Impact of intravascular ultrasound guidance in stent deployment on 6-month restenosis rate: a multicenter,randomized study comparing two strategies—with and without intravascular ultrasound guidance

Objectives. We aimed to investigate the impact of intravascular ultrasound (IVUS)-guided stent implantation on the 6-month restenosis rate, which has not yet been fully established in randomized trials.Background. The 6-month angiographic restenosis rate was compared in patients with symptomatic ischemic heart disease who were randomly allocated to angioplasty and stent deployment, with versus without IVUS guidance.Methods. After successful stent implantation, patients were randomized into two groups: Group A had no further dilation, and Group B had additional balloon dilation until achievement of IVUS criterion for stent expansion. The study group consisted of 164 patients, assuming a 50% reduction of the restenosis rate in Group B (15% vs. 30%) (alpha = 10%, beta = 20%).Results. We enrolled 155 patients. Overdilation was carried out in 31 (39%) of 79 Group B patients, with the IVUS criterion being achieved in 63 (80%) of 79. No significant difference was observed in the minimal luminal diameter (MLD), but the stent lumen cross-sectional area (CSA) was significantly larger in Group B (mean ± SD) (7.16 ± 2.48 vs. 7.95 ± 2.21 mm², p = 0.04). At 6 months, there was no significant difference in the restenosis rate, (28.8% [21 of 73] in Group A vs. 22.5% [16 of 71] in Group B, p = 0.25), but according to the observed difference in the restenosis rate, the power of the study was only 40%. The difference in MLD was also nonsignificant (1.60 ± 0.65 mm in Group A vs. 1.70 ± 0.64 mm in Group B, p = 0.20), whereas the lumen CSA was 20% larger in the IVUS-guided group (4.47 ± 2.59 vs. 5.36 ± 2.81 mm², p = 0.03). Lumen CSA was the only predictor of restenosis by multivariate logistic regression analysis.Conclusions. A nonsignificant 6.3% absolute reduction in the restenosis rate and a nonsignificant difference in MLD were observed in this study. Nonetheless, we still cannot rule out a beneficial effect of IVUS guidance, although this may have gone undetected owing to a lack of statistical power. A significant increase was observed in immediate and 6-month lumen size, as detected by IVUS, indicating that ultrasound guidance in stent deployment may be beneficial.     

旋磨术联合切割球囊成形术治疗冠状动脉重度钙化病变

目的血管内超声评价旋磨术联合切割球囊成形术治疗冠状动脉重度钙化病变的安全性及有效性。方法收集冠状动脉造影及血管内超声检查确认至少1处病变为高度钙化,并行旋磨术处理的冠心病患者80例,根据是否使用切割球囊分为单纯旋磨组34例和旋磨联合切割组46例。患者在支架置入前及置入后均行血管内超声检查,评价支架置入效果。结果单纯旋磨组与旋磨联合切割组最大钙化弧度分别为(215.88±21.81)°vs(226.55±21.59)°,钙化长度比为(0.72±0.06)vs(0.78±0.05),支架置入前最小管腔面积为(2.52±0.07)mm2 vs(2.46±0.09)mm2,2组比较差异无统计学意义(P>0.05)。支架置入后,旋磨联合切割组最小支架面积(6.12±0.37)mm2和即刻管腔获得面积(3.66±0.34)mm2,单纯旋磨组分别为(5.42±0.24)mm2和(2.90±0.24)mm2,2组比较差异有统计学意义(P=0.016)。2组术中并发症的发生比例比较,差异无统计学意义(P>0.05)。结论在冠状动脉重度钙化病变中,使用旋磨术联合切割球囊成形术可以获得更好的支架置入后效果。     

