Trial Outcomes & Findings for The MASS COMM Post-Randomization Phase Cohort Study (NCT NCT02072421)

NCT ID: NCT02072421

Last Updated: 2015-04-07

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 2879 participants
• Primary outcome timeframe: 30-days
• Results posted on: 2015-04-07

Participant Flow

Participant milestones

Measure	PCI at Hospitals Without On-Site Cardiac Surgery PCI at a hospital without on-site cardiac surgery
Overall Study STARTED	2879
Overall Study COMPLETED	2489
Overall Study NOT COMPLETED	390

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The MASS COMM Post-Randomization Phase Cohort Study

Baseline characteristics by cohort

Measure	PCI at Hospitals Without On-Site Cardiac Surgery n=2879 Participants PCI at a hospital without on-site cardiac surgery
Age, Continuous	64.92 years STANDARD_DEVIATION 11.48 • n=5 Participants
Sex/Gender, Customized Male	1955 participants n=5 Participants
Sex/Gender, Customized Female	924 participants n=5 Participants
Race/Ethnicity, Customized Caucasian	2595 participants n=5 Participants
Race/Ethnicity, Customized Black	61 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	153 participants n=5 Participants
Race/Ethnicity, Customized Asian	50 participants n=5 Participants
Race/Ethnicity, Customized Native American	1 participants n=5 Participants
Race/Ethnicity, Customized Other	19 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	PCI at Hospitals Without On-Site Cardiac Surgery n=2879 Participants Assigned to PCI at a hospital without on-site cardiac surgery
Major Adverse Cardiac Event (MACE)	229 participants

SECONDARY outcome

Timeframe: 30 days

all-cause mortality through 30 days post-procedure

Outcome measures

Measure	PCI at Hospitals Without On-Site Cardiac Surgery n=2879 Participants Assigned to PCI at a hospital without on-site cardiac surgery
All-Cause Mortality	15 participants

SECONDARY outcome

Timeframe: 30 days

Stroke through 30 days post-procedure

Outcome measures

Measure	PCI at Hospitals Without On-Site Cardiac Surgery n=2879 Participants Assigned to PCI at a hospital without on-site cardiac surgery
Stroke	2 participants

SECONDARY outcome

Timeframe: 30 days

Repeat coronary revascularization including emergency or urgent revascularization through 30 days post-procedure

Outcome measures

Measure	PCI at Hospitals Without On-Site Cardiac Surgery n=2879 Participants Assigned to PCI at a hospital without on-site cardiac surgery
Revascularization	75 participants

SECONDARY outcome

Timeframe: 30 days

Major vascular complications, including access site complications and major bleeding events requiring transfusion,through 30 days post-procedure.

Outcome measures

Measure	PCI at Hospitals Without On-Site Cardiac Surgery n=2879 Participants Assigned to PCI at a hospital without on-site cardiac surgery
Major Vascular Complications	28 participants

Adverse Events

PCI at Hospitals Without On-Site Cardiac Surgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Priscilla Driscoll-Shemp

Harvard Clinical Research Institute

Phone: 617-307-5200

Email: priscilla.driscoll-shempp@hcri.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place