Comparison of myocardial fractional flow reserve and intravascular ultrasound for the assessment of slotted-tube stents.

Intravascular ultrasound (IVUS) and myocardial fractional flow reserve (FFR) have been reported to provide similar results for assessment of coil stent deployment. Their relative value in slotted-tube stents has not been investigated. Fourteen patients subjected to coronary angioplasty and IVUS-guided elective stenting with a slotted-tube stent underwent IVUS assessment and FFR measurement following stent implantation at inflation pressures of 12 and 18 atm. FFR values (mean +/- SD) preangioplasty, postangioplasty, and poststenting at 12 atm and 18 atm, were 0.58 +/- 0.07, 0.83 +/- 0.05, 0.94 +/- 0.02, and 0.94 +/- 0.02, respectively. After inflation at 12 atm, the area under the receiver operating characteristic (ROC) curve for the concordance of IVUS and FFR measurements was 0.89 (P = 0.02). Six patients had either an abnormal IVUS (n = 2) or FFR < 0.94 (n = 1) or both abnormal IVUS and FFR < 0.94 (n = 3) after the first inflation and had a second inflation at 18 atm. The area under the ROC curve for the concordance between IVUS and FFR final measurements was 0.855 (P = 0.10). Perfect concordance between IVUS and FFR was seen only for FFR values less than 0.91 or larger than 0.94. Overall, IVUS and FFR have substantial concordance with respect to slotted-tube stent deployment. However, FFR values between 0.91 and 0.94 after inflation are difficult to interpret.     

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.     

Assessment of optimum stent deployment by stent boost imaging: comparison with intravascular ultrasound

Stent boost (SB) imaging is an enhancement of the radiologic edge of the stent by digital management of regular X-ray images. The purpose of the present study was to validate SB imaging by comparison with the anatomical standard using intravascular ultrasound (IVUS). We investigated SB and IVUS after stent implantation in 68 arteries in 60 patients. Based on those findings, we added high-pressure dilatation in four patients and another stent implantation in four patients. We defined the SB criteria for adequate stent deployment as: complete stent expansion, stent minimum diameter ≥70% of reference diameter, and stent minimum diameter ≥2.0 mm; and IVUS criteria for adequate stent deployment as: minimal stent area ≥5.0 mm². If the reference vessel was <2.8 mm, adequate stent deployment was defined as minimum stent area ≥4.5 mm². IVUS findings indicated inadequate stent deployment in 21/72 observations (29%). Seven SB images showed inadequate stent expansion. SB predicted inadequate findings of IVUS with 100% specificity, 33% sensitivity, and 81% agreement. Although the sensitivity of SB image for adequate stent deployment is low, the specificity is sufficiently high for it to be the first-line for monitoring just after stent implantation in centers where IVUS is not used routinely.     

Angiographic and intravascular ultrasound follow up of paclitaxel‐ and sirolimus‐eluting stent after poststent high‐pressure balloon dilation: From the poststent optimal stent expansion trial

Objectives : The aims of this study were to identify the efficacy of optimal stent expansion (OSE) according to the Multicenter Ultrasound Stenting in Coronaries Study (MUSIC Study) criteria in drug‐eluting stent (DES) and compare paclitaxel‐eluting stent (PES) to sirolimus‐eluting stent (SES). Background : Although poststent high‐pressure balloon dilatation is proposed after bare metal stent implantation according to OSE, defined by the criteria of the MUSIC Study, very little data are available in DES. Methods : Two hundred fifty patients (M:F = 149:101; age, 61.5 ± 9.2 years) who underwent 9‐month follow‐up angiography in the Poststent Optimal Stent Expansion Trial (POET) were included in this study. We assessed angiographic in‐stent restenosis (ISR) and neointima volume (NV) using IVUS at 9 months. Results : At 9‐month follow up, there were no significant differences in ISR and NV index (NV/stent length, mm²) between patients with and without OSE. However, the rate of ISR and NV index were higher in PES [ISR: 18 (13.7%) and 4 (3.4%), P = 0.004; NV index: 1.02 ± 0.99 mm² and 0.21 ± 0.37, P < 0.001 in PES and SES]. Conclusions : OSE according to the MUSIC Study criteria was not related to ISR and NV in the DES era but PES had a significantly higher ISR rate and NV than SES after poststent high‐pressure balloon dilatation. © 2010 Wiley‐Liss, Inc.     

