Comparison of Zotarolimus-Eluting Stents and Sirolimus-Eluting Stents in Patients With Coronary Artery Disease - SORT-OUT III — Presented at TCT 2008

Oct 16, 2008
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Date Presented:
01/01/2008
Date Updated:
10/16/2008
Original Posted Date:
10/16/2008
References

Description:

Zotarolimus-eluting stents (ZES) are newer drug-eluting stents that have recently become available. The SORT-OUT III study sought to compare the relative safety and efficacy of ZES with sirolimus-eluting stents (SES).

Hypothesis:

ZES would be similar in efficacy and safety to SES.

Study Design

Study Design:

Patients Enrolled: 2,333
Mean Follow Up: 9 months
Mean Patient Age: 64.3 years
Female: 26
Mean Ejection Fraction: 51%

Patient Populations:

Patients undergoing PCI for any indication

Primary Endpoints:

Safety:
  • All-cause mortality
  • Cardiac mortality
  • MI
  • Definite stent thrombosis

Efficacy:
  • Clinically driven target lesion revascularization
  • Clinically significant re-stenosis (ISR)

Drug/Procedures Used:

Percutaneous coronary intervention (PCI) with ZES or SES in 1:1 fashion

Concomitant Medications:

Dual antiplatelet therapy for 12 months; lipid-lowering therapy (70%), glycoprotein IIb/IIIa inhibitors (17%)

Principal Findings:

A total of 2,333 patients were randomized, 1,162 to ZES and 1,171 to SES. Baseline characteristics were fairly similar between the two groups, except prior PCI, which was more frequent in the ZES group. About 14% of the patients had diabetes. About one-half of the patients (52%) underwent PCI for stable angina, 38% for unstable coronary syndromes, and 7% for ST-elevation myocardial infarction (STEMI). The mean number of stents per patient was 1.7, with a total stent length of 19.8 mm.

There was no difference between ZES and SES in the incidence of all-cause mortality at 9 months (hazard ratio [HR] 1.45, 95% confidence interval [CI] 0.75-2.79, p = 0.27). However, MI was significantly higher in the ZES arm compared with the SES arm (HR 3.47, 95% CI 1.14-10.5, p = 0.03). Similarly, definite stent thrombosis was significantly higher in the ZES arm compared with the SES arm (1.2% vs. 0.2%, HR 4.62, 95% CI 1.33-16.1, p = 0.02). The need for target lesion revascularization was also significantly higher with ZES compared with SES (HR 4.19, 95% CI 2.10-8.35, p < 0.0001); clinically significant restenosis was also noted more frequently with ZES (HR 6.59, 95% CI 2.57-16.9, p < 0.0001).

Interpretation:

The results of the SORT-OUT III trial indicate that the ZES are associated with a higher incidence of MI, target lesion revascularization, clinically significant restenosis, as well as definite stent thrombosis at 9 months, compared with SES. Both groups were on dual antiplatelet therapy for at least 12 months. In this trial, the investigators tried to include as diverse a population as possible, with no major exclusions, thus mirroring “real-world” practice as best as possible.

The results of this trial are somewhat similar to the ENDEAVOR II and III trials, which noted a higher incidence of late lumen loss, with a trend toward higher target lesion revascularization with ZES compared with PES. The current findings merit further investigation, and final publication of these data, as well as further studies validating these findings, are necessary.

One limitation of this trial is that although they prospectively followed patients, outcomes data were obtained from national registries, rather than direct patient contact. Thus, although it is unlikely that there would be a differential bias with respect to outcomes, there could be an under-reporting or a lag in reporting of certain outcomes. In events with a low incidence rate, such as stent thrombosis, this might be an important consideration.

References:

Presented by Dr. Jens Flensted Lassen at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2008), Washington, DC, October 2008.


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