Angioplasty and Stents, Helping Millions

Here's how 40 years of angioplasty and heart stents have improved the lives of millions of patients.

NO IMAGE
Healthy Heart | Dec. 19, 2017

Every year, 17.7 million people die from cardiovascular diseases, of which coronary artery disease is the most common.

But without a big idea 40 years ago, that number might be higher.

Back then, angioplasty — a procedure to widen blocked arteries in the heart that cause coronary artery disease — was the dream of one dedicated physician, Zurich's Dr. Andreas Gruentzig.

Since Dr. Gruentzig performed the first coronary angioplasty in 1977 with a catheter and balloon set-up he created in his own kitchen, this technology and clinical knowledge has progressed into a lifesaving procedure that more than 1 million people receive annually in the United States, according to a report published by Cardiovascular Diagnosis & Therapy.

Abbott has developed many tools and devices that have improved the angioplasty procedure itself as well as patient outcomes. We are proud to carry on this pioneering legacy.

What is Cardiac Angioplasty?

For patients with coronary artery disease, plaque builds up inside arteries that supply oxygen-rich blood to the heart.

If blood flow to the heart is reduced or blocked, a person could feel chest pain or discomfort (angina), and when the artery becomes completely blocked, it can lead to a heart attack, according to the American Heart Association. The goal of angioplasty — also known as percutaneous coronary intervention (PCI) — is to open clogged arteries, allowing blood to flow freely through them.

Once real-time imaging determines the catheter is in the correct place, the balloon is inflated, compressing the plaque and opening the blockage.

Innovations in Angioplasty: Heart Stents

In 1986, a team of physicians led by Dr. Jacques Puel in Toulouse, France, performed an angioplasty with an important new piece of hardware: a bare-metal stent.

During a heart stent procedure, a catheter is inserted through an artery, such as in the arm or leg, then guided up into the heart to the blocked artery. The stent, a mesh-like tube of thin wire, was inserted after the balloon was inflated, and helped support the inner walls of the artery as it healed.

With bare-metal stents, however, patients experienced restenosis — the reblocking or closing of the artery due to tissue growth either inside or around the edge of the stent that was placed.

The next innovation was drug-eluting stents, metal stents coated with a medicine known to suppress restenosis.

These drug-eluting stents were thinner, more flexible, and coated with improved polymers to release the medicine that prevented tissue growth; and showed improved results for patients compared to bare-metal stents.

Now, stents are used in nearly all coronary angioplasty procedures, and significantly reduce the likelihood of the artery becoming obstructed again.

From balloon angioplasty in the 1970s to bare-metal stents in the 1980s and drug-eluting stents in the 2000s, scientific innovations in coronary artery disease have come a long way.

XIENCE

It's one of the most-used drug-eluting stents in the world. A medicine to reduce scar tissue formation, as well as a special coating, called fluoropolymer, helps reduce the risks of restenosis and thrombosis (artery blockage due to blood clots around the stent) and improve patient results.

Look at the numbers:

  • More than eight million people around the world have received a XIENCE stent since its initial regulatory approval in 2006. It has been implanted twice as many times as any other drug-eluting stent, making it one of the most-used drug-eluting stent in the world.
  • 10 years of real-world experience and over 100 clinical trials. Results have consistently shown better outcomes with XIENCE than with metallic stents or other drug-eluting stents.
  • Only one drug-eluting stent is FDA-approved for chronic total occlusion. Yep, XIENCE.1
  • The special fluoropolymer coating on XIENCE interacts with proteins in the blood to reduce the risk for blood clots in the stent.
  • XIENCE has an unprecedented safety profile, with consistently low rates of stent thrombosis, even in complex cases.

Reference

1Abbott Vascular. XIENCE Alpine Overview. Abbott Vascular Website. https://www.vascular.abbott/us/products/coronary-intervention/xience-alpine-drug-eluting-stent.html. Accessed December 7, 2017.

IMPORTANT SAFETY INFORMATION

The XIENCE V®, XIENCE nano®, XIENCE PRIME®, XIENCE PRIME® LL, XIENCE Xpedition®, XIENCE Xpedition® SV and XIENCE Xpedition® LL , XIENCE Alpine®, and XIENCE SierraTM (XIENCE Family) of Everolimus Eluting Coronary Stents on the MULTI-LINK VISION® or MULTI-LINK MINI VISION® Delivery System

INDICATIONS

The XIENCE Sierra stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32 mm) with reference vessel diameters of ≥ 2.25 mm to ≤ 4.25 mm. In addition, the XIENCE Sierra stent system is indicated for treating de novo chronic total coronary occlusions.

CONTRAINDICATIONS

The XIENCE Sierra stent system is contraindicated for use in:

Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or the post-procedural antiplatelet regimen.

Patients with hypersensitivity or contraindication to everolimus or structurally related compounds, or known hypersensitivity to stent components (cobalt, chromium, nickel, tungsten, acrylic, fluoropolymers), or with contrast sensitivity.

WARNINGS

It is not recommended to treat patients having a lesion that prevent complete inflation of an angioplasty balloon.

Judicious patient selection is necessary because the use of this device carries the associated risk of stent thrombosis, vascular complications, and/or bleeding events.

This product should not be used in patients who are not likely to comply with the recommended antiplatelet therapy.

