Drug-eluting stent

Atherosclerosis is considered to be the most common form of arteriosclerosis, which refers to the loss of arterial elasticity caused by thickening and stiffening of blood vessels.

[20] When restenosis occurs, another procedure may be needed to correct the problem, such as the placement of a DES[20][55] that gradually release a drug compound that suppresses cellular growth, thereby reducing the potential for blockage within the stent area itself.

What sets them apart is their special coating, which incorporates a drug delivery system that enables controlled release of medication over a specific period, typically within the first 30 to 45 days following implantation.

This procedure, previously known as angioplasty with a stent, is considered non-surgical as it is performed through a small puncture in a peripheral artery, avoiding the need to open the chest wall.

While bleeding from the puncture site was once a concern, advancements in PCI practices have mitigated this issue through the use of pressure bands and arterial closure systems.

[68][69][51] The use of DESs in peripheral arterial interventions has shown encouraging results in terms of primary patency (PP) and target lesion revascularization (TLR) compared with bare-metal stents (BMSs).

Other factors that could rule out the use of stents include a history of in-stent blockage, bleeding problems, complex or unsuitable coronary anatomy, or a short life expectancy due to other serious medical conditions.

For people from each of these groups, PCI procedures may vary slightly, with particular modifications as to how they are sedated, pain management, and broader intensive care issues such as breathing support.

[99] Many people who are not in critical care situations are usually fully awake during the PCI procedure and DES placement, but they receive local anesthetic at the site of catheter entry, to ensure there is no pain.

During the procedure, the information obtained from these two sources enables the cardiologist to track the path of the catheter-DES device as it moves through the arterial blood vessels.

Much of the time immediately after the stenting is spent in a recovery area to make sure the access site is not bleeding and to ensure vital signs are stable.

People who have symptoms or show signs of reduced blood flow to the heart in a stress test may need to have a diagnostic cardiac re-catheterization.

[121] A key benefit of DES usage compared to BMS is a lower incidence of repeat revascularization procedures (re-stenting, invasive bypass surgeries etc.).

[120] Newer generations of DES devices have substantially improved safety outcomes, specifically regarding stent thrombosis, recurrent myocardial infarctions, and death.

[123] Vascular stents are classified by the US as class III medical devices,[124] meaning that they pose the highest risk to patients and are subject to both general and premarket approval, which requires clinical trials and scientific evidence of safety and effectiveness, as well as rigorous mechanical testing.

[128] Charles Theodore Dotter and Melvin Judkins had proposed using prosthetic devices inside arteries in the leg to maintain blood flow after dilation as early as 1964.

[135][136][137] The sirolimus-eluting Cypher stent received CE mark approval in Europe in 2002, and then underwent a larger trial to demonstrate its safety and effectiveness for the US market.

[138][139][140] The trial, published in 2003, enrolled 1058 patients with more complex lesions and confirmed the superiority of SES over bare metal stents in terms of angiographic and clinical outcomes.

The trials showed a significant reduction in target lesion revascularization and major adverse cardiac events with the Taxus stent at 9 and 12 months.

[149][150] The concept of using absorbable (also called biodegradable, bioabsorbable or bioresorbable)[151] materials in stents was first reported in 1878 by Huse who used magnesium wires as ligatures to halt the bleeding in vessels of three patients.

[157] Boston Scientific also announced termination of its Renuvia bioresorbable coronary stent program as studies showed higher risk of serious adverse events.

[163][164][159] Due to challenges in developing resorbable stents, many manufacturers have focused efforts on targeting or reducing drug release through bioabsorbable-polymer coatings.

Boston Scientific's Synergy bioabsorbable polymer stent has been shown potential to reduce the length of dual antiplatelet therapy post-implantation.

[153] Resorbable stents have held the promise of providing an acute treatment that would eventually allow the vessel to function normally, without leaving a permanent device behind.

The lower strut thickness is believed to be associated with better stent-related outcomes including target lesion revascularization, myocardial infarction, and stent thrombosis.

In 2012, a meta-analysis of clinical trial data[174] showed no benefit of the use of DES for people with stable coronary artery compared to treatment with drugs, yet, The New York Times interviewed David Brown, an author of the analysis, who said that more than half of patients with stable coronary artery disease were implanted with stents without even trying drug treatment and that he believed this happened because hospitals and doctors wanted to make more money.

[175] The interview sparked a debate among cardiologists, researchers, and patients about the appropriateness and effectiveness of DES for stable coronary artery disease: some agreed with the study's findings and questioned the overuse of stents,[176][177][178] while others criticized the study's methods and limitations and defended the benefits of stents, arguing that the interviewee's statement was "outrageous and defamatory" and that he was "insulting the integrity of the entire profession.

As a result, BSC has been ordered to pay $42 million in lost royalties to both TissueGen and the University[185][186] Drug-eluting stents have been associated with legal and ethical controversies, and there have been related class action lawsuits.

In 2014, the former owners of St. Joseph Medical Center in Maryland settled a class action lawsuit for $37 million with hundreds of patients who received unnecessary DES implantation.

The lawsuit alleged that Dr. Mark Midei, a cardiologist at the center, falsified the degree of coronary artery stenosis to justify the use of DES, exposing the patients to increased risks of thrombosis, bleeding, and infection.

Stent placement in an artery using a percutaneous coronary intervention (PCI) minimally invasive technique
Diagram of stent placement. In A , the catheter is inserted across the lesion. In B , the balloon is inflated, expanding the stent and compressing the plaque. In C , the catheter and deflated balloon have been removed. Before-and-after cross-sections of the artery show the results of the stent placement.
Graphic representation of a drug-eluting stent expanded into artery. The lower section is referred to as a catheter. The DES and catheter are usually one integrated medical system. The white particles represent the drug eluting into the arterial walls - inhibiting the growth of tissue into the stented area.