Planned angiographic control versus clinical follow-up for patients with unprotected left main stem stenosis treated with second generation drug-eluting stents: A propensity score with matching analysis from the FAILS (failure in left main with second gen

2017 ◽  
Vol 92 (4) ◽  
pp. E271-E277 ◽  
Author(s):  
Fabrizio D'Ascenzo ◽  
Mario Iannaccone ◽  
Marco Pavani ◽  
Hiroyoshi Kawamoto ◽  
Javier Escaned ◽  
...  
Keyword(s):  
Propensity Score ◽  
Second Generation ◽  
Main Stem ◽  
Drug Eluting Stents ◽  
Left Main ◽  
Left Main Stem ◽  
Control Versus ◽  
Drug Eluting

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

Simultaneous kissing drug-eluting stents to treat unprotected left main stem bifurcation disease: medium term outcome in 150 consecutive patients

2012 ◽  
Vol 8 (6) ◽  
pp. 691-700 ◽  
Author(s):  
Anjan Siotia ◽  
Allison C. Morton ◽  
Christopher J. Malkin ◽  
Tushar Raina ◽  
Julian Gunn
Keyword(s):  
Main Stem ◽  
Drug Eluting Stents ◽  
Left Main ◽  
Medium Term ◽  
Term Outcome ◽  
Left Main Stem ◽  
Drug Eluting

scholarly journals Drug-Eluting Balloons versus Second-Generation Drug-Eluting Stents for Treating In-Stent Restenosis in Coronary Heart Disease after PCI: A Meta-Analysis

2018 ◽  
Vol 2018 ◽  
pp. 1-14 ◽  
Author(s):  
Wen-Juan Xiu ◽  
Hai-Tao Yang ◽  
Ying-Ying Zheng ◽  
Yi-Tong Ma ◽  
Xiang Xie
Keyword(s):  
Observational Studies ◽  
Second Generation ◽  
Meta Analysis ◽  
Drug Eluting Stents ◽  
Randomized Controlled ◽  
Stent Restenosis ◽  
Significant Difference ◽  
Drug Eluting ◽  
In Stent Restenosis

Background. In-stent restenosis (ISR) remains a common problem following percutaneous coronary intervention (PCI). However, the best treatment strategy remains uncertain. There is some controversy over the efficacy of drug-eluting balloons (DEBs) and second-generation drug-eluting stents (DESs) for treating ISR. Methods. A meta-analysis was used to compare the efficacy of the DEB and second-generation DES in the treatment of ISR. The primary endpoint is the incidence of target lesion revascularization (TLR). The secondary endpoint is the occurrence of target vessel revascularization (TVR), myocardial infarction (MI), all-cause death (ACM), cardiac death (CD), major adverse cardiac events (MACEs), minimum luminal diameter (MLD), late luminal loss (LLL), binary restenosis (BR), and percent diameter stenosis (DS%). Results. A total of 12 studies (4 randomized controlled trials and 8 observational studies) including 2020 patients with a follow-up of 6–25 months were included in the present study. There was a significant difference in the MLD between the two groups during follow-up (P=0.007, RR = 0.23, and 95% CI: 0.06–0.4 mm). There was no significant difference in LLL, BR, or DS% and the overall incidence of MACEs between the two groups. Subgroup analysis showed no significant difference in the incidence of primary and secondary endpoints when considering RCTs or observational studies only. Conclusions. The efficacy of the DEB and second-generation DES in the treatment of ISR is comparable. However, our results need further verification through multicenter randomized controlled trials.

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.

Improved clinical outcome with biodegradable polymer drug-eluting stents compared to durable polymer drug-eluting stents for primary percutaneous coronary intervention

2020 ◽  
pp. postgradmedj-2020-138243
Author(s):  
Ratna Andriyati ◽  
Doni Firman ◽  
Yovi Kurniawati ◽  
Amir Aziz Alkatiri ◽  
Raymond Pranata ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Second Generation ◽  
Coronary Intervention ◽  
Drug Eluting Stents ◽  
Recurrent Myocardial Infarction ◽  
Repeat Revascularisation ◽  
Durable Polymer ◽  
Percutaneous Coronary ◽  
Drug Eluting

BackgroundStudies comparing the clinical outcomes of second-generation biodegradable polymer drug-eluting stents (BP-DES) and second-generation durable polymer drug-eluting stents (DP-DES) in patients with ST-segment elevation myocardial infarction (STEMI) with follow-up duration of more than 1 year are still limited.ObjectiveThis study aimed to compare the 2-year clinical outcome of BP-DES with second-generation DP-DES in patients undergoing primary percutaneous coronary intervention (PPCI).MethodsThis is a retrospective cohort study in patients with STEMI, the primary endpoint was major adverse cardiac events (MACE) defined as recurrent myocardial infarction, total repeat revascularisation and cardiac death. The secondary endpoint was stent thrombosis (ST) defined as definite, probable or possible.ResultsA total of 400 patients were analysed (197 BP-DES groups and 203 DP-DES groups). BP-DES were independently associated with lower incidence of MACE (adjusted HR 0.67, 95% CI 0.21 to 0.91, p=0.005) and ST (adjusted HR 0.62, 95% CI 0.19 to 0.73, p<0.016) within 2 years of follow-up. Subgroup analysis of MACE individual components showed that BP-DES were associated with lower cardiac deaths (HR 0.35; 95% CI 0.18 to 0.94; p<0.001) compared to DP-DES, but not recurrent myocardial infarction and total repeat revascularisation.ConclusionsBP-DES were associated with better clinical outcomes compared to second-generation DP-DES in patients with STEMI undergoing PPCI.

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