Randomized Comparison of a CrossBoss First vs. Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusions - CrossBoss First

Oct 31, 2017
Font Size
A
A
A
Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Boston Scientific
Date Presented:
10/31/2017
Date Published:
10/31/2017
Date Updated:
10/31/2017
Original Posted Date:
10/31/2017
References

Contribution To Literature:

The CrossBoss First trial showed that using a CrossBoss microcatheter upfront vs. antegrade wire escalation have similar procedural success, procedure times, and equipment costs among patients undergoing antegrade CTO PCI.

Description:

The goal of the trial was to assess the safety and efficacy of using a CrossBoss catheter versus antegrade wire escalation for antegrade wire crossing of chronic total occlusions (CTOs).


Study Design

Patients with a CTO undergoing an antegrade wire crossing attempt were randomized in a 1:1 fashion to either initially attempt CTO crossing using the CrossBoss catheter or using antegrade wire escalation. Randomization was stratified by Japan Chronic Total Occlusion (J-CTO) score and by site.

  • Total number screened: 966
  • Total number of enrollees: 246
  • Duration of follow-up: 1 year
  • Mean patient age: 65.5 years
  • Percentage female: 18%
  • Percentage with diabetes: 37%

Inclusion criteria:

  • Age >18 years
  • Scheduled for clinically indicated CTO percutaneous coronary intervention (PCI) with a planned antegrade crossing approach

Exclusion criteria:

  • Ostial CTO lesions (within 5 mm of vessel ostium)
  • If the operator planned to use a primary retrograde approach for CTO crossing

Other salient features/characteristics:

  • Prior coronary artery bypass grafting: 26%
  • CTO target vessel: right coronary artery: 65%
  • Moderate to severe calcification: 44%, in-stent restenosis: 23%
  • Occlusion length: 22 mm
  • Distal vessel reference vessel diameter: 1.8 mm
  • J-CTO score: 2.07

Principal Findings:

The primary efficacy outcome, time to cross CTO or abort for CrossBoss vs. antegrade wire escalation, was 56 vs. 66 minutes, p = 0.32.

  • Primary safety outcome: Major adverse cardiac events (MACE): 3.3% vs. 4.0%, p = 1.0
  • Death: 1.6% vs. 0.8%, p = 0.62

Secondary outcomes for CrossBoss vs. antegrade wire escalation:

  • Technical success: 88.5% vs. 87.1%, p = 0.85
  • Total procedure time: 109 vs. 109 minutes, p = 0.67
  • Pericardiocentesis: 0% vs. 3.2%, p = 0.06
  • Number of guidewires used: 7.4 vs. 8.1, p = 0.47
  • Overall equipment cost: $5,500 vs. $5,038, p = 0.18

Interpretation:

The results of this trial indicate that using a CrossBoss microcatheter upfront vs. antegrade wire escalation have similar procedural success, procedure times, and equipment costs among patients undergoing antegrade CTO PCI. The CrossBoss catheter is frequently used in combination with a re-entry device such as the Stingray system. For operators performing CTO PCI, this trial provides rigorous data for choosing CTO crossing strategies, rather than relying on expert and personal opinions alone.

References:

Karacsonyi J, Tajti P, Rangan BV, et al. Randomized Comparison of a CrossBoss First vs. Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusions: the “CrossBoss First” trial. JACC Cardiovasc Interv 2017;Oct 31:[Epub ahead of print].

Presented by Dr. Emmanouil S. Brilakis at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2017), Denver, CO, October 31, 2017.

Keywords: Calcification, Physiologic, Coronary Occlusion, Coronary Restenosis, Coronary Vessels, Percutaneous Coronary Intervention, Pericardiocentesis, Stents, Transcatheter Cardiovascular Therapeutics, TCT17


< Back to Listings