Sirolimus-Eluting vs. Paclitaxel-Eluting Stents for Coronary Revascularization-Late - SIRTAX-LATE

Description:

An earlier network meta-analysis demonstrated the superiority of sirolimus-eluting stents (SES) over paclitaxel-eluting stents (PES) over an intermediate duration of follow-up. The SIRTAX-LATE trial sought to compare the safety and efficacy of SES vs. PES over 5 years of follow-up, and SIRTAX VERY LATE trial over 10 years of follow-up.

Contribution to the Literature: The SIRTAX-LATE trial showed that SES were superior for MACE at 1 year compared with PES, but not out to 10 years (in SIRTAX VERY LATE).

Study Design

Patients Enrolled: 1,012
Mean Follow-Up: 5 years, 10 years
Mean Patient Age: 62 years
Female: 23%
Mean Ejection Fraction: 57%

Patient Populations:

  • Symptomatic coronary artery disease (stable angina, silent ischemia, or acute coronary syndrome)
  • Presence of at least one lesion covered with one or multiple stents of ≥50% stenosis
  • Anatomy suitable for coronary stenting

Primary Endpoints:

  • Major adverse cardiac events (MACE), including cardiovascular death, myocardial infarction (MI), and clinically indicated target lesion revascularization

Secondary Endpoints:

  • Death, cardiovascular death, MI, target lesion revascularization, target vessel revascularization
  • Definite Academic Research Consortium (ARC) stent thrombosis
  • In-stent % restenosis

Drug/Procedures Used:

Patients were randomized to receive either SES or PES in a 1:1 fashion.

Concomitant Medications:

Aspirin (≥100 mg) and clopidogrel (300 mg loading dose and 75 mg/day); unfractionated heparin during the procedure

Principal Findings:

A total of 1,012 patients were enrolled, 503 to SES and 509 to PES. Baseline characteristics were fairly similar between the two groups. Presenting syndrome was stable angina in 49% of patients and acute coronary syndromes in 51%, with 22% ST-segment elevation MI. Device success occurred in 99% of patients. The mean number of lesions per patient was 1.4.

Although SES was superior to PES in the reduction of the primary endpoint of MACE at 1 year (8.3% vs. 13.8%, hazard ratio [HR] 0.59, 95% confidence interval [CI] 0.40-0.86, p < 0.01), there was no difference noted at 5 years of follow-up (21.3% vs. 24.2%, HR 0.85, 95% CI 0.65-1.1, p = 0.21). A landmark analysis demonstrated similar results (HR 1.18, 95% CI 0.84-0.65, p = 0.35). Similarly, there was no difference in the incidence of death or MI (16.9% vs. 14.9%, p = 0.46), or TLR (14.9% vs. 17.9%, p = 0.16) at 5 years. Similarly, although in-stent late lumen loss was lower with SES as compared with PES at 1 year (0.12 vs. 0.30 mm, p < 0.001), this was not noted at 5-year follow-up (0.25 vs. 0.37 mm, p = 0.21).

10-year follow-up: Follow-up was available for 88.4% of patients. Ischemia-driven target lesion revascularization (ID-TLR) was 8.1% at 1 year, 14.6% at 5 years, and 17.7% at 10 years. Beyond 1 year, the annual risk of ID-TLR was significantly higher for the period between 1 and 5 years (1.8%/year, 95% CI 1.3-2.2%/year) as compared with the period between 5 and 10 years [0.7%/year, 95% CI 0.4-1.0%/year; HR 0.36, 95% CI 0.21-0.62, p < 0.001]). The cumulative incidences of definite stent thrombosis were 1.9% at 1 year, 4.5% at 5 years, and 5.6% at 10 years. The annual risk of stent thrombosis beyond 1 year was significantly higher for the period between 1 and 5 years (0.67%/year, 95% CI 0.41-0.93%/year) as compared with the period between 5 and 10 years (0.23%/year, 95% CI 0.069-0.38%/year; HR 0.31, 95% CI 0.13- 0.75, p = 0.01). The cumulative incidence of cardiac death amounted to 5.8% at 5 years and 15.4% at 10 years. Of 135 patients who suffered from cardiac death throughout 10 years, only 14.1% had undergone ID-TLR prior to death, whereas the remainder (85.9%) did not. All clinical endpoints, including MACE and stent thrombosis, were similar between the PES and SES arms at 10 years.

Interpretation:

The results of this trial indicate that although earlier studies demonstrated superior outcomes with SES compared with PES over an intermediate period of follow-up, this difference was no longer noted at 5 or 10 years of follow-up. Differences in stent thrombosis were not significant between the two stents either. Similar long-term follow-up of second-generation DES is also necessary.

References:

Yamaji K, Räber L, Zanchin T, et al. Ten-year clinical outcomes of first-generation drug-eluting stents: the Sirolimus-Eluting vs. Paclitaxel-Eluting Stents for Coronary Revascularization (SIRTAX) VERY LATE trial. Eur Heart J 2016;Aug 30:[Epub ahead of print].

Presented by Dr. Lorez Raber at the European Society of Cardiology Congress, Rome, Italy, August 30, 2016.

Räber L, Wohlwend L, Wigger M, et al. Five-year clinical and angiographic outcomes of a randomized comparison of sirolimus-eluting and paclitaxel-eluting stents: results of the Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization LATE trial. Circulation. 2011 Jun 21;123(24):2819-28.

Presented by Dr. Lorenz Raber at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2009), San Francisco, CA, September 23, 2009.


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