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  • Ovid Technologies (Wolters Kluwer Health)  (13)
  • Han, Jung-Kyu  (13)
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  • Ovid Technologies (Wolters Kluwer Health)  (13)
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  • 1
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 147, No. 18 ( 2023-05-02), p. 1358-1368
    Abstract: Limited data are available on short-term dual antiplatelet therapy (DAPT) after percutaneous coronary intervention using third-generation drug-eluting stents with ultrathin struts and advanced polymer technology. We investigated whether 3- to 6-month DAPT was noninferior to 12-month DAPT after implantation of drug-eluting stents with ultrathin struts and advanced polymer technology. Methods: We performed an open-label, randomized trial at 37 centers in South Korea. We enrolled patients undergoing percutaneous coronary intervention using the Orsiro biodegradable-polymer sirolimus-eluting stents or the Coroflex ISAR polymer-free sirolimus-eluting stents. Patients with ST-segment–elevation myocardial infarction were excluded. Patients were randomly assigned to receive either 3- to 6-month or 12-month DAPT after percutaneous coronary intervention. The choice of antiplatelet medications was at the physician’s discretion. The primary outcome was a net adverse clinical event, a composite of cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization, stent thrombosis, or major bleeding, defined as Bleeding Academic Research Consortium type 3 or 5 at 12 months. The major secondary outcomes were target lesion failure, a composite of cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization, and major bleeding. Results: A total of 2013 patients (mean age, 65.7±10.5 years; 1487 males [73.9%]; 1110 [55.1%] presented with acute coronary syndrome) were randomly assigned to 3- to 6-month DAPT (n=1002) or 12-month DAPT (n=1011). The primary outcome occurred in 37 (3.7%) patients in the 3- to 6-month DAPT group and 41 (4.1%) in the 12-month DAPT group. The noninferiority of the 3- to 6-month DAPT group to the 12-month DAPT group was met (absolute risk difference, –0.4% [1-sided 95% CI, –∞% to 1.1%]; P 〈 0.001 for noninferiority). There were no significant differences in target lesion failure (hazard ratio, 0.98 [95% CI, 0.56–1.71], P =0.94) or major bleeding (hazard ratio, 0.82 [95% CI, 0.41–1.61], P =0.56) between the 2 groups. Across various subgroups, the treatment effect of 3- to 6-month DAPT was consistent for net adverse clinical event. Conclusions: Among patients undergoing percutaneous coronary intervention using third-generation drug-eluting stents, 3- to 6-month DAPT was noninferior to 12-month DAPT for net adverse clinical event. Further research is needed to generalize this finding to other populations and to determine the ideal regimen for 3- to 6-month DAPT. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02601157.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2023
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  • 2
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 130, No. suppl_2 ( 2014-11-25)
    Abstract: Background: Long term outcomes are imperative to confirm safety of drug-eluting stents. There have been two randomized controlled trials comparing everolimus-eluting stents (EES) and Resolute zotarolimus-eluting stents (ZES-R). To date, long-term clinical outcomes of these stents were limited to only one report which has recently reported 4-year comparisons of these stents. Therefore, more evidences are needed regarding long-term clinical outcomes of the second generation stents. This study compared the long-term clinical outcomes of EES with ZES-R in “all-comer” cohorts up to 3-year follow-up. Methods: The EXCELLENT and RESOLUTE-Korea registries prospectively enrolled 3,056 patients treated with EES and 1,998 with ZES-R. Target lesion failure and patient-related composite events were compared in crude and propensity score matched analyses. Results: Of 5054 patients, 3830 patients (75.8%) had off label indication (2217 with EES and 1613 with ZES-R). The stent-related outcome (189 [6.2%] vs. 127 [6.4%] , p=0.812) and the patient-related outcome (420 [13.7%] vs. 250 [12.5%] , p=0.581) did not differ between EES and ZES-R respectively at 3 year, which was corroborated by similar results from the propensity score-matched cohort (HR 0.92, 95% CI 0.70-1.20, p=0.523 and 0.85, 95% CI 0.70-1.02, p=0.081, for stent and patient related outcomes, respectively). The rate of definite or probable stent thrombosis up to 3 years (22 [0.7%] vs. 10 [0.5%] , p=0.370) was also similar. The rate of stent thrombosis was very low and comparable between the two stents (3 [0.1%] vs. 1 [0.1%] , p=0.657). In multivariate analysis, chronic renal failure (adjusted HR 3.615, 95% CI 2.440-5.354, p 〈 0.001) and off label indication (adjusted HR 1.782, 95% CI 1.169-2.718, p=0.007) were the strongest predictors of target lesion failure. Conclusion: In this robust real world registry with unrestricted use of EES and ZES-R, both stents showed comparable safety and efficacy at 3-year follow-up. Overall incidences of target lesion failure and definite stent thrombosis, including very late stent thrombosis, were low, even in the patients with off label indications, suggesting excellent long term safety and sustained efficacy of both types of second generation drug-eluting stents.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2014
