Abstract
BackgroundIn the setting of primary percutaneous coronary intervention, patients with a chronic total occlusion in a non-infarct related artery were recently identified as a high-risk subgroup. It is unclear whether ST-elevation myocardial infarction patients with a chronic total occlusion in a non-infarct related artery should undergo additional percutaneous coronary intervention of the chronic total occlusion on top of optimal medical therapy shortly after primary percutaneous coronary intervention. Possible beneficial effects include reduction in adverse left ventricular remodeling and preservation of global left ventricular function and improved clinical outcome during future coronary events.Methods/DesignThe Evaluating Xience V and left ventricular function in Percutaneous coronary intervention on occLusiOns afteR ST-Elevation myocardial infarction (EXPLORE) trial is a randomized, prospective, multicenter, two-arm trial with blinded evaluation of endpoints. Three hundred patients after primary percutaneous coronary intervention for ST-elevation myocardial infarction with a chronic total occlusion in a non-infarct related artery are randomized to either elective percutaneous coronary intervention of the chronic total occlusion within seven days or standard medical treatment. When assigned to the invasive arm, an everolimus-eluting coronary stent is used. Primary endpoints are left ventricular ejection fraction and left ventricular end-diastolic volume assessed by cardiac Magnetic Resonance Imaging at four months. Clinical follow-up will continue until five years.DiscussionThe ongoing EXPLORE trial is the first randomized clinical trial powered to investigate whether recanalization of a chronic total occlusion in a non-infarct related artery after primary percutaneous coronary intervention for ST-elevation myocardial infarction results in a better preserved residual left ventricular ejection fraction, reduced end-diastolic volume and enhanced clinical outcome.Trial registrationtrialregister.nl NTR1108.
Highlights
In the setting of primary percutaneous coronary intervention, patients with a chronic total occlusion in a non-infarct related artery were recently identified as a high-risk subgroup
Prognosis after primary percutaneous coronary intervention (PCI) After primary PCI for acute ST-elevation myocardial infarction (STEMI), patients with multivessel disease (MVD) have a worse clinical outcome when compared to patients with single vessel disease (SVD).[1,2,6,17]
Previous randomized studies investigating multivessel PCI during the primary procedure or shortly thereafter have been hampered by small patient numbers and have failed to show clinical benefit of additional revascularization after primary PCI. [18,19] a number of observational studies investigating the value of additional revascularization after primary PCI have reported inconclusive results. [3,4,5,20,21,22]
Summary
Prognosis after primary PCI After primary PCI for acute STEMI, patients with MVD have a worse clinical outcome when compared to patients with SVD.[1,2,6,17] Previous randomized studies investigating multivessel PCI during the primary procedure or shortly thereafter have been hampered by small patient numbers and have failed to show clinical benefit of additional revascularization after primary PCI. [18,19] a number of observational studies investigating the value of additional revascularization after primary PCI have reported inconclusive results. [3,4,5,20,21,22]. [9] a CTO in a non-IRA was associated with reduced LVEF during the index hospitalization and a further reduction in LVEF within the first year thereafter.[6] rather than a significant diseased concomitant coronary artery, a CTO in a non-IRA is a target for additional revascularization after primary PCI These findings drive the rationale behind the EXPLORE trial. When compared to bare metal stents, drug eluting stents (DES) are effective in decreasing the need for repeat intervention in successfully treated CTO patients.[27] there have been concerns about long-term delay of arterial healing as a consequence of both Sirolimus eluting stent (SES) and Paclitaxel eluting stent (PES) placement and the associated risk of late stent thrombosis Both preclinical and clinical data for a second-generation DES, the EES, are encouraging in terms of arterial healing and low restenosis rates. The Explore trial will determine whether recanalization of a CTO within one week after primary PCI for STEMI results in a better preserved residual left ventricular ejection fraction and reduced end-diastolic volume
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