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
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