Health Science Journal

Abstract

The endovascular method that is based on dilating a stenotic or obstructed artery is called angioplasty, which is carried out with the purpose of restoring the blood flow that is blocked, for which we must emphasize that this problem can have multiple etiologies. This technique is performed by means of a catheter through an artery, until the affected artery is located, then a guide is inserted through the catheter that passes through the diseased vessel, fixing it at the end of the occlusion, thus placing a balloon in said arterial segment, which will be inflated as many times as possible and necessary to achieve a better blood flow, therefore a stent is implanted. However, it is essential to mention the famous "in-stent restenosis" since this occurs when the stent located in the occluded artery causes stenosis again, that is, it causes a narrowing again in the area that was affected or obstructed. Stent occlusions can be fixed in a number of ways, such as balloon procedure to break up the formed clot or placing another stent in the damaged area.

Keywords

Angioplasty; Medicated Balloon; Simple Balloon; Stenosis; Arteries; Lower Limb.

Introduction

Angioplasty is a method or treatment aimed at unclogging narrowed or blocked blood vessels that supply blood to the heart. These blood vessels are called coronary arteries [1]. This is carried out by means of a catheter with a balloon attached to its end, the blocked artery is opened so that blood can reach the myocardium again in a normal way. It is necessary to mention that angioplasty is not surgery. It must be said that angioplasty is performed mostly in people suffering from coronary artery disease caused by atherosclerosis. Most patients are male, over 45 years of age and those with coronary risk factors such as smoking, high blood pressure, high cholesterol and diabetes mellitus. In patients with chronic symptoms, angioplasty is performed by coordinating the procedure. On the other hand, if the patient shows an acute coronary obstruction due to a clot, angioplasty is performed on an emergency basis. Thus, the artery is unblocked and blood returns to irrigate the myocardium [2].

The physician specializing in this area, in this case the cardiologist, introduces a catheter into an artery, either in the upper or lower limbs. Observing the catheter with X-rays, he incorporates it until he reaches the coronary artery that is compromised. He places the catheter balloon in the obstructed area, inflates the balloon which compresses the plaque and dilates the artery. This procedure is repeated as many times as necessary until there is good blood flow through the coronary artery. Sometimes a stent is installed, which is a kind of small spring, once expanded it helps to keep the artery open. In addition, when it is assured that there is a good blood flow through the coronary artery, the balloon is deflated and the catheter is removed [2].

Now, a stent is a small metal mesh tube that extends into an artery in the heart. A stent is usually placed during or shortly after angioplasty and helps prevent the artery from becoming blocked. Drug-eluting stents include an indwelling medication that supports and prevents the artery from closing for a long time [1]. Likewise, we often find patients with pathologies in the arteries of the lower limbs, thus causing occlusion of these arteries and also causing loss of circulation, resulting in pain, skin ulcers and amputation of the leg. To avoid ischemic damage to the limbs, techniques or methods can be used to open the occluded artery with an artificial graft, or to place a wire and unclog the artery with a balloon, followed by placement of a stent to prevent closure of the artery. Although stents are very durable and can last a long time, sometimes stents placed inside an artery can become narrowed and possibly blocked. This process is called in-stent restenosis. Stent occlusions can be resolved in several ways, such as a balloon procedure to break up the clot that has formed or placing another stent in the damaged area. However, all treatment options have their pros and cons, as the technologies available to treat this problem have evolved. One such advance requires coating the balloon to manage stent occlusion with a cytotoxic drug used in chemotherapy, which delays occlusion after stent placement. These specially designed balloons, called "drug-impregnated balloons," have shown some encouraging results in the treatment of patients with arterial disease in the legs [3].

Stents are placed in the femoropopliteal arteries due to different pathologies that may develop for various reasons. We speak of "in-stent restenosis" when a stent produces a stenosis that restricts blood flow. In-stent restenosis is thought to be the consequence of an activity referred to as "intimal hyperplasia" omitting variation or change in atherosclerotic disease. Treatment can be accomplished by balloon angioplasty, however the role of drug-eluting technologies (DOTs) is unclear. It is essential to implement such a systematic review to score the efficacy of drug-impregnated balloons as it presents a possibility of higher costs compared to uncoated balloon angioplasty or also known as plain old simple angioplasty (POBA) [3].

