MASS COMM: Percutaneous Coronary Intervention (PCI) Outcomes in Community Versus Tertiary Settings

• Sponsor: Baim Institute for Clinical Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT01116882
• Collaborator: Brockton Hospital (Other), Good Samaritan Hospital Medical Center, New York (Other), Norwood Hospital (Other), Holy Family Hospital, Methuen, MA (Other), Lawrence General Hospital (Other), Lowell General Hospital (Other), Melrose Wakefield Hospital (Other), Metro West Medical Center (Other), Saints Memorial Medical Center (Other), South Shore Hospital (Other)
• Enrollment: 3,691
• Locations: 17
• Arms: 2
• Duration (Months): 78
• Patients Per Site: 217.1
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Diseases	Procedure: PCI	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 3691 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: A Randomized Trial to Compare Percutaneous Coronary Intervention Between Massachusetts Hospitals With Cardiac Surgery-On-Site and Community Hospitals Without Cardiac Surgery-On-Site
• Study Start Date: Jun 1, 2006
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: SOS Patients randomized to the SOS arm are transferred to tertiary hospitals for their PCI procedure.	Procedure: PCI
Experimental: Non-SOS Patients in the non-SOS arm are randomized to stay at the community hospitals for their PCI procedure.	Procedure: PCI

Outcome Measures

Primary Outcome Measures

1. 30-day Composite Major Adverse Cardiac Event (MACE) [30 days]

2. 12-month Composite Major Adverse Cardiac Event (MACE) [12 month]

Secondary Outcome Measures

1. All Cause Mortality at 30 Days [30 days]

2. Ischemia-driven Target Lesion Revascularization [30 days]

3. Ischemia-driven Target Lesion Revascularization [12 months]

4. Rate of Stent Thrombosis [12 months]

5. Any Repeat Revascularization [12 months]

6. Emergency or Urgent Revascularization [30 days]

7. Procedural Success [Post-Procedure]

   Procedural success is defined as residual stenosis of the target lesion of less than 20%

8. Major Vascular Complications [30 days]

9. 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.

10. 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.

11. All Cause Mortality at 12 Months [12 months]

12. Ischemia-driven Target Vessel Revascularization [30 days]

13. Ischemia-driven Target Vessel Revascularization [12 months]

14. Rate of Stent Thrombosis [30 days]

15. Any Repeat Revascularization [30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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).

Exclusion Criteria:

1. The patient is pregnant or breastfeeding.

2. Evidence of STEMI within 72 hours of the intended treatment on infarct related or non-infarct related artery.

3. Cardiogenic shock on presentation or during current hospitalization.

4. Left ventricular ejection fraction less than 20%.

5. Known allergies to: aspirin, clopidogrel (Plavix) and ticlopidine (Ticlid), heparin, bivalirudin, stainless steel, or contrast agent (which cannot be adequately premedicated).

6. A platelet count less than 75,000 cells/mm3 or greater than 700,000 cells/mm3 or a WBC less than 3,000 cells/mm3.

7. Acute or chronic renal dysfunction (creatinine greater than 2.5 mg/dl or less than 150µmol/L).

8. Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials).

9. Prior participation in this study.

10. Within 30 days prior to the index study procedure, the subject has undergone a previous coronary interventional procedure of any kind. Note: This exclusion criterion does not apply to post-STEMI patients.

11. Stroke or transient ischemic attack within the prior 3 months.

12. Active peptic ulcer or upper gastrointestinal bleeding within the prior 3 months.

13. Subject has active sepsis.

14. Unprotected left main coronary artery disease (stenosis greater than 50%).

15. In the investigator's opinion, subject has a co-morbid condition(s) that could limit the life expectancy to less than one year, or limit the subject's ability to participate in the study or comply with follow-up requirements or impact the scientific integrity of the study.

16. Subject has normal or insignificant coronaries (i.e. coronary lesion(s) less than 50% stenosis).

17. Any target vessel has evidence of:

• excessive thrombus (e.g. requires target vessel thrombectomy)

• tortuousity (greater than 60 degree angle) that makes it unsuitable for proper stent delivery and deployment,

• heavy calcification.

