Clinical trial NCT00133237: Drug-eluting-stents for Unprotected Left Main Stem Disease (ISAR-LEFT-MAIN)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Disease
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
Collaborators: name: Technical University of Munich
First posted: 2005-08-23
Enrollment: 607
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Major adverse cardiac events (composite of death, myocardial infarction and target lesion revascularization) at one year
timeFrame: one year
Secondary outcomes:
measure: Angiographic restenosis at 6-9 month follow-up angiography (based on left main area analysis)
timeFrame: 6-9 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum
city: Munich
country: Germany
facility: First Medizinische Klinik, Klinikum rechts der Isar
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Albert Schömig, MD
role: STUDY_CHAIR
affiliation: Deutsches Herzzentrum Muenchen
name: Adnan Kastrati, MD
role: PRINCIPAL_INVESTIGATOR
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citation: Mehilli J, Kastrati A, Byrne RA, Bruskina O, Iijima R, Schulz S, Pache J, Seyfarth M, Massberg S, Laugwitz KL, Dirschinger J, Schomig A; LEFT-MAIN Intracoronary Stenting and Angiographic Results: Drug-Eluting Stents for Unprotected Coronary Left Main Lesions Study Investigators. Paclitaxel- versus sirolimus-eluting stents for unprotected left main coronary artery disease. J Am Coll Cardiol. 2009 May 12;53(19):1760-8. doi: 10.1016/j.jacc.2009.01.035.
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