Clinical trial NCT01230606: Same Day Versus Next Day Discharge: Ambulatory Closure Device Percutaneous Intervention
Official title: Ambulatory Closure Device Percutaneous Intervention: a Multi-Center Randomized Trial Evaluating Patient Satisfaction, Safety, and Cost Effectiveness of Ambulatory PCI in the Current Era
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Keywords: Percutaneous Intervention
Percutaneous Coronary Intervention
Catheterization
Coronary Catheterization
Same day Discharge
Next Day Discharge
Patient Satisfaction
Multi-Center
Randomized
Low-risk PCI
BlindedClosure device
Vascular closure device
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2010-10-29
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The target population for this study will include patients undergoing an elective PCI. Overall, 600 patient will be recurited from two sites in the United Sates. As this is a feasiblity study, enrollment will be restricted to low-risk patients. For this reason, the study will be limited to patients under 75 years of age. All patients must meet all of the inclusion criteria and have none of the exclusion criteria to be enrolled into the study.

Brief summary: This is a multi-center trial that will evaluate the safety, feasibility, and cost effectiveness of discharging patients, who have had successful percutaneous coronary intervention (PCI) and deployment of the AngiomaxTM closure device, 6 hours after against 24 hours after the procedure. Patients will be randomized in a 3 (test): 1 (control) fashion and will have a study population of 600 patients over 6 investigational sites all within the United States. Patients \<65 years old will be chosen in order to stay within the low risk group and will be followed up after 24 hours, 7 days, and 30 days via phone or office visit. The primary endpoint will be a composite of major adverse cardiac and cerebral events, and the incidence of major bleeding or vascular complications. Data acquired from the study, such as blinded financial information and patient satisfaction surveys, will be used in order to evaluate cost analysis and safety of the procedure.

Detailed description: Closure devices are a relatively new method for sealing the femoral arterial puncture following procedures including percutaneous intervention (PCI). Because the risk of severe complications (e.g., bleeding, myocardial infarction, stroke, and mortality) associated with PCI when closure devices are very low, many patients undergoing PCI may be considered eligible for a same day hospital discharge. As the practice of ambulatory PCI is becoming more common, it is important to evaluate the readiness of patients under-going PCI for same-day discharge and anxiety and coping abilities of patients post-discharge. Our hypothesis is that same day discharge of patients who have undergone a PCI procedure with closure using a vascular closure device is safe, patients will be comfortable with a same day discharge and this process will be more cost efficient than the current standard of staying in the hospital overnight. The current pilot study is a multi-center, randomized parallel arm, controlled trial of low-risk patients undergoing an elective PCI procedure. Overall, 600 patients will be enrolled. After providing informed consent, participants will be randomized to leave the hospital on the same day as the PCI procedure or stay overnight in a 1:1 ratio. Data collection includes a self-administered questionnaire at hospital discharge, telephone interviews at 7-days and 30-days post-hospital discharge, and chart abstraction. The primary outcome for this study is differences across randomization arm in patient satisfaction scores on the validated 10-item Post-discharge coping difficulty scale assessed 7 days post-discharge. Secondary outcomes will include differences across randomization group for symptoms of anxiety, readiness for hospital discharge, patient satisfaction with the timing of their discharge, post-procedure pain and soreness, and cost-savings. While a data safety monitoring board will track all adverse events (i.e., myocardial infarction, hematoma, hospitalizations, and mortality), we anticipate too few events to occur to make meaningful inferences beyond that PCI is safe regardless of the timing of hospital discharge. The data from this pilot study will determine the comfort patients experience after undergoing PCI with an ambulatory (i.e, same-day) hospital discharge. Furthermore, this pilot study will provide the foundation for a large scale non-inferiority study of same-day discharge on outcomes including myocardial infarction, bleeding, and mortality. Such data will indicate the overall feasibility of early ambulatory PCI and has the potential to radically alter health care delivery following PCI.

Eligibility criteria: Inclusion Criteria:

. \<75 years of age at the time of procedure.

2. Patient has a type A or B lesion(s)

3. Femoral access site is amenable to closure with a vascular closure device.

4. Over 2 hours since the completion of the PCI procedure (at least 2 hours must elapse from completion of the PCI before subjects become eligible).

Exclusion Criteria:

1. Patient has a life expectancy less than 12 months.
2. Patient has recent evidence of an acute coronary syndrome (MI)
3. Femoral access is difficult or site is not amenable to closure device
4. Anticoagulants other than unfractionated heparin or bivalirudin were used during the procedure (i.e. enoxaparin).
5. Patient has sub optimal angiographic outcome or clinical complication(s) during PCI
6. The PCI occurred in something other than a native coronary artery
7. Angiographic evidence of thrombus
8. Patient has more than 3 stents implanted during this PCI
9. Patient has an INR \>2, Platelet count \<100,000 or Hematocrit \<25
10. Occlusion of major side branch during PCI of \>1.5mm
11. Patient has ejection fraction ≤30%
12. Known allergy to PCI procedural medications
13. Patient reports living further than 30 minutes from a hospital by ambulance.
14. Patient provides informed consent and agrees to the follow-up schedule.
15. Evidence of vascular complication(s) (e.g. dissection, hematoma, bleeding) peri-procedure
16. Patient is pregnant
17. Evidence of infection (e.g. fever, pus, swelling) peri-procedure
18. Patients with chronic renal insufficiency (e.g. serum creatinine ≥1.5 mg/dL)

Primary outcomes:
measure: Post-hospitalization patient satisfaction
timeFrame: 30 days after enrollment
Secondary outcomes:
measure: Patient satisfaction with timing of discharge
timeFrame: 30 days after enrollment
measure: Patient Satisfaction Outcome Assessment
timeFrame: 30 days After Enrollment
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Michael C Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim M, Muntner P, Sharma S, Choi JW, Stoler RC, Woodward M, Mann DM, Farkouh ME. Assessing patient-reported outcomes and preferences for same-day discharge after percutaneous coronary intervention: results from a pilot randomized, controlled trial. Circ Cardiovasc Qual Outcomes. 2013 Mar 1;6(2):186-92. doi: 10.1161/CIRCOUTCOMES.111.000069. Epub 2013 Mar 12.