血管内超声与光学相干断层扫描在冠状动脉临界病变中的长期随访对比研究

目的:研究血管内超声(intravenous ultrasound,IVUS)与光学相干断层扫描(optical coher-ence tomography,OCT)在冠状动脉临界病变中的长期随访研究。方法:共入选经过冠状动脉造影(至少4体位造影)证实病变狭窄处于临界病变的患者90例。将入选者按照2∶1随机分为:血管内超声组(IVUS)60例,光学相干断层成像(OCT)组30例。通过血管内超声定量分析最小管腔直径、参考血管直径、最小管腔面积等参数指标;通过光学相干断层扫描分析最小管腔直径、最小管腔面积。同时依据两组检查方法不同特征确定斑块的性质进行定性亚组分析:纤维性斑块、钙化斑块及脂质斑块等,对于高危易损斑块进行冠状动脉介入治疗,术后规律服用药物,观察两组术后住院期间、30d、3个月、9个月、1年和2年的主要心血管事件。采用COX回归模型分析两组2年内免于心血管事件的差异。结果:IVUS和OCT进行亚组软斑块分析,两组测得最小管腔直径分别为[(1.84±0.06)vs.(1.84±0.13)mm,P=0.947]。另外,在最小管腔面积方面两组分别为[(4.7±0.98)vs.(4.8±1.17)mm2,P=0.853]。OCT组通过分析软斑块纤维帽厚度为(94±24.72)μm。通过COX回归模型显示,两组在免于心血管事件的差异无统计学意义(P=0.826)。结论:对于临界病变的患者,采用IVUS或OCT成像系统能够更好的分辨血管内斑块性质,尤其易识别易损斑块。对于临界病变的患者,采用介入影像学方法进行测量分析是安全的、可靠的,能更好指导临床治疗。     

Impact of moderate lesion calcium on mechanisms of coronary stenting as assessed with three-dimensional intravascular ultrasound in vivo

Axial plaque redistribution is an important mechanism of lumen enlargement after stenting of noncalcified lesions. To assess effects of lesion calcification on mechanisms of coronary stenting, we analyzed 55 lesions with noncircumferential calcification with 3-dimensional intravascular ultrasound (IVUS) (standard qualitative and quantitative analyses) before and after implantation of balloon-expandable stents. Thirty-two plaques (58%) showed arcs of calcium <120 degrees of vessel circumference (group A), whereas 23 lesions (42%) contained arcs of calcium > or =120 degrees of vessel circumference (group B). In the entire cohort of 55 lesions, as well as groups A and B, which were studied separately, both single-slice IVUS analysis (performed at minimum lumen site before intervention) and mean stented segment IVUS analysis showed an increase in lumen and vessel area and a decrease in plaque area (p <0.001). The magnitude of lumen and vessel increase and of plaque decrease was similar in both groups. Group A lesions showed significant plaque extrusion into the distal reference segment that was not observed in group B (increase in plaque area of 1.3 +/- 1.9 vs 0.1 +/- 2.0 mm(2), p <0.04). Stenting did not alter plaque area of the proximal reference segment in either group. In addition, there was an increase in vessel area of the distal reference of both groups, indicating that stent-induced vessel expansion observed within the lesion also affected the distal reference. Thus, longitudinal plaque redistribution and vessel expansion contribute to increased lumen dimensions during stenting of lesions with varying amounts of calcium; however, marked plaque extrusion was found only in lesions with a calcium arc of <120 degrees.     

Comparison of Stent Expansion Guided by Optical Coherence Tomography Versus Intravascular Ultrasound: The ILUMIEN II Study (Observational Study of Optical Coherence Tomography [OCT] in Patients Undergoing Fractional Flow Reserve [FFR] and Percutaneous Coronary Intervention)

ObjectivesThe present study sought to determine whether optical coherence tomography (OCT) guidance results in a degree of stent expansion comparable to that with intravascular ultrasound (IVUS) guidance.BackgroundThe most important predictor of adverse outcomes (thrombosis and restenosis) after stent implantation with IVUS guidance is the degree of stent expansion achieved.MethodsWe compared the relative degree of stent expansion (defined as the minimal stent area divided by the mean of the proximal and distal reference lumen areas) after OCT-guided stenting in patients in the ILUMIEN (Observational Study of Optical Coherence Tomography [OCT] in Patients Undergoing Fractional Flow Reserve [FFR] and Percutaneous Coronary Intervention) (N = 354) and IVUS-guided stenting in patients in the ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) study (N = 586). Stent expansion was examined in all 940 patients in a covariate-adjusted analysis as well as in 286 propensity-matched pairs (total N = 572).ResultsIn the matched-pair analysis, the degree of stent expansion was not significantly different between OCT and IVUS guidance (median [first, third quartiles] = 72.8% [63.3, 81.3] vs. 70.6% [62.3, 78.8], respectively, p = 0.29). Similarly, after adjustment for baseline differences in the entire population, the degree of stent expansion was also not different between the 2 imaging modalities (p = 0.84). Although a higher prevalence of post-PCI stent malapposition, tissue protrusion, and edge dissections was detected by OCT, the rates of major malapposition, tissue protrusion, and dissections were similar after OCT- and IVUS-guided stenting.ConclusionsIn the present post-hoc analysis of 2 prospective studies, OCT and IVUS guidance resulted in a comparable degree of stent expansion. Randomized trials are warranted to compare the outcomes of OCT- and IVUS-guided coronary stent implantation.     

