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Comparison of Bare metal Vs Drug eluting stents for in-stent Restenosis among Diabetics
Mynuddin Ahmed Nawaz1, Ia Avaliani1, Irakli Davitashvili1, Georgi Getmansky1 Khatuna Jalabadze1, Kakhaber 1: Tbilisi State Medical University, Tbilisi, Georgia.
* Corresponding Author: Dr.Mynuddin Ahmed Nawaz, 33, Vazha-Pshavela ave. Tbilisi 0177, Georgia,
+95.558119645, [email protected]
ABSTRACT:
Background:
Diabetes mellitus is associated with an increased risk of restenosis, stent thrombosis, and death after
percutaneous coronary interventions. Little is known about the late outcome of patients with diabetes mellitus who
receive drug-eluting stents (DES) or bare metal stents (BMS).
Methods: From January 2008 to January 2010, six patients with DES and 20 with BMS, ISR were identified at our
institution.
Results: The median age of our diabetic cohort was 63 years, and 87 of the patients were male. For two years, rates
of repeat target-vessel revascularization were significantly lower among diabetic patients treated with DES
compared
Conclusions: DES is effective among diabetic patients in substantially reducing the need for repeat TVR.
Keywords: Diabetics; Bare metal stents (BMS); Drug eluting stents (DES); In-stent restenosis (ISR); Target Vessel
Revascularization (TVR).
Received: 11 December 2010
Revised: 20 May 2011
Accepted: 10 June 2011
Published: 20 June 2011
2009-2011 Electronic Physician
1. INTRODUCTION
has been dampened by some data showing higher Cardiovascular disease is a major cause of rates of late-stent thrombosis and possibly higher morbidity and mortality among patients with diabetes rates of myocardial infarction and death (11, 12).
(1, 2). It is currently estimated that 25 to 30 percent Although our group has demonstrated the safety of of all percutaneous coronary interventions (PCI) are DES in a large population-based cohort, the safety of performed among patients with diabetes (3, 4).
diabetic patients was not assessed specifically (13).
Although ISR was once a feared consequence of PCI Indeed, the safety concerns of DES are perhaps even greater among diabetic patients with a recent study demonstrated DES to be highly effective in reducing showing a three-fold increase in the hazard of death restenosis and thereby minimizing the need for future coronary revascularization (5-9). Several trials are limitations of the study led the authors to urge underway to evaluate whether PCI with DES would cautious interpretation of their findings (14).
be superior to coronary bypass grafting surgery Addressing this important gap in knowledge among diabetic patients with multivessel coronary could have a substantial impact on the choice of artery disease (10). Recently, the enthusiasm for DES coronary revascularization for diabetic patients with coronary artery disease. Accordingly, the main was implanted if the patient needed >1 stent. Aspirin objective of our study was to evaluate the long-term safety and effectiveness of diabetic patients who according to standard practice. After the intervention, received DES and BMS using a population-based the patients received aspirin 200 mg indefinitely and clopidogrel 150 mg for the first three days and 75 mgfor ≥ six months. BMS patients received aspirin 200 2. MATERIAL AND METHODS
mg and Clopidogrel 150mg indefinitely. Follow-up Evaluation: Baseline, post-procedural, and follow-up coronary angiograms or exercise stress test by experienced interventionists. Measurements were implantation (sirolimus or paclitaxel) in native performed on cineangiogram recorded after the coronary arteries at our center. All patients were intracoronary administration of nitroglycerin. Binary asked to return for follow-up angiography at six angiographic restenosis was defined as a diameter months after the procedure. Diabetes was defined as stenosis ≥50 percent at angiographic follow-up at six active treatment with insulin or an oral antidiabetic months measured at any point within the stented agent or if the patient had an abnormal blood glucose segment or in the 5-mm proximal or distal segments level after an overnight fasting or abnormal glucose adjacent to the stent or positive exercise stress test tolerance test results according to the WHO criteria Target lesion revascularization (clinical restenosis), “GULI” maintains a medical record section, hence clinical angina symptoms and mortality at two years prospective clinical data was collected with the help of follow-up were the primary end points of the of the medical record section for relevant data collection when needed. This study was approved by thrombosis, and the composite of death or myocardial the board at Cardiological Clinic “GULI.” infarction were selected as the secondary end points.
