Dominant Neointimal Coverage Grade Research Articles

Angioscopic Evaluation of Vascular Response After Fluoropolymer-Based Drug-Eluting Stent Implantation for Femoropopliteal Artery Lesions.

Although favorable clinical outcomes have been demonstrated for fluoropolymer-based paclitaxel-eluting stents (FP-DES) in the treatment of femoropopliteal lesions, the vascular response after implantation has not been systematically studied through intravascular imaging.Methods and Results: We angioscopically compared FP-DES: 24 in the early phase (mean [±SD] 3±1 months), 26 in the middle phase (12±3 months), and 20 in the late phase (≥18 months) after implantation. The dominant neointimal coverage grade, heterogeneity of neointimal coverage grade, and thrombus adhesion in the stent segment were evaluated. Neointimal coverage was graded as follows: Grade 0, stent struts exposed; Grade 1, struts bulging into the lumen, although covered; Grade 2, struts embedded in the neointima, but visible; Grade 3, struts fully embedded and invisible. Dominant neointimal coverage and heterogeneity grades were significantly higher in the middle and late phases than in the early phase (all P<0.05), but did not differ significantly between the middle and late phases. The incidence of thrombus adhesion was recorded for all stents in each of the 3 different phases. The middle and late phases after FP-DES implantation were associated with significantly higher dominant neointimal coverage and heterogeneity grades than the early phase. However, thrombus adhesion was observed in all phases after FP-DES implantation. Arterial healing may not be completed even in the late phase after FP-DES implantation.

Angioscopic evaluation of vascular healing at 1 and 12 months after drug-coated stent implantation

Abstract Background Polymer- and carrier-free Biolimus-A9-coated stent (DCS) is expected better vascular healing compared with conventional durable polymer drug-eluting stents (DES). Moreover, DCS had been demonstrated in clinical trials to allow one-month short dual antiplatelet therapy, which might achieve sufficient healing at only 1 month after implantation. However, the process of vascular healing after DCS implantation has not been elucidated by angioscopic observation. Purpose To evaluate the process of vascular healing at 1 month and 12 months after DCS implantation. Methods This study included 57 patients treated with DCS or durable polymer everolimus-eluting stents (EES) in our hospital from April 2017 to April 2019. Firstly, the angioscopic findings of DCS at 1 month (n=16) and 12 months (n=14) after implantation were respectively compared with EES at 12 months after implantation (EES-12, n=35) as a standard healing status of DES. Secondary, angioscopic findings of DCS at 1 month and 12 months after implantation were compared among the serially observed eight patients. Neointimal coverage (NIC) grade, yellow colour grade, and the presence of thrombus were evaluated. NIC grade was classified as grade 0 (no neointimal coverage), grade 1 (struts were bulged into lumen but covered), grade 2 (struts were embedded in the neointima but visible), or grade 3 (struts were fully embedded and invisible). Yellow colour grade was classified as grade 0 (white), grade 1 (light yellow), grade 2 (yellow), or grade 3 (intensive yellow). Results At 1 month after DCS implantation, dominant NIC grade was lower (0.3±0.5 vs. 1.5±0.7, p&amp;lt;0.001) and the frequency of thrombus was higher (38% vs. 6%, p=0.008) than EES-12. On the other hands, at 12 months after DCS implantation, dominant NIC grade was higher (2.1±0.6 vs. 1.5±0.7, p=0.013) and the frequency of thrombus was not different (7% vs. 6%, p=1.000) in comparison with EES-12. By serial observation of DCS, dominant NIC grade was higher at 12 months than at 1 month (2.3±0.5 vs. 0.4±0.5, p&amp;lt;0.001), while yellow colour grade (1.0±0.5 vs. 1.5±1.2, p=0.227) and the frequency of thrombus adhesion (0% vs. 38%, p=0.200) were not different. Conclusion Compared with EES-12, vascular healing of DCS was inferior at 1 month but superior at 12 months. Figure 1 Funding Acknowledgement Type of funding source: None

Angioscopic assessments and clinical outcomes one year after polymer-free biolimus A9-coated coronary stent implantation

