|Year : 2020 | Volume
| Issue : 1 | Page : 47-52
Evaluation of baseline hemoglobin levels and creatinine clearance as independent prognostic factors for patients undergoing primary percutaneous coronary intervention
Sharad Chandra1, Birendra Kumar2, Pravesh Vishwakarma1, Sudhanshu K Dwivedi1, Rishi Sethi1, Akshyaya Pradhan1, Gaurav Chaudhary1, Akhil Sharma1, Monika Bhandari1, Varun S Narain1
1 Department of Cardiology, King George's Medical University, Lucknow, Uttar Pradesh, India
2 Department of Cardiology, Amrita Hospital, Patna, Bihar, India
|Date of Submission||16-Dec-2019|
|Date of Decision||23-Feb-2020|
|Date of Acceptance||20-Mar-2020|
|Date of Web Publication||17-Apr-2020|
Department of Cardiology, King George's Medical University, Chowk, Lucknow - 226 003, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
Objective: The objective is to evaluate the impact of baseline hemoglobin (Hb) levels and creatinine clearance (CrCl) levels in acute ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI). Methods: This was a single-center, prospective observational study conducted at a tertiary-care center in India. We enrolled 337 STEMI patients between November 2015 and December 2016. Patients were divided into four groups on the basis of baseline Hb and CrCl levels: Group-1: patients with normal Hb and normal CrCl (102 [30.2%]); Group-2: patients with low Hb and normal CrCl (78 [23.2%]); Group-3: patients with normal Hb and low CrCl (79 [23.4%]); and Group-4: patients with low Hb and low CrCl (78 [23.2%]). Results: The mean age group at presentation was 40–70 years. In-hospital complications were observed in 11 (10.8%) patients of Group-1, 11 (14.1%) patients of Group-2, 37 (46.8%) patients of Group-3, and 52 (66.7%) patients of Group-4, respectively (P = 0.03). Adverse events at 30-day follow-up were found to be higher in Group-4 (15 [19.2%] patients) followed by Group-3 (8 [10.1%] patients), Group-2 (4 [5.1%] patients), and Group-1 (2 [2%] patients), respectively (P = 0.01). Death was observed in one (1%) patient of Group-1, three (3.8%) patients of Group-2, five (6.3%) patients in Group-3, and eight (10.3%) patients of Group-4 (P = 0.03). Conclusion: Low Hb levels and CrCl levels in acute STEMI patients undergoing primary PCI were associated with increased risk of 30-day event rates.
Keywords: Anemia, creatinine, percutaneous coronary intervention, renal insufficiency, ST - elevation myocardial infarction
|How to cite this article:|
Chandra S, Kumar B, Vishwakarma P, Dwivedi SK, Sethi R, Pradhan A, Chaudhary G, Sharma A, Bhandari M, Narain VS. Evaluation of baseline hemoglobin levels and creatinine clearance as independent prognostic factors for patients undergoing primary percutaneous coronary intervention. J Pract Cardiovasc Sci 2020;6:47-52
|How to cite this URL:|
Chandra S, Kumar B, Vishwakarma P, Dwivedi SK, Sethi R, Pradhan A, Chaudhary G, Sharma A, Bhandari M, Narain VS. Evaluation of baseline hemoglobin levels and creatinine clearance as independent prognostic factors for patients undergoing primary percutaneous coronary intervention. J Pract Cardiovasc Sci [serial online] 2020 [cited 2020 May 27];6:47-52. Available from: http://www.j-pcs.org/text.asp?2020/6/1/47/282817
| Introduction|| |
Acute ST-segment elevation myocardial infarction (STEMI) is the most dramatic manifestation of coronary artery disease. Primary percutaneous coronary intervention (PCI) is the most effective therapy for the management of STEMI. Timely reperfusion therapy has proved to reduce the adverse events and increase the clinical outcomes in STEMI patients but, risk stratification is an important step in the evaluation of patients with STEMI. Previous studies have demonstrated that even after the administration of fibrinolysis, or primary angioplasty,, renal insufficiency and lower hemoglobin (Hb) levels are considered as an independent risk factor for short- and long-term mortality among patients with myocardial infarction (MI).,, A study in the U.S showed that low levels of Hb and creatinine clearance (CrCl) significantly increased the risk of death in STEMI patients.