The arteries of the legs play an important role in supplying blood to the bones, muscles, tendons and nerves of the lower limbs to maintain the mobility of the body. The main artery of the lower extremities is the femoral artery. It is an extension of the external iliac artery (terminal branch of the abdominal aorta). The external iliac becomes the femoral artery when it passes through the inguinal ligament and enters the femoral triangle. Essentially, it can be said that the arteries of the lower extremities can be divided into three vascular regions, which are: the aorto-iliac sector, the femoro-popliteal sector and the infrapatellar sector (below the knee) [4]. The aim of the present literature review is to assess and/or estimate the safety, efficacy and efficiency of drug-coated balloons versus plain old balloon or uncoated balloon angioplasty in patients with in-stent restenosis in the arteries of the lower limbs.

Methodology

For this article, a bibliographic search was performed in various databases such as Elsevier, Scielo, Medline, pubmed, ScienceDirect and Ovid, selecting original articles, case reports and literature reviews from 2021 to 2013, in Spanish and English using MeSH terms: angioplasty, drug-impregnated balloon, old simple balloon, in-stent restenosis and lower limb arteries, the Boolean operators and and or. Thus including all papers dealing with drug-impregnated balloon angioplasty and plain old balloon angioplasty for in-stent restenosis in lower limb arteries, the data found were between 12-20 records, thus using 16 articles for the completion of this paper.

Literature review

The meaning of angioplasty was previously understood; therefore in the following section a more in-depth review of the subject will be made.

The vast majority of people require angioplasty, which is performed in a health institution in a special room, prepared and conditioned for this purpose, called cardiac catheterization laboratory or catheterization. The person will be awake and lying down for the procedure to be performed, and a medication is administered intravenously (IV) in order to relax the patient [5].

This procedure is performed through a blood vessel in the patient's arm, wrist or groin. The health personnel in charge of this technique will perform the following steps:

• It makes a small incision in the highlighted area to insert the catheter into a blood
• He passes the catheter through the middle of the vessel to your heart, using X- rays for guidance.
• It injects a contrast medium into the patient's arteries, for which the dye highlights the heart and other blood vessels in the X-rays.
• Replace the first tube or catheter with another one that has a small deflated balloon on one end.
  It guides the balloon to the blockage and inflates it to push the plaque against the artery wall. This is to widen the artery to improve blood flow.
• Sometimes a mesh tube is placed in the artery to help keep it This is known as a stent, several of which have a drug coating to help prevent the formation of blood clots [6].

Common uses of angioplasty: Percutaneous coronary intervention is performed to treat the storage of fatty plaques that occur in some arteries. This build-up is a type of heart disease called atherosclerosis [Figure 1]. Angioplasty may be used when the person has already used medications or implemented some lifestyle changes, but these do not improve health. When they present angina pectoris, which is getting stronger and stronger. Also when the patient has had a heart attack, since this treatment can quickly open the blocked artery and improve blood flow [7].

Figure 1:Development of atherosclerosis. Source: Mayo Foundation for Medical Education and Research.

Angioplasty, with or without the implementation of stents, is used to manage those pathologies that obstruct the arteries and interrupt adequate blood flow. Among these conditions, we can find the following:

• Coronary artery pathology, a narrowing of the arteries that carry blood and oxygen to the myocardium.
• Thinning of the major arteries due to hardening of the arteries, or atherosclerosis.
• Peripheral arterial disease (PAD), a narrowing of the arteries of the upper and lower limbs.
• Stenosis or narrowing of the carotid artery.
• Obstruction in the veins of the thorax, abdomen, pelvis, upper and lower
• The narrowing in a dialysis fistula or graft. These are artificial blood vessel connections that doctors use in kidney Angioplasty is usually used when these connections become narrowed or blocked. In some cases the use of a stent may also be needed [8].

