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Publicaciones > Revista > 13V42N1

Randomized trial comparing same-day discharge with overnight hospital stay after transradial coronary stent implantation.

Javier Courtis [1], Alejandro Sarría Allende [1],
Mario Castellari [1], Magdalena Dimitroff [2], Analía González [3].

[1] Servicio de Hemodinamia e Intervencionismo endovascular, Clínica Romagosa, Clínica de la Familia e Instituto Oulton (Córdoba, Argentina)
[2] Facultad de Cs. Exactas, Físicas y Naturales, UN de Córdoba;
[3] Facultad de Biología, UN de Córdoba (Córdoba, Argentina).
Instituto Oulton
Av. Vélez Sarsfield 562 (CP 5000).
Córdoba (Capital), Argentina.
Tel: 351-4267700 (int 183). Fax: 351-4267765.
E Mail

Recibido 17-DIC-12 – ACEPTADO después de revisión el 31-ENERO-2013.

The authors declare not having conflicts of interest


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SUMMARY

In our region, the aftercare of patients undergoing percutaneous coronary intervention (PCI) with stenting is done in intensive care units over a period of approximately 24 h. It is unknown whether patients with low or moderate risk can be safely discharged the same day of a PCI without any complications. That is why this study was designed, randomized, controlled and open by comparing same day discharge vs. overnight hospitalization after a successful PCI stenting by transradial approach. Patients will give their informed consent before percutaneous intervention and they will be randomized after therapeutic procedure to group 1 (in which they will be discharged 8-10 h after finished PCI) or group 2 (remain hospitalized until morning after the procedure) and the data will be analyzed according to the "intention to treat". There will be a primary endpoint consisting of the combination of major adverse cardiovascular events (MACE) and serious complications of arterial puncture site, both produced during the first 24 h after angioplasty. In addition, three secondary endpoints will be analyzed from the hospital discharge up to 30 days post PCI, each separately: a) cost analysis, b) patient’s comfort and satisfaction, and c) a combination of MACE and complications at the puncture site. This research protocol has been authorized and supervised by the Faculty of Medical Sciences (National University of Cordoba – Provision Numbers: 3577) and was approved by the ethics committee of the institutions involved (CIEIS Oulton Romagosa) and registered and recorded in the Council on Health Research Ethics (Co.E.I.S.) of the Ministry of Health of the Province of Córdoba (Argentina).

Key words:Percutaneous coronary interventions. Transradial access. Outpatient.
Rev Fed Arg Cardiol. 2013; 42(1): -

 

INTRODUCTION
Since the first percutaneous coronary intervention (PCI) described by Grüntzig in 1977 [1] to this date, we have observed the development and continuing improvement of this therapeutic mode. Currently, guidelines indicate that the aftercare of patients who undergo this type of interventions should be made in intensive or semi-intensive care units for a period of approximately 24 h, even though no complications may have occurred and the patient is in optimal clinical conditions; this is mainly due to the concern inherent to adverse reactions that may happen after such interventions [2]. Over recent years, the progress reached in different surgical techniques has generated a great safety, thus encouraging an increasing development of outpatient surgery in a wide range of cardiac interventions. In spite of the significant development reached by cardiovascular interventionism in recent decades, in this area of cardiology only a minimal reduction of the post-PCI stay (PPCIS) has been achieved; while the latter is considered one of the main determinants for hospital costs and quality of medical care. Shortening this stay would not affect negatively the post-procedure care; on the contrary, we would see benefits in the comfort of the patient and we would reduce expenses [3]. As sanitary agents, we should consider the premise that the level of care of a patient and his/her location in the institution should be determined by his/her clinical condition and not by conditions imposed by health insurances. Lately, the number of percutaneous coronary interventions increased considerably, generating greater costs and use of hospital beds [4,5]. Based on this, and adding the fact that these procedures are currently very safe in most clinically stable patients, the outpatient modality is being considered in selected patients that undergo simple PCI and without complications [6-18]. The main advantages of post-PCI outpatient management, also called “same-day discharge” (SDD), would be a reduction in the expenses of medical care, a better use of beds in high-volume institutions, and a greater wellbeing of the operated patient. In brief, in selected individuals, SDD after elective, simple and uncomplicated PCI is nowadays a feasible and safe procedure that probably allows the comfort of the patient and reducing the costs caused by prolonged and unnecessary hospital stays.

With the aim of investigating if this modality of work can be applied in our area, the current project of investigation proposes corroborating the hypothesis that outpatients with PCI and coronary stent implantation without clinical and/or angiographic complications could be discharged safely 8-10 h after the procedure, without increasing the rate of complications in comparison to those that remain hospitalized overnight (ONH).

