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Drug Eluting Coronary Stenting

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Drug-eluting stents


Do they increase heart attack risk ?

In recent years, there has been some concern about the use of some types of popular medical devices called stents. Stents are used to keep arteries open after a procedure called angioplasty. More than 2 million people receive stents each year, including a million Americans.

Some studies have suggested a certain type of stent known as a drug-eluting stent might increase your risk of heart attack. Other studies didn't find much risk.


What's a stent ?

Stents are metal mesh tubes inserted after an angioplasty into an artery that has become partially or completely blocked. Stents help prevent restenosis - when the artery becomes blocked again. Without the use of stents, about 30 percent of arteries become blocked again.

There are two basic kinds of stents: bare-metal stents and drug-eluting stents : -


  • Bare-metal stents, as the name implies, are metal stents with no special coating. Bare-metal stents act as simple scaffolding to prop open blood vessels after they are widened with angioplasty. As the artery heals, tissue grows around the stent holding it in place. However, sometimes an overgrowth of this scar tissue in the arterial lining increases the risk that the artery will become blocked again, hence the invention of the drug-eluting stent.
  • Drug-eluting stents are coated with medication that is slowly released (eluted) to help prevent the growth of scar tissue in the artery lining. This helps the artery remain smooth and open, assuring good blood flow through it. Drug-eluting stents were developed because in about 20 percent of those who get bare-metal stents, tissue growth over the stent eventually leads to re-blockage. Drug-eluting stents reduce this risk to less than 10 percent, and less than 5 percent of people need repeat procedures.

Millions of people with heart problems have been successfully treated with drug-eluting stents, preventing the need for more-invasive procedures such as coronary artery bypass surgery. The reduced risk of re-narrowing from drug-eluting stents minimizes the need for repeat hospitalization and repeat angioplasty procedures - each of which carry some risk of complications including heart attack and stroke.


Why is there some concern about using drug-eluting stents ?

The Food and Drug Administration (FDA), which monitors the use of medical devices, considers both bare-metal and drug-eluting stents to be safe and effective in most people. But, all stents involve some risk. Sometimes the angioplasty procedure itself can cause complications such as a heart attack, blood clots, bleeding or injury to the blood vessels. Both bare-metal and drug-eluting stents have a risk of clotting both early and late after implantation.

It appears that in some people who get drug-eluting stents, there's a small increased risk of blood clots forming in the stent once the drug coating has been used up - sometimes a year or more after stent implantation. This risk is still quite low; about 0.5 percent or less when stents are used for FDA-approved reasons. The risk appears to be slightly higher when drug-eluting stents are used for off-label uses, ranging from about 0.4 to 1.6 percent.

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Do drug-eluting stents increase risk of heart attacks ?

An FDA advisory panel found that when drug-eluting stents are used "on-label" - meaning for specific situations approved by the FDA - there was no increased risk of heart attack or death with drug-eluting stents compared with bare-metal stents. However, about 60 percent of the time stents are used for "off-label" indications - meaning for reasons that, while appropriate, are not specifically spelled out in the FDA guidelines. When stents are used off-label, it's generally for more-complex cases, such as in someone who has multiple blockages and other complications.

The FDA panel said when drug-eluting stents are used off-label, there's a small but increased risk of blood clotting that can lead to heart attack and death. But, it's unknown if drug-eluting stents cause this increased risk or whether people in this group tend to be at higher risk in the first place.
There are a variety of potential explanations for blood clots developing later after implantation. Much of it may have to do with how long a person takes anti-platelet medications - aspirin, clopidogrel (Plavix) - which help prevent blood clots from forming in the stents. If these medications are stopped earlier than recommended or an individual doesn't have an effective response to the anti-clotting medications, there can be problems. People also have varying healing times.


So, bottom line, are drug-eluting stents safe or not ?

Based on all presently available information, drug-eluting stents are safe and effective in most circumstances. The key is you must be willing to take your medications in the prescribed manner and for the prescribed duration to help ensure safety.

It's worth remembering that you basically have four options if your arteries become narrowed, each with risks : -


  • Bare-metal stents : - These stents can work well, but have a much higher rate of restenosis than drug-eluting stents. If you will need some type of noncardiac surgery soon (for example, a stomach or hernia operation), you may do better with a bare-metal stent.


  • Drug-eluting stents : - As we've been discussing, these stents work well and have a lower rate of restenosis than bare-metal stents. The issue we're trying to sort out is whether the use of drug-eluting stents in some people causes a higher risk of dangerous blood clots. As of right now, we can't give a definitive answer.


  • Coronary bypass surgery : - Bypass surgery is used to divert blood around blocked arteries in the heart. This surgery uses a healthy blood vessel harvested from your leg, arm, chest or abdomen and connects it to the other arteries in your heart so that blood is bypassed around the diseased or blocked area. While bypass surgery does work well, it's also more invasive than using stents, which means a longer recovery time. In addition, the risk of complications for bypass surgery can be higher than with stents.


