Lumen Area Loss Research Articles

Drug-coated balloon strategy following orbital atherectomy for calcified coronary artery compared with drug-eluting stent: One-year outcomes and optical coherence tomography assessment.

Percutaneous coronary intervention (PCI) for calcified coronary artery remains challenging in the drug-eluting stent (DES) era. While recent studies reported the efficacy of orbital atherectomy (OA) combined with DES for calcified lesion, the effectiveness of drug-coated balloon (DCB) following OA has not been fully elucidated. Between June 2018 and June 2021, 135 patients who received PCI for calcified de novo coronary lesions with OA were enrolled and divided into two groups; OA followed by DCB (n = 43) if the target lesion achieved acceptable preparation, or second- or third-generation DESs (n = 92) if the target lesion showed suboptimal preparation between June 2018 and June 2021. All patients underwent PCI with optical coherence tomography (OCT) imaging. The primary endpoint was 1-year major adverse cardiac event (MACE), that was a composite of cardiac death, nonfatal myocardial infarction, or target lesion revascularization. Mean age was 73 years and 82% was male. In OCT analysis, maximum calcium plaque was thicker (median: 1050 µm [interquartile range (IQR): 945-1175 µm] vs. 960 µm [808-1100 µm], p = 0.017), calcification arc tended to larger (median: 265° [IQR: 209-360°] vs. 222° [162-305°], p = 0.058) in patients with DCB than in DES, and the postprocedure minimum lumen area was smaller in DCB compared with minimum stent area in DES (median: 3.83 mm2 [IQR: 3.30-4.52 mm2 ] vs. 4.86 mm2 [4.05-5.82 mm2 ], p < 0.001). However, 1 year MACE free rate was not significantly different between 2 groups (90.3% in DCB vs. 96.6% in DES, log-rank p = 0.136). In the subgroup analysis of 14 patients who underwent follow-up OCT imaging, late lumen area loss was lower in patients with DCB than DES, despite lower lesion expansion rate in DCB than DES. In calcified coronary artery disease, DCB alone strategy (if acceptable lesion preparation was performed with OA) was feasible compared with DES following OA with respect to 1-year clinical outcomes. Our finding indicated using DCB with OA might be reduce late lumen area loss for severe calcified lesion.

Chronic vascular response after self-expanding nitinol stent implantation in superficial femoral arteries: a serial intravascular ultrasound analysis

The mechanical properties of the self-expanding nitinol stents (SENS) and chronic biological stimulation on the wall from the SENS have not been fully investigated. This study evaluated the mechanical vascular response to SENS implantation in superficial femoral artery (SFA) lesions using serial volumetric intravascular ultrasound (IVUS). Twenty-five symptomatic patients due to de novo SFA lesions scheduled for SENS placement were prospectively enrolled. Serial IVUS studies were performed immediately after crossing with a guidewire, immediately after the procedure, and at a 8-month follow-up. Serial IVUS volumetric analysis was conducted after stent deployment and at follow-up. Mean stent, lumen and neointimal areas were calculated as the volume divided by the stent length, and the calcium arc was measured. At follow-up, SENS had increased 40.6% in overall volume. The chronic stent expansion tended to be larger, and the mean neointimal area at the 8-month follow-up was significantly larger in less calcified lesions compared to heavily calcified lesions. As a result, the mean late lumen area loss was significantly larger in lesions with calcium arcs of 0° and in the first and second quadrants than in those with calcium arcs in the third and fourth quadrants (2.8±7.2, 1.3±5.6, 0.6±5.9, 1.2±5.4, -0.8±5.2 mm(2), respectively; p<0.001). SENSs continued to enlarge with intimal proliferation over 8months in all lesions. Although arterial calcium affected the degree of chronic stent expansion during the follow-up period, neointimal proliferation was smaller in heavily calcified lesion compared to less calcified lesion following SENS implantation.

Effect of Angiotensin converting enzyme inhibitors on soluble tumor-necrosis-factor-related apoptosis-inducing ligand levels - association with neointimal hyperplasia in drug eluting stents.

