Equipoise ethics clinical research

This open-label, nonrandomized study reports that PCI using the SYNTAX-II strategy was associated with superior clinical outcomes compared with the PCI arm of the original SYNTAX-I trial, with a lower incidence of MACCE driven by a reduction in MI, revascularization, and definite stent thrombosis at 1-year follow-up. Importantly, physiological assessment, which was feasible in 75% of lesions, contributed to deferring treatment in 25% of the interrogated stenosis. An exploratory analysis at 1 year suggests that PCI with the SYNTAX-II strategy was associated with similar clinical outcomes to the equipoise-derived SYNTAX-I CABG cohort. While the initial results of SYNTAX II provide evidence of the impact of the technological developments in the field of PCI on clinical outcomes, longer-term follow-up is indicated to determine whether the noninferiority of PCI using the SYNTAX-II strategy compared with CABG is maintained. A randomized clinical trial of contemporary PCI versus CABG will be needed to provide definitive evidence of equivalence.

Packer said that it is impossible to dismiss the theoretical dangers of neprilysin inhibition but that the unequivocal benefits of valsartan-sacubitril in PARADIGM-HF should not be dismissed. He noted that the “relatively short” followup period “was because the trial was terminated early by the overseeing ethical committee when it observed that fewer patients were dying when they were treated with sacubitril/valsartan.” He asked: “How many excess deaths can Dr. Feldman tolerate to justify his desire for clarity?  I can assure him that — with greater follow-up — his fears might be justified, but only because it is not possible for dead patients to develop dementia.”

Equipoise ethics clinical research

equipoise ethics clinical research

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