  • Medications and lifestyle changes : - This is a good option for many people. If you have symptoms from your narrowed arteries, such as angina, and your condition isn't severe or immediately life-threatening, it may be worth first trying medications such as statins and lifestyle changes such as eating a more balanced diet. This option can be as effective as receiving a stent, especially for those who don't have unstable and "acute" chest pain (angina). Keep in mind that even if you receive a stent, your doctor will likely also prescribe medications such as statins.

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What should you do if you have a drug-eluting stent ?

It's very important that you take anti-clotting medications exactly as directed by your doctor.

Here's what to do if you have a stent of any kind : -


  • Take aspirin : - If you have a stent, you'll have to take aspirin daily and indefinitely to reduce the risk of clotting.


  • Take anti-clotting medication : - People with stents are given prescription anti-clotting medications such as clopidogrel (Plavix). The American Heart Association and FDA recommend that people who have had drug-eluting stents inserted should continue to take medications such as Plavix to reduce the risk of blood clots for at least one year after the stent is inserted.


  • Listen to your cardiologist : - Always talk with your cardiologist about how long you should take anti-clotting and other medications because the answer will vary depending on the nature of the blockage you had and your risk of bleeding. The most important thing to remember is to take all your medications exactly as your doctor prescribes.


If you're considering noncardiac surgery (meaning, not related to your heart) in the year after receiving your stent

There are some additional things to keep in mind : -


  • If possible, you should postpone your noncardiac surgery for one year after receiving a stent.
  • If the surgery can't be postponed, discuss with your doctor medications you should be taking at the same time, such as aspirin or clopidogrel. Your medication dosages might need to be changed.


What if you need a stent? Should you get a bare-metal stent instead of a drug-eluting stent ?

Generally, no. The most important thing to do is have a conversation with your doctor about the risks and benefits. Keep in mind that compared with a bare-metal stent, a drug-eluting stent dramatically reduces the chances your artery will become clogged again.

However, if you're likely to need surgery in the year after you get a stent, are at an increased risk of bleeding or don't think you'll be able to take anti-clotting medications as prescribed by your doctor, a bare-metal stent - or another treatment - might be a better choice. Again, talk with your doctor about your situation.

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Drug Eluting Stent Questions (for patients) : -


1) Can my stent be removed so I no longer have a risk of it clotting and causing a heart attack ?

NO. The stent must remain in place. The lining of the main artery in the heart grows into the stent, so that removing it would damage the artery and probably cause a heart attack. The drug-eluting stent is designed to limit the growth of the artery lining enough for it not to block the artery. The stent is supposed to allow for enough growth so that the stent itself is covered with the patient's cells.

At the same time it is supposed to prevent excessive cell growth into the artery channel, which would narrow it for the passage of blood. For some sensitive people the stent limits this growth so well that portions of the stent are not covered by cells and come in contact with the blood. An uncovered part of a stent can be a site for clotting. For this reason, patients with drug-eluting stents should continue to take their anticlotting medicine for a long time.


2) What are my chances of clotting my drug-eluting stent and having a heart attack if I do or do not take Plavix (clopidogrel) and aspirin ?

One study from Duke University evaluated the records of patients who received stents at Duke. People who did not have trouble for the first 6 months had only a 1 in 40 chance of clotting over the next year if they continued their anticlotting medicines, but a 1 in 20 chance of clotting if they stopped their anticlotting medicines 6 months after their stents were inserted. (A)

A different study from Denver evaluated patients beginning one month after stent placement until the end of the first year. They found that 99 patients out of 100 who continued medication were alive at that time. The patients who stopped the anticlotting medicines after only a month and may have discontinued their other medicines as well were older and sicker than the ones who continued the medicines. They had a 1 in 13 chance of dying by the end of the first year. (B)

Another study found that 7 of 121 people (6%) with drug-eluting stents who stopped their medicine developed clots in their stents, while only 4 of many (1790) patients who continued their anticlotting medicine had their stents clot during the period up to 1 Ĺ years after the stent was inserted. (C)

In a European study, late stent clotting (after 30 days) occurred in 6 per thousand patients per year during the three years after the stent was inserted. (D) One can conclude that it is much better to keep taking the medicine to prevent the stent from clotting than to stop taking the medicine too soon.


3) What is my chance of staying alive with my drug-eluting stent in place ?

93% after 4 year follow up (A)
94% after 4 year follow up (B)
94% after 3 years (C)
90% after 5 years (D)


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4) Should I stop my aspirin and Plavix (clopidogrel) before I go to the dentist ?

No. A good study has found that people taking aspirin bleed no more after having a tooth pulled than people taking a sugar pill for comparison. In addition, bleeding after a dental procedure can be controlled by direct pressure on the bleeding site until it stops. The risk of harm from a drug-eluting stent clotting if you stop your medicines before one year of therapy is greater than any harm that might occur from some extra dental bleeding.

