Coronary Artery Disease
Conditions
Brief summary
The primary objective of the Post-Randomization Phase Cohort Study is to continue to assess the safety of non-emergency PCI performed at hospitals without cardiac surgery on-site in patients with myocardial ischemia (other than ST-segment elevation myocardial infarction \[STEMI\]).
Detailed description
The MASS COMM Post-Randomization Phase Cohort Study (Cohort Study is a prospective, multi-center, single-arm study of non-emergency PCI performed at non-SOS hospitals in patients with myocardial ischemia (other than STEMI). The Cohort Study is designed to allow non-SOS hospitals to continue to perform non-emergency PCI after enrollment to the MASS COMM trial is completed and before the 30-day and 12-month results are available. Specifically, all eligible subjects, after enrollment to the MASS COMM randomized controlled trial is completed and before the final results are available and a decision is reached by the MA-DPH, will be consented and enrolled into this Cohort Study. Subjects will be followed through 30 days post procedure.
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
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Candidates for this study must meet ALL of the following criteria: * Subject is at least 18 years old. * Subject requires single- or multi-vessel percutaneous coronary intervention (PCI) of de novo or restenotic target lesion (including in-stent restenotic lesions). N.B. staged procedure will not be considered to meet the endpoint component of repeat revascularization if either of the following pre-catheterization procedure qualifying clinical laboratory values are met: * eGFR is less than 60 ml/min or * creatinine is greater than 1.5 mg/dl * Subject's lesion(s) is (are) amenable to stent treatment with currently available FDA-approved bare metal or drug eluting stents. * Subject is an acceptable candidate for non-emergency, urgent or emergency CABG. * Subject has clinical evidence of ischemic heart disease in terms of a positive functional study, or documented symptoms. * 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. * Subject and the treating physician agree that the subject will comply with all follow-up evaluations. * Subject has been informed of the nature and purpose 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. Angiographic Inclusion Criteria * The target lesion(s) is (are) de novo or restenotic (including in-stent restenotic) native coronary artery lesion(s) with greater or equal to 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. * If Fractional Flow Reserve (FFR) is measured, target lesion(s) has (have) evidence of a hemodynamically significant stenosis determined by FFR measurement (FFR less than or equal to 0.8). * 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) greater than 72 hours following the STEMI. Lesions treated with PCI greater 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 | Description |
|---|---|---|
| Major Adverse Cardiac Event (MACE) | 30-days | MACE is a composite of all cause mortality, myocardial infarction (Q wave and non-Q wave), repeat coronary revascularization (of the target vessel or non-target vessel) by either percutaneous or coronary artery bypass graft (CABG) methods, or stroke, at 30-days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-Cause Mortality | 30 days | all-cause mortality through 30 days post-procedure |
| Stroke | 30 days | Stroke through 30 days post-procedure |
| Revascularization | 30 days | Repeat coronary revascularization including emergency or urgent revascularization through 30 days post-procedure |
| Major Vascular Complications | 30 days | Major vascular complications, including access site complications and major bleeding events requiring transfusion,through 30 days post-procedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PCI at Hospitals Without On-Site Cardiac Surgery PCI at a hospital without on-site cardiac surgery | 2,879 |
| Total | 2,879 |
Baseline characteristics
| Characteristic | PCI at Hospitals Without On-Site Cardiac Surgery |
|---|---|
| Age, Continuous | 64.92 years STANDARD_DEVIATION 11.48 |
| Race/Ethnicity, Customized Asian | 50 participants |
| Race/Ethnicity, Customized Black | 61 participants |
| Race/Ethnicity, Customized Caucasian | 2595 participants |
| Race/Ethnicity, Customized Hispanic | 153 participants |
| Race/Ethnicity, Customized Native American | 1 participants |
| Race/Ethnicity, Customized Other | 19 participants |
| Sex/Gender, Customized Female | 924 participants |
| Sex/Gender, Customized Male | 1955 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Major Adverse Cardiac Event (MACE)
MACE is a composite of all cause mortality, myocardial infarction (Q wave and non-Q wave), repeat coronary revascularization (of the target vessel or non-target vessel) by either percutaneous or coronary artery bypass graft (CABG) methods, or stroke, at 30-days.
Time frame: 30-days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCI at Hospitals Without On-Site Cardiac Surgery | Major Adverse Cardiac Event (MACE) | 229 participants |
Secondary
All-Cause Mortality
all-cause mortality through 30 days post-procedure
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCI at Hospitals Without On-Site Cardiac Surgery | All-Cause Mortality | 15 participants |
Secondary
Major Vascular Complications
Major vascular complications, including access site complications and major bleeding events requiring transfusion,through 30 days post-procedure.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCI at Hospitals Without On-Site Cardiac Surgery | Major Vascular Complications | 28 participants |
Secondary
Revascularization
Repeat coronary revascularization including emergency or urgent revascularization through 30 days post-procedure
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCI at Hospitals Without On-Site Cardiac Surgery | Revascularization | 75 participants |
Secondary
Stroke
Stroke through 30 days post-procedure
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCI at Hospitals Without On-Site Cardiac Surgery | Stroke | 2 participants |