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ORIGINAL ARTICLE
Year : 2022 | Volume
: 11
| Issue : 4 | Page : 96-101
The short outcomes and in-hospital complications in patients with STEMI revascularized with primary PCI: A prospective registry from India
Ambukeshwar Singh1, Varun Narain2, Jayesh Sharma1, Gaurav Chaudhary2, Pravesh Vishwakarma2, Sharad Yadav2, Sudhanshu Dwivedi2
1 Department of Cardiology, Divine Heart and Multispecialty Hospital, Lucknow, Uttar Pradesh, India
2 Department of Cardiology, King George's Medical University, Lucknow, Uttar Pradesh, India
Correspondence Address:
Dr. Ambukeshwar Singh
Divine Heart and Multispecialty Hospital, Lucknow, Uttar Pradesh - 226 010
India
Source of Support: None, Conflict of Interest: None
DOI: 10.4103/rcm.rcm_25_22
Context: Primary percutaneous coronary intervention (PCI) is the most effective reperfusion therapy with low complication rate in comparison to thrombolysis. Aims: We aimed to study the short-term outcomes of primary PCI at a large tertiary care center in India. Settings and Design: A prospective cohort of patients with ST-elevation myocardial infarction (STEMI) who underwent primary PCI was enrolled between December 2015 and November 2016. Subjects and Methods: The demographic profile, risk factors, clinical characteristics, inhospital complications, and outcomes at 30 days were assessed. The primary outcome was a composite of death, reinfarction, and repeat revascularization. Acute left ventricular failure (LVF), complete heart block (CHB) or bradyarrhythmia, ventricular tachycardia (VT) or ventricular fibrillation, stroke, and major thrombolysis in myocardial infarction bleeding were the inhospital complications that were considered the secondary outcomes. Results: A total of 237 STEMI patients with primary PCI were enrolled, accounting for 7.5% of all PCI procedures performed during this period. The mean age was 55.4 ± 11.9 years, and 86.5% were male. The mean window period was 5.1 ± 3.18 h, and the mean door-to-balloon time was 58.4 ± 11.5 min. Prior to PCI, the most often administered antiplatelets were clopidogrel in 54.4% of patients and prasugrel in 55.6%. The aspiration thrombectomy was done in 70.8% of patients. Predilatation with balloon was required in 41.8% of patients. Drug-eluting stents were implanted in 98.3% of patients. The primary outcome was found in 3.3% of patients (deaths – 2.9% and reinfarction – 0.4%) and the secondary outcomes were observed in 13%. The common inhospital complication was CHB or bradyarrhythmia in 5.0% followed by acute LVF in 4.6% and then VT in 2.1%. Conclusions: The primary outcome rate is as good as reported in developed Western countries in contemporary treatment practices of STEMI. CHB and acute LVF were the major inhospital complications among patients of STEMI treated with primary PCI.
Keywords: Acute coronary syndrome, major adverse cardiac events, primary percutaneous coronary intervention, ST-elevation myocardial infarction
Coronary artery disease (CAD) is the most common noncommunicable disease in a country like India with significant mortality and morbidity rates and poses a great challenge to deal with rising toll of patients suffering from it. Till the end of 2015, over 65 million of our population have been affected by CAD. Acute ST-elevation myocardial infarction (STEMI) is a common manifestation of CAD resulting in high morbidity and mortality rates. Timely reperfusion therapy has been proven the best therapy for the management of acute STEMI. Unfortunately, in our country, the overall use and quality of acute reperfusion therapy are far behind in comparison to North America and Europe.[1] Primary percutaneous coronary intervention (PCI) is the most effective reperfusion therapy with low complication rate in comparison to thrombolysis.[2] The American College of Cardiology or American Heart Association (ACC/AHA) guidelines 2013 endorse primary PCI for the management of STEMI as class IA indication within 12 h of initiation of myocardial infarction (MI) and as class 1B indication in patients with STEMI if there is clinical and/or echocardiographic (ECG) evidence of ongoing ischemia between 12 and 24 h, as well as in case of cardiogenic shock or contraindication to thrombolysis irrespective of delay in time after the onset of MI.[3] At 30 days, STEMI patients who underwent primary PCI have mortality rates of 3%–5%, reinfarction of 2.5%, and stroke of 1% globally.[2] A study conducted in India showed inhospital mortality rates of 4.2%, reinfarction of 1.2%, major bleeding of 1.3%, urgent coronary artery bypass grafting (CABG) of 0.6%, and stroke of 0.14% in the study population. The study also reported outcomes at 30 days that showed mortality rates of 5.2%, reinfarction of 2.1%, major bleeding of 1.5%, urgent CABG of 0.6%, and stroke of 0.1%.[4] Similarly, a research conducted in Pakistan showed 5.8% inhospital mortality rates, no out-of-hospital 30-day mortality, reinfarction of 1%, recurrent angina of 1%, and left ventricular failure (LVF) of 5%.[5] In the prospective CREATE registry, which enrolled 20,468 patients with acute coronary syndrome at 80 centers in various parts of the country, primary PCI was performed in only 8% of the patients presenting with acute STEMI.[6] Only very few studies have shown the outcome of primary PCI in India. Our center is a leading center in North India providing primary PCI care. In lieu of the above, we aimed to study the outcome of STEMI patients who underwent primary PCI at 30 days.
