Background: Coronary artery diseases in diabetic patients are challenging because these patients represent about 25% of surgical coronary revascularization and percutaneous coronary intervention (PCI) procedures and have worse outcomes than patients without diabetes mellitus (DM) irrespective of the invasive management they receive. Patients and Methods: 53 insulin-dependent diabetic patients (ID) and non-insulin-dependent diabetic patients (NID) who underwent PCI with deployment of at least 1 drug-eluting stent (DES) in coronary arteries. Patients were divided into 2 groups: 18 ID patients & 35 NID patients. A comprehensive clinical work-up was planned one month and twelve months following the surgery, with angiographic follow-up scheduled 6-12 months thereafter. Results: Hyperlipidemia was more prevalent in the NID patients, while Coronary Artery Bypass Grafting (CABG) and multi-vessel disease were found more prevalent in the ID group than NID (p-value < 0.05). One-month follow-up showed no variations in the frequency of in-hospital mortality, Q-wave MI, or vascular sequelae. On the other hand, the rate of Target Lesions Revascularization (TRL), Non-Target Lesions Revascularization (NTLR), Nonfatal MI, and Cardiac death were high in ID patients. Conclusion: DES deployment, in comparison to coronary restenosis (ISR) following DES deployment, which remained considerably more prevalent in individuals with IDDM than in NIDDM patients, was observed to enhance angiographic and clinical results for IDDM and NIDDM patients. Long-term efficacy in those with IDDM was reduced due to an increased risk of revascularization.
Coronary angioplasty is a nonsurgical procedure used to treat the CAD. PCI has high risk factor and major complication like Stroke, ventricular arrhythmia, death [1, 2, 3]. Myocardial infarction characterized by increased levels of cardiac enzyme, and this may occur in about 30% of all PCI procedures [4, 5]. PCI can be done after ischemic heart diseases such as ST elevation MI, NSTEMI and stable angina [6, 7, 8]. Bare metal stent (BMS) provides mechanical frame work that prevent coronary arteries restenosis [9, 10]. PCI with stenting is superior over angioplasty alone without stenting [11]. DES including 5 drugs (umirolimus, zotarolimus, sirolimus, everolimus and paclitaxel) are coated with drugs, which release certain drugs over time [12]. Stent thrombosis (ST) occurs in 0.9% of patients [13, 14]. DES in comparison with BMS, DES is superior over BMS (decrease risk of restenosis) [15, 16, 17].
Diabetes mellitus (DM) has major risk factor for CAD and responsible for more than 80% of death in diabetics patients [18, 19, 20]. CAD can be treated by either by PCI or CABG but increased level of restenosis in patient with IDDM than NIDDM [21, 22, 23, 24, 25, 26]. PCI with BMS is associated with bad long-term outcomes and increased Insulin Secretion Rate (ISR) than in the NIDDM patients [27, 28]. PCI with DES with good antiplatelet are still significantly worse than for NIDDM [29, 30]. Diabetes mellitus is usually associated with high risk for thrombosis and atherosclerosis [31, 32, 33]. The fundamental hallmark of type 2 diabetes is resistance to insulin, which occurs before hyperglycemia develops, diabetes continues to be an important risk indicator for restenosis following BMS and DES implantation [34, 35].
A. Aim of Study
The goal of this study is to assess the outcomes of drug eluting stents in IDDM patients in compare to NIDDM with coronary artery disease.
The prospective study was occurred in the AL-Najaf Cardiac Center between September 20, 2013, and Dec 31, 2014, A total of 53 insulin dependent diabetic patients (insulin alone or insulin plus oral hypoglycemic drug) and non-insulin dependent diabetic patients who underwent PCI with deployment of at least one DES in native coronary arteries. The patients were divided into 2 groups:18 patients IDDM and 35 NIDDM patients. Inclusion criteria; Stable angina and acute coronary syndrome including (STEMI, NSTEMI) and left main stem (LMS) or 3 vessels who refuse CABG or unfit for surgery. While the exclusion criteria include patients with hemorrhagic diathesis, significant comorbidity conditions, and patients with noncompliance to medication.
A. Coronary Stent Procedure
The coronary intervention was carried out using normal procedures. All patients were received aspirin (100mg once daily and Plavix tab 75mg once daily for one year). Angiographic success was defined as the achievement of residual stenosis of \(\leq\)20%, associated with TIMI3 flow, in the absence of a dissection.
B. Follow Up
Clinical follow up was scheduled at immediate 1, 6 and 12 months after PCI, and coronary Angio follow-up was scheduled at 6, 12 months post-procedure. The primary outcome was the incidence of major cardiac events such as all-cause mortality, non-fatal MI, and TLR. Secondary outcomes were cerebrovascular accident (CV), stent thrombosis (ST), and Non-Target Lesions Revascularization (NTLR). TRL refers to a repeated PCI to treat coronary stenosis greater than 70% within the stent; NTLR refers to a procedure in another lesion owing to disease progression.
C. Statistical Analysis
We were comparing frequencies and proportions, the Chi-square test was utilized, and the Fisher’s exact test was employed when the chi square test was inapplicable. To be deemed as a significant difference or correlation, the degree of significant (P. value was 0.05). IBM SPSS Statistics, Version 22.0. Armonk, NY: IBM Corp; 2013.
