Brigham and Women’s Hospital (BWH) has been a center for virtually all drug-eluting stent trials in the United States, and BWH investigators are currently involved in several trials of new stent designs and new drugs to refine DES technology. The newer stents are generally easier to use and position than earlier devices.
SPIRIT III Trial
Dr. Rogers, Director of BWH’s Cardiac Catheterization Laboratory, is national principal investigator for the SPIRIT III trial, which is currently enrolling appropriately selected patients whose blockages fit within prescribed boundaries of length, size, and location. This randomized trial will compare a new drug-eluting stent with an existing approved drug-eluting stent. Important outcomes to be tracked and compared will include safety (e.g. assessing the risk of developing a blood clot causing stent thrombosis) and efficacy (e.g. angiographic analysis over time and the prevention of restenosis). As with all DES patients, patients who enroll in the trial must commit to an antiplatelet medication regimen for several months while the artery and stent heal. For further information on the SPIRIT III trial, contact Dr. Campbell Rogers at (617) 732-8136.
As the refinements of DES technology continue, BWH physicians expect to offer enrollment in additional new stent trials that will feature new stent designs and new drugs.
On the Horizon
The next generation of drug-eluting stent trials – investigating new designs, new drugs, and new approaches – may have three potential benefits for patients. It is hoped that they will first, improve even further the safety and efficacy of current devices, second, make stent delivery easier, faster, and safer for patients, and third, assess DES technology in a broader set of disease states and vascular beds than is the case at present.
The expansion of drug-eluting stent therapy into peripheral, renal, and carotid circulations may revolutionize the treatment of disease in these essels as it has already done in coronary circulation. In the future, drug-eluting stents may be used to treat vulnerable plaque. Although there is not yet a reliable method for predicting where vulnerable plaque will occur, there is evidence that suggests it is most likely to develop in the first 30 to 40 millimeters of the coronaries. When it is possible to predict the location of vulnerable plaque development, stents may be used to provide a scaffold that will prevent plaque rupture and interrupt the cascade that otherwise would lead to myocardial infarction. Dr. Rogers, says, “Our accumulated experience over more than five years during the preclinical and clinical phases of DES technology development demonstrates that in competent and experienced hands, drug-eluting stents are both safe and effective in preventing restenosis. In our practice, we place approximately 4,000 stents in coronary arteries every year, and we use drug-eluting devices to treat more than 95 percent of stentable lesions.”
Clinical Team
BWH physicians have among the longest experience in the United States with DES technology. Richard Kuntz, MD, Jeffrey Popma, MD, Laura Mauri, MD, Elazer Edelman, MD, and Dr. Rogers, have all made significant contributions to understanding the biology of in-stent stenosis, the engineering aspects of drug-delivering stents, and the analysis of safety and efficacy data. In addition, Donald Baim, MD, an internationally renowned expert and author of a well-regarded textbook on invasive cardiology, was principal investigator at BWH for a seminal trial comparing drug-coated and bare stents.
Indications for Treatment
Patients who may benefit from and should be considered for drug-eluting stent therapy include:
- Patients with acute coronary syndromes;
- Patients with chronic angina;
- Patients who experience angina with exertion. Stent therapy has been demonstrated to decrease the need for medication and improve exercise tolerance in this group;
- Patients who have had bypass surgery and are experiencing recurrent chest pain.
Although the uses of stents have expanded significantly – notably to include patients with total occlusions and patients experiencing acute MI – some patients are still not appropriate candidates for stent treatment. Patients with multiple blockages in places that are difficult for catheters to reach, and most patients with narrowing of the left main coronary artery may be better served by bypass surgery. BWH interventional cardiologists work closely with their colleagues in cardiac surgery to offer the most appropriate care for each patient.
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