Peripheral artery disease is characterized by the narrowing of blood vessels, which restricts blood flow. Interventional methods such as balloon angioplasty and stent placement are frequently preferred for treating this condition. Balloon angioplasty involves inserting a small balloon into the narrowed segment and inflating it to expand the artery. On the other hand, stents are metal meshes permanently placed inside the vessel to prevent it from narrowing again. Drug‑eluting stents and coated balloons reduce the risk of restenosis. The LEVANT II trial proved the efficacy of these modern devices, achieving high effectiveness. However, restenosis remains a significant obstacle, especially in long lesions.
Prof. Dr. Özgür KILIÇKESMEZ
Interventional Radiology / Interventional Neuroradiology
How Does Balloon Angioplasty Work in PAD Treatment?
In the treatment of peripheral artery disease, balloon angioplasty is an effective method used to widen narrowed sections of the arteries. The procedure begins under local anesthesia. During the intervention, the physician makes a small incision to access the narrowed artery. A specialized catheter is then introduced through this incision into the artery. The catheter’s tip contains a balloon, which is inflated once it reaches the blockage.
Preparation Stage:
- Local anesthesia is administered.
- A small incision is made in the hip or groin area.
Catheter Placement and Advancement:
- The catheter is carefully advanced into the artery through the incision.
Balloon Inflation:
- Once the balloon reaches the narrowed segment, it is inflated.
Inflating the balloon applies pressure to the arterial wall, expanding it and restoring normal blood flow. After inflation, the balloon is deflated and the catheter is removed from the body. In some cases, a stent is placed to keep the artery open. These stents remain permanently in the artery to prevent re‑narrowing. Post‑procedure, patients are usually monitored for a few hours. Most can return to normal activities within a few days.
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What Are the Benefits of Drug‑Coated Balloons in PAD Treatment?
In the treatment of peripheral artery disease, drug‑coated balloons offer substantial benefits by reducing restenosis rates. These balloons release antiproliferative drugs—particularly paclitaxel—into the vessel wall, preventing excessive smooth muscle cell growth. As a result, they help maintain arterial patency. During treatment, drug‑coated balloons provide the following advantages:
- Long‑term maintenance of vessel openness
- Lower restenosis risk compared to conventional methods
- Minimized need for repeat interventions
The LEVANT II trial validated the efficacy of drug‑coated balloons. In this study, drug‑coated balloons preserved vessel openness better than plain balloon angioplasty at one year. The trial’s results can be summarized as:
- Primary patency rate was 65.2% with drug‑coated balloons versus 52.6% with plain balloons.
- Drug‑coated balloons reduced target lesion revascularization, leading to fewer repeat procedures.
The IN.PACT SFA trial yielded similar findings, showing that drug‑coated balloons:
- Achieved higher primary patency rates (82.2%).
- Significantly lowered clinically driven target lesion revascularization (2.4% vs. 20.6%).
What Are the Risks and Complications of Interventional PAD Treatments?
Interventional treatments for peripheral artery disease carry certain risks and complications. Restenosis—the re‑narrowing of the treated artery due to neointimal hyperplasia or scar tissue formation—occurs in 30%–50% of cases. Drug‑coated balloons and drug‑eluting stents are used to mitigate this issue, but the risk remains.
Stent fractures are another notable complication:
- Stents can fracture under high mechanical stress, especially in the legs.
- Fractures may lead to re‑occlusion or restenosis of the artery.
Stent thrombosis, though rare, can cause acute ischemic events if clots form within the stent. This was more common with first‑generation stents and can be related to suboptimal placement.
Contrast agents used during angioplasty also carry risks:
- Allergic reactions
- Nephropathy in patients with preexisting kidney disease
Infection risk, although uncommon, should be taken seriously:
- Infections at the catheter entry site
- Infections in the stented artery
Balloon angioplasty and stent placement are minimally invasive methods for treating peripheral artery disease (PAD). During balloon angioplasty, a catheter with a balloon at its tip is inserted into the narrowed artery and inflated to press the plaque against the vessel wall, restoring blood flow. Stent placement often follows to maintain vessel patency; the stent remains in place after balloon dilation. Some stents release drugs to prevent re‑narrowing. These procedures are usually performed under local anesthesia, and patients may stay overnight. Post‑procedure, the entry site is monitored for infection, and gradual return to normal activities is advised.
