|Year : 2018 | Volume
| Issue : 4 | Page : 127-132
Baseline hemoglobin and creatinine clearance as independent risk factors for 30-day event rate in patients of acute ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention
Richa Agrawal, RK Nath, Neeraj Pandit, Ajay Raj
Department of Cardiology, PGIMER and Dr. Ram Manohar Lohia Hospital, New Delhi, India
|Date of Web Publication||17-Dec-2018|
Dr. Richa Agrawal
No. 39, Avas Vikas Colony, Civil Lines, Pili Kothi, Moradabad - 244 001, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
Background: Primary percutaneous coronary intervention (PCI) is the most effective therapy for managing acute ST-segment elevation myocardial infarction (STEMI). Studies have shown baseline low hemoglobin (Hb) and reduced creatinine clearance (CrCl) as risk factors for adverse outcomes in patients with heart failure, in patients undergoing PCI, and in acute coronary syndrome. However, their similar role in patients of acute STEMI undergoing primary PCI is not known.
Objective: The main objective is to study whether baseline Hb and CrCl are the independent risk factors for the 30 days event rate in patients of acute STEMI undergoing primary PCI.
Methods: We prospectively studied 500 patients of acute STEMI undergoing primary PCI. Hb and CrCl were measured at baseline and then at 15th and 30th day after the event. Patients were divided into four groups based on whether they have normal or abnormal baseline Hb and CrCl. Patients were followed for 30-day postdischarge for incidence of major adverse events in the form of death, reinfarction, reintervention, and hemodynamically unstable ventricular tachyarrhythmias. We assessed correlation between baseline Hb, CrC, l and 30-day event rate among four groups using Chi-square test.
Results: On comparison among groups, compared to Group 1, Group 2, 3, and 4 had significantly higher adverse events ([6.48% vs. 19.44%] [P = 0.021]), ([6.48% vs. 30%] [P = 0.0003]), ([6.48% vs. 51.66%] [P ≤ 0.0001]), respectively, at 30 days after primary PCI.
Conclusion: In patients of acute STEMI undergoing primary PCI, both baseline impaired CrCl and low Hb behaved independently as risk factors for increased 30-day event rates.
Keywords: Creatinine clearence, hemoglobin, percutaneous coronary intervention, ST-elevation myocardial infarction
|How to cite this article:|
Agrawal R, Nath R K, Pandit N, Raj A. Baseline hemoglobin and creatinine clearance as independent risk factors for 30-day event rate in patients of acute ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. Heart India 2018;6:127-32
|How to cite this URL:|
Agrawal R, Nath R K, Pandit N, Raj A. Baseline hemoglobin and creatinine clearance as independent risk factors for 30-day event rate in patients of acute ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. Heart India [serial online] 2018 [cited 2019 May 27];6:127-32. Available from: http://www.heartindia.net/text.asp?2018/6/4/127/247572
| Introduction|| |
Acute ST-segment elevation myocardial infarction (STEMI) has high morbidity and mortality and timely reperfusion by primary percutaneous coronary intervention (PCI) is the most effective therapy for its management. Risk stratification is of utmost importance for better patient outcome. Anemia worsens myocardial ischemia in acute MI, both by decreasing the oxygen content of the blood supplied to the jeopardized myocardium and by increasing myocardial oxygen demand., Numerous studies have shown that comorbidities such as anemia and reduced baseline creatinine clearance (CrCl) adversely affect cardiovascular events in heart failure,,,, in patients undergoing PCI,, and in acute coronary syndrome.,,,,,,, Yet, little information is available about the effects of baseline low hemoglobin (Hb) and altered CrCl on the 30-day event rate in patients of acute STEMI undergoing primary PCI. Therefore, the present study was undertaken to evaluate whether low Hb and reduced CrCl at presentation leads to increased adverse outcomes at 30 days in patients presenting with acute STEMI undergoing primary PCI.
| Methods|| |
This was a prospective, observational study conducted in patients of acute STEMI undergoing primary PCI in the Department of Cardiology, PGIMER, and Dr. Ram Manohar Lohia Hospital, New Delhi, from November 1, 2015 to July 31, 2017. Informed written consent was obtained from all the participants. The study protocol was approved by Institutional Ethical Committee.