Restenosis rate after intravascular ultrasound-guided coronary stent implantation

This study was designed to test the hypothesis that patients fulfilling intravascular ultrasound (IVUS) criteria for optimal coronary stent implantation show a reduction in the restenosis rate at 6 months. IVUS guidance for stent dilation may be associated with faciliated stent implantation and an increased acute luminal gain, but it has not yet been determined, whether and to what extent this procedure is associated with a reduction in the restenosis rate. IVUS-guided optimization of Palmaz-Schatz stent placement was performed in 125 consecutive patients, 64 of whom fulfilled IVUS-criteria for optimal stent placement. Another 125 patients served as the non-IVUS control group. In 107 patients (86%) of the non-IVUS control group and 105 patients (84 %) of the IVUS group, angiographic follow-up was performed. The IVUS group of patients revealed a significantly lower restenosis rate of 20.9% as compared with 29.9% in the control group (P = 0.033). Patients that met IVUS criteria for optimal stent placement had a larger minimal lumen diameter immediately after stent implantation (3.13 ± 0.44 vs. 2.95 ± 0.47 mm; P = 0.045) and at 6-month follow-up (2.23 ± 0.78 vs. 1.87 ± 0.76 mm; P = 0.019) as well as a significantly lower restenosis rate (13.5% vs. 28.3%; P = 0.038) as compared with patients that did not fulfil these criteria. Our data suggest that patients fulfilling IVUS criteria for optimal stent placement demonstrate a reduced risk for the development of restenosis. Thus, IVUS investigation identifies factors predictive of restenosis after coronary stent placement. Cathet. Cardiovasc. Diagn. 44:380–386, 1998. © 1998 Wiley-Liss, Inc.     

Provisional stenting strategies: systematic overview and implications for clinical decision-making

Coronary stents reduce the rates of abrupt closure, emergency coronary artery bypass graft surgery and restenosis, but do not prevent myocardial infarction or death at six months. The financial burden of increased stent use and the difficulty in managing in-stent restenosis have provided the impetus to develop provisional stenting strategies. Patients at low risk for restenosis after balloon angioplasty may not derive additional benefit from stent implantation and may be successfully managed with percutaneous transluminal coronary angioplasty (PTCA) alone. Numerous patient, lesion and procedural predictors of restenosis have been identified. Postprocedural assessment using quantitative coronary angiography, intravascular ultrasound (IVUS), coronary flow velocity reserve (CVR) or fractional flow reserve (FFR) may further enhance the ability to predict adverse outcomes after PTCA. Several studies have been performed to investigate the feasibility of provisional stenting strategies using various modalities to identify low risk patients who could be managed with PTCA alone. An optimal or "stent-like" angiographic result after PTCA is associated with favorable clinical outcomes. Preliminary results of studies using IVUS or CVR to guide provisional stenting appear promising. Angiography alone may be inadequate to identify truly low risk patients and may need to be combined with clinical factors, assessment of recoil, IVUS or physiologic indexes. Strategies that avoid unnecessary stenting in even a small proportion of patients may have large impacts on health care costs. Provisional stenting may potentially reduce costs and rates of in-stent restenosis without compromising the quality of health care delivery.     