The predictive value of computed tomography calcium scores: a comparison with quantitative volumetric intravascular ultrasound

ObjectiveTo evaluate the relationship between coronary artery calcium scoring (CACS) and intravascular ultrasound (IVUS) calcification and disease severity.MethodsForty-five angina patients who underwent CACS 18±23 days before IVUS were studied. The CACS was recorded for each lesion matched to a specific IVUS lesion. Cross-sectional area measurements of the external elastic membrane, lumen area, plaque and media, and plaque burden were performed. The arc and length of calcification were measured.ResultsThere were 106 calcified lesions detected by IVUS. Eighty-five of those lesions (80%) were detected by CACS, but 21 calcified lesions (20%) were missed. Fourteen (50%) out of 28 of the lesions with an IVUS-calcium arc below the 25th percentile (51.4°) were detected by CACS vs. 91% of lesions with an IVUS-calcium arc >51.4° (P<.05). Similarly, 21 (58%) of 36 lesions ≤3 mm in length were detected vs. 91% of lesions >3 mm (P<.05). We divided IVUS-calcified lesions into CACS ≤10 and >10. Mean plaque burden, calcified length, and arc of calcium increased significantly, while minimum lumen area decreased with increasing CACS. There was the same tendency in culprit and nonculprit calcified lesions, respectively. Multivariate analysis showed a calcified length (regression coefficient=8.718, 95% CI 4.668–12.77, P<.001) and an arc of calcium (regression coefficient=2.789, 95% CI 1.419–4.119, P<.001) were significant predictors for CACS.ConclusionsThis study suggests that a CACS could evaluate coronary calcium burden noninvasively through the accurate estimation of calcium-arc and length.     

Feasibility of intravascular ultrasound studies: Predictors of imaging success before coronary interventions

Background: Intravascular ultrasound (IVUS) is currently used to study lesions during transcatheter coronary therapy. However, before dilation some lesions cannot be reached or crossed with the imaging catheter. Hypothesis: This study seeks to elucidate which factors determine the feasibility of IVUS examination before coronary interventions. Methods: Accordingly, 100 consecutive patients undergoing IVUS examination before coronary angioplasty were prospectively studied. The clinical and angiographic characteristics of 77 patients with a successful IVUS study (Group A) were compared with those of 23 patients in whom IVUS was attempted but the target lesion could not be interrogated (Group B). The echogenic characteristics of the target lesion [before (n = 77) or after intervention (in 18 patients in Group B)] were also studied. Results: Patients in Group B were significantly older (62 ± 7 vs. 57 ± 10 years, p < 0.05) and more frequently had stable angina [8 (35%) vs. 9 (11%), p < 0.05]. The distribution of lesions within the coronary tree and angiographic lesion characteristics including length, eccentricity, calcification, bend location, and the American College of Cardiology/American Heart Association classification were similar in both groups. However, proximal tortuosities (>45° at end diastole) were more frequently found in Group B [20 (87%) vs. 47 (61%), p < 0.05]. In addition, by quantitative angiography, patients in Group B had smaller arteries (reference diameter 2.8 ± 0.4 vs. 3.1 ± 0.4 mm, p < 0.05) and more severe lesions (minimal lumen diameter 0.46 ± 0.24 vs. 0.65 ± 0.34 mm, p < 0.05). On IVUS, calcified lesions were more frequently visualized in Group B (61 vs. 38%, p < 0.05). On multivariate analysis, catheter size, baseline minimal lumen diameter, angiographic proximal tortuosities, and lesion calcification on imaging were independent predictors of the feasibility of IVUS studies. Conclusions: Unsuccessful IVUS studies before intervention occur more frequently (1) in vessels with proximal tortuosities or severe lumen narrowing, (2) in lesions that are calcified on IVUS, and (3) when large imaging catheters are used.     

