An Open Randomized Study Prague-5 ˆ

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1 Next Day Discharge After Successful Primary Angioplasty for Acute ST Elevation Myocardial Infarction An Open Randomized Study Prague-5 Radovan JIRMÁR, 1 MD, Petr WIDIMSKÝ, 1 MD, Jan CAPEK, 1 MD, Ota HLINOMAZ, 2 MD, and Ladislav GROCH, 2 MD SUMMARY This study tested the feasibility and safety of next day hospital discharge after successful primary PCI for uncomplicated STEMI. Twenty-three p-pci patients (out of 271 consecutive patients) who fulfilled the study inclusion criteria were enrolled in the pilot nonrandomized phase (transfer of patients from the coronary unit to a standard ward within 24 hours after their admission) of the study. The randomized phase of the study screened a total of 1946 consecutive STEMI patients undergoing p-pci in the two participating centers. Only 56 (ie, 2.9% from all p-pci) very low risk patients residing less than 2 km from the PCI center were selected. They were randomized 1:2 to either a standard hospital stay (group A, n = 19, age, 58 ± 8) or first day discharge (group B, n = 37, age, 56 ± 1; NS). There were no serious complications among 79 study patients within 3 days. The duration of hospital stay was 15 ± 45 hours (group A) and 29 ± 3 hours (P <.1) in group B. Ejection fraction after 3 days was 56.8 ± 6.5% in group A versus 57.3 ± 7% in group B (NS). A patient comfort questionnaire showed a clear preference of first day discharge in all patients randomized into group B. The results indicate that next day discharge after successful p-pci is feasible and safe in selected uncomplicated STEMI patients. (Int Heart J 28; 49: ) Key words: Myocardial infarction, Angioplasty, Early hospital discharge THE early mobilization of patients following an acute myocardial infarction (AMI) has gradually shortened the hospital stay over the last 4 years. The average hospital stay for AMI patients was 4-6 weeks in the 197s, 2-3 weeks in the 198s, and 1-2 weeks at the beginning of the 199s. In recent years, several studies 1-4) showing the possibility of an even further reduction in the hospital stay From the 1 Cardiocenter, Department of Cardiology, 3rd Faculty of Medicine, Charles University in Prague and University Hospital Kralovské Vinohrady, Prague, and 2 Internal-Cardiovascular Clinic, St. Anne s University Hospital, Brno, Czech Republic. Address for correspondence: Radovan Jirmár, MD, Cardiocenter, Department of Cardiology, 3rd Faculty of Medicine, Charles University in Prague and University Hospital Kralovské Vinohrady, Srobárova 5, Prague , Czech Republic. This study was supported by grant NA/ IGA of the Ministry of Health, Czech Republic. Data analysis and manuscript preparation was partly supported by Charles University Research Project MSM Received for publication July 28, 28. Revised and accepted August 28,

2 654 JIRMAR, ET AL Int Heart J November 28 in a group of low-risk acute coronary syndrome patients were published. Efforts to reduce the treatment costs played a certain role when these studies were started. The Cardiocenter Kralovské Vinohrady in Prague has been engaged in the routine p-pci treatment of all STEMI patients since October Our experience of more than 1 years with primary PCI led us to investigate whether selected uncomplicated STEMI patients treated by successful p-pci could be discharged within a few hours. METHODS Inclusion and exclusion criteria: A set of strict inclusion and exclusion criteria was predefined after discussion with the hospital ethics committee to allow enrollment of only the lowest risk patients who were unlikely to suffer from any serious complications. The committee suggested that the permanent residence of these patients should be close to the PCI center and they should be visited shortly after discharge at home by a physician. These criteria are listed in Table I. Screened STEMI patients: A total of 2217 consecutive patients with acute STEMI were treated by primary PCI in the two participating centers during the study period (23-26). Only 79 of these (3.6%) fulfilled the strict inclusion/ Table I. Inclusion and Exclusion Criteria for the Study Inclusion criteria 1. Signed informed consent and subsequent written agreement of a family member (confirming good social background). 2. Acute STEMI (ST elevation in 2 leads) treated by p-pci within 6 hours after the onset of symptoms. 3. Optimal result of p-pci (TIMI-3 flow and < 2% residual stenosis) 4. Single-vessel disease: the infarctrelated artery is the only major coronary artery with significant (> 7%) stenosis. 5. Patient permanent residence < 2 km from PCI center. 6. Left ventricular ejection fraction > 4% (echocardiography hours after admission). 7. Age < 75 years. 8. Telephone contact between the patient and PCI center after discharge is available 24 hours daily. Exclusion criteria 1. Previous Q-MI in other location. 2. Signs of heart failure (Killip II-IV). 3. Hypotension (< 1 mmhg SBP) persisting after p-pci. 4. Chest pain recurrence. 5. Clinically significant arrhythmia (requiring treatment) occurring > 6 hours after PCI. 6. Serious clinical/laboratory findings requiring additional evaluation. 7. Need for anticoagulation therapy. 8. Patient enrolled in other research project during this STEMI.

