The role of residual intrastent thrombus during primary angioplasty: insights from the COCTAIL II study.

AIMS: Recent frequency-domain optical coherence tomography studies showed that a complete removal of thrombotic materials is rarely achieved after percutaneous coronary interventions for ST segment elevation myocardial infarction. Residual intrastent thrombus can embolize distally leading to microcirculatory injury. The aim was to find a possible correlation between residual intrastent thrombus and angiographic indexes of myocardial reperfusion. METHODS: The population consisted of 128 ST segment elevation myocardial infarction patients enrolled in the COCTAIL II trial. Intrastent thrombus at optical coherence tomography was defined as the maximum percentage value of thrombus area (thrombus area/stent area × 100 in the cross-section with largest thrombus). A thrombus area of at least 16% (mean value) was considered indicative of high residual intrastent thrombus. The following angiographic indexes of myocardial reperfusion were evaluated: thrombolysis in myocardial infarction (TIMI) value, corrected TIMI frame count and myocardial blush grade. RESULTS: Angiographic and optical coherence tomography results are available in 119 patients: 64 had a maximum percentage value of thrombus area less than 16%, whereas the remaining 55 had a residual intrastent thrombus at least 16%. No differences were found regarding the microcirculatory indexes at baseline angiogram. After intervention, patients with intrastent thrombus less than 16% showed a significant improvement in the final TIMI value (2.87 ±â€Š0.33 vs 2.67 ±â€Š0.54; P = 0.014), final TIMI frame count (11.71 ±â€Š4.58 vs 18.04 ±â€Š17.32; P = 0.012) and a nonsignificant improvement in the final myocardial blush grade value (2.58 ±â€Š0.58 vs 2.43 ±â€Š0.76; P = 0.255). CONCLUSION: Data obtained from this ancillary study of the COCTAIL II suggest that the presence of high residual intrastent thrombus in patients undergoing primary angioplasty is associated with worsened final microcirculatory indexes.

Limitations of OCT in identifying and quantifying lipid components: an in vivo comparison study with IVUS-NIRS.

AIMS: We aimed to assess the agreement between IVUS-NIRS and OCT to assess lipid plaques in patients with acute coronary syndromes or stable angina. In addition, the impact of both macrophages and calcifications was investigated. METHODS AND RESULTS: Forty-three patients undergoing both IVUS-NIRS and OCT assessment of the culprit and/or non-culprit coronary lesions were enrolled. Cross-sections from lipid plaques, calcified plaques and normal-appearing vessel tracts were identified and matched with the two imaging techniques. Lipid arc was measured by both IVUS-NIRS and OCT. Macrophage presence and calcifications were also investigated with OCT. OCT detected a lipid plaque in 90 cross-sections (48.9%), with a sensitivity of 85.5% and a specificity of 69.7% as compared with IVUS-NIRS. The percentage of OCT false positive was 20.1% and of false negative was 4.9% for lipid plaque detection. The Pearson correlation coefficient for lipid arc was 0.675, p=0.0001. Macrophages were detected in 73% of OCT false positive cross-sections. Conversely, calcifications were present in 66.7% of OCT false negative cross-sections. The variability of lipid arc was independently associated with macrophages (beta=0.295, p=0.013). CONCLUSIONS: Agreement between IVUS-NIRS and OCT for lipid plaque detection is suboptimal. The presence of macrophages and superficial calcifications on OCT negatively affects lipid detection.

Clinical Impact of OCT Findings During PCI: The CLI-OPCI II Study.

