Fibrinolysis vs PCI, Research Paper Example

Evaluation of Mortality Rates and Efficacy in STEMI Patients

Fibrinolysis vs PPCI

How would emergent fibrinolysis in STEMI patients who live more than 120 minutes away from a Cath Lab, presenting within 1hr of Symptom onset effect mortality rates over a one-years’ time

Introduction

Statistics show that the leading cause of death in the United States is heart disease, in both women and men (Heart Attack, 2017) while there is variance throughout ethnicities. These statistics include myocardial infarction (MI) and coronary artery disease. Early recognition and treatment is paramount in the survival of these patients. It is well known that the American Heart Association (AHA) recommends a door-to-balloon time of 90 minutes or less for cardiac reperfusion (Elliot & Antman, 2004). The AHA door-to-balloon time primarily focuses on treatment for patients experiencing ST-Segment Myocardial Infarction (STEMI) receiving Primary Percutaneous Intervention (PCI).  However, what if there are delays to this treatment? Unfortunately, not every hospital has the capabilities to perform PCI. Transport from non-PCI capable hospital to a PCI center is recommended to be within 120 minutes, therefore, physicians must act quickly in treatment to ensure favorable outcomes for this patient population. There are two treatment modalities for STEMI patient. The first treatment option is PCI which is recognized as the gold standard. The second option is Fibrinolysis for patients that meet criteria. Fibrinolysis is usually considered when time and location are a .

PICOT

In this review, the goal is to examine w who live more than 120 minutes away from a Cath lab, presenting within 1 hour of symptom onset effect mortality rates over a one-years’ time. The population of interest are patients experiencing ST-segment elevation of greater than 1.5 – 2mm in two or more contiguous leads accompanied by characteristic symptoms of myocardial ischemia (Kelly, 2010). Patients who experience chest pain in relation to pericarditis, myocarditis or electrocardiogram (EKG) changes without ST-segment elevation were all excluded. The intervention of focus is emergent fibrinolysis. Fibrinolysis is the treatment option of choice for physicians in a non-PCI compatible facility, giving them the ability to begin treatment for a patient that meets STEMI criteria (Kelly, 2010). As previously mentioned, the gold standard is PCI, which is the comparison intervention. Percutaneous Intervention is the most successful option but not always the most feasible or convenient option. The outcome measurement is mortality rates. Mortality rates in both PCI and fibrinolysis groups will be measured to illustrate clearly the outcomes of both interventions. This review aims to gather a clear depiction of the efficacy of fibrinolysis regarding mortality rates. Thus, the chosen time frame of one year was found to be sufficient to gather enough data and make a comparison.

Significance of the Problem

We have all heard the expression time is muscle. Every 40 seconds someone in the United States has a heart attack (Heart Attack, 2017). Myocardial infarction occurs when there is insufficient blood supply to the heart cutting off essential nutrients to sustain the function of the cardiac tissues. When this happens, it is essential that restoration of blood flow takes place as soon as possible to allow proper function of the muscle. Every year about 790,000 people suffer a heart attack (Heart Attack, 2017).  The most frequent culprit of myocardial ischemia is coronary artery disease (Heart Disease Facts, 2017). Heart disease is the leading cause of death in the United States in many ethnicities (Heart Disease Facts, 2017). This is a major public health concern for US citizens because so many people are affected by this.  As healthcare providers we must find a way to minimize the effects of this disease on our communities and prevent morbidity and mortality. One of the ways we can do that is developing treatment plans that promote the best patient outcomes for our patients.  Current research shows that primary percutaneous intervention is the recommended treatment for patients diagnosed with ST-elevation myocardial infarction (Elliot & Antman, 2004). However, in rural communities not every hospital has the capability of performing this intervention. This means that the patient will need to be transferred to a capable facility, which depending on location can take more than 120 minutes. When PPCI cannot be performed within 60 minutes the next best treatment option is fibrinolysis, a pharmacoinvasive strategy to reestablish perfusion (citation required). Delay in reperfusion could result in permanent cardiac damage resulting in heart failure which can drastically alter an individual’s quality of life or death in many cases.  About 610,000 people die of heart disease in the United States every year; that’s 1 in every 4 deaths (Heart Attack, 2017). That is alarming. Since the mortality rates in heart attacks are so high it is paramount that healthcare providers evaluate treatment options that provide the best patient outcomes and implement these interventions into practice.

