{"id":"823313368992","type":"article","url":"https://hartvaat.nl/2016/01/09/ranolazine-bij-incomplete-revascularisatie-na-pci-de-river-pci-trial/","title":"Ranolazine bij incomplete revascularisatie na PCI: de RIVER-PCI-trial","title_en":"Ranolazine in patients with incomplete revascularisation after percutaneous coronary intervention (RIVER-PCI): a multicentre, randomised, double-blind, placebo-controlled trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(15)00459-6","source_url":"https://doi.org/10.1016/S0140-6736(15)00459-6","authors":["Giora Weisz","Philippe Généreux","Andres Iñiguez","Aleksander Zurakowski","Michael Shechter","Karen P Alexander","Ovidiu Dressler","Anna Osmukhina","Stefan James","E Magnus Ohman","Ori Ben-Yehuda","Ramin Farzaneh-Far","Gregg W Stone"],"significance":7,"published":"2016-01-09","source_date":"2016-01-09","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/antistolling-bij-kankerpatienten/","https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/"],"congress":"","summary_en":"The RIVER-PCI trial showed that ranolazine did not improve outcomes in patients with incomplete revascularization after PCI, a common clinical scenario associated with increased mortality and recurrent ischemia.","created":"2026-07-03T10:25:52Z","updated":"2026-07-03T13:25:14Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Multicenter dubbelblinde RCT die onderzocht of ranolazine de prognose verbetert bij patiënten met incomplete revascularisatie na PCI. Incomplete revascularisatie komt frequent voor en is geassocieerd met verhoogde mortaliteit.","abstract_original":"BACKGROUND: Incomplete revascularisation is common after percutaneous coronary intervention and is associated with increased mortality and adverse cardiovascular events. We aimed to assess whether adjunctive anti-ischaemic pharmacotherapy with ranolazine would improve the prognosis of patients with incomplete revascularisation after percutaneous coronary intervention. METHODS: We performed this multicentre, randomised, parallel-group, double-blind, placebo-controlled, event-driven trial at 245 centres in 15 countries in Europe, Israel, Russia, and the USA. Patients (aged ≥18 years) with a history of chronic angina with incomplete revascularisation after percutaneous coronary intervention (defined as one or more lesions with ≥50% diameter stenosis in a coronary artery ≥2 mm diameter) were randomly assigned (1:1), via an interactive web-based block randomisation system (block sizes of ten), to receive either twice-daily oral ranolazine 1000 mg or matching placebo. Randomisation was stratified by diabetes history (presence vs absence) and acute coronary syndrome presentation (acute coronary syndrome vs non-acute coronary syndrome). Study investigators, including all research teams, and patients were masked to treatment allocation. The primary endpoint was time to first occurrence of ischaemia-driven revascularisation or ischaemia-driven hospitalisation without revascularisation. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, number NCT01442038. FINDINGS: Between Nov 3, 2011, and May 27, 2013, we randomly assigned 2651 patients to receive ranolazine (n=1332) or placebo (n=1319); 2604 (98%) patients comprised the full analysis set. After a median follow-up of 643 days (IQR 575-758), the composite primary endpoint occurred in 345 (26%) patients assigned to ranolazine and 364 (28%) patients assigned to placebo (hazard ratio 0·95, 95% CI 0·82-1·10; p=0·48). Incidence of ischaemia-driven revascularisation and ischaemia-driven hospitalisation did not differ significantly between groups. 189 (14%) patients in the ranolazine group and 137 (11%) patients in the placebo group discontinued study drug because of an adverse event (p=0·04). INTERPRETATION: Ranolazine did not reduce the composite rate of ischaemia-driven revascularisation or hospitalisation without revascularisation in patients with a history of chronic angina who had incomplete revascularisation after percutaneous coronary intervention. Further studies are warranted to establish whether other treatment could be effective in improving the prognosis of high-risk patients in this population. FUNDING: Gilead Sciences, Menarini."}