Coronary artery diseaseLong-Term (Three-Year) Safety and Efficacy of Everolimus-Eluting Stents Compared to Paclitaxel-Eluting Stents (from the SPIRIT III Trial)
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)
- et al.
3-Year clinical follow-up of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with de novo coronary artery lesions: the SPIRIT II trial (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions)
JACC Cardiovasc Interv
(2009) - et al.
Quantitative angiographic methods for appropriate end-point analysis, edge-effect evaluation, and prediction of recurrent restenosis after coronary brachytherapy with gamma irradiation
J Am Coll Cardiol
(2002) - et al.
American College of Cardiology clinical expert consensus document on standards for acquisition, measurement and reporting of intravascular ultrasound studies (IVUS)A report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents
J Am Coll Cardiol
(2001) - et al.
Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy
Lancet
(2004) - et al.
Incomplete neointimal coverage of sirolimus-eluting stents: angioscopic findings
J Am Coll Cardiol
(2006) - et al.
5-year clinical outcomes after sirolimus-eluting stent implantation: Insights from a patient-level pooled analysis of 4 randomized trials comparing sirolimus-eluting stents with bare-metal stents
J Am Coll Cardiol
(2009) - et al.
Long-term safety and efficacy with paclitaxel-eluting stents: 5-year final results of the TAXUS IV clinical trial (TAXUS IV-SR: treatment of de novo coronary disease using a single paclitaxel-eluting stent)
J Am Coll Cardiol Interv
(2009) - et al.
Clinical efficacy of drug-eluting stents in diabetic patients: a meta-analysis
J Am Coll Cardiol
(2008) - et al.
Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial
Lancet
(2010) - et al.
Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: A randomized trial
JAMA
(2008)
Cited by (37)
Contemporary Drug-Eluting Stent Platforms: Design, Safety, and Clinical Efficacy
2017, Cardiology ClinicsCitation 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.
Promus Premier versus Xience V and Taxus Liberte in contemporary United States practice (REWARDS premier registry)
2017, Cardiovascular Revascularization MedicineContemporary Drug-Eluting Stent Platforms. Design, Safety, and Clinical Efficacy
2016, Interventional Cardiology ClinicsCitation 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 InterventionsCitation 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 MedicineEvolving management of patients treated by drug-eluting stent: Prevention of late events
2014, Cardiovascular Revascularization MedicineCitation 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].
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.