Evaluating the safety and effectiveness of the COMBO bio-engineered stent

This article investigated the safety and effectiveness y of the COMBO stent for patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). 

The authors concluded that the COMBO stent is safe and effective in these patients.

In patients with CAD, one or more of the blood vessels supplying oxygen to the heart becomes blocked. One of the methods to treat this is PCI. This involves inserting a stent (a tiny tube) into a blocked blood vessel to keep it open. There are multiple types of stents. Metal stents have the downside that they can become blocked forming clots. 

An alternative is a drug-coated stent (DES or drug-eluting stent). This drug is slowly released into the circulation to prevent further blockage. Stents can also be made from a biodegradable polymer (breaks down after its purpose). This also reduces this risk of the stent becoming blocked. The COMBO stent is a type of DES combining a biodegradable polymer with the release of the drug sirolimus (Rapamune) which acts to reduce inflammation at the site. It's safety and effectiveness remain under investigation.

The study involved 2614 patients. All patients received the COMBO stent during PCI. The patients received dual antiplatelet therapy (DAPT; 2 drugs to prevent their blood from clotting). The primary outcomes to be measured were cardiac death, heart attack or need for a repeat stent. They were followed up at 1, 6, and 12 months.

96.7% completed the study at 12 months follow up. Cardiac death (2%), heart attack (1.4%) or re-stenting (1.4%) occurred in 3.4% of patients after 1 year. Blockage of the stent occurred in 0.5% of patients. 

The authors concluded that the COMBO stent is safe and effective in patients undergoing PCI. 

This study only followed patients for up to 1 years. Longer follow-up studies are needed to determine the safety and effectiveness of this stent long-term.