Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival (SYNTAXES)

January 28, 2020 updated by: Stuart Head, Erasmus Medical Center
An investigator-driven, retrospective study to compare long-term survival-data (10-year follow-up) of patients with coronary artery disease (CAD), previously enrolled in the SYNTAX trial, who were randomized to percutaneous coronary intervention (PCI) using a paclitaxel (TAXUS) drug-eluting-stent (DES) or coronary artery bypass grafting (CABG).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2636

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients enrolled in the SYNTAX trial and registries had to be diagnosed with three-vessel (3VD) or left main (LM) coronary artery disease. The vessels (diameter ≥1.5 mm and significant stenosis > 50%) deemed important to revascularize were determined by the Heart Team prior to randomization. The group of 3VD consists of patients with significant stenosis in vessels supplying all three major epicardial territories in absence of LM disease, as determined by the site investigators. The group of patients with LM disease consists of patients with a significant stenosis of the left main coronary artery, irrespective of additional vessel disease.

Description

Patients which have previously been enrolled in the SYNTAX trial (randomized and registry patients)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Randomized CABG patients
Patients which were randomized to undergo CABG.
Other: No intervention will take place for this retrospective and observational study.
No intervention will take place for this retrospective and observational study.
Randomized PCI patients
Patients which were randomized to undergo PCI.
Other: No intervention will take place for this retrospective and observational study.
No intervention will take place for this retrospective and observational study.
Registry CABG
Patients for whom only one treatment option was suitable were included into a parallel, nested registry: the CABG registry for PCI-ineligible patients.
Other: No intervention will take place for this retrospective and observational study.
No intervention will take place for this retrospective and observational study.
Registry PCI
Patients for whom only one treatment option was suitable were included into a parallel, nested registry: the PCI registry for CABG-ineligible patients.
Other: No intervention will take place for this retrospective and observational study.
No intervention will take place for this retrospective and observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term survival status
Time Frame: 10-year
All-cause death
10-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cause of death
Time Frame: 10-year
Cause-specific death, separated in cardiovascular and non-cardiovascular death with specific causes for cardiovascular deaths.
10-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Investigators

  • Principal Investigator: A. Pieter Kappetein, MD, PhD, Erasmus Medical Center
  • Principal Investigator: Friedrick W. Mohr, MD, PhD, German Heart Center, Leipzig, Germany
  • Principal Investigator: Patrick W.J.C. Serruys, MD, PhD, Imperial College London
  • Principal Investigator: Michael J. Mack, MD, PhD, Baylor Scott & White Health, Plano, TX, United States
  • Principal Investigator: David R. Holmes, MD, Mayo Clinic, Rochester, MN, United States
  • Principal Investigator: Marie-Claude Morice, MD, ICPS Ramsay-Generale de Sante, Massy, France
  • Principal Investigator: Piroze M. Davierwala, MD, German Heart Center, Leipzig, Germany
  • Principal Investigator: Stuart J. Head, MD, PhD, Erasmus Medical Center
  • Study Chair: Daniel J.F.M. Thuijs, MD, Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

August 8, 2019

Study Completion (Actual)

August 8, 2019

Study Registration Dates

First Submitted

January 25, 2018

First Submitted That Met QC Criteria

January 25, 2018

First Posted (Actual)

January 31, 2018

Study Record Updates

Last Update Posted (Actual)

January 29, 2020

Last Update Submitted That Met QC Criteria

January 28, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC-2016-716

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on No intervention will take place for this retrospective and observational study.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe