Drug-eluting-stents for Unprotected Left Main Stem Disease (ISAR-LEFT-MAIN)
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|ClinicalTrials.gov Identifier: NCT00133237|
Recruitment Status : Completed
First Posted : August 23, 2005
Last Update Posted : March 15, 2010
|Condition or disease||Intervention/treatment||Phase|
|Coronary Disease||Device: Sirolimus-eluting stent Device: Paclitaxel-eluting stent||Phase 4|
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.
Sirolimus-eluting stents compared with paclitaxel-eluting stent for treatment of lesions allocated at left main trunk.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||607 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||July 2005|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
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
- Major adverse cardiac events (composite of death, myocardial infarction and target lesion revascularization) at one year [ Time Frame: one year ]
- Angiographic restenosis at 6-9 month follow-up angiography (based on left main area analysis) [ Time Frame: 6-9 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00133237
|Munich, Germany, 80636|
|First Medizinische Klinik, Klinikum rechts der Isar|
|Munich, Germany, 81675|
|Study Chair:||Albert Schömig, MD||Deutsches Herzzentrum Muenchen|
|Principal Investigator:||Adnan Kastrati, MD||Deutsches Herzzentrum Muenchen|