Hospital and 18-months Results of HREVS (Randomized Trial of the Hybrid Approach for Myocardial Revascularization)
Vadim Popov, Kirill Kozyrin, Egor Malyshenko, Vladimir Ganyukov, Olga Barbarash, Leonid Barbarash.
Research Institute of Complex Issues of Cardiovascular Diseases, Kemerovo, Russian Federation.
OBJECTIVE: To evaluate hospital and 18-months results of prospective RCT HREVS (Hybrid REvascularization Versus Standarts).
METHODS: 150 patients with multivessels coronary desease was randomly allocated in 3 groups (50 pts in each groups). In group I (hybrid myocardial revascularization) we did MIDCAB (LIMA to LAD) and next PCI for the remained lesions of coronary arteries. Group II was included the conventional CABG. Group III was included multivessels PCI.
Randomization was carried out by the blind method ("envelopes"). In hospital time, 18 months and 60 months after primary myocardial revascularization were planned control points of the trial. As a primary points of the trial are accepted death, MACCE, a repeated revascularization. Secondary endpoint include bloodloss, quality of life, myocardial ischaemia by SPECT (inferiority)
RESULTS: 96 peoples has included in RCT at this moment. Clinical characteristics of patients in all groups did not differ significantly. As a first stage in the group I the MIDCAB was performed (n=27). Good patency of the grafts were confirmed with flowmetry at the OR and angography than at the cath lab. As a second stage the PCI were performed from 1 to 3 days after surgery. Patency of CA is restored in all cases. In the group II CABG were successfully performed in all cases(n=32). There are no unsuccessfully PCI’s in the group III (n=37). There was no mortality and any MACCE, repeated revascularization at inhospital time of our trial.
Median follow-up was 18 months and started recently. It is complete in 37.7% (56 patient includes now) with overall survival of 99.4 % (1 case from an unrelated cause) and MACCE-free survival of 100%. Two hybrid patients had a re-intervention of the LAD (0,8%). RCT will finish at January 1 2015 as well as SPECT analizing will at April 2015.
CONCLUSIONS: The hybrid approach at inhospital and 18-months point RCT HREVS showed the good results comparable to results of traditional approaches of myocardial revascularization. Patients who undergone hybrid revascularization had shorter in-hospital stay period, reabilitation period, less pain and return to work early than patient after CABG.
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