Trial Outcomes & Findings for Distal Protection Device in ST-elevation Myocardial Infarction (STEMI) (NCT NCT01384019)

Results Overview

postinfarct remodeling as evidenced by decreased left ventricular (LV) dilatation measured by CMR 6 months post PCI

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

126 participants

Primary outcome timeframe

6 months

Results posted on

2013-03-18

Participant Flow

Between Jan 24, 2004, and June 16, 2008, 550 patients with STEMI were screened.

Among them, 126 patients were randomized to receive either PCI with distal protection (n=65) or PCI alone (n=61). Fifty five patients per each group received post-PCI CMR. Forty one patients underwent 6 month MRI in distal protection group and 43 patients, in conventional PCI group.

Participant milestones

Participant milestones
Measure	DP-TA distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)	c-PCI conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
Overall Study STARTED	65	61
Overall Study COMPLETED	55	55
Overall Study NOT COMPLETED	10	6

Reasons for withdrawal

Reasons for withdrawal
Measure	DP-TA distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)	c-PCI conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
Overall Study Withdrawal by Subject	3	0
Overall Study Death	1	0
Overall Study MRI refusal	6	6

Baseline Characteristics

Distal Protection Device in ST-elevation Myocardial Infarction (STEMI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DP-TA n=65 Participants distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)	c-PCI n=61 Participants conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction	Total n=126 Participants Total of all reporting groups
Age Continuous	58 years STANDARD_DEVIATION 12 • n=5 Participants	58 years STANDARD_DEVIATION 11 • n=7 Participants	58 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants	48 Participants n=7 Participants	100 Participants n=5 Participants
Region of Enrollment Korea, Republic of	65 participants n=5 Participants	61 participants n=7 Participants	126 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Forty one patients underwent 6 month CMR in distal protection group and 43 patients, in conventional PCI group.

postinfarct remodeling as evidenced by decreased left ventricular (LV) dilatation measured by CMR 6 months post PCI

Outcome measures

Outcome measures
Measure	DP-TA n=41 Participants distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)	c-PCI n=43 Participants conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
Postinfarct Remodeling	11 Number of participants with remodeling	6 Number of participants with remodeling

SECONDARY outcome

Timeframe: 3-5 days

microvascular obstruction, myocardial salvage, and infarct size measured using post-PCI CMR

Outcome measures

Outcome data not reported

Adverse Events

DP-TA

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

c-PCI

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DP-TA n=65 participants at risk distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)	c-PCI n=61 participants at risk conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
Cardiac disorders Death	1.5% 1/65 • Number of events 1 • 6 months	3.3% 2/61 • Number of events 2 • 6 months
Cardiac disorders revascularization	9.2% 6/65 • Number of events 6 • 6 months	6.6% 4/61 • Number of events 4 • 6 months
Cardiac disorders stroke	0.00% 0/65 • 6 months	1.6% 1/61 • Number of events 1 • 6 months
Cardiac disorders admission due to heart failure	0.00% 0/65 • 6 months	3.3% 2/61 • Number of events 2 • 6 months

Other adverse events

Adverse event data not reported

Additional Information

Dr. Chang-Hwan Yoon

Seoul national university Bundang hospital

Phone: +82-31-787-7052

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place