A randomised trial of endoluminal reconstruction comparing the NIR stent and the Wallstent in angioplasty of long segment coronary disease: results of the RENEWAL Study

BACKGROUND: The role of coronary stents in reducing the incidence of acute complications and late restenosis after angioplasty has been established in randomized studies focusing on simple, short coronary lesions. The development of long coronary stents has provided a safe and predictable means of treating long coronary lesions, but this carries with it a higher risk of restenosis. By comparing the outcome of treating long lesions with two different stent types, we aimed to assess the influence of stent design rather than the nature of long lesions per se on the relatively high restenosis rates in this subgroup. METHODS: This study was designed to assess procedural complications and 6-month restenosis rates in a randomized trial comparing a slotted tube stent with a self-expanding stent for the treatment of long coronary lesions. Randomization of vessels to either stent occurred after successful balloon angioplasty. Intravascular ultrasound (IVUS) was used to assess and optimize stent deployment. The patients were restudied angiographically and by IVUS at 6 months. RESULTS: A total of 82 patients (85 vessels) were recruited (slotted tube stent, n = 44 vessels; self-expanding stent, n = 41 vessels). Successful deployment occurred in 41 (100%) of 41 of the self-expanding stent group and 41 (93%) of 44 of the slotted tube stent group. There was no difference in lesion length between the two groups (slotted tube stent, 26.6 +/- 6.9 [SD] mm; self-expanding stent, 28.7 +/- 9.8 [SD] mm; P = .2), but the mean length of the self-expanding stent was greater than that of the slotted tube stent (41.6 +/- 18.8 [SD] mm vs 35.4 +/- 16.2 [SD] mm, respectively; P < .05). There was no significant difference in the rate of major events between the two groups at 6-month follow-up. The angiographic restenosis rate at follow-up was less in the slotted tube stent group, but this did not reach statistical significance (26% vs 46%, respectively; P = .1) and the target lesion revascularization rate was similar for both groups (7.9% vs 7.7%, respectively; P = .8). IVUS assessment of plaque/stent ratios suggested a greater plaque burden in the self-expanding stent compared with the slotted tube stent at follow-up (0.42 +/- 1.2 [SD] vs 0.3 +/- 0.08 [SD]), but this was not statistically significant (P = .1). CONCLUSIONS: Long stents can be safely and successfully deployed in long segment coronary disease, with an acceptable 6-month target lesion revascularization rate. Our results showed a trend toward lower angiographic restenosis and a lesser in-stent plaque burden at follow-up in the slotted tube stent compared with the self-expanding stent. This suggests that stent design may influence the restenotic process in long coronary lesions.     

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.     

Discrepancy between morphologic and functional criteria of optimal stent deployment using intravascular ultrasound and pressure derived myocardial fractional flow reserve

BACKGROUND: Pressure derived myocardial FFR, a functional index of epicardial stenosis has been proposed for the assessment of optimal stent deployment. The following study evaluated the potential of serial fractional flow reserve (FFR) measurements in comparison to the ‘gold standard’ intravascular ultrasound (IVUS) for optimal stent deployment and its long‐term outcome. METHODS: 35 patients with a single de novo lesion underwent PTCA followed by stent implantation with an initial inflation pressure of 12 atm. If optimal stent expansion using IVUS‐criteria were not fulfilled, re‐dilatation at 16 atm as well as additional inflations with larger balloon sizes were performed to reach the procedural end‐point. IVUS and FFR were performed after each dilatation (n?=?136). Angiography was repeated after 6 months. RESULTS: In 30 pts who fulfilled IVUS criteria, mean lumen area (2.9±1.3?mm²) increased after PTCA and stent implantation to 10.0±3.0?mm². In six pts, optimum stent deployment according to a value of FFR?0.94 was not reached. Four of six pts reached the IVUS criteria at 12 atm and two pts at 16 atm, respectively. Positive and negative predictive values of FFR were 26 and 64%. Three of the 30 pts (10%) revealed a restenosis at three months follow‐up. One of these restenosis was seen in a patient with a post‐procedural FFR<0.94. CONCLUSIONS: FFR was not valid to predict optimal stent expansion according to IVUS criteria but could delineate under‐expanded stents despite a reasonable angiographic appearance. Morphologic (IVUS) and functional criteria (FFR) for optimal stent deployment revealed a comparably low restenosis rate.     

Angiographic and intravascular ultrasound predictors of in-stent restenosis

Objectives. This study was performed to determine predictors of in-stent restenosis from a high volume, single-center practice.Background. Intracoronary stents have been shown to reduce the restenosis rate as compared with balloon angioplasty, but in-stent restenosis continues to be an important clinical problem.Methods. Between April 1993 and March 1997, 1,706 patients with 2,343 lesions were treated with a variety of intracoronary stents. The majority of stents were placed with high pressure balloon inflations and intravascular ultrasound (IVUS) guidance. Angiographic follow-up was obtained in 1,173 patients with 1,633 lesions (70%). Clinical, angiographic and IVUS variables were prospectively recorded and analyzed by univariate and multivariate models for the ability to predict the occurrence of in-stent restenosis defined as a diameter stenosis ≥50%.Results. In-stent restenosis was angiographically documented in 282 patients with 409 lesions (25%). The restenosis group had a significantly longer total stent length, smaller reference lumen diameter, smaller final minimal lumen diameter (MLD) by angiography and smaller stent lumen cross-sectional area (CSA) by IVUS. In lesions where IVUS guidance was used, the restenosis rate was 24% as compared with 29% if IVUS was not used (p < 0.05). By multivariate logistic regression analysis, longer total stent length, smaller reference lumen diameter and smaller final MLD were strong predictors of in-stent restenosis. In lesions with IVUS guidance, IVUS stent lumen CSA was a better independent predictor than the angiographic measurements.Conclusions. Achieving an optimal stent lumen CSA by using IVUS guidance during the procedure and minimizing the total stent length may reduce in-stent restenosis.     

Intravascular ultrasonic predictors of angiographic restenosis after long coronary stenting

The intravascular ultrasound (IVUS) criteria for stent optimization have not been determined in stenting long lesions. We evaluated the predictors of angiographic restenosis and compared it with stent lumen cross-sectional area (CSA) and stent length between short (stent length <20 mm) and long (> or =20 mm) coronary stenting. IVUS-guided coronary stenting was successfully performed in 285 consecutive patients with 304 native coronary lesions. Six-month follow-up angiogram was performed in 236 patients (82.8%) with 246 lesions (80.9%). Results were evaluated using conventional (clinical, angiographic, and IVUS) methods. The overall angiographic restenosis rate was 22.8% (56 of 246 lesions) (short stent 17.6% vs. long stent 32.2%, p = 0.009). Using multivariate logistic regression analysis, the independent predictors of angiographic restenosis were the IVUS stent lumen CSA (odds ratio 1.51, 95% confidence intervals 1.18 to 1.92, p = 0.001) and stent length (odds ratio 0.95, 95% confidence intervals 0.91 to 1.00, p = 0.039). The angiographic restenosis rate was 54.8% for stent lumen CSA of <5.0 mm2 (short stent 37.5% vs. long stent 73.3%, p = 0.049), 27.4% for CSA between 5.0 and 7.0 mm2 (short stent 24.1% vs. long stent 31.7%, p = 0.409), 10.5% for CSA between 7.0 and 9.0 mm2 (short stent 10.0% vs. long stent 12.5%, p = 0.772), and 11.4% for stent lumen CSA of > or =9.0 mm2 (short stent 10.4% vs. long stent 13.3%, p = 0.767) (p = 0.001). Compared with short coronary stenting, long coronary stenting is effective treatment modality to cover long lesions with comparable long-term clinical outcomes in cases of stent lumen CSA of > or =7.0 mm2. Regardless of the stent length, the most important factor determining angiographic restenosis was the IVUS stent lumen CSA in relatively large coronary artery lesions.     

Should every eligible lesion undergo direct stenting?

Although significant coronary artery (CA) calcification is believed to affect stent deployment, the exact impact on stent deployment after high-pressure balloon inflations is unknown. Intracoronary intravascular examination (ICUS) was performed in 27 moderate-severe calcified CA lesions before and after stent implantation. In case of unsatisfactory results (in-stent area < 90%, minimal in-stent diameter/maximal in-stent diameter < 0.8), further inflations up to 20 atm guided by ICUS were applied. Initially, stent expansion was adequate in 10 stents (37%) and symmetric in 19 (70%). After inflation at 20 atm, stents with adequate expansion increased to 16 (59%, P = 0.0036), but stents with symmetry decreased to 13 (48%, P = 0.0045). Stent expansion was inversely correlated to the arc of calcium (r = -0.8, P < 0.0001). There were five patients with clinical restenosis at 6 months (18%). Increases in stent lumen area with high-pressure balloon inflations in moderate-severe calcified CA lesions are at the expense of symmetry. This may affect clinical restenosis.     

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.     

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.     

Long-term outcomes of minor plaque prolapsed within stents documented with intravascular ultrasound.

The direct relationship between minor plaque prolapsed within stents and late in-stent restenosis is unknown. Therefore, we evaluated the impact of minor plaque prolapse on late angiographic in-stent restenosis. Intravascular ultrasonography (IVUS)-guided single-coronary stenting was successfully performed on 384 consecutive patients with 407 native coronary lesions. Six-month follow-up angiographic evaluation was performed on 315 patients (82. 0%) with 334 lesions (82.1%). Minor plaque prolapsed within the stent was found in 75 of 334 lesions (22.5%). Results were evaluated using angiographic and IVUS methods. The development of minor plaque prolapse was significantly associated with infarct-related artery (P = 0.000) and small pre-intervention minimal lumen diameter (P = 0. 001). The overall angiographic restenosis rate was 23.1% (77/334)-21.3% (16/75) in the lesions with plaque prolapse vs. 23.6% (61/259) in the lesions without plaque prolapse (P = 0.806). In conclusion, minor plaque prolapsed within stents might not be associated with late angiographic in-stent restenosis.     

Primary and mid-term outcome of sirolimus-eluting stent implantation with angiographic guidance alone

BACKGROUND: Usefulness and efficacy of intravascular ultrasound (IVUS) for the implantation of sirolimus-eluting stent (SES) is controversial. We investigated the primary and mid-term results of SES deployment with angiographic guidance comparing with IVUS guidance, retrospectively. METHODS AND RESULTS: SESs were deployed in 480 de novo lesions of 459 patients (341 lesions treated without IVUS and 139 lesions treated using IVUS); 368 lesions underwent follow-up coronary angiography. Late luminal loss, in-stent restenosis (ISR) rate and target lesion revascularization (TLR) rate were not significantly different between the non-IVUS group and the IVUS group. There was no acute thrombosis or other major adverse cardiac events except for TLR in both groups. Multivariate logistic regression analysis showed that SES implantation without IVUS was not an independent risk factor for restenosis. On the other hand, in one case, target-vessel revascularization was difficult because of the mal-apposition of the SES previously implanted without IVUS. CONCLUSIONS: For lesions for which stent size and endpoint are decided from angiographic information alone, angio-guided SES implantation is safe and provides a good mid-term outcome that is comparable to the IVUS-guided SES stent deployment., while IVUS may be helpful to decide stent size for complex lesions and reduce possible complications.     

Intracoronary ultrasound: A necessary tool for stent implantation? Arguments in favor]

Intracoronary ultrasound (ICUS), as opposed to angiography, provides high resolution, tomographic images of the coronary vessel and lumen. Because of its superior diagnostic sensitivity ICUS is indicated in the evaluation of suboptimal results and complications following stent implantation. Only a few years ago the use of stents was limited by a high incidence of subacute thrombosis. ICUS demonstrated that the deployment technique used at that time was inadequate and that stent expansion could be improved by the routine use of high pressure inflation, leading to a simplification in the anticoagulation regimen and a decrease in the subacute thrombosis rate in elective procedures to < or = 1%. However, the routine use of high balloon pressures does not assure an adequate expansion of the stent. Only about one third of the stents deployed under angiographic guidance are optimally expanded, with intra-stent luminal dimensions similar to the adjacent, reference, luminal sizes. Significantly, these underdeployed stents can be recognized by ICUS and a large proportion adequately expanded. It should be emphasized that the best predictors of stent restenosis are two ICUS parameters, the postprocedural luminal dimensions and the % cross sectional narrowing, and not the angiographic parameters. Likewise, two of the lowest restenosis rates ever reported (12.8% and 7.3%) have occurred in two studies (WEST-2 and MUSIC) in which stent deployment was guided by ICUS. Two trials (AVID and OPTICUS) have been specifically designed to test the hypothesis that routine use of ICUS to guide stent implantation could diminish the restenosis rate, but their final results are not yet available. The CRUISE study was designed to evaluate the impact of routine ICUS not on angiographic restenosis but on the clinical need of revascularization. In this trial, the larger luminal dimensions of the stents implanted under ICUS guidance translated into a 40% reduction in the 6 month revascularization rate (14.8% vs. 8.9%, p < 0.05). Although the final answer is still pending, the available information suggests that the routine use of ICUS might translate into a direct clinical benefit, something remarkable for a diagnostic tool. In any case, the most effective way of using ICUS would probably be identifying those lesions that most benefit from the technique and avoiding its use in lesions with, a priori, excellent results.     

Optimization of stent deployment by intravascular ultrasound

Intravascular ultrasound (IVUS) is a useful diagnostic method that provides valuable information in addition to angiography regarding the coronary vessel lumen, dimensions, plaque burden, and characteristics. The major use of IVUS in coronary intervention is to guide interventional strategies and assess optimal stent deployment. Since the introduction of the drug-eluting stent (DES), concerns about restenosis have decreased. However, high-risk lesion subsets are being routinely treated with DESs, and the incidence of suboptimal results after stent deployment, such as stent underexpansion, incomplete stent apposition, edge dissection, geographic miss, and the risk of stent thrombosis, have correspondingly increased. Thus, optimization of stent deployment under IVUS guidance may be clinically important. In this review, we focus on the potential role of IVUS in stent optimization during percutaneous coronary intervention and its clinical benefits.     

Intravascular ultrasound observations during iliac stent deployment.

BACKGROUND: To evaluate the role of intravascular ultrasound (IVUS) during iliac stent deployment, with comparison of four major types of iliac stents. METHODS: Thirty-eight iliac arteries of 37 patients were observed with intravascular ultrasound after implantation of various stents including Palmaz stents in 10, Memotherm stents in 11, Wallstent in 10, and Strecker stents in 7. Quantitative measurements on ultrasound included the ratio of the short-axial to the long-axial diameters of the stent (symmetry index), the ratio of stent cross-sectional area to that of the reference lumen (expansion index), and stent-to-wall apposition. RESULTS: Intravascular ultrasound revealed significant differences among four major types of iliac stent, in spite of satisfactory angiographic appearances in all patients. It demonstrated significant deformity of the Strecker stent (symmetry index of 0.76-0.09) compared with other stents. The Memotherm stent and the Palmaz stent were superior to other stents in terms of degree of expansion (mean expansion index of 0.87 and 0.82 respectively). Stent cross-sectional area greater than 80% of the reference lumen could be sufficient for iliac stent deployment. The Palmaz stent was superior to other stents in terms of stent-to-wall apposition. CONCLUSIONS: Intravascular ultrasound can provide precise and useful cross-sectional morphological and quantitative information in terms of stent configuration, degree of stent expansion, and stent-to-wall apposition.     

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.     

Relation between residual plaque burden after stenting and six-month angiographic restenosis

The degree of residual plaque burden outside of a stent might be correlated with the degree of intimal hyperplasia. However, the relation between residual plaque burden and angiographic restenosis are still unknown in a large number of patients. Therefore, we evaluated the effect of residual plaque burden after stenting on 6-month angiographic restenosis. Intravascular ultrasound (IVUS)-guided coronary stenting was successfully performed in 723 patients with 785 native coronary lesions. Six-month follow-up angiograms and evaluation of residual plaque burden by IVUS were available in 566 patients (78.3%) with 622 lesions (79.2%). Results were evaluated using conventional methods. The overall angiographic restenosis rate was 23.0% (143 of 622 lesions). There was no significant difference in residual plaque burden between the lesions with and without restenosis (52% vs 51%, respectively, p = 0.148). The angiographic restenosis rate was 20.8% (11 of 53 lesions), 21.6% (51 of 236 lesions), 22.0% (55 of 250 lesions), and 31.3% (26 of 83 lesions) in the lesions with residual plaque burden < 40%, between 40% and 50%, between 50% and 60%, and > 60%, respectively (p = 0.284). Using multivariate logistic regression analysis, the only independent predictor of angiographic restenosis was the IVUS stent area (odds ratio 0.807, 95% confidence intervals 0.69 to 0.95, p = 0.011). Furthermore, even in the lesions with residual plaque burden > 60%, the restenosis rate was 37.3% (23 of 61 lesions) versus 13.6% (3 of 22 lesions ) in IVUS stent areas of < 7 and > or =7 mm(2), respectively (p = 0.031). In conclusion, residual plaque burden outside the stent might not predict angiographic restenosis. IVUS stent area was the only independent predictor of angiographic restenosis.     

