The Five-Year Clinical and Angiographic Follow-Up Outcomes of Intracoronary Transfusion of Circulation-Derived CD34+ Cells for Patients With End-Stage Diffuse Coronary Artery Disease Unsuitable for Coronary Intervention—Phase I Clinical Trial

2018 ◽  
Vol 46 (5) ◽  
pp. e411-e418 ◽  
Author(s):  
Pei-Hsun Sung ◽  
Fan-Yen Lee ◽  
Meng-Shen Tong ◽  
John Y. Chiang ◽  
Sung-Nan Pei ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Clinical Trial ◽  
Coronary Artery ◽  
Phase I ◽  
Coronary Intervention ◽  
Diffuse Coronary Artery Disease ◽  
Cd34 Cells ◽  
Artery Disease ◽  
End Stage

scholarly journals Baseline Factors Identified For Prediction of Good Responders in Patients With End-Stage Diffuse Coronary Artery Disease Undergoing Intracoronary CD34+ Cell Therapy

2020 ◽  
Author(s):  
Pei-Hsun Sung ◽  
Hsin-Ju Chiang ◽  
Yi-Chen Li ◽  
John Y Chiang ◽  
Chi-Hsiang Chu ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Coronary Artery ◽  
Cell Therapy ◽  
Phase I ◽  
Diastolic Dysfunction ◽  
Diffuse Coronary Artery Disease ◽  
Artery Disease ◽  
End Stage

Abstract Background: Treating patients with end-stage diffuse coronary artery disease (EnD-CAD) unsuitable for coronary intervention remains a clinical challenge. They usually express refractory angina and have high risk for mortality. Although growing data have indicated cell therapy is an alternative solution to medical or invasive therapy, there are still lacking useful markers to predict whether heart function will improve in the EnD-CAD patients who underwent circulatory-derived CD34+ cell therapy. By utilizing the baseline variables and results from our previous phase I/II clinical trials, the aim of this study tried to elucidate the variables predictive of the “good response” to CD34+ cell therapy.Methods: This retrospective study included 38 patients in the phase I clinical trial (2011-2014), and 30 patients in the phase II clinical trial (2013-2017). These patients were categorized into “good responders” and “non-responders” according to their 1-year improvement of LVEF ≥7.0% or <7.0% after intracoronary CD34+ cell therapy. Univariate and multivariate logistic regression model was performed to identify potential independent predictors of good responder to cell therapy, followed by Hosmer–Lemeshow (H-L) test for goodness of fit and prediction power.Results: Among baseline data, multivariate analysis demonstrated that history of former smoker was independently predictive of good responders (p=0.006). On the other hand, male gender, the baseline Canadian Cardiovascular Society angina score ≥3 and grades of LV diastolic dysfunction ≥2 were significantly negative predictors of good responders (all p<0.01). After administration of subcutaneous granulocyte-colony stimulating factor (G-CSF), a higher post-G-CSF neutrophil count in addition to the above four baseline variables played crucial roles in early prediction of good response to CD34+ cell therapy for EnD-CAD (all p<0.03). The H-L test displayed a good prediction power with sensitivity 83.3%, specificity 85.3% and accuracy 84.4%. Conclusions: Using the results of our phase I/II clinical trials, previous smoking habit, female sex, lower grades of angina score and diastolic dysfunction were identified to be independently predictive of “good response” to CD34+ cell therapy in the patients with EnD-CAD.Trial registration: This is a retrospective analysis based on the phase I (ISRCTN72853206) and II (ISRCTN26002902) clinical trials

scholarly journals Baseline factors identified for prediction of good responders in patients with end-stage diffuse coronary artery disease undergoing intracoronary CD34+ cell therapy

