COPERNICAN TRIAL

ST-segment elevation myocardial infarction (STEMI) is the leading cause of death in Europe, posing significant social and economic burdens. Despite high mortality rates, revascularization strategies for STEMI have remained unchanged for over a decade, centering on primary percutaneous coronary intervention (PCI) with drug-eluting stents (DES). 

Despite advancements in DES technologies—such as reduced short-term target lesion revascularisation, stent thrombosis, and myocardial infarction—complications persist, with a 32.4% rate of cardiac events over 10 years after the index procedure. Drug-coated balloons (DCBs), which deliver antiproliferative drugs to the vessel wall without leaving a permanent scaffold, may reduce cardiac events and preserve vessel physiology, but their role in STEMI is unknown.

The COPERNICAN trial is a pragmatic, multicenter, randomized clinical study conducted in Spain, Italy, and France aimed to evaluate the safety and efficacy of a reduced stent strategy (DCB-based) compared to conventional DES-based revascularization for STEMI. Eligible patients will be randomised 1:1 to:

1. Study Group: coronary revascularisation with DCB.
2. Control Group: coronary revascularisation with DES.

The primary endpoint is target lesion failure (TLF), defined as cardiac death, myocardial infarction, or ischemia-driven revascularization. A total of 1,450 patients will be enrolled using a sequential design: 12-month non-inferiority followed by 3-year superiority testing. The trial is powered to detect non-inferiority with 1,272 patients (non-inferiority margin: 3.6%). An additional 178 patients will allow superiority testing, assuming a 3-year TLF rate of 11% with DES and 4 per cent absolute difference.

The COPERNICAN trial will be the first randomised clinical trial evaluating a change in the revascularization paradigm in patients presenting with STEMI by assessing the role of DCB-PCI.

Population: Adult | Intervention type: Interventional

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