Vessel tearing at the edge of intracoronary stents detected with intravascular ultrasound imaging

Stent deployment strategies have changed significantly in the past 2 yr, with “high-pressure” balloon inflations postdilatation being performed in the large majority of cases. There is currently little information about the effects of high pressure on the geometry of stent expansion and on the adjacent areas of the vessel wall. Intravascular ultrasound (IVUS) imaging is well-suited to investigate these issues, since it provides information not only about stent expansion and apposition but also about adjacent vessel-wall morphology at transition points such as the articulation site of the stent and the stent borders. We report on the results of a cohort of 30 consecutive stent cases which were systematically examined by IVUS following high-pressure inflation. All deployments were deemed successful by angiographic inspection. However, in 6 cases, intimal disruptions or “edge tears” were noted at the stent borders by IVUS. In 5 cases, edge tears were seen to occur at the distal border, whereas in one case edge tears were seen at both the proximal and distal edges of the stent. No angiographic and sonographic parameters were different except percent plaque area at the stent margins, which was significantly higher (53 ± 11%) in the lesions with edge tears, compared to 40 ± 10% plaque area in the group without evidence of pocket flaps (P = 0.007). This experience suggests that intimal disruptions or “edge tears” are a relatively common occurrence following high-pressure stent deployment, and may be related to the extent of marginal dissections. Cathet. Cardiovasc. Diagn. 40:152–155, 1997. © 1997 Wiley-Liss, Inc.     

Role of intracoronary ultrasound after high-pressure stent implantation

BACKGROUND: Poststent high-pressure balloon inflation has been shown to improve clinical outcomes. However, it is unknown whether intracoronary ultrasound (ICUS) provides additional clinical guidance after initial high-pressure balloon inflation is used during stent placement. Thus the purpose of this study was to determine if stent deployment techniques are improved with ICUS imaging despite an optimal angiographic result achieved with high-pressure balloon inflation. METHODS AND RESULTS: Prospective data were collected on 96 consecutive patients in whom 151 stents were deployed. Stents and high-pressure balloons were angiographically sized 1:1 by visual estimation. High-pressure (> or =12 atm in all cases) balloon inflations were continued until angiographic completion (<10% residual stenosis), after which index ICUS imaging was performed. Stent apposition, symmetry, and lumen dimensions were evaluated. An optimal ICUS result was defined as full apposition of the stent, symmetry ratio > or =0.80, and acute gain > or =0.80 of the reference lumen area. If inadequate ICUS results were found, further dilations with higher pressures or larger balloons and subsequent stent reevaluation with ICUS were performed. Sixty-nine (46%) stents required additional balloon inflations. Of these stents, 35 (23%) had initial acute gains that were <80% of the reference lumen area. Forty-six (30%) stents were found to have unapposed struts and 24 (16%) had a symmetry ratio <0.80. In patients requiring additional inflations, minimum stent area increased from 7.6 +/- 2.2 mm(2) to 9.2 +/- 2.4 mm(2) (P <.0001). Similarly, complete stent apposition improved from 33% to 68% of total stents (P <.0001). After initial ICUS, higher-pressure dilations were performed in 40 patients, whereas larger balloons greater than or equal to ICUS reference vessel diameter were used in 33 patients. Follow-up was obtained in 95 (99%) patients. The overall major adverse cardiac event rate at 6 months was 9.3%, which consisted of 8 target vessel revascularizations and 1 abrupt closure requiring repeat intervention. CONCLUSIONS: Even when poststent high-pressure balloon inflation achieves an optimal angiographic result, ICUS assists in optimizing acute gain, symmetry, and apposition of intracoronary stents in approximately 50% of patients. Moreover, ICUS guidance is associated with low rates for target vessel revascularization and major adverse cardiac events at 6-month follow-up.     

Intracoronary ultrasound: A necessary tool for stent implantation? Arguments in against]

Intracoronary ultrasound has shown the little reliability of angiography to predict the interaction of stents with the arterial wall. In spite of implanting the stents with high pressures and a good angiographic result, a great proportion are still incompletely expanded. The use of intracoronary ultrasound as a guide for stent implant allows us to optimize the degree of expansion and apposition of the stent to the arterial wall, achieving greater intraluminal dimensions than with angiography. Nevertheless, this strategy is not necessarily translated in a clear clinical benefit. The rate of acute and subacute complications of stents implanted under angiographic control with high pressures and treatment with ticlopidine and aspirin is less than 1% and identical to the studies that use intracoronary ultrasound to optimize stent deployment. At the present time, it has not been documented either that the optimization of stent deployment with intracoronary ultrasound significantly reduces the rate of restenosis, the incidence of target vessel revascularization or the rate of major adverse cardiac events in mid-term follow-up. In addition, the use of intracoronary ultrasound to optimize stent deployment adds a small risk to the procedure, extends the time of occupation of the cardiac catheterization laboratory and prohibitively increases the costs of coronary stenting them being already high ones. Thus, the universal use of coronary intracoronary ultrasound to optimize stent deployment seems not to be, at present, a useful strategy.     

