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Proposal 918

Title of the Proposed Research

Outcomes after Percutaneous Coronary Intervention in Cancer patients with Acute Coronary Syndrome

Lead Researcher

Partha Sardar MD

Affiliation

New York Medical College
New York, NY
US

Funding Source

None

Potential Conflicts of Interest

None

Data Sharing Agreement Date

8 August 2014

Lay Summary

Coronary artery disease (CAD) and cancer are the most common causes of death in the Western world. Coronary artery disease alone causes 385,000 deaths annually in the USA. An increased risk of CAD has been reported in patients with cancer. Cancer and CAD are more common in the elderly population and share common risk factors such as tobacco smoking. Cancer is commonly associated with a hypercoagulable state, increasing the risk for venous and possibly arterial thrombosis. There are many potential prothrombotic mechanisms in cancer patients, such as increased platelet activation and aggregability, damaged or dysfunctional endothelium, increased number of circulating microparticles, procoagulants changed due to chemotherapy and angiogenesis. Chemotherapeutic agents like anthracyclines and antimetabolites have cardiotoxic properties have potential to develop irreversible cardiomyopathy or cardiac ischemia. Regardless of the numerous factors influencing development and prognosis of CAD in patients with cancer, there are little to no data covering the influence of cancer on outcome after myocardial infarction and percutaneous coronary intervention (PCI). A recent observational study reported, a cancer diagnosis in the 6 months before primary PCI was strongly associated with early cardiac mortality (Velders et al, Am J Cardiol. 2013).

How the research will add to medical science or improve patient care:

Recently diagnosed patients with cancer represent a challenge for the operator performing primary PCI. Antithrombotic treatment and vascular access increase the risk of bleeding, which may worsen the anemia present in many of these patients, increasing the risk of heart failure. Knowledge regarding outcome of PCI in cancer patients might help in special care of this important vernalable group and helps in resource allocation.

The aims and objectives of the research:

  • The aim of the present study is to evaluate the outcomes after PCI in cancer patients with acute myocardial infarction (AMI).
  • To compare the safety of two unfractionated heparin regimens (low-dose vs standard-dose unfractionated heparin in cancer patients treated with fondaparinux during PCI).

How the research will be conducted:

Design and methods

Patients with pre-existing cancer will be identified from the double-blind randomized parallel-group FUTURA/ OASIS 8 trial. The initial trial was conducted from February 2009 to March 2010.

Patient undergoing PCI for AMI, received standard treatment including fondaparinux, and received either low or standard dose of unfractionated heparin.

How the findings will be interpreted and communicated:

We will compare the clinically relevant outcomes in patients with cancer vs patients without cancer, using proper statistical methods. The study will be designed, analyzed and drafted by the same research team. We will present our findings in a scientific meeting, followed by publication in a peer reviewed journal.

Study Data Provided

Study AR1108888: FondaparinUx Trial with Unfractionated Heparin (UFH) during Revascularization in Acute Coronary Syndromes (ACS) (FUTURA). A prospective study evaluating the safety of two regimens of adjunctive intravenous UFH during PCI in high risk patients with Unstable Angina/Non ST segment elevation myocardial infarction (UA/NSTEMI) initially treated with subcutaneous fondaparinux and referred for early coronary angiography (OASIS 8)

Statistical Analysis Plan

This will be added after the research is published.

Publication Citation