BackgroundPolymer-free biolimus A9-coated coronary stent (DCS) has novel features which lead to the expectation of better arterial healing. However, comparisons of intravascular status between DCS and drug-eluting stents (DES), and robust real-word clinical assessments of DCS have been lacking to date. MethodsFrom September 2017 to September 2018, we evaluated the intra-vascular status of 74 DCS implanted in 55 lesions from 43 patients using coronary angioscopy (CAS) approximately one year after implantation from a cohort of 219 lesions in 158 patients. We set 239 second-generation durable-polymer DES (DP-DES) implanted in 211 lesions from 180 patients from a cohort of 2652 lesions in 1914 patients as the control. Angioscopic images were analyzed to determine (1) the dominant degree of neointimal coverage (NIC) over the stent; (2) the heterogeneity of NIC; (3) yellow color grade of the stented segment; and (4) the presence of intra-stent thrombus. The primary outcome was the incidence of thrombus and secondary outcomes were the other CAS findings, and the 1-year clinical outcomes which included target lesion revascularization (TLR) and major adverse cardiac events (MACE). To minimize inter-group differences in baseline characteristics, propensity score matching was performed for clinical outcomes. ResultsIncidence of thrombus adhesion was similar in DCS and DP-DES groups (28.4% versus 22.6%, p=0.31). However, the dominant NIC grade was significantly higher in DCS (p<0.001), while NIC was more heterogeneous in DCS than in DP-DES (p=0.001). Maximum yellow color grade was similar (p=0.22). After propensity score matching, 202 lesion pairs from 146 patient pairs were retained for analysis. The cumulative incidence of TLR (4.6% versus 3.8%, p=0.38) and MACE (11.6% versus 11.7%, p=0.84) was similar for DCS and DP-DES. ConclusionsDCS showed thrombus adhesion and clinical outcomes at 1 year similar to DP-DES. DCS can thus be used with similar safety and efficacy as DP-DES.

Impact of different coronary angioscopic findings on arterial healing one year after bioresorbable-polymer and second-generation durable-polymer drug-eluting stent implantation

BackgroundThe advantage of using bioresorbable-polymer drug-eluting stent (BP-DES) compared with second-generation durable-polymer drug-eluting stent (2G DP-DES) still remains controversial in clinical situations. The purpose of this study to evaluate the degree of re-endothelialization and the prevalence of high-grade yellow-colored plaque (YCP), which might concern arterial healing after BP-DES and 2G DP-DES implantation using a high-resolution coronary angioscopy (CAS). MethodsIn total, 104 DESs (52: 2G DP-DES and 52: BP-DES) were prospectively observed using CAS 12±1 months after coronary intervention. The grade of neointimal coverage (NIC) over the stent was scored on a 4-point scale from 0 (no coverage) to 3 (complete coverage). YCP grade was also scored on a 4-point scale as 0 (white) to 3 (intensive yellow). High-grade YCP was defined as maximum grade ≥2. Moreover, the prevalence of high-grade YCP and the incidence of thrombus were investigated. ResultsBP-DES revealed better dominant NIC grade and less NIC heterogeneity than 2G DP-DES (p=0.0001 and p=0.015, respectively). The prevalence of high-grade YCP was lower for BP-DES than for 2G DP-DES (p=0.05). However, the incidence of thrombus was not significantly different (p=0.41). Multivariate analysis identified that low-density lipoprotein cholesterol levels [odds ratio (OR), 1.03; 95% Confidence Interval (CI): 1.01–1.06, p=0.01] and the usage of BP-DES [OR, 0.36; 95% CI: 0.14–0.91, p=0.03] as independent predictors of high-grade YCP. ConclusionsCompared with 2G DP-DES, BP-DES was less heterogeneous and well-covered NIC and less prevalence of the high-grade YCP implying optimal arterial healing.

