FDA PanelWords
--Drug-Eluting Stents Not Safe for All...Yet--
[This piece is a continuation of an investigation I'm doing for Anesthesiology News in light of the FDA panel that convened earlier this month.]
A man who underwent hip surgery seven weeks after receiving a drug-eluting stent experienced a heart attack within 12 hours of his hip procedure, according to a study published last month in the Journal of Clinical Anesthesia.
Presumably, the heart attack was a result of discontinuing Plavix®—the anti-clotting medication required after placement of a drug-eluting stent.
Providing adequate surgical care for patients with drug-eluting stents is a big issue,” said the study’s lead author, Mayo Clinic anesthesiologist Michael Brown.
This issue surfaces amidst general controversy over drug-eluting stents. Earlier this month, the FDA convened a two-day panel in Gaithersburg, Maryland, to evaluate the safety of these devices, which now prop open the arteries of 3 million Americans.
Unlike conventional stents, drug-eluting stents ooze chemicals designed to battle restenosis, or renarrowing. But the chemicals they spew not only prevent the growth of artery-clogging cells, they also inhibit cells that would naturally fight clotting.
This means that patients with drug-eluting stents suffer suppressed anti-clotting systems and should stay on medications like Plavix for several months to a year.
According to Roger Moore, vice president of the American Association of Anesthesiologists, people on anti-clotting medication present unique challenges for anesthesiologists. That’s because anti-clotting drugs reduce the tendency to clot at the expense of bleeding—a risk inherently high during surgery. As such, patients on medications like Plavix are often recommended to discontinue their regimens before surgery.
But without Plavix, clotting risks skyrocket, and clotting—unlike restenosis—is linked to heart attacks, and even death.
The FDA panel in Gaithersburg sought to determine how likely drug-eluting stents are to cause long-term blood clots, and what should be done. While the American Heart Association recommends at least 3 to 6 months of Plavix treatment following drug-eluting stent placement, the optimal duration of this medication has not yet been established. The Gaithersburg panel meeting marked the first time the FDA sought the help of anesthesiologists and surgeons to inform such guidelines.
During the trial, presentations by doctors and stent manufacturers and data from numerous studies verified that drug-eluting stents increase clotting—both for approved patients, as well as for those who are “off-label.” Despite clotting risks, however, the panel concluded that drug-eluting stents are safe, as long as they’re used in conjunction with anti-clotting medication and in the intended population.
But—as evidenced by Michael Brown’s study—drug-coated stents cause problems even within the FDA-approved group when people who have them undergo surgery.
“The fact of the matter is that more and more people will be getting drug-eluting stents,” said Richard Shemin, a cardiac surgeon who was present on the FDA panel, “and surgeons and anesthesiologists are going to have to learn how to take care of people who have them.”
The most obvious strategy, according to Dr. Moore, is to postpone surgical procedures during the 6 month window directly after stenting.”
If surgery is emergent, however, a preoperative cardiology consultation is the next best approach.
“Communication between the surgical team and the cardiologist who placed the stent is vital,” said Sanjay Kaul, Director of the Vascular Physiology and Thrombosis Research Laboratory at Cedars-Sinai Medical Center in Los Angeles. His medical center has formed a Plavix Taskforce Committee to encourage interdisciplinary discussion.
“The problem now is that too often these conversations don’t take place,”
said Thomas Slater, an interventional cardiologist at NYU’s Tisch Hospital in Manhattan. He emphasized the need for anesthesiologists to consult with a patient’s cardiologist to understand the trade-off between the risk of stent thrombosis, or clotting, versus the risk of surgical bleeding.
“Anesthesiologists should learn why and when the stent was placed, how big it was, and how long the patient has been on anti-clotting medication,” said Dr. Slater. The risk of stent thrombosis is contingent upon these factors, as well as others such as presentation of the initial acute coronary syndrome, vessel lesions, bifurcation stenting, and an underdeployed stent.
In patients for whom the clotting risk is low, discontinuing Plavix to avoid excessive bleeding is less of a concern. For patients at an increased risk, however, remaining on anti-clotting medication during surgery should be a definite consideration.
And there are other ways anesthesiologists and surgeons can make the operating room safer for patients with drug-eluting stents.
For example, while stenting may have successfully opened significant obstructions in a patient’s major coronary arteries, obstructions could still exist in coronary arteries in the periphery. “This needs to be considered in approaches to anesthetic management,” said Dr. Moore.
He said that anesthesiologists operating on patients with drug-eluting stents should also avoid anesthetic techniques that could increase bleeding in areas already sensitized to it by Plavix. Additionally, anesthesiologists should monitor a patient’s cardiac status since any patient with a stent has previously had cardiac disease, which the stent may not have cured.
Finally, a study published this month in the Canadian Journal of Anesthesia discusses the potential for new anti-clotting medications—drugs with predictably short onsets and offsets of anti-clotting action. A patient on such a drug could stop the long-acting antiplatelet agent and switch to the short-acting, reversible one before surgery, to minimize bleeding. The short-acting agent could even be continued throughout the surgical procedure if the bleeding incurred was not excessive.
“Ultimately, drug-eluting stents are still great devices as long as patients who have them are well-managed in a surgical setting,” said Dr. Shemin. “With time and experience, as well as the willingness of specialists to communicate, we’ll know better how to do that.”
