Treatment of In-Stent Restenosis by Excimer Laser Coronary Atherectomy and Drug-Coated Balloon: Serial Assessment with Optical Coherence Tomography.

OBJECTIVES: We aimed to compare the results of neointimal modification before drug-coated balloon (DCB) treatment with excimer laser coronary atherectomy (ELCA) plus scoring balloon predilation versus scoring balloon alone in patients presenting with in-stent restenosis (ISR). BACKGROUND: Treatment of ISR with ELCA typically results in superior acute gain by neointima debulking. However, the efficacy of combination therapy of ELCA and DCB remains unknown. METHODS: A total of 42 patients (44 ISR lesions) undergoing DCB treatment with ELCA plus scoring balloon (ELCA group, n = 18) or scoring balloon alone (non-ELCA group, n = 24) were evaluated via serial assessment by optical coherence tomography (OCT) performed before, after intervention, and at 6 months. RESULTS: Although there was significantly greater frequency of diffuse restenosis and percent diameter stenosis (%DS) after intervention in the ELCA group, comparable result was shown in %DS, late lumen loss, and binary angiographic restenosis at follow-up. On OCT analysis, a decreased tendency in the minimum lumen area and a significant decrease in the minimum stent area were observed in the ELCA group between 6-month follow-up and after intervention (-0.89 ± 1.36 mm2 vs. -0.09 ± 1.25 mm2, p = 0.05, -0.49 ± 1.48 mm2 vs. 0.28 ± 0.78 mm2, p = 0.03, respectively). The changes in the neointimal area were similar between the groups, and target lesion revascularization showed comparable rates at 1 year (11.1% vs. 11.4%, p = 0.85). CONCLUSIONS: Despite greater %DS after intervention, ELCA before DCB had possible benefit for late angiographic and clinical outcome.

Assessment of the relationship between preprocedural C-reactive protein/albumin ratio and stent restenosis in patients with ST-segment elevation myocardial infarction.

INTRODUCTION: Stent restenosis remains a clinical challenge for patients with ischemic heart disease, since it is associated with repeated coronary interventions as well as higher hospitalization rates and medical costs. Inflammation plays a significant role. Although an association between stent restenosis, increased C-reactive protein (CRP) and decreased albumin levels has been previously reported, no studies have investigated the ability of the CRP/albumin ratio to predict stent restenosis. METHODS: This retrospective study included 448 patients who had previously undergone primary percutaneous coronary intervention and who were referred for subsequent reintervention due to recurrence of anginal symptoms. The study population was divided into two groups based on whether the patient had developed stent restenosis. They were then stratified into three groups according to their CRP/albumin ratio. RESULTS: Out of 448 patients, stent restenosis was observed in 24.5% (n=110), as determined by coronary angiography. Patients with stent restenosis had a higher CRP/albumin ratio, greater platelet distribution width (PDW), higher CRP levels, and lower levels of both high-density lipoprotein (HDL) cholesterol and serum albumin. The CRP/albumin ratio (OR: 2.289, 95% CI: 1.056-4.959; p=0.036), stent diameter, PDW and HDL cholesterol levels were found to be independent predictors of stent restenosis. A ROC curve comparison demonstrated that the CRP/albumin ratio was a better predictor of restenosis than either albumin and CRP individually, but it was not better than PDW and HDL cholesterol. CONCLUSION: As a novel inflammation-based risk score, the CRP/albumin ratio may be an easily accessible marker for assessment of stent restenosis risk.

Intravascular Ultrasound Assessment of In-Stent Restenosis in Saphenous Vein Grafts.

