RAMSES Compares Drug-Coated Balloons and Drug-Eluting Stents to Treat Small Coronary Vessels

March 6, 2018—Findings from the RAMSES trial were presented at CRT 2018, the Cardiovascular Research Technologies conference held March 3–6 in Washington, DC. The study showed that the use of drug-coated balloons to treat de novo lesions in small coronary vessels appears to be as safe and effective as drug-eluting stents.

The RAMSES study included 94 patients with 137 de novo lesions with a reference vessel diameter of 2.00 to 2.75 mm. Patients were randomized to the In.Pact Falcon paclitaxel-coated balloon (Medtronic) or the Resolute Integrity zotarolimus-eluting stent (Medtronic). Both treatment arms had 100% follow-up at 12 months.

The trial showed no significant differences between the drug-coated balloon and drug-eluting stent groups for major adverse cardiovascular events at 12-month follow-up. Additionally, there were similar procedural success rates and no significant differences in periprocedural complications between the two groups.

The RAMSES study was led by Victor Alfonso Jimenez Diaz, MD, of Hospital Alvaro Cunqueiro and University Hospital in Vigo, Spain.

In the CRT announcement, Dr. Jimenez Diaz commented on the study's implications, stating “Don’t be afraid to use drug-coated balloons in patients with de novo lesions. They work as well as drug-eluting stents in small vessels.” He added that a study with a larger patient population and longer follow-up period is desirable.