Two-year follow-up of the genous™ endothelial progenitor cell capturing stent versus the taxus liberté stent in patients with De Novo coronary artery lesions with a high-risk of restenosis

2011 ◽  
Vol 78 (2) ◽  
pp. 189-195 ◽  
Author(s):  
Marcel A.M. Beijk ◽  
Margo Klomp ◽  
Nan van Geloven ◽  
Karel T. Koch ◽  
José P.S. Henriques ◽  
...  
2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K.M.Z Mohd Saad Jalaluddin

Abstract Background Drug-coated balloon has been widely used to treat In-Stent Restenosis as recommended by ESC/EACT coronary intervention guideline. However, trials of effectiveness of DCB in treating de novo lesions in diabetic patients are limited. This study will highlight the impact of DCB in diabetic patients with only de novo lesions against non-diabetic patients. Aim To compare the outcomes of Paclitaxel Drug Coated Balloon (DCB) in Diabetic and non-diabetic patients with only de novo coronary artery disease. Methods A retrospective, single center study was conducted from January 2016 till December 2018. All diabetic and non-diabetic patients underwent angioplasty to only de novo coronary artery lesions were included in the study. Patients' baseline characteristic, angiographic data, post procedural and 12 months follow-up outcomes including major adverse coronary artery event (MACE), target lesion revascularization (TLR) and myocardial infarction (MI) are compared. Results A total of 1257 patients (726 diabetic and 531 non-diabetic patients) with total 1385 de novo coronary artery lesions (791 lesions in diabetic group and 594 lesions in non-diabetic group) were included in this study. Mean age for non-diabetic group was 57.6±10.6 years and diabetic group was 59.6±9.6 years with male predominance (91.1% in non-diabetic group, n=484 and 79.2% in diabetic group, n=575). Majority of diabetic group has hypertension (83.7%, n=608 vs 58.6%, n+311), chronic renal failure (10.3%, n=75 vs 1.9%, n=10), documented coronary artery disease (55.6%, n=404 vs 47.5%, n=252) and previous coronary angioplasty 39.5%, n=287 vs 28.8%, n=153). Adequate pre-dilatation was done in both groups (98.5%, n=585 in non-diabetic group and 99.4%, n=786 in diabetic group; p=0.000). Mean DCB diameter and length were almost similar in both groups. Mean residual stenosis after DCB was 11.15±16.9% in non-diabetic group and 13.13±13.4% in the diabetic group (p=0.008). 74.6% of non-diabetic group (n=396) and 77.1% of diabetic group (n=560) were on double antiplatelet therapy for 12 months. 86.8% (n=461) of non-diabetic and 88.4% (n=642) of diabetic patients were available for follow up. MACE events were significantly higher (p=0.000) in diabetic group (4.3%, n=31) as compare to non-diabetic group (0.6%, n=3). Target lesion revascularization (TLR) and myocardial infarction (MI) was also significantly higher in diabetic group (TLR 1.4%, N=10 vs 0.6%, n=3, p=0.049; MI 2.6%, n=19 vs 0.4%, n=2, p=0.002). Conclusion Treating de novo coronary lesions in diabetic patients with DCB associated with significantly higher MACE events, target lesion revascularization and myocardial infarction. Diabetic patients appear to have a greater volume of atherosclerotic plaque and increased propensity for atherosclerotic plaque rupture. Funding Acknowledgement Type of funding source: None


Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
H Duckers ◽  
Yoshinobu Onuma ◽  
Edouard Benit ◽  
Robert J de Winter ◽  
William Wijns ◽  
...  

