Feature | November 04, 2013

Hybrid Procedure Feasible, Safe Compared to Traditional CABG

Results of the HYBRID Trial Presented at TCT 2013

November 4, 2013 — A hybrid approach to treating coronary artery disease that involves a hybrid procedure combining a minimally invasive bypass surgery with percutaneous coronary intervention (PCI) was found to be feasible and safe in a clinical trial. This is the first randomized study of the technique. These findings were presented at the 25th annual Transcatheter Cardiovascular Therapeutics scientific symposium (TCT 2013).
 
Hybrid coronary artery revascularization (HCR), as studied within this trial, combined a minimally invasive left internal mammary artery bypass grafting to the left anterior descending artery (LAD) with percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation to other coronary arteries. Due to the lack of data from large, prospective, randomized trials comparing HCR with standard surgical revascularization, HYBRID was designed as a feasibility study to assess the safety and efficacy of HCR in patients with multi-vessel coronary artery disease referred for standard coronary artery bypass grafting (CABG).
 
Two hundred consecutive patients, with angiographically confirmed multi-vessel coronary artery disease (CAD) involving the LAD and a critical (> 70 percent) lesion in at least one major epicardial vessel (except LAD) amenable to both PCI and CABG, were randomized in a one-to-one fashion to HCR or standard surgical revascularization.
 
The primary objectives of this trial were to investigate the feasibility and safety of HCR. The feasibility assessment was defined both as the percentage of patients in the hybrid group that had a complete HCR procedure according to the study protocol and a percentage that had to be converted to standard CABG. The safety endpoint was the occurrence of major adverse cardiac events (MACE) such as death, myocardial infarction, stroke, repeat revascularization or major bleeding within the 12-month period after randomization. 
 
In the trial, 93.9 percent of the patients in the hybrid group had the completed HCR procedure and 6.1 percent were converted to CABG.  
 
At one year, 92.2 percent of the CABG group and 89.8 percent of the hybrid group were free from MACE. No strokes were reported in either group. The rate of death was 2.9 percent in the CABG group and 2.0 percent in the HCR group.
 
“This first randomized pilot study on hybrid coronary revascularization shows promising feasibility and safety results supporting the idea of hybrid coronary revascularization in patients with multi-vessel disease,” said Michal Hawranek, M.D, Ph.D., on behalf of the investigation team at the Silesian Center for Heart Disease, Zabrze, Poland. 
 
For more information: www.crf.org

Related Content

News | Heart Failure| August 28, 2015
August 28, 2015 — BioControl Medical said it has completed enrollment in its INOVATE-HF (INcrease Of VAgal TonE in He
Stent graft, computational fluid dynamics, CFD, stent engineering

In this vector velocity model, brighter colors indicate blood flow acceleration as it passes through a bifurcation. Computation fluid dynamic modeling provides insight on blood flow through and near the walls of the stent graft. Image courtesy of Sanford Health

News | Cath Lab| August 27, 2015
August 27, 2015 — The use of computational fluid dynamics (CFD) modeling has been used for years to better engineer l
News | Cath Lab| August 26, 2015
August 26, 2014 — The Cardiovascular Research Foundation (CRF) announced the late-breaking trials and first report in

Mitral regurgitation viewed under color Doppler. Image courtesy of Toshiba.

Feature | Heart Valve Repair| August 26, 2015
August 25, 2015 — Medtronic announced it entered a definitive agreement to acquire Twelve Inc., a start–up medical de
NuCART, CompView Medical, mobile boom system, cath lab, hybrid OR
Technology | Cath Lab| August 21, 2015
August 21, 2015 — CompView Medical announced the release of the NuCART, a turn-key, all-in-one mobile boom system wit
BioSig Technologies, research agreement, UCLA, Pure EP System, EP lab, ventricular tachycardia model, VT
Technology | EP Lab| August 20, 2015
BioSig Technologies announced it has signed a sponsored research agreement with the regents of the University of...
Corindus, Corpath, radiation dose monitoring, cath lab, vascular robotic system

The Corindus Corpath vascular robotic system.

Technology | Radiation Dose Management| August 19, 2015
Corindus Vascular Robotics Inc. and Unfors RaySafe Inc., a Fluke Biomedical Company, announced a distribution agreement...
Sunshine Heart, COUNTER HF pivotal study, resumes enrollment, C-Pulse, FDA
News | Heart Failure| August 18, 2015
Sunshine Heart Inc. announced an update in late July on its COUNTER HF U.S. pivotal study for the C-Pulse Heart Assist...
Biotronik, BioCONTINUE study, CRT-D, defibrillator, cardiac resynchronization therapy device, heart failure, first replacement
News | Cardiac Resynchronization Therapy Devices (CRT)| August 17, 2015
Biotronik announced that the first patient has been enrolled in the BioCONTINUE clinical trial (BIOtronik study to...
corpath, corindus, robotic PCI, robots in the cath lab

The Corindus CorPath robotic system enables precise catheter manipulation in PCI procedures outside of the the radiation field. Buffalo General Medical Center, Buffalo, N.Y

Feature | Robotic Systems| August 17, 2015 | Dave Fornell
In the current healthcare economic climate of evaluating “nice vs.
Overlay Init