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  • 3
    In: Circulation: Cardiovascular Interventions, Ovid Technologies (Wolters Kluwer Health), Vol. 14, No. 4 ( 2021-04)
    Abstract: β-Blockers can improve prognosis after acute myocardial infarction. However, it remains unclear how long β-blockers should be prescribed. Methods: We included patients from the prospective, nationwide Korea Acute Myocardial Infarction Registry-National Institutes of Health registry and collected data on β-blockers and left ventricular ejection fraction (LVEF) at 1-year follow-up. Patients were stratified into 2 groups: 1001 patients with a 1-year LVEF 〈 50% and 3007 patients with a 1-year LVEF≥50%. The primary outcome was 2-year all-cause mortality from the 1-year follow-up. Results: A total of 3177 patients received β-blockers at 1 year, and 151 patients died during the 2-year follow-up from 1 year after index hospitalization. β-Blockers showed survival benefits in patients with a 1-year LVEF 〈 50% (log-rank P =0.001) but not in those with a 1-year LVEF≥50% (log-rank P =0.311). After adjusting covariates, β-blockers were associated with a 51% reduction in mortality in patients with a 1-year LVEF 〈 50% ( P =0.020) but not in their counterparts ( P =0.322). Indeed, there was a prognostic interaction between the use of β-blockers at 1 year and 1-year LVEF ( P for interaction=0.004). Conclusions: Use of β-blockers at 1-year follow-up after acute MI was associated with improved outcomes in patients with an LVEF 〈 50% at 1 year but not in those with an LVEF 〉 50% at 1 year. This study provides valuable information about differential responsiveness to β-blockers according to 1-year LVEF and might suggest the proper duration of β-blockers after acute MI. Registration: URL: http://cris.nih.go.kr/cris/en/ ; Unique identifier: KCT0000863.
    Type of Medium: Online Resource
    ISSN: 1941-7640 , 1941-7632
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
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  • 4
    In: Circulation: Cardiovascular Interventions, Ovid Technologies (Wolters Kluwer Health), Vol. 17, No. 7 ( 2024-07)
    Abstract: The efficacy and safety of each third-generation drug-eluting stent with ultrathin struts and advanced polymer technology remain unclear. We investigated the clinical outcomes of percutaneous coronary intervention using the Coroflex ISAR polymer-free sirolimus-eluting stent (SES) or Orsiro biodegradable polymer SES. METHODS: The HOST-IDEA trial (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis–Coronary Intervention With Next-Generation Drug-Eluting Stent Platforms and Abbreviated Dual Antiplatelet Therapy), initially designed with a 2×2 factorial approach, sought to randomize patients undergoing percutaneous coronary intervention based on dual antiplatelet therapy duration (3 versus 12 months) and stent type (Coroflex ISAR versus Orsiro). Despite randomizing 2013 patients for dual antiplatelet therapy duration, the stent arm transitioned to a registry format during the trial. Among these, 328 individuals (16.3%) were randomized for Coroflex ISAR or Orsiro SES, while 1685 (83.7%) underwent percutaneous coronary intervention without stent-type randomization. In this study, the Coroflex ISAR (n=559) and Orsiro groups (n=1449) were matched using a propensity score. The prespecified primary end point was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization at 12 months. RESULTS: The baseline patient and procedural characteristics were well balanced between the Coroflex ISAR and Orsiro groups after propensity score matching (n=559, each group). The Coroflex ISAR group was significantly associated with a higher rate of target lesion failure, mainly driven by clinically driven target lesion revascularization, compared with the Orsiro group (3.4% versus 1.1%; hazard ratio, 3.21 [95% CI, 1.28–8.05]; P =0.01). A higher risk of target lesion failure in the Coroflex ISAR group was consistently observed across various subgroups. The rates of any bleeding (hazard ratio, 0.85 [95% CI, 0.51–1.40]; P =0.52) and major bleeding (hazard ratio, 1.58 [95% CI, 0.61–4.08]; P =0.34) were comparable between the 2 groups. CONCLUSIONS: In this propensity score-matched analysis of the stent arm registry from the HOST-IDEA trial, the Orsiro SES was associated with significantly better outcomes in terms of 1-year target lesion failure, mainly driven by clinically driven target lesion revascularization, than the Coroflex ISAR SES. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02601157.
