Hybrid approach to myocardial revascularization: early results of randomized trial
Vadim Popov, Kirill Kozyrin, Egor Malyshenko, Vladimir Ganyukov.
Research Institute of Complex Issues of Cardiovascular Diseases, Kemerovo, Russian Federation.
OBJECTIVE: To evaluate early results of prospective RCT HREVS (Hybrid REvascularization Versus Stents).
METHODS: The RCT HREVS is started at our clinic in April 2012 (http://www.clinicaltrials.gov/ct2/show/NCT01699048). The trial design includes 150 patients, who divided in 3 groups of 50 peoples. Group I is the group of hybrid myocardial revascularization, where the first stage is MIDCAB (LAD-LIMA
) and the second stage is PCI of the remained lesions of coronary arteries. Group II is the group of the conventional CABG. Group III is the group of endovascular revascularization only with the same 2nd generation clinically proven DES.
Criteria of inclusion in our trial are multivessel lesions of CA with equal ability to perform all three comparing methods of a revascularization. Randomization is carried out by the blind method ("envelopes"). In hospital time, 24 months and 60 months after primary myocardial revascularization were planned as the control points. As a final points of the trial are accepted death, MACCE, a repeated revascularization.
45 peoples are included in research at this moment. 10, 14 and 21 patients were randomized to the group I, group II and group III respectively. Clinical characteristics of patients in all groups did not differ significantly.
RESULTS: As a first stage in the group I the MIDCAB was performed. Good patency of the grafts were confirmed with flowmetry at the OR and than at the cath-lab. As a second stage the PCI were performed from 1 till 3 days after surgery with good patency of CA and grafts in all cases. In the group II CABG were successfully performed in all cases. There are no unsuccessfully or incompletely PCI’s in the group III.
There were no mortality and any MACCE, repeated revascularization at inhospital time in our trial. There are no cases of incomplete myocardial revascularization, technical difficulties and others complications.
CONCLUSIONS: The hybrid approach at inhospital point RCT HREVS showed the good results comparable with results of traditional approaches for myocardial revascularization.
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