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SES Show Advantage Over ZES, PES for Diabetic Patients

By Yael L. Maxwell

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Diabetic patients implanted with sirolimus-eluting stents (SES) report lower rates of major adverse cardiac events (MACE) than those implanted with either zotarolimus- (ZES) or paclitaxel-eluting (PES) stents, according to a substudy of the ZEST trial published in the June 2013 issue of Catheterization and Cardiovascular Interventions. ZES also show a diabetes-related interaction with regard to MACE compared with SES, but not with PES.

In the multicenter ZEST trial, 2,645 patients were randomized to PCI with ZES (Endeavor, Medtronic; Minneapolis, MN), SES (Cypher Select; Cordis, Miami Lakes, FL) or PES (Taxus Liberté; Boston Scientific, Natick, MA). Over 2 years, ZES yielded similar rates of MACE (death, MI, or ischemia-driven TVR) compared with SES and fewer events compared with PES.

For the substudy, Seung-Jung Park, MD, of Asan Medical Center (Seoul, South Korea), and colleagues looked specifically at the 760 patients with diabetes who were implanted with ZES (n = 268), SES (n = 247), and PES (n = 245).

Sirolimus Comes Out Ahead

At 24-month follow-up, overall MACE was similar in diabetic and nondiabetic patients (12.3% vs. 12.2%; P = 0.710). However, mortality was higher in diabetic compared with nondiabetic patients (2.4% vs. 0.8%; P = 0.001). In addition, while there was no difference in TVR (5.5% vs. 6.1%; P = 0.717), there was a trend toward more stent thrombosis in diabetic patients (1.1% vs. 0.4%; P = 0.058). The pattern of clinical outcomes between diabetic and nondiabetic patients did not differ for any stent group.

Among diabetic patients, ZES and PES yielded similar 2-year rates of MACE (P = 0.584), but ZES showed a trend toward higher rates compared with SES (P = 0.052). The rates of death or MI were similar among the groups, but rates of ischemia-driven TLR and TVR were lower with SES than ZES or PES (table 1).

Table 1. Clinical Outcomes at 2 Years: Diabetic Patients

ZES
(n = 268)

SES
(n = 247)

PES
(n = 245)

P Value for Trend

Death

2.6%

1.2%

3.3%

0.178

MI

6.3%

5.7%

7.8%

0.608

Death or MI

8.2%

6.9%

9.6%

0.573

TLR

6.8%

1.3%

6.6%

0.018

TVR

7.2%

1.7%

7.4%

0.018

Definite or Probable Stent Thrombosis

1.5%

–

1.9%

0.138

MACE

13.8%

7.7%

15.3%

0.047

By contrast, among nondiabetic patients, the 2-year rate of MACE was similar in the ZES and SES groups (P = 0.724) but was lower with ZES compared with PES (P = 0.007). The rate of death or MI was similar among the 3 groups, while TLR and TVR were highest with PES (table 2).

Table 2. Clinical Outcomes at 2-Years: Nondiabetic Patients

ZES
(n = 615)

SES
(n = 631)

PES
(n = 639)

P Value for Trend

Death

0.7%

1.3%

0.6%

0.507

MI

4.9%

6.8%

6.9%

0.260

Death or MI

5.4%

7.8%

7.4%

0.220

TLR

5.1%

2.7%

8.8%

< 0.001

TVR

5.6%

3.7%

9.1%

0.001

Definite or Probable Stent Thrombosis

0.3%

0.3%

0.6%

0.627

MACE

10.3%

10.8%

15.3%

0.011

Looking at ZES and SES, the researchers observed a substantial interaction between diabetic status and stent types for MACE (P = 0.07 for interaction). However, this association was not apparent when comparing ZES and PES (P = 0.25 for interaction). Moreover, there were no interactions comparing ZES with either SES or PES for any secondary outcomes.

Early Optimism ‘Tempered’ for ZES

With regard to the diabetes-related treatment interaction for MACE with ZES, Dr. Park and colleagues write that it may be partially explained by differences of stent platforms, drug-delivery systems, active drugs, or elution kinetics. "The complex lesion characteristics, which are generally found in diabetic patients, might exacerbate this difference between stent types," they add.

In an accompanying editorial, Pragnesh P. Parikh, MD, and Michael S. Levy, MD, MPH, both of the Mayo Clinic (Jacksonville, FL), argue that the results combined with other recent studies "have served to temper the early optimism regarding the potential of zotarolimus-eluting stents to improve outcomes in diabetic patients."

Both SES and EES are "likely superior to the Endeavor generation of zotarolimus-eluting stents in diabetic patients," they continue. "Among the newer generation stents, everolimus-eluting stents may be the best available option. However, data continue to evolve in the Resolute generation of zotarolimus-eluting stents."

Drs. Parikh and Levy conclude that future study is needed to "evaluate the complex interaction of diabetes with drug-eluting stents and develop future stents targeted to improve outcomes in this high-risk population."

　

Sources:
1. Jang S-J, Park D-W, Kim W-J, et al. Differential long-term outcomes of zotarolimus-eluting stents compared with sirolimus-eluting and paclitaxel-eluting stents in diabetic and nondiabetic patients: Two-year subgroup analysis of the ZEST randomized trial. Cath Cardiovasc Interv. 2013;81:1106-1114.

2. Parikh PP, Levy MS. Drug-eluting stents and diabetes: A generation gap [editorial]? Cath Cardiovasc Interv. 2013;81:1115-1116.

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Disclosures
  • Drs. Park, Parikh, and Levy report no relevant conflicts of interest.

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