Search Strategy and Results

A multi-database search was conducted to find mortality and efficacy information on the use of fibrinolysis and percutaneous intervention. The keywords and associated acronyms used in the search strategy included primary percutaneous intervention (PPCI), percutaneous intervention (PCI), ST-elevation myocardial infarction (STEMI), myocardial infarction (MI), fibrinolysis, mortality, rural, and reperfusion. The use of a boolean operator was used. Combinations included fibrinolysis and PCI and mortality, reperfusion and fibrinolysis, and fibrinolysis in STEMI and rural. Exclusion criteria included the location of stenting, NSTEMI, no treatment options, PCI trends, specific drug usage (studies only related to the use of low molecular weight heparin as a treatment option), the feasibility of treatment, guidelines, studies only focusing on individuals age 75 years and older. Inclusion criteria included all primary evidence and meta-analysis studies in relation PCI, fibrinolysis in STEMI, MI, reperfusion, and mortality rates. The databases used to conduct the search were PubMed, Cochrane database and google scholar. From these outlined criteria and keywords, a total of 305 primary resources and one meta-analysis were located. PubMed resulted in 181 primary sources and one meta-analysis. Cochrane database yielded 114 primary sources, and Google Scholar yielded ten primary sources. Of these 306 resources, five primary resources and one meta-analysis were retained for this review which met all inclusion criteria. All included studies in this review were observational cohort studies, prospective and retrospective. A detailed depiction of the search strategy used for this review of evidence can be found in Appendix A fig.1

Critical Appraisal of the Literature

While conducting the critical appraisal of this primary evidence, there were three major concepts in the body of evidence. The first of these concepts was the difference between the two therapeutic interventions in treating ST-elevation myocardial infarction, fibrinolysis, and PPCI. The second concept is delay in reperfusion therapy. Lastly, the difference in mortality rates amongst the two interventions coupled with delays in treatment. Aggregated findings provided a similar result throughout the body of evidence in this review. Multiple factors contributed to the strength of the methodologic rigor in this review. Among these contributing factors were study design, data collection, sampling, and populations. Overall these factors increased the strength of the body of evidence. Another strength of this body of evidence was the inclusion of a meta-analysis which encompassed 27 individual studies. Although there were a few limitations within the body of evidence the strength of the evidence far outweighed the limitations. The system used to evaluate the body of evidence used in this review was the Let Evidence Guide Every New Decision (LEGEND) table of evidence levels. This guide proved to be the most useful for evaluating the strength of each individual study by clearly defining each study and the domain of the clinical question.

Conceptualization of the Problem

The research problem in this review was designed to evaluate the efficacy of treatment between two variables, fibrinolysis and PPCI, and measured by mortality. The conceptual framework included the variables contributing to the research problem as well as defining relationships between variables. All studies in this body of evidence shared the same dependent and independent variables. The outcome measurements were also consistent with some studies also accounting for time delays in treatment. The primary sources used in this review were consistent in their definition of the research problem, variables, and outcomes. All the five primary resource studies in this review were observational cohort studies the researcher had limited control which minimized the likelihood of any concept bias.

Findings

There were conflicting findings in the review of this body of evidence between the primary resources and the findings in the meta-analysis. Throughout the collection of primary evidence, a consistent finding was that PPCI and fibrinolysis shared similar mortality rates. Fibrinolysis was found to be an effective reperfusion option in patients presenting early in symptom onset. Also, a common finding throughout the body of evidence was an increased propensity for intracranial and other bleeding in patients receiving fibrinolysis.  Fibrinolysis was recommended for adoption in remote areas where transport to a PCI-capable hospital or delays in reperfusion will be longer than 120 minutes (ElGuuindy, 2014). Important to note is that in the STREAM trial fibrinolysis was found to result in aborted MI (defined as a >50% decrease in ST-elevation with minimal biomarker raise) in 11.1% of evaluated patients (ElGuuindy, 2014)…… Evaluation of age-related differences found that older adults have more delays in reperfusion therapy and experience higher mortality rates in comparison to individuals <75 years-old (Turk et al., 2018). The meta-analysis found that there was significantly higher mortality associated with fibrinolysis when compared to PPCI. However, the key finding amongst all the resources in this review is that PCI is the recommended and preferred treatment modality for patients experiencing STEMI.

