European Journal of Cardiovascular Medicine

Diabetes mellitus is considered as a health emergency worldwide as it affects nearly 451 million subjects globally and the number of affected subjects is considered to increase by 693 million by the end of year 2045. Diabetes is considered as one of the most prominent risk factors for coronary heart disease. Subjects with diabetes are at 10-fold higher risk of coronary artery involvement compared to subjects without diabetes along with more diffuse and complex patterns of coronary artery lesions. Coronary artery disease is presently the biggest reason for death in diabetics and diabetes was also considered as predictor for cardiac death.¹

Surgical and percutaneous revascularization are most commonly used management modality for coronary artery disease. In more than 25% of subjects that undergo PCI (percutaneous coronary intervention) are diabetics. Repeated revascularization and long-term mortality following percutaneous coronary intervention has also been considered in diabetic subjects. BMs or bare metal stents have been used in percutaneous coronary intervention for many years, however, recently, it has been seen that with introduction of DESs (drug-eluting stents) along with advantage of reduce rates of restenosis. Also, subjects with coronary artery disease and diabetes have been shown to have welfare from DES implantation compared to bare metal alone.²

Complexity of the lesions also play a vital role in post percutaneous coronary intervention clinical events occurrence. Size of the stent along with its diameter and length is a relative parameter to represent the complexity of the lesion. Using the long stents usually represents a more complex lesion and poor associated clinical outcome. However, few studies report that clinical outcomes are independent for the size of the stent.³

There is enough supporting data to suggest the beneficial effect of glycemic control in reducing the microvascular complications. However, it is still unclear if glycemic control can improve the clinical outcomes and decrease the microvascular complications in subjects with diabetes. Existing literature data is limited concerning the effects of glycemic control following percutaneous coronary intervention which has more value compared to preprocedural glycemic control considering the incidence for adverse events.⁴ Hence, the present study was aimed to assess the probable relationship in clinical outcomes and varying stent sizes following PCI (Percutaneous Coronary Intervention) in subjects with diabetes mellitus manages using DAPT (dual antiplatelet therapy) and DESs (drug-eluting stents).

The present clinical study was aimed to assess the probable relationship in clinical outcomes and varying stent sizes following PCI (Percutaneous Coronary Intervention) in subjects with diabetes mellitus manages using DAPT (dual antiplatelet therapy) and DESs (drug-eluting stents). The study was done at Department of Cardiology, BMRC Hospital, Barrackpore Trunk Rd, Talpukur, Titagarh, Barrackpore, West Bengal in the period between May 2024 to May 2025. Verbal and written informed consent were taken from guardians/parents of all the subjects before study participation.

The study included subjects that underwent elective Percutaneous Coronary Intervention for stable coronary artery disease in the defined study period. In subjects with coronary artery disease, the exclusion criteria for the study were subjects with acute coronary syndromes, atrial fibrillation, and multivessel disease. Percutaneous Coronary Intervention was done using the standard drug-eluting stents. The criteria for angioplasty were minimum 75% narrowing in left circumflex, diagonal, left anterior descending, posterior left ventricular, posterior descending, right coronary, and obtuse marginal branch arteries. Depending on the availability, first generation of drug-eluting stents such as paclitaxel-eluting stent and sirolimuseluting stent or the second-generation DESs as everolimus-eluting stent and zotarolimus-eluting tent were used.

Diabetes was considered as fasting plasma glucose level of 126mg/dl or more, 2-hour plasma glucose level of ≥200 mg/dl during oral glucose tolerance test, A1c level of 6.5% or more, anti-diabetic medication use, and random plasma glucose level of ≥200 mg/dl.⁵ Hypertension was considered for minimum systolic and diastolic blood pressure of ≥130 mmHg and ≥80 mmHg respectively and subjects on antihypertensive agents before PCI.⁶ Subjects on antihyperlipidemic medications or hyperlipidemia were considered as hyperlipidemic. Subjects on any type or amount of smokables before PCI or minimum 1 cigarette per day were considered as smokers. All the subjects were followed for cardiovascular death, repeated revascularization (PCI or coronary artery bypass grafting), and/or myocardial infarction which was defined as MACE (major adverse cardiac events).

All the subjects visited the Institute for follow-up visit. In subjects that were non-compliant, subjects were assessed telephonically. Data were collected in a preformed structured proforma. At follow-up, diabetics were assessed under direct supervision of endocrinologist to closely monitor the glycemic status. Medical therapy type as injectable or oral with or without change in the diet was customed and individualized. The time from PCI to earliest MACE was taken as time to event. Age was considered as age of subjects at PCI time. Diameter and length of the stent were depicted in nominal value.

Aspirin (325 mg) and clopidogrel (600 mg) were given before PCI and was continued as Aspirin (325 mg) and 150 mg clopidogrel for 3 weeks⁷ followed by 80 mg clopidogrel (160 mg in diabetics) for minimum 1 year in non-diabetics and 2 years for diabetics. Also, atorvastatin as 40-80 mg dose was given to all the subjects. Heparin as 80-100 mg/kg were given to all the subjects with PCI. All subjects were monitored closely via periodic recall visits. Any subject that had MACE was considered as a case.

The data gathered was subjected to statistical evaluation using the chi-square test, Fisher’s exact test, Mann Whitney U test, and SPSS (Statistical Package for the Social Sciences) software version 24.0 (IBM Corp., Armonk. NY, USA) using ANOVA, chi-square test, and student's t-test. The significance level was considered at a p-value of <0.05.

