Patient Satisfaction is Comparable to Early Discharge versus Overnight Observation after Elective PCI (see full title below)

ABSTRACT: Background. Previous investigation has suggested that early discharge after percutaneous coronary intervention (PCI) is feasible and safe, but these studies have utilized largely radial approaches or been conducted in non-U.S. cohorts. We sought to assess patient satisfaction, safety and cost of a strategy of selective early discharge in U.S. patients undergoing PCI via a femoral approach with contemporary adjunctive pharmacologic and hemostasis agents. Methods and Results. Patients with stable coronary artery disease undergoing elective PCI were prospectively recruited and randomized to either routine care, with an overnight hospital stay, versus early discharge 2 hours following successful PCI with adjunctive bivalirudin therapy and a femoral arterial closure device at the end of the procedure. The primary endpoints were safety and patient satisfaction as measured by a validated patient satisfaction survey during the index hospital stay and at 30 days. A total of 39 patients were randomized, with 20 to routine care and 19 to early discharge. There was no difference in major safety endpoints including death, non-fatal MI, urgent target lesion revascularization and thrombolysis in myocardial infarction (TIMI) major bleeding, with none in either group. Mean patient satisfaction scores were similar and high in both groups (89.6 for early discharge patients and 90.7 for routine care patients, p = 0.68). There was lower cost in the early discharge group, with a mean cost of $8,604 versus $10,565 in the routine care group (mean difference $1,961, 95% confidence interval, -$96 to $4,017). Conclusion. Patients undergoing elective PCI for stable coronary artery disease may have similar safety and satisfaction with early discharge when using a careful strategy that incorporates optimal stent and hemostasis results and contemporary adjunctive anticoagulation therapy, with lower cost. This strategy may serve as a basis for a larger-scale randomized trial. J INVASIVE CARDIOL 2009;21:464–467 Key words: PCI, angioplasty, stent, coronary artery disease, cost More than 1.2 million percutaneous coronary interventions (PCIs) were performed in the United States in 2005.1 Periprocedural mortality rates have declined to Methods Patient selection. Patients were recruited prospectively from two centers (Hospital of the University of Pennsylvania, Penn Presbyterian Medical Center) in Philadelphia. Informed consent was obtained from each patient prior to the procedure and approval for the protocol was obtained from the Institutional Review Board of the University of Pennsylvania. Only patients with stable coronary artery disease with optimal final angiographic results after PCI were eligible for participation. Patients known to be at higher risk for ischemic and vascular complications were excluded from the study. This included patients with acute coronary syndromes (ACS) including unstable angina, non-ST-elevation myocardial infarction (NSTEMI), ST-elevation MI (STEMI), or recent MI (in the past 30 days). Other exclusions were age > 75 years, ejection fraction 2.2), bleeding diathesis or anemia, intraprocedural vascular access site complications, saphenous vein graft intervention, interventions involving the left main coronary artery, thrombus seen prior to intervention, ACC Type-C lesions and any previous intervention on the same vessel requiring radiation therapy. Procedures requiring adjunctive devices such as rotational or direct atherectomy, laser excision and angioplasty procedures without stent use were also excluded. As the study protocol evaluated patients undergoing femoral approach to PCI, only those eligible for vascular closure device, determined by arteriogram, were included. Procedural methods. PCI was performed in standard fashion via a femoral approach. During PCI all patients received adjunctive intravenous bivalirudin at a dose of 0.75 mg/kg bolus, followed by a continuous intravenous infusion at 1.25 mg/kg/hour until the end of the procedure. All patients received aspirin (325 mg) and clopidogrel (600 mg) immediately post procedure if not previously administered. A vascular closure device (Angio-Seal™, St. Jude Medical, St. Paul, Minnesota) was deployed immediately upon termination of the procedure to achieve hemostasis. Once satisfactory coronary and vascular immediate results were achieved, patients were eligible for randomization to early discharge or overnight stay in the hospital. Early discharge group. Patients randomized to early discharge were observed for 2 hours post procedure in the catheterization laboratory recovery unit. If vascular complications or bleeding occurred during this time, they were admitted for routine in-patient care; if not, patients were discharged. Serum hemoglobin, platelet count and cardiac panel were drawn 6 hours post procedure and the following morning by a visiting study nurse and the out-patient laboratory. Patients were contacted by the responsible nurse/physician for admission to the hospital if the hemoglobin was decreased from baseline by > 1.5 gm, if the hemoglobin was 100,000, or if creatine kinase or troponin I was 2 times above the upper limit of normal. Patients without complications post PCI in the out-patient group were discharged to a nearby hotel with a responsible family member. Routine care group: Those patients randomized to routine care were admitted to the hospital after completion of PCI. Patients in both groups received a phone call 30 days post discharge to assess for further ischemic or vascular events, other complications and to reassess patient satisfaction. Outcomes. The primary endpoints were patient safety and satisfaction as measured by the Press Ganey patient satisfaction survey (Press Ganey Associates, Inc.). Major safety endpoints included death, nonfatal MI, urgent target lesion revascularization and thrombolysis in myocardial infarction (TIMI) major bleed. Minor endpoints included minor bleeding and