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Ranolazine in patie...
Ranolazine in patients with incomplete revascularisation after percutaneous coronary intervention (RIVER-PCI) : a multicentre, randomised, double-blind, placebo-controlled trial
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- Weisz, Giora (författare)
- 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 USA
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- Généreux, Philippe (författare)
- Cardiovasc Res Fdn, New York, NY USA; Univ Montreal, Hop Sacre Coeur Montreal, Montreal, PQ, Canada
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- Iñiguez, Andres (författare)
- Hosp Meixoeiro, Vigo, Spain
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- Zurakowski, Aleksander (författare)
- Amer Heart Poland SA, Katowice, Poland
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- Shechter, Michael (författare)
- Chaim Sheba Med Ctr, IL-52621 Tel Hashomer, Israel
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- Alexander, Karen P. (författare)
- Duke Clin Res Inst, Durham, NC USA; Duke Univ, Durham, NC USA
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- Dressler, Ovidiu (författare)
- Cardiovasc Res Fdn, New York, NY USA
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- Osmukhina, Anna (författare)
- Gilead Sci Inc, Foster City, CA 94404 USA
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- James, Stefan (författare)
- Uppsala universitet,Institutionen för medicinska vetenskaper,Uppsala kliniska forskningscentrum (UCR)
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- Ohman, E. Magnus (författare)
- Duke Clin Res Inst, Durham, NC USA; Duke Univ, Durham, NC USA
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- Ben-Yehuda, Ori (författare)
- Cardiovasc Res Fdn, New York, NY USA
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- Farzaneh-Far, Ramin (författare)
- Gilead Sci Inc, Foster City, CA 94404 USA
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- Stone, Gregg W. (författare)
- Columbia Univ, Med Ctr, New York Presbyterian Hosp, New York, NY USA; Cardiovasc Res Fdn, New York, NY USA
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(creator_code:org_t)
- 2016
- 2016
- Engelska.
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Ingår i: The Lancet. - 0140-6736 .- 1474-547X. ; 387:10014, s. 136-145
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- 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
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Allmänmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- General Practice (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
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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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MEDICIN OCH HÄLS ...
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The Lancet
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Uppsala universitet