P3389Angioscopic differences in quality and quantity of neointima in patients experiencing an acute coronary syndrome treated with bare metal, first-, second-, and third generation drug-eluting stents

Abstract Background Although drug-eluting stents (DES) have substantially reduced the need for early target lesion revascularization (TLR) compared with bare-metal stents (BMS) by inhibiting neointima hyperplasia, early generation DES have been associated with an increased risk of very late stent failure (VLSF) due to stent thrombosis and TLR after 1 year. Although the incidence of VLSF is reduced with newer generation DES, VLSF remains an unresolved problem and its mechanisms are not fully explored. Purpose The purpose of this study was to evaluate quality and quantity of neointima and presence of thrombus by using coronary angioscopy at long-term follow-up in patients who experienced an acute coronary syndrome (ACS) treated with BMS and DES on dual antiplatelet therapy. Methods Coronary angioscopy was performed at 6 and 10 months after BMS and DES implantation, respectively, in ACS patients. We assessed neointimal coverage (NC) of the stent struts, yellow color grade (YG) of stented segment and the existence of thrombus. Angioscopic NC was defined as follows: grade 0= fully visible struts; grade 1= visible struts through thin neointima; grade 2= no visible struts. We determined maximum (Max-NC) and minimum coverage (Min-NC) grades and the dominant NC grades. YG was classified into 4 grades (0= white; 1= slight yellow; 2= yellow; 3= intensive yellow). The obtained findings were compared with BMS, first-generation (1st-) DES, second-generation (2nd-) DES and third-generation (3rd-) DES. Results A total of 212 patients were enrolled: BMS (n=127), 1st DES (n=26, sirolimus-eluting stent), 2nd-DES (n=38, permanent polymer everolimus-eluting stent), and 3rd-DES (n=21, bioresorbable polymer everolimus-eluting stent). Max-NC and Min-NC grade were significantly lower with 1st- and 2nd-DES than with BMS and 3rd-DES (Figure). The same trend was also observed in the dominant NC grades. There was a lower trend of YG in BMS and 3rd-DES than in 1st or 2nd-DES (Figure). The presence of thrombus was significantly lower in 3rd-DES in comparison with BMS, 1st-, and 2nd-DES (3rd-DES 0%, BMS 20.5%, 1st-DES 24%, 2nd-DES 13.5%, P=0.01). Figure 1 Conclusion Patients treated with 3rd-DES have higher NC grade, lower incidence of intrastent thrombus, and lower YG than in 1st and 2nd-DES. These findings may explain the lower incidence of VLSF associated with these newer generation stent platforms.

Vascular response to paclitaxel-eluting nitinol self-expanding stent in superficial femoral artery lesions: post-implantation angioscopic findings from the SHIMEJI trial (Suppression of vascular wall Healing after IMplantation of drug Eluting peripheral stent in Japanese patients with the Infra inguinal lesion: serial angioscopic observation).

The aim of this study was to elucidate the vascular responses to paclitaxel-eluting stent (Zilver PTX stent) in superficial femoral artery lesion at different elapsed times using angioscopy. Patients who received Zilver PTX stent implantation from five centers were enrolled. We performed angioscopic examinations at 2, 6, and 12months after implantation and evaluated neointimal coverage (NIC) grade, intra-stent thrombus (IS-Th) grade, and presence of yellow plaque. NIC grade 0 was defined as stent struts exposed; grade 1, struts transparently visible although covered; grade 2, struts embedded in the neointima, but translucent; and grade 3, struts fully embedded and invisible. IS-Th was graded as follows: grade 0 (none), 1 (focal), and 2 (diffusely spread). Angioscopic follow-up evaluation was performed at 2months (25 patients, 42 lesions), 6months (18 patients, 23 stents), and 12months (14 patients, 24 stents) after stent implantation. Dominant NIC grade significantly increased over time; however, 16.3% of the cases had NIC grade 1 or 2 at 12months. IS-Th grade decreased; however IS-Th and yellow plaque were persistently observed in 62.5% and 83.3% cases, respectively, at 12months. An ongoing healing response was observed at 12months after implantation; however, thrombogenic findings were noted. Prolonged dual antiplatelet therapy could potentially enhance the clinical utility of Zilver PTX.