To test the hypothesis that angiotensin converting enzyme inhibitors (ACEi) affect soluble tumor-necrosis-factor-related apoptosis-inducing ligand (sTRAIL) and this interaction is associated with less in-drug-eluting-stent (DES) neointimal hyperplasia following percutaneous coronary intervention (PCI). From our database of patients with elective PCI and baseline intravascular ultrasound (IVUS) evaluation of the implanted DES, we randomly selected 60 patients who were prescribed an ACEi and 60 matched controls, who did not receive an ACEi following PCI. All patients underwent coronary angiography and IVUS. sTRAIL was measured in samples from the stented coronary artery and a peripheral vein. sTRAIL concentration was higher in the ACEi group, both in coronary and peripheral samples: 104 [78-139] pg/ml versus 63 [45-100] pg/ml (P < 0.001) and 99 [73-135] pg/ml versus 69 [49-103] pg/ml (P = 0.002), respectively. There was an inverse association (standardized beta -0.760; P < 0.001) between sTRAIL and lumen area loss in both treatment groups. In the multivariable analysis, log(sTRAIL) was an independent negative predictor of lumen area loss (standardized beta -0.660, adjusted 95% confidence interval -0.722 to -0.466). Treatment with ACEi was associated with higher sTRAIL levels and lower lumen area loss in the IVUS evaluation of implanted DES. sTRAIL levels were negatively associated with in-stent neointima hyperplasia in these post-PCI patients.

Colchicine Treatment for the Prevention of Bare-Metal Stent Restenosis in Diabetic Patients

This study sought to test the hypothesis that colchicine treatment after percutaneous coronary intervention (PCI) can lead to a decrease in in-stent restenosis (ISR). ISR rates are particularly high in certain patient subsets, including diabetic patients, especially when a bare-metal stent (BMS) is used. Pharmacological interventions to decrease ISR could be of clinical relevance. Diabetic patients with contraindication to a drug-eluting stent, undergoing PCI with a BMS, were randomized to receive colchicine 0.5 mg twice daily or placebo for 6 months. Restenosis and neointima formation were studied with angiography and intravascular ultrasound 6 months after the index PCI. A total of 196 patients (63.6 ± 7.0 years of age, 128 male) were available for analysis. The angiographic ISR rate was 16% in the colchicine group and 33% in the control group (p = 0.007; odds ratio: 0.38, 95% confidence interval: 0.18 to 0.79). The number needed to treat to avoid 1 case of angiographic ISR was 6 (95% confidence interval: 3.4 to 18.7). The results were similar for IVUS-defined ISR (odds ratio: 0.42; 95% confidence interval: 0.22 to 0.81; number needed to treat = 5). Lumen area loss was 1.6 mm(2) (interquartile range: 1.0 to 2.9 mm(2)) in colchicine-treated patients and 2.9 mm(2) (interquartile range: 1.4 to 4.8 mm(2)) in the control group (p = 0.002). Treatment-related adverse events were largely limited to gastrointestinal symptoms. Colchicine is associated with less neointimal hyperplasia and a decreased ISR rate when administered to diabetic patients after PCI with a BMS. This observation may prove useful in patients undergoing PCI in whom implantation of a drug-eluting stent is contraindicated or undesirable.

Intravascular Ultrasound Results From the NEVO ResElution-I Trial

Background— The NEVO sirolimus-eluting stent (NEVO SES) is a novel cobalt-chromium stent combining sirolimus release from reservoirs with bioabsorbable polymer to reduce spatial and temporal polymer exposure. The aim of this study was to assess the arterial response to the NEVO SES in a randomized, blinded comparison versus the surface-coated TAXUS Liberte paclitaxel-eluting stent (TAXUS Liberté PES) in human native coronary lesions using intravascular ultrasound (IVUS). Methods and Results— The NEVO ResElution-I IVUS substudy enrolled 100 patients (1:1 randomization). In addition to standard IVUS variables, uniformity of neointimal distribution within stents was evaluated in 3 dimensions by computing mean neointimal thickness within 12 equally spaced radial sectors on every 1-mm cross section along the stented segment. The NEVO SES showed significantly less neointimal proliferation (neointimal obstruction: 5.5±11.0% versus 11.5±9.7%, P =0.02), resulting in less late lumen area loss and smaller maximum cross-sectional narrowing at 6 months. The absolute variability of neointima distribution, assessed by the standard deviation of neointimal thickness within each stent, was significantly reduced with the NEVO SES compared with the TAXUS Liberté PES(0.04±0.04 mm versus 0.10±0.07 mm, P &lt;0.0001). TAXUS Liberté PES showed significantly greater positive vessel remodeling than the NEVO SES (Δvessel volume index: 1.30±1.36 mm 3 /mm versus 0.36±0.63 mm 3 /mm, respectively, P =0.003). Conclusions— The NEVO SES with focal release of sirolimus from reservoirs achieved significantly greater and more consistent suppression of neointimal hyperplasia than the surface-coated TAXUS Liberté PES. This was associated with less positive remodeling and no increased morphological or morphometric abnormalities surrounding the stent or at the stent margins. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00714883.

