4 research outputs found
Fiveâyear followâup of patients who underwent everolimusâeluting bioresorbable scaffold implantation
Objectives
The aim of this study was to evaluate very longâterm results after unrestricted everolimusâeluting bioresorbable scaffolds (BRS) implantation.
Background
Previous randomized studies mainly included selected patients differing from those seen during daily routine and longâterm data from allâcomers registries are sparse.
Methods
Consecutive patients undergoing BRS implantation were included in this observational, single center study. Clinical followâup was conducted up to 5âyears. Endpoint of interest was the composite of target lesion failure (TLF), including targetâvessel myocardial infarction and target lesion revascularization and cardiac death. Furthermore, ARCâdefined scaffold thrombosis (ScT) were assessed.
Results
A total of 176 patients with a median age of 64 (55 â 72) years were analyzed, of which 59.6% presented an acute coronary syndrome. A total of 183 mainly complex lesions (55.8%) were treated. At 5âyears, the rate for TLF was 21.6%. Definite or probable ScT rate was 4.1%. The rate of ScT within the first year was 2.8% and afterwards 1.2%. Notably, no ScT was seen later than 2âyears.
Conclusions
Although this realâworld registry displays high rates of clinical events during longâterm followâup, no ScT was seen after 2âyears
Incidental Finding of Strut Malapposition Is a Predictor of Late and Very Late Thrombosis in Coronary Bioresorbable Scaffolds
Malapposition is a common finding in stent and scaffold thrombosis (ScT). Evidence from studies with prospective follow-up, however, is scarce. We hypothesized that incidental observations of strut malapposition might be predictive of late ScT during subsequent follow-up. One hundred ninety-seven patients were enrolled in a multicentre registry with prospective follow-up. Optical coherence tomography (OCT), performed in an elective setting, was available in all at 353 (0−376) days after bioresorbable scaffold (BRS) implantation. Forty-four patients showed evidence of malapposition that was deemed not worthy of intervention. Malapposition was not associated with any clinical or procedural parameter except for a higher implantation pressure (p = 0.0008). OCT revealed that malapposition was associated with larger vessel size, less eccentricity (all p < 0.01), and a tendency for more uncovered struts (p = 0.06). Late or very late ScT was recorded in seven of these patients 293 (38−579) days after OCT. OCT-diagnosed malapposition was a predictor of late and very late scaffold thrombosis (p < 0.001) that was independent of the timing of diagnosis. We provide evidence that an incidental finding of malapposition—regardless of the timing of diagnosis of the malapposition—during an elective exam is a predictor of late and very late ScT. Our data provide a rationale to consider prolonged dual antiplatelet therapy if strut malapposition is observed
Safety and effectiveness of coronary intravascular lithotripsy in eccentric calcified coronary lesions: a patient-level pooled analysis from the Disrupt CAD I and CAD II Studies
Background!#!The aim of this study was to assess the safety and effectiveness of intravascular lithotripsy (IVL) in treating eccentric calcified coronary lesions.!##!Methods!#!Between December 2015 and March 2019, 180 patients were enrolled in the Disrupt CAD I and CAD II studies across 19 sites in 10 countries. Patient-level data were pooled from these two studies (nâ=â180), within which 47 eccentric lesions (26%) and 133 concentric lesions were identified.!##!Results!#!Clinical success, defined as residual stenosisâ&lt;â50% after stenting and no in-hospital MACE, was similar between the eccentric and concentric cohorts (93.6% vs. 93.2%, pâ=â1.0). There were no perforations, abrupt closure, slow flow or no reflow events observed in either group, and there were low rates of flow-limiting dissections (Grade D-F: 0% eccentric, 1.7% concentric; pâ=â0.54). Final acute gain and percent residual stenosis were similar between the two groups. Final residual stenosis of 8.6â±â9.8% in eccentric and 10.0â±â9.0% (pâ=â0.56) in concentric stenosis confirms the significant effect of IVL in calcified coronary lesions.!##!Conclusion!#!In this first report from a pooled patient-level analysis of coronary IVL from the Disrupt CAD I and CAD II studies, IVL use was associated with consistent improvement in procedural and clinical outcomes in both eccentric and concentric calcified lesions
Stent optimization using optical coherence tomography and its prognostic implications after percutaneous coronary intervention
Background
Stent underexpansion has been known to be associated with worse outcomes. We sought to define optical coherence tomography assessed optimal stent expansion index (SEI), which associates with lower incidence of followâup major adverse cardiac events (MACEs).
Methods and Results
A total of 315 patients (involving 370 lesions) who underwent optical coherence tomographyâaided coronary stenting were retrospectively included. SEI was calculated separately for equal halves of each stented segment using minimum stent area/mean reference lumen area ([proximal reference area+distal reference area]/2). The smaller of the 2 was considered to be the SEI of that case. Followâup MACE was defined as a composite of allâcause death, myocardial infarction, stent thrombosis, and target lesion revascularization. Average minimum stent area was 6.02 (interquartile range, 4.65â7.92) mm2, while SEI was 0.79 (interquartile range, 0.71â0.86). Fortyâseven (12.7%) incidences of MACE were recorded for 370 included lesions during a median followâup duration of 557 (interquartile range, 323â1103) days. Receiver operating characteristic curve analysis identified 0.85 as the best SEI cutoff (P=0.02). Least absolute shrinkage and selection operator regression identified SEI PP=0.05) as independent predictors of followâup MACE.
Conclusions
The present study identified SEI <0.85, associated with increased incidence of MACE, as the optimal cutoff in daily practice. Along with suboptimal SEI (<0.85), coronary calcification was also found to be a significant predictor of followâup MACE.</p