Clinical trial NCT00549796: Randomized Comparison Angioplasty Outcomes at Hospitals With and Without On-site Cardiac Surgery
Official title: Randomized Comparison Angioplasty Outcomes at Hospitals With and Without On-site Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Arteriosclerosis
Angina Pectoris
Keywords: coronary artery disease
angioplasty
stent
percutaneous coronary intervention
on-site cardiac surgery
randomized trial
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Duke University
name: Maryland Medical Research Institute
First posted: 2007-10-26
Enrollment: 18876
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Angioplasty is a procedure which opens blocked heart arteries using balloons and/or stents. Most U.S. states and all national heart organizations require that angioplasty be done only at hospitals that can also perform open heart surgery. The reason for this is that there is a risk that angioplasty can cause injury to the heart artery that might require open heart surgery to fix. Open heart surgery is a backup in case it is needed. The risk that open heart surgery will be needed is very small. Nevertheless, without more research, many state Departments of Health and all national heart organizations do not want to change the requirement for having on-site open heart surgery wherever angioplasty is performed. Some States already allow this; and European heart organizations already allow it, as well.

This study is designed to determine whether the safety and benefits of angioplasty are the same at hospitals that perform angioplasty either with or without open heart surgery backup.

Patient who enter the study have a heart catheterization at a hospital without a heart surgery program. If they need angioplasty, then they are randomized to either stay at the hospital without heart surgery for their angioplasty or to be transferred for the procedure to a hospital with heart surgery. For every four patients, three stay at the hospital without heart surgery and one is transferred.

The study is designed to show that there is no detectable difference between the safety and benefits of the procedure at the two types of hospital (with and without heart surgery). The cost of the procedure at the two hospital types is also compared.


Eligibility criteria: Inclusion Criteria:

Pre-catheterization:

* Must be undergoing diagnostic cardiac catheterization for suspected CAD
* Be at least 18 years of age
* Must not be pregnant (negative pregnancy test) or must not be of childbearing potential must be able to give informed consent.

Post-catheterization:

* Coronary artery disease judged to be clinically and angiographically significant
* Ability to perform PCI with equipment available at the local site
* Procedure risk judged to be not high (see below)

Exclusion Criteria:

Pre-catheterization:

* Inability to give informed consent
* ST-segment elevation myocardial infarction
* Pregnancy

Post-catheterization:

* High likelihood of requiring a device not available at the hospitals without SOS
* No need for PCI
* Need for coronary artery bypass surgery
* High procedural risk (see below)

High procedural risk criteria are:

* PCI of unprotected left main coronary artery
* PCI of left circulation lesion in the presence of critical (\>70%) unprotected left main coronary artery lesion
* Poor left ventricular function (EF\< 20%) and need to perform PCI in a vessel supplying significant myocardium