 

OBJECTIVES
The present paper has a general objective and two specific ones. The general objective is to prove that it is safe to discharge selected patients the same day of PCI without complications. The specific objectives are: a) to prove that post-PCI SDD allows saving costs and b) to show that SDD provides more comfort than remaining hospitalized overnight.

 

MATERIAL AND METHODS

  1. Selection of patients. All individuals older than 21 years of age sent to our hemodynamic labs (Romagosa Clinic, Clínica de la Familia, and the Oulton Institute, Córdoba, Argentina) will be invited to participate in the investigation, by undergoing a diagnostic coronary angiography (CA) with possible ad hoc angioplasty or scheduled PCI. In all cases it will be attempted to place one or more coronary stents and the transradial or transcubital access will be used as vascular approach. The exclusion criteria will be:
    a) Clinical:
    a.1) recent (<72 h) ST segment or non-ST segment elevation myocardial infarction (STEMI or NSTEMI); a.2) left ventricular ejection fraction (LVEF) ≤35%; hemodynamic collapse (sustained hypotension with signs and symptoms compatible with shock) during PCI; a.4) use of femoral artery access; a.5) allergy or intolerance to aspirin, thienopyridine, and/or iodine; a.6) INR ≥2.0 before the intervention; a.7) advanced heart failure (III-IV FC); a.8) advanced renal failure (creatinine clearance ≤30 ml/min or creatininemia ≥2 mg/dl) or terminal renal failure (hemodialyzed);
    b) Angiographic:
    b.1) transient occlusion (during PCI and except for balloon insufflation and/or stent) or persistent occlusion of the treated or an untreated vessel; b.2) persistent dissection ≥type B (according to the National Heart, Lung, and Blood Institute of USA) of the treated or an untreated vessel; b.3) involvement (residual ostial – proximal lesion >50% or involvement of distal TIMI flow) of a lateral branch (>1.5 mm of diameter of reference) to the treated segment; b.4) unfavorable change in coronary TIMI flow of the treated or an untreated vessel; and b.5) residual presence of intraluminal coronary thrombus;
    c) Social: c.1) patients hard to follow; and c.2) individuals that live beyond 60 Km from the health center. In the case the patient presents an enzymatic increase (total creatine phosphokinase (CPK) and the myocardial band (CPK-MB)) compatible with peri-procedure infarction (measurement made 6 h after finishing the PCI) and/or a significant and adverse change in the post-PCI electrocardiogram (ECG), he/she should remain hospitalized. Those patients with medical and/or social conditions that would justify their hospitalization according to their attending physician would remain so too. The present protocol of investigation is part of the project and PhD thesis career of the author, presented and authorized by the School of Medical Sciences of the Universidad Nacional de Córdoba (provision numbers 3577); it has also been approved by the Committee on Ethics of the Institutions participating (CIEIS Oulton Romagosa) and registered and recorded in the Council of Ethical Evaluation of Investigation in Health Care (Co.E.I.S. by its acronym in Spanish) from the Ministry of Health of the Province of Córdoba (Argentina).

  2. Management of the study. The present investigation has been designed as a collaborative work between the Romagosa clinic, the Clínica de la Familia, the Oulton Institute, the Universidad Nacional de Córdoba, and the main investigator. The first three mentioned centers will be in charge of enrolling patients and coordinating the logistics necessary to execute the study. Besides, it will be the responsibility of all the participating institutions to prepare the database of the study and to verify and analyze the results obtained. All the components of the primary and secondary endpoints will be allocated by members of an independent organization (Committee of Events) that will not know about the randomization and the follow-up of patients.