.MGW.
[This piece is a continuation of an investigation I'm doing for Anesthesiology News in light of the FDA panel that convened earlier this month.]
A man who underwent hip surgery seven weeks after receiving a drug-eluting stent experienced a heart attack within 12 hours of his hip procedure, according to a study published last month in the Journal of Clinical Anesthesia.
Presumably, the heart attack was a result of discontinuing Plavix®—the anti-clotting medication required after placement of a drug-eluting stent.
Providing adequate surgical care for patients with drug-eluting stents is a big issue,” said the study’s lead author, Mayo Clinic anesthesiologist Michael Brown.
This issue surfaces amidst general controversy over drug-eluting stents. Earlier this month, the FDA convened a two-day panel in Gaithersburg, Maryland, to evaluate the safety of these devices, which now prop open the arteries of 3 million Americans.
Unlike conventional stents, drug-eluting stents ooze chemicals designed to battle restenosis, or renarrowing. But the chemicals they spew not only prevent the growth of artery-clogging cells, they also inhibit cells that would naturally fight clotting.
This means that patients with drug-eluting stents suffer suppressed anti-clotting systems and should stay on medications like Plavix for several months to a year.
According to Roger Moore, vice president of the American Association of Anesthesiologists, people on anti-clotting medication present unique challenges for anesthesiologists. That’s because anti-clotting drugs reduce the tendency to clot at the expense of bleeding—a risk inherently high during surgery. As such, patients on medications like Plavix are often recommended to discontinue their regimens before surgery.
But without Plavix, clotting risks skyrocket, and clotting—unlike restenosis—is linked to heart attacks, and even death.
The FDA panel in Gaithersburg sought to determine how likely drug-eluting stents are to cause long-term blood clots, and what should be done. While the American Heart Association recommends at least 3 to 6 months of Plavix treatment following drug-eluting stent placement, the optimal duration of this medication has not yet been established. The Gaithersburg panel meeting marked the first time the FDA sought the help of anesthesiologists and surgeons to inform such guidelines.
During the trial, presentations by doctors and stent manufacturers and data from numerous studies verified that drug-eluting stents increase clotting—both for approved patients, as well as for those who are “off-label.” Despite clotting risks, however, the panel concluded that drug-eluting stents are safe, as long as they’re used in conjunction with anti-clotting medication and in the intended population.
But—as evidenced by Michael Brown’s study—drug-coated stents cause problems even within the FDA-approved group when people who have them undergo surgery.
“The fact of the matter is that more and more people will be getting drug-eluting stents,” said Richard Shemin, a cardiac surgeon who was present on the FDA panel, “and surgeons and anesthesiologists are going to have to learn how to take care of people who have them.”
The most obvious strategy, according to Dr. Moore, is to postpone surgical procedures during the 6 month window directly after stenting.”
If surgery is emergent, however, a preoperative cardiology consultation is the next best approach.
“Communication between the surgical team and the cardiologist who placed the stent is vital,” said Sanjay Kaul, Director of the Vascular Physiology and Thrombosis Research Laboratory at Cedars-Sinai Medical Center in Los Angeles. His medical center has formed a Plavix Taskforce Committee to encourage interdisciplinary discussion.
“The problem now is that too often these conversations don’t take place,”
said Thomas Slater, an interventional cardiologist at NYU’s Tisch Hospital in Manhattan. He emphasized the need for anesthesiologists to consult with a patient’s cardiologist to understand the trade-off between the risk of stent thrombosis, or clotting, versus the risk of surgical bleeding.
“Anesthesiologists should learn why and when the stent was placed, how big it was, and how long the patient has been on anti-clotting medication,” said Dr. Slater. The risk of stent thrombosis is contingent upon these factors, as well as others such as presentation of the initial acute coronary syndrome, vessel lesions, bifurcation stenting, and an underdeployed stent.
In patients for whom the clotting risk is low, discontinuing Plavix to avoid excessive bleeding is less of a concern. For patients at an increased risk, however, remaining on anti-clotting medication during surgery should be a definite consideration.
And there are other ways anesthesiologists and surgeons can make the operating room safer for patients with drug-eluting stents.
For example, while stenting may have successfully opened significant obstructions in a patient’s major coronary arteries, obstructions could still exist in coronary arteries in the periphery. “This needs to be considered in approaches to anesthetic management,” said Dr. Moore.
He said that anesthesiologists operating on patients with drug-eluting stents should also avoid anesthetic techniques that could increase bleeding in areas already sensitized to it by Plavix. Additionally, anesthesiologists should monitor a patient’s cardiac status since any patient with a stent has previously had cardiac disease, which the stent may not have cured.
Finally, a study published this month in the Canadian Journal of Anesthesia discusses the potential for new anti-clotting medications—drugs with predictably short onsets and offsets of anti-clotting action. A patient on such a drug could stop the long-acting antiplatelet agent and switch to the short-acting, reversible one before surgery, to minimize bleeding. The short-acting agent could even be continued throughout the surgical procedure if the bleeding incurred was not excessive.
“Ultimately, drug-eluting stents are still great devices as long as patients who have them are well-managed in a surgical setting,” said Dr. Shemin. “With time and experience, as well as the willingness of specialists to communicate, we’ll know better how to do that.”
.MGW.
posted by Meagan G at
12:01 PM
<< Home