Outcomes after percutaneous coronary interventions (PCI) in saphenous vein grafts (SVG) are inferior compared with native coronary arteries, but the mechanisms of SVG in-stent restenosis (ISR) have not been well-described. Thus, we aimed to evaluate the patterns of SVG ISR using intravascular ultrasound (IVUS) in 54 SVG ISR lesions. Stent underexpansion was defined as minimum stent area (MSA) <5 mm2. The time from stent implantation to presentation with ISR (9 BMS, 18 first-generation DES, and 27 second-generation DES) was 3.7 ± 3.0 years. IVUS-defined ISR patterns were categorized as mechanical (33%) or biological (67%). Mechanical patterns comprised 10 cases of stent underexpansion (MSA = 4.2 ± 0.9 mm2), 6 stent fractures or deformations, and 2 uncovered aorto-anastomotic lesions. Biological patterns comprised 19 cases of neoatherosclerosis, 13 excessive neointimal hyperplasia (NIH, 65 ± 11%), and 4 thrombi. Compared with biological patterns of ISR, mechanical patterns were more frequently located at the SVG anastomosis (72% vs 39%, p = 0.04) and at the SVG hinge motion site (55% vs 21%, p = 0.02). Although patients with mechanical patterns of ISR presented earlier than those with biological patterns (2.3 vs 4.4 years, p = 0.009), 61% of them were diagnosed >1 year after stent implantation. In conclusion, SVG ISR is dominated by biological patterns including neoatherosclerosis. Mechanical patterns of SVG ISR are associated with earlier presentation and location at graft anastomosis or hinge motion site.

Mechanisms of atherothrombosis and vascular response to primary percutaneous coronary intervention in women versus men with acute myocardial infarction: results of the OCTAVIA study.

OBJECTIVES: This study sought to assess in vivo sex differences in the pathophysiology of ST-segment elevation myocardial infarction (STEMI) and vascular response to primary percutaneous coronary intervention (PCI). BACKGROUND: There is no consensus on whether differences in the pathophysiology of STEMI and response to primary PCI between women and men reflect biological factors as opposed to differences in age. METHODS: In this prospective, multicenter study, 140 age-matched men and women with STEMI undergoing primary PCI with everolimus-eluting stent were investigated with intravascular optical coherence tomography, histopathology-immunohistochemistry of thrombus aspirates, and serum biomarkers. Primary endpoints were the percentages of culprit plaque rupture at baseline and everolimus-eluting stent strut coverage at 9-month follow-up as determined by optical coherence tomography. RESULTS: Men and women had similar rates of plaque rupture (50.0% vs. 48.4%; risk ratio [RR]: 1.03; 95% confidence interval [CI]: 0.73 to 1.47; p = 0.56). Nonruptured/eroded plaques comprised 25% of all cases (p = 0.86 in men vs. women). There were no sex differences in composition of aspirated thrombus and immune and inflammatory serum biomarkers. At 9 months, women had similar strut coverage (90.9% vs. 92.5%; difference in medians: RR: 0.2%; 95% CI: -0.4% to 1.3%; p = 0.89) and amount of in-stent neointimal obstruction (10.3% vs. 10.6%; p = 0.76) as men did. There were no sex differences in clinical outcome either at 30-day or 1-year follow-up. CONCLUSIONS: In patients presenting with STEMI undergoing primary PCI, no differences in culprit plaque morphology and factors associated with coronary thrombosis were observed between age-matched men and women. Women also showed similar vascular healing response to everolimus-eluting stents as men did. (Optical Coherence Tomography Assessment of Gender Diversity In Primary Angioplasty: The OCTAVIA Trial [OCTAVIA]; NCT01377207).

Comparative effectiveness of drug-eluting stents on long-term outcomes in elderly patients treated for in-stent restenosis: a report from the National Cardiovascular Data Registry.