Optical coherence tomography and intravascular ultrasound imaging of bioabsorbable magnesium stent degradation in porcine coronary arteries

BackgroundAbsorbable metallic stents (AMS) composed of magnesium alloy were designed to complete degradation within 90–120 days. Among the potential advantages of these stents, when compared to conventional stents, are the elimination of late stent thrombosis, chronic inflammation, and artifacts during noninvasive imaging.MethodsMagnesium-based AMS were deployed in juvenile domestic pig coronary arteries. Angiography, optical coherence tomography (OCT), and intravascular ultrasound (IVUS) were performed before and after implant and then at 28 days and 3 months following stenting. The animals were sacrificed at 28 days or 3 months following stent implantation. Stented vessels were harvested and analyzed by histomorphometry.ResultsOver time, OCT, IVUS, and histologic images revealed a progressive degradation of the stents. Mean stent strut width in the OCT images after implantation was 0.24±0.032 mm, then decreased to 0.12±0.007 mm (P<.0001) at 28 days and to 0.151±0.032 mm at 3 months (P<.0001 vs. implant, P=.078 vs. 28 days).ConclusionMagnesium-based AMS degrade over a 3-month time period in a porcine model. Its structure is not apparent by angiography but is well-visualized by OCT and IVUS. OCT allowed quantitative assessment of stent degradation.     

Stepwise intravascular ultrasound (IVUS) guidance of high-pressure coronary stenting does not result in an improved acute or long-term outcome: A randomized comparison to “final-look” IVUS assessment

The objective of this study was to evaluate the potential benefit of stepwise intravascular ultrasound (IVUS)-guided coronary stent deployment compared to angiographic stent implantation with final IVUS assessment only. Acute procedural success and 6-month angiographic follow-up were compared in both groups. Intravascular ultrasound was performed using a 20- or 30-MHz mechanically rotated catheter in 85 patients who were prospectively randomized to group A (n = 42; IVUS-guided) and group B (n = 43; angiography + final IVUS assessment). There was no difference in the number of stents implanted (1.5 ± 0.9 stents/lesion in group A and 1.3 ± 0.6 stents/lesion in group B), the duration of the procedure, or the amount of contrast medium used. Defined criteria of optimal stent deployment (stent apposition, stent symmetry, complete coverage of dissections, >90% in-stent lumen area/reference lumen area) were achieved in 54.2% in group A and 56.6% in group B (NS). Angiographic follow-up was 87.1% at 6 ± 2 months, and clinical follow-up was 100% at 8 ± 1 months. There was no significant difference in restenosis rate (33.3% vs. 34.9%) applying a binary >50% diameter stenosis criterion for both groups. There was no significant difference in minimal in-stent lumen area at both baseline (7.91 ± 2.64 mm² vs. 7.76 ± 2.21 mm²) and follow-up (5.84 ± 2 mm² vs. 5.52 ± 1.87 mm²). With regard to immediate procedural lumen gain and rate of restenosis, multiple IVUS examinations during the procedure showed no advantage compared to final IVUS assessment only. Cathet. Cardiovasc. Intervent. 46:135–141, 1999. © 1999 Wiley-Liss, Inc.     

Benefit of intravascular ultrasound in Wiktor stent implantation

The goal of this study was to evaluate retrospectively the efficacy and safety of intravascular ultrasound (IVUS) during Wiktor stent implantation. Until 1996, the success of stent implantation was assessed by angiographic criteria only, but in 1997, the procedure was expanded to include pre- and postprocedural IVUS imaging. Sixty-six patients were included, 28 treated in 1996 (group A) and 38 treated in 1997 (group B). Stent size was larger in group B than in group A (3.6 ± 0.4 vs. 3.1 ± 0.2, P < 0.001). Acute gain was greater in group B than in group A (2.58 ± 0.61 vs. 2.11 ± 0.56, P < 0.001). Restenosis rate was 31% in group A and 14% in group B. No major acute complications due to IVUS examination occurred. IVUS is helpful in choosing optimal stent size. Cathet. Cardiovasc. Intervent. 47:28–35, 1999. © 1999 Wiley-Liss, Inc.     

Efficacy and Safety of Intravascular Lithotripsy in Calcified Coronary Lesions: A Systematic Review and Meta-Analysis

BackgroundIntravascular lithotripsy (IVL) is a recently introduced therapeutic modality in the management of calcified coronary lesions (CCAD). IVL delivers sonic pressure waves to modulate calcium, hence promote vessel compliance and optimize stent deployment.MethodsWe performed a comprehensive literature search for studies that evaluated the utility of adjunctive IVL. The primary outcomes of our study were the clinical success, defined as the ability of IVL to produce residual diameter stenosis <50% (RDS < 50%) after stenting with no evidence of in-hospital major adverse cardiac events, and the angiographic success, defined as success in facilitating stent delivery with RDS < 50% and without serious angiographic complications. The secondary outcomes included post-IVL and post-stenting changes in lumen area, calcium angle, and the maximum calcium thickness. Proportional analysis was used for binary data and mean difference was used for continuous data. All meta-analyses were conducted using a random-effect model and 95% confidence intervals (CIs) were included.ResultsA total of eight single-arm observational studies, including 980 patients (1011 lesions), were included. 48.8% of the patients presented with acute coronary syndrome. Severe calcifications were present in 97% of lesions. Clinical success was achieved in 95.4% of patients (95%CI:92.9%–97.9%). Angiographic success was achieved in 97% of patients (95%CI:95%–99%). There was an overall increase in postprocedural lumen area as well as significant reduction of calcium angle and maximum calcium thickness.ConclusionsIVL seems to have excellent efficacy and safety in the management of CCAD. However, adequately powered RCTs are needed to evaluate IVL compared to other calcium/plaque modifying techniques.     

