Samin K Sharma1, Ryan W Bolduan2, Manesh R Patel3, Brad J Martinsen2, Talhat Azemi4, Gregory Giugliano5, Jon R Resar6, Roxana Mehran1, David J Cohen7, Jeffrey J Popma8, Ron Waksman9. 1. Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. 2. Scientific Affairs, Cardiovascular Systems, Inc., St. Paul, Minnesota. 3. Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina. 4. Department of Cardiovascular Medicine, Hartford Hospital, Hartford, Connecticut. 5. Division of Cardiology, Department of Internal Medicine, Baystate Medical Center, Springfield, Massachusetts. 6. Department of Medicine, Division of Cardiology, Johns Hopkins University School of Medicine, Baltimore, Maryland. 7. Cardiovascular Research, St. Luke's Mid America Heart Institute, Kansas City, Missouri. 8. Interventional Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts. 9. Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia.
Abstract
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.
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.
Authors: Adrian Włodarczak; Piotr Rola; Mateusz Barycki; Jan Jakub Kulczycki; Marek Szudrowicz; Maciej Lesiak; Adrian Doroszko Journal: J Clin Med Date: 2021-04-26 Impact factor: 4.241