Randomized trial of Rotational Atherectomy Versus Balloon Angioplasty for Diffuse In-stent Restenosis (ROSTER)

Background

Various autopsy and intravascular ultrasound (IVUS) studies have shown neointimal proliferation as the main mechanism of in-stent restenosis (ISR) responsible for >95% of luminal narrowing while stent struts are not compressed. ISR of diffuse type has a high incidence of recurrence (up to 70%) after balloon angioplasty (PTCA). Tissue ablation with percutaneous rotational coronary atherectomy (PRCA) may be more efficacious compared to tissue compression or extrusion after PTCA for the interventional treatment of diffuse ISR.

Methods

The Rotational Atherectomy Versus Balloon Angioplasty for Diffuse In-Stent Restenosis (ROSTER) trial is a single-center, randomized trial comparing PRCA to PTCA (both with IVUS guidance) in the treatment of diffuse ISR in 200 patients. In the PRCA group (n = 100), rotablation was performed using a burr-to-artery ratio >0.7 followed by adjunctive balloon dilatation at low pressure (4-6 atm). In the PTCA group (n = 100), high-pressure (>12 atm) balloon dilatation was performed using an optimal size balloon. The study's primary end point was target lesion revascularization (TLR) at 9 months and secondary end points included clinical events at 1 year and angiographic restenosis in a substudy of the last 75 patients enrolled.

Results

Baseline clinical and angiographic variables were comparable between the 2 groups with similar procedural and angiographic success, but a higher rate of repeat stenting occurred in the PTCA group (31% vs 10%; P <.001). Although the angiographic acute luminal gain was similar between the 2 groups, IVUS analysis revealed lower residual intimal hyperplasia area after PRCA versus PTCA (2.1 ± 0.9 mm² vs. 3.3 ± 1.8 mm²; P = .005). At a mean follow-up of 12 ± 2 months, there were 2 deaths, 3 myocardial infarctions, and 3 coronary artery bypass graft procedures in each group. TLR incidence was 32% in the PRCA group and 45% in the PTCA group (P = .042), with a similar trend noted in the angiographic substudy.

Conclusion

The ROSTER trial for diffuse ISR revealed both PRCA and PTCA to be safe and effective, but PRCA resulted in less residual intimal hyperplasia, lower repeat stent use, and decreased TLR.     

Intravascular ultrasonography in the evaluation of results of coronary angioplasty and stenting

The main advantage of intravascular ultrasonography (IVUS) over angiography in assessing the effect of coronary interventions is the ability of IVUS to directly visualize the vessel wall. IVUS often reveals a high residual plaque burden after angiographically successful angioplasty, and this can motivate the operator to use additional, more aggressive measures in an attempt to increase lumen dimensions. Studies using IVUS imaging before and after balloon angioplasty have shown that luminal gain after percutaneous transluminal coronary angioplasty (PTCA) results from a combination of plaque reduction and vessel wall stretch. Minimal luminal area and residual area stenosis after PTCA and stent deployment, as measured by IVUS, have been shown to be predictors of restenosis. IVUS studies have pointed to vessel shrinkage, not intimal hyperplasia, as the main mechanism of restenosis after PTCA. IVUS guidance of stent deployment has often revealed inadequate stent expansion despite optimal results on angiography, leading to high-pressure stent deployment with significant additional luminal gain. Restenosis rates may be lower with IVUS-guided stent deployment.     

Impact of intravascular ultrasound guidance in patients with acute myocardial infarction undergoing percutaneous coronary intervention