readmission to the hospital. Hospitalization cost was a secondary endpoint. Patient satisfaction and cost assessment. The Press Ganey patient survey is a validated questionnaire that reports scores up to 100 to assess patient satisfaction in the in-patient setting. Only validated, standard questions from the questionnaire were used (Appendix I). Question categories included: admission details, nur-sing, physician, personnel, tests and treatments, meals, patient family and visitors. Patients were given a validated response scale of very poor, poor, fair, good and very good. Patients were also asked the following question: If given a choice, when would you prefer to be discharged to your home after this coronary stent procedure? • The morning after the procedure; • Later the same day (2–4 hours after the procedure); • No preference. The response to this question was not summed with the scoring of the Press Ganey survey. Both measures were used to assess patient satisfaction and preferences in the early discharge and routine care groups on the day after the procedure, as well as at 30 days. Actual in-patient costs were obtained with patient-specific medical billing data. Statistical analysis. Continuous variables were compared using a Student’s t-test. Categorical variables were compared with a Fisher’s exact test. All results are based on an intention-to-treat analysis. Results Patients were recruited between September 2004 and July 2006. A total of 39 patients were enrolled. Twenty patients were randomized to routine care and 19 were randomized to early discharge. One patient, who was randomized and discharged after a post-PCI intensive care stay, was excluded from the study for failing to meet inclusion criteria, having multiple exclusion criteria and for protocol violation. There were no significant differences between the two groups in terms of patient and angiographic characteristics (Table 1). Safety. Seventeen of 19 patients (89%) randomized to early discharge were successfully discharged early. One patient had minor puncture-site bleeding at the 2-hour point and was admitted to have a pressure bag applied. The bleeding resolved and the patient was discharged the following morning with a normal vascular ultrasound. A second patient reported dizziness at the 2-hour point and remained in the hospital for observation without complication. There were no ischemic, bleeding or vascular complications in either group after 1 day. Thirty-day follow up was obtained for all patients. There were no predefined major complications at 30 days. Two patients, 1 from each group, presented to the hospital within 30 days, but neither required intervention (Table 2). One patient in the in-patient group presented to the emergency room 1 week later for malaise, but was not admitted and did not require further treatment. One patient randomized to same-day discharge presented to the emergency room with chest pain 14 days after PCI. Cardiac catheterization showed a patent stent, and the patient was discharged without intervention. Patient satisfaction and discharge preference. Press Ganey satisfaction questionnaires were completed by 95% of patients after 1 day (Table 3). Overall satisfaction was high in both groups. Mean scores were 89.6 for early discharge patients and 90.7 for routine care patients (p = 0.68). Satisfaction questionnaires were completed by 95% of patients at 30 days (Table 3, Figure 1). The scores remained high and similar between groups (94.8 vs. 97.0; p = 0.27). When asked directly whether they would prefer routine in-patient care versus early discharge, slightly more patients in both groups preferred early discharge than next-day discharge in both groups (Table 3) (47% of early-discharge patients and 53% of routine care patients preferred early discharge). Eighteen percent in the routine-care group had no preference compared with 16% in the early-discharge group. Thirty-day patient preference questionnaires were completed by 97% of patients (Table 3). Patient preferences did not change significantly by 30 days (58% of early discharge patients and 47% of routine care patients preferred early discharge). Cost. Cost data were obtained for all study patients (Table 4). The mean cost was lower in the early-discharge group compared with the routine-care group ($8,604 vs. $10,565, respectively, mean difference: $1,961, 95%. Confidence interval of the difference: -$96 to $4,017). Discussion Early discharge after PCI has been shown in various studies to be feasible in stable patients, and possibly cost effective,2–13 but our study is the first published prospective, U.S.-based, randomized, controlled trial that assessed more rigorously the cost and satisfaction benefits of early discharge. Our study is consistent in its findings regarding the safety and feasibility of early discharge in a population of patients undergoing PCI for stable angina. The procedural complication rate was low, with no major complications and minor complications in only 5%, and with no difference between groups, similar to other randomized trials of early discharge versus routine in-patient care.9,12,13 Our successful discharge of 89% of patients is similar to that seen in other trials, but our trial design differs in several important ways. Unlike our study, one used a radial approach and included patients with ACS, while another randomized patients before PCI results.12,13 We believe that our unique study design could be a model for a large-scale trial. It is consistent with good clinical practice in that it allows discharge only after a successful procedure, including satisfactory hemostasis, and preserves the benefits of early discharge. We sought to maximize safety using a short-acting antithrombin and a femoral closure device. Bivalirudin is especially attractive for stable outpatients because bivalirudin is given only during the time of the procedure and has a short half-life, allowing rapid tapering of the anticoagulant effect. Furthermore, bivalirudin has been shown to be superior to unfractionated heparin combined with a