Study Sample: We initially identified a cohort who Adverse cardiac events were monitored throughout the follow-up period by a telephone interview at 30 Cardiological Clinic “GULI” from January 1, 2008, days, a clinical visit at six to eight months, and to January 31, 2010. This time frame was chosen to telephone interviews at one-year intervals after allow adequate follow-up to examine the long-term procedure. If patients reported cardiac symptoms outcomes of DES and BMS. We excluded patients during the telephone interview, at least one clinical, without diabetes, who had stenting of the left main exercise stress test and electrocardiographic follow- artery, and patients who had PCI within the past year up visit was performed at the outpatient clinic.
(possibly indicative of ISR) because these patients Relevant data were collected and entered into a were likely to have received a DES, and thus, it computer database. The criteria for target lesion would be difficult to identify a suitably matched BMS patient. We also excluded patients who had angiographic restenosis accompanied by symptoms placement of both BMS and DES during PCI.
and/or positive exercise test results.
was defined as repeat PCI with new stent placement 3. RESULTS
in the same vessel, repeat PCI without stent, or Baseline Patient Characteristics: The median subsequent coronary artery bypass graft surgery or age was 63 ± 10 years, 77% were male. Procedural Characteristics: DES were used in 25.66% of cases, BMS were used in 74.33% of cases, and the mean stent length per case was 18.99 mm and a mean stent characteristics between the DES and BMS groups diameter of 3.05 mm. Clinical Characteristics: The stratified by diabetes status using student tests for mean time from PCI to follow up was six, 12, and 18 continuous variables, and Microsoft Excel 2007 was months. 76.99% were asymptomatic and 23.01% utilized for the graphic representations and graphs.
presented with angina pectoris. The overall incidence All analyses were performed using Microsoft Excel of angiographic stent thrombosis in the 113 patients 2007. A P value < .05 was considered to indicate underwent coronary angiography because ischemia Intervention and Adjunct Drug Therapy: All was detected on stress testing. Out of the 23.01% patients received a loading dose of 300 mg of patients who presented with angina pectoris, 31 clopidogrel at least two hours before undergoing coronary angiography (16). The same type of DES used myocardial infarction after PCI and exercise stress test as a measurement of safety. This liberal quantitative coronary angiography (QCA) within a definition for safety assessment would tend to previously (at least four months) stented vessel introduce a large number of events and tend to segment. ISR was classified as focal (<10 mm long), diminish the ability to find significant differences diffuse (>10 mm long), proliferative (>10 mm long and extending outside the stent edges), or totallyoccluded. The pathophysiology of restenosis involves 5. CONCLUSION
a complex cascade of the effects of various growth factors and cytokines, each of which contributes to lower risk of future need for TVR. The overall rates the progressive loss of luminal diameter due to of angina did not differ significantly between DES and BMS-treated patients. Most importantly, our datasuggest diabetic patients treated with DES are at 4. DISCUSSIONS
decreased risk ISR compared to diabetic patients treated with BMS. New and better strategies for and efficacy of diabetic patients treated with DES and BMS using a small population-based PCI. We following PCI with DES in diabetic patients are found that DES was highly efficacious among required. Drug-eluting stents with improved designs diabetic patients in reducing the need for TVR.
or drug elution systems that further decrease the diabetic patients treated with DES and BMS havebeen mixed, with some studies showing similar ACKNOWLEDGEMENTS
safety between DES and BMS and others showing higher risk of adverse outcomes associated with DES immense favors on me. I would like to thank all my (17-20). Most of these studies, however, have limited patients for their patience and co-operation without power to detect a difference in outcomes because which this thesis work entitled COMPARISON OF relatively few events were observed at follow-up. It is noteworthy that patients in Ontario ≥65 years old are eligible to receive a one-year supply of clopidogrel DIABETICS, would not be a reality. First, I wish to after DES placement and most of the younger express my sincere gratitude to the Head of the Cardiology Department, for their supervision and findings because randomized studies have not shown guidance in completion of this thesis. I would like to a mortality benefit (22-24). With regard to the thank Dr. Anzor Melia, Dr. Khatuna Jalabadze, efficacy of DES among diabetic patients, we found Kakhaber Etsadashvili, and Dr. Georgi Getmasky for that future TVR was reduced by approximately one half compared with BMS. Furthermore, the absolute reviewing the thesis and making it more meaningful rate reduction in TVR continued to diverge in our and Mr. Alexandra for his technical help with the study period favoring diabetic patients treated with angiogram retrieval from database. I would like to DES. One of the reasons for the discrepancy in TVR thank my family members who supported me in rates between clinical trials and registry data may relate to the performance of routine angiographicfollow-up REFERENCES
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