were identified in the current meta-analysis. Pioglitazone did not significantly reduce the rate of ISR (P = 0.20) with low heterogeneity (I2 = 13.3%, P = 0.32). For the secondary outcomes, pioglitazone did not substantially affect the pooled estimates of these endpoints except late loss (P = 0.01) and TVR (P = 0.04). CONCLUSIONS: The limited evidence indicates that pioglitazone does not demonstrate markedly beneficial effect in patients subjected to coronary DES implantation. However, the results should be interpreted with care given the small sample size. Further large-scale RCTs are needed.

A novel stent coated with antibodies to endoglin inhibits neointimal formation of porcine coronary arteries.

Endoglin/CD105 is an accessory protein of the transforming growth factor-ß receptor system that plays a critical role in proliferation of endothelial cells and neovasculature. Here, we aimed to assess the effect of novel stents coated with antibodies to endoglin (ENDs) on coronary neointima formation. Thirty ENDs, thirty sirolimus-eluting stents (SESs), and thirty bare metal stents (BMSs) were randomly assigned and placed in the coronary arteries in 30 juvenile pigs. Histomorphometric analysis and scanning electron microscopy were performed after stent implantation. Our results showed that after 7 days, there was no difference in the neointimal area and percent area stenosis in ENDs compared with SMSs or BMSs. After 14 days, the neointima area and percent area stenosis in ENDs were markedly decreased than those in BMSs or SESs (P < 0.05). Moreover, the percentage of reendothelialization was significantly higher in ENDs than that in SESs or BMSs (P < 0.01) at 7 and 14 days. The artery injury and the inflammation scores were similar in all groups at 7 and 14 days. In conclusion, our results demonstrated for the first time to our knowledge that endoglin antibody-coated stents can markedly reduce restenosis by enhancing reendothelialization in the porcine model and potentially offer a new approach to prevent restenosis.

Apolipoprotein E gene polymorphism and risk for coronary heart disease in the Chinese population: a meta-analysis of 61 studies including 6634 cases and 6393 controls.

BACKGROUND: Numerous studies have evaluated the association between the apolipoprotein E (apoE) gene polymorphisms in coronary heart disease (CHD). However, the results remain uncertain. We carried out a meta-analysis to derive a more comprehensive estimation of the association in Chinese population. METHODS: Case-control studies in Chinese and English publications were identified by searching databases of PubMed, EMBASE, Web of Science, CNKI, CBM, Wanfang, VIP and hand searching of relevant journals and the reference lists of retrieved articles. Odds ratio (OR) and 95% confidence interval (CI) were applied to assess the strength of the associations. Subgroup analysis and sensitivity analysis were performed to explore the between-study heterogeneity. RESULTS: We finally identified 61 relevant studies which comprised 6634 case-patients and 6393 controls. The pooled OR for ε4 carriers was 96% higher than the ε3/3 genotype for CHD (OR, 1.96; 95% CI, 1.70 to 2.24; P<0.001). However, there was no evidence of statistically significant association between ε2 carriers and risk of CHD (OR, 1.02; 95% CI, 0.91 to 1.13; P = 0.729). In the subgroup analysis, different endpoints may partially account for the heterogeneity. No publication bias was found. CONCLUSIONS: Our meta-analysis suggests that the apoE ε4 allele may be a risk factor for CHD in the Chinese population, however, ε2 allele has no significant association.

Clinical effect of Maixuekang Capsule (脉血康胶囊) on long-term prognosis in patients with acute coronary syndrome after percutaneous coronary intervention.

OBJECTIVE: To study the changes of adenosine diphosphate (ADP)-induced platelet aggregation rate, and evaluate the effects of Maixuekang Capsule (, MKC) on platelet aggregation rate and long-term prognosis of patients with acute coronary syndrome after percutaneous coronary intervention (PCI). METHODS: A total of 236 patients with acute coronary syndrome, who received successful PCI, were randomly assigned to a trial group (116 cases) and a control group (120 cases) according to random numbers; treatment allocation occurred when the participants met the inclusion criteria and signed the informed consent forms. In the trial group, the patients were treated with MKC combined with routine medication, and in the control group the patients were treated with routine medication. The therapeutic course for the two groups was 12 months and the follow-up was 12 months. The levels of ADP-induced platelet aggregation rate and serum high-sensitive C-reactive protein (hs-CRP) were determined before PCI, 12 h and 30 days after PCI. In the meantime, the incidence of cardio-/cerebrovascular events was recorded during the 12-month follow-up. RESULTS: Compared with before PCI, the levels of ADP-induced platelet aggregation rate and serum hs-CRP were significantly higher at 12 h after PCI (P<0.05). They were significantly reduced after 30-day-treatment of MKC, showing statistical differences when compared with those in the control group (P<0.05). During the 12-month follow-up, the incidence of cardio-/cerebrovascular events was significantly lower in the trial group than in the control group (6.9% vs. 12.5%, P<0.01). CONCLUSIONS: ADP-induced platelet aggregation function was significantly elevated after PCI. MKC improved the prognosis of patients with acute coronary syndrome, possibly through inhibiting the platelet aggregation, fighting against inflammation, and protecting the vascular endothelial function.

