XIMA: DES, BMS yielded encouraging outcomes in elderly patients

Comparable procedural success and mortality rates for bare-metal and drug-eluting stents were reported in a large cohort of octogenarians.

For the multicenter, randomized XIMA trial, researchers investigated outcomes associated with BMS vs. DES in octogenarian patients with angina. They noted that prolonged use of dual antiplatelet therapy in patients aged 80 years or older may cause complications in using DES to treat complex coronary disease.

The analysis included 800 patients aged 83.5 ± 3.2 years.

A 1-year composite of death, MI, cerebrovascular accident, target vessel revascularization or major hemorrhage served as the primary outcome measure.

There were 401 patients in the BMS group and 399 patients in the DES group. Thirty-two percent of the cohort underwent treatment for stable angina, whereas 68% were treated for ACS.

Procedural success rates were 97.7% for BMS patients and 95.4% for DES patients (P=.07). PCI in at least two vessels occurred in 38% of the cohort and 66% underwent complete revascularization. Stent implant lengths were 24.0 ± 13.4 mm in the BMS group and 26.6 ± 14.3 mm (P=.01) in the DES group.

At 1 year, DAPT use was reported in 32.2% of the BMS arm and 94% of the DES arm.

Clinicians reported that the primary endpoint was achieved in 18.7% of patients who received BMS and 14.3% of those in the DES arm (P=.09).

Mortality rates were 7.2% for BMS and 8.5% for DES (P=.50). Major hemorrhage (1.7% vs. 2.3%; P=.61) and cerebrovascular accident (1.2% vs. 1.5%; P=.77) rates also were similar between the two groups.

Patients in the BMS group experienced more MI (8.7% vs. 4.3%; P=.01) and TVR (7% vs. 2%; P=.001).

Mikkel M. Schoos

In an accompanying editorial, Mikkel M. Schoos, MD, and George D. Dangas, MD, from the division of cardiology at Mount Sinai Medical Center, New York, wrote that the study may be limited because the results are not clear about whether bleeding had a causative impact on noncardiac death. “Reporting bleeding endpoints also by Bleeding Academic Research Consortium or including Thrombolysis In Myocardial Infarction minor bleeding might have changed the outcome measure with respect to 1-year mortality,” they wrote.

The editorialists also addressed the results in terms of DAPT use. “The XIMA trial would have provided very valuable lessons on duration, interruption and disruption of DAPT if detailed data on these variables were available,” they wrote. “Bleeding (and perhaps noncardiac death) rates might have been lower if the duration of DAPT were shorter.”

George D. Dangas

Schoos and Dangas concluded that the use of everolimus-eluting stents via radial access in elderly patients may be an attractive strategy because it improves MI and TVR rates while reducing vascular complications.

“In addition, the duration of DAPT in potentially frail patients remains an important question, and outcomes may improve if the duration of DAPT can be shortened safely,” they wrote. “A crucial aspect of this trial and any other clinical investigation in elderly patients is an understanding of the noncardiac mortality trends and their relationship with treatment arms and primary outcome measures. The only way to decipher these questions is to conduct more trials including elderly patients.”

For more information:

de Belder A. J Am Coll Cardiol. 2014;63:1371-1375.

Schoos MM. J Am Coll Cardiol. 2014;63:1376-1377.

Disclosure: The researchers report financial disclosures with Abbott Vascular, AstraZeneca, Biosensors, Biotronik, Boston Scientific, Daiichi Sankyo, Eli Lilly, Haemonetics, Medtronic, Spectranetics, St. Jude Medical and Volcano Corp. Dangas reports that his spouse is on the advisory board of Abbott Vascular. Schoos reports no relevant financial disclosures.