Abstract 1781: Nonprotected Left Main Stenosis: Multicenter Randomized Trial Between Total Arterial Revascularization and Interventional Treatment

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Enno Boudriot ◽  
Gerhard Schuler ◽  
Thomas Walther ◽  
Volkmar Falk ◽  
Christoph Liebetrau ◽  
...  
Keyword(s):  
Randomized Trial ◽  
De Novo ◽  
Drug Eluting Stents ◽  
Interventional Treatment ◽  
Left Main ◽  
Arterial Revascularization ◽  
Left Main Stenosis ◽  
Total Arterial Revascularization ◽  
Drug Eluting

Background: Nonprotected left main coronary stenosis is still considered an indication for bypass surgery. We conducted a multicenter prospective randomized trial to compare total arterial revascularization (CABG) with interventional treatment (PCI) in these patients. Methods and Demographics: Between 8/2003 and 5/2007 a total of 156 pts with significant stenosis of the nonprotected left main coronary artery were recruited for the study. We report the first 111 pts whith one year follow up. They were randomized to undergo CABG or PCI using drug eluting stents (Sirolimus). Additional lesions in other locations were treated concurrently. Angiographic control was performed at 12 months. Primary endpoints were death, acute myocardial infarction and re-intervention at 12 months. Out of the 111 pts 55 pts were randomized for CABG and 56 for PCI. Mean age was 65 ± 7 years, diabetes was present in 35%. There were no significant differences between both groups with respect to other baseline variables. The lesion was located at the ostium in 17%, midshaft in 11%, and distally in 72%. An average of 2.4 ± 1.1 stents were implanted, and 2.4 ± 0.6 bypass grafts were performed. Of the operated patients 70% received complete arterial revascularization. Results: Early outcome revealed a procedural success of in all 55 pts for CABG and in 53 of 56 pts for PCI , three pts assigned to PCI had to be successfully converted to CABG. Early mortality in surgery was 1.8%, no patient died early after PCI. Periprocedural NSTEMI were noted in 2 pts after PCI and in six pts after CABG, of those one pt. underwent graft revision. After 12-month follow up control angiography was performed, in 2 pts (3,5%) after CABG and in 7 pts. after PCI (13,2%) reintervention was necessary. 5 pts required target vessel revascularization (TVR). 2 pts developed a de-novo lesion. One of the PCI cohort died at 10 months. MACE rate after 12 month was comparable for CABG group with 18,1% and 17,9% for the PCI group . Conclusions: In pts with nonprotected left main stenosis both CABG and PCI using drug eluting stents can be performed with few periprocedural complications, low mortality and at 12 months mace rate and survival compare favourably, reintervention rate is higher in PCI.

scholarly journals Angiographic control versus ischaemia-driven management of patients undergoing percutaneous revascularisation of the unprotected left main coronary artery with second-generation drug-eluting stents: rationale and design of the PULSE trial

Open Heart ◽  
2020 ◽  
Vol 7 (2) ◽  
pp. e001253
Author(s):  
Ovidio De Filippo ◽  
Matteo Bianco ◽  
Matteo Tebaldi ◽  
Mario Iannaccone ◽  
Luca Gaido ◽  
...  
Keyword(s):  
Second Generation ◽  
Controlled Trial ◽  
Drug Eluting Stents ◽  
Major Adverse Cardiovascular Events ◽  
Relative Reduction ◽  
Left Main ◽  
Bleeding Events ◽  
Open Label ◽  
Drug Eluting

BackgroundThe role of planned angiographic control (PAC) over a conservative management driven by symptoms and ischaemia following percutaneous coronary intervention (PCI) of the unprotected left main (ULM) with second-generation drug-eluting stents remains controversial. PAC may timely detect intrastent restenosis, but it is still unclear if this translated into improved prognosis.Methods and analysisPULSE is a prospective, multicentre, open-label, randomised controlled trial. Consecutive patients treated with PCI on ULM will be included, and after the index revascularisation patients will be randomised to PAC strategy performed with CT coronary after 6 months versus a conservative symptoms and ischaemia-driven follow-up management. Follow-up will be for at least 18 months from randomisation. Major adverse cardiovascular events at 18 months (a composite endpoint including death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina, stent thrombosis) will be the primary efficacy outcome. Secondary outcomes will include any unplanned target lesion revascularisation (TLR) and TLR driven by PAC. Safety endpoints embrace worsening of renal failure and bleeding events. A sample size of 550 patients (275 per group) is required to have a 80% chance of detecting, as significant at the 5% level, a 7.5% relative reduction in the primary outcome.Trial registration numberNCT04144881

Long-Term (≥10 Years) Safety of Percutaneous Treatment of Unprotected Left Main Stenosis With Drug-Eluting Stents

