Bare-metal Stents Are Better For Some Heart Patients

"The issue here," says Michael Savage, M.D., Catheterization Laboratory Director at Thomas Jefferson University Hospital in Philadelphia, "is that studies have demonstrated that those patients who receive drug-eluting stents may develop life-threatening cardiac complications if they undergo subsequent, non-cardiac surgery."

This prescription for the potentially deadly problem begins when a person, often a senior citizen, learns that she or he must have elective surgery. The surgery can be for a minor to a major problem--from vacular surgery to fix blood flow problems, to broken hips or bones, neurological or urological issues and more.

Often, severe coronary artery disease is discovered during the pre-surgical testing. If severe, it presents a more-immediate problem and therefore, must be treated before the patient undergoes the elective surgery.

Prior studies have shown that patients may suffer fatal heart attacks due to clotting inside of the stents when surgery is performed within a few weeks after stent placement. In the case of drug-eluting stents, clotting of the stent may occur even months or years after their heart procedure, particularly when their blood thinning medicine (usually aspirin and Plavix) are stopped before the surgery.

To avoid the potentially deadly scenario, the Jefferson Medical College researchers developed a clinical protocol to enable patients to have both procedures successfully with little risk. Led by Agostino Ingraldi, M.D., a fellow in cardiovascular diseases, they developed the following four-part strategy:

• Avoidance of drug-eluting stents in favor of bare metal stents during the interventional heart procedure.
• A four-week course of the blood thinner clopidogrel (Plavix) after an interventional heart procedure.
• Deferral of the second, non-cardiac surgery for five to 12 weeks after the interventional procedure.
• Discontinuation of clopidogrel (Plavix) at least five days prior to the non-cardiac surgery.

The researchers studied a total of 60 patients (33 men and 27 women) who averaged 68 years old and who were treated with the strategy. Twenty seven percent suffered from diabetes which can complicate surgery.

The results show the coronary interventional procedure was successful in all patients where a total of 82 heart lesions were treated with bare-metal stents. The second, non-cardiac, surgery was performed an average of 47 days later. All were performed under general anesthesia and were successful. There were no deaths or clotting leading to problems. Also, clotting of the stents--a major problem seen with drug-eluting stents in this setting--were not seen in any patient.

"This research provides a safe treatment strategy for interventional cardiologists and their patients who will be undergoing further surgery," adds Dr. Savage, who is also associate professor of Medicine, Jefferson Medical College of Thomas Jefferson University. "Drug-eluting stents have proven benefits but may not be the best solution for every patient."

 Members of the team who conducted this study at Thomas Jefferson University Hospital in Philadelphia, Pa., are:

• Agostino Ingraldi, M.D., Nicholas J. Ruggiero II, M.D., Mark Awar, M.D.,
• Saum Shamimi-Noori, M.D., Utpal Sager, M.D., David Fischman, M.D.,
• Paul Walinsky, M.D., Howard H. Weitz, M.D., and Michael Savage, M.D.