Circulation: DES are safe, effective for elderly CAD patients
Stents coated with paclitaxel (Taxus from Boston Scientific) may be a safe, effective treatment option for coronary artery disease (CAD) patients age 70 and older, and should not be withheld due to advanced patient age, according to a study reported in the June 2 issue of Circulation: Cardiovascular Interventions.
The study of nearly 10,000 patients in randomized clinical trials and real-world registries found that:
"The outcomes of DES in elderly patients who are fundamentally at higher risk due to increased prevalence of co-existing conditions as well as more complex and extensive atherosclerosis remain poorly studied," said the study's lead author Daniel E. Forman, MD, director of cardiac rehabilitation and the exercise testing laboratory at Brigham and Women's Hospital in Boston. "In the absence of age-specific data, some physicians avoid DES in elderly patients, potentially depriving them of what may be a more beneficial treatment alternative."
The researchers reviewed data on 2,271 patients who received Taxus stents in one of five stent randomized clinical trials and 7,492 more complex real-world patients who received Taxus in one of two stent registries. The data was important, "since clinical trials typically enroll healthier patients," according to Forman.
The researchers divided patients into three groups according to age: younger than 60 years; 60 to 70 years; and older than 70 years. They then compared the annual risk of death, MI, stent thrombosis and need for repeat treatment among these three age groups up to five years after having coronary stenting to determine if advancing age had an effect on these outcomes.
"The elderly constitute an expanding population segment, and since the risk of CAD increases with age, the number of elderly patients seeking treatment is on the rise," Forman said. "Advanced age alone should not be taken as a contraindication to percutaneous intervention using paclitaxel-eluting stents in elderly patients."
The investigators said the result may not apply to other drug-eluting stents.
"This study extends our knowledge about DES outcomes in the aged population, and demonstrates that the paclitaxel-eluting stent is as safe in elderly patients who have indications for invasive treatment, as in their younger counterparts," the authors wrote.
Boston Scientific of Natick, Mass., funded the study.
The study of nearly 10,000 patients in randomized clinical trials and real-world registries found that:
- Even though patients older than 70 years had significantly more risk factors (such as congestive heart failure, high blood pressure, kidney disease, prior stroke or transient ischemic attacks and prior CABG), their rates of MI, stent thrombosis and repeat treatment during follow-up were similar to those of younger clinical trial patients.
- While the annual rate of death was significantly higher in the older patients compared to younger patients in the trials and registries, the death rates in the older patients in the randomized trials were similar to people of like ages in the general U.S. population.
- Most outcomes were similar between elderly patients treated with a bare-metal stent (BMS) or a Taxus stent; however, patients treated with drug-eluting stents (DES) had a 54 percent lower need for repeat treatments than did patients treated with BMS.
"The outcomes of DES in elderly patients who are fundamentally at higher risk due to increased prevalence of co-existing conditions as well as more complex and extensive atherosclerosis remain poorly studied," said the study's lead author Daniel E. Forman, MD, director of cardiac rehabilitation and the exercise testing laboratory at Brigham and Women's Hospital in Boston. "In the absence of age-specific data, some physicians avoid DES in elderly patients, potentially depriving them of what may be a more beneficial treatment alternative."
The researchers reviewed data on 2,271 patients who received Taxus stents in one of five stent randomized clinical trials and 7,492 more complex real-world patients who received Taxus in one of two stent registries. The data was important, "since clinical trials typically enroll healthier patients," according to Forman.
The researchers divided patients into three groups according to age: younger than 60 years; 60 to 70 years; and older than 70 years. They then compared the annual risk of death, MI, stent thrombosis and need for repeat treatment among these three age groups up to five years after having coronary stenting to determine if advancing age had an effect on these outcomes.
"The elderly constitute an expanding population segment, and since the risk of CAD increases with age, the number of elderly patients seeking treatment is on the rise," Forman said. "Advanced age alone should not be taken as a contraindication to percutaneous intervention using paclitaxel-eluting stents in elderly patients."
The investigators said the result may not apply to other drug-eluting stents.
"This study extends our knowledge about DES outcomes in the aged population, and demonstrates that the paclitaxel-eluting stent is as safe in elderly patients who have indications for invasive treatment, as in their younger counterparts," the authors wrote.
Boston Scientific of Natick, Mass., funded the study.