Abstract 5995: Efficacy Of The Everolimus-eluting Stent in Diabetic Patients: Comparison With The Paclitaxel-eluting Stent

Background: In the diabetic subgroup of the Spirit III trial (randomized, multicenter trial comparing Everolimus-eluting XIENCE ™ V stent (EES) to Paclitaxel-eluting Taxus ™ stent (PES) in de novo native coronary artery lesions), PES showed a trend toward fewer major adverse cardiac event compared with EES during 1 year follow-up in patients with diabetes despite lower observed late loss with EES at 8 months. Methods: The Stanford University IVUS Core Laboratory database was queried to evaluate the efficacy of EES in diabetics compared with PES. A total of 113 lesions treated with EES (n=58) and PES (n=55) undergoing 8 or 9 months follow up 3-D intravascular ultrasound (IVUS) were enrolled. Volume index (volume/length) was calculated for vessel (VVI), peri-plaque (PVI), neointima (NIV), and lumen (LVI). %NIV was calculated as neointimal volume / stent volume × 100. Cross-sectional narrowing (CSN) was defined as neointimal area divided by stent area (%). Late lumen area loss was calculated as minimum lumen area (MLA) at post-intervention (Post) minus MLA at follow-up (FUP). Late incomplete stent apposition (LISA) was defined as separation of at least 1 strut from the vessel wall with blood speckle behind the strut, where Post IVUS revealed well apposition. Results: Average stent length was significantly longer in EES. EES showed less neointimal hyperplasia and smaller LVI loss than PES (Table ), whereas no statistical interactions were observed between EES and serial changes for VVI and PVI. PES showed a significant increase in PVI (Post: 7.6±3.1, FUP: 8.4±3.1; p=0.049) and a trend toward increase in VVI (Post: 14.8±5.5, FUP: 15.5±4.2; p=0.07) between Post and FUP. One case with LISA was observed in EES group. Conclusions: EES demonstrated significant suppression of neointimal hyperplasia in diabetic patients without vessel expansion compared with PES up to 8 months follow up. Figure 1 Intra Individual matched In-Stent Late Luminal Loss[mm]

Determinants of Lumen Loss Between Years 1 and 2 After Cardiac Transplantation

We previously reported that negative remodeling, not plaque progression, correlated with lumen loss during the first year after cardiac transplantation and that cytomegalovirus antibody seropositivity correlated with increased negative remodeling and greater lumen loss. Whether these findings persist between years 1 and 2 after transplantation is unknown. Serial 3-dimensional intravascular ultrasound analysis in the left anterior descending coronary artery was performed in 30 cardiac transplant recipients at year 1 and 2 after transplantation. Vessel, lumen, and plaque area were determined at 0.5-mm axial intervals in the first 50 mm of the left anterior descending coronary artery, and volumes were computed using Simpson's method. Univariate and multivariate regression analyses were performed to identify clinical predictors of change in coronary dimensions. Although mean vessel area did not change (13.6+/-3.4 to 13.4+/-3.3 mm/mm(3), P=0.45), mean plaque area increased (3.4+/-2.3 to 3.8+/-2.2 mm/mm(3), P=0.012), resulting in significant mean lumen area loss (10.3+/-2.5 to 9.6+/-2.3 mm/mm(3), P=0.016). However, the degree of luminal change strongly correlated with the degree of change in vessel size (R=0.81, P<0.0001), but not with change in plaque amount (R=-0.19, P=0.32). In fact, in 57% of the patients who demonstrated lumen loss, negative remodeling contributed more to lumen loss than did plaque progression. Diabetes at 2 years was the only significant independent clinical predictor of plaque progression and lumen loss. Despite significant plaque progression, negative remodeling correlated with coronary lumen loss between years 1 and 2 after cardiac transplantation.