In the same way, we find that to a great extent, people who undergo angioplasty also have the possibility of having a stent placed in the blocked artery during the procedure [Figure 2]. We know that the stent is similar to a small coil of mesh or wire, which is in charge of supporting the walls of the artery and favoring or preventing them from becoming obstructed again after the angioplasty has been performed. This process consists of the insertion of a catheter in the damaged artery, which has a balloon at the tip, looking for the narrowing; once the obstruction is found, the balloon is inflated and the spring-shaped stent is expanded and fixed in the corresponding place in the artery; then the stent remains in the artery in a fixed manner to keep it open and reestablish the blood flow. In some cases, more than one stent may be needed to open an obstruction; after the stent is in place, the balloon catheter is deflated and removed; finally, angiograms can be performed to observe in detail how the blood flows through the treated artery [7].

Figure 2: Stent located in the affected artery. Source: Mayo Foundation for Medical Education and Research.

Some stents placed during angioplasty are coated with drugs. This drug is slowly released in order to prevent the accumulation of plaque or fat in the future and thus the obstruction of the arteries [7].

Benefits of angioplasty: in contrast to bypass surgery, balloon angioplasty and stent placement are less invasive techniques, with fewer risks and lower prices. This method uses local anesthesia and the fact that it does not require general anesthesia in most patients, it does not require a long hospital stay. On the other hand, it has the advantage that it does not require a surgical incision and the patient will be able to return to his daily chores very soon [8].

Risks of angioplasty: risks are rarely present in the procedure (image 3). However, we must take into account the possibilities that may arise. Among these we have:

image 3 : Risks that can occur during angioplasty. Source: Healthwise. Cigna.

(A)     The insertion performed to introduce the catheter can injure the artery and there is a low risk of blood clots forming.

(B)     When angioplasty alone is performed, there is a possibility that these obstructions may reoccur, since the artery, not having a secure support to keep it open, may reopen.

(C)     Bleeding from the catheter insertion site, which may require some special drugs and even a transfusion.

(D)     A stroke contingency exists when angioplasty and/or stenting is performed in the carotid artery.

Other complications include heart attacks and sudden cardiac death [9]. In addition, drug-eluting balloons (DEB) emerged in 2002 as a very promising option for narrowing the arteries. The first balloons, with Paccocathr technology, have already demonstrated safety and efficacy in animal models and in randomized clinical trials in patients with in-stent restenosis. DEBs have been consolidated in the treatment of coronary pathology because they result in an instantaneous and more homogeneous release of the antiproliferative agent on the vessel wall. This prevents the presence of polymer and sustained release of the drug that ends up reducing reendothelialization and increasing the risk of late thrombosis. In the basic principles of these medicated balloons there is great similarity between the different manufacturers, since all of them have paclitaxel (3 μg/mm² ) as an antiproliferative agent. However, there are differences in the "transporter" [Table 1] which, together with paclitaxel, forms the hydrophilic matrix and improves the transfer of this drug to the vessel wall [10].

Table 1: DEBs developed by manufacturers for the coronary setting. Source: Colombian journal of cardiology. Drug-eluting balloons: an alternative.

Research with DEB has shown excellent results in the treatment of in-stent restenosis [Table 2]. In fact, for this indication the European Society of Cardiology, in its guidelines for percutaneous coronary interventions, has recently awarded them class IIa (weight of evidence/opinion is in favor of utility/efficacy). Encouraged by the findings, companies are now investigating the value of DEBs in other types of lesions and complex settings [Table 2]. Early results identified certain advantages in their use in de novo lesions, bifurcations or small vessel lesions, among others. The availability of DEB is also a new option for the treatment of peripheral artery pathologies when currently, surgical therapy, balloon angioplasty and stents are the treatments of choice. Although the immediate result is generally pleasing and pleasant, the effort to restore normal flow often fails in the long term due to restenosis and in this regard medicated balloons have proven to be a very optimistic alternative to reduce this problem. Since 2010, the first specific DEBs for the femoral and popliteal arteries (Freeway, Eurocor) are available for use in Latin America. It is also worth mentioning that Dr. Juan Pablo Martínez treated the first patients in Cali and obtained excellent results [10].

