Saturday, June 13, 2009

Paclitaxel-Eluting Stents May Be Safe, Effective in Certain Elderly Patients

Paclitaxel-eluting stents (PES) may be a safe, effective treatment option for coronary artery disease in patients 70 years and older, according to the results of a study reported online in the June 2 issue of Circulation: Cardiovascular Interventions.

"While drug-eluting stents (DES) have become a mainstay of percutaneous coronary intervention (PCI), information about DES outcomes in elderly patients is limited," write Daniel E. Forman, MD, from Brigham and Women's Hospital and the Veterans Administration Boston Health Care System in Boston, Massachusetts, and colleagues. "Data from the...PES trials and registries were pooled to assess PES benefits relative to advancing patient age, including comparison to bare metal stents (BMS)."

The investigators separately pooled data from 5 randomized trials enrolling a total of 2271 patients who received PES and 1397 patients who received BMS and from 2 postmarketing registries reporting on a total of 7492 patients in the PES group. For each dataset, patients were stratified into age groups: younger than 60 years, ages 60 to 70 years, and older than 70 years. In both datasets, patients older than 70 years had significantly more adverse baseline characteristics vs younger patients.

Trial data through 5 years showed that patients older than 70 years had higher mortality rates vs younger patients, but rates of myocardial infarction, stent thrombosis, and target lesion revascularization were similar in both groups. In patients older than 70 years, those treated with PES or BMS had similar rates of mortality, myocardial infarction, and stent thrombosis, but target lesion revascularization rate was significantly lower (22.2% vs 10.2%; P < .001).

Analysis of registry data through 2 years showed similar results. Compared with younger patients, patients older than 70 years treated with PES had significantly higher mortality rates but lower rates of myocardial infarction, stent thrombosis, and target lesion revascularization. Death rates of patients older than 70 years were higher vs those of younger patients but similar to those in the general population matched by age and sex.

"This analysis of almost 10,000 patients demonstrated that PCI with PES is a safe and effective treatment option that should not be withheld based on age," the study authors write. "Although patients >70 have a higher annual death rate, this rate is comparable to patients treated with BMS, as well as age and gender matched norms for the general population. Advanced age alone should not be taken as a contraindication to PCI using PES in elderly patients with compelling indications for revascularization, suitable coronary anatomy, and ability to undergo the procedure."

Limitations of this study acknowledged by the authors include post hoc analysis of prospective trials, observational design, heterogeneity among age-derived groups, limited generalizability of the findings to other types of DES, lack of comparison to other therapeutic options, and failure to evaluate non–life-threatening bleeding risks associated with long-term antiplatelet therapy.

"This is a very relevant paper, although one has to be careful with the interpretation of the data as it is observational and the fact that each study included in the analysis has different follow up times and endpoints according to each individual study design," Juan F. Granada, MD, FACC, told Medscape Cardiology when asked for independent comment. "The data are strong and suggest that PCI in the elderly appears to be safe and effective."

Dr. Granada, who is medical director of the Skirball Center for Cardiovascular Research, Cardiovascular Research Foundation, Columbia University Medical Center in New York, NY, noted certain limitations of the study and of the conclusions that can be drawn from its findings:

• The lesions treated were highly selective (relatively short, and two thirds type A, B1, or B2).

• Complex intervention or anatomy was avoided or was not reported.

• The incidence of myocardial infarction during the first year appeared to be high for all groups, then normalized, although in the group of patients older than 70 years, mortality rate did not seem to be increased. The relatively high incidence of myocardial infarction during the first year could be a global effect occurring at all ages.

• The definition of stent thrombosis was adequate but was limited to a single definition.

• The etiology of all-cause mortality was not described in detail.

• The effect of dual antiplatelet therapy in clinical outcomes was not taken into consideration.

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