2020 ◽  
Author(s):  
Pei-Hsun Sung ◽  
Hsin-Ju Chiang ◽  
Yi-Chen Li ◽  
John Y Chiang ◽  
Chi-Hsiang Chu ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Coronary Artery ◽  
Cell Therapy ◽  
Phase I ◽  
Diastolic Dysfunction ◽  
Diffuse Coronary Artery Disease ◽  
Artery Disease ◽  
End Stage

Abstract Background: Treating patients with end-stage diffuse coronary artery disease (EnD-CAD) unsuitable for coronary intervention remains a clinical challenge. They usually express refractory angina and have high risk for mortality. Although growing data have indicated cell therapy is an alternative solution to medical or invasive therapy, there are still lacking useful markers to predict whether heart function will improve in the EnD-CAD patients who underwent circulatory-derived CD34+ cell therapy. By utilizing the baseline variables and results from our previous phase I/II clinical trials, the aim of this study tried to elucidate the variables predictive of the “good response” to CD34+ cell therapy.Methods: This retrospective study included 38 patients in the phase I clinical trial (2011-2014), and 30 patients in the phase II clinical trial (2013-2017). These patients were categorized into “good responders” and “non-responders” according to their 1-year improvement of LVEF ≥7.0% or <7.0% after intracoronary CD34+ cell therapy. Univariate and multivariate logistic regression models were performed to identify potential independent predictors of good responder to cell therapy, followed by Hosmer–Lemeshow (H-L) test for goodness of fit and prediction power.Results: Among baseline data, multivariate analysis demonstrated that history of former smoker was independently predictive of good responders (p=0.006). On the other hand, male gender, the baseline Canadian Cardiovascular Society angina score ≥3 and grades of LV diastolic dysfunction ≥2 were significantly negative predictors of good responders (all p<0.01). After administration of subcutaneous granulocyte-colony stimulating factor (G-CSF), a higher post-G-CSF neutrophil count in addition to the above four baseline variables also played crucial roles in early prediction of good response to CD34+ cell therapy for EnD-CAD (all p<0.03). The H-L test displayed a good prediction power with sensitivity 83.3%, specificity 85.3% and accuracy 84.4%. Conclusions: Using the results of our phase I/II clinical trials, previous smoking habit, female sex, lower grades of angina score and diastolic dysfunction were identified to be independently predictive of “good response” to CD34+ cell therapy in the patients with EnD-CAD.Trial registration: This is a retrospective analysis based on the phase I (ISRCTN72853206) and II (ISRCTN26002902) clinical trials

scholarly journals Correlation between Therapeutic Efficacy of CD34+ Cell Treatment and Directed In Vivo Angiogenesis in Patients with End-Stage Diffuse Coronary Artery Disease

2018 ◽  
Vol 2018 ◽  
pp. 1-8 ◽  
Author(s):  
Tien-Hung Huang ◽  
Cheuk-Kwan Sun ◽  
Yi-Ling Chen ◽  
Pei-Hsun Sung ◽  
Chi-Hsiang Chu ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Therapeutic Efficacy ◽  
Peripheral Blood Mononuclear ◽  
Angiogenesis Assay ◽  
Diffuse Coronary Artery Disease ◽  
Significant Difference ◽  
Artery Disease ◽  
End Stage