Objectives: The aim of this study was to examine the utility of routine intravascular ultrasound (IVUS) guidance in patients with acute myocardial infarction (MI) undergoing percutaneous coronary intervention (PCI) with stent implantation. Background: Stent thrombosis (ST) is a serious complication of PCI with stent implantation for patients presenting with acute MI. Mechanical factors such as incomplete stent expansion and smaller stent diameters are known to correlate with ST and restenosis. IVUS guidance for stent deployment is reported to reduce these events in stable patients. Methods: We analyzed a cohort of 905 consecutive patients who underwent primary PCI for acute MI and were discharged alive. The clinical outcomes of 382 patients who underwent IVUS‐guided PCI were compared to those of 523 patients who did not. Patients who presented with cardiogenic shock and rescue PCI were excluded. The primary composite endpoint of death, MI, and target lesion revascularization at 1‐year follow‐up was systematically indexed and a propensity score was performed with regard to the use of IVUS‐guided PCI. Results: Patients undergoing IVUS‐guided PCI were older, more diabetic and hypertensive, but presented with less history of previous MI. The severity of coronary artery disease was balanced between both groups. The number of treated lesions and stents used was higher in the IVUS‐guided group, with a longer procedural duration. The overall rates of the composite primary outcome were similar (14.5% vs. 14.3%, P = 0.94) as were the rates of definite and probable stent thrombosis at 1 year (2.1% vs. 2.1%, P = 0.99) in the IVUS‐guided and no‐IVUS groups, respectively. After multivariate and propensity score adjustment, IVUS guidance was not an independent predictor for the primary endpoint. Conclusion: This study does not support the routine use of IVUS guidance for stent deployment in patients who present with acute MI and undergo primary PCI. © 2009 Wiley‐Liss, Inc.     

In vitro study of FFR, QCA, and IVUS for the assessment of optimal stent deployment.

We tested whether fractional flow reserve (FFR) discriminates between suboptimally and optimally deployed stents. Latex tubes (diameter solidus in circle = 4 mm) with diameter stenosis 40% (n = 3), 50% (n = 3) and 60% (n = 3) were tested in a pulsatile flow system, using water. Measurements were done at baseline (n = 9; FFR/QCA) and after suboptimal (SOD; 3-mm balloon at 8 atm) and optimal (OD; 4 mm balloon at 16 atm) deployment of a 35-mm stent (n = 6; FFR/QCA/IVUS). Varying Q from 150 to 50 ml/min increased FFR by 2-7%. Conversely, at 100 ml/min, FFR increased by only 0.8% from SOD to OD (P < 0.05). Extrapolating data to blood flow, the gain in FFR from SOD to OD is less than 5% for Q = 100 ml/min, while FFR may increase by 15-20% by changes in blood flow from 50 to 150 ml/min. We conclude that IVUS and QCA are more appropriate for the assessment of optimal stent deployment.     

Rotational atherectomy for in-stent restenosis: acute and long-term results of the first 100 cases

Objectives. This study evaluated the clinical safety and long-term results of rotational atherectomy (RA) followed by low-pressure balloon dilatation (percutaneous transluminal coronary angioplasty [PTCA]) for the treatment of in-stent restenosis (ISR).Background. In-stent restenosis is associated with a high incidence of recurrence after interventional treatment. Because ISR is due to neointimal hyperplasia, rotational ablation may be a more effective treatment than PTCA.Methods. Between November 1995 and November 1996, 100 consecutive patients with first-time ISR were treated by RA. Quantitative coronary angiography and intravascular ultrasound (IVUS) were used to analyze the acute procedural results. The incidence of repeat in-stent restenosis and target vessel revascularization (TVR) at follow-up was determined.Results. Procedural success without any major in-hospital complications was achieved in 100% of cases. Slow flow was observed in 3% and creatine kinase-MB enzyme elevation >3× normal occurred in 2%. The mean burr-to-artery ratio was 0.68 ± 0.18 and adjuvant balloon dilatation was performed at 4.2 ± 2.1 atm. Minimum luminal diameter increased from 0.86 ± 0.28 mm to 1.89 ± 0.21 mm after RA and to 2.56 ± 0.29 mm after adjunct PTCA. Quantitative IVUS analysis showed that 77% of the luminal gain occurred due to rotational ablation of the restenotic tissue and only 23% occurred after adjunct balloon dilation, and further stent expansion did not contribute to the luminal enlargement. At a mean follow-up of 13 ± 5 months, repeat in-stent restenosis occurred in 28% of patients with TVR of 26%. Univariate predictors of repeat restenosis were burr-to-artery ratio <0.6, ISR in <90 days of stenting, ostial lesion, stent for a restenotic lesion and diffuse type ISR.Conclusions. Rotational atherectomy is a safe and feasible technique for treatment of ISR and is associated with a relatively low recurrent restenosis in comparison to historical controls of balloon angioplasty.     