Table 2: Studies with LBP and inclusion of Latin American patients. Source: Colombian Journal of Cardiology. Drug-eluting balloons: an alternative.

Now, it is necessary to talk about the two types of balloons that we can find. The old simple balloon (POBA) or classic balloon in angioplasty, which is responsible for mechanically widening the vessels that are obstructed. But in the case of the patient presenting a restenosis, it is necessary to implement the other type of balloon, in this case the drug-coated balloon.

Plain old balloon angioplasty (POBA): to access the vascular system, the health personnel in charge of the procedure make a small incision to introduce the catheter through which the balloons and stents are guided into the femoral artery. After guiding the catheter and finding the obstruction, the physician injects a contrast medium in order to pinpoint the exact location of the stenosis. Using the guidewire, the balloon catheter is moved to the site of the affected area. The physician injects contrast into the catheter by inflating the end of the balloon; when the balloon is inflated, he presses the plaque against the wall of the coronary artery to widen or reopen the vessel. After the affected segment has been adequately widened, the balloon is deflated before it is removed from the body [11].

Drug-coated balloon angioplasty: Medicated balloons are used to reduce the risk of vessel re-narrowing (restenosis). The coating of these balloons contains a medication that decreases inflammation and reduces restenosis, as well as inactive substances, i.e. excipients that release the medication into the compromised vessel wall. Before making use of drug-coated balloons, the vessel must be prepared with a method similar to the use of the balloon in angioplasty, after dilating the vessel the drug-coated balloon is placed in the prepared vessel section through the catheter and inflated. Once the liner is in contact with the vessel, the drug is released into the vessel walls. The physician keeps the balloon inflated for a certain amount of time to ensure that the tissue absorbs enough medication. The balloon is then deflated and removed from the body. The procedure ends as in the previous case, with femoral closure [11].

In any case, it is possible to speak of some differences between these two balloons since when comparing the different studies carried out on these subjects, there are certain advantages for drug-eluting balloons (DAB) in terms of some main anatomical evaluation variables such as patency of the primary vessel, binary restenosis rate and target lesion revascularization up to 12 months. But it is important to mention that there is no evidence yet that BLFs benefit other clinical endpoints, such as amputation, death or change in ankle-brachial index (ABI) [12].

Peripheral arterial disease (PAD): this pathology occurs when there is a narrowing of the blood vessels outside the heart. The etiology of this disease is arteriosclerosis, which was mentioned previously. This happens when plaque collects on the walls of the arteries that supply blood to the upper and lower limbs. Plaque is a substance composed of fat and cholesterol and causes the arteries to become narrowed or clogged. This can minimize or interrupt blood flow, usually to the legs. If the blockage of blood flow is severe enough, it can cause tissue death and sometimes amputation of the foot or leg [13].

PAD is presented by arterial obstruction, the reduction in blood flow may be asymptomatic or produce symptoms of arterial insufficiency such as intermittent claudication, pain at rest in the affected muscle group, as well as the presence of varying degrees of tissue loss, such as ulcers, this being one of the most obvious signs of limb ischemia. This disease encompasses a range of non-coronary arterial syndromes that are caused by alterations in the structure and function of the arteries at the level of the non-coronary circulation. In many cases, the underlying pathological process is the storage of lipid and fibrous material between the layers of the artery leading to stenosis in the vessel lumen. There are many factors involved in the progression of atherosclerosis [14].

Discussion

Based on the review of this article it can be said that to some extent drug-eluting balloons have more advantages or benefits than plain old balloons, since the latter by containing a specific drug in them help prevent or avoid restenosis of the arteries. Well-designed randomized trials with long-term follow-up are required to adequately pit BLFs against uncoated balloons with respect to anatomic and clinical endpoints before widespread use of this expensive technology can be justified.