All patients between 18 and 80 years of age presented with acute STEMI undergoing primary PCI were screened to enroll in the study. Exclusion criteria included known case of chronic kidney disease with glomerular filtration rate <60 ml/min/1.73 m2, bleeding diathesis or active or recent (<3 months) bleeding episodes. Criteria for acute MI was defined according to the third universal definition of MI given by the American Heart Association. After history, physical examination, ECG, and echocardiography, blood sample was taken to know baseline Hb and CrCl from eligible patients before shifting them for primary PCI. Low Hb was defined as <10 g/dl and impaired CrCl as <60 ml/min/1.73 m2. CrCl was measured by Cockcroft–Gault formula. Routine blood investigations were also sent. All patients were loaded with 325 mg of aspirin, 600 mg clopidogrel or 60 mg prasugrel, or 180 mg ticagrelor and 80 mg of atorvastatin. In case of multivessel disease, PCI was limited to infarct-related artery only. Time from pain onset to hospital arrival and door-to-balloon time were recorded. At the time of discharge, all the patients continued on optimal medical therapy which included dual antiplatelets, statin, beta-blocker, angiotensin-converting enzyme inhibitor if not contraindicated, and a proton pump inhibitor (PPI).
Data collection and end points
Patients were divided into four groups based on whether they had normal baseline Hb and CrCl (Group 1), low Hb and normal CrCl (Group 2), normal Hb and impaired CrCl (Group 3), and both low Hb and impaired CrCl (Group 4). Demographic variables such as age, gender, and risk factors (e.g. smoking, diabetes, hypertension) were noted for each patient. In-hospital complications (persistent complete heart block, left ventricular failure, cardiogenic shock, ventricular tachycardia [VT] or ventricular fibrillation [VF], reinfarction, reintervention, death) if any were noted. All the study patients were asked to visit the outpatient department on 15th and 30th day after discharge in a special post-PCI clinic. Blood samples for Hb and CrCl were also taken in those visits. Patients were followed up for 30 days after discharge to know the endpoints in the form of death, reinfarction, reintervention, and VT/VF. The term “reinfarction” was defined as an acute MI that occurs within 28 days of the primary event or recurrent MI characterized by the recurrence of ST elevation ≥0.1 mV or appearance of new pathognomonic Q wave in at least two contiguous leads, particularly when associated with ischemic symptoms for 20 min or longer. Reintervention was defined as repeat PCI or bypass graft placement for reocclusion at the lesion treated during index PCI. Telephonic inquiry was made if a patient missed his/her appointment and asked about adverse events if not able to come on a follow-up visit. Patients were subjected to continuous long-term follow-up subsequently.
Categorical variables were presented in number and percentage (%) and continuous variables were presented as mean ± standard deviation and median. Normality of data was tested by Kolmogorov–Smirnov test. If the normality was rejected then nonparametric test was used.
Statistical tests were applied as follows:
- Quantitative variables were compared using ANOVA/Kruskal–Wallis test (for nonparametric data) between four groups and for post hoc comparison, Unpaired t-test/Mann–Whitney test (when the datasets were not normally distributed) was used
- Qualitative variables were compared using Chi-square test/Fisher's exact test.
P < 0.05 was considered statistically significant. The data were entered in MS Excel Spreadsheet and analysis was done using Statistical Package for the Social Sciences (SPSS) version 21.0 (IBM, Chicago, USA).
| Results|| |
A total of 542 acute STEMI patients undergoing primary PCI were screened for this study, out of which 503 patients were enrolled in the study after satisfying the inclusion and exclusion criteria. These patients were followed up for a period of 30-day postdischarge. Three patients were lost to follow-up. Final data analysis was done for 500 patients divided into four groups who completed the study.
[Table 1] compares the baseline characteristics of four groups. Majority of patients were of more than 50 years age and males. Traditional coronary artery disease risk factors were significantly more frequent in patients with low Hb and low CrCl as compared to those having both normal Hb and CrCl (P < 0.05). [Table 2] compares the clinical, angiographic, and angioplasty details among the four groups. Majority of patients in all the four groups presented with anterior wall MI with single-vessel disease with left anterior descending coronary artery being the most culprit infarct-related artery.
|Table 2: Comparison of clinical, angiographic, and angioplasty details among the four groups|
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At 30-day follow-up among the groups, 3 patient out of 180 (1.66%) in Group 1, 5 patient out of 120 (4.16%) in Group 2, 7 patient out of 100 (7.0%) in Group 3, and 13 patient out of 100 (13.0%) in Group 4 died (P = 0.0009). Reinfarction occurred in 2 (1.11%), 7 (5.83%), 6 (6.0%), and 12 (12.0%) in Group 1, Group 2, Group 3, and Group 4, respectively (P = 0.002). Reintervention occurred in 2 (1.11%), 5 (4.16%), 5 (5.0%), and 11 (11.0%) in Group 1, Group 2, Group 3, and Group 4, respectively (P = 0.002). VT/VF occurred in 5 (2.77%), 6 (5.0%), 7 (7.0%), and 16 (16%) in Group 1, Group 2, Group 3 and Group 4, respectively (P = 0.0003). Total adverse events occurred in 12 (6.6%), 23 (19.16%), 25 (25%), and 52 (52.0%) in Group 1, Group 2, Group 3, and Group 4, respectively (P < 0.0001). [Table 3] shows 30 days comparison of adverse events among four groups.
