Use of a Universal Guiding Catheter to Reduce Reperfusion Time in Patients with ST-segment Elevation Myocardial Infarction

1. Rationale
Reduction of reperfusion time is associated with mortality reduction in patients with ST-segment elevation myocardial infarction. Therefore, the time spent on every step taken from symptom onset to reperfusion should be optimized. Although PCI is one such step, it has not been a target for time reduction.
A universal guiding catheter can engage both the left and right coronary arteries thereby obviating the need for catheter exchange, which could save time during PCI. Ikari-Curve is one of the best universal guiding catheters.

2. Aim
To assess whether reperfusion time is shorter for PCI using Ikari-Curve universal guiding catheter vs. conventional PCI

3. Study design
1) Multicenter retrospective comparison between the two groups

2) Endpoints
Primary endpoint
• Sheath insertion-to-balloon (or first device) time
• Secondary endpoints
Door-to-balloon (or first device) time
• All-cause mortality at 30 days
• Factors associated with the primary endpoint

4. Statistical analysis
In preliminary assessment, sheath insertion-to-balloon time was 15 + 11 min for PCI using Ikari-Curve universal guiding catheter and 25 + 11 min for conventional PCI.
Based on a 10 min difference between groups, standard deviation of 1.7 min, level of significance of 0.05, and power of 0.9, a case number of 60 was estimated.
This retrospective analysis therefore will include 60 cases from each of 20 institutions.

5. Inclusion and exclusion criteria
Inclusion criteria
• Age >21 and <99 years
• ST-segment elevation myocardial infarction
• Primary PCI performed within 12 hours from symptom onset
Exclusion criteria
• Cardiogenic shock
• Cardiopulmonary arrest
• Renal failure requiring dialysis

6. Methods
Each participating site will enroll 30 cases using Ikari-Curve universal guiding catheter for both left and right coronary arteries, and 30 conventional PCI cases. To minimize selection bias, consecutive cases are recommended.

If you are interested in participating, please contact us and we will send you a study protocol.