Trial Outcomes & Findings for SYNTAX III REVOLUTION Trial: A Randomized Study Investigating the Use of CT Scan and Angiography of the Heart to Help the Doctors Decide Which Method is the Best to Improve Blood Supply to the Heart in Patients With Complex Coronary Artery Disease (NCT NCT02813473)

Results Overview

Inter-rater agreement, as assessed by Cohen's Kappa Kappa, on revascularization strategy of two Heart Teams using an "Angio-first" algorithm (based on invasive SYNTAX Score II) or a "CT-first" algorithm (based on non-invasive SYNTAX Score II, without FFRCT) and 95% confidence intervals (CI).

Recruitment status

COMPLETED

Target enrollment

223 participants

Primary outcome timeframe

Heart Team meetings took place in average 1 to 2 weeks afer patient enrollment

Results posted on

2019-09-27

Participant Flow

223 patients with presence of 3 vessel dissease or left-main disease were enrolled in 6 centers in Europe to assess the coronary artery disease of the 223 patients randomized with either coronary CTA or conventional angiography blinded to the other modality.

Participant milestones

Participant milestones
Measure	Patients With Left Main or 3 Vessel Artery Disease 223 patients with left main or 3 vessels artery desease were enrolled in the study. For each given patient the Heart Team is randomly assigned to an "Angio-First" or a "CT-First" decision algorithm. Each patient was assessed by both teams. The concordance or discordance of decision makings based on either conventional angiography (Angio first algorithm) or MSCT angiography (CT first algorithm) constitute the primary endpoint.
Overall Study STARTED	223
Overall Study COMPLETED	223
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Left Main or 3 Vessel Artery Disease n=223 Participants Patients with left main or three-vessel coronary artery disease, diagnosed with either coronary CTA or conventional angiography and candidates for either CABG or PCI.
Age, Continuous	67.6 years STANDARD_DEVIATION 8.9 • n=223 Participants
Sex: Female, Male Female	35 Participants n=223 Participants
Sex: Female, Male Male	188 Participants n=223 Participants

PRIMARY outcome

Timeframe: Heart Team meetings took place in average 1 to 2 weeks afer patient enrollment

Inter-rater agreement, as assessed by Cohen's Kappa Kappa, on revascularization strategy of two Heart Teams using an "Angio-first" algorithm (based on invasive SYNTAX Score II) or a "CT-first" algorithm (based on non-invasive SYNTAX Score II, without FFRCT) and 95% confidence intervals (CI).

Outcome measures

Outcome measures
Measure	Patients With Left Main or 3 Vessel Artery Disease n=223 Participants 223 patients with left main or 3 vessels artery desease were enrolled in the study. For each given patient the Heart Team is randomly assigned to an "Angio-First" or a "CT-First" decision algorithm. Each patient was assessed by both teams. The concordance or discordance of decision makings based on either conventional angiography (Angio first algorithm) or MSCT angiography (CT first algorithm) constitute the primary endpoint.
Inter-rater Agreement on Revascularization Strategy of Two Heart Teams Using an "Angio-first" Algorithm or a "CT First" Algorithm.	0.82 proportion of agreement Interval 0.73 to 0.91

Adverse Events

Patients With Left Main or 3 Vessel Artery Disease

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

Ron van Amsterdam

ECRI

Phone: +31102062802

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place