Assessment of Post-Dilatation Strategies for Optimal Stent Expansion in Calcified Coronary Lesions: Ex Vivo Analysis With Optical Coherence Tomography

IntroductionInterventional cardiologists make adjustments in the presence of coronary calcifications known to limit stent expansion, but proper balloon sizing, plaque-modification approaches, and high-pressure regimens are not well established. Intravascular optical coherence tomography (IVOCT) provides high-resolution images of coronary tissues, including detailed imaging of calcifications, and accurate measurements of stent deployment, providing a means for detailed study of stent deployment.ObjectiveEvaluate stent expansion in an ex vivo model of calcified coronary arteries as a function of balloon size and high-pressure, post-dilatation strategies.MethodsWe conducted experiments on cadaver hearts with calcified coronary lesions. We assessed stent expansion as a function of size and pressure of non-compliant (NC) balloons (i.e., nominal, 0.5, 1.0, and 1.5 mm balloons at 10, 20 and 30 atm). IVOCT images were acquired pre-stent, post-stent, and at all post-dilatations. Stent expansion was calculated using minimum expansion index (MEI).ResultsWe analyzed 134 IVOCT pullbacks from ten ex-vivo experiments. The mean distal and proximal reference lumen diameters were 2.2 ± 0.5 mm and 2.5 ± 0.7 mm, respectively, 80% of times using a 3.0 mm diameter stent. Overall, based on stent sizing, a good expansion (MEI ≥ 80%) was reached using the 1:1 NC balloon at 20 atm, and expansion > 100% was reached using the 1:1 NC balloon at 30 atm. In the subgroup analysis, comparing low-calcified and high-calcified lesions, good expansion (MEI ≥ 80%) was reached using the 1:1 NC balloon at nominal pressure (10 atm) versus using 1:1 NC balloon at 30 atm, respectively. Significant vessel rupture was identified in all the vessels mainly upon post-dilatation with larger balloons, and 60% of the experiments (6 vessels, 3 in each calcium subgroup) presented rupture with the +1.0 mm NC balloon at 20 atm.ConclusionWhen treating calcified lesions, good stent expansion was reached using smaller balloons at higher pressures without coronary injuries, whereas bigger balloons yielded unpredictable expansion even at lower pressures and demonstrated potential harmful damages to the vessels. As these findings could help physicians with appropriate planning of stent post-dilatation for calcified lesions, it will be important to clinically evaluate the recommended protocol.     

Rotational Atherectomy or Balloon-Based Techniques to Prepare Severely Calcified Coronary Lesions

BackgroundThe comparative efficacy of percutaneous techniques for the preparation of calcified lesions before stenting remains poorly studied.ObjectivesThis study sought to compare the performance of up-front rotational atherectomy (RA) or balloon-based techniques before drug-eluting stent implantation in severely calcified coronary lesions as assessed by angiography and optical coherence tomography (OCT).MethodsPatient-level data from the PREPARE-CALC (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions) and ISAR-CALC (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions) randomized trials were pooled. The primary endpoint was stent expansion as assessed by OCT imaging. The secondary endpoints included stent eccentricity, stent asymmetry, angiographic acute lumen gain, strategy success and in-hospital occurrence of cardiac death, target vessel myocardial infarction, and repeat revascularization.ResultsAmong 274 patients originally randomized, 200 participants with available OCT data after lesion preparation with RA (n = 63), a modified balloon (MB, n = 103), or a super high-pressure balloon (n = 34) before stenting were analyzed. The use of RA versus MB or a super high-pressure balloon led to comparable stent expansion (73.2% ± 11.6% vs 70.8% ± 13.6% vs 71.8% ± 12.2%, P = 0.49) and stent asymmetry (P = 0.83). Compared with RA or MB, a super high-pressure balloon was associated with less stent eccentricity (P = 0.03) with a numerically higher acute lumen gain, albeit not significantly different (P = 0.08). Strategy success was more frequent with RA versus MB (P = 0.002) and numerically more frequent with RA versus a super high-pressure balloon (P = 0.06). Clinical outcomes did not differ between groups.ConclusionsIn patients with severely calcified lesions undergoing drug-eluting stent implantation, lesion preparation with RA, MB, or a super high-pressure balloon was associated with comparable stent expansion. A super high-pressure balloon is associated with less stent eccentricity, whereas strategy success is more frequent with RA.     

