Same Day Versus Next Day Discharge: Ambulatory Closure Device Percutaneous Intervention

Cardiovascular Disease Clinical Trial

— ABCD-PCI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01230606
• Other study ID #: GCO 07-1324
• Status: Completed
• Phase: N/A
• First received: March 31, 2010
• Last updated: July 26, 2011
• Start date: January 2008
• Est. completion date: June 2010

Study information

• Verified date: July 2011
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Other:
• discharge vs. overnight stay
At six hours post-PCI,patients will be randomized to be discharged immediately or to stay overnight in the hospital for observation and discharged the following day. Randomization will occur in a 1:1 ratio. Additionally, randomization will be performed stratified by study site.

Locations

Country	Name	City	State
United States	Baylor University Medical Center	Dallas	Texas
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	St. Jude Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-hospitalization patient satisfaction	The primary endpoint is the difference in post-hospitalization patient satisfaction during the initial seven days following PCI. Post-hospitalization patient satisfaction will be assessed using the 10-item Post-Discharge Coping Difficulty scale.	30 days after enrollment	No
Secondary	Patient satisfaction with timing of discharge	Secondary outcomes will include post-hospital anxiety, readiness for hospital discharge, patient satisfaction with the timing of their discharge, post-procedure pain and soreness, resource utilization and cost-savings.	30 days after enrollment	No
Secondary	Patient Satisfaction Outcome Assessment	These outcomes will be assessed using standardized questionnaires and validated techniques. The composite of major adverse cardiac events (MACE) and cerebral events and the incidence of major bleeding or vascular complications will be monitored for all patients through the 30 day follow-up period.	30 days After Enrollment	No