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Posted by on Sep 20, 2019 in Coronary artery disease | 0 comments

In a nutshell

This study investigated drug-coated balloons (DCBs) used for percutaneous coronary intervention (PCI) in patients with a high risk of bleeding.

They found that DCBs were superior to bare-metal stents (BMSs) in these patients.

Some background

Coronary artery disease (CAD) is caused by blockages in the coronary arteries. This reduces blood flow to the heart. It can lead to heart attacks and stroke. There are several strategies to treat CAD. Drugs can be administered to break up clots or lower lipid (fat) levels in the blood. This can reduce the formation of blockages. In some cases, surgery is required to restore blood flow.

Percutaneous coronary intervention (PCI) is a minimally invasive surgery. It involves using a stent (a small tube that keeps a blood vessel open for blood to flow normally) to restore blood flow. Bare-metal stents (BMSs) physically restore blood flow by keeping the blood vessel open. Drug-eluting stents (DESs) also release small amounts of drugs that prevent blood clotting. A balloon can be used with a stent to remove the blockage. Drug-coated balloons (DCBs) are also available.

Many patients with CAD take blood thinners. This leads to a higher risk of bleeding. It is unclear what type of stent is most appropriate in patients with a high risk of bleeding undergoing PCI. 

Methods & findings

This study included 208 patients with CAD. Patients were randomly assigned to PCI with a BMS (106) or a DCB (102). All patients received antiplatelet therapy (APL). APL reduces the risk of blood clots. However, it may also increase bleeding risk. The main outcome was the rate of major adverse cardiovascular events (MACE). Heart attack, death, and stroke are MACEs. Patients were followed up for an average of 36 months.

At 9 months, MACE had occurred in 1 patient (1%) in the DCB group and 15 (14%) in the BMS group. The risk of MACE was significantly lower (by 99.3%) in the DCB group. Repeat PCI was required in no patients with DCB compared to 6 (6%) in the BMS group at 9 months.

At 12 months the rates of MACE was 4% in the DCB group and 14% the BMS group. Repeat PCI rates were 2% for the DCB group compared to 6% for BMS. 13% of the DCB group had a bleeding event compared to 10% of the BMS group. 

The bottom line

The authors concluded that DCBs were superior to BMSs in patients with a high bleeding risk.

The fine print

More patients with diabetes were assigned to the BMS group. Diabetics have higher rates of CAD. More studies are needed. This study received funding from Braun Medical, developer of DCBs.

Published By :

Lancet (London, England)

Date :

Jun 13, 2019

Original Title :

Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial.

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