Numerous studies have compared transradial (TR) versus transfemoral (TF) access for percutaneous coronary intervention (PCI) in patients with acute ST-segment elevation myocardial infarction. These studies have focused on clinical efficacy and safety; yet little is known about the effect of the vessel access on the health-related quality of life (HRQoL). In the present study, patients were randomly assigned to TR (n = 52) or TF (n = 51) access groups. Generic (EQ-5D-3L) and cardiac-specific (Quality of Life Index and MacNew) tools were used to assess HRQoL before PCI and 2 hours and 4 days after PCI. Baseline HRQoL was comparable in both groups and improved after PCI. The mean ± SD EQ-5D-3L health utility score 2 hours after PCI was 0.46 ± 0.291 and was higher in the TR group (TR: 0.60 ± 0.299 versus TF: 0.32 ± 0.283, p <0.001). Patients in the TR group reported fewer problems with mobility (TR: 71.7% vs TF: 94.4%, p <0.01) and self-care (TR: 62.5% vs TF: 97.2%, p <0.001). At day 4, fewer patients reported problems with anxiety and/or depression in the TR group than in the TF group (TR: 42.9% vs TF: 75.0%, p <0.001); no differences between groups in other measures were observed (Quality of Life Index and MacNew). The N-terminal of the prohormone brain natriuretic peptide levels were inversely correlated with EQ-5D-3L visual analog scale (r = −0.348, p <0.05) and EQ-5D-3L health utility score (r = −0.322, p <0.05). There was a correlation between in-hospital mortality and 2 MacNew domains: physical (r = −0.329, p <0.05) and emotional (r = −0.374, p <0.01). In conclusion, radial access should be the preferred approach in patients with ST-segment elevation myocardial infarction undergoing PCI when considering HRQoL. Radial access is associated with fewer problems with mobility and self-care and better psychological outcome after PCI.
The World Health Organization defined health as a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity. Along with interventional and pharmacologic advances that have improved life expectancy and symptom control came an urge to address the ways to improve health-related quality of life (HRQoL). Numerous studies have focused on functional status and HRQoL in cardiac patients, including patients with coronary heart disease ; yet little is known about the impact of the choice of vascular access in percutaneous coronary interventions (PCI) in ST-segment elevation myocardial infarction (STEMI) on HRQoL. Accordingly, we performed a substudy of the “Access for percutaneous coronary intervention in STEMI: radial vs. fermoral—prospective, randomized clinical trial” (OCEAN RACE) to assess whether radial access was more beneficial to femoral in terms of patients’ HRQoL and to evaluate a potential association between HRQoL and clinical outcomes after PCI.
Methods
Patients presenting with acute coronary syndrome were considered to participate in the study. The inclusion criteria comprised electrocardiographic confirmation of STEMI, age >18 years, and a negative Allen’s test result. Patients were ineligible for OCEAN RACE if they presented with an international normalized ratio of >1.4; a platelet count of <100,000; a history of bypass surgery; active bleeding; a history of gastric or duodenal ulcer; the need for dialysis; end-stage liver failure; uncontrolled hypertension; cardiogenic shock; or the likelihood of dropping out in follow-up. Before enrollment all patients signed a written informed consent form and, thereafter, were randomly assigned (1:1) to transradial (TR) or transfemoral (TF) access. All clinical outcomes including general clinical status, assessment of symptoms, and laboratory and echocardiographic findings were reported by the investigators. Patients and investigators were not blinded to the treatment strategy. The protocol and design of the study was reviewed by an independent board and approved by the Bioethics Committee of the Medical University of Warsaw, Poland (KB/115/A/2010). Clinical success was defined as restoration of the coronary blood flow, survival till discharge, and avoidance of any major adverse cardiac events during hospitalization. The HRQoL was assessed using 1 generic instrument (EQ-5D ) and 2 disease-specific instruments (MacNew and Cardiac Quality of Life Index [QLI] developed as a heart disease–specific version of the QLI ).