OBJECTIVE: We assessed the long-term outcomes of elderly patients who had in-stent restenosis (ISR) treated with drug-eluting stents (DES) compared with other treatment strategies. BACKGROUND: Elderly patients with ISR represent a vulnerable group of which little is known regarding the safety and efficacy of repeat percutaneous coronary intervention (PCI). METHODS: We analyzed patients ≥ 65 years of age who underwent PCI for ISR in the National Cardiovascular Data Registry(®) from 2004 to 2008. Death, myocardial infarction (MI), revascularization, stroke, and bleeding were assessed for up to 30 months by a linkage with Medicare rehospitalization claims. RESULTS: Of 43,679 linked patients, 30,012 were treated with DES, 8,277 with balloon angioplasty (BA), and 4,917 with bare metal stents (BMS). Compared with BMS, DES use was associated with a lower propensity score-matched (PM) risk of death (hazard ratio [HR] 0.72; 95% confidence interval [CI] 0.66-0.80, P < 0.001), MI (HR 0.81; 95% CI 0.70-0.93, P = 0.003), and revascularization (HR 0.90; 95% CI 0.82-1.00, P = 0.055). Compared with BA, DES use was associated with a lower PM risk of death (HR 0.82; 95% CI 0.76-0.89, P < 0.001) and revascularization (HR 0.86; 95% CI 0.80-0.93, P < 0.001), but no statistically significant difference across other endpoints. There were no significant differences in long-term outcomes for BA compared with BMS. CONCLUSIONS: There was lower mortality and reduced risk for MI, revascularization, and stroke, but a similar rate of bleeding with DES compared with other modalities. Our results indicate that DES use is a comparatively effective strategy to treat elderly patients with ISR.

Tissue coverage and neointimal hyperplasia in overlap versus nonoverlap segments of drug-eluting stents 9 to 13 months after implantation: in vivo assessment with optical coherence tomography.

BACKGROUND: Histologic experimental studies have reported incomplete neointimal healing in overlapping with respect to nonoverlapping segments in drug-eluting stents (DESs), but these observations have not been confirmed in human coronary arteries hitherto. On the contrary, angiographic and optical coherence tomography studies suggest that DES overlap elicits rather an exaggerated than an incomplete neointimal reaction. METHODS: Optical coherence tomography studies from 2 randomized trials including sirolimus-eluting, biolimus-eluting, everolimus-eluting, and zotarolimus-eluting stents were analyzed at 9- to 13-month follow-up. Coverage in overlapping segments was compared versus the corresponding nonoverlapping segments of the same stents, using statistical pooled analysis. RESULTS: Forty-two overlaps were found in 31 patients: 11 in sirolimus-eluting stents, 3 in biolimus-eluting stents, 17 in everolimus-eluting stents, and 11 in zotarolimus-eluting stents. The risk ratio of incomplete coverage was 2.35 (95% CI 1.86-2.98) in overlapping versus nonoverlapping segments. Thickness of coverage in overlaps was only 85% (95% CI 81%-90%) of the thickness in nonoverlaps. Significant heterogeneity of the effect was observed, especially pronounced in the comparison of thickness of coverage (I(2) = 90.31). CONCLUSIONS: The effect of overlapping DES on neointimal inhibition is markedly heterogeneous: on average, DES overlap is associated with more incomplete and thinner coverage, but in some cases, the overlap elicits an exaggerated neointimal reaction, thicker than in the corresponding nonoverlapping segments. These results might help to understand why overlapping DES is associated with worse clinical outcomes, both in terms of thrombotic phenomena and in terms of restenosis and revascularization.

Serial morphological and functional assessment of drug-eluting balloon for in-stent restenotic lesions: mechanisms of action evaluated with angiography, optical coherence tomography, and fractional flow reserve.