Complete blood count and CrCl are the routine tests, which can be readily performed on the patient at initial presentation to the emergency and can be easily incorporated into risk stratification. There are only few studies about the effects of anemia and renal insufficiency on the prognosis of patients with acute STEMI undergoing primary PCI. We, therefore, sought to evaluate the impact of baseline Hb levels and CrCl on 30-day clinical outcomes in STEMI patients undergoing primary PCI.
| Methods|| |
Study design and patient population
This was a single-center, prospective observational study conducted in India between November 2015 and December 2016. We enrolled 337 STEMI patients aged 18–80 years, who got admitted to our tertiary-care center and were willing to undergo primary PCI within 12 h of onset of chest pain. Patients with chronic kidney disease, sensitive to aspirin and unable to take dual antiplatelet therapy for at least 3 months were excluded from the study. We considered a low Hb level as <10 g/dL and low CrCl as <90 mL/min/1.73 m2. Patients were divided into four groups on the basis of baseline Hb and CrCl, Group-1: patients with normal Hb and normal CrCl; Group-2: patients with low Hb and normal CrCl; Group-3: patients with normal Hb and low CrCl; and Group-4: patients with low Hb and low CrCl. The study was approved by the institutional ethics committee. All patients provided signed informed consent at the time of enrollment.
PCI was performed according to standard techniques through the femoral or radial artery in the cardiac catheter laboratory. After diagnostic angiogram, the type of stent implanted (bare metal stent or drug-eluting stent), type of wire used, thrombosuction, predilation or postdilation, and use of glycoprotein IIb/IIIa inhibitors were chosen at the discretion of the operator. Before the PCI, all patients were prescribed a loading dose of dual antiplatelet therapy including 325 mg aspirin and 60 mg prasugrel or 600 mg clopidogrel if prasugrel was contraindicated. Postprocedure, the arterial sheath was removed after 4–6 h. After discharge, all patients were prescribed to continue the optimal medical therapy which included dual antiplatelets, statins, beta-blockers, and angiotensin-converting enzyme inhibitors if they were not contraindicated.
Data collection and follow-up
All patients' baseline demographics, such as history of risk factors such as smoking, tobacco chewing, diabetes, and hypertension were collected. Before intervention, blood samples were collected to identify the baseline levels of Hb and CrCl. Patients were taken for primary PCI without waiting for baseline results. Serum creatinine was repeated 48 h postintervention to rule out any contrast-induced nephropathy (CIN). A brief history was recorded to rule out any contraindications to dual antiplatelet therapy. Clinical examinations were performed through echocardiography to exclude mechanical complications. Time from pain onset to hospital arrival window period (WP) and door-to-balloon (DTB) time were recorded. In case of multivessel disease, PCI was limited to infarct-related artery only. In-hospital complications (complete heart block [CHB], left ventricular failure [LVF], CIN, ventricular tachycardia/fibrillation [VT/VF], cardiogenic shock, thrombolysis in myocardial infarction [TIMI] flow, major bleeding, and stroke) and adverse events (death, reinfarction, and target lesion revascularization) were noted. Patients were followed up at 30 days for clinical outcomes (death, reinfarction, reintervention, and VT/VF) through outpatient visits or telephonic contact.
