DENVER — A hybrid surgery plus stenting procedure for multivessel coronary artery disease didn’t improve outcomes or cut residual ischemia compared with a purely surgical approach or stenting alone, a small head-to-head trial showed.
Residual ischemia at 12 months was found by single-photon emission CT (SPECT) in 6.4% of patients with left internal mammary artery grafting (LIMA) of the left anterior descending (LAD) coronary artery and drug-eluting stents for other blocked vessels compared with 6.7% of patients with coronary artery bypass grafting alone (CABG) alone and 7.9% of patients with drug-eluting stents (DESs) alone.
The 12-month freedom from major adverse cardiac and cerebral events events was 88.6% compared with 88.0% , and 86.8%, respectively among the arms, none of which differed significantly in the HREV trial.
Target vessel or graft failure was likewise similar across arms, at 11.5%, 12.0%, and 11.3%, respectively, Roman Tarasov, MD, PhD, of the State Research Institute for Complex Issues of Cardiovascular Diseases in Kemerovo, Russia, reported at a press conference here at the Transcatheter Cardiovascular Therapeutics meeting.
Press conference moderator Roxana Mehran, MD, of the Icahn School of Medicine at Mount Sinai in New York City, noted that the importance of this small study — really the first pilot study that has hybrid multivessel, PCI and CABG head-to-head — is in finding the hybrid approach is safe.
“Hybrid revascularization is something we talked about 2 decades ago. Because we knew — before drug-eluting stents came along — we knew the best therapy to LAD to protect the patient is LIMA … We know that vein grafts also don’t have the durability as a LIMA to the LAD. So the best of two worlds would be a LIMA to the LAD, and drug-eluting stents do extremely well in the non-LAD distribution, hence hybrid revascularization.”
While logistically challenging, she said, “I do believe there are a tremendous number of sites in the U.S. that have some appetite for this. Especially now with heart team approach now … we are having shared decisions with [patients] and the heart team to give them best of both worlds. But you have to prove this is the best possible treatment modality for these patients, which means long follow-up and good comparator arms.”
The Cardiothoracic Surgical Network’s Hybrid Coronary Revascularization Trial funded by the NIH should give the more definitive answer, said David Cohen, MD, of Saint Luke’s Mid-America Heart Center in America Heart Institute in Kansas City, Missouri, a press conference discussant.
“Really, the benefit of the LIMA is not the first year so much, it’s 10 years, 20 years. And I think it’s going to take something on that order to really show the benefit of this type of approach,” he said.
The trial included 150 patients randomized to the three treatment arms at a single Russian center. Left main and chronic total occlusion were excluded, as were other scenarios for which the three procedures weren’t deemed equally feasible.
Hybrid procedures were minimally-invasive, off-pump revascularization of the left anterior descending artery with the left internal mammary artery followed by consecutive percutaneous coronary intervention (PCI) in the rest of the arteries, done in two stages within 3 days. All PCI was done with the same second-generation Xience V and Xience Prime DES.
Nearly 10% of the hybrid group (five patients) required conversion to conventional on-pump CABG with a median sternotomy for surgical technical reasons (two cases) or due to hemodynamic instability following grafting in the absence of other lesion revascularization (three cases). However, there was less with BARC 3-4 bleeding than with CABG (9.6% versus 20.0%).
The trial was sponsored by the Russian Academy of Medical Sciences.
The researchers disclosed no relevant relationships with industry.