Association of Subclinical Intrastent Thrombus Detected 9 Months After Implantation of 2nd-Generation Drug-Eluting Stent With Future Major Adverse Cardiac Events ― A Coronary Angioscopic Study ―

Detection of yellow plaques (YP) by coronary angioscopy (CAS) 1 year after 1st-generation drug-eluting stent (DES) implantation has been related to future coronary events. However, the association between CAS findings and clinical outcomes following 2nd-generation DES implantation has not been investigated. Methods and Results: This study included a total of 248 2nd-generation DES in 179 patients, who were examined by CAS 9±2 months after implantation. Angioscopic evaluation included dominant neointimal coverage (NIC) grade, heterogeneity of NIC, presences of YP and intrastent thrombus. The outcome measure was major adverse cardiac events (MACE) defined as a composite of cardiac death, acute myocardial infarction and any coronary revascularization. The association between the CAS findings and MACE was evaluated using the Kaplan-Meier method. A Cox proportional hazards model was used to assess the predictors of MACE. The mean follow-up duration was 1,367±843 days. Dominant NIC grade (P=0.98), heterogeneity of NIC (P=0.20) and YP (P=0.53) were not associated with the incidence of MACE. However, intrastent thrombus was significantly associated with MACE (P=0.033). Intrastent thrombus (adjusted hazard ratio: 2.22; 95% confidence interval [CI]: 1.12-4.39), acute coronary syndrome (2.83; 95% CI: 1.42-5.67) and B2/C lesion (2.13; CI: 1.12-4.05) were independent predictors of MACE. Subclinical intrastent thrombus observed by CAS at 9 months after 2nd-generation DES implantation was independently associated with poor clinical outcome.

Satisfactory arterial repair 1year after ultrathin strut biodegradable polymer sirolimus-eluting stent implantation: an angioscopic observation.

The ultrathin strut biodegradable polymer sirolimus-eluting stent (Orsiro, O-SES) exhibits satisfactory clinical outcomes. However, no report to date has documented the intravascular status of artery repair after O-SES implantation. We examined 5 O-SES placed in 4 patients (age 65±12years, male 75%) presenting with stable angina pectoris due to de novo lesions in native coronary arteries. Coronary angioscopy was performed immediately after percutaneous coronary intervention and 1year later. Angioscopic images were analyzed to determine the following: (1) dominant grade of neointimal coverage (NIC) over the stent; (2) maximum yellow plaque grade; and (3) existence of thrombus. Yellow plaque grade was evaluated both immediately after stent implantation and at the time of follow-up observation. The other parameters were evaluated at the time of follow-up examination. NIC was graded as: grade 0, stent struts exposed; grade 1, struts bulging into the lumen, although covered; grade 2, struts embedded in the neointima, but translucent; grade 3, struts fully embedded and invisible. Yellow plaque severity was graded as: grade 0, white; grade 1, light yellow; grade 2, yellow; and grade 3, intensive yellow. Angioscopic findings at 1year demonstrated the following: dominant NIC grade 1, grade 2, and grade 3 in 1, 2, and 2 stents, respectively; all stents were covered to some extent; focal thrombus adhesion was observed in only 1 stent. Yellow plaque grade did not change from immediately after stent implantation to follow-up. O-SES demonstrated satisfactory arterial repair 1year after implantation.

Comparison of early-phase arterial repair following cobalt-chrome everolimus-eluting stent and slow-release zotarolimus-eluting stent: an angioscopic study.

Whether arterial repair following implantation of drug-eluting stents (DES) of the second generation differs among stent types remains unknown. We examined 41 DES placed in 28 patients (age 72±7years, male 89%) presenting with stable angina pectoris due to de novo lesions in native coronary arteries. Coronary angioscopy was performed 4±1months after stent implantation. Patients were divided into two groups based on the DES types: 22 cobalt-chrome everolimus-eluting stents (CoCr-EES) in 13 patients and 19 slow-release zotarolimus-eluting stents (R-ZES) in 15 patients. Neointimal coverage (NIC) was graded as: grade 0, stent struts exposed; grade 1, struts bulging into the lumen, although covered; grade 2, struts embedded in the neointima, but translucent; grade 3, struts fully embedded and invisible. NIC was defined as heterogeneous when the NIC grade variation was ≥1. Presence of thrombus was also investigated. Distribution of dominant NIC grade (CoCr-EES: grade 0, 9%; grade 1, 77%; grade 2, 9%; grade 3, 5%; R-ZES: grade 0, 16%; grade 1: 47%; grade 2, 37%; grade 3, 0%, P=0.38) and heterogeneity of NIC (P=0.43) were similar between CoCr-EES and R-ZES groups. Existence of thrombus was not significantly different in CoCr-EES and R-ZES (18 versus 42%, P=0.17). Arterial repair occurred without significant differences between CoCr-EES and R-ZES 4months after implantation.