Methodological Rigor

As previously mentioned, the study design used in the primary sources was an observational case-control cohort design. This kind of research design focuses on defining cause-effect relationships. Therefore, the researchers exert very little control over the study or participants which increases the internal validity of the study.  The meta-analysis was composed of only randomized controlled trials (RCT). The researcher included funnel plots to detect publication bias, in which they found “very little evidence of publication bias amongst the 27 studies” (Yanamala, Bundhun, & Ahmed, 2017). Each study in this review included all patients diagnosed with STEMI presenting less than 12 hours of symptom onset and whose electrocardiogram (ECG) showed ST-segment elevation at least 1-4 mm in 2 contiguous leads on ECG. Sampling was on a continuous basis for a defined period ranging from one month to eight years, which decreased selection bias in the body of evidence. Overall diversity noted in all studies included in the review. All researchers provided a detailed analysis of characteristics such as age, gender, height, weight and coexisting medical conditions. In one study there were six patients lost to follow-up and one patient lost to withdraw. However, these seven patients were not significant enough to affect the rigor of this body of evidence as a whole.

Strengths and Limitations

ST-elevation myocardial infarction is a widely researched medical diagnosis. There have been numerous research studies conducted for several years which makes the total body of evidence on the subject robust. This review has many strengths, one of which is the amount of time given for follow-up. All studies in this review accounted for short and long-term follow-ups to accurately portray outcome variables in the study. Another strength is that the cumulative findings of the study are clinically significant to the health professionals. Health professionals can take the data from these studies and implement change in their communities and in their professional setting that will help many Americans nationwide. The overall study structure of this compilation of literature was consistent which increased the reliability of this research. Lastly, although the mortality findings were inconsistent the efficacy findings were consistent which increased generalizability of treatment options. The major limitations found to be a contributing factor in this body of evidence is the conflicting evidence in the meta-analysis. Other limitations worthy of noting that could be of significance for further research. One weakness is that further investigation is warranted to evaluate the use of half doses of tenecteplase for patients <75 years old to limit bleeding. Also, new research aimed at effective reduction of patient-related delays was found to be necessary because there is the potential for improving the short and long-term outcome of patients with acute STEMI.

Summary Statement Regarding Strength of the Evidence

The results of this review show that there was no significant difference in that mortality rates for patients given fibrinolysis in STEMI who live more than 120 minutes away from a PCI-capable facility, presenting within 1hr of symptoms. However, a single meta-analysis showed that the mortality rates in fibrinolysis treatment for STEMI are significantly higher than that of the PCI treatment.  Although the evidence is conflicting in the primary research and the meta-analysis, the evidence supports the current practice of PPCI can still be applied to practice now. The results also show that the fibrinolysis can be a feasible option to patients who live more than 120 minutes away from a PCI capable hospital, with caution due to the higher mortality rates and the increased risk of bleeding.  The quality of evidence overall was strong, and so . Using the LEGEND system, this review is graded as Moderate due to the conflicting findings.

New Section  The nursing model that will be applied to the examination of the PICOT questions is the Iowa Change Model (Ryan et al., 2017). This model is frequently employed as a part of the clinical decision-making process. The three steps of the model include: forming a practice question, collecting evidence, and translating the evidence into practice. This enables findings from the evidence to be quickly and accurately implemented into patient care. The research question was identified by conducting a literature review to reveal the gap in knowledge that is present in the field.

It is necessary to use this information to determine how current practiced in the field could be improved. Following the review, it was determined that there was a need to assess the relationship between emergent fibrinolysis in STEMI patients and the distance they life from Cath labs, in terms of their mortality outcomes. If it is then determined that distance from the Cath lab has a negative impact on patient outcomes, there is reason to promote the increased availability of Cath labs that are closer to the patient’s homes. Furthermore, this information could be used after the results are determined to assess where these facilities are most needed based on the population distribution of patients in this category.

The collection of the evidence will be based on evidence from the literature. By summarizing the available evidence about outcomes associated with fibrinolysis in STEMI patients as well as their outcomes related to different treatment and accessibility modalities, it will be possible to make this recommendation. After making a practice change, it would then be necessary to view outcome data once again to determine if there has been a reasonable change in patient outcomes since the change has occurred. This will allow involved health care professionals and administrators understand whether the proposed recommendation is suitable for lowering the mortality rate of patients with fibrinolysis.

The change model that will be used to guide this change process is the Iowa model of evidence-based practice. It is necessary for health care professionals to become accustomed to considering the distance that patients live from their facilities, since this will help them determine whether their patients are potentially being impacted by their distance to the facility. It is then possible for them to make recommendations about facilities that require less travel, if they exist, or to make their administrators aware of these issues so that when expansions of facilities are considered, they are placed where they are needed by patients the most. This is advantageous for for-profit Cath labs, as well as for the patients who will be better able to access these services.

