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

Acute Mechanical Performance of Magmaris vs. DESolve Bioresorbable Scaffolds in a Real-World Scenario

Background: After the bioresorbable PLLA-based vascular scaffold (Absorb BVS) was taken from the market due to its high adverse event rates, a magnesium-based scaffold (Magmaris) was introduced. Objective: To compare the acute performance of the sirolimus-eluting magnesium alloy Magmaris scaffold with that of the novolimus-eluting PLLA-based DESolve scaffold in terms of appropriate scaffold deployment using optical coherence tomography (OCT). Methods and Results: Data from the final OCT pullback of 98 patients were included (19 Magmaris, 79 DESolve) and analyzed at 1-mm intervals. The following indices were calculated: mean and minimal area, residual area stenosis, incomplete strut apposition, tissue prolapse, eccentricity index, symmetry index, strut fracture, and edge dissection. OCT showed a minimum lumen area for Magmaris vs. DESolve of 6.6 ± 1.6 vs. 6.0 ± 1.9 (p = 0.06). Scaffolds with residual area stenosis >20% were predominantly seen in the DESolve group (15.8 vs. 46.8%; p = 0.01). The mean eccentricity index did differ significantly (0.74 ± 0.06 vs. 0.63 ± 0.09; p < 0.001). No fractures were observed for Magmaris scaffolds, but 15.2% were documented for DESolve BRS (p < 0.001). Incomplete scaffold apposition area was significantly higher in the DESolve group (0.01 ± 0.02 vs. 1.05 ± 2.32 mm2; p < 0.001). Conclusion: This is the first study to compare the acute mechanical performance between Magmaris and DESolve in a real-world setting. The acute mechanical performance of Magmaris BRS seems to be superior to that of DESolve BRS, whereas OCT showed a good acute mechanical performance for both BRS in terms of generally accepted imaging criteria

Five‐year follow‐up of patients who underwent everolimus‐eluting bioresorbable scaffold implantation

Objectives The aim of this study was to evaluate very long‐term results after unrestricted everolimus‐eluting bioresorbable scaffolds (BRS) implantation. Background Previous randomized studies mainly included selected patients differing from those seen during daily routine and long‐term data from all‐comers registries are sparse. Methods Consecutive patients undergoing BRS implantation were included in this observational, single center study. Clinical follow‐up was conducted up to 5 years. Endpoint of interest was the composite of target lesion failure (TLF), including target‐vessel myocardial infarction and target lesion revascularization and cardiac death. Furthermore, ARC‐defined scaffold thrombosis (ScT) were assessed. Results A total of 176 patients with a median age of 64 (55 – 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 5 years, 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 2 years. Conclusions Although this real‐world registry displays high rates of clinical events during long‐term follow‐up, no ScT was seen after 2 years

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&#8722;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 &lt; 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&#8722;579) days after OCT. OCT-diagnosed malapposition was a predictor of late and very late scaffold thrombosis (p &lt; 0.001) that was independent of the timing of diagnosis. We provide evidence that an incidental finding of malapposition&#8212;regardless of the timing of diagnosis of the malapposition&#8212;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 (n = 180), within which 47 eccentric lesions (26%) and 133 concentric lesions were identified.!##!Results!#!Clinical success, defined as residual stenosis &amp;lt; 50% after stenting and no in-hospital MACE, was similar between the eccentric and concentric cohorts (93.6% vs. 93.2%, p = 1.0). 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; p = 0.54). Final acute gain and percent residual stenosis were similar between the two groups. Final residual stenosis of 8.6 ± 9.8% in eccentric and 10.0 ± 9.0% (p = 0.56) 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 follow‐up major adverse cardiac events (MACEs). Methods and Results A total of 315 patients (involving 370 lesions) who underwent optical coherence tomography–aided 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. Follow‐up MACE was defined as a composite of all‐cause death, myocardial infarction, stent thrombosis, and target lesion revascularization. Average minimum stent area was 6.02 (interquartile range, 4.65–7.92) mm2, while SEI was 0.79 (interquartile range, 0.71–0.86). Forty‐seven (12.7%) incidences of MACE were recorded for 370 included lesions during a median follow‐up duration of 557 (interquartile range, 323–1103) 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 follow‐up 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 follow‐up MACE.</p