1. Any target lesion requires treatment with a device other than percutaneous transluminal coronary angioplasty (PTCA) prior to stent placement (e.g. but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).

2. Any lesion that is located in a saphenous vein graft, however, lesions located within the native vessel but accessed through the graft are eligible.

3. The target vessel is in a "last remaining" epicardial vessel (e.g. greater than 2 non-target epicardial vessels and the bypass grafts to these territories [if present] are totally occluded).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tufts New England Medical Center	Boston	Massachusetts	United States	02111
2	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
3	Boston University Medical Center	Boston	Massachusetts	United States	02118
4	Brigham and Women's Hospital	Boston	Massachusetts	United States	02120
5	Beth Israel Deaconnes Medical Center	Boston	Massachusetts	United States	02215
6	Caritas St. Elizabeth's Hospital	Brighton	Massachusetts	United States	02135
7	Brockton Hospital	Brockton	Massachusetts	United States	02301
8	Caritas Good Samaritan Medical Center	Brockton	Massachusetts	United States	02301
9	Lahey Clinic	Burlington	Massachusetts	United States	01805
10	Metrowest Medical Center	Framingham	Massachusetts	United States	01702
11	Lawrence General Hospital	Haverhill	Massachusetts	United States	01803
12	Saints Memorial Medical Center	Lowell	Massachusetts	United States	01853
13	Lowell General Hospital	Lowell	Massachusetts	United States	01854
14	Melrose Wakefield Hospital	Melrose	Massachusetts	United States	02176
15	Caritas Holy Family Hospital	Methuen	Massachusetts	United States	01844
16	Caritas Norwood Hospital	Norwood	Massachusetts	United States	02062
17	South Shore Hospital	Weymouth	Massachusetts	United States	02190

Sponsors and Collaborators

• Baim Institute for Clinical Research
• 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

Investigators

• Principal Investigator: Alice K Jacobs, MD, Boston University School of Medicine , Boston Medical Center
• Principal Investigator: Sharon-Lise Normand, Ph.D., Harvard Medical School (HMS and HSDM)
• Principal Investigator: Laura Mauri, M.D., Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Baim Institute for Clinical Research
• ClinicalTrials.gov Identifier: NCT01116882
• Other Study ID Numbers: DPH00
• First Posted: May 5, 2010
• Last Update Posted: Apr 7, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Baim Institute for Clinical Research: PCI; heart disease; ischemic heart disease
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

Participant Flow

Arm/Group Title	PCI at a Hospital Without On-site Cardiac Surgery	PCI at Hospital With On-Site Cardiac Surgery
Arm/Group Description	Assigned to PCI at a hospital without on-site cardiac surgery	Assigned to PCI at a hospital with on-site cardiac surgery
Period Title: 30-day
STARTED	2774	917
COMPLETED	2706	886
NOT COMPLETED	68	31
Period Title: 30-day
STARTED	2706	886
COMPLETED	2439	787
NOT COMPLETED	267	99

Baseline Characteristics

Arm/Group Title	PCI at Hospitals Without On-Site Cardiac Surgery	PCI at Hospital With On-Site Cardiac Surgery	Total
Arm/Group Description	Assigned to PCI at a hospital without on-site cardiac surgery	Assigned to PCI at a hospital with on-site cardiac surgery	Total of all reporting groups
Overall Participants	2774	917	3691
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.71 (11.84)	64.16 (11.81)	64.57 (11.83)
Sex/Gender, Customized (participants) [Number]
Female	883 31.8%	308 33.6%	1191 32.3%
Male	1891 68.2%	609 66.4%	2500 67.7%
Race/Ethnicity, Customized (participants) [Number]
White	2526 91.1%	852 92.9%	3378 91.5%
Black	51 1.8%	9 1%	60 1.6%
Hispanic	117 4.2%	35 3.8%	152 4.1%
Other	80 2.9%	21 2.3%	101 2.7%