  3. Design and procedure.The study will be randomized, controlled and open, comparing SDD vs. overnight hospitalization (ONH) after successful PCI with stent placement and performed by transradial access. The patients will give their informed consent before the percutaneous intervention, will be randomized after the therapeutic procedure and the data will be analyzed according to the “intention to treat” principle. The individuals with at least one of the exclusion criteria will not be randomized and will be included in a parallel registry. All the patients with scheduled PCI will be pre-treated with aspirin (81-325 mg) and clopidogrel (minimal load dose of 300 mg orally the afternoon prior to the procedure). In the case of ad hocPCI, if the patient is not taking antiplatelet drugs, he/she will receive a load of clopidogrel (600 mg orally) and ASA (500 mg orally) in the hemodynamic lab and before the therapeutic intervention. If on the contrary, both in the scheduled or ad hoc PCI scenarios, the patient has been chronically taking antiplatelet drugs, the load of both will not be necessary. After placing the radial introducer and in the case of there being no problems to access the aortic root with the chosen catheter, a bolus of 70 U/kg of sodium heparin (IV) will be given for a CA (30 U/kg will be added in the case of continuing with ad hocPCI) and 100 U/kg in the case of scheduled PCI. Once the PCI is over (i.e. the stent has been implanted under standardized and accepted techniques, its good clinical angiographic result has been verified and the radial introducer has been withdrawn) the patients will be allocated randomly and through a system of closed envelopes to group 1 (in which they will be discharged 8-10 h after finishing the PCI) or to group 2 (to remain hospitalized until the morning after the procedure). The patients added to the registry will be discharged according to the decision of the operator and/or attending physician. The transradial artery introducer should be withdrawn at the end of the procedure in the hemodynamic lab and a hemostasis band will compress the puncture area for a theoretical period of 2 h; once the hemostasis has been ensured, the mentioned band will be removed and the patient will be advised not to perform sudden movements with the hand. Hospital surveillance will be made in the coronary unit under the usual care given to this type of patients. Both the blood analysis and ECGs carried out in both groups of patients, previous and after the procedure and made to control the evolution of the patients, will be as strictly indicated and advised, in number and type of determination for this type of medical practice. Serum analysis of hematology (cytological), chemical (total CPK, CPK-MB, creatininemia and uremia) and coagulation (prothrombin time, INR and platelets) will be made before the procedure. After the angioplasty and before the hospital discharge, cardiac enzymes (total CPK and CPK-MB) will be evaluated in both groups and all the studied population will fulfill a form on comfort and satisfaction analysis. Those individuals included in group 1 will be requested before their discharge to move and work by their own means for at least 10 minutes; during this period it will be evaluated whether the patients display symptoms and/or discomfort that would arise the suspicion of a complication. In the case the attending physician sees medical conditions that would prevent a safe discharge, the patient will remain in the hospital until the next day. In both groups two electrocardiograms (ECGs) will be performed; the first before the PCI (it will be taken as valid if the patient already has an ECG made within the 30 days prior to the procedure) and the second before the hospital discharge. All the ECGs will be reviewed by an independent cardiologist and blind to the randomization. The staff participating in the study will get in touch by phone with all the patients of group 1 the day after the PCI and a personal interview will be attempted at 30±7 days in all randomized individuals; both times the following will be recorded: a) clinically adverse and relevant events; b) admittance by any cause; and c) repetition of the unrequested medical visits. All the recorded events will be allocated by a member of the cardiological-clinical committee, blind to the allocation of the treatment. (Figure 1).


    Figure 1. Algoritmo de trabajo propuesto para el desarrollo del proyecto.



  4. Endpoints: There will be one primary endpoint that will consist of the combination of: a) major adverse cardiovascular events (MACE) and b) severe complications of the artery puncture site (forearm hematoma ≥grade III with need for blood transfusion or repeating compression), both occurring during the first 24 h after the angioplasty. Moreover, three secondary endpoints will be evaluated, each separately: a) analysis of costs; b) comfort and satisfaction of the patient, and c) the combination of MACE and the complications of the puncture site since the hospital discharge until 30 days after PCI.
    a- MACE is defined as the presence of any of the following clinical situations: sudden cardiac death, myocardial infarction, stroke and the need to repeat the PCI in the treated vessel.

    b- Hematoma ≥grade III is defined as when it extends in the forearm of the patient for more than 10 cm from the puncture site and is accompanied by blood muscular effusion.

    c- The financial effect of the same-day discharge will be evaluated by an analysis of minimization of costs. The prices per unit will be on the basis of real costs or derived costs from the Ca.E.S.Cor(Company Council of Health of Córdoba by its acronym in Spanish) guidelines. The real costs are estimated based on the directly involved staff, the unit of observation, the cardiological ward, the emergency room, and the costs of each of the medications and consumables used during the hospital stay of the patient. In the total estimation, the phone call made the day after the PCI to the patients in group 1 (SDD) will be included. The cost per hour of admittance in the coronary unit (without mechanical respiratory assistance) and that of a coronary angioplasty (with stent placement) will be based on the system of costs developed by the Ca.E.S.Corfor the second six-month period of 2012. The readmittance costs within 30 days will be the same as those previously allocated.

    d- For the analysis of comfort and the satisfaction of the patient, all the participants of the study will be requested to fill in a questionnaire with specific questions related to the procedure, which should be answered before the discharge. Such forms will be provided to the patients with specific instructions according to previously established guidelines [19].

