scholarly journals CLINICAL EVALUATION OF THE INDIGENOUSLY MANUFACTURED REJUVENATE® BARE METAL STENT SYSTEM IN PAKISTANI PATIENTS WITH CORONARY ARTERY DISEASE

2021 ◽  
Vol 54 (3) ◽  
pp. 261-267
Author(s):  
Azhar Mahmood Kayani ◽  
Syed Nadeem Hassan Rizvi ◽  
Khusrow A. Niazi ◽  
Murtaza Najabat Ali ◽  
Muhammad Mubashar Aslam ◽  
...  

Objectives: The aim of this pilot study was the first-in-man evaluation of the safety, feasibility, deliverability, and efficiency of the newly developed REJUVENATE® bare metal stent system in coronary artery disease. Methodology: Current study was a pilot non-randomized, multi-centric and prospective study which was intended to study the safety of the REJUVENATE® bare metal stent in Pakistani population over 10 months. Study endpoints included target vessel related myocardial infarction, stent thrombosis, in-stent restenosis, stroke and death. The diameter of the target lesions selected was between 3-4mm with length no more than 22mm. Only one BMS was implanted per patient. These patients had well defined regular clinical follow-ups and CT scan coronary angiography at the end of 10 months. Results: 20 patients suffering from coronary artery disease (CAD) including15 male subjects and 5 female subjects were enrolled in this study and were treated with REJUVENATE® BMS. 65% patients were hypertensive, 25% diabetics and 25% were active smokers. Out of the 20 stents implanted, 14 stents were implanted in the right coronary artery and 6 were implanted in the left circumflex artery. During this 10-month study period there was 10.65% of cases in which late lumen loss (lumen stenosis <70%) was observed, however no cases of in stent restenosis and stent thrombosis were observed. There was no target vessel related myocardial infarction or stroke as well. One patient died of pneumonia during the follow up period. Conclusion: The current study demonstrated the deliverability and clinical safety of REJUVENATE® bare metal stent over a period of 10 months.

2016 ◽  
Vol 23 (3) ◽  
pp. 235-240 ◽  
Author(s):  
Sani Namik Murat ◽  
Mikail Yarlioglues ◽  
Ibrahim Etem Celik ◽  
Alparslan Kurtul ◽  
Mustafa Duran ◽  
...  

In-stent restenosis (ISR) is a common clinical problem in patients with coronary artery disease treated with percutaneous coronary intervention. Inflammatory process plays a pivotal role in the development of ISR. Both lymphocytes and monocytes are associated with inflammatory status. Recently, it has been shown that the lymphocyte-to-monocyte ratio (LMR) is a novel inflammatory marker. We aimed to investigate the association of serum LMR levels and ISR in patients undergoing bare-metal stent (BMS) implantation. The study included 273 patients (aged 61 ± 11 years, 66.5% men) with a history of BMS implantation and a further control coronary angiography due to stable angina pectoris. Patients were divided into 2 groups: patients with and without ISR. The LMR levels were significantly lower in patients with ISR than in those without ISR (2.50 ± 0.95 vs 3.87 ± 1.51, respectively, P < .001). On multivariate logistic regression analysis, the LMR was independently associated with ISR (odds ratio [OR]: 0.310, 95% confidence interval: 0.166-0.579, P < .001) together with high-sensitivity C-reactive protein (OR: 1.244, P = .008), reason for stent implantation (OR: 6.566, P = .003), stent diameter (OR: 0.015, P < .001), and stent length (OR: 1.137, P = .007). In conclusion, LMR levels are inversely related to ISR in patients treated with BMS implantation.


Medicine ◽  
2017 ◽  
Vol 96 (12) ◽  
pp. e6397 ◽  
Author(s):  
Wenjie Lu ◽  
Yongjian Zhu ◽  
Zhanying Han ◽  
Xi Wang ◽  
Xule Wang ◽  
...  

Angiology ◽  
2015 ◽  
Vol 67 (5) ◽  
pp. 478-483 ◽  
Author(s):  
Ibrahim Etem Celik ◽  
Mikail Yarlioglues ◽  
Alparslan Kurtul ◽  
Mustafa Duran ◽  
Cemal Koseoglu ◽  
...  

In-stent restenosis (ISR) remains a significant clinical problem in patients with coronary artery disease treated with percutaneous coronary intervention. Decreased serum albumin (SA) level is related to an increased risk of cardiovascular events. The aim of the present study was to assess whether SA levels at admission are an independent predictor of ISR in patients undergoing bare-metal stent (BMS) implantation. A total of 341 patients (aged 61 ± 11, 65.4% men) with a history of BMS implantation and a further control coronary angiography due to stable angina pectoris (SAP) were included. The study population was classified into 2 groups: patients with and without ISR. The ISR was observed in 140 (41.1%) patients. We found significantly lower SA levels in patients who developed ISR than in those who did not (3.69 ± 0.41 vs 4.07 ± 0.35 mg/dL, P < .001). Multivariate analysis revealed that SA level (odds ratio 0.109, 95% confidence interval 0.017-0.700, P = .020), stent diameter, reason for stent implantation, and body mass index were independent risk factors for the development of ISR. The SA level at admission is inversely associated with ISR in patients with SAP.


JAMA ◽  
2005 ◽  
Vol 294 (10) ◽  
pp. 1215 ◽  
Author(s):  
Gregg W. Stone ◽  
Stephen G. Ellis ◽  
Louis Cannon ◽  
J. Tift Mann ◽  
Joel D. Greenberg ◽  
...  

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