No Excess Bleeding with EES vs. BMS in Octogenarians Despite Prolonged DAPT

MIAMI BEACH, FLA.—A comparison of BMS and everolimus-eluting stents (EES) in patients age 80 or older found that overall both stents provide strong clinical results. However, EES hold an edge in reducing MI and need for repeat revascularization, and do not increase the risk of major hemorrhage despite requiring longer dual antiplatelet therapy (DAPT).

At TCT 2012, presenter Adam J. de Belder, MD, of Brighton and Sussex Hospitals, Brighton, United Kingdom, described the clinical dilemma in treating this fast-growing segment of the PCI population, who often have extensive comorbidities and refractory angina and are commonly excluded from randomized trials. On one hand, the very elderly are more likely to have complex disease with increased risk of stenosis—which would favor use of DES. On the other hand, they are at increased risk of bleeding and present issues of compliance and drug interaction with DAPT—which would favor use of BMS.

For the prospective XIMA trial, 800 patients age 80 or older with stable angina or ACS at 11 centers in Spain and 11 in the United Kingdom were randomized to BMS (n = 401; Multi-Link Vision) or EES (n = 399; Xience, both Abbott Vascular). The BMS group received DAPT for one month, while the DES group was prescribed the therapy for 12 months.

De BelderAt one year there was no difference between the groups for the primary endpoint (the composite of death, major hemorrhage, MI, TVR, and stroke), or for the individual endpoints of death, stroke, or major hemorrhage. However, DES were associated with lower rates of MI and TVR (see Figure).

In a press conference, de Belder said there was initial concern that bleeding would be a significant risk in this cohort, but between 6 and 12 months the rate of major hemorrhage was only 1.0% in the EES group.

In discussion, Sigmund Silber, MD, of the Heart Center at the Isar, Munich, Germany, pointed out that about half of the cohort had ACS, for which guidelines recommend 12 months of DAPT regardless of stent choice. He therefore suggested that perhaps the higher MI incidence with BMS was due to the fact that these patients did not receive the recommended therapy. De Belder replied that “we’re still in the process of teasing out whether that the differences in DAPT duration had any impact on [MI].”

Another discussant, Donald Cutlip, MD, of Beth Israel Deaconess Hospital, Boston, Mass., observed that a concern in selecting stent type for older patients is the prevalence of atrial fibrillation and the need for anticoagulation on top of DAPT. De Belder agreed that this remains a major concern.

Cutlip added that the short duration of DAPT in the BMS group is of less concern than the long duration of DAPT in the EES group. Agreeing, de Belder noted that between 6 and 12 months, there was a fivefold higher rate of bleeding in the EES group. “The requirement for DAPT after DES in Europe is heading more toward 6 months,” he said. “Maybe if we reduced [the 1-year duration], some of this would be diminished.”

But overall, de Belder concluded, “these results give the interventional community strong reassurance that DES technology is not causing any harm in this group of patients and in fact may be giving some benefit in terms of reducing clinical events in the future.”

No Excess Bleeding with EES vs. BMS in Octogenarians Despite Prolonged DAPT

MIAMI BEACH, FLA.—A comparison of BMS and everolimus-eluting stents (EES) in patients age 80 or older found that overall both stents provide strong clinical results. However, EES hold an edge in reducing MI and need for repeat revascularization, and do not increase the risk of major hemorrhage despite requiring longer dual antiplatelet therapy (DAPT).
Disclosures
  • The study was funded by an unrestricted educational grant from Abbott Vascular.
  • Dr. de Belder reports receiving grant support from Abbott Vascular and Medtronic and consulting fees from Boston Scientific.

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