The EQ-5D-3L questionnaire, a cognitively simple and easy-to-use psychometric instrument designed to measure generic HRQoL, consists of 5 dimensions: mobility, self-care, usual activities, pain and/or discomfort and anxiety and/or depression, and a visual analog scale (VAS). It has since been translated into 150 languages and has become one of the most frequently used measures of HRQoL. The investigators of this study have obtained written permission from the EuroQol Group to use the EQ-5D-3L questionnaire. Quality of life for each EQ-5D-3L dimension was analyzed as a comparison of the percentage of patients with complaints in each of the study groups (TR and TF). EQ-5D-3L utility scores were calculated based on the Polish EQ-5D-3L valuation study of the EQ-5D-3L questionnaire.
The MacNew questionnaire is a self-administered HRQoL assessment tool designed for patients with myocardial infarction, heart failure, and angina pectoris. The MacNew questionnaire consists of 27 items evaluated by patients on a 7-point Likert scale (severe symptoms—1 and little or no symptoms—7). A global score can also be calculated as the average of 3 domains’ scores (emotional, physical, and social). Permission for use was obtained.
There is 1 generic version of the QLI questionnaire for various medical conditions and 14 specific versions developed for use in selected diagnostic groups, including heart diseases. Respective QLI subscales scores for 4 domains (health and functioning, social and economic, psychological and spiritual, and family) can be analyzed and compared between patient groups. The instrument consists of 2 parts; the first part is designed to assess the patient’s satisfaction with his or her own health, symptom control, and the domains of his or her life described previously. In the second part the patient is asked to define the importance of the elements assessed in the first part. The investigators of the study translated the cardiac version of the QLI questionnaire into Polish according to the current translation method for patient-reported outcomes instruments. The forward-backward translation method was used by a team of 7 independent translators, and the results were verified before the final version was developed. The first stage involved 2 independent translations from English to Polish (forward translation) followed by 2 backward translations (from Polish to English). Finally, an independent bilingual board consisting of 3 members revised the results, compared them with the original English version, and introduced necessary corrections. The cardiac version of the QLI questionnaire was based on the Polish adaptation of the generic QLI questionnaire developed by Jaracz and Kozubski. Content validity of the Polish version of the Cardiac QLI was verified by in-depth interviews with 5 cardiac patients (2 patients with myocardial infarction, 2 patients with decompensated heart failure, and 1 patient with supraventricular arrhythmia). They were presented with the Polish versions of the manual and the Cardiac QLI questionnaire, asked to fill it out, and to reply to the following questions: (1) Was the questionnaire manual easy to understand? (2) Did you find any of the questions unclear or ambiguous? (3) Did any expression used in the questionnaire require explanation by medical personnel? The patient panel provided 8 remarks, which were considered in the subsequent version of the questionnaire. The final version of the Polish Cardiac QLI questionnaire was examined by 2 translators involved in the translation process before its use in the study. The translation was supported by the developers of the QLI questionnaire. MacNew scores and QLI scores were calculated according to the method developed by the authors of the questionnaires.
HRQoL was assessed at 3 time points: preinterventional, early postinterventional, and late postinterventional. Preinterventional assessment was performed in the catheterization laboratory, immediately before PCI, using the EQ-5D-3L VAS, a part of the EQ-5D-3L questionnaire. Early postinterventional HRQoL was assessed using both parts of the EQ-5D-3L questionnaire (descriptive system and VAS) 2 hours after PCI, when patients were still in the cardiac intensive care unit (ICU). Late postinterventional HRQoL was assessed on day 4 after PCI or at the time of discharge from hospital (depending on which occurred first) using all 3 questionnaires—EQ-5D-3L including VAS, QLI, and MacNew. At this point, most patients were in the general cardiology ward from where they were then discharged home.
