Coronary Artery Diseases
Conditions
Keywords
PCI, heart disease, ischemic heart disease
Brief summary
The primary objective of the trial is to compare the acute safety and long term outcomes between hospitals with cardiac surgery on-site (SOS hospitals) and hospitals without cardiac surgery on-site (non-SOS hospitals) for patients with ischemic heart disease treated with elective percutaneous coronary intervention (PCI) (stable angina, acute coronary syndrome, or non-Q wave MI) presenting to non-SOS hospitals.
Detailed description
The MASS COMM trial is a prospective, multi-center, randomized, controlled two-arm trial of PCI performed at non-SOS hospitals (non-SOS-PCI arm) versus PCI performed at SOS hospitals (SOS-PCI arm). The trial is designed to reject the null-hypothesis of inferiority, and thereby show the non-inferiority of the non-SOS-PCI arm to the SOS-PCI arm. Specifically, 3690 subjects will be enrolled in a multi-center, randomized, controlled trial (RCT), in which eligible subjects will be consented and randomized in a 3:1 ratio at the non-SOS hospitals for PCI to be performed at either the enrolling non-SOS hospital (3 chances out of 4) or a corresponding SOS hospital (1 chance out of 4).
Interventions
PROCEDUREPCI
Sponsors
Brockton Hospital
Good Samaritan Hospital Medical Center, New York
Norwood Hospital
Holy Family Hospital, Methuen, MA
Lawrence General Hospital
Lowell General Hospital
Melrose Wakefield Hospital
Metro West Medical Center
Saints Memorial Medical Center
South Shore Hospital
Baim Institute for Clinical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is at least 18 years old. 2. Subject requires single- or multi-vessel percutaneous coronary intervention (PCI) of de novo or restenotic target lesion (including in-stent restenotic lesions). 3. Subject's lesion(s) is (are) amenable to stent treatment with currently available FDA-approved bare metal or drug eluting stents. 4. Subject is an acceptable candidate for elective, urgent or emergency coronary artery bypass graft (CABG). 5. Subject has clinical evidence of ischemic heart disease in terms of a positive functional study, or documented symptoms. 6. Documented stable angina pectoris \[Canadian Cardiovascular Society Classification (CCS) 1, 2, 3, or 4\], unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), non-ST segment elevation myocardial infarction, or documented silent ischemia. 7. Subject is willing and able to undergo percutaneous intervention at SOS hospital, if randomized to SOS study arm. 8. Subject and the treating physician agree that the subject will comply with all follow-up evaluations. 9. Subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site. 10. The target lesion(s) is (are) de novo or restenotic (including in-stent restenotic) native coronary artery lesion(s) with greater than 50 and less than 100% stenosis (visual estimate), or the target lesion is an acute (less than 1 month) total occlusion as evidenced by clinical symptoms. 11. Target lesions(s) is (are) located in an infarct (if not treated with primary PCI) or non-infarct-related artery with a 70% or greater stenosis (by visual estimate) more than 72 hours following the ST segment elevation myocardial infarction (STEMI). Lesions treated with PCI more than 72 hours following STEMI would be subject to the same protocol inclusion/
Exclusion criteria
listed above and below with the exception that a target lesion of 70% or greater stenosis may be treated with or without symptoms or abnormal stress test).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30-day Composite Major Adverse Cardiac Event (MACE) | 30 days |
| 12-month Composite Major Adverse Cardiac Event (MACE) | 12 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Stent Thrombosis | 12 months | — |
| Any Repeat Revascularization | 12 months | — |
| Emergency or Urgent Revascularization | 30 days | — |
| Procedural Success | Post-Procedure | Procedural success is defined as residual stenosis of the target lesion of less than 20% |
| All Cause Mortality at 30 Days | 30 days | — |
| Complete Revascularization | Post-Procedure | Complete revascularization was defined as the successful treatment, according to the criteria of procedural success, of all epicardial vessels with more than 70% and less than 100% stenosis. |
| Met Indication Criteria for PCI | Post-Procedure | Included here are the number of treated lesions that met the class I or II recommendations for anatomical indications for PCI, according to the PCI guidelines fo the American College of Cardiology Foundation-American Heart Association-Society for Cardiovascular Angiography and Interventions. |
