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Development and validation of a prediction model for angiographic perforation during chronic total occlusion
Taishi Hirai1,2,3, James Aaron Grantham1,2, James Sapontis4
1Saint Luke's Mid America Heart Institute, Kansas City, Missouri, USA.
Insights
Perforation is a common complication of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). The OPEN-CLEAN score, using pre-procedure variables, helps predict perforation risk in CTO PCI patients.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Perforation is the most frequent complication of chronic total occlusion (CTO) percutaneous coronary intervention (PCI).
- CTO PCI-related perforations are associated with adverse events, including mortality.
Purpose of the Study:
- To describe clinical and angiographic predictors of angiographic perforation during CTO PCI.
- To develop a risk prediction model for perforation during CTO PCI.
Main Methods:
- A prospective study of 1,000 consecutive patients undergoing CTO PCI (OPEN CTO).
- Angiographic core-lab review of all perforations.
- Comparison of 89 patients with perforation to 911 patients without.
Main Results:
- Independent risk factors for perforation included prior coronary artery bypass grafting (CABG), occlusion length, reduced ejection fraction, older age, and heavy calcification.
- A simplified 5-variable prediction score (OPEN-CLEAN score) was developed.
- The OPEN-CLEAN score demonstrated good discrimination (c-statistic = 0.75) and calibration for predicting angiographic perforation.
Conclusions:
- The OPEN-CLEAN score is a simple tool to risk-stratify patients for angiographic perforation before CTO PCI.
- This score utilizes pre-procedure variables readily available to operators.
Background:
Perforation is the most frequent complication of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) and is associated with adverse events including mortality.
Methods:
Among 1,000 consecutive patients enrolled in 12 center prospective CTO PCI study (OPEN CTO), all perforations were reviewed by the angiographic core-lab. Eighty-nine patients (8.9%) with angiographic perforation were compared to 911 patients without perforation. We sought to describe the clinical and angiographic predictors of angiographic perforation during CTO PCI and develop a risk prediction model.
Results:
Among eight clinically important candidate variables, independent risk factors for perforation included prior CABG (OR 2.0 [95% CI, 1.2-3.3], p < .01), occlusion length (OR 1.2 per 10 mm increase [95% CI, 1.1-1.3], p < .01), ejection fraction (OR 1.2 per 10% decrease [95% CI, 1.1-1.5], p < .01), age (OR 1.3 per 5 year increase [95%CI, 1.1-1.5], p < .01), and heavy calcification (OR 1.7 [95% CI, 1.0-2.7], p = .04). Three other potential candidate variables, glomerular filtration rate, proximal cap ambiguity, and target vessel, were not independently associated with perforation. The model was internally validated using bootstrapping methods. From the full model, a simplified perforation prediction score (OPEN-CLEAN score: CABG, Length [occlusion], EF < 50%, Age, CalcificatioN) was developed, which discriminated the risk of angiographic perforation well (c-statistics = 0.75) and demonstrated good calibration.
Conclusion:
This simple 5-variable prediction score may help CTO operators to risk-stratify patients for angiographic perforation using variables available prior to CTO PCI procedures.
