A MAajor RAdiation-based PCI Study in STEMI and NSTEMI

Condition(s) studied

Investigational drug(s) / intervention(s)

Non Complex PCI: The patient cohort included individuals who had been hospitalized with a diagnosis of either STEMI or non-STEMI. The procedure involved percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES).

Complex PCI: The patient cohort included individuals who had been hospitalized with a diagnosis of either STEMI or non-STEMI. The procedure involved complex percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES).This designation is applied to angioplasty procedures that meet at least one criterion for complexity. The complex angioplasty involved patients with unprotected left coronary common trunk (UT-PCI), the use of rotablator rotary atherectomy (ARota-PCI), the angioplasty of chronic coronary occlusion (CCO-PCI), or the angioplasty of a bifurcation lesion (CBL-PCI).The highly intricate angioplasty procedure was conducted on patients who met at least two criteria indicative of complexity.

Study summary

In France and Italy, approximately 240,000 percutaneous coronary angioplasties (PCI) are performed annually, with an increasing number of complex procedures, including those involving the left coronary common trunk, a bifurcation, chronic occlusion, or requiring Rotablator Rotary Atherectomy (ARota). The medical literature lacks sufficient data regarding several key aspects of complex angioplasty. These include the epidemiological characteristics of patients undergoing such procedures, the impact of irradiation delivered and the quantity of iodine injected on these lengthy procedures, their procedural complication rate, and in-hospital mortality.

Eligibility

Primary outcome measure(s)

• Death — 30 days
  The primary end point of the study is the rate of death
• Death — 1 year
  The primary end point of the study is the rate of death
• Death — 5 years
  The primary end point of the study is the rate of death
• Myocardial Infarction — 30 days
  The primary end point of the study is the rate of myocardial infarction
• Myocardial Infarction — 1 year
  The primary end point of the study is the rate of myocardial infarction
• Myocardial Infarction — 5 years
  The primary end point of the study is the rate of myocardial infarction
• Stent Thrombosis — 30 days
  The primary end point of the study is the rate of stent thrombosis
• Stent Thrombosis — 1 year
  The primary end point of the study is the rate of stent thrombosis
• Stent Thrombosis — 5 years
  The primary end point of the study is the rate of stent thrombosis
• Acute Kidney Injury — 30 days
  The primary end point of the study is the rate of acute kidney injury
• Acute Kidney Injury — 1 years
  The primary end point of the study is the rate of acute kidney injury
• Coronary Obstruction Requiring Intervention — 30 days
  The primary end point of the study is the rate of coronary obstruction requiring intervention
• Coronary Obstruction Requiring Intervention — 1 year
  The primary end point of the study is the rate of coronary obstruction requiring intervention
• Coronary Obstruction Requiring Intervention — 5 years
  The primary end point of the study is the rate of coronary obstruction requiring intervention
• Increase in Tnl and Tnt Levels — 30 days
  The primary end point of the study is the rate in increase of Tnl and Tnt levels
• Increase in Tnl and Tnt Levels — 1 year
  The primary end point of the study is the rate in increase of Tnl and Tnt levels
• Rehospitalization — 30 days
  The primary end point of the study is the rate of rehospitalization (coronary-related or procedure-related, including heart failure)
• Rehospitalization — 1 year
  The primary end point of the study is the rate of rehospitalization (coronary-related or procedure-related, including heart failure)
• Rehospitalization — 5 years
  The primary end point of the study is the rate of rehospitalization (coronary-related or procedure-related, including heart failure)

Trial sites (1)

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