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Randomized Controlled Trial
. 2014 Aug 20;175(3):539-44.
doi: 10.1016/j.ijcard.2014.06.039. Epub 2014 Jul 2.

Predictors of response to intramyocardial bone marrow cell treatment in patients with refractory angina and chronic myocardial ischemia

Sander F Rodrigo  1 , Jan van Ramshorst  1 , Imke Mann  1 , Darryl P Leong  1 , Suzanne C Cannegieter  2 , Imad Al Younis  3 , Petra Dibbets-Schneider  3 , Albert de Roos  4 , Willem E Fibbe  5 , Jaap Jan Zwaginga  6 , Jeroen J Bax  1 , Martin J Schalij  1 , Saskia L Beeres  1 , Douwe E Atsma  7
Affiliations
Randomized Controlled Trial

Predictors of response to intramyocardial bone marrow cell treatment in patients with refractory angina and chronic myocardial ischemia

Sander F Rodrigo et al. Int J Cardiol. .

Abstract

Background: We previously showed that intramyocardial bone marrow cell (BMC) injection in patients with refractory angina and chronic myocardial ischemia improves myocardial perfusion, cardiac function and disease-related complaints. Treatment effect varied between patients, but the predictors of response remain to be identified. Therefore, the aim of the present study was to assess whether patient characteristics, procedural data and baseline measurements influence the response to intramyocardial BMC treatment in a large cohort of refractory angina patients.

Methods and results: In 120 patients (64 ± 9 years, 88% men) with refractory angina, 97 ± 13 × 10(6) BMCs were injected intramyocardially in regions with stress-inducible ischemia as assessed by single photon emission computed tomography (SPECT). Canadian Cardiovascular Society angina (CCS) class, quality-of-life score, exercise testing, SPECT and magnetic resonance imaging were performed at baseline and at 3 months follow-up demonstrating significant improvements in CCS class, quality-of-life, exercise capacity, myocardial perfusion and left ventricular function (all variables P<0.001). Multivariate analysis was performed to evaluate the influence of patient characteristics, procedural data and baseline measurements on BMC treatment response. Based on the improvement of myocardial perfusion at stress, diabetes and a large number of ischemic segments at baseline were shown to be independently associated with a large response to BMC therapy.

Conclusion: The present study demonstrates that diabetes and a large number of ischemic segments are predictors of a large response to intramyocardial BMC injection in refractory angina and chronic ischemia. Furthermore, the safety and efficacy results of previous trials are now confirmed in a larger study population.

Keywords: Bone marrow cell; Cell therapy; Chronic ischemia; Intramyocardial injection.

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