In the current study, STEMI was defined as angina or anginal equivalent lasting for >20 min with ST-segment elevation of ≥1 mm in ≥2 contiguous leads, or a new left bundle branch block, or a true posterior MI with ST depression of ≥1 mm in ≥2 contiguous anterior leads. Diabetes mellitus was considered as fasting blood glucose >126 mg/dL or on treatment. Systemic hypertension was defined as systolic blood pressure >140 mmHg and diastolic blood pressure >90 mmHg or on treatment. Time from hospital admission to establishment of infarct-related artery flow was estimated as the DTB time. During hospitalization, re-infarction was defined as recurrent chest pain or ischemic equivalent symptoms lasting >30 min and new electrocardiogram (ECG) changes consistent with reinfarction and the next creatine kinase-muscle brain/creatine kinase level measured approximately 8–12 h after the event should be at least 50% above the previous level or >3 times upper limit of normal value. Target lesion revascularization was defined as repeat PCI or bypass graft placement for restenosis at the lesion treated during the index PCI or occurring within 5 mm of the PCI site as determined clinically by the investigator at each site. Major bleeding was defined as the occurrence of any of the following: intracranial bleeding, intraocular bleeding, retroperitoneal bleeding, access-site hemorrhage requiring surgery/intervention, hematoma ≥5 cm in diameter at the puncture site without an overt source of bleeding, reduction in Hb concentration of >4 g/dL or with an overt source of bleeding reduction in Hb concentration of >3 g/dL and re-operation for bleeding or use of any blood product transfusion. CIN was defined as rise in serum creatinine of more than 0.5 mg/dL above the baseline value within 48 h of intervention.
Data were expressed as mean ± standard deviation for continuous variables and as counts and percentages for categorical variables. Categorical variables were compared using Chi-square test. Continuous variables were compared with analysis of variance test. A P < 0.05 was considered to be statistically significant. All statistical analyses were performed using Statistical Package for the Social Sciences 16.0 version (SPSS; Chicago, Illinois, USA).
| Results|| |
Total 337 STEMI patients were included in the study, of them 102 (30.2%) patients had normal Hb and normal CrCl levels, 78 (23.2%) patients had low Hb and normal CrCl levels, 79 (23.4%) patients had normal Hb and low CrCl levels and 78 (23.2%) patients had low Hb and low CrCl levels, respectively. The mean age at presentation was 40–70 years. The average age of Group-1, Group-2, Group-3, and Group-4 was 53.08 ± 11.45 years, 54.62 ± 12.14 years, 56.78 ± 13.01 years, and 57.8 ± 11.92 years, respectively (P = 0.06). Group-1 had younger patients whereas Group-4 had older patients. There was a male predominance in all groups (P = 0.48). Smoking was found to be the most common risk factor among all the groups (P = 0.03). Tobacco chewing was the second-most common risk factor among all the groups (P = 0.005). In Group-4, there was significantly higher prevalence of diabetes (31 [39.7%] patients) and hypertension (33 [42.3%] patients) as compared to the other groups (P = 0.003 and P = 0.01, respectively). In this study, most of the patients were diagnosed with anterior wall myocardial infarction (AWMI). AWMI patients were found to be more in Group-2 (50 [64.1%]) and Group-4 (47 [60.3%)] as compared to the other groups (P = 0.18). WP was found to be numerically higher in Group-4 (5.99 ± 3.67 h) patients (P = 0.48). In our study, only 14 (26.6%) of patients reached to hospital within 3 h of symptom onset. All consecutive 337 patients received dual antiplatelet treatment in which 190 (56.4%) patients were administered with clopidogrel and the remaining 147 (43.6%) patients were administered with prasugrel as a loading dose (P = 0.36). The left ventricular ejection fraction (LVEF)% was found to be higher in Group-1 patients (47.41% ± 4.51%) and lower in Group-4 patients (43.19% ± 4.15%) (P = 0.0001). Baseline demographic characteristics of the study population are shown in [Table 1].