OBJECTIVES: This study sought to elucidate the underlying mechanism through which drug-eluting balloons (DEB) restore coronary blood flow, by assessing the coronary vessel before, immediately after, and at 6-month follow-up with angiography, optical coherence tomography (OCT), and fractional flow reserve (FFR). BACKGROUND: In-stent restenosis (ISR) treatment remains challenging. Drug-eluting balloons have been shown to be a valid treatment option in several studies. These studies focused on efficiency of the device, whereas the mechanisms of action of DEB in ISR treatment have not been investigated. METHODS: In this prospective, single-center observational study, patients with ISR were treated with a second-generation DEB. Serial angiographic, OCT, and FFR measurements were performed before and after the procedure, as well as at 6-month follow-up. RESULTS: Twenty-five patients were assigned to DEB treatment, with an angiographic and device success of 100% and 92%, respectively. Late luminal loss was 0.01 ± 0.43 mm. Median percent changes [interquartile range] between pre-and post-procedure, and post-procedure and follow-up were, respectively: lumen volume 75.1% increase [43.7 to 115.0], and 8% increase [-14.0 to 25.8]; stent volume 23.7% increase [15.5 to 40.0], and -1.2% decrease [-6.9 to 5.9]; and neointimal volume -14.4% decrease [-29.2 to -9.5], and -15.8% decrease [-38.1 to 28.3]. The FFR gradient along the treated stent (difference in FFR between the distal and the proximal stent edge) was 0.37 ± 0.18 pre-procedure, 0.06 ± 0.04 post-procedure, and 0.05 ± 0.05 at follow-up. In all post-procedural OCT images, intrastent dissections were seen, which were sealed at follow-up OCT. CONCLUSIONS: DEB restore coronary blood flow by means of a short-term mechanical effect, causing an increase in lumen and stent volumes and compression of neointimal hyperplasia (with intra-stent dissections). Due to the local drug effect, patency persists and may even improve at follow-up, with further increase in lumen volume, decrease in neointimal volume, and complete sealing of neointimal dissections.

Incidence, predictors and management of left main coronary artery stent restenosis: a comprehensive review in the era of drug-eluting stents.

International guidelines recommend surgical revascularisation for unprotected left main (ULM) coronary artery disease. The introduction of drug-eluting stents (DES) as an emergency therapy has resulted in increasing numbers of patients having stents placed in ULM. As a consequence, important data on the safety and long-term outcome of PCI for ULM have progressively accumulated over recent years, derived mainly from registries rather than prospective randomised trials. These studies indicate that restenosis of the ULM still represents the main predictor of clinical events following stenting. However, the observed incidence is highly variable amongst the published studies and there is little data about the clinical management of restenosis of stents placed in the ULM. In the present paper we review the available literature regarding ULM restenosis, identify its predictors and suggest an algorithm for optimal management.

Usefulness of functional assessment in the treatment of patients with moderate angiographic paclitaxel-eluting stent restenosis.

BACKGROUND: In recent years there has been a debate about the functional severity of restenosis of drug-eluting stents. The aim of the present study was to assess the functional severity of stenosis in patients with moderate angiographic restenosis after paclitaxel-eluting stents (PES) deployment. METHODS AND RESULTS: Forty-two patients with moderate angiographic restenosis at the in-stent segment and/or approximately 5mm from the stent edge were enrolled. For comparison, furthermore, 42 patients with de novo stenosis lesions matched for angiographic severity were assigned to the control group. Quantitative coronary angiography and functional assessment using fractional flow reserve (FFR) were performed. Although percent diameter stenosis was not significantly different between the 2 groups (PES group, 40.6±11.2%; de novo group, 40.6±9.0%, P=0.981), the functional severity of stenosis was significantly less in the PES group than in the de novo group (FFR: PES group, 0.86±0.07; de novo group, 0.79±0.10, P=0.002). CONCLUSIONS: FFR was preserved in patients with moderate angiographic restenosis after PES deployment, and the functional severity of restenosis is often limited. Therefore, revascularization should be performed with caution for patients with moderate angiographic restenosis after PES deployment.

First serial assessment at 6 months and 2 years of the second generation of absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study.

