Device-oriented Clinical Endpoint Research Articles

Clinical Implications of Acute Stent Mal-Apposition in the Left Main Coronary Artery.

Intravascular ultrasound (IVUS) has been utilized to determine acute stent mal-apposition (ASM) after percutaneous coronary intervention (PCI) in the left main coronary artery (LMCA). However, the clinical consequences of this finding remain uncertain. This research aimed to evaluate the clinical implications of ASM in the LMCA using IVUS. In this study, 408 patients who underwent successful drug-eluting stent (DES) implantation in the LMCA were evaluated. We analyzed the prevalence and characteristics of ASM and its correlation with clinical outcomes. ASM is characterized by stent struts that are not in immediate proximity to the intimal surface of the vessel wall after initial stent deployment. The observed incidence of LMCA-ASM post-successful PCI was 26.2%, both per patient and per lesion. Lesions with LMCA-ASM had a longer stent diameter, larger stent areas, and larger lumen areas compared to those without LMCA-ASM (4.0 0.5 vs. 3.7 0.4 mm, p 0.001; 9.8 2.0 vs. 9.0 1.6 , p 0.001; 12.3 1.9 vs. 10.1 2.1 , p 0.001, respectively). The mean external elastic membrane (EEM) area (odds ratio (OR): 1.418 [95% confidence interval (CI): 1.295-1.556]; p 0.001) emerged as an independent predictor of LMCA-ASM. During the observation period, LMCA-ASM did not display any association with device-oriented clinical endpoints (DoCE), which included cardiac death, target vessel-induced myocardial infarction (MI), stent thrombosis, and target lesion revascularization (TLR). Moreover, the DoCE incidence exhibited no significant disparity between patients with or without ASM (13.1 vs. 6.0%, p = 0.103). While LMCA-ASM was a not uncommon finding post-PCI, it did not correlate with adverse cardiac events in the present study.

Volumetric Stent Expansion Index to Assess Tapering Lesions Using Intravascular Ultrasound and Its Clinical Outcomes.

This study aimed to assess the clinical significance of generating a volumetric stent expansion index for tapering lesions through intravascular ultrasound (IVUS). Previous IVUS studies have used minimal stent area (MSA) to predict adverse outcomes. A total of 251 tapering lesions were treated in this study via IVUS guidance in 232 patients. Eight stent expansion indices were evaluated to determine the association of these indices with device-oriented clinical endpoints (DoCEs) after two-year follow-ups. These were the ILUMIEN III and IV standards, the ULTIMATE (Intravascular Ultrasound Guided Drug Eluting Stents Implantation in "All-Comers" Coronary Lesions) standard, the IVUS-XPL (Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions) standard, the minimal volumetric expansion index (MVEI) using the Huo-Kassab or linear model, the MSA/vessel area at the MSA cross-section, the traditional stent expansion (MSA/mean proximal and distal reference lumen cross-sectional area), and MSA. The MVEI was the only stent expansion index that correlated significantly with the two-year DoCEs (hazard ratio [HR], 1.91; 95% confidence interval [CI]: 1.16-3.96; p = 0.028). In the ROC analysis, the area under the curve for the MVEI was 0.71 (p = 0.002), with an optimal cut-off value of 62.2 for predicting the DoCEs. This is the first study to use IVUS for tapering lesions and demonstrate that the MVEI is an independent predictor of two-year DoCEs.

Stent expansion evaluated by optical coherence tomography and subsequent outcomes

Regarding stent expansion indices, previous optical coherence tomography (OCT) studies have shown minimal stent area (MSA) to be most predictive of adverse events. We sought to evaluate the impact of various stent expansion and apposition indices by post-stent OCT on clinical outcomes and find OCT-defined optimal stent implantation criteria. A total of 1071 patients with 1123 native coronary artery lesions treated with new-generation drug-eluting stents with OCT guidance and final post-stent OCT analysis were included. Several stent expansion indices (MSA, MSA/average reference lumen area, MSA/distal reference lumen area, mean stent expansion, and stent expansion by linear model [stent volume/adaptive reference lumen volume]) were evaluated for their association with device-oriented clinical endpoints (DoCE) including cardiac death, target vessel-related myocardial infarction (MI) or stent thrombosis, and target lesion revascularization. MSA was negatively correlated with the risk of DoCE (hazard ratio [HR] 0.80 [0.68‒0.94]). However, stent expansion by linear model representing the overall volumetric stent expansion was associated with greater risk of DoCE (HR 1.02 [1.00‒1.04]). As categorical criteria, MSA < 5.0 mm2 (HR 3.90 [1.99‒7.65]), MSA/distal reference lumen area < 90% (HR 2.16 [1.12‒4.19]), and stent expansion by linear model ≥ 65.0% (HR 1.95 [1.03‒3.89]) were independently associated with DoCE. This OCT study highlights the importance of sufficient stent expansion to achieve adequate, absolute, and relative MSA criteria for improving clinical outcome. It also emphasises that overall volumetric excessive stent expansion may have detrimental effects.