Primary outcomes:
measure: Mortality
timeFrame: 6 weeks
measure: MACE = death + MI + TVR
timeFrame: 9 Months
Secondary outcomes:
measure: emergency CABG
timeFrame: hosp DC, 6 wks, 3, 6 and 9 months
measure: myocardial infarction
timeFrame: hosp DC, 6 wks, 3, 6 and 9 months
measure: target vessel revascularization (TVR)
timeFrame: hosp DC, 6 wks, 3, 6 and 9 months
measure: any subsequent revascularization (ASR)
timeFrame: hosp DC, 6 wks, 3, 6 and 9 months
measure: heart failure and class
timeFrame: hosp DC, 6 wks, 3, 6 and 9 months
measure: angina and class
timeFrame: hosp DC, 6 wks, 3, 6 and 9 months
measure: stroke
timeFrame: hosp DC, 6 wks, 3, 6 and 9 months
measure: composite adverse endpoint (MACE)
timeFrame: hosp DC, 6 wks, 3, 6 and 9 months
measure: MACE = death + MI + TVR
timeFrame: hosp DC, 6 wks, 3, 6 and 9 months
measure: MACE = death + MI + ASR
timeFrame: hosp DC, 6 wks, 3, 6 and 9 months
measure: angiographic (end-procedure) complications (embolization, dissection, no reflow, etc)
timeFrame: hosp DC, 6 wks, 3, 6 and 9 months
measure: angiographic (procedural) success (<20% residual stenosis and TIMI 3 flow)
timeFrame: hosp DC, 6 wks, 3, 6 and 9 months
measure: completeness of revascularization
timeFrame: hosp DC, 6 wks, 3, 6 and 9 months
measure: percent of patients with complete or partial revascularization
timeFrame: hosp DC, 6 wks, 3, 6 and 9 months
measure: bleeding (non-CABG transfusion, vascular repair)
timeFrame: hosp DC, 6 wks, 3, 6 and 9 months
measure: length of stay
timeFrame: hosp DC, 6 wks, 3, 6 and 9 months
measure: total direct medical cost
timeFrame: hosp DC, 6 wks, 3, 6 and 9 months
measure: major resource consumption patterns (hospital and ICU days, surgeries, hospitalizations)
timeFrame: hosp DC, 6 wks, 3, 6 and 9 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Crestwood Medical Center
state: Alabama
city: Austell
country: United States
facility: Wellstar Cobb Hospital
state: Georgia
city: Brunswick
country: United States
facility: Southeast Georgia Health System
state: Georgia
city: Carrollton
country: United States
facility: Tanner Medical Center
state: Georgia
city: Dalton
country: United States
facility: Hamilton Medical Center
state: Georgia
city: Dublin
country: United States
facility: Fairview Park Hospital
state: Georgia
city: Griffin
country: United States
facility: Spalding Regional Medical Center
state: Georgia
city: LaGrange
country: United States
facility: West Georgia Health
state: Georgia
city: Riverdale
country: United States
facility: Southern Regional Medical Center
state: Georgia
city: Thomasville
country: United States
facility: Archbold Memorial Hospital
state: Georgia
city: Tifton
country: United States
facility: Tift Regional Medical Center
state: Georgia
city: Evergreen Park
country: United States
facility: Little Company of Mary Hospital
state: Illinois
city: Hazel Crest
country: United States
facility: Advocate South Suburban Hospital
state: Illinois
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Baltimore
country: United States
facility: St. Agnes Hospital
state: Maryland
city: Clinton
country: United States
facility: Southern Maryland Hospital Center
state: Maryland
city: Frederick
country: United States
facility: Frederick Memorial Hospital
state: Maryland
city: Glen Burnie
country: United States
facility: Baltimore Washington Medical Center
state: Maryland
city: Hagerstown
country: United States
facility: Meritus Medical Center
state: Maryland
city: Rockville
country: United States
facility: Shady Grove Adventist Hospital
state: Maryland
city: Silver Spring
country: United States
facility: Holy Cross Hospital
state: Maryland
city: Bayonne
country: United States
facility: Bayonne Medical Center
state: New Jersey
city: Belleville
country: United States
facility: Clara Maas Medical Center
state: New Jersey
city: Edison
country: United States
facility: JFK Medical Center
state: New Jersey
city: Elizabeth
country: United States
facility: Trinitas Hospital
state: New Jersey
city: Evesham
country: United States
facility: Virtua-West Jersey Hospital Marlton
state: New Jersey
city: Hamilton
country: United States
facility: Robert Wood Johnson Medical Center
state: New Jersey
city: Long Branch
country: United States
facility: Monmouth Medical Center
state: New Jersey
city: Perth Amboy
country: United States
facility: Raritan Bay Medical Center
state: New Jersey
city: Red Bank
country: United States
facility: Riverview Medical Center
state: New Jersey
city: Somerville
country: United States
facility: Somerset Medical Center
state: New Jersey
city: South Plainfield
country: United States
facility: Muhlenberg Regional Medical Center
state: New Jersey
city: Summit
country: United States
facility: Overlook Medical Center
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Hospital
state: New Jersey
city: Toms River
country: United States
facility: Community Medical Center
state: New Jersey
city: Raleigh
country: United States
facility: Duke Health Raleigh Hospital
state: North Carolina
city: Salisbury
country: United States
facility: Rowan Regional Medical Center
state: North Carolina
city: Bryan
country: United States
facility: Community Health and Wellness Center
state: Ohio
city: Chardon
country: United States
facility: University Hospitals Case Medical Center / Geauga Medical Center
state: Ohio
city: Columbus
country: United States
facility: University Hospital East Ohio State University Medical Center
state: Ohio
city: Dayton
country: United States
facility: Southview Medical Center
state: Ohio
city: Fort Hamilton
country: United States
facility: Fort Hamilton Hospital
state: Ohio
city: Marietta
country: United States
facility: Marietta Memorial Hospital
state: Ohio
city: Mount Vernon
country: United States
facility: Knox Community Hospital
state: Ohio
city: Newark
country: United States
facility: Licking Memorial Hospital
state: Ohio
city: Portsmouth
country: United States
facility: Southern Ohio Medical Center
state: Ohio
city: Westerville
country: United States
facility: Mt. Carmel St. Ann's Hospital
state: Ohio
city: Portland
country: United States
facility: Legacy Meridian Park Hospital
state: Oregon
city: Allentown
country: United States
facility: Sacred Heart Hospital
state: Pennsylvania
city: Chambersburg
country: United States
facility: Chambersburg Hospital
state: Pennsylvania
city: Kittanning
country: United States
facility: Armstrong County Memorial Hospital
state: Pennsylvania
city: Lewisburg
country: United States
facility: Evangelical Community Hospital
state: Pennsylvania
city: McKeesport
country: United States
facility: UPMC McKeesport
state: Pennsylvania
city: Meadville
country: United States
facility: Meadville Medical Center
state: Pennsylvania
city: Monongahela
country: United States
facility: Monongahela Valley Hospital
state: Pennsylvania
city: West Chester
country: United States
facility: West Chester Hospital
state: Pennsylvania
city: York
country: United States
facility: Memorial Hospital
state: Pennsylvania
city: Kingwood
country: United States
facility: Kingwood Medical Center
state: Texas
city: Texas City
country: United States
facility: Mainland Medical Center
state: Texas
Study officials:
affiliation: Johns Hopkins University
name: Thomas Aversano, MD
role: STUDY_DIRECTOR
References:
citation: Hiremath PG, Aversano T, Spertus JA, Lemmon CC, Naiman DQ, Czarny MJ. Sex Differences in Health Status and Clinical Outcomes After Nonprimary Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2022 Feb;15(2):e011308. doi: 10.1161/CIRCINTERVENTIONS.121.011308. Epub 2022 Jan 23.
citation: Aversano T, Lemmon CC, Liu L; Atlantic CPORT Investigators. Outcomes of PCI at hospitals with or without on-site cardiac surgery. N Engl J Med. 2012 May 10;366(19):1792-802. doi: 10.1056/NEJMoa1114540. Epub 2012 Mar 25.