3 Vol 49 No 6 EARLY DISCHARGE OF MI PATIENTS AFTER PRIMARY PCI 655 exclusion criteria. The most frequent reasons for exclusion of a patient from the study were a residence more than 2 km from the hospital (48% of excluded patients), significant multivessel disease (16%), and age > 75 years (11%). Pilot nonrandomized phase (suggested by the ethics committee prior to the randomized phase) means the transfer of patients from the coronary care unit to a cardiology ward with free regimen within 24 hours after their admission. In this phase, 23 p-pci patients (age, 58 ± 1 years) who fulfilled the study inclusion criteria were enrolled. There were no complications during standard hospital stay in these patients. The randomized phase of the study was approved by the ethics committee based on the encouraging outcomes of the pilot phase. Fifty-six very suitable patients were randomized to either a standard hospital stay group (group A, n = 19, age, 58 ± 8) or first day discharge group (group B, n = 37, age, 56 ± 1; NS). The baseline data of all 79 study patients are presented in Table II. Randomization: Patients fulfilling the inclusion and exclusion criteria were randomized by the envelope method into two groups: A (standard hospital stay) and B (discharge within 24-3 hours after admission). The randomization ratio was 1:2. Patients randomized into the early discharge group were given detailed instructions concerning the physical load, and dietary and regimen steps for each individual day until the seventh day after discharge from hospital. The member of the family who helped with the home care was informed about the patient s condition in detail and was briefed on the basic symptoms that might point to the recurrence of a coronary event or heart failure. Follow-up: Patients were carefully followed during the first month (clinical check up on the 1 st, 2 nd, 3 rd, 7 th and 3 th day, laboratory examinations on the 1 st and 7 th day, and echocardiography on 1 st and 3 th day). The patients were contacted by phone on day 2, while on day 3 a physician visited the patient at home (group B) and on days 7 and 3 the patients visited the PCI center. Study duration and endpoints: As this study was designed as a feasibility and safety study and the pilot phase showed a low proportion (among all p-pci Table II. Baseline Clinical Data of the Study Patients Pilot phase patients Group A patients Group B patients n Mean age ± SD Females Diabetes mellitus Hypertension Smokers (incl. past) Hypercholesterolemia Anterior location of MI ± 1 13% 22% 39% 7% 3% 57% ± 8 68% 37% 21% ± 1 46% 19% 46% 57% 24%