Outcome Measures

1. Primary Outcome

Title	30-day Composite Major Adverse Cardiac Event (MACE)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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/Group Title	PCI at Hospitals Without On-Site Cardiac Surgery	PCI at Hospital With On-Site Cardiac Surgery
Arm/Group Description	Assigned to PCI at a hospital without on-site cardiac surgery	Assigned to PCI at a hospital with on-site cardiac surgery
Measure Participants	2706	886
Number [participants]	256 9.2%	83 9.1%

2. Primary Outcome

Title	12-month Composite Major Adverse Cardiac Event (MACE)
Time Frame	12 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PCI at Hospitals Without On-Site Cardiac Surgery	PCI at Hospital With On-Site Cardiac Surgery
Arm/Group Description	Assigned to PCI at a hospital without on-site cardiac surgery	Assigned to PCI at a hospital with on-site cardiac surgery
Measure Participants	2439	787
Number [participants]	421 15.2%	140 15.3%

3. Secondary Outcome

Title	All Cause Mortality at 30 Days
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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/Group Title	PCI at Hospitals Without On-Site Cardiac Surgery	PCI at Hospital With On-Site Cardiac Surgery
Arm/Group Description	Assigned to PCI at a hospital without on-site cardiac surgery	Assigned to PCI at a hospital with on-site cardiac surgery
Measure Participants	2708	885
Number [participants]	18 0.6%	3 0.3%

4. Secondary Outcome

Title	Ischemia-driven Target Lesion Revascularization
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PCI at Hospitals Without On-Site Cardiac Surgery	PCI at Hospital With On-Site Cardiac Surgery
Arm/Group Description	Assigned to PCI at a hospital without on-site cardiac surgery	Assigned to PCI at a hospital with on-site cardiac surgery
Measure Participants	2689	882
Number [participants]	36 1.3%	12 1.3%

5. Secondary Outcome

Title	Ischemia-driven Target Lesion Revascularization
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PCI at Hospitals Without On-Site Cardiac Surgery	PCI at Hospital With On-Site Cardiac Surgery
Arm/Group Description	Assigned to PCI at a hospital without on-site cardiac surgery	Assigned to PCI at a hospital with on-site cardiac surgery
Measure Participants	2364	766
Number [participants]	117 4.2%	38 4.1%

6. Secondary Outcome

Title	Rate of Stent Thrombosis
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PCI at Hospitals Without On-Site Cardiac Surgery	PCI at Hospital With On-Site Cardiac Surgery
Arm/Group Description	Assigned to PCI at a hospital without on-site cardiac surgery.	Assigned to PCI at a hospital with on-site cardiac surgery
Measure Participants	2364	771
Number [participants]	27 1%	16 1.7%

7. Secondary Outcome

Title	Any Repeat Revascularization
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PCI at Hospitals Without On-Site Cardiac Surgery	PCI at Hospital With On-Site Cardiac Surgery
Arm/Group Description	Assigned to PCI at a hospital without on-site cardiac surgery	Assigned to PCI at a hospital with on-site cardiac surgery
Measure Participants	2372	769
Number [participants]	202 7.3%	76 8.3%

8. Secondary Outcome

Title	Emergency or Urgent Revascularization
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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/Group Title	PCI at Hospitals Without On-Site Cardiac Surgery	PCI at Hospital With On-Site Cardiac Surgery
Arm/Group Description	Assigned to PCI at a hospital without on-site cardiac surgery	Assigned to PCI at a hospital with on-site cardiac surgery
Measure Participants	2774	917
Number [participants]	7 0.3%	2 0.2%

9. Secondary Outcome

Title	Procedural Success
Description	Procedural success is defined as residual stenosis of the target lesion of less than 20%
Time Frame	Post-Procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PCI at Hospitals Without On-Site Cardiac Surgery	PCI at Hospital With On-Site Cardiac Surgery
Arm/Group Description	Assigned to PCI at a hospital without on-site cardiac surgery in the angiographic cohort	Assigned to PCI at a hospital with on-site cardiac surgery in the angiographic cohort
Measure Participants	289	87
Number [participants]	235 8.5%	65 7.1%

