NCT02015832

Trial Evaluating New Strategy in the Functional Assessment of 3-vessel Disease Using SYNTAXII Score in Patients With PCI

Completed Results posted Last updated 21 July 2022

What this trial tests

trial testing Coronary stent in Heart Diseases in 454 participants. Completed in 4 February 2021.

Timeline

6 February 2014

Primary endpoint
28 March 2017

4 February 2021

Quick facts

Lead sponsor	ECRI bv
Status	Completed
Study type	OBSERVATIONAL
Enrollment	454
Start date	6 February 2014
Primary completion	28 March 2017
Estimated completion	4 February 2021
Sites	22 locations across Spain, Netherlands, United Kingdom, Poland

Drugs / interventions tested

• Coronary stent
• Multi Slice Computed Tomography
• instantaneous wave-free ratio
• Fractional flow reserve
• Intravascular Ultrasound

Conditions studied

• Heart Diseases — all drugs for Heart Diseases →
• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• 3 Vessel Coronary Artery Disease — all drugs for 3 Vessel Coronary Artery Disease →

Sponsor

ECRI bv — full company profile →

Who can join

21 and older, any sex, with Heart Diseases or Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Umber of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE) Primary · 1 year

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

Group	Value	95% CI
SYNTAX II PCI Strategy Arm	47
Pre-defined SYNTAX I PCI Cohort	54

Number of Participants With All-cause Death, Stroke, or Myocardial Infarction Secondary · 1 Year

Safety endpoint

Group	Value	95% CI
SYNTAX II PCI Cohort	17
SYNTAX I PCI Cohort	20

Number of Participants With All-cause Death Secondary · 1 Year

All-cause death

Group	Value	95% CI
SYNTAX II PCI Cohort	9
SYNTAX I PCI Cohort	9

Number of Participants With Stroke Secondary · 1 Year

Stroke

Group	Value	95% CI
SYNTAX II PCI Cohort	2
SYNTAX I PCI Cohort	2

Number of Participants With Myocardial Infarction Secondary · 1 year

Any myocardial infarction

Group	Value	95% CI
SYNTAX II PCI Cohort	6
SYNTAX I PCI Cohort	15

Number of Participants With Revascularization Secondary · 1 Years

Any coronary revascularization

Group	Value	95% CI
SYNTAX II PCI Cohort	36
SYNTAX I PCI Cohort	42

Number of Participants With Definite Stent Thrombosis Secondary · 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 de

Group	Value	95% CI
SYNTAX II PCI Cohort	3
SYNTAX I PCI Cohort	8

Number of Participants With Probable Stent Thrombosis Secondary · 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.

Group	Value	95% CI
SYNTAX II PCI Cohort	1
SYNTAX I PCI Cohort	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 5 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Percutaneous Coronary Intervention

Serious: 125/454 (28%)

Deaths: 36/454

Serious adverse events (5 terms)

Reaction	System	Percutaneous Coronary Inte…
All-cause Revascularization	Cardiac disorders	—
Death	General disorders	—
Myocardial Infarction	Cardiac disorders	—
Stroke	Cardiac disorders	—
Stent Thrombosis	Cardiac disorders	—

Most-reported serious reactions: All-cause Revascularization, Death, Myocardial Infarction, Stroke, Stent Thrombosis.

Data from ClinicalTrials.gov NCT02015832 adverse events section.

Sponsor's own description

Clinical study that aims to evaluate a new strategy using the SYNTAX II Score calculator in the functional assessment of patients with new coronary 3-vessel-disease who undergo percutaneous coronary intervention (PCI)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical outcomes of state-of-the-art percutaneous coronary revascularization in patients with de novo three vessel disease: 1-year results of the SYNTAX II study.
   Escaned J, Collet C, Ryan N, De Maria GL, et al · · 2017 · cited 208× · PMID 29020367 · DOI 10.1093/eurheartj/ehx512
2. Fractional Flow Reserve Derived From Computed Tomographic Angiography in Patients With Multivessel CAD.
   Collet C, Miyazaki Y, Ryan N, Asano T, et al · · 2018 · cited 92× · PMID 29802016 · DOI 10.1016/j.jacc.2018.02.053
3. Comparison of Clinically Adjudicated Versus Flow-Based Adjudication of Revascularization Events in Randomized Controlled Trials.
   Wang R, Kawashima H, Hara H, Gao C, et al · · 2021 · cited 7× · PMID 34666500 · DOI 10.1161/circoutcomes.121.008055
4. Bypass Grafting Versus Percutaneous Intervention-Which Is Better in Multivessel Coronary Disease: Lessons From SYNTAX and Beyond.
   Farooq V, Serruys PW. · · 2015 · cited 7× · PMID 26529569 · DOI 10.1016/j.pcad.2015.10.002
5. Physiological evaluation of the provisional side-branch intervention strategy for bifurcation lesions using instantaneous wave-free ratio.
   Shaheen M, Mokarrab M, Youssef A, Aref M, et al · · 2018 · cited 4× · PMID 30595269 · DOI 10.1016/j.ihj.2018.01.028
6. Impact of periprocedural major adverse events on 10-year mortality after revascularisation.
   Kotoku N, Serruys PW, Ninomiya K, Soo A, et al · · 2023 · cited 2× · PMID 36632743 · DOI 10.4244/eij-d-22-00681
7. Balancing idealism with realism to safeguard the welfare of patients: The importance of Heart Team led decision-making in patients with complex coronary artery disease.
   Farooq V, Di Mario C, Serruys PW. · · 2016 · cited 2× · PMID 26896257 · DOI 10.1016/j.ihj.2015.10.385
8. Current developments and future applications of intracoronary hemodynamics.
   Coverstone E, Shapiro R, Singh J. · · 2015 · cited 2× · PMID 25946656 · DOI 10.1097/mca.0000000000000253