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Original research article
Biological effect of microengineered grooved stents on strut healing: a randomised OCT-based comparative study in humans
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  • Published on:
    Unanswered Questions

    In his response to my CardioBrief blog post ( Juan Granada implies that my article was neither factual, nor accurate, nor professional. However, at no point does Granada give examples backing his assertions.

    Granada neglects to mention that prior to publication of my blog post I had emailed him, offering him the opportunity to clarify or respond to the questions I raised prior to publication and to prevent any misunderstanding. Granada did not respond to my emails. In fact, after I emailed my questions to Granada I received a “cease-and-desist” letter from Julio Palmaz's attorneys. Is this his idea of "very high ethical and academic standards”?

    In his statement Granada also fails to address the differences between the listing of the study on ClinicalTrials.Org (, in which the stents are described as Palmaz stents, and the Open Heart publication, in which they are described as Abbott stents. This discrepancy may, potentially, raise troubling issues, including questions about the IRB evaluation of the study and how the study was described to potential subjects during the informed consent process. Granada also offers no explanation for the discrepanc...

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    Conflict of Interest:
    None declared.
  • Published on:
    Response to CardioBrief blog post
    • Juan F Granada, Cardiologist, President and CEO Skirball Center for Cardiovascular Research, Cardiovascular Research Foundation, Orangeburg, New York, USA

    Clinical practice has been historically driven by evidence-based medicine. Properly sized randomized controlled trials have been the basis of accepting or rejecting research hypotheses, and clinical guidelines are developed based on data reported in such trials. Clinical research is not perfect. However, most clinical trials are conducted in a highly regulated environment and accepted for publication following a strict peer review process led by independent experts. While limitations exist in conducting and reporting clinical trials, investigators are judged at very high ethical and academic standards.

    A blog posted on September 11, 2017[1] questioned the integrity of the data and ethical conduct of the investigators of this study published in Open Heart. Due to the respect I have for the editor and this journal, I am obliged to respond on behalf of the authors.

    First, I did not receive ANY type of financial compensation as the principal investigator for this study. Second, no financial obligations or equity arrangements exist between the sponsor of the study, myself or my current Institution. Third, although all financial disclosures of all authors were properly disclosed to the journal at the time of submission, they were unfortunately not included in the final published article and therefore published subsequently as a correction[2]. Fourth, the objective of the study was to assess the 3-week healing properties of a surface-modified stent. The patient wi...

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    Conflict of Interest:
    None declared.