Optical coherence tomography factors for adverse events in patients with severe coronary calcification

BackgroundSevere coronary calcification is a factor for worse outcomes after percutaneous coronary intervention. AimsTo identify factors of pre- and post-stent optical coherence tomography (OCT) for device-oriented clinical endpoints (DoCE) in patients with severely calcified lesions requiring drug-eluting stent (DES) implantation. MethodsA total of 237 consecutive patients with stable coronary disease who underwent OCT imaging of severe coronary lesions were included. Lesions with a maximum calcium angle >180°, maximum calcium thickness > 0.5 mm, and calcium length > 5 mm were defined as having severe calcification. ResultsThe prevalence of eruptive calcified nodules (41% vs. 18%, p = 0.002) and medial dissection with calcified flaps (59% vs. 26%, p < 0.001) was significantly higher in patients with DoCE (n = 34) than those without DoCE (n = 203). Multivariate analyses demonstrated that the presence of a medial dissection with calcified flap within the DES-implanted segment was independently associated with a higher incidence of DoCE (odds ratio, 3.367; 95% confidence interval, 1.503–7.543; p = 0.003). The combined presence of eruptive calcified nodules and medial dissection with calcified flaps was associated with a higher incidence of DoCE (p < 0.001) during a median of 756 days after DES implantation. ConclusionsOCT-defined severely calcified lesions with eruptive calcified nodules and medial dissection with calcified flaps were associated with a higher incidence of DoCE after DES implantation.

Abstract 13084: Clinical Outcomes and Factors for Adverse Events in Patients With Severe Coronary Calcification Assessed by Optical Coherence Tomography

Introduction: Severe coronary calcification is a known factor for worse clinical and angiographic outcomes after percutaneous coronary intervention (PCI). However, the association between lesion characteristics and post-stent findings and worse clinical outcomes in patients with severely calcified lesions remains to be elucidated. Hypothesis: Among patients with severely calcified lesions, pre and post stent findings assessed by optical coherence tomography (OCT) are associated with future adverse events. Methods: A total of 241 consecutive patients with severely calcified lesions, who underwent OCT imaging of the culprit lesion were included. Severely calcified lesion was defined as a lesion with a maximum calcium angle &gt;180°, maximum thickness &gt;0.5 mm and calcium length &gt;5 mm, which were assessed by OCT. The device-oriented clinical endpoint (DoCE) was defined as a composite of cardiac death, target vessel-related myocardial infarction, ischemia-driven target lesion revascularization, and stent thrombosis. Results: The presence of eruptive calcified nodule (eCN) (41% vs. 18%, p =0.003) in the culprit lesion and medial dissection with calcified flaps (59% vs. 26%, p &lt;0.001) after stenting was significantly higher in patients with DoCE than in those without. Among the four groups classified by the presence of eCN and medial dissection with calcified flap, incidence of DoCE was the highest in lesions with both eCN and medial dissection with calcified flap ( p &lt;0.001) (Figure). Conclusions: An increased incidence of DoCE was demonstrated in lesions with the combined presence of eCN and medial dissection with calcified flap. The present results may explain the importance of the careful assessment of severely calcified lesions using OCT for the risk stratification of future adverse events.