Other studies conducted release their review, which included 11 clinical trials that randomized 1838 participants (2015). The trials included arteries of the thigh and leg above and below the knee. The trials were conducted in Europe and the US and all used paclitaxel-containing BLFs. Four companies prepared the BLF devices: Bard, Bavaria Medizin, Biotronik and Medtronic. Most participants were followed for 12 months or longer. At 6- and 12-month follow-up, BLFs were associated with improved primary vessel patency, which is an indicator of whether a vessel is still patent without any additional intervention, i.e., blood flows well, late luminal loss, which is the difference in millimeters between the segment with angioplasty and how narrow it is at follow-up, target lesion revascularization, which is an indicator of whether a patient received more than one treatment in the same artery during the period covered by the study, and binary restenosis, which occurs when a treated artery is narrowed again after being previously treated [12].

Unfortunately, the early anatomic benefits of BLFs were not accompanied by improvements in quality of life, functional gait capacity, or the occurrence of amputation or death. When specifically examining below-knee arteries and patients with very advanced peripheral arterial disease, no clinical and angiographic advantages of BLFs were found at 12-month follow-up compared with uncoated balloon angioplasty. Ultimately, BLFs have several anatomic advantages over uncoated balloons for the treatment of lower limb PAD up to 12 months after the procedure is performed. However, more data are needed to adequately assess the long-term results of this treatment option [12].

In addition, another study shows its evaluation, in which 158 records of patients between 30 and 95 years of age were evaluated. The most frequently intervened vessels were the superficial femoral artery (64%), the most frequent type of endovascular intervention was the combination of balloon + medicated balloon (32.9%), the most frequently used postoperative pharmacological treatment was the combination of acetylsalicylic acid (ASA) and clopidogrel (86.1%). There were 21 cases of complications, the most frequent being minor amputation (52%). A higher risk of minor amputation was found when the surgical procedure was performed urgently (p = 0.012; OR [95% CI] [15], [16].

Regarding the type of endovascular intervention, the most frequent was the combination of balloon + medicated balloon (32.9%), followed by balloon (22.2%), medicated balloon (13.9%), stent + medicated balloon (11.4%), balloon + medicated balloon + stent (10.8%), stent + balloon (5.7%), stent (2.5%) and finally stent + medicated stent (0.6%). The pharmacological treatment indicated after angioplasty was mostly the combination of acetylsalicylic acid (ASA) and clopidogrel (86.1%); in a smaller proportion, cilostazol was associated with the previous combination (12.7%); only 2 patients (1.3%) used ASA as monotherapy. The most frequent complication was minor amputation (52%), followed by major amputation (16%), surgical site infection (16%), stent thrombosis (8%), bleeding (4%) and dissection of the intervened vessel (4%). The complications were compared taking into account the type of surgical procedure: emergency vs. elective, finding that there is no association between the type of surgery and the incidence of stent thrombosis, bleeding and arterial dissection, however, it was found that there is a higher risk of minor amputation when the surgical procedure is performed urgently [15].

Conclusion

In summary, it can be said that angioplasty is a procedure performed by healthcare personnel in order to restore an occluded artery, that is, this method consists of opening or dilating again a blood vessel that is stenotic. This is done in order to improve the patient's blood flow and restore the quality of life of the person with this disease. In the same sense, it should be emphasized that peripheral arterial disease in the lower limbs of atherosclerotic cause, has a high risk of comorbidity with cardiovascular diseases such as myocardial infarction and stroke and an increased risk of mortality. It is of great importance that the health professional is aware of the risk factors for this pathology, suspects it and considers it as a differential diagnosis if necessary during clinical practice, remembering that it can present in the absence of symptoms. Early diagnosis by means of an adequate clinical history and physical examination, together with the calculation of the ankle-brachial index, is essential to provide optimal treatment and thus minimize the important complications of this pathology. Finally, it is essential to clarify that in angioplasty matters it will sometimes be better to use the medicated balloon or drug-eluting balloon (DAB) compared to the plain old balloon, since the latter does not contain drugs that help prevent the re-narrowing of the compromised arteries and thus the possibility of re-clogging the blood vessels.

Neighborhood Environment

The neighborhood in which individuals live can greatly influence their health outcomes. Factors such as housing quality, safety, and availability of recreational spaces play a role in shaping health behaviors and access to healthcare.