    Type of Medium: Online Resource
    ISSN: 1941-7640 , 1941-7632
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2024
    detail.hit.zdb_id: 2450801-9
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  • 5
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 130, No. suppl_2 ( 2014-11-25)
    Abstract: Objective: The optimal treatment option for in-stent restenosis (ISR) is not established. We performed a Bayesian network meta-analysis comparing the efficacy and safety of drug-eluting balloon (DEB), drug-eluting stent (DES) or plain old balloon angioplasty (POBA) for treatment of ISR. Design: Systemic review and Bayesian network meta-analysis using random-effects model. The primary outcome was target lesion revascularization (TLR). The secondary outcomes were myocardial infarction (MI), all-cause mortality or major adverse cardiovascular events (MACE). The pairwise posterior median odds ratio (OR) with 95% credible interval (CrI) was the effect measure. Data Sources: PubMed, EMBASE, BioMed Central, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, conference proceedings through February 2014. Eligibility Criteria for Selecting Studies: Randomized controlled trials (RCTs) comparing DEB, DES, or POBA for treatment of ISR. Results: This analysis included 2,059 patients from 11 RCTs. The risk of TLR was markedly lower in patients treated with DEB (OR 0.22, 95% CrI 0.10-0.42) or DES (OR 0.24, 95% CrI 0.11-0.47) than in those treated with POBA. The risk of TLR (OR 0.92, 95% CrI 0.43-1.90) was similar between DEB and DES. The risk of MI or all-cause mortality was lowest in the DEB group compared with DES or POBA, which did not meet statistical significance. The risk of MACE was significantly lower in DEB (OR 0.24, 95% CrI 0.12-0.39) or DES (OR 0.28, 95% CrI 0.14-0.53) than in POBA, but it was similar between DEB and DES group (OR 0.84, 95% CrI 0.45-1.50). The probability to be ranked as the best treatment were 59.9% (DEB), 40.1% (DES), and 0.1% (POBA) in terms of TLR, whereas, 63.0% (DEB), 35.3% (POBA), and 1.7% (DES) in terms of MI. Conclusions: DEB or DES was markedly better than POBA in preventing TLR, but not for MI or mortality in treatment of ISR. DEB resulted in less MI than DES without statistical significance.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2014
    detail.hit.zdb_id: 1466401-X
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  • 6
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 143, No. 11 ( 2021-03-16), p. 1081-1091
    Abstract: Large-scale randomized comparison of drug-eluting stents (DES) based on durable polymer versus biodegradable polymer technology is currently insufficient in patients with acute coronary syndrome (ACS). The present study aimed to prove the noninferiority of the durable polymer DES (DP-DES) compared with the biodegradable polymer DES (BP-DES) in such patients. Methods: The HOST-REDUCE-POLYTECH-ACS (Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases—Comparison of Reduction of Prasugrel Dose or Polymer Technology in ACS Patients) trial is an investigator-initiated, randomized, open-label, adjudicator-blinded, multicenter, noninferiority trial comparing the efficacy and safety of DP-DES and BP-DES in patients with ACS. The primary end point was a patient-oriented composite outcome (a composite of all-cause death, nonfatal myocardial infarction, and any repeat revascularization) at 12 months. The key secondary end point was device-oriented composite outcome (a composite of cardiac death, target-vessel myocardial infarction, or target lesion revascularization) at 12 months. Results: A total of 3413 patients were randomized to receive the DP-DES (1713 patients) and BP-DES (1700 patients). At 12 months, patient-oriented composite outcome occurred in 5.2% in the DP-DES group and 6.4% in the BP-DES group (absolute risk difference, –1.2%; P non inferiority 〈 0.001). The key secondary end point, device-oriented composite outcome, occurred less frequently in the DP-DES group (DP-DES vs BP-DES, 2.6% vs 3.9%; hazard ratio, 0.67 [95% CI, 0.46–0.98]; P =0.038), mostly because of a reduction in target lesion revascularization. The rate of spontaneous nonfatal myocardial infarction and stent thrombosis were extremely low, with no significant difference between the 2 groups (0.6% versus 0.8%; P =0.513 and 0.1% versus 0.4%; P =0.174, respectively). Conclusions: In ACS patients receiving percutaneous coronary intervention, DP-DES was noninferior to BP-DES with regard to patient-oriented composite outcomes at 12 months after index percutaneous coronary intervention. Registration: URL: https://wwwclinicaltrials.gov ; Unique identifier: NCT02193971.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
    detail.hit.zdb_id: 1466401-X
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  • 7