Abstract 2771: Comparison of Everolimus-Eluting Stents with Paclitaxel-Eluting Stents in De Novo Native Coronary Artery Lesions: Intravascular Ultrasound Results From the SPIRIT III Trial

Background : SPIRIT III is a pivotal, multicenter, 2:1 randomized, controlled trial comparing Everolimus-eluting cobalt-chromium alloy XIENCE™ V stents (EES) to Paclitaxel-eluting Taxus ™ stents (PES) in de novo native coronary artery lesions. Intravascular ultrasound (IVUS) was performed in a subset of Spirit III to further investigate the safety and efficacy profiles of EES. Methods : The SPIRIT III IVUS study enrolled 305 patients who received 359 stents (244 EES in 205 patients; 115 PES in 100 patients). Serial IVUS imaging was performed post-intervention and at 8 months follow-up. Late lumen area loss was calculated as minimum lumen area (MLA) at post-intervention minus MLA at follow-up. Volume index, defined as volume data divided by stent length, was obtained for vessel (VVI), stent (SVI), lumen (LVI), plaque (PVI), and neointima (NVI). Results : At baseline, the incidence of tissue prolapse, edge dissections, and incomplete stent apposition (ISA) were not significantly different between EES and PES (15.6 vs 19.7%, 1.3 vs 2.8%, and 31.8 vs 28.2%, respectively). At follow-up, edge dissections and late-acquired ISA were not significantly different between EES and PES (1.4 vs 3.1%, 1.7 vs 4.1%, respectively). EES showed significantly less neointimal hyperplasia and a trend toward larger follow-up lumen than PES (Table ), whereas no statistical interactions were observed between EES and serial changes for VVI and PVI. PES showed a significant increase in VVI and PVI between post-intervention and follow-up. Reference segment analysis showed no unfavorable edge effect adjacent to either EES or PES. Conclusion : Detailed IVUS analysis confirmed significantly greater neointimal suppression with EES, with no apparent adverse vessel response, as compared to PES. Additional drug-eluting stent trials in more complex lesions are warranted to further validate the clinical utility of these new technologies.

Adventitial VEGF 165 gene transfer prevents lumen loss through induction of positive arterial remodeling after PTCA in porcine coronary arteries

Negative arterial remodeling still plays an important role in the pathogenesis of coronary restenosis even in the era of interventional stenting (e.g. arterial narrowing occurs proximal and distal of a stented segment). Previous studies suggest that increased angiogenesis and inhibited regression of injury-induced adventitial microvessels prevents negative remodeling. We have examined the effect of local vascular endothelial growth factor (VEGF 165) gene transfer on adventitial microvessel angiogenesis/regression and arterial remodeling after coronary angioplasty. Twenty pigs underwent angioplasty, each one in two major coronary arteries, followed by plasmid liposome gene transfer with either VEGF 165 or control gene LacZ (50 μg DNA with 50 μg of Lipofectine) into the (peri)adventitial space using a needle injection catheter. Arteries were examined at days 1, 7, 14, and 28. Local delivery of VEGF 165 gene into the outer compartments of balloon-injured porcine coronary arteries reduced lumen area loss due to distinct positive remodeling (arterial enlargement). Prevention of adventitial microvessel regression, enhanced adventitial elastin accumulation, reduced adventitial myofibroblast numbers, and a pronounced adventitial inflammatory response considered as a part of arterial healing seem to be the main VEGF-mediated mechanisms indicating the therapeutic potential of VEGF for restenosis prevention.

Mechanisms of acute gain and late lumen loss after atherectomy in different preintervention arterial remodeling patterns

The main mechanism of restenosis after directional coronary atherectomy (DCA) remains obscure. We investigated mechanisms of restenosis after DCA in different coronary artery remodeling patterns. DCA was performed in 51 de novo lesions. The lesions were evaluated by intravascular ultrasound (IVUS) before, immediately after, and 6 months after the procedure. According to the IVUS findings before DCA, we classified the lesions into the following 3 groups: (1) positive (n = 10), (2) intermediate (n = 25), and (3) negative (n = 16) remodeling. We measured lumen area, vessel area, and plaque area using IVUS before DCA, immediately after DCA, and at follow-up. Lumen area increase after DCA was mainly due to plaque area reduction in the positive and intermediate remodeling groups (90 ± 15% and 80 ± 25% increase in lumen area, respectively), whereas that in the negative remodeling group was due to both plaque area reduction (57 ± 22% increase in lumen area) and vessel area enlargement (43 ± 33% increase in lumen area). The plaque area increase correlated strongly with late lumen area loss in the positive and intermediate remodeling groups (r = 0.884, p <0.001; r = 0.626, p <0.001, respectively), but the decrease in vessel area was not correlated with lumen area loss. In contrast, both an increase in plaque area and a decrease in vessel area were correlated with late lumen area loss (r = 0.632, p = 0.009; r = 0.515, p = 0.041) in the negative remodeling group. Coronary artery restenosis after atherectomy was primarily due to an increase in plaque in the positive and/or intermediate remodeling groups. However, in the negative remodeling group, late lumen loss might have been caused by both an increase in plaque and vessel shrinkage.

