A Multicenter Randomized Clinical Trial To Evaluate The Efficiency Of Small Vessel Coronary Treatment Using Paclitaxel Drug-coated Balloon Versus Zotarolimus-eluting Stent: RAMSES trial - Victor Jimenez Diaz

Written by Katrina Mountford, Medical Editor.
19th March 2018

Abstract

Drug-coated balloons (DCB) are useful in a number of different areas to treat coronary artery disease (CAD), including small coronary vessels: which are often complex, involving, secondary branches, distal lesions and/or tortuosity, and for which no dedicated devices are available. The use of drug-eluting stents (DES) in small vessels is associated with higher rates of restenosis than in larger vessels. Comparisons between studies are difficult, as is the applicability to standard practice since different studies involve different clinical populations and devices, different endpoints and timepoints of measurements, and non-standardised techniques. In vessels of <2.25 mm, the clinical relevance of DCB’s is often underestimated.

Dr Diaz described the Bivalirudin vs. Heparin in ST-Segment and Non-ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy (RAMSES) study, a prospective, multicentre, randomised controlled trial in which 94 patients with 137 de novo coronary lesions located in small vessels (reference vessel diameter: 2.00 to 2.75 mm) were randomised to a paclitaxel DCB (IN.PACT Falcon, Medtronic Inc.); or a zotarolimus-DES (Resolute Integrity, Medtronic Inc.). The primary endpoint was a composite of major adverse cardiac events (MACE), comprising cardiac death, myocardial infarction (MI), coronary artery bypass graft (CABG), and clinically-driven target vessel revascularisation (TVR) or clinically driven target lesion revascularisation (CD-TLR) at 12-month follow-up. Patients (n=94) were randomised to the DCB (49 patients, 74 lesions) or DES (45 patients, 63 lesions). Clinical follow-up in hospital and 6 and 12 months after PCI was achieved in all patients. The incidence of MACE was low and did not differ significantly between groups (4.44 % in DCB vs. 11.11 % in DES groups).

In summary, the findings of this study suggest that use of a paclitaxel DCB for the treatment of de novo lesions in small coronary vessels is as safe and effective as second generation. Zotarolimus DES. The two techniques had similar procedural success rates and there were no significant differences in periprocedural complications and MACEs at 12-month follow up. A further study with a larger population of patients and longer FU period is warranted.