  5. Protocol of care for patients in SDD: All patients allocated to group 1 (SDD) will be discharged between 7 and 9 pm of the day of the procedure and before the patient is discharged, the points described below will be verified:
    1. Written consent. Patient, relative and participating physicians will provide their written consent to discharge the patient in the scheduled time.
    2. Distance to their home. The patient should remain at less than 60 km from the hospital where he/she was operated.
    3. Moving resources: The patient should have resources (emergency service and/or personal means to move) to return to the hospital if necessary.
    4. Possible post-discharge symptoms: Explanations will be given to the patient in detail about signs and symptoms that should cause a phone call to the staff participating or those manifestations by which he/she should return immediately to the institution.
    5. Phone contact: The patient will be given the phone numbers of the staff participating in the investigation to get in touch if necessary.
    6. Ambulation: The patients will be requested to move before they are discharged and to walk by their own means for at least 10 minutes. During this period, they will be evaluated for symptoms and/or discomfort that would arise the suspicion of a complication.
    7. Puncture site: The site of the radial puncture should not present severe complications and a proper hemostasis should be verified.
    8. Electrocardiogram: 12-lead ECG after angioplasty without significant changes in regard to previous ones.
    9. Medications: The patient should have all the required medications for the night and the following day. If clopidogrel and/or ASA are needed for 48-72 h, the participating institutions should provide them.
    10. Safety: In the case the attending physician, the patient and/or a relative see medical and/or social conditions preventing a safe discharge, the patient will remain hospitalized until the following day.
    11. Post-discharge phone call: A phone call will be made the day after the PCI, during the morning (9 to 12 am). In such call, a questionnaire with this purpose will be asked and answered. 

  6. Dedicated report of cases (DRC): All the detailed and relevant information of each patient will be recorded in specially designed binders (DRC). Besides the demographic, clinical and procedural data, all the consumables used and complications that may arise will be documented. We will also include the exact time of hospital admittance, the end of PCI and the time of the institutional discharge. All the evaluations in the follow-up should be documented in the DRC. Whenever possible, accurate details will be given on the cases in which it is necessary to repeat the CA and/or PCI, a new admittance (>24 h), new medications, tests and unscheduled visits to the physician.

  7. Statistical analysis: The absolute difference between the primary endpoint rates to prove our main hypothesis that the discharge of the patient on the same day of a successful PCI in selected patients would not produce more complications (cardiac or related to the puncture site) will be used, compared with the overnight hospitalization. In the analysis, the allocation of events is made according to the randomization of patients independently from the final mode of the hospital discharge (“intention to treat”). The minimal number of patients that is estimated to work with will be 150, since there is no prior background or similar works in our area that would allow estimating the percentage of patients that will cover the requirements of the study (acceptance of the protocol and exclusion criteria). The comparison of the clinical variables will be made with the difference in absolute risk and 95% CI; the categorical data will be expressed as % and will be analyzed through the Fisher’s exact test and the continuous variables will be described as average±SD. A value of p<0.05 will be considered statistically significant and a 95% CI will be used. The data will be analyzed with the computer programs JMPTM 7 (SAS Institute, Cary, NC) and SPSS Advanced Statistics V.17.0 (Chicago: SPSS Inc, 2008).


REFERENCES.

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  3. Patel M, Kim M, Karajgikar R, et al. Outcomes of Patients Discharged the Same Day Following Percutaneous Coronary Intervention. J Am Coll Cardiol Intv 2010; 3: 851-858.
  4. Denvir MA, Lee AJ, Rysdale J, et al. Effects of changing clinical practice on costs and outcomes of percutaneous coronary intervention between 1998 and 2002. Heart 2007; 93 (2): 195-199.
  5. Ellis SG, Miller DP, Brown KJ, et al. In-hospital costs of percutaneous coronary revascularisation. Circulation 1995; 92: 741-747.
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  7. Koch KT, Piek JJ, de Winter RJ, et al. Short-term (4 hours) observation after elective coronary angioplasty. Am J Cardiol 1997; 80: 1591-1594.
  8. Knopf WD, Cohen-Bernstein C, Ryan J, et al. Outpatient PTCA with same day discharge is safe and produces high patient satisfaction level. J Invasive Cardiol 1999; 11: 290-295.
  9. Kiemeneij F, Laarman GJ, Slagboom T, et al. Outpatient coronary stent implantation. J Am Coll Cardiol 1997; 29: 323-327.
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  16. Carere RG, Webb JG, Buller CE, et al. Suture closure of femoral arterial puncture sites after coronary angioplasty followed by same-day discharge. Am Heart J 2000; 139: 52-58.
  17. Yee KM, Lazzam C, Richards J, Ross J, Seidelin PH. Same-day discharge after coronary stenting: A feasibility study using a hemostatic femoral puncture closure device. J Interv Cardiol 2004; 17: 315-320.
  18. Wilentz JR, Mishkel G, McDermott D, et al. Outpatient coronary stenting: Femoral approach with vascular sealing. Herz 1999; 24: 624-633.
  19. Cooper CJ, El-Shiekh RA, Cohen DJ, et al. Effect of transradial access on quality of life and cost of cardiac catheterization: A randomized comparison. Am Heart J. 1999; 138: 430-43

 

Publicación: Marzo 2013

 
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