PRECAUTIONS

Ensure that the inner package sterile barrier has not been opened or damaged prior to use.

Stent implantation should only be performed by physicians who have received appropriate training.

Stent placement should be performed at hospitals where emergency coronary artery bypass graft surgery (CABG) is accessible.

Subsequent restenosis may require repeat dilatation of the arterial segment containing the stent. Long-term outcomes following repeat dilatation of the stent are presently unknown.

Care should be taken to control the guiding catheter tip during stent delivery, deployment and balloon withdrawal. Before withdrawing the stent delivery system, visually confirm complete balloon deflation by fluoroscopy to avoid guiding catheter movement into the vessel and subsequent arterial damage.

When DES are used outside the specified Indications for Use, patient outcomes may differ from the results observed in the SPIRIT family of trials.

Compared to use within the specified Indications for Use, the use of DES in patients and lesions outside of the labeled indications may have an increased risk of adverse events, including stent thrombosis, stent embolization, MI, or death.

Orally administered everolimus combined with cyclosporine is associated with increased serum cholesterol and triglycerides levels.

A patient’s exposure to drug and polymer is proportional to the number and total length of implanted stents. See Instructions for Use for current data on multiple stent implantation.

Safety and effectiveness of the XIENCE Family of stents have not been established for subject populations with the following clinical settings:

Patients with prior brachytherapy of the target lesion or the use of brachytherapy for treated site restenosis, patients in whom mechanical atherectomy devices or laser angioplasty catheters are used in conjunction with XIENCE Family stents, women who are pregnant or lactating, men intending to father children, pediatric patients, unresolved vessel thrombus at the lesion site, coronary artery reference vessel diameters < 2.25 mm or > 4.25 mm or lesion length > 32 mm, lesions located in saphenous vein grafts, unprotected left main coronary artery, ostial lesions, lesions located at a bifurcation or previously stented lesions, diffuse disease or poor flow (TIMI < 1) distal to the identified lesions, excessive tortuosity proximal to or within the lesion, recent Acute Myocardial Infarction (AMI) or evidence of thrombus in target vessel, multivessel disease, and in-stent restenosis.

Everolimus has been shown to reduce the clearance of some prescription medications when administered orally along with cyclosporine (CsA). Formal drug interaction studies have not been performed with the XIENCE Family of stents because of limited systemic exposure to everolimus eluted from the stent.

Everolimus is an immunosuppressive agent. Consideration should be given to patients taking other immunosuppressive agents or who are at risk for immune suppression.

Oral everolimus use in renal transplant patients and advanced renal cell carcinoma patients was associated with increased serum cholesterol and triglycerides, which in some cases required treatment.

Non-clinical testing has demonstrated that the XIENCE Sierra stent, in single and in overlapped configurations up to 71 mm in length, is MR Conditional. It can be scanned safely under the conditions in the Instructions for Use.

The XIENCE Family of stents should be handled, placed, implanted, and removed according to the Instructions for Use.

POTENTIAL ADVERSE EVENTS

Adverse events (in alphabetical order) which may be associated with percutaneous coronary intervention treatment procedures and the use of a coronary stent in native coronary arteries include, but are not limited to, the following:

Abrupt closure, hematoma, or hemorrhage, Acute myocardial infarction, Allergic reaction or hypersensitivity to latex, contrast agent, anesthesia, device materials (platinum, polymer, cobalt, chromium, nickel, tungsten, acrylic, fluoropolymers), and drug reactions to everolimus, anticoagulation, or antiplatelet drugs, Arterial rupture, Arteriovenous fistula, Arrhythmias, atrial and ventricular, Bleeding complications, which may require transfusion, Cardiac tamponade, Coronary artery spasm, Coronary or stent embolism, Coronary or stent thrombosis, Death, Dissection of the coronary artery, Fever, Hypotension and/or hypertension, Ischemia (myocardial), Myocardial infarction (MI), Nausea and vomiting, Palpitations, Peripheral ischemia, Pseudoaneurysm, Renal Failure, Restenosis, Shock/pulmonary edema, Stroke/cerebrovascular accident (CVA), Total occlusion of coronary artery, Unstable or stable angina pectoris, Vascular access complications which may require vessel repair, Vessel dissection

The risks described below include, but are not limited to, the anticipated adverse events relevant for the cardiac population referenced in the contraindications, warnings, and precautions sections of the everolimus labels.

Abdominal pain; Anemia; Angioedema; Constipation; Cough; Diarrhea; Dyslipidemia (including hyperlipidemia and hypercholesterolemia); Dyspnea; Edema (peripheral); Headache; Hyperglycemia; Hypertension; Hypokalemia; Elevations of serum creatinine; Infections: bacterial, viral, fungal, and protozoan infections (may include opportunistic infections); Lymphoma and skin cancer; Male infertility; Oral ulcerations; Nausea; Non-infectious pneumonitis; Pain; Proteinuria; Pyrexia; Rash; Thrombotic microangiopathy (TMA)/Thrombotic thrombocytopenic purpura (TTP)/Hemolytic uremic syndrome (HUS); Urinary tract infection; Upper respiratory tract infection; Vomiting

Live vaccines should be avoided and close contact with those that have had live vaccines should be avoided. Fetal harm can occur when administered to a pregnant woman. There may be other potential adverse events that are unforeseen at this time.