Arterial Repair 4 Months After Zotarolimus-Eluting Stent Implantation Observed on Angioscopy

Arterial repair in the early phase following implantation of a zotarolimus-eluting stent (ZES) remains unknown. Following implantation of 49 Endeavor ZES in 33 patients, follow-up angioscopy was performed in 13 patients (26 ZES) in the early phase (EP; 123±24 days) and in 20 patients (23 ZES) in the middle phase (MP; 247±17 days). Neointimal coverage (NIC) was graded as follows: grade 0, stent struts exposed; grade 1, struts bulging into the lumen, although covered; grade 2, struts were embedded by the neointima but were seen translucently; grade 3, struts fully embedded and invisible. NIC was defined as heterogeneous for NIC grade variation≥1. The presence of thrombus and yellow plaque was also investigated. Although NIC heterogeneity tended to be more frequent in EP than in MP (50% vs. 22%, P=0.070), and yellow plaque significantly more frequent (58% vs. 13%, P=0.0025), the majority of stents were dominant NIC grade 3 at both follow-up periods (73% in EP vs. 78% in MP, P=0.75). There was no significant difference in thrombus (23% in EP vs. 4% in MP, P=0.10) between the follow-ups. Sufficient arterial repair may have occurred by 4 months after ZES implantation.

Comparisons of detailed arterial healing response at seven months following implantation of an everolimus- or sirolimus-eluting stent in patients with ST-segment elevation myocardial infarction

The difference of arterial healing response following everolimus-eluting stent (EES) or sirolimus-eluting stent (SES) implantation in patients with ST-segment elevated myocardial infarction (STEMI) has not been compared in detail. Thirty-five patients with STEMI were randomly implanted with an EES or SES (23 EES, 12 SES). At seven months, neointimal thickness (NIT) and strut malapposition were evaluated by optical coherence tomography (OCT) and the grade and heterogeneity of neointimal coverage (NIC) and development of intra-stent thrombi were evaluated by angioscopy. No significant differences were noted in clinical events experienced by the two groups, although one patient with an EES died following a papillary muscle rupture and one patient with a SES experienced sub-acute stent thrombosis. On OCT, although the EES implants showed a greater NIT than the SES implants (94.8 ± 88.8 μm vs 65.6 ± 63.3 μm, P<0.0001), both the EES and SES showed an excellent suppression of neointimal proliferation in the culprit lesion of STEMI. The frequency of uncovered and malapposed struts of EES was significantly lower than that of SES (2.7% vs. 15.7%, P<0.0001, 0.7% vs. 2.3%, P<0.0001, respectively). The ratio of stents fully covered with neointima of EES group was significantly higher than that of SES group (P=0.04). Angioscopic analysis also showed greater dominant NIC grade with homogenous NIC in EES than in SES (P=0.03, P=0.0002, respectively). The incidence of massive intra-stent thrombus of EES was lower than that of SES (P=0.05). For patients with STEMI, EES may promote better arterial healing response than SES.

