Anti-inflammatory Lowers In-Stent Late Loss After BMS Implantation

CHICAGO, IL—The anti-inflammatory bindarit significantly reduces in-stent late loss vs. placebo in patients undergoing percutaneous coronary intervention (PCI) with bare metal stents (BMS), according to results presented March 24, 2012, at the annual American College of Cardiology/i2 Scientific Session.

For the pilot phase II trial, Antonio Colombo, MD, of San Raffaele Hospital (Milan, Italy), and colleagues randomized PCI patients implanted with BMS (Multi-link Vision; Abbott, Santa Clara, CA) to either 600 mg of bindarit (n = 48), 1200 mg of bindarit (n = 49), or placebo (n = 51). Bindarit was prescribed within 3 hours of PCI with no loading dose or pretreatment. Heparin and dual antiplatelet therapy were given according to standard protocol.

The study was carried out between January 2007 and April 2011 at 22 centers in Italy, Russia, and Ukraine. The compliance rate of bindarit in each dosage arm was greater than 90%.

At 6 months, in-stent late loss (primary endpoint) was lower in the 2 bindarit groups compared with placebo, although there was no difference in MACE (table 1).

Table 1. Outcomes at 6 Months

^aTook at least 1 dose of the experimental drugs and had a quality care assessment.
^bCompleted recommended treatment with at least 80% compliance and were assessed with an angiogram at 6 months. 

There were no differences in the occurrence of serious adverse events between both the bindarit groups and the placebo-treated patients. Patients treated with 1200 mg of bindarit had a slightly higher rate of adverse events (36%) compared with patients who received 600 mg of bindarit (30%) and placebo (34%). Only 5 of the 83 total adverse events were attributed to the treatment. Of the deaths that occurred, both patients were not on treatment at time of death.

Pushing for Lower Late Loss

The panel suggested amending future studies to switch the dose from twice to once a day and to just look at a high-risk patient group. Dr. Colombo said that testing bindarit in a high-risk patient group would be “like testing antibiotics in septic shock” because “it’s not going to have a dramatic effect.”

Dr. Colombo said the next step would be to conduct another pilot study with only 1 dose of bindarit in addition to a loading dose the day before the procedure, out to 3 months. The main focus should be on lowering late loss even more. He noted the late loss achieved with bindarit was roughly in the middle between that of DES and BMS.

“If you stay with 0.7, then I think it’s still not acceptable,” he concluded. “But if you get late loss in [the 0.4 to 0.5] range, I think it makes it [practical].”