No Apparent Advantage for Everolimus vs. Paclitaxel Stents in Diabetic Patients

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Patients without diabetes who undergo percutaneous coronary intervention (PCI) experience fewer adverse events with everolimus-eluting stents (EES) compared with paclitaxel-eluting stents (PES), researchers conclude in an analysis published online August 8, 2011, ahead of print in Circulation. However, for diabetic patients, there appears to be clinical equipoise between the 2 stent types.

Researchers led by Gregg. W. Stone, MD, of Columbia University Medical Center (New York, NY), examined outcomes of 6,780 patients enrolled in 4 large clinical trials who underwent PCI with PES or EES. Slightly more than one-quarter of the patients had diabetes (n = 1,869).

The 4 trials were: SPIRIT II (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions II), SPIRIT III, SPIRIT IV, and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice). Different PES were evaluated; the SPIRIT trials used Taxus Express2 (Boston Scientific, Natick, MA), while COMPARE used Taxus Liberté (Boston Scientific). All trials compared PES with Xience V (Abbott Vascular, Santa Clara, CA) as the EES.

No Real Difference for Diabetics at 2 Years

Compared with PES-treated patients, nondiabetic patients who received EES had reduced 2-year rates of mortality, MI, stent thrombosis, and ischemia-driven TLR (table 1).

Table 1. Nondiabetic Patients

 

EES
(n = 3,056)

PES
(n = 1,855)

P Value

Death

1.9%

3.1%

0.01

MI

2.5%

5.8%

< 0.0001

Stent Thrombosis

0.3%

2.4%

< 0.0001

TLR

3.6%

6.9%

< 0.0001


But among patients with diabetes, none of the above endpoints differed between the 2 stent types (table 2).

Table 2. Diabetic Patients

 

EES
(n = 1,188)

PES
(n = 681)

P Value

Death

3.9%

2.9%

0.27

MI

4.2%

4.9%

0.49

Stent Thrombosis

1.6%

2.0%

0.50

TLR

5.5%

6.1%

0.60


Multivariable adjustment for differences in baseline characteristics did not change the findings. Interactions were present between diabetes status and stent type for the 2-year endpoints of MACE (P = 0.0009), MI (P = 0.01), stent thrombosis (P = 0.0006), and ischemia-driven TLR (P = 0.02) but not for cardiac death (P = 0.25).

When insulin-dependent diabetic patients were compared with those not using insulin, a significant interaction was seen related to stent type. Although 2-year rates of cardiac death, MI, or stent thrombosis were equivalent for EES and PES in diabetic patients regardless of insulin treatment, ischemia-driven TLR was reduced in the non-insulin-treated diabetics assigned to EES compared with PES (3.7% vs. 6.3%; P= 0.04). Insulin-dependent diabetics showed the opposite pattern, with a trend toward more TLR with EES than with PES (10.8% vs. 5.5%; P = 0.08).

No Need for Change in Practice

“Longer-term follow-up is necessary to determine whether meaningful differences between the stent types in diabetic patients will emerge over time,” Dr. Stone and colleagues write.

However, for the time being, EES should clearly be preferred over PES in nondiabetic patients, they write, adding that “[f]or those using EES routinely in patients with and without diabetes mellitus, the current analysis does not require a change in practice, especially because the present study suggests that EES compared with PES may reduce ischemia-driven TLR in non-insulin-treated diabetic patients.”

Note: Dr. Stone is a faculty member of the Cardiovascular Research Foundation, which owns and operates TCTMD.


Source:
Stone GW, Kedhi E, Kereiakes DJ, et al. Differential clinical responses to everolimus-eluting and paclitaxel-eluting coronary stents in patients with and without diabetes mellitus. Circulation. 2011;124:893-900.

 

 

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Disclosures
  • The analysis was funded in part by a research grant from Abbott Vascular.
  • Dr. Stone reports having served as a consultant for Abbott Vascular, Boston Scientific, and Medtronic.

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