Coronary disease & ACSRandomised controlled trial
Imaging Comparisons Between Bifurcation Stenting Procedures Performed in Human Patients and Those Within Reanimated Swine Hearts
- pooled individual-case data from 2 randomized (1:1) trials sharing 1 protocol
Authors' conclusion
A reanimated swine-heart model showed close concordance with the human geometric result of bifurcation techniques, matching the direction at 8 of 10 endpoints and, approximately, the magnitude. This is descriptive concordance, not proven predictive equivalence, and supports the model as a preclinical screening tool pending prospective validation.
Study context
- Population
- Provisional bifurcation percutaneous coronary interventions in reanimated swine hearts and in patients30 percutaneous coronary interventions in 17 reanimated swine hearts and 60 patients · percutaneous coronary interventions in reanimated swine hearts 30 · reanimated swine hearts 17 · patients 60
- Comparison
- proximal optimization technique (POT)/kissing/POT and POT/side/POT (PSP); stent geometry by human-optical coherence tomography (OCT), swine-OCT, and micro-computed tomography (CT) of the explanted swine stents
Primary result
As reported in the abstract
concordance correlation coefficient
0.83
Further findings
Distal main-vessel expansion
swine
patients
Agreement of the technique effect between swine and humans
- endpoints agreeing in direction
- 8 of 10
- descriptive calibration slope (indistinguishable from unity)
- 1.04
- case-level bootstrap slope (imprecise)
- 0.88; 95% CI: 0.47-1.54
Distal main-vessel expansion
- lowest with PSP
Major malappositions
- rare after POT/kissing/POT but affected about half of PSP cases in both species
OCT vs micro-CT agreement; extent of underexpansion
- OCT matched micro-CT for expansion but not eccentricity
- underexpansions extended farther along the larger human vessel
Original publication
Summarised from the published abstract; every number is checked against it