'Hybrid' Procedure on Par With CABG, Modern PCI in Pilot Study

October 31, 2017

DENVER, CO — A randomized comparison of a hybrid coronary revascularization strategy with standard PCI and CABG in patients with multivessel CAD showed few differences between approaches in outcomes at either 30 days or 12 months[1].

The rate of residual ischemia by SPECT imaging at 12 months, the trial's primary end point, ranged nonsignificantly from 6% to 8% for the trial's three strategies, standard CABG vs PCI with contemporary drug-eluting stents (DES) vs a staged combination of minimally invasive direct coronary artery bypass (MIDCAB) surgery followed several days later by PCI with the same kinds of DES.

Nor was there a significant difference at 12 months for the secondary end point of major adverse cardiovascular and cerebrovascular events (MACCE), a composite of death, MI, stroke, or clinically driven target-vessel revascularization (TVR).

The Hybrid Revascularization Versus Standards (HREVS) trial, with only 155 patients, was described here at TCT 2017 as de facto pilot study to prepare for the kind of larger, longer-term randomized trials needed to truly test the hybrid approach in such patients.

Dr Roman Tarasov

MIDCAB consisted of off-pump surgical bypass of the left anterior descending artery (LAD) by a left internal mammary artery (LIMA) through a "keyhole" thoracotomy in the HREVS trial, which was presented here today by Dr Roman Tarasov (State Research Institute for Complex Issues of Cardiovascular Diseases, Kemerovo, Russia).

In the current study, Tarasov told theheart.org | Medscape Cardiology, patients who underwent the hybrid procedure or PCI received dual antiplatelet therapy (DAPT) for 12 months.

Almost 10% of patients assigned to the hybrid actually underwent standard CABG, the crossover decision made intraoperatively, he said. And hospitalization time was significantly shorter with PCI alone.

"I think this study, for me, confounds the questions regarding multivessel revascularization, and in fact, yet again proves that we've reached a point of clinical equipoise for PCI," Dr Jonathan M Hill (King's College Hospital, London, UK) at a media briefing on the study. In a low- to intermediate-risk cohort, he said, "it again shows that the performance with the latest-generation stents is as good as surgery."

HREVS "can be interpreted several ways," according to Dr Mark A De Belder (James Cook University Hospital, Middlesbrough, UK), speaking as a panelist following Tarasov's formal presentation of the trial. One could say none of the three approaches was better or worse than another; or one could say, "why bother, just do some stenting," he said.

"But I think there are individual cases where you've got incredibly complex LAD disease, which is very difficult to stent, where these results would be encouraging that the hybrid approach is good."

Patients in HREVS had multivessel CAD with LAD involvement, with either a >70% stenosis, a 50% to 69% stenosis plus pressure-wire fractional flow reserve (FFR) indicating functional impairment, or SPECT evidence of regional ischemia. Also, all patients had to be appropriate for all three procedures.

There were no significant differences in baseline features among the three groups. More than half in each group had a history of MI, mean LVEF ranged from 53% to 56%, and almost half of patients had at least triple-vessel disease.

Excluded were patients with any coronary revascularization history, left main stenoses, or CTO or needing cardiac surgery other than CABG.

With 50 randomized to CABG only, 52 to MIDCAB plus PCI, and 53 to PCI only, the rates of residual ischemia by SPECT at 12 months, the primary end point, were 6.7%, 6.4%, and 7.9% (P=0.46), respectively. MACCE-free survival at that point was 88%, 86.6%, and 86.8%, respectively.      

Outcomes of Three Revascularization Strategies Compared

End points CABG, n=50 MIDCAB/PCI, n=52 PCI, n=53 P
30 d
 MACCE (%) 8 5.8 3.8 0.37
Hospital days 13.8 13.5 4.5 <0.001
12 Mo
 MACCE (%) 12 13.4 13.2 0.83
Target vessel or graft failure (%) 12 11.5 11.3 0.98

HREVS is "the first pilot study that actually has hybrid revascularization, multivessel PCI, and CABG all in the same study," and it shows that all three are safe, said Dr Roxana Mehran (Mount Sinai School of Medicine, New York, NY) at the media briefing.

Even before the advent of DES, she said, surgeons said the best bypass results were with LIMA to the LAD. "So the best of two worlds would be a LIMA to the LAD, and drug-eluting stents that do extremely well in the non-LAD distribution."

The idea of hybrid procedures has been around a long time, but minimally invasive coronary revascularization didn't catch on as much as many anticipated, so the hybrid approach didn't either.

In an interview, Dr Cindy L Grines (Hofstra Northwell School of Medicine, Hempstead, NY) explained that MIDCAB is a beating-heart cardiac surgery that takes lots of expertise to do well. The procedure is also time-consuming, and studies over the past decade suggest that its grafts, overall, aren't as long-lasting as arterial grafts at standard CABG.

"So that incentivized a lot of physicians to abandon the beating-heart surgery because it was more difficult for them," she said. "As physicians we want to first do no harm, second we want to do what's easy for us, and we want to be reimbursed for our time. So if it takes you longer, and they're not reimbursing you any more, why would you do it?" she said.

"There still isn't a great buy-in to this in the United States," agreed Dr David J Cohen (Saint Luke's Mid America Heart Institute, Kansas City, MO) in an interview.

That's largely "because of logistic challenges coordinating the two procedures between two different specialties," he said. "And when there are lots of questions around the logistics, and there's no proven benefit, it gets hard to mount a strong campaign to support the technique."

Tarasov and his coauthors on the study declared they have no relevant financial relationships. Mehran discloses within the past 12 months she has had a financial interest/arrangement or affiliation with Abiomed, Abbott Vascular, CardioKinetix, Spectranetics, AstraZeneca, Bayer, Eli Lilly, Novartis, OrbusNeich, Medtronic, Bristol-Myers Squibb, Claret Medical, Janssen, Osprey Medical, the Medicines Company, Boston Scientific, Shanghai Braccosine, Elixer, and Medscape. Hill discloses within the past 12 months he has had a financial interest/arrangement or affiliation with Abbott Vascular, Abiomed, Boston Scientific, St Jude Medical, and Medtronic. De Belder has no relevant financial relationships. Grines discloses within the past 12 months she has had a financial interest/arrangement or affiliation with Abbott Vascular and Volcano Corp. Cohen discloses within the past 12 months he has had a financial interest/arrangement or affiliation with Abbott Vascular, AstraZeneca, Boston Scientific, Edwards Lifesciences, Medtronic, Merck/Schering Plough, Corvia Medical, and Svelte Medical.

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