OBJECTIVES: The goal of this study was to assess the clinical impact of optical coherence tomography (OCT) findings during percutaneous coronary intervention (PCI). BACKGROUND: OCT provides unprecedented high-definition visualization of plaque/stent structures during PCI; however, the impact of OCT findings on outcome remains undefined. METHODS: In the context of the multicenter CLI-OPCI (Centro per la Lotta contro l'Infarto-Optimisation of Percutaneous Coronary Intervention) registry, we retrospectively analyzed patients undergoing end-procedural OCT assessment and compared the findings with clinical outcomes. RESULTS: A total of 1,002 lesions (832 patients) were assessed. Appropriate OCT assessment was obtained in 98.2% of cases and revealed suboptimal stent implantation in 31.0% of lesions, with increased incidence in patients experiencing major adverse cardiac events (MACE) during follow-up (59.2% vs. 26.9%; p < 0.001). In particular, in-stent minimum lumen area <4.5 mm(2) (hazards ratio [HR]: 1.64; p = 0.040), dissection >200 µm at the distal stent edge (HR: 2.54; p = 0.004), and reference lumen area <4.5 mm(2) at either distal (HR: 4.65; p < 0.001) or proximal (HR: 5.73; p < 0.001) stent edges were independent predictors of MACE. Conversely, in-stent minimum lumen area/mean reference lumen area <70% (HR: 1.21; p = 0.45), stent malapposition >200 µm (HR: 1.15; p = 0.52), intrastent plaque/thrombus protrusion >500 µm (HR: 1.00; p = 0.99), and dissection >200 µm at the proximal stent edge (HR: 0.83; p = 0.65) were not associated with worse outcomes. Using multivariable Cox hazard analysis, the presence of at least 1 significant criterion for suboptimal OCT stent deployment was confirmed as an independent predictor of MACE (HR: 3.53; 95% confidence interval: 2.2 to 5.8; p < 0.001). CONCLUSIONS: Suboptimal stent deployment defined according to specific quantitative OCT criteria was associated with an increased risk of MACE during follow-up.

Quantification of manual thrombus removal in patients with acute coronary syndromes: a study exploiting serial frequency domain-optical coherence tomography.

AIMS: Thrombus aspiration is useful in improving myocardial reperfusion in comparison to conventional percutaneous coronary intervention in patients with acute myocardial infarction. Nonetheless, assessment of thrombus aspiration efficacy is lacking. Aim of this study was to quantify by frequency domain optical coherence tomography (OCT) the amount of thrombus removal in patients with acute coronary syndromes undergoing manual thrombus aspiration, correlating it with the actual size of the retrieved material. METHODS: Twenty-five consecutive patients with acute coronary syndrome were enrolled. OCT assessment of thrombotic lesions was performed before and after thrombus aspiration and repeated after stent deployment. OCT thrombus assessment was based on an established scoring technique. The aspirated material was analyzed by histology, and its planimetry was correlated with OCT-derived thrombus removal. RESULTS: The percentage of thrombus removal [(prethrombus aspiration minus post-thrombus aspiration)/(prethrombus aspiration × 100)] was 48.9; the delta measurement of the removed thrombus calculated by OCT correlated well with the planimetry-measured aspirated material (r = 0.56, P < 0.01). CONCLUSION: The present study showed the following: the thrombus score derived by OCT measurements correlated reasonably well with the planimetry measure of surface area of the actual aspirated material; after thrombus aspiration a large amount of residual thrombus can be appreciated at the target lesion site; and tissue components such as cholesterol debris and inflammatory cells can often be retrieved during thrombus aspiration.

Optical coherence tomography guided in-stent thrombus removal in patients with acute coronary syndromes.

The persistence of thrombus inside stent struts is a frequent event in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI), and this phenomenon might be associated with an increased risk of stent thrombosis. We sought to quantify by means of optical coherence tomography (OCT) the presence of in-stent thrombus after achievement of an optimal angiographic result in patients with ACS undergoing PCI. In addition, we evaluated the feasibility and safety of an OCT-guided strategy of in-stent thrombus removal. Eighty consecutive patients with ACS undergoing PCI were treated with two different strategies equally divided into two groups: angio-guided PCI, and OCT-guided PCI, in which additional OCT-driven in-stent balloon dilatation was adopted to reduce thrombus encroachment of the lumen. Overall in-stent thrombus area was 4.3 % with a maximal thrombus encroachment of 16.7 %. In the OCT-guided group, use of high pressure intra-stent dilatation led to a significant increase in stented area (9.6 ± 2.4 vs. 9.1 ± 2.49 mm(2), p = 0.002) and lumen area (9.2 ± 2.4 vs. 8.7 ± 2.3 mm(2), p < 0.001) and also significantly decreased in-stent thrombus area in absolute (0.35 ± 0.29 vs. 0.42 ± 0.30 mm(2), p = 0.001) and relative terms (3.58 ± 3.25 vs. 4.53 ± 3.01 %, p = 0.001). Values of TIMI flow, frame count and blush grade, as well as clinical outcomes were not detrimentally affected by such additional dilatations. The use of additional OCT-driven in-stent balloon dilatations is feasible, safe and might be effective in the treatment of in-stent thrombus for patients with ACS.

