TY - JOUR
T1 - Final 5-Year Follow-Up of a Randomized Controlled Trial of Everolimus- and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice
T2 - The COMPARE Trial (A Trial of Everolimus-Eluting Stents and Paclitaxel Stents for Coronary Revascularization in Daily Practice)
AU - Smits, Pieter C
AU - Vlachojannis, Georgios J
AU - McFadden, Eugene Patrick
AU - Royaards, Kees-Jan
AU - Wassing, Jochem
AU - Joesoef, Kaiyum Sheik
AU - van Mieghem, Carlos
AU - van de Ent, Martin
N1 - Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
PY - 2015/8/17
Y1 - 2015/8/17
N2 - OBJECTIVES: This study sought to report the 5-year outcomes of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in an all-comers population undergoing percutaneous coronary intervention (PCI).BACKGROUND: The medium-term 1 and 2-year results of the prospective randomized COMPARE trial (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) showed superior clinical outcomes with EES compared with PES in an all-comers PCI population. Whether this benefit is sustained over longer-term follow-up is unknown. Furthermore, systematic long-term follow-up data on these metallic drug eluting stents with durable polymers are scarce.METHODS: We randomly assigned 1,800 patients undergoing PCI to EES or PES. The pre-specified composite primary endpoint was death, myocardial infarction (MI), or target vessel revascularization (TVR).RESULTS: Follow-up at 5 years was completed in 1,791 (99.5%) patients. Treatment with EES compared with PES led to a relative risk reduction of the primary endpoint by 27% (18.4% vs. 25.1%, p = 0.0005), driven by lower rates of MI (7.0% vs. 11.5%, p = 0.001) and TVR (7.4% vs. 11.4%, p = 0.003), but not with mortality (9.0% vs. 10.3%, relative risk 0.88, p = 0.36). Moreover, patients treated with EES compared with PES had lower rates of definite/probable stent thrombosis at 5 years (3.1% vs. 5.9%, p = 0.005). The hazard curves for TVR, MI, and stent thrombosis diverge over the first 3 years and, subsequently, progress in parallel.CONCLUSIONS: The early- and medium-term superiority of EES over PES measured both by safety and efficacy endpoints is sustained at 5 years in this all-comer population. (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice [COMPARE]; NCT01016041).
AB - OBJECTIVES: This study sought to report the 5-year outcomes of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in an all-comers population undergoing percutaneous coronary intervention (PCI).BACKGROUND: The medium-term 1 and 2-year results of the prospective randomized COMPARE trial (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) showed superior clinical outcomes with EES compared with PES in an all-comers PCI population. Whether this benefit is sustained over longer-term follow-up is unknown. Furthermore, systematic long-term follow-up data on these metallic drug eluting stents with durable polymers are scarce.METHODS: We randomly assigned 1,800 patients undergoing PCI to EES or PES. The pre-specified composite primary endpoint was death, myocardial infarction (MI), or target vessel revascularization (TVR).RESULTS: Follow-up at 5 years was completed in 1,791 (99.5%) patients. Treatment with EES compared with PES led to a relative risk reduction of the primary endpoint by 27% (18.4% vs. 25.1%, p = 0.0005), driven by lower rates of MI (7.0% vs. 11.5%, p = 0.001) and TVR (7.4% vs. 11.4%, p = 0.003), but not with mortality (9.0% vs. 10.3%, relative risk 0.88, p = 0.36). Moreover, patients treated with EES compared with PES had lower rates of definite/probable stent thrombosis at 5 years (3.1% vs. 5.9%, p = 0.005). The hazard curves for TVR, MI, and stent thrombosis diverge over the first 3 years and, subsequently, progress in parallel.CONCLUSIONS: The early- and medium-term superiority of EES over PES measured both by safety and efficacy endpoints is sustained at 5 years in this all-comer population. (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice [COMPARE]; NCT01016041).
KW - Cardiovascular Agents/administration & dosage
KW - Coronary Artery Disease/diagnosis
KW - Drug-Eluting Stents
KW - Everolimus/administration & dosage
KW - Female
KW - Humans
KW - Kaplan-Meier Estimate
KW - Male
KW - Metals
KW - Middle Aged
KW - Myocardial Infarction/etiology
KW - Netherlands
KW - Paclitaxel/administration & dosage
KW - Percutaneous Coronary Intervention/adverse effects
KW - Prospective Studies
KW - Prosthesis Design
KW - Risk Factors
KW - Single-Blind Method
KW - Thrombosis/etiology
KW - Time Factors
KW - Treatment Outcome
U2 - 10.1016/j.jcin.2015.03.028
DO - 10.1016/j.jcin.2015.03.028
M3 - Article
C2 - 26210806
SN - 1936-8798
VL - 8
SP - 1157
EP - 1165
JO - JACC. Cardiovascular Interventions
JF - JACC. Cardiovascular Interventions
IS - 9
ER -