Trial Outcomes & Findings for Percutaneous Coronary Intervention (PCI) Outcomes in Community Versus Tertiary Settings (NCT NCT01116882)

NCT ID: NCT01116882

Last Updated: 2015-04-07

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 3691 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2015-04-07

Participant Flow

Participant milestones

Measure	PCI at a Hospital Without On-site Cardiac Surgery Assigned to PCI at a hospital without on-site cardiac surgery	PCI at Hospital With On-Site Cardiac Surgery Assigned to PCI at a hospital with on-site cardiac surgery
30-day STARTED	2774	917
30-day COMPLETED	2706	886
30-day NOT COMPLETED	68	31
12-month STARTED	2706	886
12-month COMPLETED	2439	787
12-month NOT COMPLETED	267	99

Reasons for withdrawal

Measure	PCI at a Hospital Without On-site Cardiac Surgery Assigned to PCI at a hospital without on-site cardiac surgery	PCI at Hospital With On-Site Cardiac Surgery Assigned to PCI at a hospital with on-site cardiac surgery
30-day Lost to Follow-up	50	21
30-day Withdrawal by Subject	2	4
30-day Other Reasons	16	6
12-month Lost to Follow-up	111	42
12-month Other Reasons	151	49
12-month Withdrawal by Subject	5	8

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	PCI at Hospitals Without On-Site Cardiac Surgery n=2774 Participants Assigned to PCI at a hospital without on-site cardiac surgery	PCI at Hospital With On-Site Cardiac Surgery n=917 Participants Assigned to PCI at a hospital with on-site cardiac surgery	Total n=3691 Participants Total of all reporting groups
Age, Continuous	64.71 years STANDARD_DEVIATION 11.84 • n=93 Participants	64.16 years STANDARD_DEVIATION 11.81 • n=4 Participants	64.57 years STANDARD_DEVIATION 11.83 • n=27 Participants
Sex/Gender, Customized Female	883 participants n=93 Participants	308 participants n=4 Participants	1191 participants n=27 Participants
Sex/Gender, Customized Male	1891 participants n=93 Participants	609 participants n=4 Participants	2500 participants n=27 Participants
Race/Ethnicity, Customized White	2526 participants n=93 Participants	852 participants n=4 Participants	3378 participants n=27 Participants
Race/Ethnicity, Customized Black	51 participants n=93 Participants	9 participants n=4 Participants	60 participants n=27 Participants
Race/Ethnicity, Customized Hispanic	117 participants n=93 Participants	35 participants n=4 Participants	152 participants n=27 Participants
Race/Ethnicity, Customized Other	80 participants n=93 Participants	21 participants n=4 Participants	101 participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	PCI at Hospitals Without On-Site Cardiac Surgery n=2706 Participants Assigned to PCI at a hospital without on-site cardiac surgery	PCI at Hospital With On-Site Cardiac Surgery n=886 Participants Assigned to PCI at a hospital with on-site cardiac surgery
30-day Composite Major Adverse Cardiac Event (MACE)	256 participants	83 participants

PRIMARY outcome

Timeframe: 12 month

Outcome measures

Measure	PCI at Hospitals Without On-Site Cardiac Surgery n=2439 Participants Assigned to PCI at a hospital without on-site cardiac surgery	PCI at Hospital With On-Site Cardiac Surgery n=787 Participants Assigned to PCI at a hospital with on-site cardiac surgery
12-month Composite Major Adverse Cardiac Event (MACE)	421 participants	140 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	PCI at Hospitals Without On-Site Cardiac Surgery n=2708 Participants Assigned to PCI at a hospital without on-site cardiac surgery	PCI at Hospital With On-Site Cardiac Surgery n=885 Participants Assigned to PCI at a hospital with on-site cardiac surgery
All Cause Mortality at 30 Days	18 participants	3 participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	PCI at Hospitals Without On-Site Cardiac Surgery n=2689 Participants Assigned to PCI at a hospital without on-site cardiac surgery	PCI at Hospital With On-Site Cardiac Surgery n=882 Participants Assigned to PCI at a hospital with on-site cardiac surgery
Ischemia-driven Target Lesion Revascularization	36 participants	12 participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	PCI at Hospitals Without On-Site Cardiac Surgery n=2364 Participants Assigned to PCI at a hospital without on-site cardiac surgery	PCI at Hospital With On-Site Cardiac Surgery n=766 Participants Assigned to PCI at a hospital with on-site cardiac surgery
Ischemia-driven Target Lesion Revascularization	117 participants	38 participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	PCI at Hospitals Without On-Site Cardiac Surgery n=2364 Participants Assigned to PCI at a hospital without on-site cardiac surgery	PCI at Hospital With On-Site Cardiac Surgery n=771 Participants Assigned to PCI at a hospital with on-site cardiac surgery
Rate of Stent Thrombosis	27 participants	16 participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	PCI at Hospitals Without On-Site Cardiac Surgery n=2372 Participants Assigned to PCI at a hospital without on-site cardiac surgery	PCI at Hospital With On-Site Cardiac Surgery n=769 Participants Assigned to PCI at a hospital with on-site cardiac surgery
Any Repeat Revascularization	202 participants	76 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	PCI at Hospitals Without On-Site Cardiac Surgery n=2774 Participants Assigned to PCI at a hospital without on-site cardiac surgery	PCI at Hospital With On-Site Cardiac Surgery n=917 Participants Assigned to PCI at a hospital with on-site cardiac surgery
Emergency or Urgent Revascularization	7 participants	2 participants