In majority of the patients, the procedure was done through the right transfemoral access (232 [68.8%]) followed by the right transradial access (105 [31.2%]) and there was a statistical difference among all groups (P = 0.04). Left anterior descending was the most common infarct related artery in all the groups compared to the other culprit vessels (P = 0.001). DTB of 30–50 min was observed in 35%–38% patients from all groups (P = 0.11). The mean diameter of stent was 2.93 ± 0.31 mm in Group-1, 3.24 ± 2.56 mm in Group-2, 2.96 ± 0.27 mm in Group-3 and 2.89 ± 0.47 mm in Group-4 patients (P = 0.33). The mean length of stent was 27.47 ± 9.63 mm in Group-1, 24.93 ± 9.51 in Group-2, 27.25 ± 10.62 in Group-3 and 25.16 ± 8.75 in Group-4 patients (P = 0.19). Postdilation was done more frequently in Group-4 (24 [30.8%]) patients (P = 0.01). Mean contrast volume used during procedure was 110 + 45 ml in Group-1, 100.5 + 55.5 ml in Group-2, 126 + 52 ml in Group-3 and 98 + 66 ml in Group-4.(P = 0.46). Group IIb/IIIa inhibitors such as eptifibatide bolus was used more in Group-4 (50 [64.1%]) patients, eptifibatide infusion was used more in Group-2 (15 [19.2%]) patients and tirofiban infusion was used more in Group-3 (10 [12.7%]) patients (P = 0.03). TIMI II and TIMI III flow was achieved more frequently in Group-4 (18 [23.1%]) and Group-1 (99 [97.1%]) patients, respectively (P = 0.36). Procedural characteristics of the study population are displayed in [Table 2].
The in-hospital complications were observed in 11 (10.8%) patients of Group-1, 11 (14.1%) patients of Group-2, 37 (46.8%) patients of Group-3 and 52 (66.7%) patients of Group-4, respectively (P = 0.03). Of the 52 patients belonging to Group-4, two (2.6%) patients had coronary artery bypass graft, four (5.1%) patients had CHB, two (2.6%) patients had cardiogenic shock, eight (10.3%) patients had cardipulmonary resuscitation (CPR), six (7.7%) patients died, seven (9%) patients had LVF, eight (10.3%) patients had hypotension, and five (6.4%) patients had VT/VF, respectively. Ten (12.8%) patients developed CIN in Group-4 but fortunately none of them required hemodialysis. Comparison of in-hospital complications among the groups is demonstrated in [Table 3].
Adverse events at 30-day follow-up were found to be more in Group-4 (15 [19.2%]) patients followed by Group-3 (8 [10.1%]), Group-2 (4 [5.1%]) and Group-1 (2 [2%]) patients (P = 0.01). Death was observed in one (1%), three (3.8%), five (6.3%), and eight (10.3%) patients of Group-1, Group-2, Group-3 and Group-4, respectively (P = 0.03). In Group-4, one (1.3%) patient had re-infarction and one (1.3%) patient had undergone re-intervention. VT/VF was observed in one (1%) patient of Group-1, one (1.3%) patient of Group-2, three (3%) patients of Group-3, and five (6.4%) patients of Group-4. Outcomes at 30-day follow-up of the study population are shown in [Table 4].
| Discussion|| |
The main finding of this study showed that in STEMI patients undergoing primary PCI, the combination of laboratory predictors of mortality provided a powerful tool for risk assessment. We found a statistically significant increase in 30-day mortality in patients with Hb concentrations <10 g/dL and CrCl <90 mL/min compared to the other patients. We believe that this information if added to the current practice can help risk stratify this subset of patients better, though larger studies will be needed to substantiate our findings.