    In: Circulation: Cardiovascular Interventions, Ovid Technologies (Wolters Kluwer Health), Vol. 14, No. 5 ( 2021-05)
    Abstract: The role of immediate percutaneous coronary intervention (PCI; door-to-balloon time ≤90 minutes) in patients with ST-segment–elevation myocardial infarction who present ≥12 hours after symptom onset is still obscure. We sought to explore the clinical outcomes of immediate PCI in patients with ST-segment–elevation myocardial infarction depending on presentation time. Methods: Using the Korea Acute Myocardial Infarction Registry, a nationwide prospective multicenter registry in the Republic of Korea, we analyzed data from 5968 patients with ST-segment–elevation myocardial infarction. These patients were classified into the following groups: early presenters (n=5104 with symptom onset-to-door time 〈 12 hours), late presenters (n=599 with symptom onset-to-door time 12–48 hours), and very late presenters (n=265 with symptom onset-to-door time ≥48 hours). The primary outcome was major adverse cardiac events, a composite of cardiac death, any myocardial infarction, and clinically driven target lesion revascularization. Results: In early presenters, immediate PCI was significantly associated with a lower rate of major adverse cardiac events compared with delayed PCI (door-to-balloon time 〉 90 minutes; immediate versus delayed PCI, 8.6% versus 17.9%; inverse probability weighting adjusted hazard ratio, 0.63 [95% CI, 0.56–0.71]). In late presenters, immediate PCI was not associated with better major adverse cardiac events outcomes (13.0% versus 14.8%; inverse probability weighting adjusted hazard ratio, 1.05 [95% CI, 0.77–1.44] ). The same trend was found for cardiac death (early presenters: immediate versus delayed PCI, 5.6% versus 14.3%; inverse probability weighting adjusted hazard ratio, 0.55 [95% CI, 0.48–0.64]; late presenters: 9.9% versus 9.8%; inverse probability weighting adjusted hazard ratio, 1.25 [95% CI, 0.86–1.82] ). Very late presenters also showed the same trends as late presenters. Immediate PCI was an independent predictor of major adverse cardiac events in early presenters but not in late presenters. Conclusions: Immediate PCI, defined by time door-to-balloon time ≤90 minutes, for patients with ST-segment–elevation myocardial infarction who present ≥12 hours after symptom onset is not associated with improved long-term clinical outcomes as compared with delayed PCI (door-to-balloon time 〉 90 minutes).
    Type of Medium: Online Resource
    ISSN: 1941-7640 , 1941-7632
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
    detail.hit.zdb_id: 2450801-9
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  • 8
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 148, No. Suppl_1 ( 2023-11-07)
    Abstract: Introduction: Third generation drug-eluting stents with ultrathin struts and advanced polymer technology have been introduced. However, their safety and efficacy have not been fully elucidated, particularly in complex percutaneous intervention (PCI). Aim To investigate the clinical outcomes of complex PCI using the Coroflex ISAR polymer-free sirolimus-eluting stent (SES) or Orsiro biodegradable polymer SES. Methods: This study was a post-hoc analysis of the HOST-IDEA trial that randomly assigned 2,013 patients undergoing PCI with Orsiro or Coroflex ISAR into either 3-month dual antiplatelet therapy (DAPT) or 12-month DAPT arms from January 2016 to May 2021 at 37 centers in South Korea. We compared a 1:1 propensity score (PS)–matched cohort balanced by patient and procedural characteristics. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and clinically-driven target lesion revascularization at 1 year. Complex PCI was defined as any of the following features: ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI, total stent length ≥ 60 mm, left main PCI, or heavy calcification. Results: After PS matching, baseline patient and procedural characteristics were balanced between Coroflex ISAR and Orsiro groups (n=542 in each). Complex PCI was significantly associated with a higher rate of TLF compared with non-complex PCI (5.3% vs. 1.1%, hazard ratio (HR) 5.12 [95% confidence interval (CI) 2.21-11.86], P 〈 0.001). Compared with the Coroflex ISAR SES, the better outcomes of TLF associated with the Orsiro SES was more pronounced in the complex PCI group (HR 0.14 [95% CI 0.03-0.60], P =0.008 in complex PCI; HR 0.99 [95% CI 0.25-3.98], P =0.993 in non-complex PCI; P for interaction 0.054). Conclusion In patients undergoing complex PCI with third-generation DES, the Orsiro SES was associated with significantly better outcomes in terms of TLF than the Coroflex ISAR SES.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2023
    detail.hit.zdb_id: 1466401-X
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  • 9
    Online Resource