Built Environment: The built environment includes infrastructure, transportation systems, and housing conditions [4]. Poorly maintained neighborhoods with limited access to parks, grocery stores, and healthcare facilities can lead to unhealthy lifestyles, including sedentary behavior and poor dietary choices.

Social Cohesion: Neighborhoods characterized by strong social networks and community support can foster healthier behaviors and improve mental health [5]. Conversely, areas with high levels of violence, crime, and social disorganization may contribute to stress and poorer health outcomes.

Discrimination and Social Inequality

Systemic discrimination based on race, ethnicity, gender, sexual orientation, and other factors contributes to health disparities. Discriminatory practices in healthcare, employment, and housing can limit opportunities and access to essential resources.

Racial and Ethnic Disparities

Racial and ethnic minorities often experience worse health outcomes compared to their white counterparts. These disparities stem from a combination of factors, including historical injustices, socioeconomic inequalities, and limited access to quality healthcare [6]. For example, Black and Hispanic populations are disproportionately affected by conditions such as diabetes, hypertension, and certain cancers.

Gender Disparities: Gender also plays a role in health disparities, as women and men may face different health risks and access challenges. Women, for instance, may encounter barriers related to reproductive health services, while men may be less likely to seek preventive care.

The Interplay of Social Determinants and Health Disparities

The relationship between SDOH and health disparities is complex and multifaceted. These determinants do not operate in isolation; rather, they interact with one another, compounding their effects on health outcomes [7].

Cumulative Disadvantage: Individuals facing multiple disadvantages—such as low income, limited education, and residing in unsafe neighborhoods—are at an increased risk of poor health outcomes. This cumulative disadvantage creates a cycle of poverty and poor health that can persist across generations.

Life Course Perspective

A life course perspective emphasizes that health is influenced by factors at different stages of life. Adverse experiences during childhood, such as poverty and trauma, can have lasting effects on physical and mental health, leading to disparities later in life.

Policy and Structural Factors

Health disparities are often the result of structural inequities in society. Policies that perpetuate socioeconomic inequalities, such as discriminatory housing policies or unequal educational opportunities, contribute to ongoing health disparities. Addressing these structural factors is essential for promoting health equity.

Strategies for Addressing Health Disparities

Policy Interventions

Effective policies can help mitigate the impact of SDOH on health disparities. Strategies may include:

• Expanding Access to Healthcare: Policies that enhance access to affordable healthcare services, particularly for low-income populations, can improve health outcomes.
• Investing in Education: Supporting educational initiatives and improving access to quality education can empower individuals to make healthier choices and improve their socioeconomic status.

Community Engagement

Engaging communities in identifying and addressing their specific health needs can lead to more effective interventions [8]. Community-based programs that promote health education, preventive care, and access to resources can help reduce disparities.

Cross-Sector Collaboration

Collaboration between sectors, including healthcare, education, housing, and social services, is vital for addressing the multifaceted nature of health disparities. Integrated approaches that consider the social determinants of health can lead to more comprehensive solutions.

Research and Data Collection

Ongoing research is essential for understanding the impact of SDOH on health disparities. Collecting disaggregated data by race, ethnicity, and socioeconomic status can help identify at-risk populations and inform targeted interventions.

Conclusion

Social determinants of health play a crucial role in shaping health disparities among populations. By addressing these determinants such as socioeconomic status, access to healthcare, neighborhood environment, and systemic discrimination public health initiatives can more effectively promote health equity. Recognizing the interplay between these factors is essential for developing comprehensive strategies to reduce health disparities and improve health outcomes for all individuals, regardless of their background. As society moves toward a more equitable future, a concerted effort is needed to address the root causes of health disparities. Collaborative approaches that involve policymakers, healthcare providers, and communities will be critical in creating an inclusive health system that prioritizes the well-being of all individuals.

Citation: Puello Meza LF, et al. (2024) Medicated Balloon Angioplasty versus Plain Old Balloon Angioplasty for In-Stent Restenosis in Lower Limb Arteries. Health Sci J. Vol. 18 No. 12: 1205.