Article Text
Abstract
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
- coronary angiography
- coronary artery disease
- coronary intervention (PCI)
- CT scanning
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Footnotes
Twitter @GianlucaCampo78
Contributors FD, GCo conceived the study idea, led the funding application and protocol development. ODF, FA, LZ, LG and LF contributed to protocol drafting and development and coordinated ethical approval process. MB and EC contributed to protocol development and supported FD and GCa with development of the study database, and plans for quantitative data management and statistical analysis. GM, FV, MT contributed to protocol development and provided expert cardiovascular advice about clinical management and follow-up planning. GM led the coordinating centre. PF contributed to protocol development and provided expert radiology advice as lead of radiology unit of coordinating centre. MI, MG, GQ, AG, RG, GB, VG, AS contributed to protocol development and provided expert advice about revascularisation procedures and techniques. AD, DT, CG, FS, PV and GCa contributed to protocol development and provided advices about CCT devices, software and image acquisitions. AV and FM contributed to the revised version of the protocol and the revised draft of this manuscript, provided advices about CCT devices, software and image acquisition. All authors have read and approved the final version of the manuscript.
Funding This research is funded by the Italian Minister of Health, General Direction for Health and Biomedical research, via a dedicated programme for finalised research (project code: GR-2016–02362546).
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The protocol and amendments have been reviewed, approved and granted by the Italian Minister of Health (General Direction for the Research and Health Innovation, protocol number GR-2016–02362546) and by ethical committees of each involved centre.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement No data are available.