Standardized angiographically guided over-dilatation of stents using high pressure technique optimize results without increasing risks

BACKGROUND: Routine angio-guided stent deployment results in a relatively high restenosis rate, which is mostly due to stent sub-expansion. Several different intravascular ultrasound (IVUS) criteria for optimal stent deployment have been proposed. A minimal in-stent restenosis and a minimal in-stent lumen area of > or = 9 mm2 have been associated with low rates of restenosis and target lesion revascularization (TLR) at 6 months. The role of high-pressure stent deployment and/or upsizing the post-dilatation balloon has not yet been clarified. The aim of this study was to evaluate the possibility of achieving accepted IVUS criteria safely without IVUS guidance with the combination of high-pressure deployment and post-dilatation with a 0.25 mm oversized balloon. METHODS: Thirty-four stents (26 NIR, 3 AVE GFX, 3 ACS GFX, 1 Bard, 1 Jostent) were implanted in 30 patients until optimal angiographical results were obtained (< 10% residual stenosis visually). Forty percent of the patients had unstable angina pectoris, forty-four percent had complex lesions (B2 and C) and 29% were occlusions. Mean inflation pressure was 12.6 +/- 1.6 atm, mean stent diameter was 3.2+/- 0.4 mm and mean stent length was 15.1+/- 5.4 mm. Post-dilatation was performed with the same stent using a short (compared to the angiographic reference segment), 0.25 mm oversized Scimed Maxxum Energy 3.5 +/- 0.4 mm balloon using high pressure (16.1 +/- 1.7 atm) followed by an off-line IVUS examination of the stents. There was clinical follow-up for 1 year. Results in patients with single-vessel disease were compared with those of non-randomized controls, who were stented with high pressure but without over-dilatation. RESULTS: No stent achieved the nominal diameter, in spite of over-dilatation. Mean minimal stent diameter (MLD) according to IVUS was 2.9 +/- 0.4 mm (92% of the angiographic reference diameter). Mean minimal lumen area (MLA) was 7.7 +/- 2.2 mm2. An in-stent MLA > or = 90% of the distal reference segment (AVID criteria) and an MLA > or = 100% or > or = 90% of the smallest/average reference segment (MUSIC criteria) was found in 67% and 57%, respectively. MLA > or = 9 mm2 was achieved in 38%. All stents had good apposition and obtained a symmetry index > or = 0.7 mm. No acute perforations, dissections or other serious complications occurred during the over-dilatation. At 1 year, five patients had re-angina leading to a new coronary angiography; only 1 patient had a significant in-stent restenosis requiring re-PTCA. Compared to non-overdilated historical controls, the standardized over-dilatation seemed to give a larger MLD (3.0 +/- 0.4 mm vs. 2.7 +/- 0.4 mm; p = 0.03), more patients who fulfilled AVID criteria (70% vs. 32%; p = 0.048) and more stents with MLA > or = 9 mm2 (46% vs. 11%; p = 0.02). CONCLUSION: A standardized 0.25 mm over-dilatation of stents never achieved nominal stent size, but did improve lumen gain and was associated with low target vessel revascularization without adding complications to the routine stenting procedure.     

