Trial Outcomes & Findings for Trial Evaluating New Strategy in the Functional Assessment of 3-vessel Disease Using SYNTAXII Score in Patients With PCI (NCT NCT02015832)

NCT ID: NCT02015832

Last Updated: 2022-07-21

Results Overview

MACCE is defined as: all-cause death; cerebrovascular event (stroke); documented myocardial infarction or all-cause revascularization

• Recruitment status: COMPLETED
• Target enrollment: 454 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2022-07-21

Participant Flow

Participant milestones

Measure	Percutaneous Coronary Intervention All-Comers, angiographic, de-novo 3-vessel disease without left main involvement (visual % diameter stenosis #50%).
Overall Study STARTED	454
Overall Study COMPLETED	443
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Percutaneous Coronary Intervention n=454 Participants All-Comers, angiographic, de-novo 3-vessel disease without left main involvement (visual % diameter stenosis #50%).
Age, Continuous	66.7 years STANDARD_DEVIATION 9.7 • n=454 Participants
Sex: Female, Male Female	31 Participants n=454 Participants
Sex: Female, Male Male	423 Participants n=454 Participants
Region of Enrollment Netherlands	36 participants n=454 Participants
Region of Enrollment Poland	38 participants n=454 Participants
Region of Enrollment United Kingdom	230 participants n=454 Participants
Region of Enrollment Spain	150 participants n=454 Participants

PRIMARY outcome

Timeframe: 1 year

Population: All patients enrolled in the SYNTAX II single-arm study were compared with a historical cohort selected from the SYNTAX I PCI arm (NCT00114972). Patients had three-vessel disease at presentation and qualified to enter the study based on equipoise to undergo either PCI or CABG according to the SYNTAX score II calculator (www.syntaxscore.org).

MACCE is defined as: all-cause death; cerebrovascular event (stroke); documented myocardial infarction or all-cause revascularization

Outcome measures

Measure	SYNTAX II PCI Strategy Arm n=454 Participants Use of the SYNTAX II PCI strategy in patients with de novo three vessel disease. SYNTAX II PCI strategy included use of new generation DES, coronary physiology, and coronary imaging for stent implantation.	Pre-defined SYNTAX I PCI Cohort n=315 Participants The historical comparator consisted on subjects enrolled in the SYNTAX I trial, treated with PCI, who would fulfill the SYNTAX II score criteria used in SYNTAX II (i.e. similar risk of undergoing PCI or CABG based on predicted mortality at 4 years).
Umber of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE)	47 Participants	54 Participants

SECONDARY outcome

Timeframe: 1 Year

Population: SYNTAX II PCI cohort vs. SYNTAX I PCI selected cohort.

Safety endpoint

Outcome measures

Measure	SYNTAX II PCI Strategy Arm n=454 Participants Use of the SYNTAX II PCI strategy in patients with de novo three vessel disease. SYNTAX II PCI strategy included use of new generation DES, coronary physiology, and coronary imaging for stent implantation.	Pre-defined SYNTAX I PCI Cohort n=315 Participants The historical comparator consisted on subjects enrolled in the SYNTAX I trial, treated with PCI, who would fulfill the SYNTAX II score criteria used in SYNTAX II (i.e. similar risk of undergoing PCI or CABG based on predicted mortality at 4 years).
Number of Participants With All-cause Death, Stroke, or Myocardial Infarction	17 Participants	20 Participants

SECONDARY outcome

Timeframe: 1 Year

All-cause death

Outcome measures

Measure	SYNTAX II PCI Strategy Arm n=454 Participants Use of the SYNTAX II PCI strategy in patients with de novo three vessel disease. SYNTAX II PCI strategy included use of new generation DES, coronary physiology, and coronary imaging for stent implantation.	Pre-defined SYNTAX I PCI Cohort n=315 Participants The historical comparator consisted on subjects enrolled in the SYNTAX I trial, treated with PCI, who would fulfill the SYNTAX II score criteria used in SYNTAX II (i.e. similar risk of undergoing PCI or CABG based on predicted mortality at 4 years).
Number of Participants With All-cause Death	9 Participants	9 Participants

SECONDARY outcome

Timeframe: 1 Year

Stroke

Outcome measures

Measure	SYNTAX II PCI Strategy Arm n=454 Participants Use of the SYNTAX II PCI strategy in patients with de novo three vessel disease. SYNTAX II PCI strategy included use of new generation DES, coronary physiology, and coronary imaging for stent implantation.	Pre-defined SYNTAX I PCI Cohort n=315 Participants The historical comparator consisted on subjects enrolled in the SYNTAX I trial, treated with PCI, who would fulfill the SYNTAX II score criteria used in SYNTAX II (i.e. similar risk of undergoing PCI or CABG based on predicted mortality at 4 years).
Number of Participants With Stroke	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 1 year

