Impact of calcification on percutaneous coronary intervention: MACE-Trial 1-year results.

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.

One-Year Results of the LIBERTY 360 Study: Evaluation of Acute and Midterm Clinical Outcomes of Peripheral Endovascular Device Interventions.

PURPOSE: To report the 1-year results of a multicenter study of peripheral artery disease (PAD) treatment with a variety of endovascular treatment strategies employed in routine practice. MATERIALS AND METHODS: The LIBERTY trial ( ClinicalTrials.gov identifier NCT01855412) is a prospective, observational, core laboratory-assessed, multicenter study of endovascular device intervention in 1204 subjects (mean age 69.8±10.7 years; 770 men) stratified by Rutherford category (RC): claudicants (RC2,3; n=501) and critical limb ischemia (CLI) with no/minimal tissue loss (RC4,5; n=603) or significant tissue loss (RC6; n=100). Key outcomes included quality of life (QoL) measures (VascuQol and EuroQol) and freedom from major adverse events (MAE), defined as death (within 30 days), major amputation, and target vessel revascularization based on Kaplan-Meier analysis. RESULTS: Successful revascularization was beneficial, with RC improvement noted across all groups. Thirty-day freedom from MAE estimates were high across all groups: 99.2% in RC2,3, 96.1% in RC4,5, and 90.8% in RC6. At 12 months, the freedom from MAE was 82.6% in RC2,3, 73.2% in RC4,5, and 59.3% in RC6 patients. Estimates for freedom from major amputation at 12 months were 99.3%, 96.0%, and 81.7%, respectively. QoL scores improved significantly across all domains in all groups with 12-month VascuQol total scores of 5.3, 5.0, and 4.8 for RC2,3, RC4,5, and RC6, respectively. CONCLUSION: The results indicate that peripheral endovascular intervention is a viable treatment option for RC2,3, RC4,5, and RC6 patients as evidenced by the high freedom from major amputation, as well as the improvement in QoL and the RC at 12 months. Furthermore, primary unplanned amputation is often not necessary in RC6.