Background: In contrast to a cytotoxic or cytostatic pharmacotherapy, promoting the vascular healing response by capturing and sequestering circulating endothelial progenitor cells (EPC) to the stent surface by a CD34 antibody coating (Genous ™ stent) may accelerate stent reendo-thelialization and prevent restenosis formation, as well as stent thrombosis (ST) Methods: The HEALING IIB study was a multi-center, prospective trial designed to assess the safety and efficacy of the Genous ™ bio-engineered stent in conjunction with HmG CoA reductase inhibitors (statins) to stimulate EPC recruitment, in the treatment of patients with de novo coronary artery lesions (n=100 pts). The primary safety endpoint was major adverse cardiac events (MACE) at 30 days, whereas the primary efficacy endpoint was late luminal loss by QCA at 6 months follow-up. Results: At interim analysis of the first 45 patients that completed the 6-month angiographic follow-up, the composite MACE rate was 11.1%, whereas 6.6% clinically justified target lesion revascularizations were observed. 2 Patients died within the first 30 days after stent implantation due to angiographically verified stent thrombosis. Low circulating EPC titers were previously associated with a poor response to the EPC capture stent with TLR events and high late loss. Therefore, patients were pre-treated with Atorvastatin 80 mg qd prior to the PCI in order to augment EPC levels. Statin therapy stimulated the levels of committed EPCs by +294%, but failed to increase the titer of CD34+cells (+25%). Although statin pretreatment stimulated EPC levels, the angiographic outcome of the EPC capture stent was not improved in these patients: in-stent late luminal loss was 0.77±0.46 mm. We anticipate to complete analysis of the 6 month angiographic follow-up of all 100 patients by the time of the AHA2008. Conclusions: The HEALING-IIB study suggests that the EPC capture coronary stent in combination with statin therapy does not sufficiently impede stent restenosis formation for the treatment of de novo coronary artery disease. Although concomitant statin therapy was able to stimulate EPC recruitment, it failed to stimulate CD34+ stem cell levels and did not improve the angiographic outcome of the bioengineered EPC capture stent.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C Camaro ◽  
H Suryapranata ◽  
J P Ottervanger ◽  
J H E Dambrink ◽  
M Gosselink ◽  
...  

Abstract Background The Endothelial Progenitor Cell (EPC) stent was designed to capture circulating EPCs and promote early stent re-endothelization. Erythropoietin (EPO) stimulates mobilization of EPC from the bone marrow. Combination of EPO and the EPC stent in the setting of ST-segment elevation myocardial infarction (STEMI) has never been investigated. Methods STEMI patients enrolled in the HEBE-III trial were randomized to a single bolus of EPO or No-EPO after implantation of the EPC capture stent. Late lumen loss (LLL) was determined at 9-month angiographic follow-up. Clinical data was collected at 30 days and 12 months. Results 196 patients were randomized to EPO (n=100) or No-EPO (n=96). No significant difference in baseline characteristics was observed between the two groups. A significant reduction in angiographic LLL was observed with EPO (0.43±0.57mm) as compared to No-EPO (0.74±0.63mm) (p=0.011). At 12 months follow up, no difference with regard to death or re- infarction was observed in both groups, whereas significant reduction in the need for target vessel revacularization for the EPO versus No-EPO was observed with rates of 7.1% and 19.1% respectively (p=0.013). Angiographic and clinical results EPO (n=39) No-EPO (n=45) P-value Angiography   Lume late loss 0.43±0.57 0.74±0.63 0.011 12 months clinical   Death 0 0 ns   Re infarction 0 1 (2.2%) ns   Additional PCI 4 (10.3%) 17 (37.8%) 0.004   CABG 2 (5.1%) 2 (4.4%) ns   CVA 0 0 ns   Bleeding 3 (7.7%) 4 (8.9%) ns ns = not significant; CVA = cerebrovascular accident; CABG = coronary bypass graft; PCI = percutaneous coronary intervention. Conclusion In STEMI patients treated with EPC capture stent, additional EPO can further improve angiographic LLL


2014 ◽  
Vol 172 (2) ◽  
pp. 516-517 ◽  
Author(s):  
M.C. Barsotti ◽  
T. Santoni ◽  
M.E.L. Picoi ◽  
N. Mancini ◽  
F. Massaro ◽  
...  

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