Early vessel healing of the Avantgarde cobalt-chromium coronary stent: the ON-GARDE OCT study.

INTRODUCTION: Uncoverage and malapposition of stent struts at optical coherence tomography (OCT) have been associated with stent thrombosis. Stent uncoverage by OCT is being used as a surrogate to address the propensity of a stent to develop thrombosis. We aimed to appraise early vessel healing in patients with ST-elevation myocardial infarction (STEMI) treated with the novel Avantgarde stent. METHODS: Patients with STEMI and multivessel disease were enrolled. The stent deployed on the infarct-related artery was imaged by frequency domain-OCT during deferred intervention (4-7 days apart). The primary end-point was the percentage of uncovered struts. Secondary end-points were the percentage of malapposed struts and struts covered with thrombus. RESULTS: Twenty patients (20 lesions) were enrolled, with 18 (18 stents) achieving a complete OCT pull-back and thus entering the final analysis (1497 cross-sections, 11 446 struts). Uncovered struts were 3.9%, whilst 8.0% of struts were malapposed and 2.6% were covered by thrombus. At per-stent analysis, all stents but two had a homogeneous distribution of strut coverage (i.e. % of uncovered struts ≥10). CONCLUSIONS: This study, originally exploiting OCT data early after stenting in STEMI patients, shows that the Avantgarde stent is associated with favourable vessel healing features.

Association between proximal stent edge positioning on atherosclerotic plaques containing lipid pools and postprocedural myocardial infarction (from the CLI-POOL Study).

Postprocedural myocardial infarction is an ominous complication of percutaneous coronary intervention (PCI). Despite several patient, lesion, and procedural factors that may affect its occurrence and severity, it is unclear if implanting a stent edge on a coronary lipid pool, as appraised by optical coherence tomography (OCT), adversely affects outcomes. The aim of this study was to assess the association between postprocedural myocardial infarction and the implantation of a stent edge on a lipid pool, as assessed by OCT. A database was screened for patients without ongoing myocardial infarctions; who underwent PCI with stenting for single, native, de novo lesions; without periprocedural side-branch occlusion or compromise; who underwent post-PCI OCT; and had postprocedural myocardial infarctions. These subjects were matched 1:1 with patients with similar features but without postprocedural myocardial infarctions. Plaque characterization with OCT was performed using established criteria. Specifically, lipid pools within stent edges were quantified by computing the number of involved quadrants and the degree of lipid arc on cross-sectional images. A total of 30 patients were included (15 with postprocedural myocardial infarctions and 15 controls without infarctions). Whereas no patient or control subject had lipid pools in correspondence to distal stent edges, landing of proximal stent edges on lipid pools was significantly more frequent in patients than in controls (10 [66%] vs 2 [13%], p = 0.009), Moreover, patients with postprocedural myocardial infarctions had more extensive lipid pools at proximal stent edges than those without postprocedural myocardial infarctions. Accordingly, lipid pool arc at proximal stent edge was significantly associated with peak post-PCI creatine kinase-MB/upper limit of normal ratio (Spearman's ρ = 0.49, p = 0.006). In conclusion, incomplete stent coverage of coronary lipid pools appears to be associated with an increased risk for postprocedural myocardial infarction in patients who undergo PCI.

Randomized trial of standard versus ClearWay-infused abciximab and thrombectomy in myocardial infarction: rationale and design of the COCTAIL II study.

