ABSTRACT
OBJECTIVES: In this study we sought to evaluate coverage and apposition of Synergy™ stent at 3 and 6 months after implantation. BACKGROUND: The Pt-Cr everolimus-eluting stent with abluminal bioabsorbable polymer (Synergy™) is a new generation drug-eluting stent with features potentially favoring an early healing process which could make safe a shorter period of dual antiplatelet-therapy treatment. METHODS: Prospective, two-centers study enrolling patients with similar lesions treated with Synergy™ stents undergoing examination with OCT at 3 and 6 months in the respective centers. Blinded analysis was done at a core lab. Co-primary endpoints were proportion of struts with coverage and with apposition at 3 and 6 months. RESULTS: Finally, 22 patients (30 stents) in the 3 months group and 20 patients (30 stents) in the 6 months group were included. There were no significant differences between groups regarding clinical, angiographic measurements, and procedural data. The rate of strut coverage was 94.5% at 3 months and 96.6% at 6 months (P < 0.001), the rates of apposition were 93.8% and 96.2%, respectively, (P < 0.001), the proportion of uncovered but apposed struts was 2.5% and 1.9% (P = 0.03) and the proportion of uncovered and malapposed struts was 3% and 1.8%, respectively (P < 0.001). The maximal area of malapposition related with uncovered struts was 0.43 ± 0.4 mm(2) at 3 months and 0.14 ± 0.2 mm(2) at 6 months (P = 0.001). CONCLUSIONS: The everolimus-eluting stent with absorbable polymer, Synergy™, is associated to a high degree of intimal coverage and apposition at 3 months after implantation with additional increase at 6 months. © 2015 Wiley Periodicals, Inc.
Subject(s)
Absorbable Implants , Cardiovascular Agents/administration & dosage , Coronary Artery Disease/therapy , Coronary Vessels/drug effects , Drug-Eluting Stents , Everolimus/administration & dosage , Percutaneous Coronary Intervention/instrumentation , Polymers/chemistry , Tomography, Optical Coherence , Wound Healing/drug effects , Aged , Cardiovascular Agents/adverse effects , Coronary Angiography , Coronary Artery Disease/diagnostic imaging , Coronary Vessels/diagnostic imaging , Everolimus/adverse effects , Female , Humans , Male , Middle Aged , Neointima , Percutaneous Coronary Intervention/adverse effects , Platelet Aggregation Inhibitors/administration & dosage , Predictive Value of Tests , Prospective Studies , Prosthesis Design , Spain , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVE: To compare the sensitivity and specificity for coronary calcium detection of two fluoroscopic systems: 1) conventional system based on image intensifier chains (CONV); and 2) flat panel digital detector (FPDD) system, using intravascular ultrasound (IVUS) as the gold standard. BACKGROUND: Coronary calcification represents advanced atherosclerotic disease and has implications during coronary interventions. Angiography has been reported to have low sensitivity for calcium detection compared with IVUS. METHODS: Lesion calcification was assessed by two different fluoroscopic systems (FPDD and CONV), and by IVUS. RESULTS: In two consecutive periods, a total of 200 consecutive patients were included, 100 in each group. Clinical characteristics were similar, without significant differences between groups. In the CONV group, IVUS detected calcium in 77% of cases, and angiography in 32%. Sensitivity was 41.6% and specificity 91.3%. In the FPDD group, IVUS reported calcification in 79% of patients, and angiography in 57%. Sensitivity was 72% (p < 0.0001 for comparison with CONV) and specificity was 90.4%. CONCLUSION: The new fluoroscopic systems, based on FPDD, considerably increase the sensitivity for calcium detection without detrimental effect on specificity.