10. Secondary Outcome

Title	Major Vascular Complications
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PCI at Hospitals Without On-Site Cardiac Surgery	PCI at Hospital With On-Site Cardiac Surgery
Arm/Group Description	Assigned to PCI at a hospital without on-site cardiac surgery	Assigned to PCI at a hospital with on-site cardiac surgery
Measure Participants	2687	882
Number [participants]	41 1.5%	13 1.4%

11. Secondary Outcome

Title	Complete Revascularization
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PCI at Hospitals Without On-Site Cardiac Surgery	PCI at Hospital With On-Site Cardiac Surgery
Arm/Group Description	Assigned to PCI at a hospital without on-site cardiac surgery in the angiographic cohort	Assigned to PCI at a hospital with on-site cardiac surgery in the angiographic cohort
Measure Participants	289	87
Number [participants]	174 6.3%	52 5.7%

12. Secondary Outcome

Title	Met Indication Criteria for PCI
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PCI at Hospitals Without On-Site Cardiac Surgery	PCI at Hospital With On-Site Cardiac Surgery
Arm/Group Description	Assigned to PCI at a hospital without on-site cardiac surgery in the angiographic cohort	Assigned to PCI at a hospital with on-site cardiac surgery in the angiographic cohort
Measure Participants	289	87
Measure Lesions	392	106
Number [lesions]	369	97

13. Secondary Outcome

Title	All Cause Mortality at 12 Months
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PCI at Hospitals Without On-Site Cardiac Surgery	PCI at Hospital With On-Site Cardiac Surgery
Arm/Group Description	Assigned to PCI at a hospital without on-site cardiac surgery	Assigned to PCI at a hospital with on-site cardiac surgery
Measure Participants	2424	785
Number [participants]	56 2%	19 2.1%

14. Secondary Outcome

Title	Ischemia-driven Target Vessel Revascularization
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PCI at Hospitals Without On-Site Cardiac Surgery	PCI at Hospital With On-Site Cardiac Surgery
Arm/Group Description	Assigned to PCI at a hospital without on-site cardiac surgery	Assigned to PCI at a hospital with on-site cardiac surgery
Measure Participants	2689	882
Number [participants]	41 1.5%	13 1.4%

15. Secondary Outcome

Title	Ischemia-driven Target Vessel Revascularization
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PCI at Hospitals Without On-Site Cardiac Surgery	PCI at Hospital With On-Site Cardiac Surgery
Arm/Group Description	Assigned to PCI at a hospital without on-site cardiac surgery	Assigned to PCI at a hospital with on-site cardiac surgery
Measure Participants	2366	766
Number [participants]	133 4.8%	41 4.5%

16. Secondary Outcome

Title	Rate of Stent Thrombosis
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PCI at Hospitals Without On-Site Cardiac Surgery	PCI at Hospital With On-Site Cardiac Surgery
Arm/Group Description	Assigned to PCI at a hospital without on-site cardiac surgery	Assigned to PCI at a hospital with on-site cardiac surgery
Measure Participants	2695	883
Number [participants]	16 0.6%	7 0.8%

17. Secondary Outcome

Title	Any Repeat Revascularization
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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/Group Title	PCI at Hospitals Without On-Site Cardiac Surgery	PCI at Hospital With On-Site Cardiac Surgery
Arm/Group Description	Assigned to PCI at a hospital without on-site cardiac surgery	Assigned to PCI at a hospital with on-site cardiac surgery
Measure Participants	2689	883
Number [participants]	73 2.6%	31 3.4%

Adverse Events

Adverse Event Reporting Description	Serious and other adverse events were not collected in this study.
Arm/Group Title	Non-Surgery-On-Site (Non-SOS)		Surgery-On-Site (SOS)
Arm/Group Description	Patients in the non-SOS arm are randomized to stay at the community hospitals for their PCI procedure.		Patients randomized to the SOS arm are transferred to tertiary hospitals for their PCI procedure.
All Cause Mortality
	Non-Surgery-On-Site (Non-SOS)		Surgery-On-Site (SOS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Non-Surgery-On-Site (Non-SOS)		Surgery-On-Site (SOS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Non-Surgery-On-Site (Non-SOS)		Surgery-On-Site (SOS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.