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.

Clinical Topics: Acute Coronary Syndromes, Anticoagulation Management, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Anticoagulation Management and ACS, Cardiac Surgery and SIHD, Interventions and ACS, Interventions and Coronary Artery Disease, Chronic Angina

Keywords: Acute Coronary Syndrome, Angina, Stable, Aspirin, Coronary Artery Disease, Drug-Eluting Stents, Heparin, Myocardial Infarction, Myocardial Revascularization, Paclitaxel, Sirolimus, Stents, Thrombosis, ESC Congress


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