Intravascular ultrasound-guided stenting in long lesions: an insight into possible mechanisms of restenosis and comparison of angiographic and intravascular ultrasound data from the MUSIC and RENEWAL trials

The high restenosis rates in long stents may be related to suboptimal stent deployment. In an attempt to understand the potential components associated with restenosis in long stents, this study compares angiographic and intravascular ultrasound (IVUS) data from the MUSIC and RENEWAL studies where IVUS was used to optimize stent deployment in short (< 15 mm) and long (> 20 mm) coronary lesions, respectively. The RENEWAL study, a randomized trial, compared the NIR stent and Wallstent in long (> 20 mm) coronary lesions and used on-line visual IVUS criteria to optimize stent expansion. Detailed analysis of IVUS data was performed off line. Angiographic and IVUS data from this study was compared to that from the MUSIC study. Initial stent deployment was deemed optimal by the operator after visual angiographic and IVUS assessment in 50 of 70 lesions. In the remaining 20 lesions further balloon inflations were required to optimize stent apposition that led to an average gain in minimal in-stent luminal area (MISA) of 15.9% (P < 0.01). Off-line IVUS data analysis showed that the number reaching "MUSIC criteria" for optimal stent deployment preredilatation was 8 (11.4%) of 70 and 14 (20%) of 70 postredilatation. The ratio of MISA/MRAprox (mean proximal reference area) was 0.69 in RENEWAL. At 6-month follow-up, the angiographic restenosis rate in RENEWAL was 36% and target lesion revascularization (TLR) rate was 7.8%, compared with MUSIC's 9.7% and 4.5%, respectively. In conclusion, angiographic assessment of stent deployment in long lesions is limited. On-line visual IVUS with further balloon inflations to improve stent apposition led to a significant gain in MISA, but the MISA/MRAprox ratio remained suboptimal. Therefore, suboptimal stent deployment due to constraint by lesion resistance may be an important mechanism underlying the high restenosis rates in long stents.     

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.     

Intravascular ultrasound imaging after excimer laser angioplasty

To help elucidate the mechanism of excimer laser coronary angioplasty (ELCA), intra-vascular ultrasound (IVUS) imaging was performed in 19 of 29 patients who were treated with ELCA. The results were compared with a non-randomized control group of 18 patients who had IVUS studies both before and after PTCA alone. After ELCA alone, lumen diameter (1.9 × 1.7 mm) and lumen cross-sectional area (CSA) (2.9 mm²) by IVUS were not significantly different from baseline values in the patients before PTCA alone (2.1 × 1.8 mm, 3.2 mm²). After balloon dilatation in the laser treated group, lumen diameter (2.5 × 2.1 mm) and lumen CSA (4.9 mm²) were significantly greater than those post ELCA alone. However, there was no difference in lumen CSA or atheroma CSA in the group treated with excimer laser plus balloon dilatation vs. these measurements in the group treated with PTCA alone. ELCA does not ablate a large amount of atheroma (9% reduction) but creates a pathway to permit easier passage of a PTCA balloon. These quantitative and morphologic results may help explain why the restenosis rate with ELCA is similar to PTCA alone. © 1994 Wiley-Liss,Inc..     

In vivo tomographic assessment of the heart and blood vessels with intravascular ultrasound

Intravascular ultrasound (IVUS) has emerged from being a research tool to becoming an intrinsic part of modern invasive cardiology mainly due to imaging micro anatomy in vivo. For the first time, it is possible to base therapeutic decisions not only on lumenograms but also on vessel wall assessment. IVUS has both diagnostic and intervention associated potential. The diagnostic strength of IVUS is its ability to describe compensatory coronary artery enlargement as a response to arteriosclerosis, to assess intermediate lesions, and to reveal occult left main stem disease and angiographically “silent” arteriosclerosis. The intervention associated potential of IVUS is the optimal device selection, i.e., rotablators in calcified lesions or atherectomy devices in large plaque burden. The effects of PTCA on vessel wall morphology can be studied in great detail and the effect on luminal gain can be assessed. Several groups have shown that the residual plaque area (“plaque burden”) even after angiographically successful PTCA still lies in the range of 60%. A significant reduction in this number may influence long-term outcome after PTCA. Minimal luminal area and residual plaque area after PTCA seem to be indicators of restenosis, while the presence or absence of dissections seems to be less predictive. The main mechanism of restenosis after PTCA is vessel shrinkage, not intimal hyperplasia. Intravascular monitoring of stent expansion led to high-pressure stent deployment with a significant increase in post-procedural luminal diameters and the ability to withhold anticoagulation in patients with optimal stent deployment. In pulmonary and aortic diseases, IVUS contributed significantly to the understanding of aortic dissection and pulmonary hypertension. Additionally, with intracardiac ultrasound left and right ventricular function can be assessed. Intracardiac ultrasound has gained clinical usefulness for guiding transcatheter ablation in patients with conduction system abnormalities. In the future, integrated devices, such as balloons on IVUS catheters, steerable catheters, integrated flow and pressure transducers, tissue characterization, and 0.018” IVUS guide wires will further enhance the usefulness of IVUS. Received: 6 May 1997, Returned for revision: 4 July 1997, Revision received: 29 January 1998, Accepted: 17 February 1998     