The anatomic- and clinical-based NERS (new risk stratification) score II to predict clinical outcomes after stenting unprotected left main coronary artery disease: results from a multicenter, prospective, registry study.

OBJECTIVES: The present study aimed to establish a risk score using a simple calculation with an enhanced predictive value for major adverse cardiac events (MACE) in patients with unprotected left main coronary artery (UPLMCA) disease after the implantation of a drug-eluting stent (DES). BACKGROUND: The anatomic-, clinical-, and procedure-based NERS (New Risk Stratification) score was superior to the SYNTAX (Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery) score in predicting MACE after stenting UPLMCA. The complexity of the calculation was its major limitation. METHODS: The NERS score II was derived from our previous 2 studies and externally compared with the NERS and SYNTAX scores in 1,463 patients with UPLMCA disease who underwent implantation of a DES in a prospective, multicenter registry trial. The primary endpoint was MACE at 1 year after the index procedure, including myocardial infarction, cardiac death, and target vessel revascularization. RESULTS: The NERS score II system consisted of 16 (7 clinical and 9 angiographic) variables. A NERS score II ≥19 demonstrated enhanced MACE sensitivity and specificity of 84.0% and 76.0% (MACE as the state variable), respectively, which were similar to the NERS score but significantly higher compared with the SYNTAX score. A NERS score II ≥19 was the only independent predictor of cumulative MACE (hazard ratio: 3.27; 95% confidence interval [CI]: 1.86 to 5.23; p ≤ 0.001) and stent thrombosis (odds ratio: 22.15; 95% CI: 12.47 to 57.92; p ≤ 0.001) at follow-up. CONCLUSIONS: The NERS score II, similar to the conventional NERS score, is more predictive of MACE than the SYNTAX score in UPLMCA patients after implantation of a DES.

Comparison of double kissing crush versus Culotte stenting for unprotected distal left main bifurcation lesions: results from a multicenter, randomized, prospective DKCRUSH-III study.

OBJECTIVES: The study aimed to investigate the difference in major adverse cardiac event (MACE) at 1-year after double kissing (DK) crush versus Culotte stenting for unprotected left main coronary artery (UPLMCA) distal bifurcation lesions. BACKGROUND: DK crush and Culotte stenting were reported to be effective for treatment of coronary bifurcation lesions. However, their comparative performance in UPLMCA bifurcation lesions is not known. METHODS: A total of 419 patients with UPLMCA bifurcation lesions were randomly assigned to DK (n = 210) or Culotte (n = 209) treatment. The primary endpoint was the occurrence of a MACE at 1 year, including cardiac death, myocardial infarction, and target vessel revascularization (TVR). In-stent restenosis (ISR) at 8 months was secondary endpoint, and stent thrombosis (ST) served as a safety endpoint. Patients were stratified by SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) and NERS (New Risk Stratification) scores. RESULTS: Patients in the Culotte group had significant higher 1-year MACE rate (16.3%), mainly driven by increased TVR (11.0%), compared with the DK group (6.2% and 4.3%, respectively; all p < 0.05). ISR rate in side branch was 12.6% in the Culotte group and 6.8% in the DK group (p = 0.037). Definite ST rate was 1.0% in the Culotte group and 0% in the DK group (p = 0.248). Among patients with bifurcation angle ≥70°, NERS score ≥20, and SYNTAX score ≥23, the 1-year MACE rate in the DK group (3.8%, 9.2%, and 7.1%, respectively) was significantly different to those in the Culotte group(16.5%, 20.4%, and 18.9%, respectively; all p < 0.05). CONCLUSIONS: Culotte stenting for UPLMCA bifurcation lesions was associated with significantly increased MACEs, mainly due to the increased TVR. (Double Kissing [DK] Crush Versus Culotte Stenting for the Treatment of Unprotected Distal Left Main Bifurcation Lesions: DKCRUSH-III, a Multicenter Randomized Study Comparing Double-Stent Techniques; ChiCTR-TRC-00000151).

[Using the combination of traditional risk factors and quantitative coronary angiography (QCA) in predicting the risk of individuals with subclinical artherosclerosis].