|Table 3: Comparison of adverse events at 30-day follow-up among four groups|
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On comparison among groups, compared to Group 1, Group 2, 3, and 4 had significantly higher adverse events ([6.6% vs. 19.16%] odds ratio [OR] =15.167, 95% confidence interval [CI] = 7.495–30.692, P < 0.0001), ([6.6% vs. 28%], OR = 4.667, 95% CI = 2.226–9.783, P < 0.0001), ([6.6% vs. 50.0%], OR = 3.320, 95% CI = 1.582–6.967, P = 0.002), respectively. Compared to Group 2, Group 3 had higher adverse events, but not statistically significant ([19.16% vs. 25%], OR = 1.406, 95% CI = 0.74–2.6, P = 0.298). Compared to Group 2, Group 4 had higher adverse event, that was statistically significant ([19.16% vs. 52.0%], OR = 4.569, 95% CI = 2.506–8.329, P < 0.0001). Compared to Group 3, Group 4 had higher adverse events that was statistically significant ([25% vs. 52%], OR = 3.240, 95% CI = 1.785–5.916, P = 0.0001).
| Discussion|| |
Considerable variability in survival rate is reported in literature after primary PCI in the different study population and accurate risk stratification is of utmost clinical importance to know the reasons for this variability for better survival and guiding patient management and resource utilization. Anemia and renal insufficiency are recognized increasingly as conditions strongly predictive of mortality after acute MI., The incremental prognostic value of these conditions was demonstrated in the current analysis of 500 patients of acute STEMI. Databases from the two largest multicenter, randomized AMI trials of primary PCI to date were utilized for score derivation ([CADILLAC trial, n = 2082] and [STENT-PAMI trial, n = 900]), shows anemia and renal insufficiency along with other five variables as risk factors for 30-day and 1-year mortality. Similarly, the Washington Risk Score showed lower baseline hematocrit and chronic renal failure as risk factors for increased 1-year mortality following PCI. However, this trial excluded the patients of cardiogenic shock and included all patients undergoing PCI. On the other hand our study was unique one in the sense that it was done exclusively on acute STEMI patients undergoing primary PCI, (including patients with cardiogenic shock) while excluding established cases of chronic renal failure. Contrary to above trials, our study not only showed anemia and renal insufficiency as independent risk factors for 30-day mortality but also as risk factors for reinfarction, reintervention, and VT/VF. Polanska et al. and Kim et al. showed impaired CrCl as a risk factor for in-hospital complications and increased 30-day mortality in acute STEMI patients undergoing primary PCI. However, this trial did not include patients with baseline low Hb. In our study also, the in-hospital complication were significantly increased in patients with both low Hb as well as with low CrCl as compared to those having normal values for these risk factors (67% vs. 13.3%, respectively, value <0.0001, OR = 13.197, 95% CI = 7.252–24.015). [Table 4] shows comparison of in-hospital complications among the four groups. Vis et al. in 2007 found that admission Hb concentration is an independent predictor for 1-year mortality in patients with STEMI undergoing primary PCI. Similar findings were there in our study at 30 days in addition to other additional adverse events. Apart from low Hb and low CrCl behaving independently as risk factors, adverse events significantly increases further when both were present simultaneously in a patient of acute STEMI at presentation compared to when either of the above risk factor present in isolation. This fact was shown in EXTRACT TIMI 25 trial, in which the term laboratory index which contained both Hb and CrCl as risk factors, that is, ([15 Hgb] + [100 CrCl]/8) was validated to have prognostic utility to predict mortality in STEMI patients at presentation. However, this trial was done on STEMI patients undergoing fibrinolysis, but our study was rare one to prove the above-mentioned fact in acute STEMI patients undergoing primary PCI. [Table 5] compares the total adverse event rates among four groups at 30 days using multivariate analysis taking into account various confounding factors such as diabetes, hypertension, smoking, and dyslipidemia which showed that these confounding factors were not the significant risk factors for 30-day event rate and only low baseline Hb and CrCl were the independent risk factors for 30-day event rate.
There were few limitations of our study. First is that our study was single-center study and had small number of patients. Second, our study had short-term follow-up of 30 days. Although the results were significant in just 30-day follow-up period, long-term follow-up is required, which is undergoing and will be reported.
| Conclusion|| |
This study concludes that in patients of acute STEMI undergoing primary PCI, baseline reduced CrCl, and low Hb were associated with increased risk of 30 days adverse event rate (i.e. cardiac mortality, reinfarction, reintervention, and hemodynamically unstable ventricular tachyarrthmias) and were independent risk factor for the 30-day event rate. Furthermore, when these two risk factors are simultaneously present in these patients, the rate of adverse events further increased significantly compared to when either of the above risk factor is present in isolation.
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Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]