Subjects and MethodsPatients with STEMI who underwent primary PCI were prospectively enrolled between December 2015 and November 2016. The inclusion criteria were patients who presented within 12 h of onset of chest pain to the hospital. Patients who were sensitive to aspirin and not able to administer dual antiplatelet therapy for at least 3 months were excluded from this study. The study protocol was approved by the Institutional Ethics Committee and adhered to the tenets of the Declaration of Helsinki. Informed consent was taken from all patients.
A brief history was taken to rule out any contraindication to dual antiplatelet treatment, and a focused clinical examination was done followed by screening echocardiography to exclude any mechanical complications. All patients received a loading dose of aspirin 325 mg, and either clopidogrel 600 mg or prasugrel 60 mg, and 80 mg of atorvastatin. The procedure was performed either through radial or femoral route. As a routine practice, noninfarct-related artery (IRA) expected based on ECG finding was imaged first with a diagnostic catheter to rule out any critical lesions with compromised blood flow. Then, IRA was engaged with an appropriately sized guiding catheter. After diagnostic angiogram, the type of wire used, thrombosuction, predilatation, type of stent, postdilatation, and use of glycoprotein IIb/IIIa inhibitors (GPIs) were decided by an operator. In case of multivessel disease, PCI was performed in non-IRA if cardiogenic shock persisted despite successful PCI in IRA. The time from the onset of chest pain to hospital arrival (window period) and the door-to-balloon (DTB) time were recorded. The arterial sheath was removed after 4–6 h of the procedure. At the time of discharge, all the patients continued dual antiplatelets, statins, beta-blockers, and angiotensin-converting enzyme inhibitors if not contraindicated. The primary outcome of the study was considered a composite of death, nonfatal MI, and reinfarction requiring target lesion revascularization (TLR), collectively termed as major adverse cardiac events (MACEs). The MACE was determined at 30 days following primary PCI. Follow-up was done at 30 days in the outpatient department and, if not possible then, through telephonic contact. Major inhospital complications taken into account were complete heart block (CHB), complete blood count or bradyarrhythmia, LVF, ventricular tachycardia (VT) or ventricular fibrillation, cardiogenic shock, major thrombolysis in myocardial infarction (TIMI) bleeding, and stroke.
Definitions
STEMI is defined as angina or anginal equivalent lasting for >20 min and ST-segment elevation of mm in ≥2 contiguous leads, or new left bundle branch block, or true posterior MI with ST depression of ≥1 mm in ≥2 contiguous anterior leads. Window period is defined as time from onset of chest pain to arrival of patient to our hospital. DTB time is defined as time from hospital admission to establishment of IRA flow. Reinfarction was defined as recurrent chest pain or ischemic equivalent symptoms lasting >30 min, new ECG changes consistent with reinfarction, and the next creatinine kinase-MB level (measured approximately 8–12 h after the event) was at least 50% above the previous level or >3 times the upper limit of normal whichever was greater. TLR is defined as repeat PCI or bypass graft placement for restenosis at the lesion treated during index PCI or occurring within 5 mm of the PCI site (edge effect) as determined clinically by the investigator at each site. TIMI major bleeding: It was considered when any of the following events occurred in the patient: intracranial bleeding, intraocular bleeding, retroperitoneal bleeding, access site hemorrhage requiring surgery or a radiological or an interventional procedure, hematoma ≥5 cm in diameter at the puncture site, reduction in hemoglobin concentration of >4 g/dL without an overt source of bleeding, and reduction in hemoglobin concentration of >3 g/dL with an overt source of bleeding, re-operation for bleeding, or use of any blood product transfusion. Acute LVF is defined as the sudden or gradual onset of the signs or symptoms of heart failure requiring unplanned office visits, emergency room visits, or hospitalization.
Statistical analysis
Categorical data are presented as number and percentages. Continuous variables are presented as mean ± standard deviation. The Chi-square test was used to compare the categorical variables. P < 0.05 was considered statistically significant. All the analysis was carried out on SPSS statistical software, version 16 (Statistical Package for the Social Sciences, Inc., Chicago, Illinois, USA).
