Comparison of Paclitaxel- and Sirolimus-Eluting Stents in Everyday Clinical Practice - SORT OUT II

Apr 13, 2017
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Unrestricted research grants from Boston Scientific and Cordis.
Date Presented:
01/01/2008
Date Published:
02/14/2017
Date Updated:
04/13/2017
Original Posted Date:
01/29/2008
References

Contribution To Literature:

The SORT OUT II trial showed that there is no appreciable difference in the efficacy or safety between sirolimus-eluting stents compared with paclitaxel-eluting stents in unselected patients with obstructive coronary artery disease.

Description:

The goal of this trial was to evaluate symptom-driven clinical endpoints among unselected patients from the use of sirolimus-eluting stents, compared with paclitaxel-eluting stents.

Study Design

  • Randomized
  • Blinded

Patients Screened: 11,766
Patients Enrolled: 2,098
Mean Follow-Up: Approximately 18 months; 10 years
Mean Patient Age: 64 years
Female: 25%

Patient Populations:

Unselected patients undergoing PCI with the planned use of a drug-eluting stent

Exclusions:

Planned use of a bare-metal stent or balloon angioplasty only during PCI

Primary Endpoints:

Change in the composite endpoint of cardiac death, acute myocardial infarction, target lesion revascularization, and target vessel revascularization at 18 months

Secondary Endpoints:

Change in individual components of the composite endpoint of cardiac death, acute myocardial infarction, target lesion revascularization, and target vessel revascularization. Additional secondary endpoints were all-cause mortality and stent thrombosis.

Drug/Procedures Used:

Among 11,766 patients undergoing percutaneous coronary intervention (PCI) who were eligible for study participation, 9,668 were excluded due to selection criteria. This resulted in 2,098 randomized patients (1,065 patients received sirolimus-eluting stents and 1,033 patients received paclitaxel-eluting stents).

Principal Findings:

The index diagnosis was stable angina in 45%, non-ST-elevation acute coronary syndrome in 33%, and ST-elevation myocardial infarction in 17%. There was one vessel treated in 78% of the patients, two vessels treated in 18%, and three vessels treated in 3%. Type C lesions were treated in 61%.

The primary composite outcome occurred in 10% of the sirolimus group and 11.6% of the paclitaxel group (p = 0.21). There was no difference in cardiac death (1.7% vs. 1.5%, p = 0.80), acute myocardial infarction (4.2% vs. 5.1%, p = 0.32), target lesion revascularization (4.5% vs. 5.9%, p = 0.14), target vessel revascularization (6.6% vs. 7.8%, p = 0.25), or stent thrombosis (2.6% vs. 2.8%, p = 0.70) for sirolimus compared with paclitaxel stents, respectively.

10 year outcomes:

  • Major adverse cardiac events: 32.5% of the sirolimus group vs. 33.1% of the paclitaxel group (p = 0.6)
  • All-cause mortality: 27.4% of the sirolimus group vs. 26.3% of the paclitaxel group
  • Definite stent thrombosis: 5.3% of the sirolimus group vs. 6.0% of the paclitaxel group (p = 0.07)
  • Probable stent thrombosis: 2.1% of the sirolimus group vs. 3.3% of the paclitaxel group

Interpretation:

Among unselected patients with obstructive coronary artery disease, including acute coronary syndromes and type C lesions, there is no appreciable difference in the efficacy or safety between sirolimus-eluting stents compared with paclitaxel-eluting stents. This finding is important since sirolimus-eluting stents have been associated with less late lumen loss and target lesion revascularization compared with paclitaxel-eluting stents. Moreover, comparison between these two stents has largely been conducted among select populations.

In addition to the broad patient population studied, one of the strengths of the study is that the outcomes were clinically driven and not a result of protocol-mandated angiography.

The cumulative incidence of definite and probable stent thrombosis was somewhat generous and persisted during 10-year follow-up (~7.4%), although there was no bare-metal stent group for comparison. Another limitation of this trial was lack of power to detect a clinically meaningful difference because the event rates were lower than anticipated. There were also relatively few diabetics.

References:

Galløe AM, Kelbæk H, Thuesen L, et al., on behalf of the SORT OUT II Investigators. 10-year clinical outcome after randomization to treatment by sirolimus- or paclitaxel-eluting coronary stents. J Am Coll Cardiol 2017;69:616-24.

First presented by Dr. Anders M. Galløe at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2006), Washington, DC, October 2006.

Galløe AM, Thuesen L, Kelbaek H, et al. Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial. JAMA 2008;299:409-16.

Keywords: Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction, Angina, Stable, Drug-Eluting Stents, Sirolimus, Percutaneous Coronary Intervention, Stents, Paclitaxel, Patient Selection, Thrombosis, Diabetes Mellitus


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