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Senior Citizen Health & Medicine

Death Risk Jumps by Nine from not taking Medicine after Drug-Eluting Stent

Old age, low education, no spouse, cost seen as factors for skipping drugs

June 12, 2006 – Heart attack patients who stopped taking antiplatelet drugs (which help prevent blood clots) within 30 days of receiving a drug-coated stent had nine times the risk of death compared to patients who followed doctors’ orders. Shockingly, about 15 percent of those studied, who were supposed to take the medicine for months, had stopped within the first month.

 

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“An alarming one in seven patients in our study stopped taking their antiplatelet medication within the first 30 days of receiving a drug-eluting stent (DES), even though they were prescribed the drugs at the time of hospital discharge and recommendations are to continue them for a minimum of three to six months after the procedure,” said John A. Spertus, M.D., M.P.H., lead author of the study and director of cardiovascular education and outcomes research at the Mid America Heart Institute in Kansas City, Mo.

Researchers looked at the real-world use of DES in heart attack patients and a class of drugs called thienopyridines that work along with aspirin to help keep platelets in the blood from clumping and leading to the formation of blood clots. Thienopyridines include the drugs clopidogrel and ticlopidine. Blood clots can obstruct a coronary artery, causing a heart attack.

Several studies have confirmed the benefits of DES in preventing restenosis (reclosing of the artery that had been treated). With stents, however, there is the potential problem of stent thrombosis (blood clots forming inside the stent), which can be associated with devastating consequences. 

Antiplatelet agents, including thienopyridines, reduce the likelihood of stent thrombosis.  According to Spertus, no previous studies have defined the frequency and consequences of prematurely discontinuing thienopyridine therapy.

The risk of stent thrombosis with bare-metal stents (stents not coated with a drug) decreases rapidly after two to four weeks, and patients typically need thienopyridines for only about one month.   In comparison, with drug-eluting stents the risk of stent thrombosis lasts for a longer period of time and patients with DES require prolonged thienopyridine therapy (typically for several months).

In a 19-center study of 500 heart attack patients (average age 61 years and 68 percent male) who received a DES and were discharged with prescriptions for thienopyridines, 68 patients (13.6 percent) stopped their medication within 30 days.   Those who stopped were:

  ● older;
  ● less likely to have completed high school;
  ● less likely to be married;
  ● more likely to avoid health care due to cost;
  ● more likely to have pre-existing cardiovascular disease or anemia when they arrived at the hospital; and
  ● less likely to have received discharge instructions about their medications or be referred for cardiac rehabilitation.

 

Drug-Eluting Stents Praised

 
 

In December of 2005, the American Heart Association selected benefits of drug-eluting stents as one of the top 10 research advances in heart disease and stroke for 2005.

Benefits of drug-eluting stents - results from RAVEL, was number four on the list and the news release said the following.

"After three years, the rate of major adverse cardiac events (MACE) in patients treated with drug-eluting stents was half the rate of patients treated with bare metal stents. 

"At six months and one year there were dramatic reductions in clinical events in patients treated with the Cypher stent.  At three years the MACE rate (which includes death, heart attack or repeat procedures) was 15.8 percent in the drug-eluting stent group versus 33.1 percent in the control group.  

"The Cypher stent, which is made by Cordis Corporation, a Johnson & Johnson Company, is coated with sirolimus, a drug that reduces restenosis (re-blockage) in coronary arteries propped open with a stent. The study enrolled 238 men and women, average age 60, with newly diagnosed blockages in a single native coronary artery. 

"At three years, outcome data from 113 patients treated with sirolimus-eluting stents and 114 control patients were available for analysis. The dramatic difference in the MACE rate is largely due to a significantly lower rate of re-narrowing of treated blockages."

 

After one year, 7.5 percent of patients who stopped their medication within the first 30 days had died compared to 0.7 percent of the compliant patients.   In addition, 23 percent of those who stopped their medication early were readmitted to the hospital, compared to 14 percent of those who continued their medication, he said.

“The rate of death was significantly higher and the frequency of cardiac hospitalizations was almost twice as great over the next 11 months among those who stopped their thienopyridines as compared to those who continued them,” Spertus said.

Researchers said previous studies under controlled conditions found that the combination of DES plus three to six months of antiplatelet medication effectively prevented restenosis for patients with atherosclerosis.

Yet, clinical trials differ from real-world practice where patients may have less intense follow-up or limited access to the medications they need.    That’s why it was important to see how patients would fare under real-world conditions, including those getting stents on a more emergency basis, such as for treatment of heart attack, Spertus said.

“The lack of a high school education was associated with a 79 percent higher risk of stopping treatment,” Spertus said.   “This finding indicates that more patient education about why the medicine is necessary could save lives."

Treatment decisions made at the height of clinical urgency can have long-lasting consequences on the chronic care that patients need in order to have the best possible outcomes.   In this case, prolonged use of thienopyridines after DES implantation for heart attack treatment is clearly required for patients to get all the benefits of reduced restenosis and to avoid the catastrophic complication of stent clotting, he said.

Co-authors are Richard Kettelkamp, D.O.; Clifton Vance, M.D.; Carole Decker, R.N., Ph.D.; Philip G. Jones, M.S.; John Rumsfeld, M.D., Ph.D.; John C. Messenger, M.D.; Sanjaya Khanal, M.D.; Eric Peterson, M.D., M.P.H.; Richard G. Bach, M.D.; Harlan M. Krumholz, M.D., S.M. and David J. Cohen, M.D., M.Sc.

The study is reported in Circulation: Journal of the American Heart Association. The research was funded in part by CV Therapeutics, Palo Alto, CA.

 

 

 

 

 

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