BACKGROUND: Nonserial observations have shown this bioresorbable scaffold to have no signs of area reduction at 6 months and recovery of vasomotion at 1 year. Serial observations at 6 months and 2 years have to confirm the absence of late restenosis or unfavorable imaging outcomes. METHODS AND RESULTS: The ABSORB trial is a multicenter single-arm trial assessing the safety and performance of an everolimus-eluting bioresorbable vascular scaffold. Forty-five patients underwent serial invasive imaging, such as quantitative coronary angiography, intravascular ultrasound, and optical coherence tomography at 6 and 24 months of follow-up. From 6 to 24 months, late luminal loss increased from 0.16±0.18 to 0.27±0.20 mm on quantitative coronary angiography, with an increase in neointima of 0.68±0.43 mm(2) on optical coherence tomography and 0.17±0.26 mm(2) on intravascular ultrasound. Struts still recognizable on optical coherence tomography at 2 years showed 99% of neointimal coverage with optical and ultrasonic signs of bioresorption accompanied by increase in mean scaffold area compared with baseline (0.54±1.09 mm(2) on intravascular ultrasound, P=0.003 and 0.77±1.33 m(2) on optical coherence tomography, P=0.016). Two-year major adverse cardiac event rate was 6.8% without any scaffold thrombosis. CONCLUSIONS: This serial analysis of the second generation of the everolimus-eluting bioresorbable vascular scaffold confirmed, at medium term, the safety and efficacy of the new device. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856.

Quantitative optical frequency domain imaging assessment of in-stent structures in patients with ST-segment elevation myocardial infarction: impact of imaging sampling rate.

BACKGROUND: The impact of the sampling rate (SR) of optical frequency domain imaging (OFDI) on quantitative assessment of in-stent structures (ISS) such as plaque prolapse and thrombus remains unexplored. METHODS AND RESULTS: OFDI after stenting was performed in ST-segment elevation myocardial infarction (STEMI) patients using a TERUMO OFDI system (Terumo Europe, Leuven, Belgium) with 160 frames/s and pullback speed of 20 mm/s. A total of 126 stented segments were analyzed. ISS were classified as either attached or non-attached to stent area boundaries. The volume, mean area and largest area of ISS were assessed according to 4 frequencies of SR, corresponding to distances between the analyzed frames of 0.125, 0.25, 0.50 and 1.0 mm. ISS volume was calculated by integrating cross-sectional ISS areas multiplied by each sampling distance using the disk summation method. The volume and mean area of ISS became significantly larger, while the largest area became significantly smaller as sampling distance became larger (1.11 mm(2) for 0.125 mm vs. 1.00 mm(2) for 1.0 mm, P for trend=0.036). In addition, variance of difference was positively associated with increasing width of sampling distance. CONCLUSIONS: Quantification of ISS is significantly influenced by the applied frequency of SR. This should be taken into account when designing future OFDI studies in which quantitative assessment of ISS is critical for the evaluation of STEMI patients.

Diagnostic accuracy and its affecting factors of dual-source CT for assessment of coronary stents patency and in-stent restenosis.

BACKGROUND: In-stent restenosis is a common complication after stent implantation. However, the assessment of stent lumen in computed tomography (CT) coronary angiography is limited by multiple factors. Our study aimed to evaluate the accuracy and the suspected affecting factors in diagnosing coronary in-stent restenosis by dual-source CT (DSCT) compared with coronary angiography. METHODS: One hundred and fifteen stents in 50 patients were evaluated with DSCT before coronary angiography for the detection of coronary in-stent restenosis (≥ 50% luminal narrowing). Patency of each stent was analyzed by two independent expert radiologists blinded to the results of coronary angiography. The relationship between diagnostic accuracy and the suspected factors including age, body mass index (BMI), heart rate, variation of heart rate, radiation dose, image quality, location and stent characteristics (type, material, diameter, length and strut thickness) was assessed with both univariate and multivariate analysis. The fitting of a Logistic regression model was evaluated using a receiver operating characteristic (ROC) curve. RESULTS: Mean stent diameter was (2.9 ± 0.4) mm. Sensitivity, specificity, positive and negative predictive values and accuracy of DSCT in detection of in-stent restenosis were 69.2%, 91.2%, 50.0%, 95.9%, and 88.7%, respectively. In a subgroup of stents with a diameter ≥ 3.0 mm, sensitivity, specificity, positive and negative predictive values and accuracy were 100.0%, 96.5%, 75.0%, 100.0%, and 96.8%, respectively. Stent diameter < 3.0 mm and poor image quality were associated with poor diagnostic accuracy (P < 0.05). The area under curve of ROC was 0.79. CONCLUSION: DSCT can provide high accuracy for the assessment of in-stent restenosis in stents with a diameter = 3.0 mm, and can play an important role in ruling out in-stent restenosis.

