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Interventional Diagnostic Procedure: A Practical Guide for the Assessment of Coronary Vascular Function
Published on: March 15, 2022
Distal embolic protection during percutaneous intervention of aorto-coronary venous bypass grafts: the FIRST Trial
1University Clinic Schleswig-Holstein, Campus Kiel, Department of Cardiology, Schittenhelmstrasse 12, 24105 Kiel, Germany.
Insights
The TriActiv device effectively protected against debris during bypass graft interventions, showing a low major adverse cardiac event rate. This supports using protection systems for coronary artery bypass graft procedures.
Area of Science:
- Cardiovascular Interventions
- Medical Device Technology
- Interventional Cardiology
Background:
- Aorto-coronary venous bypass grafts (CABG) interventions risk distal embolization.
- Debris embolization can lead to acute procedural complications.
- The TriActiv device is a distal endovascular protection system.
Purpose of the Study:
- To evaluate the safety and effectiveness of the TriActiv device.
- To assess the TriActiv device during CABG interventions.
- To determine the incidence of complications during CABG interventions with TriActiv.
Main Methods:
- A multicenter trial (FIRST) involving 195 patients across 17 German centers.
- Patients had significant disease of a vein graft.
- Inclusion/exclusion criteria mirrored the SAFER trial.
Main Results:
- Acute procedural success was achieved in 98% of cases.
- Aspirated debris was present in 96.5% of patients.
- The 30-day rate of Major Adverse Cardiac Events (MACE) was 8.7%, with no deaths and a 7.2% Myocardial Infarction (MI) rate.
Conclusions:
- The TriActiv system demonstrated safety and effectiveness in CABG interventions.
- The device preserved normal post-procedural flow.
- The low MACE rate (8.7%) supports the use of protection systems in PCI of CABG grafts.
Objective:
Interventions in aorto-coronary venous bypass grafts (CABG) can cause acute procedural complications due to distal embolization of debris. In the FIRST (First European Investigation Regarding the Systematic use of the TriActiv device) multicenter trial the distal endovascular protection system TriActiv (Kensey Nash) was evaluated during intervention of CABG.
Methods:
195 patients in 17 centers in Germany with significant disease of a vein graft were enrolled. Inclusion and exclusion criteria were comparable to the SAFER trial.
Results:
Acute procedural success was achieved in 98% of cases. Aspirated debris was found in 96.5% of patients. Primary endpoints (MACE at 30 days) occurred in 8.7% of all pts. (ITT). No patient died and 7.2% of patients suffered from MI. The rate of early revascularization was 1.5%. Secondary endpoints (MACCE at 30 days) were found in 9.2% and at hospital discharge in 8.7% of patients.
Conclusions:
The TriActiv system is safe and effective. Normal post procedural flow can be preserved and the MACE rate is with 8.7% considerably low. The FIRST trial supports the growing belief that PCI of CABG should be performed with protection systems.
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