ORLANDO, FL — The COMBO (OrbusNeich Medical) dual-therapy stent, which was implanted in more than 3600 "all-comer" patients followed in two registries, was safe and effective at 1 year in new research.
Antonio Colombo, MD, from San Raffaele Hospital, Milan, Italy, reported these findings here at the American College of Cardiology (ACC) 2018 Annual Scientific Session.
However, although the results are "exciting," Colombo said, this was a registry study, so a randomized controlled trial is needed to provide stronger evidence.
As previously reported, the COMBO stent, which received a CE mark approval in Europe in 2013, elutes sirolimus and has a layer of anti-CD34 antibodies that capture endothelial progenitor cells, designed to prevent in-stent thrombosis and restenosis in patients who undergo percutaneous coronary interventions.
"In this very large cohort of patients treated with a novel bioengineered dual therapy stent," Colombo summarized, the stent was "safe, with very low stent thrombosis (0.8% definite and probable), and effective, with very low (3.9%) 1-year major cardiac events."
However, "we would like to see future randomized trials to test the safety and effectiveness of this stent compared to other third-generation drug-eluting stents," he concluded.
Clinicians have known about this "prohealing" stent, the only bioengineered drug-eluting stent, for a decade, said session chair Martin B Leon, MD, from the Center for Interventional Vascular Therapy, at Columbia University Medical Center in New York City.
"I'm impressed in an all-comers study to have a target lesion failure rate of 3.9%; that's extremely low," he said. However, it's possible that the definition of target vessel myocardial infarction (MI) could have led to underreporting, Leon suggested.
"I share your concern," Colombo agreed. However, this study provides some supporting data, he said, "and eventually we will retest this device in a well-done prospective randomized study" in patients with a high risk of bleeding from dual antiplatelet therapy.
"It's certainly a provocative technology to have a bioengineered device with early endothelial coverage," Leon told theheart.org | Medscape Cardiology, and it may be particularly useful in patients with a high risk of bleeding with dual antiplatelet therapy.
However, some events were probably underreported, he reiterated, "so it's difficult to come up with definitive conclusions."
A prospective randomized trial in certain subgroups "would certainly be interesting," Leon added. In the meantime, this analysis is "a step in the right direction."
Similarly, session co-chair Christopher B Granger, MD, from Duke University School of Medicine, Durham, North Carolina, told theheart.org | Medscape Cardiology that this registry study "is very exciting, and it suggests that the stent appears to be safe and effective, but...the next step is to do more robust randomized trials about the longer-term outcome."
However, this study "provides data that's reassuring about a very novel stent design," Granger said.
CE Mark in Europe
The risk for late in-stent restenosis and very late stent thrombosis remains a serious concern with current drug-eluting stents, Colombo noted.
The COMBO stent was designed to regenerate endothelium to foster natural healing, making it especially suited for patients who could not tolerate extended dual antiplatelet therapy or those at very high risk for stent thrombosis.
The device received the CE mark in Europe largely on the strength of the randomized REMEDEE safety and efficacy study, which compared the COMBO stent with the paclitaxel-eluting Taxus Liberté stent (Boston Scientific) in patients with nonacute symptomatic coronary artery disease.
Both stents were similarly effective for the primary outcome of in-stent late lumen loss at 9 months.
The Short-term Dual Antiplatelet Therapy in Patients With ACS Treated With the COMBO Dual-Therapy Stent (REDUCE) trial, which was presented at Transcatheter Cardiovascular Therapeutics (TCT) 2017, was critiqued for being underpowered.
In the current study, Colombo and colleagues aimed to evaluate the safety and efficacy of the COMBO stent in pooled data from the REMEDEE registry of 1000 patients in nine European sites who received the device between 2013 and 2014 and the MASCOT registry of 2624 patients who received the device at 61 global sites between 2014 and 2016.
Dual antiplatelet therapy was prescribed for the patients according to guidelines and local recommendations.
The registries included all patients who were candidates for receiving a stent except for those who were highly likely to be nonadherent to follow-up requirements and those who were in another study or had a life expectancy of less than a year.
The primary endpoint was target lesion failure, a composite of cardiac death, target vessel MI, and clinically driven target lesion revascularization at 1 year.
"Having this kind of stent...gave the physician confidence to be less aggressive with dual antiplatelet therapy," Colombo noted. "A lot of patients enrolled in this registry, especially the MASCOT trial, had a high risk of bleeding, and they needed to decrease the duration of [dual antiplatelet therapy]."
At baseline, the patients had a mean age of 64 years, and 24% were women. Close to a third (29%) had type 2 diabetes, and 7.5% of all patients were receiving insulin.
Half the patients had acute coronary syndrome, and a fifth had ST-segment elevation MI.
A total of 4445 lesions were treated, of which 53.4% were American College of Cardiology/American Heart Association type B2/C.
Multivessel percutaneous coronary intervention was performed in 16% of patients.
Target lesion failure at 1 year was observed in 140 patients (3.9%), of whom 1.6% had died from cardiac causes, 1.2% had target vessel MI, and 2.2% had target lesion revascularization.
Seventeen patients (0.5%) had definite stent thrombosis and 30 patients (0.8%) had probable or definite stent thrombosis.
In univariate analysis, target lesion failure was predicted by ACS, prior bypass surgery, chronic renal failure, old age, peripheral vascular disease, and complex lesions — "really nothing new from what we have known for the past 20 years," said Colombo.
In multivariate analysis, target lesion failure was predicted by diabetes, chronic renal failure, and complex lesions, again "more or less as expected," he said.
Colombo has no relevant financial disclosures. Leon has received consultant fees/honoraria from Abbott, Boston Scientific, and Medtronic and has ownership interest in Claret Medical, and has received research grants from Edwards Life Science. Granger has received consultant fees/honoraria from AbbVie, Armetheon, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Daiichi Sankyo, Gilead Sciences, GlaxoSmithKline, Janssen, Medscape, Medtronic, Merck, National Institutes of Health, Novartis, Pfizer, SIRtex, and Verseon and has received research grants from Armetheon, Astra Zeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi, the US Food and Drug Administration, GlaxoSmithKline, Janssen, Medtronic, Novartis, and Pfizer.
American College of Cardiology (ACC) 2018 Annual Scientific Session: Abstract 402-13. Presented March 10, 2018.
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Cite this: COMBO Stent Impresses at 1 Year in 'All-Comers' Registry - Medscape - Mar 11, 2018.