Multiple stent implantation in single coronary arteries: Acute results and six-month angiographic follow-up

A total of 147 stents were implanted (in overlapping manner in 76% of vessels) in a single coronary artery in 59 patients (60 vessels, 97 lesions, 2.45 stents/vessel) over a period of 18 mo using high pressure stent deployment without ultrasound guidance. The indications for stenting were suboptimal percutaneous transluminal coronary angioplasty (PTCA) result (45%), primary prevention of restenosis (44%), acute closure (10%), and restenosis after plain balloon angioplasty (1%). One patient required emergency coronary artery bypass grafting (CABG) (extensive dissection), and one required early intervention with plain balloon angioplasty and intracoronary urokinase for stent thrombosis. There were no deaths. Thirteen patients had recurrence of angina within 6 mo and angiograms were performed in all. These showed intrastent restenosis in nine (all had successful repeat plain balloon angioplasty), development of new disease in other vessels along with restenosis close to the stent in the target vessel in one (underwent elective CABG) and normal angiograms with widely patent stents in three. Forty-five patients (77%) remained free of recurrent angina and 25 of these had follow-up angiograms (56%) at a mean of 172 days, two showing restenosis. Thus, the restenosis rate per patient in the symptomatic group (angiographic follow-up in 100%) was 77% and in the asymptomatic group (angiographic follow-up in 56%) was 8%. The restenosis rate in the subgroup with bailout stenting (n = 6) was 20% (angiographic follow-up in 83%). The overall restenosis rate per patient was 32% (overall angiographic follow-up in 66%). During the 6-mo follow-up period, one patient underwent elective CABG (1.7%), one sustained a non-Q myocardial infarction (1.7%), nine had repeat PTCA to the target vessel (15.5%), and there were no deaths. The event-free survival rate was 77%. Multiple stent implantation aided by high pressure stent deployment without ultrasound guidance and with adjunctive optimal antiplatelet therapy without oral anticoagulation seems to be a useful and effective revascularisation strategy to deal with long lesions and acute dissections with a high procedural success rate. The restenosis rate is acceptable and is not appreciably high as reported in previous studies from the “warfarin era.” Cathet. Cardiovasc. Diagn. 42:158–165, 1997. © 1997 Wiley-Liss, Inc.     

Polymer-based paclitaxel-eluting stents reduce in-stent neointimal tissue proliferation: a serial volumetric intravascular ultrasound analysis from the TAXUS-IV trial

OBJECTIVES: The aim of this study was to use serial volumetric intravascular ultrasound (IVUS) to evaluate the effects of polymer-based, paclitaxel-eluting stents on in-stent neointima formation and late incomplete stent apposition. BACKGROUND: The TAXUS-IV trial demonstrated that the slow-release, polymer-based, paclitaxel-eluting stent reduces angiographic restenosis and the need for repeat revascularization procedures. Serial IVUS studies reveal details of the pattern of vascular responses provoked by stent implantation that provide insight into device safety and efficacy. METHODS: In the TAXUS-IV trial, patients were randomized to the slow-release, polymer-based, paclitaxel-eluting TAXUS stent or a bare-metal EXPRESS stent (Boston Scientific Corp., Natick, Massachusetts). As part of a formal substudy, complete volumetric IVUS data were available in 170 patients, including 88 TAXUS patients and 82 controls, at implantation and at nine-month follow-up. RESULTS: No baseline differences were present in the clinical characteristics or IVUS parameters between the control and TAXUS groups. At nine-month follow-up, IVUS lumen volumes were larger in the TAXUS group (123 +/- 43 mm(3) vs. 104 +/- 44 mm(3), p = 0.005), due to a reduction in neointimal volume (18 +/- 18 mm(3) vs. 41 +/- 23 mm(3), p < 0.001). Millimeter-by-millimeter analysis within the stent demonstrated uniform suppression of neointimal growth along the entire stent length. Late lumen loss was similar at the proximal edge of the stent between the two groups, and reduced with the TAXUS stent at the distal edge (p = 0.004). Incomplete stent apposition at nine months was observed in only 3.0% of control and 4.0% of TAXUS stents (p = 0.12). CONCLUSIONS: Polymer-based, paclitaxel-eluting TAXUS stents are effective in inhibiting neointimal tissue proliferation, and do not result in late incomplete stent apposition.