NCT02579031

A Comparison of an Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent With a Durable Polymer Everolimus-Eluting Stent for Patients With Acute ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,300 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

PCI is considered as the reperfusion strategy of choice for patients with acute STEMI. Data from RCTs and meta-analyses demonstrate a consistent and strong signal towards a significant reduction in MACE among patients with STEMI undergoing primary PCI with newer generation stents with enhanced biocompatibility. The present trial aims at filling the current gap of evidence by providing randomized data to establish the superior clinical outcome with an ultrathin strut third-generation DES with biodegradable polymer designed to improve vascular healing in patients with STEMI undergoing primary PCI, compared to the current state-of-the art second-generation DES with permanent polymer.

Detailed description

Background Primary percutaneous coronary intervention (PCI) is considered nowadays as the reperfusion strategy of choice for patients with acute ST-segment elevation myocardial infarction (STEMI, owing to a lower risk of myocardial re-infarction and improved short- and long-term survival compared to fibrinolysis. However, STEMI is still associated with poorer clinical outcomes after PCI, compared to stable CAD, with higher rates of stent thrombosis and an increased risk of myocardial re-infarction persisting throughout long-term follow-up. recent data from randomized controlled trials and meta-analyses demonstrate a consistent and strong signal towards a significant reduction in major adverse cardiac events among patients with STEMI undergoing primary PCI with third-generation DESs, compared with both first-generation and second-generation DESs with durable polymer. Importantly, this signal suggesting superiority of third-generation DESs in patients with STEMI has never been demonstrated with second-generation DESs. Third-generation DESs with enhanced biocompatibility may therefore have a particular clinical benefit in high-risk subgroups of patients with delayed vascular healing but these data warrants confirmation in appropriately designed randomized controlled trials. Objective The purpose of the study is to compare the safety and efficacy of a novel biodegradable-polymer sirolimus-eluting stent (Orsiro®) with a durable-polymer everolimus-eluting stent (Xience Xpedition or Xience Alpine®) in a superiority trial among patients presenting with acute STEMI and undergoing primary PCI. Methods Eligible patients with acute STEMI presenting within 24 hours of symptom onset will undergo primary PCI. At PCI, the randomly allocated stent has to be implanted in the culprit lesion of the target vessel. Patients will be followed-up with a hospital visit at 12 months. Patients will be followed-up for clinical endpoints by telephone at 30 days and 2 years.

Conditions

• Coronary Artery Disease
• Acute Coronary Syndrome

Interventions

Type	Name	Description
DEVICE	Orsiro	Novel biodegradable-polymer sirolimus-eluting stent used during primary percutaneous coronary intervention
DEVICE	Xience	Durable-polymer everolimus-eluting stent used during primary percutaneous coronary intervention

Timeline

• Start date: 2016-04-01
• Primary completion: 2019-04-01
• Completion: 2020-05-01
• First posted: 2015-10-19
• Last updated: 2020-09-02

Locations

10 sites across 1 country: Switzerland