Stent expansion evaluated by optical coherence tomography and subsequent outcomes

Abstract Background Regarding stent expansion indexes, previous optical coherence tomography (OCT) studies have shown minimal stent area (MSA) to be most predictive of adverse events. Purpose We sought to evaluate the impact of various stent expansion indexes by post-stent OCT on long-term clinical outcomes, and hence to find OCT-defined optimal stent expansion criteria. Methods Of the patients registered in the Yonsei OCT registry, a total of 1071 patients with 1123 native coronary artery lesions treated with new-generation drug-eluting stents under the OCT guidance and analyzable final post-stent OCT were included. Stent expansion indexes and different suboptimal stent expansion criteria were evaluated for their association with device-oriented clinical endpoints (DoCE) including cardiac death, target vessel-related myocardial infarction (TVMI) or stent thrombosis, and target lesion revascularization. Major safety events (MSE) included cardiac death, TVMI or stent thrombosis. Results The median follow-up period was 40.6 (interquartile range 22.0–50.0) months. As a continuous variable, MSA, adaptive volumetric stent expansion (stent volume/adaptive reference lumen volume) and overall volumetric stent expansion (stent volume/post-stent lumen volume) were significantly predictive of DoCE. As a categorical criteria, MSA &amp;lt;5.0 mm2 (hazard ratio [HR] 3.80; 95% confidence interval [CI] 1.53–9.45), MSA/distal reference lumen area &amp;lt;90% (HR 2.13; 95% CI 1.10–4.14), and overall volumetric stent expansion ≥96.6% (HR 2.38; 95% CI 1.09–5.22) were independently associated with DoCE after adjusting for confounders, and a total malapposition volume ≥7.0 mm3 (HR 3.38; 95% CI 1.05–10.93) was linked to MSE. Conclusions This OCT study highlights that sufficient stent expansion to achieve adequate absolute MSA and relative MSA by distal reference lumen area and alleviate significant malapposition is important to improve clinical outcome, but overall stent overexpansion may have deleterious effect. Funding Acknowledgement Type of funding sources: None.

Clinical Implications of Poststent Optical Coherence Tomographic Findings: Severe Malapposition and Cardiac Events

ObjectivesThis study sought to evaluate the impact of poststent optical coherence tomography (OCT) findings, including severe malapposition, on long-term clinical outcomes. BackgroundSuboptimal OCT findings following percutaneous coronary intervention (PCI) are highly prevalent; however, their clinical implications remain controversial. MethodsOf the patients registered in the Yonsei OCT registry, a total of 1,290 patients with 1,348 lesions, who underwent OCT immediately poststenting, were consecutively enrolled for this study. All patients underwent implantation of drug-eluting stents. Poststent OCT findings were assessed to identify predictors of device-oriented clinical endpoints (DoCE), including cardiac death, target vessel-related myocardial infarction (MI) or stent thrombosis, and target lesion revascularization (TLR). Significant malapposition criteria associated with major safety events (MSE) were also investigated, such as cardiac death, target vessel-related MI, or stent thrombosis. ResultsThe median follow-up period was 43.0 months (interquartile range [IQR] 21.4 to 56.0 months). The incidence rates of stent edge dissection, tissue prolapse, thrombus, and malapposition after intervention were not associated with occurrence of DoCE. However, patients with significant malapposition (total malapposition volume [TMV] ≥7.0 mm3] exhibited more frequent MSE. A smaller minimal stent area (MSA) was identified as an independent predictor for DoCE (hazard ratio [HR]: 1.20 [95% confidence interval [CI]: 1.00 to 1.43]; p = 0.045). Malapposition with TMV ≥7.0 mm3 was found to be an independent predictor of MSE (HR: 6.12 [95% CI: 1.88 to 19.95]; p = 0.003). Follow-up OCT at 3, 6, or 9 months after PCI showed that poststent TMV ≥7.0 mm3 was related to a greater occurrence of late malapposition and uncovered struts. ConclusionsAlthough most suboptimal OCT findings were not associated with clinical outcomes, a smaller MSA was associated with DoCE, driven mainly by TLR, and significant malapposition with TMV ≥7.0 mm3 was associated with more MSE after PCI. (Yonsei OCT [Optical Coherence Tomography] Registry for Evaluation of Efficacy and Safety of Coronary Stenting; Yonsei OCT registry; NCT02099162)

Abstract 16295: Smaller Stent Area and Eccentric Expansion are Associated With Increased Adverse Events After Drug-eluting Stent Implantation in Hemodialysis Patients