| All Cause Mortality at 12 Months | 12 months | — |
| Ischemia-driven Target Vessel Revascularization | 30 days | — |
| Major Vascular Complications | 30 days | — |
| Ischemia-driven Target Lesion Revascularization | 30 days | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PCI at Hospitals Without On-Site Cardiac Surgery Assigned to PCI at a hospital without on-site cardiac surgery | 2,774 |
| PCI at Hospital With On-Site Cardiac Surgery Assigned to PCI at a hospital with on-site cardiac surgery | 917 |
| Total | 3,691 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12-month | Lost to Follow-up | 111 | 42 |
| 12-month | Other Reasons | 151 | 49 |
| 12-month | Withdrawal by Subject | 5 | 8 |
| 30-day | Lost to Follow-up | 50 | 21 |
| 30-day | Other Reasons | 16 | 6 |
| 30-day | Withdrawal by Subject | 2 | 4 |
Baseline characteristics
| Characteristic | Total | PCI at Hospital With On-Site Cardiac Surgery | PCI at Hospitals Without On-Site Cardiac Surgery |
|---|---|---|---|
| Age, Continuous | 64.57 years STANDARD_DEVIATION 11.83 | 64.16 years STANDARD_DEVIATION 11.81 | 64.71 years STANDARD_DEVIATION 11.84 |
| Race/Ethnicity, Customized Black | 60 participants | 9 participants | 51 participants |
| Race/Ethnicity, Customized Hispanic | 152 participants | 35 participants | 117 participants |
| Race/Ethnicity, Customized Other | 101 participants | 21 participants | 80 participants |
| Race/Ethnicity, Customized White | 3378 participants | 852 participants | 2526 participants |
| Sex/Gender, Customized Female | 1191 participants | 308 participants | 883 participants |
| Sex/Gender, Customized Male | 2500 participants | 609 participants | 1891 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
12-month Composite Major Adverse Cardiac Event (MACE)
Time frame: 12 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCI at Hospitals Without On-Site Cardiac Surgery | 12-month Composite Major Adverse Cardiac Event (MACE) | 421 participants |
| PCI at Hospital With On-Site Cardiac Surgery | 12-month Composite Major Adverse Cardiac Event (MACE) | 140 participants |
Primary
30-day Composite Major Adverse Cardiac Event (MACE)
Time frame: 30 days
Population: The denominator for MACE at 30 days is defined as patients who either had MACE to 30d or had follow up of at least 23 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCI at Hospitals Without On-Site Cardiac Surgery | 30-day Composite Major Adverse Cardiac Event (MACE) | 256 participants |
| PCI at Hospital With On-Site Cardiac Surgery | 30-day Composite Major Adverse Cardiac Event (MACE) | 83 participants |
Secondary
All Cause Mortality at 12 Months
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCI at Hospitals Without On-Site Cardiac Surgery | All Cause Mortality at 12 Months | 56 participants |
| PCI at Hospital With On-Site Cardiac Surgery | All Cause Mortality at 12 Months | 19 participants |
Secondary
All Cause Mortality at 30 Days
Time frame: 30 days
Population: The denominator for MACE at 30 days is defined as patients who either died to 30d or had follow up of at least 23 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCI at Hospitals Without On-Site Cardiac Surgery | All Cause Mortality at 30 Days | 18 participants |
| PCI at Hospital With On-Site Cardiac Surgery | All Cause Mortality at 30 Days | 3 participants |
Secondary
Any Repeat Revascularization
Time frame: 30 days
Population: The denominator for any repeat revascularization at 30 days is defined as patients who either had the event to 30d or had follow up of at least 23 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCI at Hospitals Without On-Site Cardiac Surgery | Any Repeat Revascularization | 73 participants |
| PCI at Hospital With On-Site Cardiac Surgery | Any Repeat Revascularization | 31 participants |
Secondary
Any Repeat Revascularization
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCI at Hospitals Without On-Site Cardiac Surgery | Any Repeat Revascularization | 202 participants |
| PCI at Hospital With On-Site Cardiac Surgery | Any Repeat Revascularization | 76 participants |
Secondary
Complete Revascularization
Complete revascularization was defined as the successful treatment, according to the criteria of procedural success, of all epicardial vessels with more than 70% and less than 100% stenosis.