2016 ◽  
Vol 118 (1) ◽  
pp. 32-39 ◽  
Author(s):  
Imad Sheiban ◽  
Claudio Moretti ◽  
Fabrizio D'Ascenzo ◽  
Alaide Chieffo ◽  
Salma Taha ◽  
...  
Keyword(s):  
Percutaneous Treatment ◽  
Drug Eluting Stents ◽  
Left Main ◽  
Left Main Stenosis ◽  
Drug Eluting

Abstract 3350: Long-Term Outcomes After Drug-Eluting Stenting of Bifurcation Lesions With the Simultaneous Kissing Stents (SKS) Technique

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Samin K Sharma ◽  
Madhu Prattipati ◽  
Angelica M Mares ◽  
Oana C Ivan ◽  
Vatsal Inamdar ◽  
...  
Keyword(s):  
Stent Thrombosis ◽  
De Novo ◽  
Side Branch ◽  
Left Main ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Drug Eluting ◽  
Bifurcation Lesions

Percutaneous coronary interventions (PCI) of bifurcation lesions using simultaneous kissing stents (SKS) technique have shown to have good short-term and mid-term results. Limited data are available regarding long-term outcome with this strategy. Methods: We analyzed the long-term outcome of 300 consecutive patients treated with drug-eluting stenting using SKS technique for 305 de novo bifurcation lesions. Cypher stents were used in 265 lesions and Taxus stents were used in 40 lesions, from May 2003 to September 2006 at Mount Sinai Hospital. Clinical follow-up was obtained in 98.6%. All pts were given Aspirin and Plavix 75 mg daily for one year and GP IIb/IIIa inhibitors were used in 72% of cases. Results: Overall procedural success was 99% for main vessel (MV) and 98% for side-branch (SB), with one case of intra-procedural stent thrombosis of left main bifurcation. 30-day MACE (MI, death, repeat target vascularization or stent thrombosis) occurred in 5% of cases. Long-term follow-up results at a mean of 14 ± 5 months are shown in the Table . Overall incidence of stent thrombosis was 1.7% (1.5% for Cypher vs. 2.5% for Taxus). Multivariate predictors of TVR were left main (LM) intervention (odds ratio [OR] 4.97; 95% confidence interval [CI] 2.00 to 12.37, p = 0.01) and diabetes mellitus (OR 4.21; 95% CI 1.15 to 18.56, p = 0.04) and of follow-up MACE were LM intervention (OR 3.79; 95% CI 1.76 to 8.14, p = 0.01) and acute MI (OR 3.24; 95% CI 0.95 to 15.32, p = 0.02). Conclusions: The SKS technique for bifurcation lesions using Cypher or Taxus DES is associated with long-term favorable outcomes in this complex, high-risk PCI group. Delayed stent thrombosis with dual antiplatelet therapy remains within acceptable limits. Further work is needed to lower the event rates in some specific subgroups such as LM lesions and AMI settings (perhaps by IVUS guidance and Plavix 75 mg twice a day).

First generation versus second generation drug-eluting stents for the treatment of bifurcations: 5-year follow-up of the LEADERS all-comers randomized trial

2015 ◽  
Vol 87 (7) ◽  
pp. E248-E260 ◽  
Author(s):  
Maik J. Grundeken ◽  
Joanna J. Wykrzykowska ◽  
Yuki Ishibashi ◽  
Scot Garg ◽  
Ton de Vries ◽  
...  
Keyword(s):  
Randomized Trial ◽  
First Generation ◽  
Second Generation ◽  
Drug Eluting Stents ◽  
Drug Eluting

Left Main Stenosis – Where Do We Stand?

2010 ◽  
Vol 5 (1) ◽  
pp. 10
Author(s):  
Stefan Christian Bertog ◽  
Daniel Howard Steinberg ◽  
Nina Wunderlich ◽  
Jennifer Franke ◽  
Horst Sievert ◽  
...  
Keyword(s):  
Coronary Disease ◽  
Coronary Intervention ◽  
Percutaneous Intervention ◽  
Drug Eluting Stents ◽  
Limited Data ◽  
Left Main ◽  
Left Main Disease ◽  
Left Main Stenosis ◽  
Drug Eluting

The presence of significant left main coronary disease is associated with increased mortality. Limited data examining the role of surgery in patients with a left main stenosis suggest a significant improvement in longevity. With the advent of coronary stenting, particularly the use of drug-eluting stents and improvements in percutaneous technology, left main coronary intervention has become more commonplace. However, despite important advances in the understanding of left main disease, management can be challenging. Many aspects, including the assessment of significance and the need for and choice of intervention (surgical or percutaneous revascularisation), remain unclear. This article serves to facilitate the management of patients with left main coronary disease with a focus on the assessment of lesion significance and the role of percutaneous intervention.

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