The Iowa Model consists of seven steps: selection of a topic, forming a team, evidence retrieval, grading the evidence, developing an evidence-based practice standard, implementing the evidence-based practice, and evaluating it. A literature search will be conducted to identify the topic on the basis of gaps that are present in the research. A team of nurses will then be formed to investigate this concern. Evidence will be collected from the nurses based on qualitative factors associated with the intervention as well as the patient’s quantitative outcomes. The evidence from the literature will be graded, and this information will be used as a standard for practice comparison, to determine if the intervention made a different in patient outcomes.

The proposed setting for this research is within randomly selected Cath labs, because this will allow health care professionals to test the concepts that were initially detected during the literature review. The participation of at least 10 labs over a one year period will over a realistic understanding of the relationship that exists between the patient’s distance from Cath labs, as mortality as a primary indicator. This exploration could also be used to assess secondary variables associated with this condition and assess how the patients who did and did not experience mortality may be similar or different based on these additional variables. Collecting information like age, gender, and comorbidity status will allow for a greater understanding of how these variables interact.

Health care organizations and health care providers will be directly involved in collecting the data, as well as consenting to participate. Patients’ involvement will only extent to their involvement in answering questions about their demographics if the information is not already available, as well as information regarding the distance of their home from the facility. This will be checked for accuracy using a maps application. Health care workers and patients will be provided with informed consent documentation to participate, but this will be providing permission primarily for access to records and does not have the potential to harm the patient unless information about identifying information is leaked. Identifying information will not be collected for this purpose.

The proposed plan will be evaluated by assessing mortality data prior to and following the intervention. A student’s t-test will be used for this purpose, and the null hypothesis will be set to assume that the variance between mortality in these two situations is equal. A p-value less than 0.05 will indicate that the null hypothesis will be rejected, and this will offer support for the alternative hypothesis that there will be less mortality in this patient group after their distance from Cath labs is considered as a part of practice. Furthermore, health care professionals will provide qualitative feedback about the effort and will give information about what they believed the benefits of the project were, any negatives, and what could be improved to better meet the needs of the patients. This will be done through the use of an open-ended interview, in which those involved will be asked to provide their feedback on the basis of these categories. Ultimately, this research has the potential to allow for improved mortality rates among patients with fibrinolysis in STEMI, and it is valuable to track these outcomes to determine if the intervention should be applied to offer benefit to patients in additional locations.

Conclusion

In this review, the aim was to ascertain whether fibrinolysis was more or less effective in STEMI in comparison to PPCI. A multi-database search was conducted to find literature concerning STEMI mortality, Fibrinolysis, PPCI and delays in treatment. In this search 306 research studies were yielded, six of which were retained for this analysis. A thorough evaluation of the available data was conducted. From this evidence, the following information was extrapolated. Fibrinolysis in STEMI was found to be a feasible alternative in the absence of PPCI treatment within an hour with transport to PCI capable facility. Fibrinolysis was observed to have an increased propensity for bleeding. The findings in relation to mortality are variable. Lastly, PPCI remains the recommended treatment option of choice when available. Evidence of this literature analysis can be found in the Appendices included with this review which detail the search strategy and tables of evidence.

References

Prevention: https://www.cdc.gov/heartdisease/facts.htm

Kelly, V. (2010). ST-elevation MI. Retrieved from http://errolozdalga.com/medicine/pages/VK/STEMI.10.28.10.html

Rosenbaum, D., More, E., & Steane, P. (2018). Planned organisational change management. Journal Of Organizational Change Management, 31(2), 286-303. doi: 10.1108/jocm-06-2015-0089

Ryan, P., Mamaril, M., Shope, B., Rodriguez, J., Garey, T., & Obedoza, L. et al. (2017). The Johns Hopkins Evidence Based Practice (EBP) Model: Learning the Process and Appraising the Evidence. Journal Of Perianesthesia Nursing, 32(4), e29-e30. doi: 10.1016/j.jopan.2017.06.098

Turk, J., Fourny, M., Yayehd, K., Picard, N., Ageron, F., Boussat, B., . . . Debaty, G. (2018). Age-related differences in reperfusion therapy and outcomes for ST-segment elevation myocardial infarction. Journal of the American Geriatrics Society, Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/29684242

Yanamala, C., Bundhun, P., & Ahmed, A. (2017). Comparing mortality between fibrinolysis and primary percutaneous coronary intervention in patients with acute myocardial infarction: A systematic review and meta-analysis of 27 randomized-controlled trials including 11 429 patients. Coronary Artery Disease, 28(4), 315-325. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/28362665