Drug-Coated Heart Stents No More Effective Than Non-Coated Counterparts: Study

The findings of new research suggests heart stents coated with the drug paclitaxel are no more effective at preventing patient death than non-coated stents.

In a study published last week in the New England Journal of Medicine, Swedish researchers report they found the death risk was the same for both types of stents.

Researchers conducted an unplanned early analysis of the Swedish Drug Elution Trial in Peripheral Arterial Disease (SWEDEPAD); a multi-center, randomized clinical trial focusing on patients with peripheral arterial disease (PAD) and whether drug-coated heart stents reduced mortality rates.

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The findings showed an increased risk of death linked to paclitaxel-coated devices, including heart stents and angioplasty balloons, so another early analysis was conducted to determine if there was a risk.

A total of 2,289 patients were randomly assigned to treatment with paclitaxel-coated devices or with uncoated devices. Paclitaxel is a drug commonly used to treat cancer but is also approved for other uses as well.

During a 2.5 year follow-up, nearly 600 patients died. Roughly 25% were in the paclitaxel-coated stent group and 24% were in the uncoated group.

The findings of the study showed no difference in death risk between the two groups, paclitaxel-coated device group or non-coated group.

At the one year follow-up, the all-cause death risk was 10.2% in the paclitaxel-coated device group and 9.9% in the uncoated device group.

There was no significant difference in the risk of increased death between the treatment groups with chronic limb-threatening ischemia. Those with limb-threatening ischemia in the coated group had an increased risk of 33.4% and those in the uncoated group 33.1%.

There was also no major difference between the two groups among those with intermittent claudication. The risk was 10.9% in the coated group and 9.4% in the uncoated group.

Peripheral artery disease is a health condition caused by reduced blood flow to the lower limbs caused by obstructive atherosclerosis. Paclitaxel is a drug that is also approved for use on drug-coated balloons and stents for PAD patients.

“In this randomized trial in which patients with peripheral artery disease received treatment with paclitaxel-coated or uncoated endovascular devices, the results of an unplanned interim analysis of all-cause mortality did not show a difference between the groups in the incidence of death during 1 to 4 years of follow-up,” the researchers concluded.


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