Coronary artery disease
Long-Term (Three-Year) Safety and Efficacy of Everolimus-Eluting Stents Compared to Paclitaxel-Eluting Stents (from the SPIRIT III Trial)

https://doi.org/10.1016/j.amjcard.2010.10.069Get rights and content

The safety and efficacy of the XIENCE V everolimus-eluting stent (EES) compared to the Taxus Express2 paclitaxel-eluting stent (PES) has been demonstrated through 2 years in the SPIRIT II and III randomized clinical trials, but limited longer-term data have been reported. In the SPIRIT III trial, 1,002 patients with up to 2 lesions in 2 coronary arteries were randomized 2:1 to EESs versus PESs at 65 United States sites. At completion of 3-year follow-up, treatment with EES compared to PES resulted in a significant 30% decrease in the primary clinical end point of target vessel failure (cardiac death, myocardial infarction, or ischemic-driven target vessel revascularization, 13.5% vs 19.2%, hazard ratio 0.70, 95% confidence interval 0.50 to 0.96, p = 0.03) and a 43% decrease in major adverse cardiovascular events, cardiac death, myocardial infarction, or ischemic-driven target lesion revascularization (9.1% vs 15.7%, hazard ratio 0.57, 95% confidence interval 0.39 to 0.83, p = 0.003). In a landmark analysis, major adverse cardiovascular events were decreased to a similar extent with EES compared to PES 0 through 1 year and 1 year through 3 years (hazard ratio 0.56, 95% confidence interval 0.35 to 0.90; hazard ratio 0.59, 95% confidence interval 0.31 to 1.11, respectively). In conclusion, patients treated with EES rather than PES in the SPIRIT III trial had significantly improved event-free survival at 3 years. From 1 year to 3 years hazard curves continued to diverge in favor of EES, consistent with an improving long-term safety and efficacy profile of EES compared to PES, with no evidence of late catchup.

Section snippets

Methods

The SPIRIT III trial design has been described previously.2 In brief, SPIRIT III was a multicenter prospective single-blinded randomized controlled trial that evaluated the safety and efficacy of EESs compared to PESs in patients with up to 2 de novo coronary artery lesions with a reference vessel diameter of 2.5 to 3.75 mm and lesion length ≤28 mm. In total 1,002 patients were randomized 2:1 to EES versus PES at 65 United States sites.

Patients ≥18 years of age with stable or unstable angina or

Results

From June 22, 2005 through March 15, 2006, 1,002 patients were enrolled at 65 United States sites and randomized to receive EES (n = 669) or PES (n = 332). Baseline demographics and clinical and angiographic characteristics of the 2 treatment groups have been published previously2 and were well matched in the study population (Table 1).

Three-year clinical follow-up was available in 948 patients (94.6%) including 636 with EESs and 312 with PESs. Aspirin use was high in the EES and PES arms

Discussion

The 3-year findings from the SPIRIT III trial comparing second-generation EESs to first-generation PESs demonstrate increasing safety and efficacy with EESs over time, with hazard curves diverging for TVF, MACEs, composite cardiac death or myocardial infarction, ischemia-driven TLR, and stent thrombosis. Importantly, late catchup in safety or efficacy events with extended follow-up was not apparent. Notably, rate of Academic Research Consortium definite or probable very late stent thrombosis

References (20)

There are more references available in the full text version of this article.

Cited by (37)

  • Contemporary Drug-Eluting Stent Platforms: Design, Safety, and Clinical Efficacy

    2017, Cardiology Clinics
    Citation Excerpt :

    It showed significantly lower TLR (27.2% BMS vs 14.9% Pt–Cr PES; P = .049) and similar low rates of ST between them (0.5%–1.0%).50 Newer DES platforms, however, have been found to be superior to PES platforms in multiple large clinical studies and meta-analyses, with significantly lower risks of VLST and improved event-free survival on long-term follow-up.5,51,52 In the SPIRIT III trial (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System (EECSS) in the Treatment of Subjects With de Novo Native Coronary Artery Lesions) of 1002 subjects randomized 2 to 1 to Co–Cr EES versus SS-PES, EES was found to be superior in both angiographic endpoint of in-segment late loss at 8 months, as well as composite clinical endpoint of major adverse cardiac events (MACEs) due to lower rates of MI and TLR.

  • Contemporary Drug-Eluting Stent Platforms. Design, Safety, and Clinical Efficacy

    2016, Interventional Cardiology Clinics
    Citation Excerpt :

    It showed significantly lower TLR (27.2% BMS vs 14.9% Pt–Cr PES; P = .049) and similar low rates of ST between them (0.5%–1.0%).50 Newer DES platforms, however, have been found to be superior to PES platforms in multiple large clinical studies and meta-analyses, with significantly lower risks of VLST and improved event-free survival on long-term follow-up.5,51,52 In the SPIRIT III trial (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System (EECSS) in the Treatment of Subjects With de Novo Native Coronary Artery Lesions) of 1002 subjects randomized 2 to 1 to Co–Cr EES versus SS-PES, EES was found to be superior in both angiographic endpoint of in-segment late loss at 8 months, as well as composite clinical endpoint of major adverse cardiac events (MACEs) due to lower rates of MI and TLR.

  • Final 5-Year Follow-Up of a Randomized Controlled Trial of Everolimus- and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice the COMPARE Trial (A Trial of Everolimus-Eluting Stents and Paclitaxel Stents for Coronary Revascularization in Daily Practice)

    2015, JACC: Cardiovascular Interventions
    Citation Excerpt :

    In fact, only 5 of the 23 very-late ST cases within the COMPARE study would have fulfilled the inclusion and exclusion criteria for enrollment in the SPIRIT trials. Second, in the COMPARE trial, DAPT was stopped after 1 year in 89% to 85% of the patients, whereas in the SPIRIT III trial, DAPT discontinuation after 1 year was about 28% to 29% (19). However, both the SPIRIT and COMPARE trials were underpowered to evaluate differences in ST between the stent platforms.

  • Composite outcomes in 2.25-mm drug eluting stents: A systematic review

    2015, Cardiovascular Revascularization Medicine
  • Evolving management of patients treated by drug-eluting stent: Prevention of late events

    2014, Cardiovascular Revascularization Medicine
    Citation Excerpt :

    Recent observations from the Providing Regional Observations to Study Predictors of Events in the Coronary Tree (PROSPECT) study [1] and from RESOLUTE All comers trial [2] have suggested that both of these mechanisms contribute almost equally to major adverse cardiac events (MACEs) during follow-up. It is also increasingly evident that there are temporal differences in development of adverse events following implantation of drug-eluting stents (DES) as compared with bare metal stents (BMS) [2–23]. Events related to BMS seem to cluster mainly in the first year after stent implantation, while those related to DES extend beyond this time, with very late events being recognized as an entity almost specific to DES [2,4,6–26].

View all citing articles on Scopus

This trial was sponsored and funded by Abbott Vascular, Santa Clara, California. The sponsor was involved in study design, data collection, and analysis with the principal investigator and steering committees.

View full text