OBJECTIVE: To determine whether the combination of traditional risk factors and quantitative coronary angiography (QCA) assessment could provide accurate prognostic information on a population-based study including 1137 adults with subclinical artherosclerosis and with coronary risk factors. METHODS: Participants underwent coronary angiography examination before the minimal stenotic diameters, segment diameters, percent stenosis, plaque areas. Other parameters were analyzed by the computer-assisted Coronary Angiography Analysis System. The Framingham Risk Score for each participant was assessed. During the 1 year follow-up period, all kinds of endpoint cardiovascular events were screened. Endpoint events were defined as death from coronary heart disease, nonfatal myocardial infarction (MI) or unstable angina pectoris. RESULTS: During the 1 year of follow-up period, a total of 124 participants developed an endpoint event, which was significantly associated with the Framingham Risk Score, calcium of plaques and the plaque areas (all Ps<0.05). The QCA score incorporated with the QCA parameters was related to the endpoint events. The Framingham Risk Score was combined with QCA score through logistic regression for prediction of end-point events. Data from the ROC analysis showed the accuracy of this prediction algorithm was superior to the accuracy when variables themselves were used. The event-free survival rate was inferior to the control group in participates under high risk, when being screened with this prediction algorithm (P<0.05). CONCLUSION: The risk of cardiovascular attack in subclinical artherosclerosis individual seemed to be associated with the Framingham Risk Score, calcium of plaques and the plaque areas. When the traditional risk factors (the Framingham Risk Score) were combined with QCA, the new method could provide more prognostic information on those adults with subclinical artherosclerosis.

Novel side branch ostial stent.

Bifurcation lesions are technically challenging and plagued by a high incidence of restenosis, especially at the side branch orifice, which results in a more frequent need for revascularization during the follow-up period. This report discusses two clinical experiences with a novel side branch ostial stent, the BIGUARD stent, designed for the treatment of bifurcation lesions; procedural success with no in-hospital complications was observed in types IVb and Ia lesions.

[Impact of chronic anemia on in-hospital clinical outcome of revascularization in patients with coronary artery disease].

OBJECTIVE: To evaluate the in-hospital clinical outcome of revascularization in patients with coronary artery disease with chronic anemia. METHODS: Between July 2002 and June 2004, 3 679 patients in Anzhen Hospital Affiliated to Capital University of Medical Sciences were subjected to revascularization [percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)] during hospitalization. These patients were divided into anemia group and non-anemia group according to blood hemoglobin (Hb) level [World Health Organization (WHO) standard (male<120 g/L, female<110 g/L) as anemia]. Rates of in-hospital main adverse cardiac and cerebral events (MACCE), including all-cause death, new attack of myocardial infarction, stroke and repeated revascularization were compared between two groups. RESULTS: There were 426 anemia patients (11.6%) and 3 253 non-anemia patients (88.4%). In-hospital death in the anemia group was higher than that of the non-anemia group [10 cases (2.4%) vs. 64 cases (1.9%), P<0.05]. Rates of MACCE of the anemia group was higher than that of the non-anemia group (4.2% vs. 3.2%, P<0.05). There was no significant difference in rates of new attack of myocardial infarction (0.7% vs. 0.6%), stroke (1.2% vs. 0.4%) and repeated revascularization (0 vs. 0.2%) between two groups (all P>0.05). CONCLUSION: Compared with non-anemia patients, anemia patients with coronary artery disease has higher in-hospital MACCE rate and all-cause mortality.

Prevalence and impact of renal insufficiency on clinical outcomes of patients undergoing coronary revascularization.

BACKGROUND: Patients with renal insufficiency are more likely to die after coronary revascularization, but mild renal insufficiency is neglected and little is known about its clinical effects. METHODS AND RESULTS: In the present study 3,025 patients grouped by estimated creatinine clearance (CrCl) were analyzed to evaluate the association between CrCl and clinical outcome. The mean serum creatinine was 1.0+/-0.4 mg/dl, with 4.3% above normal; in 65.8% CrCl was <90 ml/min. During hospitalization, there were significant differences in mortality among the groups stratified by CrCl (p<0.0001). During follow-up after hospital discharge, there were significant differences in mortality (p<0.0001), new-onset myocardial infarction (p=0.007), and stroke (p=0.032). In patients with severe renal insufficiency, the in-hospital and follow-up mortality reached 15.4% and 31.3%, respectively. The independent risk factors for all-cause death after revascularization were the mode of revascularization, age and the CrCl level. In patients with mild renal insufficiency or normal renal function, the all-cause mortality after percutaneous coronary intervention was significantly lower than that after CABG. CONCLUSIONS: Renal insufficiency is not rare in patients undergoing coronary revascularization and in the present study even mild renal insufficiency correlated with adverse clinical outcomes after revascularization. In patients with normal renal function or mild renal insufficiency, the mode of revascularization might lead to a prognostic difference.