4 656 JIRMAR, ET AL Int Heart J November 28 patients) of patients fulfilling the strict inclusion criteria, our intention was to randomize at least 5 patients who fulfilled the study criteria. The following endpoints were followed within 3 days: death, reinfarction, stroke, unstable angina pectoris, rehospitalization, repeat target vessel revascularization, local groin complications requiring treatment, and left ventricular ejection fraction. Catheterization and arterial access site care after intervention: The coronary angiography and subsequent primary PCI were performed with 5-6 F catheters. Heparin was not applied any further after PCI was completed. When the APTT fell below 5 seconds, the inguinal sheath was removed, followed by manual compression and 6 to 8-hour application of circular compression. Antithrombotic therapy: After the initial treatment with acetylsalicylic acid 25-5 mg i.v. and heparin 13 IU/kg i.v., the patients received acetylsalicylic acid 2 mg per day, and a clopidogrel loading dose of 3 mg (during the later study course 6 mg) with a subsequent daily dose of 75 mg. Additional medication: Additional medication was left to the discretion of the attending physician. Beta-blockers, ACE inhibitors, and statins were given to all patients unless contraindicated. Approval of the study: Informed consent was obtained from each patient. The study was approved by the Ethics Committees/Institutional Review Boards of both participating hospitals. Some changes suggested by these bodies prior to the start of the study are described above. The study protocol conforms to the ethical guidelines of the 1975 Declaration of Helsinki as reflected in a priori approval by the hospital human research committee. Statistical analysis: The data are presented as the mean value ± SD or percentage. The unpaired t-test was used for continuous variables between groups, while Fisher s exact test was used for categorical variables and the Mann-Whitney test for independent two samples. A P value <.5 was considered to indicate statistical significance. RESULTS There were no serious complications among the 79 study patients within 3 days (Table III). The duration of hospital stay was 15 ± 45 hours (group A) and 29 ± 3 hours (P <.1) in group B. Ejection fraction after 3 days was 56.8 ± 6.5% in group A versus 57.3 ± 7% in group B (NS). The patient comfort questionnaire filled in on day 7 showed a clear preference for first day discharge; all patients randomized into group B were satisfied with the first day discharge, while only 37% of patients in group A were satisfied with their standard length of hospital stay. One patient in the pilot nonrandomized phase suffered from a groin arterial pseudo-aneurysm after catheterization that required surgery. One patient

5 Vol 49 No 6 EARLY DISCHARGE OF MI PATIENTS AFTER PRIMARY PCI 657 Table III. Clinical Endpoints Within 3 Days Pilot phase patients Group A patients Group B patients n Duration of hospital stay (hours) Death Reinfarction Stroke Recurrent ischemia Repeat target vessel revascularization Arterial access site complications requiring treatment Rehospitalization 3 days left ventricular ejection fraction (%) ± ± ± ± ± ± 7. in group B was rehospitalized due to dizziness of noncardiac origin during the first week after MI. The participating Coronary Care Units did not receive any telephone calls, the aim of which was consultation concerning the health condition of the patient, from B group patients (early discharge from hospital). DISCUSSION Primary PCI is a method of acute STEMI treatment, which has proved to be safe and effective. 5) In comparison with intravenous thrombolysis, it leads to a significantly greater reduction in the risk of ischemia recurrence, new myocardial infarction, and to a greater reduction in the risk of cardiac death in some groups of STEMI patients. 6,7) Compared with thrombolysis, it brings a lower risk of stroke and hemorrhagic complications. The knowledge of anatomy of the whole coronary bed enables an exact stratification of patients with regard to the risk of another coronary event in the early postinfarction period. Stent indwelling into the affected part of the coronary artery considerably reduces the risk of reocclusion in the early period after AMI. 8) The aim of our study was to identify a very low risk group of patients who would have no cardiac complications in the early postinfarction period. Considering the above mentioned details and our previous experience with treating STEMI patients, we concluded it would be sufficient to stratify the patients on the basis of physical examination, coronary angiography and coronary intervention, 24-hour ECG monitoring, and echocardiography examination. Exercise test performance was not considered beneficial in our STEMI patients who were randomized into the very early discharge group in this study. Strictly defined criteria and their observance led to the fact that only 3% of acute STEMI patients from the catchment zones of the study centers were randomized in our study. For safety and organizational reasons, the patients whose