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    Ovid Technologies (Wolters Kluwer Health) ; 2019
    In:  Circulation: Cardiovascular Interventions Vol. 12, No. 8 ( 2019-08)
    In: Circulation: Cardiovascular Interventions, Ovid Technologies (Wolters Kluwer Health), Vol. 12, No. 8 ( 2019-08)
    Abstract: The prognostic value of angiographic complete revascularization in patients with chronic kidney disease (CKD) has not been thoroughly investigated, especially for contemporary coronary stents. We compared the clinical outcomes of complete and incomplete revascularization with second-generation drug-eluting stent, according to the presence of CKD. Methods: From the Grand Drug-Eluting Stent Registry (N=17 286) in Korea, we selected 8471 patients, who were treated with second-generation drug-eluting stent and had glomerular filtration rate and quantitative coronary angiography data (3014 [35.6%] patients with CKD and 5457 (64.4%) patients with preserved renal function). Angiographic complete revascularization was defined as a residual SYNTAX score (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) of 0. The primary outcome was the patient-oriented composite outcome at 3 years, including all-cause death, any myocardial infarction, and any revascularization. Results: The patient-oriented composite outcome rate after complete revascularization was significantly lower than that after incomplete revascularization in patients with CKD (14.6% versus 21.8%; adjusted hazard ratio, 0.79; 95% CI, 0.64–0.96; P =0.020) and in patients with preserved renal function (8.0% versus 12.0%; adjusted hazard ratio 0.77; 95% CI, 0.63–0.94; P =0.011). The cutoff values of residual SYNTAX scores for predicting better patient-oriented composite outcomes were different according to the presence of CKD, that is, 〈 3 and 〈 8 in patients with CKD and with preserved renal function, respectively. Conclusions: Angiographic complete revascularization led to better clinical outcomes in patients with CKD and with preserved renal function. However, the residual SYNTAX score to achieve a better outcome was lower in patients with CKD than with preserved renal function, favoring more aggressive revascularization in patients with CKD.
    Type of Medium: Online Resource
    ISSN: 1941-7640 , 1941-7632
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2019
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  • 10
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 126, No. suppl_21 ( 2012-11-20)
    Abstract: Background PPAR-δ has been implicated in various cellular metabolism, but the roles in vascular biology are largely unexplored. Here, we investigated the effects of PPAR-δ activation on late EPC-platelet network. Methods & Results GW501516 (500nM), a highly selective PPAR-δ agonist treatment enhanced BrdU incorporation to human late EPCs, and augmented their pro-vasculogenic effects such as Matrigel tube formation and scratch-wound healing dose-dependently. To reveal the mechanism, the expression level of Edg family members was screened in late EPCs after PPAR-δ activation. We found that only Edg-2 mRNA and protein expression, which is a major receptor for LPA, were specifically upregulated by GW501516. ChIP and promoter assays demonstrated the direct transcriptional regulation of Edg-2. Edg-2 is a membrane receptor for LPA which is the major lysophospholipid growth factor generated on platelet activation. GW501516 (500nM), the supernatant of activated platelets, or LPA (100nM) induced the proliferation (BrdU incorporation) of late EPCs, and enhanced their provasculogenic functions such as chemotaxis (Transwell), planar migration (scratch wound healing), and capillary tube formation (in vitro Matrigel). Co-treatment of GW501516 and the supernatant synergistically enhanced the above results, suggesting the interaction between late EPCs and platelets augmented by PPAR-δ activation. But GSK0660 (1μM, PPAR-δ antagonist) or Ki16425 (3μM, EDG-2 blocker) treatment reversed the results. In vivo Matrigel plug assay (n=4, each group), the combination of late EPCs (106/plug) and platelets robustly induced capillary formation, compared with late EPCs or platelets alone. GW501516 potentiated the interaction, leading to more capillaries. In vivo mouse skin wound model (n=4, each group), late EPCs in platelet gel enhanced the wound healing with new vessel formation, which was augmented by GW501516 , confirming the interaction in vivo. PPAR-δ or EDG-2 siRNA transfection blocked all the in vivo effects of GW501516. Conclusions Platelets and late EPCs play a key role in vascular regeneration via Edg-2 - LPA axis. PPAR-δ augments the interaction through Edg-2 upregulation, suggesting its agonist as a good therapeutic tool for vascular regeneration.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2012
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