Stress imaging use and repeat revascularization among medicare patients with high-risk coronary artery disease.

The optimal use of stress testing after coronary revascularization remains unclear, and overuse of stress testing might increase the rates of repeat revascularization. We analyzed the association at both the patient and regional level between the use of stress testing and repeat revascularization for a cohort of Medicare beneficiaries receiving revascularization within 30 days of an admission for symptomatic coronary artery disease. The sample consisted of 219,748 Medicare beneficiaries aged >65 years who received percutaneous coronary intervention or cardiac bypass artery grafting after hospital admission for symptomatic coronary artery disease in 2003 to 2004. Medicare claims data through 2008 identified the use of stress testing and repeat revascularization. The associations between the cumulative incidence of stress testing and repeat revascularization were analyzed using linear regression analysis. Within 6 years of the initial revascularization, the cumulative incidence of events was 0.61 for stress testing and 0.23 for repeat revascularization. Most (53.1%) repeat revascularizations were preceded by a stress test. Only 10.3% of repeat revascularization procedures were preceded by myocardial infarction. The 4-year cumulative incidence of repeat revascularization and stress testing varied between the Hospital Referral Regions represented by the sample, and the positive correlation between the rates by the health referral region accounted for only a small portion of the total health referral region variation in revascularization rates. In conclusion, stress testing is commonly performed among Medicare patients after the initial revascularization, and most repeat procedures are performed for stable coronary artery disease. The variation in stress testing patterns only explained a modest fraction of the regional variation in the repeat revascularization rates.

[Multislice computed tomoangiography in assessment of coronary stent lumen].

The treatment of coronary artery stenosis has progressively shifted over the past decades from surgical (bypasses) to percutaneous (stenting). Recent introduction of drug-eluting stents further reduced the occurrence of in-stent re-stenosis (ISR). However a non-negligible number of patients need imaging tests when symptoms recur Multi-Slice computed Coronary Angiography (CT-CA) is a clinical reality for evaluation of coronary artery stenosis, but still under evaluation in the follow-up of coronary stents. Several factors may impair proper depiction of in-stent lumen even with the most recent CT equipments. In highly selected populations CT-CA may play a clinical role even though the performance requirements both from the technical standpoint (i.e., CT scanner) and from the training (i.e., operators'experience) are still very demanding. In the meantime CT technology should improve towards higher contrast, spatial and temporal resolution in order to achieve the results that may be proper for clinical implementation.

Assessment of an asymmetrical coating stent with sirolimus released from ablumial matrix in porcine model.

BACKGROUND: Delayed endothelialization contributes to stent thrombosis of current drug-eluting stents. The asymmetrical coating technique provides an anti-proliferative effect abluminally without affecting luminal endothelialization. Layer-by-layer self-assembled chitosan/heparin (C/H LBL) has been proved to promote re-endothelialization. A novel stent system, C/H LBL coated luminally and sirolimus released abluminally (C/H LBL-SES), was fabricated. METHODS: Bare metal stents (BMS), traditionally circumferential sirolimus-eluting stents (SES), and C/H LBL-SES were implanted into porcine coronary arteries. At the 7, 14 and 28 days follow-up (FU), angiography, intravascular ultrasound (IVUS), vasomotor function induced by acetylcholine (Ach), scanning-electron microscopy and histopathology were performed. Remodeling index (RI) was based on IVUS and defined as cross-sectional area (CSA) of vessel at in-stent segment divided by CSA of reference vessel and expressed as a percentage with a normal range from 0.95 to 1.05. RESULTS: Thirty-eight mini pigs were enrolled and 74 stents (BMS = 23, C/H LBL = 28, SES = 23) were implanted in this study. At 28 days after implantation, the diameter stenosis of C/H LBL-SES by quantitative coronary angiography was 18.8 ± 2.5 %, the area stenosis by histomorphometry was 24.2 ± 2.9 %, which were comparable to that of SES and superior to BMS. At 14 days, re-endothelialization of C/H LBL-SES was almost completed, while only about 50 % of surface of SES was covered by endothelium. At 7, 14 and 28 days FU, although C/H LBL-SES suffered a greater vasoconstriction induced by Ach infusion than BMS (P < 0.05), it behaved better than SES (P < 0.01). No sign of stent malapposition was detected, while RI was within the normal range by IVUS. No acute or subacute thrombotic events occurred in all three groups. CONCLUSIONS: The asymmetrically designed C/H LBL-SES successfully inhibited neointima hyperplasia, while diminishing vasoconstriction after Ach-stress. Endothelialization of C/H LBL-SES was less affected compared with traditionally circumferentially coated SES.

