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).
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).
['Smits|Pieter C|PC|', 'Vlachojannis|Georgios J|GJ|', 'McFadden|Eugene Patrick|EP|', 'Royaards|Kees-Jan|KJ|', 'Wassing|Jochem|J|', 'Joesoef|Kaiyum Sheik|KS|', 'van Mieghem|Carlos|C|', 'van de Ent|Martin|M|']
D002317:Cardiovascular Agents D003324:Coronary Artery Disease D054855:Drug-Eluting Stents D000068338:Everolimus D005260:Female D006801:Humans D053208:Kaplan-Meier Estimate D008297:Male D008670:Metals D008875:Middle Aged D009203:Myocardial Infarction D009426:Netherlands D017239:Paclitaxel D062645:Percutaneous Coronary Intervention D011446:Prospective Studies D011474:Prosthesis Design D012307:Risk Factors D016037:Single-Blind Method D013927:Thrombosis D013997:Time Factors D016896:Treatment Outcome
paclitaxel-eluting stent everolimus-eluting stent long-term follow-up coronary artery disease drug-eluting stent randomized trial