Orlando, FL - In patients with in-stent restenosis, placing another stent improves long-term clinical and angiographic outcomes in larger vessels but not smaller ones, according to the results of the Restenosis Intrastent Balloon versus Stent (RIBS) trial.

The study, presented at the American College of Cardiology 50th Annual Scientific Session in Orlando, FL on March 18, 2001, was conducted in 24 sites in Spain and Portugal. It randomized 450 patients with restenosis following elective stenting to either repeat stenting or balloon angioplasty.

Angiographic results showed that repeat stenting gave a better result in terms of minimal lumen diameter (MLD) straight after the procedure, but this benefit had been lost by 6 months follow-up. There was also no difference in restenosis rate or event-free survival between the two groups.


Results in whole study population

Endpoint Stent Balloon Preprocedure MLD 0.68 mm 0.67 mm Postprocedure MLD 2.77 mm 2.26 mm* 6 months MLD 1.63 1.52** Restenosis rate 38% 39% Event-free survival at 7 months 80% 77%

However, in a prespecified subgroup analysis, it was shown that vessel size was a key determinant of benefit. Patients whose target vessel was more than 3 mm in diameter had a lower restenosis rate and a better event-free survival with repeat stenting.


Large target vessels

Endpoint Stent Balloon Restenosis rate 27% 48%* Event-free survival at 7 months 87% 71%**

Presenting the data, Dr Fernando Alfonso (University Hospital San Carlos, Madrid, Spain) noted that the results in large vessels represented a 45% relative reduction in restenosis with repeat stenting versus angioplasty and that only 4 patients needed to be treated to prevent one restenosis.

In contrast, those with small target vessels had a worse outcome with stenting:


Small target vessels

Endpoint Stent Balloon Restenosis rate 59% 41%*

Alfonso concluded that repeat stenting seemed beneficial in vessels larger than 3 mm, but should be avoided in smaller vessels. However, he cautioned, these results need to be interpreted with some caution as they came from a subgroup analysis.

Sue Hughes sue@conceptis.com

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