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Ranolazine in patie...
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Weisz, GioraShaare Zedek Med Ctr, IL-91031 Jerusalem, Israel;Columbia Univ, Med Ctr, New York Presbyterian Hosp, New York, NY USA;Cardiovasc Res Fdn, New York, NY USA
(författare)
Ranolazine in patients with incomplete revascularisation after percutaneous coronary intervention (RIVER-PCI) : a multicentre, randomised, double-blind, placebo-controlled trial
- Artikel/kapitelEngelska2016
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Nummerbeteckningar
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LIBRIS-ID:oai:DiVA.org:uu-278690
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https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-278690URI
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https://doi.org/10.1016/S0140-6736(15)00459-6DOI
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Språk:engelska
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Sammanfattning på:engelska
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Ämneskategori:ref swepub-contenttype
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Ämneskategori:art swepub-publicationtype
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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.
Ämnesord och genrebeteckningar
Biuppslag (personer, institutioner, konferenser, titlar ...)
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Généreux, PhilippeCardiovasc Res Fdn, New York, NY USA; Univ Montreal, Hop Sacre Coeur Montreal, Montreal, PQ, Canada
(författare)
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Iñiguez, AndresHosp Meixoeiro, Vigo, Spain
(författare)
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Zurakowski, AleksanderAmer Heart Poland SA, Katowice, Poland
(författare)
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Shechter, MichaelChaim Sheba Med Ctr, IL-52621 Tel Hashomer, Israel
(författare)
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Alexander, Karen P.Duke Clin Res Inst, Durham, NC USA; Duke Univ, Durham, NC USA
(författare)
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Dressler, OvidiuCardiovasc Res Fdn, New York, NY USA
(författare)
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Osmukhina, AnnaGilead Sci Inc, Foster City, CA 94404 USA
(författare)
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James, StefanUppsala universitet,Institutionen för medicinska vetenskaper,Uppsala kliniska forskningscentrum (UCR)(Swepub:uu)stjam367
(författare)
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Ohman, E. MagnusDuke Clin Res Inst, Durham, NC USA; Duke Univ, Durham, NC USA
(författare)
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Ben-Yehuda, OriCardiovasc Res Fdn, New York, NY USA
(författare)
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Farzaneh-Far, RaminGilead Sci Inc, Foster City, CA 94404 USA
(författare)
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Stone, Gregg W.Columbia Univ, Med Ctr, New York Presbyterian Hosp, New York, NY USA; Cardiovasc Res Fdn, New York, NY USA
(författare)
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Shaare Zedek Med Ctr, IL-91031 Jerusalem, Israel;Columbia Univ, Med Ctr, New York Presbyterian Hosp, New York, NY USA;Cardiovasc Res Fdn, New York, NY USACardiovasc Res Fdn, New York, NY USA; Univ Montreal, Hop Sacre Coeur Montreal, Montreal, PQ, Canada
(creator_code:org_t)
Sammanhörande titlar
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Ingår i:The Lancet387:10014, s. 136-1450140-67361474-547X
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Weisz, Giora
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Généreux, Philip ...
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Iñiguez, Andres
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Zurakowski, Alek ...
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Shechter, Michae ...
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Alexander, Karen ...
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visa fler...
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Dressler, Ovidiu
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Osmukhina, Anna
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James, Stefan
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Ohman, E. Magnus
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Ben-Yehuda, Ori
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Farzaneh-Far, Ra ...
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Stone, Gregg W.
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