A Comparison of Intravascular Imaging Modalities for Detection of Stent Struts in Acute Coronary Syndrome

Background

We used optical coherence tomography (OCT) and intravascular ultrasound (IVUS) to assess the struts of implanted stents in patients with acute coronary syndrome (ACS).

Methods

A totle of 10,756 stent struts were analyzed with OCT in 42 patients of ACS. Of them, both of IVUS and OCT imaging were performed in 33 patients. Appearance of stent struts was classified as well apposed, buried, malapposed, and nondetectable, and the number of stent struts were counted by OCT and IVUS was compared.

Results

Most of stent struts were well apposed (78.1%, 8,407/10,756). However, malapposed struts were 5.6% (607/10,756), and 14.1% (1,514/10,756) of stent struts were buried by thrombus. The nondetectable struts were 2.11% (228/10,756) in ACS. 94.7% (216/228) of nondetectable stent struts were associated with red thrombus, and plaque prolapse was in 5.3% (12/228). The number of stent struts counted by OCT were larger than that of IVUS. The mean number of stent struts at the proximal and distal stent edges were 24 ± 6.57 in OCT, the stent struts IVUS counted were 20 ± 4.18 (P < 0.0001). Although the frequency of malapposed struts were similar 4.6% (376/8,248) in OCT versus 4.8% (369/7,674) in IVUS (P = 0.788). Stent struts were often buried by thrombus in ACS 15.2% (1,252/8,248) in OCT versus 9.7% (747/7,674) in IVUS; P = 0.006. The nondetectable struts were fewer in IVUS than OCT 0.2% (16/7,674) in IVUS versus 2.2% (187/8,248) in OCT; P < 0.0001.

Conclusion

Stent struts are frequently buried and nondetectable due to thrombi burden in ACS patients. Adequate thrombus removal and proper selection of the imaging device is warranted in ACS. (J Interven Cardiol 2016;29:99–107)

     

Effect of an anti‐PDGF‐β‐receptor‐blocking antibody on restenosis in patients undergoing elective stent placement

AIM: The aim of the study was to determine whether a single intravenous infusion of 25?mg/kg CDP860, a humanized di‐Fab′ fragment against PDGF‐β receptor, leads to a reduction of in‐stent restenosis.

METHODS: In this phase II, double‐blind, placebo‐controlled, multicentre study 145 patients presenting with stable or unstable angina were randomized to a single infusion of placebo or active drug (CDP860) before undergoing stenting. Quantitative angiography and 3D intravascular ultrasound (IVUS) were obtained at baseline and follow‐up. Primary endpoint was the IVUS assessment of percentage in‐stent volume obstruction.

RESULTS: At six‐month follow‐up, the placebo group and CDP860 group did not differ significantly regarding minimal luminal diameter (1.75?±?0.68 versus 1.82?±­0.66?mm), restenosis rate (16.2 versus 14.1%), minimal lumen area (4.71?±?1.85 versus 4.41?±?1.77?mm ² ), in‐stent neointimal volume (30?±?23 versus 31?±?31?mm ³ ) and in‐stent obstruction volume (23.8?± 14.4 versus 22.1?±?15.3%). Major adverse cardiac events at 210 days were similar in both groups: death 1.5 versus 1.4%, myocardial infarction 5.9 versus 8.1% and target vessel revascularization 16.4 versus 17.6%.

