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Updated: Jan 30, 2026

Identifying Coronary Artery Calcification on Non-gated Computed Tomography Scans
Published on: August 28, 2018
Impact of calcification on percutaneous coronary intervention: MACE-Trial 1-year results
Samin K Sharma1, Ryan W Bolduan2, Manesh R Patel3
1Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
Insights
Severe calcification significantly impacts percutaneous coronary intervention outcomes. Moderate calcification, however, showed similar results to mild or no calcification in this prospective study.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Clinical Trials
Background:
- Previous studies on coronary lesion calcification were limited by retrospective designs and lack of core lab evaluation.
- The impact of moderate versus severe calcification on percutaneous coronary intervention (PCI) outcomes requires further investigation.
Purpose of the Study:
- To evaluate the impact of moderate to severe coronary lesion calcification on procedural and long-term outcomes of percutaneous coronary intervention (PCI).
- To address limitations of prior studies by employing a prospective, multicenter design with core lab assessment of calcification.
Main Methods:
- Prospective, multicenter observational study (MACE-Trial) enrolling 350 subjects.
- Core lab assessed lesion calcification: none/mild (133), moderate (99), severe (114).
- Primary endpoints included lesion success, procedural success, and 1-year major adverse cardiac events (MACEs).
Main Results:
- Severe calcification significantly reduced lesion success (83.3%) and procedural success (86.8%) compared to none/mild calcification.
- One-year MACE rates increased with calcification severity: none/mild (4.7%), moderate (8.7%), severe (24.4%) (P < 0.001).
- Severe calcification and decreasing estimated glomerular filtration rate (eGFR) were predictors of 30-day and 1-year MACE.
Conclusions:
- Severe coronary calcification is associated with significantly worse PCI outcomes.
- Unlike prior retrospective studies, moderate calcification did not result in significantly different outcomes compared to none/mild calcification.
- This prospective data clarifies the distinct impact of varying degrees of coronary calcification on PCI success and MACE.
Objectives:
The Multi-center Prospective Study to Evaluate Outcomes of Moderate to Severely Calcified Coronary Lesions (MACE-Trial) was designed to provide further insight on the impact of calcification on procedural and long-term percutaneous coronary intervention outcomes.
Background:
Prior studies evaluating the impact of lesion calcification on percutaneous coronary intervention outcomes are limited by: retrospective nature, pooled data from multiple studies, or lack of specificity around calcification with only operator assessment and without core lab evaluation.
Methods:
The MACE-Trial was a prospective, multicenter, observational clinical study that enrolled 350 subjects at 33 sites from September 2013 to September 2015. Core lab assessed subject stratification by lesion calcification (none/mild [N = 133], moderate [N = 99], and severe [N = 114]). Endpoints were lesion success, procedural success, and 1-year major adverse cardiac events (MACEs).
Results:
Presence of severe calcification had significant impact on lesion success ([83.3%] versus none/mild calcification [94.7%, P = 0.006]) and procedural success ([86.8%] versus moderate [95.0%, P = 0.028], and none/mild [97.7%, P = 0.001]). 1-year MACE rates were associated with presence of calcification in subjects with none/mild (4.7%), moderate (8.7%), and severe (24.4%) (P < 0.001) calcification; however, no difference was noted between none/mild and moderate (P = 0.237). The risk adjusted multivariable model identified severe calcification and decreasing eGFR as predictors of 30-day and 1-year MACE.
Conclusions:
In this prospective study, patients with severe calcification had significantly worse outcomes compared to those without; however, unlike previous retrospective studies, moderate calcium resulted in similar outcomes as none/mild calcium.
Clinical Trial Registration:
URL: https://clinicaltrials.gov/ct2/show/NCT01930214. Unique Identifier: NCT01930214.
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