Angioscopic Assessment of Arterial Repair Following Biodegradable Polymer-Coated Biolimus A9-Eluting Stent Implantation - Comparison With Durable Polymer-Coated Sirolimus-Eluting Stent -

Second-generation drug-eluting stents (DES) are expected to show better arterial repair than older DES. We angioscopically compared the biodegradable polymer-coated biolimus A9-eluting stent (BES) and durable polymer-coated sirolimus-eluting stent (SES) to explore differences in arterial repair. Angioscopy was performed 9 ± 1 months after 15 BES and 16 SES were implanted initially in the native coronary artery. Heterogeneity of neointimal coverage (NIC) as well as the dominant NIC grade was examined. NIC was defined as: grade 0 = fully visible struts; grade 1 = struts bulging into the lumen, but covered; grade 2 = embedded, but translucent struts; grade 3 = invisible struts. Heterogeneity was judged when the NIC grade varied ≥ 1. In-stent late loss (0.06 ± 0.23 vs. 0.07 ± 0.18 mm, P = 0.80), and dominant NIC grade (1.5 ± 0.8 vs. 1.3 ± 0.7, P = 0.45) were similar for BES and SES. Within the stents, NIC was more heterogeneous in SES than in BES (P = 0.035). 80% of BES showed homogeneous NIC, while 56% of SES had heterogeneous NIC. BES showed limited late loss similar to that for SES. Nonetheless, the NIC with BES was more homogeneous than that with SES. Biodegradable polymer-coated BES may have an advantage in homogeneous NIC.

Coronary angioscopic findings eight months after sirolimus-eluting stent implantation: a comparison between ST-elevation myocardial infarction and stable angina pectoris

Conflicting data exist about the safety of the sirolimus-eluting stent (SES) for patients with ST-elevation myocardial infarction (STEMI). Previous studies have reported delayed neointimal proliferation over SES with high incidence of adhering thrombus. This study was undertaken to assess the neointimal coverage and thrombus formation after SES implantation between patients with STEMI and those with stable angina pectoris (SAP).We studied 23 patients with STEMI who underwent primary percutaneous coronary intervention (PCI) with SES and 18 patients with SAP who were treated with SES. Coronary angioscopic examination was performed 8.1+/-2.4 months after PCI. Neointimal coverage of the stent was classified into four grades (grade 0 to 3). Uncovered stent strut was defined as grade 0 or 1. All the patients with STEMI and 94% of patients with SAP had uncovered stent struts. There was no significant difference in minimum, maximum, and dominant neointimal coverage grade between STEMI and SAP. 96% of patients with STEMI and all the patients with SAP showed heterogeneous neointimal coverage. Thrombus adhering to uncovered stent struts was observed in eight patients after STEMI and in four patients after SAP (35% vs. 22%, p=0.38). There was no significant difference in the maximum colour grade of the plaques between STEMI and SAP (2.1+/-0.8 vs. 1.8+/-0.9, p=0.33). Most thrombus was observed at the site of yellow plaques (83%).There was no significant difference in the neointimal coverage and thrombus formation between STEMI and SAP.

Heterogeneous Arterial Healing in Patients Following Paclitaxel-Eluting Stent Implantation: Comparison With Sirolimus-Eluting Stents

We angioscopically compared paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) to explore differences in arterial healing. Drug-eluting stents may demonstrate different arterial healing processes. Angioscopy was performed 9 +/- 2 months after 30 PES and 36 SES were implanted initially in the native coronary artery. Heterogeneity of the neointimal coverage (NIC) as well as the dominant grade was examined. Neointimal coverage was defined as follows: grade 0 = fully visible struts; grade 1 = struts bulged into the lumen, but covered; grade 2 = embedded, but translucent struts; grade 3 = invisible struts. Heterogeneity was judged when the NIC grade variation >or=1. Thrombi and yellow plaques (YP) were also explored. In-stent late loss (0.44 +/- 0.44 mm vs. 0.13 +/- 0.33 mm; p < 0.0001) and dominant NIC grade (1.8 +/- 1.1 vs. 1.3 +/- 0.7; p = 0.02) were greater in PES than in SES. Of PES, 48% showed the heterogeneity of 1 grade; 26% showed that of 2 grades. Of SES, 53% showed homogeneous coverage; the remaining SES showed the heterogeneity of 1 grade; and 72% showed dominant grade 1. Thrombi were more common in PES than in SES (43% vs. 19%; p = 0.04). Both stents commonly revealed YP (83% vs. 78%; p = 0.76). NIC was more heterogeneous in PES, associated with a higher incidence of thrombi. Homogeneous NIC may be an important factor for competent arterial healing.