ResultsA total of 237 patients of STEMI who underwent primary PCI were enrolled between December 2015 and November 2016, which contributed to 7.5% of all PCIs done at our center. [Table 1] shows the demographic and clinical profile of the study population. The mean age was 55.48 ± 11.91 years, and 8.4% of patients were <40 years. Males were 86.5%. Among risk factors, smoking was present in 42.2% of patients, tobacco chewing in 36.3%, hypertension in 28.7%, and diabetes in 26.6%. Anterior wall myocardial infarction (AWMI) was diagnosed in 54% of patients. The mean left ventricular ejection fraction was 48.02 ± 5.13%. The mean window period was 5.12 ± 3.18 h. Around one-fourth of our patients had a window period <3 h. The mean DTB time was 58.48 ± 11.57 min. Clopidogrel was the frequent loading dose given prior to PCI in 54.4% of patients and prasugrel in 45.6%.
Table 1: Baseline demographic and clinical profile of the study population[Table 2] shows the procedural characteristics of the study population. Femoral access was chosen for PCI in 74.3% of patients. Radial access was used in 25.6% of patients. In three patients, radial access needed to be switched to femoral route due to procedure failure with radial route. Left anterior descending artery (LAD) was the most common culprit artery found in 54.9% of patients followed by right coronary artery (RCA) in 35.4% and left circumflex artery (LCX) in 9.7%. Multivessel disease was noted in 43.8% of patients. Aspiration thrombectomy (AT) was done in 70.8% of patients. Balloon predilatation was required in 41.8% of patients. Drug-eluting stents (DESs) were implanted in 233 patients (98.3%), and four patients (1.7%) were implanted with plain old balloon angioplasty (POBA) only. None of our patients were implanted with bare metal stent (BMS). The mean stent diameter was 2.95 ± 0.28 mm, and the mean length was 27.47 ± 10.57 mm. For stent optimization, postdilatation was done in 17.3% of patients. GPIIb/IIIa inhibitors were administrated in 66.8% of patients. Postprocedure TIMI III flow was achieved in 97% of patients. [Figure 1] outlines inhospital complications; these in decreasing frequency were CHB/bradyarrhythmia in 5.1% (10 patients in CHB and 2 patients in symptomatic bradyarrhythmia), acute LVF in 4.6%, VT in 2.1%, and cardiogenic shock in 1.3%. None of the studied patients had TIMI major bleeding and stroke. [Figure 2] depicts clinical outcomes at 30 days. Mortality occurred in 2.9% of patients and reinfarction occurred in 0.4%. There was no association found between MACE and age, gender, risk factors, window period, DTB, type of MI, multivessel disease, AT, predilatation, stent implantation, postdilatation, use of GPIIb/IIIa inhibitors, and final TIMI flow.
DiscussionThe study found MACE in STEMI patients who underwent primary PCI that was comparable to a Western country in contemporary treatment practices.[2] This similarity shows that STEMI patients are receiving the same standard of care as those in developed countries. Though there was a minor modification in the present study that is, ticagrelor was not used due to its higher cost. Moreover, clopidogrel was used as pre-PCI loading P2Y12 inhibitor in 54.4% of patients, whereas the rest were given prasugrel, even though prasugrel is preferred over clopidogrel in primary PCI. The most crucial reason to use clopidogrel instead of prasugrel was that majority of these patients were already taking clopidogrel at a non-PCI center before arriving at our hospital.
Femoral access was used in majority of the patients. The choice of arterial access was operator dependent. The recent publication of randomized trials have shown no advantage in terms of reducing MACE. Thus, enthusiasm for the use of AT has been decreased. As a result, the ACC/AHA group had to downgrade its class of indication from class II b recommendation to class III recommendation for the routine use of AT during PCI for STEMI patients.[7] Despite that AT was used in 70.8% of our patients. The reason is that most of the operators prefer to use thrombus aspiration in 100% occluded lesions by thrombus. The GPIIb/IIIa inhibitors were used in 76.8% of patients in the present study which was similar to the usage of GPIIb/IIIa inhibitors in 70% of patients in Shaikh et al.[5] study. Unlike, Subban et al.[4] used GPIIb/IIIa inhibitors only in 57.8% of their study patients. Intracoronary bolus (eptifibatide) was the most common GPIIb/IIIa inhibitor used (46.4%) followed by intravenous eptifibatide infusion (20.7%) and tirofiban infusion (9.7%). DESs are used worldwide hereafter as the DESs have shown superiority over BMS in terms of reducing restenosis.[8],[9] Here, we also used DESs in all patients until antiplatelet continuation for prolonged period was contraindicated, though we did not encounter any such patients. In four patients, only POBA was done as either lesion was very distal, or artery size was small for DESs. In our study, DESs were deployed in 98.3% of patients and POBA was done in the rest of the cases, whereas in Subban et al.[4] study, DESs were deployed in 31.5% of patients and BMSs in 68.5%. Likewise, in our study, DESs were deployed in 91% of patients in the study conducted by Shaikh et al.[5]
The mean symptom onset to hospital visit time interval was 312 min in our study similar to 300 min in CREATE study.[6] However, it is 140–170 min in developed countries. In a study by Dilu et al.,[10] 47.8% of patients reached within 6 h of symptom onset, whereas in Kerala registry,[11] around 60% of patients reached within 6 h. The delay in reaching a STEMI care hospital in our country is multifactorial. The first factor is due to delay in recognition of chest symptom by patients themselves, the second is due to unavailability of electrocardiogram machine at peripheral health-care centers, the third is due to incompetency of route label health-care provider in diagnosing and taking decision for referral to higher center, and the fourth is due to poor ambulance and transportation services. Hence, this presentation time can be reduced by creating public awareness regarding symptoms of acute coronary syndrome, educating the route label health-care provider, making ensure the availability of electrocardiogram machine at peripheral health-care centers, and, most importantly, strengthening the ambulance services.
