Maik J Grundeken1, Carlos Collet1, Yuki Ishibashi2, Philippe Généreux3,4,5,6, Takashi Muramatsu7, Laura LaSalle3, Aaron V Kaplan8, Joanna J Wykrzykowska1, Marie-Angèle Morel9, Jan G Tijssen1,9, Robbert J de Winter1, Yoshinobu Onuma2,9, Martin B Leon3,4, Patrick W Serruys10. 1. Amsterdam Heart Center, Academic Medical Center, Amsterdam, The Netherlands. 2. Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. 3. Cardiovascular Research Foundation, New York. 4. Columbia University Medical Center, New York. 5. Morristown Medical Center, Morristown, New Jersey. 6. Hôpital du Sacré-Coeur de Montréal, Université de Montréal, Montréal, Québec, Canada. 7. Department of Cardiology, Fujita Health University Hospital, Toyoake, Japan. 8. Geisel School of Medicine/Dartmouth-Hitchcock Medical Center, New Hampshire, Lebanon. 9. Cardialysis B.V, Rotterdam, The Netherlands. 10. International Centre for Circulatory Health, NHLI, Imperial College London, United Kingdom.
Abstract
OBJECTIVES: To compare visual estimation with different quantitative coronary angiography (QCA) methods (single-vessel versus bifurcation software) to assess coronary bifurcation lesions. BACKGROUND:QCA has been developed to overcome the limitations of visual estimation. Conventional QCA however, developed in "straight vessels," has proved to be inaccurate in bifurcation lesions. Therefore, bifurcation QCA was developed. However, the impact of these different modalities on bifurcation lesion severity classification is yet unknown METHODS: From a randomized controlled trial investigating a novel bifurcation stent (Clinicaltrials.gov NCT01258972), patients with baseline assessment of lesion severity by means of visual estimation, single-vessel QCA, 2D bifurcation QCA and 3D bifurcation QCA were included. We included 113 bifurcations lesions in which all 5 modalities were assessed. The primary end-point was to evaluate how the different modalities affected the classification of bifurcation lesion severity and extent of disease. RESULTS: On visual estimation, 100% of lesions had side-branch diameter stenosis (%DS) >50%, whereas in 83% with single-vessel QCA, 27% with 2D bifurcation QCA and 26% with 3D bifurcation QCA a side-branch %DS >50% was found (P < 0.0001). With regard to the percentage of "true" bifurcation lesions, there was a significant difference between visual estimate (100%), single-vessel QCA (75%) and bifurcation QCA (17% with 2D bifurcation software and 13% with 3D bifurcation software, P < 0.0001). CONCLUSIONS: Our study showed that bifurcation lesion complexity was significantly affected when more advanced bifurcation QCA software were used. "True" bifurcation lesion rate was 100% on visual estimation, but as low as 13% when analyzed with dedicated bifurcation QCA software.
RCT Entities:
OBJECTIVES: To compare visual estimation with different quantitative coronary angiography (QCA) methods (single-vessel versus bifurcation software) to assess coronary bifurcation lesions. BACKGROUND: QCA has been developed to overcome the limitations of visual estimation. Conventional QCA however, developed in "straight vessels," has proved to be inaccurate in bifurcation lesions. Therefore, bifurcation QCA was developed. However, the impact of these different modalities on bifurcation lesion severity classification is yet unknown METHODS: From a randomized controlled trial investigating a novel bifurcation stent (Clinicaltrials.gov NCT01258972), patients with baseline assessment of lesion severity by means of visual estimation, single-vessel QCA, 2D bifurcation QCA and 3D bifurcation QCA were included. We included 113 bifurcations lesions in which all 5 modalities were assessed. The primary end-point was to evaluate how the different modalities affected the classification of bifurcation lesion severity and extent of disease. RESULTS: On visual estimation, 100% of lesions had side-branch diameter stenosis (%DS) >50%, whereas in 83% with single-vessel QCA, 27% with 2D bifurcation QCA and 26% with 3D bifurcation QCA a side-branch %DS >50% was found (P < 0.0001). With regard to the percentage of "true" bifurcation lesions, there was a significant difference between visual estimate (100%), single-vessel QCA (75%) and bifurcation QCA (17% with 2D bifurcation software and 13% with 3D bifurcation software, P < 0.0001). CONCLUSIONS: Our study showed that bifurcation lesion complexity was significantly affected when more advanced bifurcation QCA software were used. "True" bifurcation lesion rate was 100% on visual estimation, but as low as 13% when analyzed with dedicated bifurcation QCA software.