Impact of calcification on percutaneous coronary intervention: MACE-Trial 1-year results
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.
CONFLICT OF INTEREST
The authors acknowledge the following potential conflicts of interest: S. Sharma is part of the speaker bureau for Abbott Vascular, Cardiovascular Systems, Inc. (CSI), Boston Scientific, and Abiomed. R. Bolduan and B. Martinsen are employed by and own stock in CSI. M. Patel receives research grants from AstraZeneca, Bayer, Jansen, NHLBI, Procyrion, and CSI; and has served on the advisory board at AstraZeneca, Bayer, and Jansen. T. Azemi is a speaker for Abbott, Astra Zeneca, and CSI; and has a consulting agreement with CSI. J. Resar has received research grants from Medtronic, Boston Scientific, Abbott Vascular and CSI; and has served on the physician advisory board for Boston Scientific. R. Mehran has received research grant support from Eli Lilly/Daiichi-Sankyo, Bristol-Myers Squibb, AstraZeneca, The Medicines Company, Abbott Laboratories, Watermark Research Partners, Novartis Pharmaceuticals, Medtronic, AUM Cardiovascular, Beth Israel Deaconess Medical Center, OrbusNeich, Bayer, CSL Behring, and Abbott Laboratories; has received institutional grant support from The Medicines Company, Bristol-Myers Squibb/Sanofi, AstraZeneca, Watermark Research Partners, Novartis Pharmaceuticals, Medtronic, AUM Cardiovascular, Beth Israel Deaconess Medical Center, Eli Lilly and Company/Daiichi-Sankyo, OrbusNeich, Bayer, and CSL Behring; has served as a consultant to and received consulting fees from Janssen Pharmaceuticals, The Medicines Company, Boston Scientific, Merck & Company, Cardiovascular Systems, Sanofi, Shanghai BraccoSine Pharmaceutical, AstraZeneca, Osprey Medical, Watermark Research Partners, and Medscape; has served on the executive committee for Janssen Pharmaceuticals and Osprey Medical; has served on the Data Safety Monitoring Board for Watermark Research Partners; owns equity in Claret Medical and Elixir Medical Group; and has served on the advisory board of Abbott Laboratories. D. Cohen has received research grant support from CSI, Boston Scientific, Medtronic, Edwards Lifesciences, Abbott Vascular; and consulting income from Medtronic, Edwards Lifesciences. J. Popma has received research grants from Medtronic, Boston Scientific, and Direct Flow Medical; consulting fees from Boston Scientific and Direct Flow Medical; and equity from Direct Flow Medical. R. Waksman serves on the advisory board for Abbott Vascular, Amgen, Boston Scientific, Medtronic, and Philips Volcano; has served as a consultant for Abbott Vascular, Amgen, Biosensors, Biotronik, Boston Scientific, Corindus, Lifetech Medical, Medtronic, and Philips Volcano; has received research grant support from Abbott Vascular, Biosensors, Biotronic, Boston Scientific, Chiesi, and Edwards Lifesciences; and is an investor in MedAlliance. G. Giugliano has no conflicts of interest to declare.