Introduction: Factors for adverse cardiac events after drug-eluting stent (DES) implantation among patients with hemodialysis (HD) remain to be elucidated. Hypothesis: Suboptimal DES implantation is associated with the increased incidence of adverse events in patients with HD. Methods: A total of 109 consecutive patients with HD who underwent optical coherence tomography (OCT)-guided DES implantation were included. The impact of post-stent OCT findings on the incidence of device-oriented clinical endpoints (DoCE) at 1 year was investigated. DoCE included cardiac death, target vessel-related myocardial infarction, target lesion revascularization, and stent thrombosis. Results: There was no significant difference in baseline clinical characteristics and pre-stent lesion characteristics between patients with DoCE (n=15) and those without DoCE (n=94). Significant hazard ratio (HR) for the incidence of DoCE was not observed in the presence of edge dissection, irregular protrusion, or incomplete stent apposition (Panel A). In receiver operating characteristic curve analyses, the best cutoff of minimum stent cross-sectional area (MSA), %stent expansion [MSA / mean reference lumen cross-sectional area х 100], and eccentricity index (minimum stent diameter / maximum stent diameter) at MSA site for detecting DoCE was 3.4 (mm 2 ), 72.0 (%), and 0.71, respectively. Significant HR for the incidence of DoCE was observed in the presence of MSA&lt; 3.4 (HR 3.58, 95% confidence interval [CI] 1.04 - 12.4, p=0.035) and eccentricity index&lt; 0.71 (HR 6.68, 95% CI 1.94 - 23.0, p=0.001) (Panel B). Conclusions: Smaller stent area and eccentric expansion were associated with increased incidence of DoCE after DES implantation in patient with HD, although the presence of other post-stent suboptimal findings were not associated with the incidence of DoCE. The present results suggest the importance of larger stent area and concentric stent expansion in patients with HD.

Clinical implications of post-stent optical coherence tomographic findings after drug-eluting stent implantation: severe malapposition and thrombotic events

Abstract Background The clinical implications of optical coherence tomography (OCT) assessment following percutaneous coronary intervention are controversial. Purpose We sought to evaluate the impact of post-stent OCT findings, including significant malapposition, on long-term clinical outcomes. Methods A total of 1,290 patients with 1,348 lesions, in which OCT was performed immediately post-stent, were consecutively enrolled in the prospective OCT registry. Post-stent OCT findings were assessed to identify predictors of device-oriented clinical end points (DoCE), including cardiac death, target vessel-related myocardial infarction (MI), stent thrombosis, and target lesion revascularization (TLR). We also looked for significant malapposition criteria that may be associated with thrombotic events such as cardiac death, target vessel-related MI, and stent thrombosis. Results Incidences of stent edge dissection, tissue prolapse, thrombus, and malapposition after intervention were not associated with occurrence of adverse thrombotic events. However, patients with significant malapposition [total malapposition volume (TMV) ≥7.0 mm3 or TMV/stent volume ≥4.1%] exhibited more frequent thrombotic events. In multivariate analysis, smaller minimal stent area (MSA) was identified as an independent predictor for DoCE (hazard ratio [HR], 1.21 [1.01–1.45]; P=0.037). Malapposition with TMV ≥7.0 mm3 was found to be an independent predictor of thrombotic events (HR, 4.62 [1.29–16.47]; P=0.018). Conclusions Although most high-resolution OCT findings were not associated with clinical outcome, smaller MSA was associated with DoCE, driven mainly by TLR, and significant malapposition with TMV ≥7.0 mm3 was associated with more thrombotic events after drug-eluting stent implantation. Kaplan-Meier curve Funding Acknowledgement Type of funding source: None

Clinical outcome of biodegradable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent in patients with diabetes

BackgroundDiabetes mellitus is a risk for increased incidence of adverse clinical events after percutaneous coronary intervention. However, the difference in the incidence of adverse clinical events according to stent type in patients with diabetes remains to be elucidated. In the present study, we aimed to compare the clinical outcomes between patients treated with the biodegradable polymer sirolimus-eluting stents (BP-SES) and the durable polymer everolimus-eluting stents (DP-EES) among patients with diabetes.MethodsAmong 631 lesions in 510 consecutive patients treated with either BP-SES or DP-EES, 165 lesions in 141 patients with diabetes mellitus and stable angina pectoris were identified and classified into the BP-SES group (48 lesions in 44 patients) and the DP-EES group (117 lesions in 100 patients). The incidence of adverse clinical events after stent implantation was compared between the 2 groups.ResultsThere was no significant difference in the prevalence of conventional risk factors, lesion characteristics, and procedural characteristics between the 2 groups. During median 386 [334–472] days follow-up, the incidence of target lesion revascularization (11.4 vs. 2.0%, p = 0.003) and device-oriented clinical endpoint (13.6 vs. 6.0%, p = 0.035) in the BP-SES group was significantly greater than that in the DP-EES group. A univariate model demonstrated that the BP-SES usage was significantly associated with the higher incidence of target lesion revascularization (odds ratio, 6.686; 95% confidence interval, 1.234–36.217; p = 0.028).ConclusionBP-SES was associated with the greater incidence of TLR than the DP-EES in patients with diabetes mellitus. Further studies with larger cohorts and longer follow-up are required to confirm the present results.

