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Updated: May 7, 2026
A Murine Model of Stent Implantation in the Carotid Artery for the Study of Restenosis
Published on: May 14, 2013
Reduced stent strategy versus conventional percutaneous coronary revascularization in patients presenting with STEMI:
Jorge Sanz-Sánchez1, Sandra Santos Martínez2, Eva Rumiz González3
1Servicio de Cardiología, Hospital Universitari i Politècnic La Fe, Valencia, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Instituto de Salud Carlos III, Madrid, Spain.
Insights
This study compares drug-coated balloons (DCB) to drug-eluting stents (DES) for ST-segment elevation myocardial infarction (STEMI) patients. It investigates if DCB offers a comparable or superior alternative to DES in reducing target lesion failure.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- Drug-eluting stents (DES) are standard for ST-segment elevation myocardial infarction (STEMI) but can lead to target lesion failure.
- Complications include stent underexpansion, malapposition, hypersensitivity, fracture, and neoatherosclerosis.
- Drug-coated balloons (DCB) offer a "leave nothing behind" strategy as a potential alternative.
Purpose of the Study:
- To compare the clinical outcomes of a reduced stent strategy using DCB versus traditional DES-PCI in STEMI patients.
- To evaluate the noninferiority of DCB compared to DES in preventing target lesion failure.
Main Methods:
- A prospective, pragmatic, multicenter, noninferiority, randomized clinical trial (COPERNICAN trial).
- 1,272 STEMI patients randomized to paclitaxel-DCB or sirolimus-DES for all lesions.
- Primary endpoint: target-lesion failure (cardiac death, target-vessel MI, or ischemia-driven revascularization) at 12 months.
Main Results:
- The primary endpoint of target-lesion failure will be assessed at 12-month follow-up.
- Clinical events will be adjudicated by an independent, masked committee.
- Extended follow-up planned at 3, 5, and 10 years.
Conclusions:
- The COPERNICAN trial is the first randomized study to directly compare DCB and DES clinical outcomes in STEMI patients.
- This research will provide crucial data on the efficacy and safety of DCB as an alternative to DES in this high-risk population.
Introduction And Objectives:
Primary percutaneous coronary intervention (PCI) with drug-eluting stent implantation (DES) is the standard of treatment in patients presenting with ST-segment elevation myocardial infarction (STEMI). However, target lesion failure can occur due to stent underexpansion, malapposition, hypersensitivity, fracture, and neoatherosclerosis. Drug-coated balloons (DCB) represent a potential alternative supported by the concept of "leaving nothing behind." The aim is to compare a reduced stent strategy based on DCB- with DES-PCI in patients presenting with STEMI.
Methods:
Prospective, pragmatic, multicenter, noninferiority, randomized clinical trial.
Results:
A total of 1 272 patients presenting with STEMI will be randomized to any paclitaxel-DCB vs any sirolimus-DES (both with CE approval) for all culprit and nonculprit lesions during PCI. The primary endpoint will be target-lesion failure: cardiac death, target-vessel myocardial infarction, or ischemia-driven target lesion revascularization at 12-month follow-up. An independent clinical events committee masked to treatment allocation will adjudicate all suspected events. Clinical follow-up will be performed after 1 month (30 days±5 days) and 1 year (365 days±30 days). An extended follow-up at 3, 5, and 10 years is planned.
Conclusions:
The COPERNICAN trial will be the first randomized study comparing clinical outcomes of DCB vs DES in STEMI patients.
Clinicaltrials:
gov: NCT06353594.
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