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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
by
Cerrato, Enrico
, Cortese, Giancarlo
, Vaudano, Paolo
, Marchisio, Filippo
, Depaoli, Alessandro
, Campo, Gianluca
, Tebaldi, Matteo
, Bianco, Matteo
, Iannaccone, Mario
, Santarelli, Andrea
, Angelini, Filippo
, Franchin, Luca
, Veltri, Andrea
, Guarnaccia, Carla
, Zaccaro, Lorenzo
, De Ferrari, Gaetano Maria
, Fonio, Paolo
, Giammaria, Massimo
, Tore, Davide
, Gaido, Luca
, D'Ascenzo, Fabrizio
, Guiducci, Vincenzo
, Gagnor, Andrea
, Varbella, Ferdinando
, Quadri, Giorgio
, Garbo, Roberto
, De Filippo, Ovidio
, Solitro, Federica
, Boccuzzi, Giacomo
in
Acute coronary syndromes
/ Adolescent
/ Adult
/ Aged
/ Aged, 80 and over
/ Angioplasty
/ Cardiology
/ Cardiovascular disease
/ Computed Tomography Angiography
/ Coronary Angiography
/ Coronary Artery Disease
/ Coronary Artery Disease - diagnostic imaging
/ Coronary Artery Disease - mortality
/ Coronary Artery Disease - physiopathology
/ Coronary Artery Disease - therapy
/ Coronary vessels
/ Drug-Eluting Stents
/ Female
/ Humans
/ Hypotheses
/ Ischemia
/ Italy
/ Kidney diseases
/ Male
/ Medical imaging
/ Medical prognosis
/ Middle Aged
/ Multicenter Studies as Topic
/ Patients
/ Percutaneous Coronary Intervention - adverse effects
/ Percutaneous Coronary Intervention - instrumentation
/ Percutaneous Coronary Intervention - mortality
/ Predictive Value of Tests
/ Prospective Studies
/ Randomized Controlled Trials as Topic
/ Statistical analysis
/ Stents
/ Time Factors
/ Treatment Outcome
/ Young Adult
2020
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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
by
Cerrato, Enrico
, Cortese, Giancarlo
, Vaudano, Paolo
, Marchisio, Filippo
, Depaoli, Alessandro
, Campo, Gianluca
, Tebaldi, Matteo
, Bianco, Matteo
, Iannaccone, Mario
, Santarelli, Andrea
, Angelini, Filippo
, Franchin, Luca
, Veltri, Andrea
, Guarnaccia, Carla
, Zaccaro, Lorenzo
, De Ferrari, Gaetano Maria
, Fonio, Paolo
, Giammaria, Massimo
, Tore, Davide
, Gaido, Luca
, D'Ascenzo, Fabrizio
, Guiducci, Vincenzo
, Gagnor, Andrea
, Varbella, Ferdinando
, Quadri, Giorgio
, Garbo, Roberto
, De Filippo, Ovidio
, Solitro, Federica
, Boccuzzi, Giacomo
in
Acute coronary syndromes
/ Adolescent
/ Adult
/ Aged
/ Aged, 80 and over
/ Angioplasty
/ Cardiology
/ Cardiovascular disease
/ Computed Tomography Angiography
/ Coronary Angiography
/ Coronary Artery Disease
/ Coronary Artery Disease - diagnostic imaging
/ Coronary Artery Disease - mortality
/ Coronary Artery Disease - physiopathology
/ Coronary Artery Disease - therapy
/ Coronary vessels
/ Drug-Eluting Stents
/ Female
/ Humans
/ Hypotheses
/ Ischemia
/ Italy
/ Kidney diseases
/ Male
/ Medical imaging
/ Medical prognosis
/ Middle Aged
/ Multicenter Studies as Topic
/ Patients
/ Percutaneous Coronary Intervention - adverse effects
/ Percutaneous Coronary Intervention - instrumentation
/ Percutaneous Coronary Intervention - mortality
/ Predictive Value of Tests
/ Prospective Studies
/ Randomized Controlled Trials as Topic
/ Statistical analysis
/ Stents
/ Time Factors
/ Treatment Outcome
/ Young Adult
2020
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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
by
Cerrato, Enrico
, Cortese, Giancarlo
, Vaudano, Paolo
, Marchisio, Filippo
, Depaoli, Alessandro
, Campo, Gianluca
, Tebaldi, Matteo
, Bianco, Matteo
, Iannaccone, Mario
, Santarelli, Andrea
, Angelini, Filippo
, Franchin, Luca
, Veltri, Andrea
, Guarnaccia, Carla
, Zaccaro, Lorenzo
, De Ferrari, Gaetano Maria
, Fonio, Paolo
, Giammaria, Massimo
, Tore, Davide
, Gaido, Luca
, D'Ascenzo, Fabrizio
, Guiducci, Vincenzo
, Gagnor, Andrea
, Varbella, Ferdinando
, Quadri, Giorgio
, Garbo, Roberto
, De Filippo, Ovidio
, Solitro, Federica
, Boccuzzi, Giacomo
in
Acute coronary syndromes
/ Adolescent
/ Adult
/ Aged
/ Aged, 80 and over
/ Angioplasty
/ Cardiology
/ Cardiovascular disease
/ Computed Tomography Angiography
/ Coronary Angiography
/ Coronary Artery Disease
/ Coronary Artery Disease - diagnostic imaging
/ Coronary Artery Disease - mortality
/ Coronary Artery Disease - physiopathology
/ Coronary Artery Disease - therapy
/ Coronary vessels
/ Drug-Eluting Stents
/ Female
/ Humans
/ Hypotheses
/ Ischemia
/ Italy
/ Kidney diseases
/ Male
/ Medical imaging
/ Medical prognosis
/ Middle Aged
/ Multicenter Studies as Topic
/ Patients
/ Percutaneous Coronary Intervention - adverse effects
/ Percutaneous Coronary Intervention - instrumentation
/ Percutaneous Coronary Intervention - mortality
/ Predictive Value of Tests
/ Prospective Studies
/ Randomized Controlled Trials as Topic
/ Statistical analysis
/ Stents
/ Time Factors
/ Treatment Outcome
/ Young Adult
2020
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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
Journal Article
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
2020
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Overview
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
Publisher
BMJ Publishing Group LTD,BMJ Publishing Group
Subject
/ Adult
/ Aged
/ Computed Tomography Angiography
/ Coronary Artery Disease - diagnostic imaging
/ Coronary Artery Disease - mortality
/ Coronary Artery Disease - physiopathology
/ Coronary Artery Disease - therapy
/ Female
/ Humans
/ Ischemia
/ Italy
/ Male
/ Multicenter Studies as Topic
/ Patients
/ Percutaneous Coronary Intervention - adverse effects
/ Percutaneous Coronary Intervention - instrumentation
/ Percutaneous Coronary Intervention - mortality
/ Randomized Controlled Trials as Topic
/ Stents
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