The novel COMBO bio-engineered stent demonstrated excellent 1-year results in an all-comers population, according to results from the REMEDEE Registry (Randomized study to Evaluate the safety and effectiveness of an abluMnial sirolimus coatED bio-Engineered StEnt).
As the researchers explained in their findings, published in JACC: Cardiovascular Interventions, this stent technology combines an abluminal sirolimus-eluting layer with a unique luminal endothelial progenitor cell-capturing layer that aims to achieve “true vessel healing” and ultimately, improve clinical outcomes post-percutaneous coronary intervention (PCI).
The primary end point of the study was target lesion failure (TLF) at 1-year follow-up, defined as a composite of cardiac death, target vessel related non-fatal myocardial infarction (MI), or target lesion revascularization (TLR). MI was considered as target vessel unless there was documentation that it arose from non-treated coronary artery.
A total of 1000 patients (mean age: 65 ± 11 years; 74% male) were included in the REMEDEE registry between June 2013 and March 2014 in 9 European sites. About half (49.9%) presented with acute coronary syndrome (ACS) and nearly 60% of the 1255 lesions were AHA (American Heart Association) type B2 or C lesions.
Type A lesions made up 16.4% of cases, type B1 made up 24.7% of cases, type B2 made up 36.9%, and type C made up 22.0%. The median lesion length was 15.0mm and the interquartile range (IQR) was 10-12mm with a median reference diameter of 3.0 with IQR 3-3.5mm.
In addition, of the total lesions, 1.3% were discovered in the left main artery, 50.6% in left anterior descending artery, 20.2% left circumflex artery, 26.1% in right coronary artery, and 1.8% in bypass graft. In 10.5% of patients, multivessel PCI was performed. Thrombus was found in 15.0% of patients and thrombus aspiration was performed in 10.8%.
Patients were followed up at 30 days, 180 days, and 1 year, and will continue to be through 5 years post-procedure.
The device success rate was 98.7%, and it was not possible to reach the target lesion in only 2 cases. Stenosis of more than 20% occurred in 0.9% of patients after the procedure, TIMI (Thrombolysis in Myocardial Infarction) flow <3 occurred in 1.3%, and unsuccessful stent delivery occurred in 0.3% (3 patients).
TLF was present in 5.7% of patients, cardiac death occurred in 1.7% of patients, and target vessel MI occurred in 0.7% of patients. TLR was performed in 4.4% of patients, and target vessel revascularization, PCI, and coronary artery bypass graft surgery were performed in 4.9% of patients.
Only 5 patients experienced definite stent thrombosis and 1 patient experienced “probable” stent thrombosis. Indication for PCI was ACS in 5 out of 6 patients and the stent thrombosis that occurred was acute or subacute. There was no incidence of stent thrombosis between 9 days until 12 months after the COMBO stent deployment.
“High initial procedural success, low revascularization rates as well as low stent thrombosis rates were observed in this true all-comers patient population,” researchers wrote. “Randomized controlled trials with the novel COMBO stent and registries are ongoing and may confirm the outstanding results found in this registry.”
Woudstra P, Kalkman DN, den Heijer P, et al. One year results of the REMEDEE Registry: clinical outcomes after deployment of the abluminal sirolimus coated bio-engineered (COMBO) stent in a multicenter, prospective all-comers registry. JACC Cardiovasc Interv. 2016. doi:10.1016/j.jcin.2016.02.052.