Time frame: Post-Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCI at Hospitals Without On-Site Cardiac Surgery | Complete Revascularization | 174 participants |
| PCI at Hospital With On-Site Cardiac Surgery | Complete Revascularization | 52 participants |
Secondary
Emergency or Urgent Revascularization
Time frame: 30 days
Population: The denominator for emergency or urgent revascularization at 30 days is defined as patients who either had the event to 30d or had follow up of at least 23 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCI at Hospitals Without On-Site Cardiac Surgery | Emergency or Urgent Revascularization | 7 participants |
| PCI at Hospital With On-Site Cardiac Surgery | Emergency or Urgent Revascularization | 2 participants |
Secondary
Ischemia-driven Target Lesion Revascularization
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCI at Hospitals Without On-Site Cardiac Surgery | Ischemia-driven Target Lesion Revascularization | 117 participants |
| PCI at Hospital With On-Site Cardiac Surgery | Ischemia-driven Target Lesion Revascularization | 38 participants |
Secondary
Ischemia-driven Target Lesion Revascularization
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCI at Hospitals Without On-Site Cardiac Surgery | Ischemia-driven Target Lesion Revascularization | 36 participants |
| PCI at Hospital With On-Site Cardiac Surgery | Ischemia-driven Target Lesion Revascularization | 12 participants |
Secondary
Ischemia-driven Target Vessel Revascularization
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCI at Hospitals Without On-Site Cardiac Surgery | Ischemia-driven Target Vessel Revascularization | 41 participants |
| PCI at Hospital With On-Site Cardiac Surgery | Ischemia-driven Target Vessel Revascularization | 13 participants |
Secondary
Ischemia-driven Target Vessel Revascularization
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCI at Hospitals Without On-Site Cardiac Surgery | Ischemia-driven Target Vessel Revascularization | 133 participants |
| PCI at Hospital With On-Site Cardiac Surgery | Ischemia-driven Target Vessel Revascularization | 41 participants |
Secondary
Major Vascular Complications
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCI at Hospitals Without On-Site Cardiac Surgery | Major Vascular Complications | 41 participants |
| PCI at Hospital With On-Site Cardiac Surgery | Major Vascular Complications | 13 participants |
Secondary
Met Indication Criteria for PCI
Included here are the number of treated lesions that met the class I or II recommendations for anatomical indications for PCI, according to the PCI guidelines fo the American College of Cardiology Foundation-American Heart Association-Society for Cardiovascular Angiography and Interventions.
Time frame: Post-Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCI at Hospitals Without On-Site Cardiac Surgery | Met Indication Criteria for PCI | 369 lesions |
| PCI at Hospital With On-Site Cardiac Surgery | Met Indication Criteria for PCI | 97 lesions |
Secondary
Procedural Success
Procedural success is defined as residual stenosis of the target lesion of less than 20%
Time frame: Post-Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCI at Hospitals Without On-Site Cardiac Surgery | Procedural Success | 235 participants |
| PCI at Hospital With On-Site Cardiac Surgery | Procedural Success | 65 participants |
Secondary
Rate of Stent Thrombosis
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCI at Hospitals Without On-Site Cardiac Surgery | Rate of Stent Thrombosis | 27 participants |
| PCI at Hospital With On-Site Cardiac Surgery | Rate of Stent Thrombosis | 16 participants |
Secondary
Rate of Stent Thrombosis
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCI at Hospitals Without On-Site Cardiac Surgery | Rate of Stent Thrombosis | 16 participants |
| PCI at Hospital With On-Site Cardiac Surgery | Rate of Stent Thrombosis | 7 participants |