The present clinical study was aimed to assess the probable relationship in clinical outcomes and varying stent sizes following PCI (Percutaneous Coronary Intervention) in subjects with diabetes mellitus manages using DAPT (dual antiplatelet therapy) and DESs (drug-eluting stents). The study screened 3260 subjects where diabetes mellitus was seen in 944 subjects that were retrospectively assessed within the defined study period. MACE (major adverse cardiac events) was considered as combined endpoint of cardiovascular death, myocardial infarction, and revascularization. There were significantly higher number of females in subjects without diabetes compared to diabetics with p<0.001. Also, hypertension and hyperlipidemia were more common in non-diabetes mellitus subjects compared to subjects with diabetes mellitus significantly with p<0.001. The difference was non-significant for age, smoking, MACE, event time, stent diameter, and stent length with p=0.317, 0.08, 0.455, 0.547, 0.208, and 0.499 respectively (Table 1).

Table 1: Comparison of demographic data in two groups of study subjects with or without diabetes mellitus

It was seen that for comparison of various parameters in subjects with and without diabetes mellitus, Odd’s ratio for gender was 1.45 with 95% CI (confidence interval) of upper and lower limit of 1.87 and 1.13 which was significant with p=0.001. Similar significant results were seen for mean age, hyperlipidemia, and hypertension with p=0.02, <0.001, and 0.01 respectively. However, results were non-significant for amoking, MACE, stent number, stent diameter, and stent length with p=0.947, 0.275, 0.775, 0.257, and 0.331 respectively (Table 2). 

Table 2: Comparison of various parameters in subjects with and without diabetes mellitus

The study results showed that for distribution of study subjects with diabetes based on the presence of MACE, the mean age was significantly higher in subject without MACE compared to subjects with MACE with p=0.01. Also, smoking and hyperlipidemia was significantly higher in subjects without MACE compared to subjects with MACE with p=0.007 and 0.04 respectively. The results were non-significant for male gender, hypertension, stent number, stent diameter, and stent length with p=0.31, 0.271, 0.775, 0.422, and 0.527 respectively (Table 3).

Table 3: Distribution of study subjects with diabetes based on the presence of MACE

On assessing the occurrence of MACE in diabetic and non-diabetic subjects with varying stent size, in subjects without diabetes mellitus, diameter of >3mm and diameter of ≤3mm were non-significant in subjects with and without MACE with p=0.805. For length of the stent in study subjects without diabetes mellitus, length of >27 mm and ≤27 mm was significantly higher in subjects without MACE with p=0.02. In subjects with diabetes mellitus, no significant difference was seen for any diameter or length of the stent used with p=0.571 for diameter and 0.191 for length (Table 4).

Table 4: Occurrence of MACE in diabetic and non-diabetic subjects with varying stent size

The present study screened 3260 subjects where diabetes mellitus was seen in 944 subjects that were retrospectively assessed within the defined study period. MACE (major adverse cardiac events) was considered as combined endpoint of cardiovascular death, myocardial infarction, and revascularization. There were significantly higher number of females in subjects without diabetes compared to diabetics with p<0.001. Also, hypertension and hyperlipidemia were more common in non-diabetes mellitus subjects compared to subjects with diabetes mellitus significantly with p<0.001. The difference was non-significant for age, smoking, MACE, event time, stent diameter, and stent length with p=0.317, 0.08, 0.455, 0.547, 0.208, and 0.499 respectively. These data were comparable to the previous studies of Fukutomi et al⁸ in 2019 and Konigstein M et al⁹ in 2018 where authors assessed subjects with demographic data comparable to the present study in their respective studies.

The study results showed that for comparison of various parameters in subjects with and without diabetes mellitus, Odd’s ratio for gender was 1.45 with 95% CI (confidence interval) of upper and lower limit of 1.87 and 1.13 which was significant with p=0.001. Similar significant results were seen for mean age, hyperlipidemia, and hypertension with p=0.02, <0.001, and 0.01 respectively. However, results were non-significant for amoking, MACE, stent number, stent diameter, and stent length with p=0.947, 0.275, 0.775, 0.257, and 0.331 respectively. These results were consistent with the findings of Rawshani A et al¹⁰ in 2018 and Bryne RA et al¹¹ in 2018 where results reported by authors in their studies were comparable to the results of the present study.

It was seen that for distribution of study subjects with diabetes based on the presence of MACE, the mean age was significantly higher in subject without MACE compared to subjects with MACE with p=0.01. Also, smoking and hyperlipidemia was significantly higher in subjects without MACE compared to subjects with MACE with p=0.007 and 0.04 respectively. The results were non-significant for male gender, hypertension, stent number, stent diameter, and stent length with p=0.31, 0.271, 0.775, 0.422, and 0.527 respectively. These findings were in agreement with the results of Messerli A et al¹² in 2018 and Wang JL et al¹³ in 2018 where distribution of study subjects with diabetes based on the presence of MACE comparable to the present study were also reported by the authors in their respective studies.

Concerning the assessment of the occurrence of MACE in diabetic and non-diabetic subjects with varying stent size, in subjects without diabetes mellitus, diameter of >3mm and diameter of ≤3mm were non-significant in subjects with and without MACE with p=0.805. For length of the stent in study subjects without diabetes mellitus, length of >27 mm and ≤27 mm was significantly higher in subjects without MACE with p=0.02. In subjects with diabetes mellitus, no significant difference was seen for any diameter or length of the stent used with p=0.571 for diameter and 0.191 for length. These results correlated with the findings of Martinez-Parachini JR et al¹⁴ in 2017 and Koskinas KC et al¹⁵ in 2016 where occurrence of MACE in diabetic and non-diabetic subjects with varying stent size reported by the authors was comparable to the results of the present study.

Considering its limitations, the present study concludes that diabetes did not affect MACE significantly. Also, varying size of the stents was not associated with MACE in diabetics. The study results suggest that using the drug-eluting stents along with long-term dual antiplatelet therapy and good glycemic control following PCI can decrease the adverse effects of diabetes.

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