OrbusNeich's Combo Stent Evaluated in All-Comers Pooled Patient Cohort

March 10, 2018—Antonio Colombo, MD, presented 1-year real-world performance outcomes from the COMBO Collaboration study at the American College of Cardiology's (ACC) 67th annual scientific session held March 10–12 in Orlando, Florida. The Combo Collaboration aimed to evaluate 1-year clinical safety and efficacy of the bioengineered, dual-therapy Combo stent (OrbusNeich) in a large all-comers pooled patient cohort.

The Combo stent features a 100-μm, stainless steel stent strut and abluminal sirolimus elution from a biodegradable polymer and a luminal prohealing layer (anti-CD34+ antibody technology), which attracts circulating endothelial progenitor cells (EPCs). These EPCs can quickly maturate into normal endothelium, providing rapid endothelialization.

The COMBO Collaboration pooled the patients in two prospective, multicenter registries, MASCOT (N = 2,614; 61 global sites) and REMEDEE (N = 1,000; nine European sites), which were evaluating clinical outcomes after attempted Combo stent placement in all-comer patients undergoing percutaneous coronary intervention (PCI).

Dual antiplatelet therapy (DAPT) was prescribed per local recommendations and in keeping with guidelines. Follow-up was conducted at 1, 6, and 12 months by phone or clinic visit to capture clinical events and DAPT adherence.

In this pooled patient-level analysis, the investigators analyzed 1-year target lesion failure (TLF; a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization). All individual components of TLF and definite/probable stent thrombosis were evaluated as secondary endpoints. All endpoints were adjudicated by an independent clinical events committee for each study using standardized definitions.

The pooled cohort of 3,614 patients were a mean age of 63.5 ± 11.2 years, and 76.2% were men. The prevalence of diabetes mellitus was 29.3%, previous PCI was 26.7%, and 54.3% patients presented with acute coronary syndrome. Multivessel PCI was performed in 16.4% of patients. A total of 4,445 lesions were treated, of which 53.4% were American College of Cardiology/American Heart Association type B2/C. Follow-up was complete in approximately 97.4% of patients.

At ACC, Dr. Colombo presented the primary and secondary endpoints. The device demonstrated its effectiveness in the primary endpoint with 1-year TLF rate of 3.9%. The secondary endpoint of safety at 1 year was met with definite/probable stent thrombosis of 0.8%, including a very low definite stent thrombosis rate of 0.5%. Other secondary endpoints were the components of TLF: cardiac death (1.6%), target vessel myocardial infarction (1.2%), and target lesion revascularization (2.2%).

Future randomized trials should test safety and effectiveness of this novel stent compared to current third-generation drug-eluting stents, advised Dr. Colombo at ACC.