RT Journal Article
SR Electronic
T1 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
JF Open Heart
JO Open Heart
FD British Cardiovascular Society
SP e001253
DO 10.1136/openhrt-2020-001253
VO 7
IS 2
A1 Ovidio De Filippo
A1 Matteo Bianco
A1 Matteo Tebaldi
A1 Mario Iannaccone
A1 Luca Gaido
A1 Vincenzo Guiducci
A1 Andrea Santarelli
A1 Lorenzo Zaccaro
A1 Alessandro Depaoli
A1 Paolo Vaudano
A1 Giorgio Quadri
A1 Andrea Gagnor
A1 Giacomo Boccuzzi
A1 Federica Solitro
A1 Giancarlo Cortese
A1 Carla Guarnaccia
A1 Davide Tore
A1 Andrea Veltri
A1 Luca Franchin
A1 Filippo Angelini
A1 Roberto Garbo
A1 Massimo Giammaria
A1 Ferdinando Varbella
A1 Filippo Marchisio
A1 Paolo Fonio
A1 Gaetano Maria De Ferrari
A1 Enrico Cerrato
A1 Gianluca Campo
A1 Fabrizio D'Ascenzo
YR 2020
UL http://openheart.bmj.com/content/7/2/e001253.abstract
AB Background The 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 analysis PULSE 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 number NCT04144881