Renal dysfunction and anemia were reported in patients above the age of 45 years., In the same way, majority of our patients belongs to the age group of 40–70 years, which is similar to the data obtained from the earlier studies.,,, In our study, 156 (46.2%) patients had low Hb levels and 157 (46.5%) patients had low creatinine levels which is comparable to the data obtained from Lee et al. and Gibson et al.'s study. Anemia and renal insufficiency is also associated with a significantly increased prevalence of baseline comorbidities such as hypertension, diabetes, and are the independent risk factors of cardiovascular disease.,, In the same way, Group-4 patients were associated with a higher prevalence of diabetes (31 [39.7%] patients, P = 0.003), hypertension (33 [42.3%] patients, P = 0.01), smoking (42 [53.8%] patients, P = 0.03), and tobacco chewing (46 [59%] patients, P = 0.005) and all these factors were significantly different when compared with the other Groups. These results were similar to the data obtained from previous studies.,,
A study conducted by Subban et al. showed that about half of the population were diagnosed with AWMI which is similar to our study showing 53.9% in Group-1, 64.1% in Group-2, 51.9% in Group-3, and 60.3% in Group-4. The mean WP was 5.19 ± 3.40 h in Group-1, 5.40 ± 3.35 h in Group-2, 5.67 ± 3.71 h in Group 3 and 5.99 ± 3.67 h in Group-4 which is similar to 300 min in CREATE registry. In a study conducted by Dilu et al. it was shown that only 47.8% of patients reached the hospital within 6 h of symptom onset while in the Kerala registry around 60% of patients reached within 6 h. In our study, only 26.6% patients reached to hospital within 3 h of symptom onset because the delay in reaching the hospital in our country is multifactorial. It includes delay in recognition of chest symptom by patients themselves, unavailability of ECG machine at peripheral health care centers, poor ambulance, and transportation services.
A study by Subban et al. showed that LVEF was 41.7% ± 20.8% which is similar to our study showing the LVEF% difference of 43.19 ± 4.15–47.41 ± 4.51 and shows a statistical difference between all the groups (P = 0.0001). According to the study results, LVEF was significantly related to CrCl and Hb levels which was not indicated in studies by Cakar et al. and Santopinto et al. Majority of the patients had DTB time of 51–70 min which is similar to the study conducted by Subban et al. showing the mean DTB time of 65 min.
Similar to the previous studies,,, lower Hb and CrCl levels increased the risk of intra-hospital death. In the same way, patients with other complications also had lower Hb and CrCl levels that could lead to death. Adverse events at 30 day follow-up were found to be more in Group-4 (19.2%) patients and were statistically significant among all the groups (P = 0.01). Subban et al. showed re-infarction of 1.6% which is comparable to our study showing that only one patient (1%) in Group-4 had re-infarction. In this study, only one (1%) patient from Group-4 patients had to undergo re-intervention and none other groups witnessed re-infarction and re-intervention. VT/VF was observed in one (1%) patient of Group-1, one (1.3%) patient of Group-2, three (3.8%) patients of Group-3, and five (6.4%) patients of Group-4. Death was found to be more in Group-4 (8 [10.3%]) patients. This mortality rate is closer to the results obtained from the earlier studies., Another study by Agrawal et al. showed significantly increased major adverse events (death, reinfarction, reintervention, and ventricular arrhythmia) in patients undergoing primary PCI who had both anemia and deranged CrCl as compared to patients having none of these derangements (51.66% vs. 6.8%).
Low levels of Hb were observed more in older patients, which can be due to nutritional deficiencies or chronic diseases and among females probably due to iron deficiency due to menstruation, pregnancy and childbirth. Even mild changes in these values can lead to a higher risk of death. Similar to the previous studies,,,, the current study findings revealed that low Hb levels and low CrCl were strongly associated with intra-hospital death in STEMI patients. Moreover, low Hb and CrCl levels of the patients were associated with cardiovascular risk factors including hypertension, diabetes, smoking, and tobacco chewing. Significantly larger number of patients in Group-3 and 4 suffered CIN (13.9% and 12.8%, respectively) despite a nonsignificant difference in contrast volume used. These parameters may also play role in the clinical outcomes of the patients. Thus, a larger study including a greater number of patients and longer follow-up may be required to indicate this association.
There are some limitations to our analysis. This is a small study with small number of patients conducted at a single center. It is possible that adverse events were confounded by other baseline characteristics associated with both low Hb levels and low CrCl levels. And also, being a short-term study where parameters were assessed at enrollment and at 30 days, it is not possible for us to comment on possible mechanisms relating to short-term mortality.
| Conclusion|| |
This study concluded that acute STEMI patients with low Hb levels and impaired CrCl undergoing primary PCI were associated with increased risk of 30-day event rates. Low Hb and low CrCl levels are the independent risk factor of 30-day event rate.
The study is approved by the institutional ethics committee.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]