SECONDARY outcome

Timeframe: Post-Procedure

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

Outcome measures

Measure	PCI at Hospitals Without On-Site Cardiac Surgery n=289 Participants Assigned to PCI at a hospital without on-site cardiac surgery	PCI at Hospital With On-Site Cardiac Surgery n=87 Participants Assigned to PCI at a hospital with on-site cardiac surgery
Procedural Success	235 participants	65 participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	PCI at Hospitals Without On-Site Cardiac Surgery n=2687 Participants Assigned to PCI at a hospital without on-site cardiac surgery	PCI at Hospital With On-Site Cardiac Surgery n=882 Participants Assigned to PCI at a hospital with on-site cardiac surgery
Major Vascular Complications	41 participants	13 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	PCI at Hospitals Without On-Site Cardiac Surgery n=289 Participants Assigned to PCI at a hospital without on-site cardiac surgery	PCI at Hospital With On-Site Cardiac Surgery n=87 Participants Assigned to PCI at a hospital with on-site cardiac surgery
Complete Revascularization	174 participants	52 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	PCI at Hospitals Without On-Site Cardiac Surgery n=392 Lesions Assigned to PCI at a hospital without on-site cardiac surgery	PCI at Hospital With On-Site Cardiac Surgery n=106 Lesions Assigned to PCI at a hospital with on-site cardiac surgery
Met Indication Criteria for PCI	369 lesions	97 lesions

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	PCI at Hospitals Without On-Site Cardiac Surgery n=2424 Participants Assigned to PCI at a hospital without on-site cardiac surgery	PCI at Hospital With On-Site Cardiac Surgery n=785 Participants Assigned to PCI at a hospital with on-site cardiac surgery
All Cause Mortality at 12 Months	56 participants	19 participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	PCI at Hospitals Without On-Site Cardiac Surgery n=2689 Participants Assigned to PCI at a hospital without on-site cardiac surgery	PCI at Hospital With On-Site Cardiac Surgery n=882 Participants Assigned to PCI at a hospital with on-site cardiac surgery
Ischemia-driven Target Vessel Revascularization	41 participants	13 participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	PCI at Hospitals Without On-Site Cardiac Surgery n=2366 Participants Assigned to PCI at a hospital without on-site cardiac surgery	PCI at Hospital With On-Site Cardiac Surgery n=766 Participants Assigned to PCI at a hospital with on-site cardiac surgery
Ischemia-driven Target Vessel Revascularization	133 participants	41 participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	PCI at Hospitals Without On-Site Cardiac Surgery n=2695 Participants Assigned to PCI at a hospital without on-site cardiac surgery	PCI at Hospital With On-Site Cardiac Surgery n=883 Participants Assigned to PCI at a hospital with on-site cardiac surgery
Rate of Stent Thrombosis	16 participants	7 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	PCI at Hospitals Without On-Site Cardiac Surgery n=2689 Participants Assigned to PCI at a hospital without on-site cardiac surgery	PCI at Hospital With On-Site Cardiac Surgery n=883 Participants Assigned to PCI at a hospital with on-site cardiac surgery
Any Repeat Revascularization	73 participants	31 participants

Adverse Events

Non-Surgery-On-Site (Non-SOS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Surgery-On-Site (SOS)

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