glycoprotein IIb/IIIa inhibitor in a combined endpoint of efficacy and safety in the REPLACE II randomized, controlled trial, an endpoint especially important in patients discharged early after PCI during a period of decreased formal.14 The combination of the retained ischemic efficacy and a reduction of bleeding complications make bivalirudin a uniquely suited adjunct to PCI in this early discharge population. A second important factor in determination of bleeding is early ambulation post PCI. The use of devices to aid in achieving hemostasis has significantly decreased ambulation times and has been shown in some retrospective series to improve bleeding and vascular complication rates.6,10,15 The use of a closure device is thus particularly suited for an early discharge population. We found high levels of satisfaction among patients in both groups at 1 day and at 30 days. On a 100-point scale, the difference between groups was only 1 point 1 day after PCI, and 2 points at 30 days. In contrast, the only other randomized trial to assess satisfaction with a standardized scale found significantly higher patient satisfaction in the out-patient group (78.6 vs. 73.6; p = 0.001).12 The similarly high satisfaction scores in our study may simply reflect the high satisfaction and acceptance of U.S. patients with an overnight stay. In this regard, we assessed through a separate question whether patients had a discharge preference. About half of the patients in our study preferred early discharge, regardless of their randomization, a preference that did not change significantly by 30 days. This also contrasts with the EPOS trial,12 where the majority of patients preferred whichever experience they were randomized to when asked (73% of early discharge patients preferred early discharge, while 32% of inpatients preferred early discharge). It is possible that cultural preferences and expectations differ in Europe, where the concept of early discharge may be more widely considered safe and acceptable compared with the U.S. Knowledge in the U.S. that early discharge is not standard care may have led to discomfort with the idea of leaving early, and thus lowered satisfaction. Finally, we provided an option of no preference, and it is possible that many of those patients would have chosen the care they experienced if forced to choose. Our satisfaction findings are more striking when considering that patients who were uncomfortable with early discharge may have been less willing to participate in this study. As an example, women have been previously demonstrated to less often prefer early discharge,16 and the low number of women consenting to our trial may support this previous finding. Thus, our cohort may have been more open to the concept of early discharge than the general U.S. PCI population. In this regard, a future trial may examine further the impact of a patient’s preconceived preference for early discharge versus routine care on his or her overall satisfaction. Our present findings suggest that further investigation may be warranted into preferences of U.S. patients before adoption of a policy of early discharge. We found a trend toward decreased cost of early discharge which was close to statistical significance despite the small number of patients in our study. Few studies have examined the cost effectiveness of early discharge, and the only randomized trial to do so failed to show a significant difference.12,17 Variability in procedural and medication costs of PCI have been suggested as a reason that cost savings could not be previously demonstrated despite early discharge in these non-U.S. systems. A longer hospital stay due to complications after early discharge, and its ensuing high costs, while feared, has not proven to be the case. Thus, our U.S.-based study suggests that perhaps with more standardized interventional practices, a larger study could demonstrate significant cost savings to an early discharge approach. Study limitations. This study was designed as a pilot study to demonstrate the safety, feasibility and patient acceptance of outpatient coronary intervention, and thus a larger study is required to confirm similar patient satisfaction and cost savings. The size of the study limits the ability to examine potential confounders such as educational status. Our findings apply to those patients managed with this hemostasis and antithrombotic strategy, and thus may not necessarily be generalized to other practice patterns. Patients were enrolled in centers in the middle Atlantic region, and patient preferences may differ in other parts of the country. The use of bivalirudin increases universal costs compared with a heparin alone strategy. Conclusion In conclusion, our study suggests that early discharge after PCI in stable patients is safe and feasible. Patient preferences are similar with both routine care and early discharge. While the potential cost savings of early discharge, suggested by our study, when applied to the U.S. stable PCI population is significant, this may need to be weighed with patient satisfaction, an area which warrants further investigation. _________________________ From aCardiology Consultants, Pennsylvania, Division of Cardiovascular Medicine, Christiana Hospital, Newark, Delaware; the bDivision of Cardiovascular Medicine, and the cDepartment of Medicine, Hospital of the University of Pennsylvania, Philadelphia; and the dDivision of Cardiovascular Medicine, Penn Presbyterian Hospital, Philadelphia. The authors report no conflicts of interest regarding the content herein. Grant Support: Partial funding provided through unrestricted medical school grants from the Medicines Company, St. Jude Medical, and from the Bach Fund of Penn Presbyterian Medical Center. Manuscript submitted January 16, 2009, provisional acceptance given February 15, 2009, final version accepted May 18, 2009. Address for correspondence: Ruchira Glaser, MD, MSCE, FACC, Cardiology Consultants, PA, 252 Chapman Road, Newark, DE 19702. E-mail: ruglaser@gmail.com

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