Any myocardial infarction

Outcome measures

Measure	SYNTAX II PCI Strategy Arm n=454 Participants Use of the SYNTAX II PCI strategy in patients with de novo three vessel disease. SYNTAX II PCI strategy included use of new generation DES, coronary physiology, and coronary imaging for stent implantation.	Pre-defined SYNTAX I PCI Cohort n=315 Participants The historical comparator consisted on subjects enrolled in the SYNTAX I trial, treated with PCI, who would fulfill the SYNTAX II score criteria used in SYNTAX II (i.e. similar risk of undergoing PCI or CABG based on predicted mortality at 4 years).
Number of Participants With Myocardial Infarction	6 Participants	15 Participants

SECONDARY outcome

Timeframe: 1 Years

Any coronary revascularization

Outcome measures

Measure	SYNTAX II PCI Strategy Arm n=454 Participants Use of the SYNTAX II PCI strategy in patients with de novo three vessel disease. SYNTAX II PCI strategy included use of new generation DES, coronary physiology, and coronary imaging for stent implantation.	Pre-defined SYNTAX I PCI Cohort n=315 Participants The historical comparator consisted on subjects enrolled in the SYNTAX I trial, treated with PCI, who would fulfill the SYNTAX II score criteria used in SYNTAX II (i.e. similar risk of undergoing PCI or CABG based on predicted mortality at 4 years).
Number of Participants With Revascularization	36 Participants	42 Participants

SECONDARY outcome

Timeframe: 1 Year

Stent Thrombosis - according to ARC definitions. Definite ST can be confirmed with 1) angiography (the presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent and presence of at least 1 of the following criteria within a 48-hour time window: Acute onset of ischemic symptoms at rest; New ischemic ECG changes that suggest acute ischemia; Typical rise and fall in cardiac biomarkers (refer to definition of spontaneous MI); Non-occlusive thrombus or Occlusive thrombus; or 2) Pathological confirmation (evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy).

Outcome measures

Measure	SYNTAX II PCI Strategy Arm n=454 Participants Use of the SYNTAX II PCI strategy in patients with de novo three vessel disease. SYNTAX II PCI strategy included use of new generation DES, coronary physiology, and coronary imaging for stent implantation.	Pre-defined SYNTAX I PCI Cohort n=315 Participants The historical comparator consisted on subjects enrolled in the SYNTAX I trial, treated with PCI, who would fulfill the SYNTAX II score criteria used in SYNTAX II (i.e. similar risk of undergoing PCI or CABG based on predicted mortality at 4 years).
Number of Participants With Definite Stent Thrombosis	3 Participants	8 Participants

SECONDARY outcome

Timeframe: 1 year

Stent Thrombosis - according to ARC definitions. Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: 1) Any unexplained death within the first 30 days; 2) Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

Outcome measures

Measure	SYNTAX II PCI Strategy Arm n=454 Participants Use of the SYNTAX II PCI strategy in patients with de novo three vessel disease. SYNTAX II PCI strategy included use of new generation DES, coronary physiology, and coronary imaging for stent implantation.	Pre-defined SYNTAX I PCI Cohort n=315 Participants The historical comparator consisted on subjects enrolled in the SYNTAX I trial, treated with PCI, who would fulfill the SYNTAX II score criteria used in SYNTAX II (i.e. similar risk of undergoing PCI or CABG based on predicted mortality at 4 years).
Number of Participants With Probable Stent Thrombosis	1 Participants	0 Participants

Adverse Events

Percutaneous Coronary Intervention

Serious events: 125 serious events

Other events: 0 other events

Deaths: 36 deaths

Serious adverse events

Measure	Percutaneous Coronary Intervention n=454 participants at risk All-Comers, angiographic, de-novo 3-vessel disease without left main involvement (visual % diameter stenosis #50%).
Cardiac disorders Myocardial Infarction	2.6% 12/454 • Number of events 125 • 5 years
Cardiac disorders All-cause Revascularization	13.2% 60/454 • Number of events 125 • 5 years
Cardiac disorders Stroke	2.2% 10/454 • Number of events 125 • 5 years
Cardiac disorders Stent Thrombosis	1.5% 7/454 • Number of events 125 • 5 years
General disorders Death	7.9% 36/454 • Number of events 125 • 5 years

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ernest Spitzer

European Cardiovascular Research Institute

Phone: +31102062828

Email: E.Spitzer@ECRI-Trials.com

Results disclosure agreements

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