The Food and Drug Administration has said that drug-coated stents made by Johnson & Johnson (J&J) and Boston Scientific Corp. (BSX) carry a small but significant risk of blood clots that appear to emerge a year or later after the stents are placed.

The agency said the risk applies to the two drug stents currently on the U.S. market made by Johnson & Johnson and Boston Scientific when compared with older, so-called bare metal stents. The FDA said it was not yet clear if the drug stents carried an increased risk of heart attacks or death compared with the bare metal stents.

Stents are tiny mesh tubes used to prop open previously clogged arteries, and drug-coated stents use medication to prevent tissue growth after implantation. The FDA said the drug stents significantly reduce the rate of tissue regrowth and the need for additional procedures to reopen the arteries.

The FDA first approved J&J’s drug-coated stent in 2003 and approved Boston Scientific’s in 2004. The drug-coated stents have largely replaced the use of bare metal stents and have quickly become a $5 billion-plus market.

However, concerns have risen about whether the newer stents increase the risk of fatal blood clots. The agency said currently available data from clinical studies suggest a small “but significant risk of late stent thrombosis,” or blood clots that emerge one year after the stent is placed. The agency said the total number of patients who have had the newer stents for three or more years is relatively small and it remains “uncertain” whether cases of blood clots will “continue to accrue with long-term follow-up.”

Panter, Panter & Sampedro, P.A., is investigating claims and drug-coated stent lawsuits nationwide. If you or a loved one has been injured after having a drug-coated coronary stent implanted, contact our drug stent attorneys at Panter, Panter & Sampedro, P.A., for a free consultation.


A stent is a tiny metal mesh tube used to prop open clogged coronary arteries:

The stent is mounted on a balloon catheter, inserted in the groin and advanced to the narrowed section of the coronary artery:

The balloon is then inflated, pushing plaque aside and expanding the stent:

The balloon is deflated and removed while the stent remains in place, supporting the artery:

Restenosis refers to occlusion of the artery after the stent is implanted due to scar tissue forming and reblocking the artery. Subacute thrombosis is one type of restenosis that occurs soon after the stent device is implanted. In subacute thrombosis, the stent or the operation causes the formation of new platelets inside the stent, causing blood clotting and blockage. It occurs within days of the surgery and is usually treated with drugs like Plavix. Another type of restenosis involves new cell growth inside the stent and takes longer to develop. Drug-coated stents such as Cypher and Taxus were developed specifically to treat this type of restenosis.


  • A bare metal stent costs about $800 and a drug-coated stent costs about $2,200.
  • Since 2003, drug-eluting stents have become some of the best-selling, most profitable products in the medical device business.
  • Only two drug-coated stent brands are available now in the United States: Taxus by Boston Scientific Corp. (made in Maple Grove, Minnesota, and Galway, Ireland), with 54 percent market share, and Cypher, by a division of Johnson & Johnson, with 46 percent market share.
  • Drug-eluting stents are inserted into the arteries of a million people a year and generate $5 billion a year in sales; this market was projected to double by 2010.
  • In stent restenosis (scar tissue formation) can occur after a bare metal stent (BMS) procedure.
  • Drug-eluting stents (DES) are simply BMS coated with a polymer containing a drug intended to reduce the risk of restenosis.
  • The drug itself is suspected of causing late-term (i.e., a year or more after implantation) thrombosis (reclotting). Patients may be required to take a blood thinner such as Plavix, possibly for life.
  • Particularly alarming is the fact that restenosis is a common but relatively benign process while stent thrombosis is life-threatening.
  • Restenosis benefits are overstated in real-world practice:
    • “The clinical benefits of DES relative to target vessel restenosis and target vessel revascularization (TVR) have been overestimated. For example, the TVR rates in the control bare-metal stent (BMS) group were nearly 50 percent higher in the DES trials than that observed in contemporary interventional trials or in ‘real-world’ clinical practice.”
  • Drug stents cause more heart attacks than metal stents:
    • Death and Q-wave myocardial infarction have a higher incidence in first-generation drug-eluting stents as compared with the bare metal control stents.
  • One study says doctors should prescribe longer-term anti-platelet therapy:
    • In a large consecutive cohort of contemporary patients receiving percutaneous coronary intervention (PCI), the long-term risk for death and major cardiac events was significantly increased among patients in the drug-eluting stent group who had discontinued clopidogrel therapy at six or 12 months.
    • Extended-duration clopidogrel therapy following drug-eluting stent implantation was associated with a lower incidence of death or myocardial infarction (MI), a finding that has immediate implications for clinical practice.
    • Longer-term anti-platelet therapy reduces heart attacks:
      • The risks of having a heart attack or dying were more than twice as high, or 7.2 percent, for patients who quit Plavix before six months compared with those who took the drug longer.
      • “A study released yesterday by researchers in Switzerland found patients with drug-coated stents who stopped taking Plavix after six months were almost four times as likely to die or have a heart attack in the next year as those who carried implanted bare metal devices.”


  • 1-10-07: Impact of drug-eluting stents on smaller heart vessels could add to risk
    • A Swiss study published in the Journal of the American College of Cardiology found that “collateral function,” the functioning of small collateral heart vessels, is more severely impaired in patients implanted with drug-eluting stents than in those implanted with bare-metal stents six months after implantation.
  • 12-12-06: Coated-stent makers rush to reassure after inquiry
    • On the same day the Food and Drug Administration launched a two-day advisory panel on the risks of drug-coated stents, doctors across the country found an email on their computers from stent maker Johnson & Johnson, inviting them to join a conference call about stent safety …
  • 12-7-06: West Palm Beach man sues J&J over drug-coated stent
    • In a move that could signal a wave of litigation, a West Palm Beach man has sued Johnson & Johnson over a drug-coated stent made by Miami Lakes-based Cordis. A man has sued Johnson & Johnson and its Cordis subsidiary for allegedly failing to warn him of complications that could be caused by drug-coated stents placed in his arteries …
  • 12-6-06: Risk of death rises with drug-coated stent:Study ties danger to stopping clot medicine
    • Patients who have received a drug-coated stent to prop open an artery face double the risk of heart attack or death after they stop taking an anti-clotting drug, researchers said. The findings mean patients might need to stay on medication beyond the three to six months currently recommended and possibly for the rest of their lives, scientists said …


Panter, Panter & Sampedro, P.A., is investigating claims and drug-coated stent lawsuits nationwide. If you or a loved one has been injured after having a drug-coated coronary stent implanted, contact our drug stent attorneys at Panter, Panter & Sampedro, P.A., for a free consultation.