TCT: No additional risk of bleeding with DES use in octogenarians

MIAMI- The results of a study with a cohort of octogenarians with severe coronary artery disease (CAD) found that the patients responded well to treatment with drug-eluting stents (DES) with no increase in bleeding compared to bare metal stents (BMS). These findings were presented Oct. 26 at the late-breaking trials session at the Transcatheter Cardiovascular Therapeutics (TCT) conference.

Noting that the mean age of participants in clinical trials that influence clinical decision making is 61, the Xience or Vision for the Management of Angina in the Elderly (XIMA) investigators sought to acquire data on the outcomes of older patients treated with stents for CAD.

“It is an increasingly common scenario that clinicians are facing patients in their 80s with severe CAD, extensive comorbidities, refractory angina and complex coronary anatomy that deems them unsuitable for coronary artery bypass surgery… It seems obvious to use DES to treat severe CAD, but the other side of the coin is that to commit to one year of anticoagulant therapy can be a problem for the elderly because of the risk of bleeding,” explained Adam de Belder, MD, director of the Cardiac Catheter Laboratories at Brighton and Sussex University Hospitals in the U.K.

Investigator deBelder and co-investigator Jose Maria de la Torre Hernandez, MD, of Hospital Universitario Marques de Valdecilla in Santander, Spain, enrolled 800 patients aged 80 and older, with 400 in the UK and 400 in Spain. The patients had undergone coronary angiography for stable angina or following an acute coronary syndrome, had lesions either greater than 15mm long or less than 3mm wide, and were deemed suitable for stenting. The investigators excluded heart attack patients but did not exclude patients with chronic total occlusions, bifurcation, severe calcification and left main stem lesions.

They randomized the enrolled patients and implanted Vision BMS in 401 patients and Xience DES in 399 patients. The primary endpoint was major adverse cardiac events (MACE), defined as death, major hemorrhage, MI, target vessel revascularization (TVR), and cardiovascular accident (CVA).

At one year, the primary endpoint was reached in 18.7 percent of the BMS patients and 14.5 percent of the DES patients, a difference that was not statistically significant. Rates of major bleeding and CVA did not differ between the two groups; the DES group required fewer TVR (4.3 percent vs 7 percent in the BMS group) and experienced a lower rate of MI (4.3 percent vs. 8.7 percent in the BMS group). There was no significant difference in mortality between the two groups at one year (8.5 percent vs. 7.2 percent). 

At the presentation, de Belder stated that the results should be “reassuring” to the clinician treating an elderly patient, offering the option of treating with DES as the DES patients did not experience significantly higher rates of bleeding. But he noted that outcomes for both groups were “pretty good.”

In response to a question about compliance with anticoagulant therapy requirements, deBelder noted that there was excellent compliance among the study cohort but conceded that compliance may have been driven in part by study monitoring. “[Drug compliance] is certainly a problem among this challenging group of patients,” he said.

The findings did not show that there were statistically significant benefits to using a DES in the elderly, but the discussants found the results important nevertheless. “When you take a group of confounding patients and present relatively clear data, that’s an accomplishment,” said William Gray, MD, director of endovascular services at Columbia University Medical Center in New York City.

Sigmund Silber, MD, of the Heart Center of the Isar in Munich, noted that the rate of revascularization was much lower in the DES. “It is a pain for the elderly patient to come back again on the cath table, so I would say, yes, in general if there is no contraindication you should go for the DES, even in the older patient,” he remarked.