P5626The clinical impact of the angle of OCT detected irregular protrusion after primary PCI at the STEMI culprit lesions

Abstract Background and introduction The percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) shows worse clinical outcomes than that for stable angina. As the one of the reasons, a recent optical coherence tomography (OCT) registry showed that the presence of irregular protrusion (IP)after coronary stenting was the worse predictor of 1-year device-oriented clinical end points. However, the impact of the quantitative findings on IP has not been well investigated in ACS patients. Aim To investigate the clinical impact of the post stent OCT findings, especially IP, detected by OCT after coronary stenting in ACS patients. Methods Consecutive 256 ACS lesions treated with OCT-guided PCI in our Medical University Hospital from January 2013 to November 2016 was retrospectively analyzed. In 256 lesions, 173 lesions were enrolled which had ST-elevation acute myocardial infarction (STEMI) with the onset to recanalization time within 720 minutes. In 170 lesions, the OCT images were available. In OCT image, IP was detected in 140 lesions (82.3%). Quantitative analysis of IP in post-procedure OCT imaging was observed to identify the OCT predictors for clinical endpoint including cardiac death, target vessel revascularization ant stent thrombosis in 1 year after index PCI. Result In post-procedure OCT findings, stent edge dissection was detected in 32.4% of lesions. Incomplete stent apposition was detected in 74.1%. Maximum angle of irregular protrusion was 194±86 degree and the incidence of maximum IP angle &gt;180 degree was 52.9%. Maximum height of IP was 0.26±0.11mm. Small minimal stent area, defined as a lesion with minimal stent area &lt;5.0 mm2 in a drug-eluting stent or &lt;5.6 mm2 in a bare metal stent, was observed in 32.4% of lesions. Maximum IP angle and that of &gt;180degree was significantly associated with the clinical endpoint (p=0.0259 and 0.0429, respectively). Conclusion In STEMI patients, IP was frequently observed in post-procedure OCT imaging during primary PCI. The maximum angle of IP was significantly associated with the clinical end points. The prognostic impact of maximum IP angle in STEMI patient needs further investigations.

Incidence and Clinical Significance of Poststent Optical Coherence Tomography Findings: One-Year Follow-Up Study From a Multicenter Registry.

Optical coherence tomography (OCT) was recently introduced to optimize percutaneous coronary intervention. However, the exact incidence and significance of poststent OCT findings are unknown. A total of 900 lesions treated with 1001 stents in 786 patients who had postprocedure OCT imaging were analyzed to evaluate the incidence of poststent OCT findings and to identify the OCT predictors for device-oriented clinical end points, including cardiac death, target vessel-related myocardial infarction, target lesion revascularization, and stent thrombosis. Patients were followed up to 1 year. Stent edge dissection was detected in 28.7% of lesions, and incomplete stent apposition was detected in 39.1% of lesions. The incidences of smooth protrusion, disrupted fibrous tissue protrusion, and irregular protrusion were 92.9%, 61.0%, and 53.8%, respectively. Small minimal stent area, defined as a lesion with minimal stent area <5.0 mm(2) in a drug-eluting stent or <5.6 mm(2) in a bare metal stent, was observed in 40.4% of lesions. One-year device-oriented clinical end points occurred in 33 patients (4.5%). Following adjustment, irregular protrusion and small minimal stent area were independent OCT predictors of 1-year device-oriented clinical end points (P=0.003 and P=0.012, respectively). Abnormal poststent OCT findings were frequent. Irregular protrusion and small minimal stent area were independent predictors of 1-year device-oriented clinical end points, which were primarily driven by target lesion revascularization.