CONCLUSION: A single intravenous administration of monoclonal antibody against PDGF‐β receptor failed to reduce the amount of neointimal hyperplasia after stent implantation. (Int J Cardiovasc Intervent 2003; 5: 214–222)     

Serial intravascular ultrasound analysis comparing double kissing and classical crush stenting for coronary bifurcation lesions

Background : Compared with the classical crush, double kissing (DK) crush improved outcomes in patients with coronary bifurcation lesions. However, there is no serial intravascular ultrasound (IVUS) comparisons between these two techniques. Objectives : This study aimed to analyze the mechanisms of the two crush stenting techniques using serial IVUS imaging. Methods : A total of 54 patients with IVUS images at baseline, post‐stenting and eight‐month follow‐up were classified into classical (n = 16) and DK (n = 38) groups. All patients underwent final kissing balloon inflation (FKBI). Unsatisfactory kissing (KUS) was defined as the presence of wrist or >20% stenosis during FKBI at the side branch (SB) ostium. The vessels at bifurcation lesions were divided into the proximal main vessel (MV) stent, the crushed segment, the distal MV stent, the SB ostium and the SB stent body. Results : KUS and incomplete crushing were commonly observed in the classical group (62.5%, 81.3%), compared with DK group (18.0%, 39.5%, P < 0.001 and P = 0.004). The post‐stenting stent symmetry in the classical group was 71.85 ± 7.69% relative to 85.93 ± 6.09% in DK group (P = 0.022), resulting in significant differences in neointimal hyperplasia (NIH, 1.60 ± 0.21 mm² vs. 0.85 ± 0.23 mm², P = 0.005), late lumen loss (1.31 ± 0.81 mm² vs. 0.55 ± 0.70 mm², P = 0.013), and minimal lumen area (MLA, 3.57 ± 1.52 mm² vs. 4.52 ± 1.40 mm^2, P = 0.042) at the SB ostium between two groups. KUS was positively correlated with the incomplete crush and was the only predictor of in‐stent‐restenosis (ISR) at the SB ostium. Conclusion : DK crush was associated with improved quality of the FKBI and larger MLA. KUS predicted the occurrence of ISR. © 2011 Wiley Periodicals, Inc.     

First Report of Edge Vascular Response at 12 Months of Magmaris,A Second-Generation Drug-Eluting Resorbable Magnesium Scaffold,Assessed by Grayscale Intravascular Ultrasound,Virtual Histology,and Optical Coherence Tomography. A Biosolve-II Trial Sub-Study

Introduction and objectiveThe edge vascular response (EVR) remains unknown in second generation drug-eluting Resorbable Magnesium Scaffold (RMS), such as Magmaris. The aim of the study was to evaluate tissue modifications in the RMS edges over time, assessed by different invasive imaging modalities.MethodsThe patients treated with the device were assessed by optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS at baseline and 12 months. The EVR study performed a segment- and frame-level analysis of the 5 mm segments proximal and distal of the actual RMS.ResultsThe segment-level grayscale IVUS (n = 10), virtual histology IVUS (n = 10), and OCT (n = 18) analysis did not show any significant changes after 12 months, except for a fibrous plaque area (FPA) reduction of 0.5mm² (p = 0.017) in the proximal segment compared to baseline. In the frame-level analysis, IVUS evaluation revealed a vessel area decreased 2.80 ± 1.43 mm² (p = 0.012) and 2.49 ± 1.53 mm² (p = 0.022) in 2 proximal frames. This was accompanied by plaque area reduction of 0.88 ± 0.70 mm² (p = 0.048) and a FPA decreased by 0.63 ± 0.48 mm² (p = 0.004) in one proximal frame. In 1 distal frame, there was a dense calcium area reduction of 0.10 ± 0.12 mm² (p = 0.045), FPA and fibrous fatty plaque increased 0.54 ± 0.53 mm² (p = 0.023) and 0.17 ± 0.16 mm² (p = 0.016), respectively. By OCT, there was a lumen area decrease of 0.76 ± 1.51 mm² (p = 0.045) in a distal frame.ConclusionAt 12 months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment. This could be translated as a benign healing process at the edges of the RMS.SummaryThe edge vascular response (EVR) remains unknown in second generation drug-eluting absorbable metal scaffolds (RMS), such as Magmaris. Patients treated with the device were assessed by multi invasive imaging modalities [i.e. optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS] evaluating the tissue changes over time in the segment- and frame-level analysis of the 5 mm segments proximal and distal of the actual RMS. As a result, after 12 months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment, translating a benign healing process at the edges of the RMS.     