A. Demographic Characteristics
Our study showed that the hyperlipidemia was significantly more prevalent in the NID group (91% vs 66.1% p-value=0.02), while the history of CABG was more common in ID group than NID group (16% vs 2% p-value 0.07). our data showed that insignificant difference (p\(>\)0.05) between ID and NID according to hypertension, smoking, previous MI, and PVD. Additionally, our data showed that multi-vessels disease more prevalent in IDDM group (88%vs 62%). (p-value=0.045) while single vessel disease was in IDDM & NIDDM group (11% vs 8%). as shown in Table 1
Demographic characteristics | ID (n=18) | NID (n=35) | P Value |
---|---|---|---|
Age | 39.3 ± 10.1 | 64.8 ± 9.6 | <0.001 |
Male gender | 15 (83%) | 28 (80.3%) | 0.78 |
Hypertension | 14 (77.3%) | 22 (62.4%) | 0.27 |
Hyper cholesterol | 12 (66.1%) | 32 (91%) | 0.023 |
Current smoking | 9 (50.1%) | 25 (71.2%) | 0.12 |
Previous MI | 7 (38%) | 15 (42.6%) | 0.77 |
PVD | 3 (16%) | 2 (5%) | 0.064 |
CVA | 0 | 0 | NA |
History of CABG | 3 (16%) | 1 (2%) | 0.071 |
Single vessels | 2 (11.3%) | 3 (8.2%) | 0.56 |
2-3 vessels | 16 (88%) | 22 (62%) | 0.045 |
B. Clinical Follow Up
Short term follows up: short term follows up (up to one months) revealed that no significant variations of inhospitable mortality, Q wave MI, or vascular sequelae. In either group, there were no PCI STEMI. IDDM patients had a higher rate of non-Q MI (P=0.04) Table 2.
Clinical follow up | ID (n=18) | NID (n=35) | P Value |
---|---|---|---|
Procedural success | 17 (95%) | 33 (93%) | 0.69 |
Post PCI STEMI | 0 | 0 | NA |
Post PCI NSTEMI | 3 (15%) | 0 | 0.044 |
Stent Thrombosis | 0 | 0 | NA |
Death | 0 | 0 | NA |
Long term follows up: long term follows up (up to 12 months) revealed that there was significant excess cardiac death of PCI, nonfatal MI, and both TRL and NTRL outcomes in IDDM group as compared with NIDDM (p\(<\)0.05). While there is insignificant difference (p\(>\)0.05) in CVA between both groups (Table 3).
Clinical follow up | ID (n=18) | NID (n=35) | P Value |
---|---|---|---|
TLR | 3 (16%) | 0 | 0.012 |
NTLR | 5 (27.2%) | 2 (5%) | 0.023 |
Nonfatal MI | 5 (27%) | 2 (5%) | 0.022 |
CVA | 1 (5.3%) | 0 | 0.20 |
Cardiac death | 2 (11%) | 0 | 0.047 |
In this study, we compared clinical & angiographic one year follow up in IDDM & NIDDM groups. The results revealed that IDDM patients had worse outcome after PCI, and reduced one-year cumulative MACE free survival rate, in compared with NIDDM. In our study we found that after 12 month follow up, there was high rate of cardiac death, nonfatal MI, and both TLR and NTRL in IDDM patients although, in diabetic individuals, PCI with DES may minimize the possibility of restenosis and TLR [36, 37]. The significant probability of failure following PCI in diabetic individuals with coronary artery disease was caused by one of two mechanisms: restenosis or disease progression. These mechanisms are influenced by metabolic dysregulation caused by persistently elevated blood sugar and insulin resistance. As in the Greek trial, only diabetes was a distinct risk indicator for angiographic re stenosis following sirolimus eluting stent insertion [38, 39, 40, 41].
In a recent real-world multicenter registry, IDDM patients exhibited no benefit after DES implantation, but NIDDM showed significant reductions in the 2 years that’s relative risk of severe serious cardiac events and TVR [42, 43, 44, 45]. As previously reported, the SIRIUS trial research unable to demonstrate benefit with sirolimus eluting stent usage in a subset of IDDM patients [46, 47]. Similarly, insulin therapy was an independent risk factor for TLR in the EVASTENT matched-cohort registry [48, 49, 50]. In addition, the DIABETES experiment found that each of the NIDDM and IDDM patients required recurrent PCI revascularization [51, 52, 53].
There was a substantial difference in the frequency of mortality among the two groups in the current investigation. At a 2-year follow-up, Ortolani et al identified IDDM as a separate predictive of all cause’s death/acute MI [54]. STEMI is still a serious problem following DES placement, particularly in diabetic individuals [55, 56, 57]. There were no noteworthy variations in the occurrence of ST among individuals who received insulin or oral medications in this investigation. In general, ST is an uncommon issue, and our research may have been underpowered to show such differences. Although the total ST rate in both groups was equal in our research, more people with IDDM than NIDDM patients had late ST. IDDM was a distinct risk indicator for ST at one year in the Cypher registry.
Even though, PCI with in both IDDM and NIDDM patients, DES implantation was observed to enhance angiographic and clinical results. But coronary artery restenosis still higher in IDDM than NIDDM, therefore the long-term outcome is need in IDDM than NIDDM .
None.
No conflicts of interest have been declared by the authors.