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Randomized Controlled Trial
Remote ischaemic postconditioning: does it protect against ischaemic damage in percutaneous coronary revascularisation? Randomised placebo-controlled clinical trial.
- Fernando Carrasco-Chinchilla, Antonio J Muñoz-García, Antonio Domínguez-Franco, Gloria Millán-Vázquez, Alicia Guerrero-Molina, Carmen Ortiz-García, Alfredo Enguix-Armada, Juan H Alonso-Briales, Jose M Hernández-García, Eduardo de Teresa-Galván, and Manuel F Jiménez-Navarro.
- Área del Corazón del Hospital Clínico Universitario Virgen de la Victoria, Fundación IMABIS, RECAVA, Málaga, Spain.
- Heart. 2013 Oct 1;99(19):1431-7.
ObjectiveDetermine whether remote ischaemic postconditioning (RIP) protects against percutaneous coronary intervention-related myocardial infarction (PCI-MI).DesignSingle-centre, randomised, blinded to the researchers, clinical trial. ClinicalTrials.gov (NCT 01113008).SettingTertiary hospital centre.Patients232 patients underwent elective PCI for stable or unstable angina.InterventionsPatients were randomised to RIP (induction of three 5-min cycles of ischaemia in the arm after the PCI) versus placebo.Main Outcome MeasuresThe primary outcome measure was the peak 24-h troponin I level. PCI-MI was defined by an elevation of troponin values >3 or >5 of the 99th percentile according to the classical or the new definition. The secondary outcome measure was hospital admission, PCI for stable angina or acute coronary syndrome and mortality after 1 year of follow-up. The use of RIP in diabetic patients was specifically studied.ResultsThe mean age was 64.6 years, and 42% were diabetic. The peak troponin in the RIP patients was 0.476 vs 0.478 ng/mL (p=0.99). PCI-MI occurred in 36% of the RIP patients versus 30.8% in the placebo group (p=0.378). Diabetic RIP patients had more PCI-MI (new definition): OR 2.7; 95% CI 1.10 to 6.92; p=0.027. The secondary outcome measure was seen in 11.7% of the RIP patients versus 10.8% in the placebo group (p=0.907).ConclusionsRIP did not reduce the damage associated with elective PCI or cardiovascular events during the follow-up. The diabetic population who underwent RIP had more PCI-MI.
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