Reduction of door to balloon time

Overview

The objectives of this study is to confirm reduction of door-to-balloon (D2B) time with single-catheter percutaneous coronary intervention (SC-PCI) method.
Ikari left curve was reported as a universal guiding catheter for left and right coronary arteries. Several procedure steps can be skipped by SC-PCI method as the advantage of a universal catheter.

Study Design

Enrollment 1,316 consecutive STEMI patients
Number of facility 14 hospitals
Interventional Model Description Patients were divided into two groups, single-catheter percutaneous coronary intervention method (SC-PCI) and conventional PCI method.
Primary endpoint Door-to-balloon (D2B) time
Radiation exposure dose
Term of study January 2014 to January 2018
clinical_evidence_d2b_study_design

Primary Endpoint

The primary endpoints were D2B time, defined as the time between the patient's arrival in the emergency department and first device activation such as a balloon, aspiration catheter, excimer laser catheter, and radiation exposure dose.

Study Outline

Material and Method

In the SC-PCI method, the Ikari left guiding catheter is used not only for diagnostic coronary angiography of both left and right coronary arteries but also for the guiding catheter of primary PCI. First, the non-culprit coronary artery's angiography, which was predicted with electrocardiogram and another non-invasive diagnostic method, was performed. Afterward, the guiding catheter was disengaged from the non-culprit coronary artery and directly engaged to the culprit. Then, the PCI procedure could begin immediately after diagnostic angiography.
The SC-PCI method using the Ikari left guiding catheter allowed operators to skip five steps, two steps or three steps compared with conventional method #1, #2 or #3. In this study, conventional method #1 was mostly used.
clinical_evidence_d2b_material_and_method
#1:Using the Judkins R and Judkins L diagnostic catheters.
#2:Using a diagnostic catheter to contrast the contralateral side of the culprit artery and a guiding catheter to contrast the culprit artery.
#3:Using a universal diagnostic catheter (TIG, Mitsudo etc.) to contrast both sides and then change to a guiding catheter.

Result

Door-to-balloon(D2B) time

The mean age was 68 ± 13 years old. Radial access was used in 85% of participants. PCI success was achieved in 99.5% of participants and the SC-PCI method was successfully performed in 92.6%. The D2B time was shorter (68 ± 46 vs. 74 ± 50 min, respectively; p = 0.02), and the radiation exposure dose was lower (1,664 ± 970 vs. 2008 ± 1,605 mGy, respectively; p <0.0001) in the SC-PCI group than in the conventional group.
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SC-PCI: single catheter primary percutaneous coronary intervention
D2S Time: door-to-sheath time S2B
Time: sheath-to-balloon time

Radiation exposure dose and fluorescent time

clinical_evidence_d2b_result_2.png

 

Reference