After one year, the risk depends somewhat on factors that may make some people more likely to develop stent clotting. These include having more than one stent, having long stents, having stents in small vessels, having a heart that isn't pumping blood efficiently, being older, having kidney failure, and having diabetes.


5) Should I stop my anticlotting medicines if I need surgery ?

This is a judgment question and often the answer is to continue the medicines. Most drug-eluting stent clotting occurs in the weeks and months after the stent is inserted, so it is essential to continue the medicines during this period. A year after stent insertion, the risk of clotting is less, but for some people the risk persists for 2 years or more. We have no way at this time to tell those at risk for clotting from those not at risk.

The best information comes from studies of patients who were given aspirin and Plavix (clopidogrel) and then had coronary artery surgery. In general, they had more blood loss and a longer hospital stay than patients having coronary surgery who had not taken these medicines. But there was no increase in the frequency of the other complications of coronary surgery, such as wound infection or having a stroke or heart attack after the operation.

In addition, much surgery today has far less risk of bleeding than in the past. For example, cataract surgery is done through the cornea in the front of the eye. The cornea has no blood vessels so it does not bleed when cut. Another example is the "minimally invasive" surgery made possible by modern fiber optics and new types of instruments. Bleeding is often stopped with lasers that seal the ends of tiny vessels, so far less bleeding occurs with these techniques. The risk of a serious complication from excessive bleeding from many modern surgical techniques is less than the risk of a serious and potentially fatal heart attack from stent clotting if the anticlotting medicine is stopped. For other types of surgery, the decision is less clear. Elective surgery should be postponed until one year after drug-eluting stent insertion, if possible.

Whether one or both anticlotting medicines should be discontinued for surgery and for how long is a question of judgment for the surgeon and the cardiologist to decide between them.


6) If bleeding occurs, how soon do the effects of anticlotting drugs wear off? What can be done to control the bleeding ?

Both aspirin and Plavix (clopidogrel) interfere with the action of existing platelets-the blood cells responsible for controlling bleeding. A study of patients having coronary artery surgery analyzed the frequency of major bleeding in patients in terms of how long before surgery they stopped their anti-platelet therapy (anticlotting drugs). The investigations found major bleeding in 44 patients per 1000 who stopped the medicine 5 days or more before surgery.

The risk increased to 93 per 1000 in those who stopped 3 days before surgery and to 111 per 1000 in those who stopped the day before surgery. If bleeding needs to be stopped immediately, platelet transfusions are recommended.

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7) What is my risk of bleeding while I am on aspirin with Plavix (clopidogrel) ?

In one study of 3759 patients taking these drugs together for 18 months, life threatening bleeding occurred in 3 patients out of 100. A comparison group took aspirin alone and they had a risk of life threatening bleeding in 1 patient per 100. In another study, during an average period of 28 months following stent insertion, patients on aspirin with clopidogrel had a 1.7% chance of severe bleeding and a 2.1% chance of moderate bleeding. In comparison, people receiving low dose aspirin alone had risks of 1.3% for severe bleeding and 1.3% for moderate bleeding.


8) Suppose my stent does clot; what will happen ?

Clotting of a stent is a serious problem. In one study, of 47 episodes of stent clotting, there were 18 non-fatal heart attacks and 28 deaths (a death rate of 60%). Another study reported 15 stent clots with 5 deaths (a 33% death rate).



The list of of world class heart hospitals in India is as follows : -


Apollo Hospitals Bangalore Apollo Hospitals, Bangalore, India
Apollo Hospital Chennai Apollo Hospital, Chennai, India
Apollo Hospitals Hyderabad Apollo Hospitals, Hyderabad, India
Apollo Hospitals Delhi Indraprastha Apollo Hospital, Delhi, India
Apollo Hospitals Kolkata Apollo Gleneagles Hospital, Kolkata, India
Wockhardt Hospital Bangalore India Wockhardt Hospital, Bangalore India
Wockhardt Hospital hyderabad, India Wockhardt Hospital, hyderabad, India
Wockhardt Hospital Mumbai, India Wockhardt Hospital, Mumbai, India
Fortis Hospital, Delhi, India Fortis Hospital, Delhi, India
Fortis Hospital Mohali, India Fortis Hospital, Mohali, India
Fortis Hospital Noida, India Fortis Hospital, Noida, India
Escorts Heart Institute Hospital, Delhi, India Escorts Heart Institute Hospital, Delhi, India
Narayana Hrudayalaya Heart Hospital, Bangalore, India Narayana Hrudayalaya Heart Hospital, Bangalore, India
Artemis Hospital, Gurgaon ( Delhi ) , India Artemis Hospital, Gurgaon ( Delhi ) , India
Max Devki Devi Heart and Vascular  hospital,  Delhi, India Max Devki Devi Heart and Vascular hospital, Delhi, India
BGS Global Hospital Bangalore, India BGS Global Hospital, Bangalore, India
BGS Global Hospital Chennai, India BGS Global Hospital, Chennai, India
BGS Global Hospital Hyderabad, India BGS Global Hospital, Hyderabad, India


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