Drug-eluting-stents for Unprotected Left Main Stem Disease (ISAR-LEFT-MAIN)

This study has been completed.
Sponsor:
Collaborator:
Technische Universität München
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00133237
First received: August 22, 2005
Last updated: March 12, 2010
Last verified: October 2008
  Purpose

The purpose of this study is to evaluate the efficacy of sirolimus- and paclitaxel-eluting stents for treatment of unprotected left main coronary artery disease.


Condition Intervention Phase
Coronary Disease
Device: Sirolimus-eluting stent
Device: Paclitaxel-eluting stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Randomized Trial of the Sirolimus-Eluting Stent and Paclitaxel-Eluting Stent for the Treatment of Unprotected Left Main Coronary Artery Disease(ISAR-LEFT-MAIN)

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Major adverse cardiac events (composite of death, myocardial infarction and target lesion revascularization) at one year [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Angiographic restenosis at 6-9 month follow-up angiography (based on left main area analysis) [ Time Frame: 6-9 months ] [ Designated as safety issue: No ]

Enrollment: 607
Study Start Date: July 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Sirolimus-eluting stent (Cypher)
Device: Sirolimus-eluting stent
cypher stent is implanted due to randomization.
Other Name: Cypher
Active Comparator: B
Paclitaxel-eluting stent (Taxus)
Device: Paclitaxel-eluting stent
taxus stent is implanted due to randomization.
Other Name: Taxus

Detailed Description:

With the advent of coronary stents and improvements in periprocedural antithrombotic regimen, the spectrum of indications of percutaneous coronary interventions has continuously expanded for patients with coronary heart disease, gaining ground in what have been traditionally considered as domains of coronary bypass surgery. Several groups reported the outcomes of patients with unprotected left main coronary artery (LMCA) disease treated with stenting. Most of them found that LMCA stenting was feasible and safe, and, in low-risk patients, it was associated with minimal periprocedural complications and low long-term morbidity and mortality. Despite these encouraging reports, a widespread use of this technique has been hampered by the still high incidence of restenosis. It is commonly accepted that coronary bypass graft surgery and stenting for unprotected LMCA disease are associated with similar rates of mortality, and that the higher incidence of restenosis and greater need for revascularization procedures after LMCA stenting remain the major contributors for the observed difference in clinical efficacy between both therapies. The recent introduction of stents eluting anti-restenotic drugs, with sirolimus and paclitaxel the most studied compounds, has opened new perspectives for the prevention of restenosis. Several randomized trials have reported excellent results in the reduction of restenosis and need for reinterventions with drug-eluting stents (DES). Although, none of these trials studied the benefit of DES for lesions located in the LMCA, their results suggested that use of these new devices may be particularly helpful for the reduction of restenosis in the group of patients with left main trunk disease. This is supported by the findings of several series of patients with unprotected LMCA disease who have been successfully treated with DES. Importantly, for patients who are unable to undergo CABG due to cardiac surgeons' refusal (poor surgical candidates) or their own unwillingness, stenting with DES remains the only revascularization alternative. Recent guidelines of PCI recommend stenting, preferentially with DES, for unprotected LMCA in the absence of other revascularization options.

Comparison:

Sirolimus-eluting stents compared with paclitaxel-eluting stent for treatment of lesions allocated at left main trunk.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥50% stenosis located in unprotected LMCA who are unable to undergo coronary artery bypass graft (CABG)
  • Pretreatment with a loading dose of 300-600 mg clopidogrel
  • Informed, written consent

Exclusion Criteria:

  • Cardiogenic shock;
  • ST-segment elevation acute myocardial infarction within 48 h from symptom onset;
  • In-stent restenosis;
  • Malignancies or other comorbid conditions with life expectancy less than one year;
  • Prior coronary artery bypass surgery with revascularization of left anterior descending (LAD) and/or left circumflex (LCx) coronary artery
  • Planned staged percutaneous coronary intervention (PCI) procedure within 30 days from index procedure or prior PCI within the last 30 days
  • Left main size >4.5mm
  • An elective surgical procedure is planned during the first six months post enrolment;
  • Known allergy to the study medications
  • Pregnancy
  • Patient's inability to fully cooperate with the study protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00133237

Locations
Germany
Deutsches Herzzentrum
Munich, Germany, 80636
First Medizinische Klinik, Klinikum rechts der Isar
Munich, Germany, 81675
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Technische Universität München
Investigators
Study Chair: Albert Schömig, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Albert Schömig, Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT00133237     History of Changes
Other Study ID Numbers: GE IDE No. S02005
Study First Received: August 22, 2005
Last Updated: March 12, 2010
Health Authority: Germany: German Institute of Medical Documentation and Information

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Paclitaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 17, 2014