Virtual histology-intravascular ultrasound assessment of lesion coverage after angiographically-guided stent implantation in patients with ST Elevation myocardial infarction undergoing primary percutaneous coronary intervention.

An occlusion or severe stenosis (angiographic culprit lesion) of the infarct-related artery is frequently located at the site of the maximum thrombus burden, whereas the origin of the plaque rupture (the true culprit) can be situated proximal or distal to it. The aim of this study was to examine stent coverage of true culprit lesions in 20 patients who underwent primary percutaneous coronary intervention and had Thrombolysis In Myocardial Infarction (TIMI) grade 3 flow restored in the infarct-related artery by angiographically guided direct stenting. Images of lesions were obtained using virtual histology-intravascular ultrasound before and after intervention (blinded to the operator). Plaque rupture sites were identified by intravascular ultrasound in 12 lesions (60%), 11 proximal and 1 distal to the minimum luminal area (MLA). Maximum necrotic core sites were found proximal to the MLA in 16 lesions, at the MLA in 3 lesions, and distal to the MLA in 1 lesion. Plaque rupture sites were fully covered by stents in 11 lesions. Virtual histology-intravascular ultrasound-derived thin-cap fibroatheroma longitudinal geographic misses were found in 10 lesions, 7 in the proximal reference segment and in 3 patients in the proximal and distal reference segments. In conclusion, in about 50% of patients who undergo primary percutaneous coronary intervention for ST-segment elevation myocardial infarction with optimal angiographic results, the stent does not fully cover the maximum necrotic core site related to the culprit lesion.

Evaluation of in-stent restenosis in the APPROACH trial (Assessment on the Prevention of Progression by Rosiglitazone On Atherosclerosis in diabetes patients with Cardiovascular History).

To determine (1) the medium-term effect of rosiglitazone and glipizide on intra-stent neointima hyperplasia, (2) restenosis pattern as assessed by intra-vascular ultrasound (IVUS) and quantitative coronary angiography (QCA) in patients with T2DM and coronary artery disease. A total of 462 patients with T2DM were randomized to rosiglitazone or glipizide for up to 18 months in the APPROACH trial, and had evaluable baseline and follow-up IVUS examinations. There was no significant difference in the size of plaque behind stent between the rosiglitazone and glipizide groups at 18 months among those treated with a bare metal stent (-5.6 mm(3) vs. 1.9 mm(3); P = 0.61) or with a drug-eluting stent (12.1 mm(3) vs. 5.5 mm(3); P = 0.09). Similarly, there was no significant difference in percentage intimal hyperplasia volume between the rosiglitazone and glipizide groups at 18 months among those treated with a bare metal stent (24.1% vs. 19.8%; P = 0.38) or with a drug-eluting stent (9.8% vs. 8.3%; P = 0.57). QCA data (intra-stent late loss, intra-stent diameter stenosis or binary restenosis) were not different between the rosiglitazone and glipizide groups. This study suggests that both rosiglitazone and glipizide have a similar effect on neointimal growth at medium term follow-up, a finding that warrants investigation in dedicated randomized trials.