6 658 JIRMAR, ET AL Int Heart J November 28 transfer distance was greater than 2 km from the facility did not participate in the project. This caused another reduction in the number of suitable patients who could be included in our study. We determined there were only a few foreign studies dealing with the problems of early discharge from hospital into home care after AMI. 2,3,4,9) There was no study in which the average time of hospitalization was less than 72 hours. The majority of these studies dealt with patients treated with intravenous thrombolysis, 2,4) and most investigated patients who underwent coronary angiography or exercise testing before discharge from the hospital. This approach, however, did not enable very early discharge. The authors of these studies came to the conclusion that organizational problems concerning the early discharge from hospital and the low socioeconomic background of the patients had been the most common reasons the duration of hospitalization could not be reduced below the limit of 72 hours. These problems were unimportant in our patients; very early discharge could not be realized in only a few as they lived on upper floors and there were no elevators in their houses. Our study may be considered as unique with regard to the average time of hospitalization achieved, which did not exceed 3 hours in the very early discharge group of patients. The patients evaluation and views of very early discharge from hospital are also important (the reaction of 1% of group B patients was favorable, 6% of group A patients preferred very early discharge to standard length of hospitalization). Our primary goal was not to evaluate the economic benefits of very early discharge in comparison with the standard time of hospitalization in STEMI patients. Emphasis was placed on the possibility and safety of very early discharge into home care and the comfort of the patient. Study limitations: Our study is limited by the small number of patients (very strict inclusion and exclusion criteria, two participating centers only), so the reproducibility in a large-scale multicenter trial is needed prior to application of this management strategy in clinical practice. Further studies are also needed to verify whether this policy is safe for patients with multivessel disease, elderly patients, and patients who reside far from a PCI center. Conclusion: Successful primary PCI performed within 6 hours of symptom onset in highly selected low-risk STEMI patients with single vessel disease enables next day discharge from the hospital. However, only a small number of patients fulfilled our criteria for this very early discharge. REFERENCES 1. Andersen HR. Final results of the DANAMI-2 trial. Presented at the Late Breaking Clinical Trials session at the Annual Meeting of the American College of Cardiology, March 22.

7 Vol 49 No 6 EARLY DISCHARGE OF MI PATIENTS AFTER PRIMARY PCI Wilkinson P, Stevenson R, Ranjadayalan K, Marchant B, Roberts R, Timmis AD. Early discharge after acute myocardial infarction: risks and benefits. Br Heart J 1995; 74: Grines CL, Marsalese DL, Brodie B, et al. Safety and cost-effectiveness of early discharge after primary angioplasty in low risk patients with acute myocardial infarction. PAMI-II Investigators. Primary Angioplasty in Myocardial Infarction. J Am Coll Cardiol 1998; 31: Senaratne MP, Irwin ME, Shaben S, et al. Feasibility of direct discharge from the coronary/intermediate care unit after acute myocardial infarction. J Am Coll Cardiol 1999; 33: Grines CL, Goldstein JA, Safian RD. Should we routinely use drug-eluting stents for acute myocardial infarction?: Let s wait and see. J Am Coll Cardiol Intv 28; 1: Zijlstra F, de Boer MJ, Hoorntje JC, Reiffers S, Reiber JH, Suryapranata H. A comparison of immediate coronary angioplasty with intravenous streptokinase in acute myocardial infarction. N Engl J Med 1993; 328: Weaver WD, Simes RJ, Betriu A, et al. Comparison of primary coronary angioplasty and intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review. JAMA 1997; 278: Widimský P, Budesínský T, Vorác D, et al: PRAGUE Study Group Investigators. Long distance transport for primary angioplasty vs immediate thrombolysis in acute myocardial infarction. Final results of the randomized national multicentre trial -- PRAGUE - 2. Eur Heart J 23; 24: Yip HK, Wu CJ, Chang HW, et al. The feasibility and safety of early discharge for low risk patients with acute myocardial infarction after successful direct percutaneous coronary intervention. Jpn Heart J 23; 44: 41-9.