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German Angioplasty Bypass Investigation - 2 - GABI-2
Description:
CABG vs. new percutaneous technologies in multivessel coronary disease.
Hypothesis:
To investigate the impact of current technology (1996-1997) on PTCA versus CABG in patients with multivessel disease.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 136
Patient Populations:
Symptomatic multivessel disease requiring revascularization for at least 2 major coronary arteries supplying different myocardial territories
Exclusions:
Previous PTCA or CABG
AMI within the previous 2 weeks
Left main disease
Total occlusion (TIMI 0 flow)
Primary Endpoints:
Freedom from angina 12 months after intervention
Secondary Endpoints:
Death, AMI, and incidence of reinterventions.
Drug/Procedures Used:
PTCA versus CABG
Principal Findings:
GABI-2 was a nonrandomized prospective registry that compared the effect of new technologies on a patient population similar to the GABI-1 study (1986-1991).
Of the 136 patients enrolled, 133 underwent the scheduled procedure.
The intervention technique applied was PTCA for 91% of the cases. Rotablation was used for 6.7%, and other treatment (DCA, laser) was used for 1.5%. Almost 2/3 of the patients received stents. There was a stent-associated complication in only 1 patient (0.75%). Other complications were bleeding (any event) 8.2%, transfusion 3%, and surgical intervention 1.5%.
The GABI-2 study included more patients with triple vessel disease and more patients with diabetes than GABI-1, but the outcome of the GABI-2 study was still favorable. There were no in-hospital deaths or urgent or emergency CABG in GABI-2, and there was a reduction in Q-wave AMI in comparison with the PTCA arm of GABI-1. There was an increase in repeat PTCA in GABI-2, but that may be due to the fact that more urgent and emergency situations can now be handled by PTCA because of the introduction of coronary stenting. Acute reinterventions decreased by almost 40% in GABI-2 over the rate for the PTCA arm of GABI-1. This effect was seen at the 6-month follow-up and sustained throughout the whole study period.
Interpretation:
Interpretation of the registry results requires a historical comparison between GABI-2 and the PTCA arm of GABI-1. These observational data are encouraging, and parallel the trends observed by the first wave of the 1996-1997 NHLBI dynamic registry.
References:
1. Eur Heart J 1998;19(Abstr Suppl):136. Preliminary results
Keywords: Coronary Disease, Coronary Vessels, Coronary Artery Bypass, Angioplasty, Balloon, Coronary, Diabetes Mellitus, Stents
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