Incomplete expansion of Palmaz-Schatz stents despite high-pressure implantation technique: impact on target lesion revascularization.

Improved expansion of stents using high-pressure implantation technique with subsequent antiplatelet therapy has improved patient outcome regarding the incidence of subacute stent thrombosis, bleeding complications and restenosis. Whether high-pressure implantation per se guarantees adequate stent expansion remains unclear. The aim of the study was to determine (1) stent expansion after high-pressure implantation technique and (2) whether stent expansion influences rate of target lesion revascularization within 6 months of follow-up. One hundred Palmaz-Schatz stents were implanted in 98 lesions (91 native vessels, 7 graft vessels) of 94 patients using high-pressure implantation technique (balloon pressure 12-20 atm). Stent expansion was investigated using intravascular ultrasound imaging (IVUS). Clinical follow-up of the patients was performed for 6 months. After implantation, stent/mean reference ratio was 0.81 +/- 0.16. Noncompliant balloons used for implantation were chosen by angiographic criteria. Mean balloon/reference ratio was 1.08 +/- 0.22; therefore balloons were not undersized. Additional balloon dilataion using higher pressures and/or larger balloons based on IVUS criteria and subsequent IVUS measurements was performed in 52 patients (55%); in these patients, stent expansion improved from 79 +/- 16 to 91 +/- 15% (mean +/- SD) of average reference areas (p < 0.002). Within the 6 months' clinical follow-up, target lesion revascularization was performed in 19 patients (20%). The only prognostic factors for the development of in-stent restenosis requiring target lesion revascularization were the vessel size (p < 0.05) and the extent of plaque distal to the stents (p < 0.05). Implantation of Palmaz-Schatz stents using high-pressure technique does not guarantee adequate stent expansion. Additional dilatation with higher pressures and/or larger balloons improves stent expansion. The size of the stented vessel and the extent of plaque at the distal stent end (residual outflow stenosis) but not the degree of stent expansion were predictors for target lesion revascularization within 6 months' follow-up.     

Comparison of paclitaxel-eluting stent and sirolimus-eluting stent expansion at incremental delivery pressures

OBJECTIVES: We sought to compare the adequacy of paclitaxel-eluting stent (PES) and sirolimus-eluting stent (SES) expansion based on intravascular ultrasound (IVUS) imaging criteria at conventional delivery pressures. METHODS: Forty-six patients underwent SES implantation and 42 patients underwent PES implantation for de novo native coronary lesions<33 mm in length with reference lumen diameters of 2.5-3.5 mm. Stents were serially expanded with gradual balloon inflations at 14 and 20 atm. IVUS imaging was performed prior to intervention and after each balloon inflation. Stent expansion (minimal stent cross-sectional area/reference lumen cross-sectional area) was measured. Inadequate stent expansion was defined using the MUSIC criteria (all struts apposed, no tissue protrusion, and final lumen cross-sectional area>80% of the reference or >90% if minimal lumen cross-sectional area was <9 mm2). RESULTS: The baseline characteristics of the two groups were similar except for shorter lesion length, larger mean lumen cross-sectional area, larger lumen diameter, and lower plaque burden in the PES group. Stent expansion was inadequate in 80% of patients with SES versus 63% of patients with PES at 14 atm, although this was not statistically significant. After 20 atm, 48% of patients with SES remained underexpanded as compared with 35% of patients with PES. CONCLUSION: Drug-eluting stents showed significant underexpansion by MUSIC criteria at conventionally used inflation pressures. Higher balloon inflations are required especially during deployment of a SES. IVUS guidance is recommended to ensure optimal results and outcomes with both stents.     