Balloon angioplasty and stenting improve blood flow by opening narrowed or blocked peripheral arteries. Balloon angioplasty expands the vessel by compressing plaque against the artery wall, but can lead to restenosis. Stents—mesh tubes—are then placed to scaffold the artery open. Drug‑eluting stents release agents like paclitaxel to limit tissue growth and reduce restenosis rates. Clinical studies show that stenting provides better long‑term patency than balloon angioplasty alone. Drug‑coated balloons also deliver antiproliferative drugs directly to the vessel wall during dilation, preventing restenosis. These interventions are critical for managing PAD symptoms and improving patient quality of life.
Yes, arteries can re‑occlude after stenting, a phenomenon known as in‑stent restenosis (ISR). In the femoropopliteal segment, restenosis rates range from 18% to 40% in the first year. Adding cilostazol reduces ISR from around 43% to 31%. Treatments for ISR include repeat balloon angioplasty, additional stenting, drug‑coated balloons, and atherectomy, each with varying success rates. Drug‑coated balloons significantly reduce recurrent restenosis compared to standard balloon angioplasty.
Balloon angioplasty and stenting are effective treatments for PAD. Drug‑coated balloon angioplasty (DCB) reduces target lesion revascularization (TLR) risk by 59% and restenosis by 54%. DCB offers 2.05‑fold higher vessel patency compared to plain balloon angioplasty (POBA). Drug‑eluting stents outperform DCB in maintaining patency and reducing repeat interventions. In the femoropopliteal region, stenting yields higher patency rates and TLR‑free survival than DCB. These interventions improve blood flow, alleviate symptoms, and enhance quality of life for PAD patients.
Recovery after PAD interventions varies by procedure and patient health. Endovascular treatments (balloon angioplasty and stenting) typically involve shorter hospital stays and faster return to daily activities. However, comorbidities common in PAD patients can affect recovery. Adherence to medication, lifestyle modifications, and supervised exercise programs are essential. Regular follow‑up is critical to prevent complications and maintain treatment success.
Atherectomy is a minimally invasive procedure that removes atherosclerotic plaque from peripheral arteries to restore blood flow. Unlike angioplasty, atherectomy physically excises plaque, potentially reducing restenosis rates. In the U.S., approximately 6.5 million people over 40 have PAD, and over 190,000 atherectomy procedures are performed annually. Techniques include directional (cutting plaque), laser (vaporizing plaque), orbital (sanding plaque), and rotational (circular cutting blades). The CONFIRM registry showed orbital atherectomy plus low‑pressure balloon angioplasty reduced stenosis from 88% to 10%. However, a Cochrane review found no clear advantage of atherectomy over conventional angioplasty or stenting in patency, mortality, or cardiovascular events. Despite mixed evidence, atherectomy usage is rising, comprising 18% of U.S. peripheral vascular interventions, often based on lesion characteristics and calcification.
In calcified PAD, intravascular lithotripsy (IVL) has shown higher procedural success than standard balloon angioplasty. The Disrupt PAD III randomized trial reported that IVL effectively modifies both superficial and deep calcium, improving vessel compliance and facilitating stent deployment. In contrast, standard balloon angioplasty often yields suboptimal results in heavily calcified lesions.
Prof. Dr. Özgür Kılıçkesmez graduated from Cerrahpaşa Medical Faculty in 1997. He completed his specialization at Istanbul Education and Research Hospital. He received training in interventional radiology and oncology in London. He founded the interventional radiology department at Istanbul Çam and Sakura City Hospital and became a professor in 2020. He holds many international awards and certificates, has over 150 scientific publications, and has been cited more than 1500 times. He is currently working at Medicana Ataköy Hospital.
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