Safety and Efficacy Study of Dual-axis Rotational Versus Standard Coronary Angiography

• Clinical safety of the patient during coronary angiography(CA) [ Time Frame: At time of CA ] [ Designated as safety issue: Yes ]
  The patients were closely observed and questioned regarding discomfort and adverse events during or immediately after CA. The sensation of warmth or pain, including chest pain, is considered as discomfort. Adverse events include arrhythmias, hemodynamic instability, chest pain lasting more than one minute and any untoward event which jeopardises the patient's life or prolongs the planned hospital stay. Hemodynamic instability is defined as severe hypotension (SBP＜90 mmHg) or severe bradycardia (HR＜60 beats/minute).
  
  

• Patient safety determined by contrast and radiation dose [ Time Frame: At time of CA ] [ Designated as safety issue: Yes ]
  The contrast usage (ml) and radiation exposure (mGycm2) are recorded from the point of selective catheter engagement in the coronary ostium to the completion of the diagnostic study. The contrast and radiation to perform isocentering are included during DARCA. The contrast and radiation required to engage the coronary ostia, exchange catheters, and perform non-coronary angiography are excluded from the analysis.
  
  
• Clinical utility of dual-axis rotational coronary angiography(DARCA) [ Time Frame: At time of CA ] [ Designated as safety issue: No ]
  The clinical utility of DARCA is determined by the number of additional acquisitions required beyond the protocol and the procedure time required for completing CA.The procedure time (sec.) is recorded from the point of selective catheter engagement in the coronary ostium to the completion of the diagnostic study. The time to perform isocentering is included during DARCA. The time required to engage the coronary ostia, exchange catheters, and perform non-coronary angiography is excluded from the analysis.
  
  

Dual-axis rotational coronary angiography (DARCA) was developed as an innovative adaptation of rotational angiography (RA), but it requires a longer coronary injection compared to standard coronary angiography (SA). The risk of complications from the contrast agent (such as discomfort, warmth, pain, hypotension and bradycardia) is increased with the use of DARCA. It remains to be evaluated whether this approach is also suitable for coronary angiography, especially using in the patients with complex coronary lesions. Previous studies revealed promising results, but the number of patients included did not provide sufficient statistical power to allow a valid comparison of DARCA with SA. The purpose of this study is to evaluate the feasibility, safety, clinical tolerance, and hemodynamic effect of DARCA in comparison to the well-established SA.