Statistical analysis was conducted using IBM SPSS Statistics, version 21.0 (IBM, New York). Data were presented as mean and SD and as proportion. The chi-square test was used to compare clinical data between the 2 study groups. The Pearson correlation coefficient (r) was applied for correlation analyses (between the HRQoL instruments and selected clinical outcomes: The N-terminal of the prohormone brain natriuretic peptide and in-hospital mortality).
Results
A total number of 103 patients with STEMI were randomly assigned to TR (n = 52) or TF (n = 51) groups. The clinical characteristics and details of the study flow have been previously reported in the publication related to the primary end points of the OCEAN RACE study.
Preinterventional assessment of HRQoL was hindered by severity of patients’ clinical status, time limitations, and necessity of immediate treatment (PCI). Therefore, at this study point HRQoL was assessed only by the EQ-5D-3L VAS, the simplest and the least time-consuming of all instruments used in this study. The mean VAS score in the total study population was 50 points (SD = 22) and was comparable in both groups (TR 51.7 ± 22.83 vs TF 49.4 ± 21.22, p = 0.59).
An improvement in HRQoL compared with preinterventional evaluation was observed. The EQ-5D-3L VAS mean score improved by 18.7 points (+37%, p <0.001) in the total population, and no difference between the study groups was observed ( Figure 1 ). The mean EQ-5D-3L health utility score at 2 hours after PCI was 0.46 (SD = 0.291) in the total patient population and was higher in the TR group than in the TF group (0.60 ± 0.299 versus 0.32 ± 0.283, p <0.001; Figure 2 ). EQ-5D-3L health utility score ≥0.85 was noted in 10 subjects, all of them representing the TR group. All patients reported having a problem at least in 1 EQ-5D-3L dimension. Approximately 80% of all patients complained of mobility problems and decreased capabilities of self-care, and >50% of patients complained of pain or anxiety and/or depression. Fewer patients in the TR group compared with TF group reported problems with mobility (71.7% vs 94.4%, p <0.01) and self-care (62.5% vs 97.2%, p <0.001; Figure 3 ).
The mean EQ-5D-3L VAS score measured 4 days after PCI in the total study population was 68.5 (SD = 20.32), and no difference was found between the TR and TF groups (66.7 ± 21.43 and 70.3 ± 19.26, respectively). An increase in the mean EQ-5D-3L health utility score by 0.33 (+72.1%, p <0.001) was observed ( Figure 2 ). Improvement of HRQoL in the total patient population was mostly determined by an increase in the individual patient’s physical capacity and enhancement of capabilities of self-care and functional status. A detailed comparison of patient performance in EQ-5D-3L dimensions between both study groups revealed several different characteristics ( Figures 3 and 4 ). On day 4 after PCI, the only difference detected between the groups was the state of anxiety and/or depression, where considerably fewer patients in the TR group than in the TF group reported problems ( Figure 4 ). Interestingly, the proportion of patients in the TF group who reported problems with anxiety and/or depression ( Figure 5 ) increased from the early postinterventional period to the late postinterventional period—from 58.3% to 75%, respectively. This tendency was not observed in the TR group where the proportion of patients was similar at both time points (47.8% and 42.9% at early and late postinterventional periods, respectively). With regard to pain and/or discomfort, no changes in the proportion of patients reporting problems at early and late postinterventional periods occurred—approximately 1/2 of the patients in both groups, and at both time points, reported pain and/or discomfort. With regard to mobility and self-care, an improvement was observed in both groups, although it was more rapid in the TF group. In the TR group, 37.1% of patients reported problems with mobility (34.6% fewer than in the early postinterventional period) compared with 31% in the TF group (63.4% fewer than at the previous time point). A similar pattern was detected regarding self-care—a decrease in the proportion of patients reporting problems occurred in both groups ( Figure 4 ), but it was less predominant in the TR than TF group. With respect to usual activities, the proportion of patients reporting problems was also reduced (slightly >30% in both groups) and the magnitude of change was similar in both groups.