In our study, the median DTB time was 60 (30–90) min, which was in accordance with the time interval mentioned in ACC/AHA guideline (DTB time <90 min). This suggests the competence of our hospital staff in dealing with primary PCI.
The LAD was the most common culprit artery in 54.9% of patients. This finding was validated by Subban et al.[4] and Shaikh et al.,[5] who had also found LAD as a culprit artery in 56.2% and 55.7% of patients. The RCA was the second most common culprit artery responsible for 35.4% of MI, which was slightly more than the RCA involved in Subban et al.[4] study (30.1%). The LCX was found as the culprit artery only in 9.7% of patients. Out of total 107 patients of inferior wall MI (IWMI), culprit artery was RCA in 84 (78.5%) patients. Multivessel disease was found in 43.8% of patients in the current investigation, which was higher than 37% of patients reported by Subban et al.[4] study. The comparison of demographic and clinical characteristics of the present study with Indian studies are summarized in [Table 3].
Table 3: Comparison of demographic and clinical characteristics of the present study with Indian studiesPredilatation of lesion was not required in around two-third of cases in our study because most of the lesions are thrombotic in patients undergoing primary PCI and predilatation will increase the possibility of no-reflow by distal embolization of thrombus. Hence, we avoid predilatation in primary PCI until the culprit lesion is very tight or having less thrombus burden.
The primary outcome was found in 8 patients (3.3%), which consisted of 7 death (2.9%) and 1 reinfarction (0.4%) in the present study, which was half of the 30-day mortality and reinfarction reported by Subban et al. (52% and 1.6%),[4] Dilu et al. (5.2%),[10] and Shaikh et al. (5.8% and 1.1%).[5] Out of seven deaths, four patients had been diagnosed with IWMI and three patients had AWMI. There was no association found between MACE and age, gender, time onset of chest pain to hospital visit, DTB time, type of MI, risk factors, multivessel disease, AT, predilatation, stent implantation, postdilatation, use of GPIIb/IIIa inhibitors, and final TIMI flow, although the study was underpowered for these outcomes.
Among inhospital complications, CHB or bradyarrhythmia was the most common (39%). All cases of CHB required temporary transvenous pacing. All cases of CHB or bradyarrhythmia were seen in patients with IWMI except one who had CHB with AWMI and required permanent pacemaker implantation. In a study conducted by Subban et al.,[4] 7.7% of patients developed CHB. Acute LVF was the second most common inhospital complication (35%), and all these patients required noninvasive ventilation support, intravenous diuretics as well as prolonged hospital stay. Patients who died in the hospital had developed acute LVF before they died. VT was developed in 2.1% and all required direct current cardioversion. Three patients had cardiogenic shock developed after primary PCI and all required vasopressor support. Out of those three patients with cardiogenic shock, two patients died and one improved. We did not find any case of stroke and TIMI major bleeding.
There are few drawbacks to this study that should be noted. First, it was a single-center study and therefore it may not represent the true treatment practices for the whole country. Second, the study is underpowered for the outcome being assessed.
ConclusionsDespite major limitations inherent to the study, the authors would like to conclude that primary outcomes are comparable to a Western country and even better than the other parts of our country. Among inhospital complications, CHB/bradyarrhythmia has been the most common followed by acute LVF and finally VT. The authors suggest a multicenter study that might truly represent the outcomes of primary PCI and may gauge the competency of health-care system prevailing in comparison to developed countries.
Ethical clearance
The study was approved by the institutional ethics committee of King George's Medical University U.P., on date 26th October 2016 with the ethical reference code: 80th ECM II B-Thesis/P8.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
References
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