A prospective multicentre observational study on the management of unprotected left main coronary artery disease: Rationale and design of the Registro Italiano sul Trattamento del tronco comune non protetto study

Imad Sheiban, Dario Sillano, Giuseppe Gl Biondi-Zoccai, Stefano De Servi, Corrado Tamburino, Antonio Marzocchi, Gian Paolo Trevi, Claudio Moretti

Research output: Contribution to journalArticle

Abstract

Background: The optimal approach for a significant unprotected left main coronary stenosis is debated in light of the recent progresses of percutaneous coronary intervention. However, bypass surgery is still considered the first choice treatment. Randomized trials comparing percutaneous intervention and bypass grafting are ongoing, yet patient selection will limit their applicability. We designed a prospective multicentre registry, which will include patients with unprotected left main disease independent of the subsequent medical, interventional or surgical treatment. OBJECTIVE: The aim of this study is to evaluate prospectively the prevalence, treatment, and prognosis of patients with unprotected left main stenosis. STUDY DESIGN: More than 30 Italian care centres will participate. Patients with unprotected left main stenosis will be enrolled, excluding those with only mild atherosclerotic irregularities or patent grafts. The primary endpoint will be the 12-month occurrence of major adverse cardiac and cerebral events (MACCE, i.e. the composite of death, non-fatal myocardial infarction, stroke, or coronary revascularization by percutaneous intervention or bypass surgery). Secondary endpoints will be the occurrence of individual components of the primary endpoint at 1, 6, 24, and 60 months, the rate of major adverse cardiac and cerebral events without stroke, functional class, and quality of life. Analyses will be stratified according to lesion severity, as well as other patient, lesion, and procedural characteristics. EXPECTED RESULTS AND IMPLICATIONS: This multicentre prospective registry of patients with unprotected left main coronary stenosis treated medically, percutaneously or surgically will provide important and updated data on the prevalence, therapeutic choices, and prognosis of this important patient population.

Original languageEnglish
Pages (from-to)826-830
Number of pages5
JournalJournal of Cardiovascular Medicine
Volume9
Issue number8
DOIs
Publication statusPublished - Aug 2008

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Multicenter Studies
Observational Studies
Coronary Artery Disease
Coronary Stenosis
Percutaneous Coronary Intervention
Registries
Pathologic Constriction
Stroke
Therapeutics
Patient Selection
Myocardial Infarction
Quality of Life
Transplants
Population

Keywords

  • Coronary artery bypass graft
  • Coronary artery disease
  • Percutaneous coronary intervention
  • Stent
  • Unprotected left main coronary stenosis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

A prospective multicentre observational study on the management of unprotected left main coronary artery disease : Rationale and design of the Registro Italiano sul Trattamento del tronco comune non protetto study. / Sheiban, Imad; Sillano, Dario; Biondi-Zoccai, Giuseppe Gl; De Servi, Stefano; Tamburino, Corrado; Marzocchi, Antonio; Trevi, Gian Paolo; Moretti, Claudio.

In: Journal of Cardiovascular Medicine, Vol. 9, No. 8, 08.2008, p. 826-830.

Research output: Contribution to journalArticle

Sheiban, Imad ; Sillano, Dario ; Biondi-Zoccai, Giuseppe Gl ; De Servi, Stefano ; Tamburino, Corrado ; Marzocchi, Antonio ; Trevi, Gian Paolo ; Moretti, Claudio. / A prospective multicentre observational study on the management of unprotected left main coronary artery disease : Rationale and design of the Registro Italiano sul Trattamento del tronco comune non protetto study. In: Journal of Cardiovascular Medicine. 2008 ; Vol. 9, No. 8. pp. 826-830.
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KW - Coronary artery bypass graft

KW - Coronary artery disease

KW - Percutaneous coronary intervention

KW - Stent

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