Minimal duration of oral matrix metalloproteinase inhibition to prevent constrictive arterial remodeling after balloon dilation in the pig.

To determine the minimal duration of oral matrix metalloproteinase (MMP) inhibition to prevent constrictive remodeling after balloon dilation. In 37 nonatherosclerotic pigs, balloon dilation was performed in 145 peripheral arteries. Pigs were treated with an MMP inhibitor for 2, 7, 14, 28, or 42 days, or they served as controls and were killed 42 days after intervention. Arteries were visualized with angiography and intravascular ultrasonography. A 69% reduction in late vessel area (VA) loss was achieved after 14 days of treatment: 1.27 mm(2) +/- 0.55 (standard error of the mean [SEM]) versus 4.04 mm(2) +/- 0.93 (SEM) in the control group (P =.1). A consistent inhibition of late VA loss was observed in the 28-day (0.89 mm(2) +/- 0.83 [SEM], P =.03) and 42-day (0.74 mm(2) +/- 0.66 [SEM], P =.02) groups treated with the MMP inhibitor. After 14 and 28 days of treatment, late lumen area loss was 65% and 55% of control values, and it decreased to 41% (P =.04) after 42 days of treatment. MMP inhibition for 14-28 days is sufficient to inhibit constrictive remodeling after balloon dilation. This implies that an essential MMP-dependent initiator of constrictive remodeling was mainly active in the first 2 weeks after intervention.

935-32 Differing Mechanisms of Late Arterial Responses to Transcatheter Therapy: A Serial Quantitative Angiographic and Intravascular Ultrasound Study

To evaluate the mechanisms of late arterial response to transcatheter therapy, we analyzed serial quantitative angiographic minimum lumen diameter (MLD) and diameter stenosis (DS) and intravascular ultrasound external elastic membrane (EEM), lumen, and plaque area in 137 lesions treated with various devices (31 PTCA, 57 directional and 26 rotational atherectomy, and 23 excimer laser angioplasty). From serial angiography (post-intervention and at follow-up 4.7 ± 2.8 mos later), lesions were divided into 3 groups based on Δ MLD and follow-up %DS. From serial intravascular ultrasound, late lumen loss (Δlumen area), geometric remodeling (ΔEEM area). and tissue growth (Δplaque area) were calculated for each group: ↑MLD (N = 14) ↓MLD, but DS &lt; 0.5 (N = 44) ↓MLD and DS ≥ 05 p (N = 79) Post-intervention EEM (mm 2 ) 20.1 ± 3.7 20.7 ± 7.0 20.2 ± 6.5 NS Lumen (mm 2 ) 7.4 ± 2.0 7.0 ± 2.3 5.4 ± 2.2 &lt; 0.0001 Plaque (mm 2 ) 12.7 ± 3.7 13.7 ± 5.9 14.8 ± 5.8 NS Follow-up EEM (mm 2 ) 21.3 ± 8.0 20.0 ± 6.6 18.0 ± 5.8 0.0849 Lumen (mm 2 ) 8.7 ± 6.7 5.6 ± 30 1.8 ± 1.5 &lt; 0.0001 Plaque (mm 2 ) 12.6 ± 4.0 13.9 ± 5.0 16.2 ± 6.0 0.0169 Late lumen loss (mm 2 ) -1.3 ± 6.3 1.4 ± 2.6 3.5 ± 2.4 &lt; 0.0001 Remodeling (mm 2 ) -1.2 ± 7.6 0.7 ± 2.9 2.3 ± 2.7 0.0014 Tissue growth (mm 2 ) -0.1 ± 4.0 0.7 ± 1.5 1.3 ± 2.4 0.0831 Geometric remodeling correlated with tissue growth (r = 0.426, p &lt; 0.0001), but was independent of device used. We conclude: Patterns of the late arterial response following coronary intervention are determined less by tissue growth than by the direction and magnitude of geometric remodeling. Late lumen gain is the result of “overcompensation” with an increase in EEM area and minimal tissue growth. Late lumen loss without angiographic restenosis is the result of modest tissue growth with no decrease in EEM area. Angiographic restenosis is associated with moderate tissue growth, but is predominantly the result of geometric remodeling; a decrease in EEM area accounts for 66% of late lumen area loss