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

Completed

• Conditions: Coronary Artery Disease
• Interventions: Other: No intervention will take place for this retrospective and observational study.

• Registration Number: NCT03417050
• Lead Sponsor: Erasmus Medical Center

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2018-01-25
• Study First Submitted QC: 2018-01-25
• Study First Posted: 2018-01-31
• Primary Completion: 2019-08-08
• Study Completion: 2019-08-08
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-28
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2636

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Long-term survival status	10-year	All-cause death

Secondary Outcome Measures

Name	Time	Method
Cause of death	10-year	Cause-specific death, separated in cardiovascular and non-cardiovascular death with specific causes for cardiovascular deaths.