Background. This study was aimed at testing the association between the therapeutic efficacy of CD34+ cell treatment in patients with end-stage diffuse coronary artery disease as reflected in angiographic grading and results of directed in vivo angiogenesis assay (DIVAA) on their isolated peripheral blood mononuclear cell- (PBMC-) derived endothelial progenitor cells (EPCs). Methods. Angiographic grades (0: <5%; 1: 5–35%; 2: 35–75%; 3: >75%) which presented the improvement of vessel density pre- and post-CD34+ treatment were given to 30 patients with end-stage diffuse coronary artery disease having received CD34+ cell treatment. The patients were categorized into low-score group (angiographic grade 0 or 1, n=12) and high-score group (angiographic grade 2 or 3, n=18). The percentages of circulating EPCs with KDR+/CD34+/CD45−, CD133+/CD34+/CD45−, and CD34+ were determined in each patient using flow cytometry. PBMC-derived EPCs from all patients were subjected to DIVAA through a 14-day implantation in nude mice. The DIVAA ratio (i.e., mean fluorescent units in angioreactors with EPCs/mean fluorescent units in angioreactors without EPCs) was obtained for each animal with implanted EPCs from each patient. Results and Conclusions. The number of EPCs showed no significant difference among the two groups. The DIVAA ratio in the high-score group was significantly higher than that in the low-score group (p=0.0178). Logistic regression revealed a significant association between the DIVAA ratio and angiographic grading (OR 3.12, 95% CI: 1.14–8.55, p=0.027). The area under the ROC curve (AUC) was 0.8519 (p=0.0013). We proposed that DIVAA may be a reliable tool for assessing coronary vascularization after CD34+ cell treatment.

P1737Influence of peripheral arterial disease on prognosis in patients with left main coronary artery disease treated with percutaneous coronary intervention

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A Martinez Leon ◽  
A Adeba Garcia ◽  
D Garcia Iglesias ◽  
P Florez Llano ◽  
A Flores Fuentes ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Multivariate Analysis ◽  
Coronary Artery ◽  
Coronary Intervention ◽  
Arterial Disease ◽  
Left Main ◽  
Percutaneous Coronary ◽  
Artery Disease ◽  
Peripheral Arterial

Abstract Introduction Percutaneous coronary intervention (PCI) in patients with left main (LM) coronary artery disease is acquiring an important role in the last years as an alternative to coronary artery bypass grafting (CABG) in selected patients. The objective of the study was to evaluate predictors of mortality in patients with LM coronary artery disease treated with PCI. Methods Prospective and observational study of consecutive patients referred to our centre for coronary angiography, with LM coronary artery disease, whom PCI was decided in a “Heart team” as a strategy for revascularization between July 2015 and December 2017. Baseline clinical, analytical and coronary angiography data were collected. Follow-up was conducted in person or by telephone for a minimum of one year. We analysed the predictive variables of mortality by means of an uni and multivariate logistic regression model. In addition, a survival analysis was performed. Results A total of 191 patients were recruited. The average age was 72 years (±11.4), 79% males. 42% had previous documented coronary artery disease. PCI was performed in the context of acute coronary syndrome in 81% of them. The mean follow-up period was 17.9 months (± 8.3). After multivariate analysis, the following variables remained as independent predictors of mortality: the hemodynamic situation of the patient, assessed by the Killip-Kimball scale (OR 1.58, 95% CI 1.03–2.43; p=0.04) and the presence of peripheral arterial disease (PAD) (OR 2.61, 95% CI 1.03–6.67; p=0.04) (table 1). The ROC curve of the multivariate model showed an AUC of 0.796 (figure 1A). In the survival analysis, patients with PAD had a significantly lower survival, with a median survival of 6 months, compared to 13.9 months in those without PAD, with p=0.008 (figure 1B). Uni and multivariate analysis Univariate analysis Multivariate analysis OR (95% CI) p OR (95% CI) p Killip-Kimbal scale 1.94 (1.39–2.72) 0 1.58 (1.03–2.43) 0.04 LVEF 0.96 (0.93–0.99) 0.01 0.99 (0.95–1.03) 0.46 Mitral regurgitation 2.54 (1.12–5.63) 0.02 1.60 (0.55–4.56) 0.38 Number of affected vessels 1.96 (1.24–3.29) 0.01 1.78 (1.03–3.37) 0.05 PAD 2.54 (1.16–5.49) 0.02 2.61 (1.03–6.67) 0.,04 Figure 1 Conclusion Although PCI revascularization of LM coronary artery disease is an attractive alternative to CABG in selected patients, a word of caution should be raised in patients with PAD, as in the present study this variable was an important predictor of short-medium term mortality.

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