Intravascular ultrasound predictors of angiographic restenosis after sirolimus-eluting stent implantation.

AIMS: In many countries, drug-eluting stent implantation is the dominant interventional strategy. We evaluated the clinical, angiographic, procedural, and intravascular ultrasound (IVUS) predictors of angiographic restenosis after sirolimus-eluting stent (SES) implantation. METHODS AND RESULTS: SES implantation was successfully performed in 550 patients with 670 native coronary lesions. Six-month follow-up angiography was performed in 449 patients (81.6%) with 543 lesions (81.1%). Clinical, angiographic, procedural, and IVUS predictors of restenosis were determined. Using multivariable logistic regression analysis, the only independent predictors of angiographic restenosis were post-procedural final minimum stent area by IVUS [odds ratio (OR)=0.586, 95% confidence interval (CI) 0.387-0.888, P=0.012] and IVUS-measured stent length (OR=1.029, 95% CI 1.002-1.056, P=0.035). Final minimum stent area by IVUS and IVUS-measured stent length that best separated restenosis from non-restenosis were 5.5 mm2 and 40 mm, respectively. Lesions with final minimum stent area<5.5 mm2 and stent length>40 mm had the highest rate of angiographic restenosis [17.7% (11/62)], P<0.001 compared with other groups. CONCLUSION: Independent predictors of angiographic restenosis after SES implantation were post-procedural final minimum stent area by IVUS and IVUS-measured stent length. The angiographic restenosis rate was highest in lesions with stent area<5.5 mm2 and stent length>40 mm.     

Nine‐Month Angiographic and Intravascular Ultrasound Outcomes After Resolute Zotarolimus‐Eluting Stent Implantation for the Treatment of In‐Stent Restenosis

Objectives

We aimed to evaluate the mid‐term outcomes of resolute zotarolimus‐eluting stent (R‐ZES) implantation for in‐stent restenosis (ISR).

Background

There has been a paucity of data regarding the effects of new‐generation drug‐eluting stent to treat ISR.

Methods

From 2009 to 2010, a total of 98 patients with 98 ISR lesions were prospectively enrolled after R‐ZES implantation for the treatment of ISR. Among 98 patients, 73 patients underwent follow‐up angiography at 9 months. Serial intravascular ultrasound (IVUS) at both postprocedure and 9 months was evaluated in 55 patients. The overlapped segment of R‐ZES was defined as the portion of R‐ZES superimposed on previous stent.

Results

Late loss and binary restenosis rate were 0.3 ± 0.5 mm and 5.5% at 9 months. On IVUS, the percentage of neointimal volume and maximum percentage of neointimal area were 3.9 ± 6.3% and 17.3 ± 15.5%, respectively. There was no significant change of vessel volume index between postprocedure and 9 months (16.9 ± 4.7 mm³/mm vs. 17.1 ± 4.6 mm³/mm, P = 0.251). Late‐acquired incomplete stent apposition was observed in 5 (5/55, 9.1%) cases. Compared with nonoverlapped segments of R‐ZES, the overlapped did not show larger neointimal volume index (0.3 ± 0.5 mm³/mm vs. 0.2 ± 0.3 mm³/mm, P = 0.187) on 9‐month IVUS. During follow‐up (median, 353 days), repeat target‐lesion revascularization was performed in four cases, but there were no death or stent thrombosis.

Conclusions

This study suggested that R‐ZES implantation for the treatment of ISR was effective up to 9 months and showed favorable vascular responses on serial IVUS assessment.