Optimal final lumen area and predictors of target lesion revascularization after stent implantation in small coronary arteries

Despite similar early clinical events, patients who undergo treatment of small vessels are at an increased risk for target lesion revascularization (TLR) after coronary artery stenting. We sought to determine predictors of TLR after stent implantation in small coronary arteries. We identified 423 consecutive patients who underwent intravascular ultrasound (IVUS)-guided small vessel stenting procedures in 465 coronary lesions with an angiographic reference vessel diameter of <2.75 mm. Patients were divided into 2 groups based on a final IVUS lumen area of < or =6.0 mm2 (n=345 lesions, group I) and >6.0 mm2 (n=115, group II). Baseline patient characteristics and in-hospital outcomes were similar between the 2 groups, except for a higher rate of restenotic lesions in group I and bifurcation lesions in group II. Group I had higher TLR rates at 1 year compared with group II patients (39% vs 26%, p = 0.02). The TLR rate appeared to decrease with greater stent expansion, especially at >90% of the reference vessel area, as assessed by IVUS. By multivariate analysis, an IVUS final stent area of < or =6 mm2, diabetes, absence of prior myocardial infarction, and history of intervention were independent predictors of 1-year TLR in this population. Final stent area of >6.0 mm2 and greater stent expansion were associated with a decrease in TLR. Therefore, there does not appear to be any "downside" to aggressive stent implantation strategies in small vessels. In contrast, IVUS allows maximization of final lumen dimensions to minimize clinical restenosis.     

Assessment of Vascular Patency and Inflammation with Intravascular Optical Coherence Tomography in Patients with Superficial Femoral Artery Disease Treated with Zilver PTX Stents

PurposeZilver PTX nitinol self-expanding drug-eluting stent with paclitaxel coating is effective for treatment of superficial femoral artery (SFA) disease. However, as with any stent, it induces a measure of vascular inflammatory response. The current clinical trial (NCT02734836) aimed to assess vascular patency, remodeling, and inflammatory markers with intravascular optical coherence tomography (OCT) in patients with SFA disease treated with Zilver PTX stents.MethodsSerial OCT examinations were performed in 13 patients at baseline and 12-month follow-up. Variables evaluated included neointimal area, luminal narrowing, thrombus area, stent expansion as well as measures of inflammation including, peri-strut low-intensity area (PLIA), macrophage arc, neovascularization, stent strut apposition and coverage.ResultsPercentage of malapposed struts decreased from 10.3 ± 7.9% post-intervention to 1.1 ± 2.2% at 12-month follow-up, but one patient showed late-acquired stent malapposition (LASM). The percent of uncovered struts at follow-up was 3.0 ± 4.5%. Average expansion of stent cross-sectional area from baseline to follow-up was 35 ± 19%. The average neointimal area was 7.8 ± 3.8 mm². Maximal luminal narrowing was 61.1 ± 25.0%, and average luminal narrowing was 35.4 ± 18.2%. Average peri-strut low-intensity area (PLIA) per strut was 0.017 ± 0.018 mm². Average number of neovessels per mm of stent was 0.138 ± 0.181. Average macrophage angle per frame at follow-up was 7 ± 11°. Average thrombus area at follow-up was 0.0093 ± 0.0184 mm².ConclusionAt 12-month follow-up, OCT analysis of Zilver PTX stent shows outward remodeling and minimal neointimal growth, but evidence of inflammation including PLIA, neovessels, thrombus and macrophages.SummaryThirteen patients with PAD had paclitaxel-coated stents implanted in their SFAs and were then imaged with OCT at baseline and 12-month follow-up. OCT proxy metrics of inflammation were quantified.     

Quantitative changes in reference segments during IVUS-guided stent implantation: Impact on the criteria for optimal stent expansion

Intravascular ultrasound is an established method to optimize stent implantation. Stent expansion is estimated from the relation between minimal in-stent cross-sectional area and reference lumen area. We analyzed the periprocedural lumen increment in the reference segments and its impact on intravascular ultrasound (IVUS) criteria for optimized stenting. Seventy-five consecutive patients were studied with a 2.9 Fr, 30-MHz system and motorized pullback (0.5 mm/sec). Lumen area was measured by planimetry; absolute and relative differences in area (Δ area) were calculated. Lumen area increment for reference segments proximal and distal to the stent was 6.4% ± 10.3% and 6.1% ± 10.8%; 49/75 patients fulfilled all IVUS criteria for optimal stent expansion at the final IVUS assessment, and 10/75 patients met all the IVUS criteria in relation to the first measurement of reference lumen area, but not in relation to the final measurement of reference lumen area. During high-pressure dilatation within the stent, reference lumen increment is visible. If reference lumen planimetry is not repeated after additional high-pressure balloon inflation, the final relative stent expansion may be overestimated. Cathet. Cardiovasc. Intervent. 47:434–440, 1999. © 1999 Wiley-Liss, Inc.