BACKGROUND: Patients with ST-elevation myocardial infarction (STEMI) are at substantial risk of suboptimal procedural results and late adverse events. Angiography and optical coherence tomography (OCT) studies have identified residual coronary thrombus and microcirculatory injury as potential culprits for these adverse outcomes. We hypothesized that coronary thrombectomy and local infusion of glycoprotein IIb/IIIa inhibitors by means of a dedicated infusion device can synergistically improve results of percutaneous coronary intervention (PCI) for STEMI, as appraised by OCT. METHODS: A total of 128 patients with STEMI will be randomized, to one of the following: abciximab infusion with the ClearWay coronary catheter (C), standard abciximab infusion (A), thrombectomy followed by abciximab infusion with the ClearWay catheter (T+C), or thrombectomy followed by standard abciximab infusion (T+A). The primary objective is to demonstrate that abciximab infusion with the ClearWay catheter with or without manual thrombus aspiration (groups C or T+C) will result in a significant reduction of intrastent thrombus formations when compared with intravenous or intracoronary abciximab with or without thrombectomy (groups A or T+A). The primary endpoint will be the number of cross-sections with thrombus area more than 10% immediately after stent implantation as assessed with OCT. Additional angiographic, ECG and clinical endpoints will be collected and adjudicated. CONCLUSION: This trial will provide important mechanistic insights on the most appropriate invasive treatment strategy for patients with STEMI and significant thrombus burden, by exploiting its factorial design and reliance on sensitive OCT endpoints.

Angiography alone versus angiography plus optical coherence tomography to guide decision-making during percutaneous coronary intervention: the Centro per la Lotta contro l'Infarto-Optimisation of Percutaneous Coronary Intervention (CLI-OPCI) study.

AIMS: Angiographic guidance for percutaneous coronary intervention (PCI) has substantial limitations. The superior spatial resolution of optical coherence tomography (OCT) could translate into meaningful clinical benefits. We aimed to compare angiographic guidance alone versus angiographic plus OCT guidance for PCI. METHODS AND RESULTS: Patients undergoing PCI with angiographic plus OCT guidance (OCT group) were compared with matched patients undergoing PCI with angiographic only guidance (Angio group) within 30 days. The primary endpoint was the one-year rate of cardiac death or myocardial infarction (MI). A total of 670 patients were included, 335 in the OCT group and 335 in the Angio group. OCT disclosed adverse features requiring further interventions in 34.7%. Unadjusted analyses showed that the OCT group had a significantly lower one-year risk of cardiac death (1.2% vs. 4.5%, p=0.010), cardiac death or MI (6.6% vs. 13.0%, p=0.006), and the composite of cardiac death, MI, or repeat revascularisation (9.6% vs. 14.8%, p=0.044). Angiographic plus OCT guidance was associated with a significantly lower risk of cardiac death or MI even at extensive multivariable analysis adjusting for baseline and procedural differences between the groups (OR=0.49 [0.25-0.96], p=0.037) and at propensity-score adjusted analyses. CONCLUSIONS: This observational study, the first ever formally to appraise OCT guidance for PCI decision-making, suggests that the use of OCT can improve clinical outcomes of patients undergoing PCI.

Detection of very early stent healing after primary angioplasty: an optical coherence tomographic observational study of chromium cobaltum and first-generation drug-eluting stents. The DETECTIVE study.

BACKGROUND: Lack of stent coverage appears to be associated with stent thrombosis, a problem of particular concern in patients with ST elevation myocardial infarction (STEMI). METHODS: The DETECTIVE European Multicenter Registry was set up to address the early modality of stent healing in the setting of STEMI. The Registry compared, with an early optical coherence tomography (OCT) evaluation performed at 3-7 days, the patterns of coverage and apposition of the first generation of drug-eluting stents (DESs) and cobalt chromium non-drug-eluting stents (CCSs) that were deployed in culprit lesions and in non-culprit segments. The Registry included only patients with a multi-vessel disease to allow, at 3-7 days from the first angioplasty, a deferred OCT examination and a staged intervention in another vessel. RESULTS: 28 stented lesions (15 patients) eventually entered the final OCT assessment. 13 stents were first-generation DESs, while the remaining 15 were CCSs. 18 stents (64%) were deployed at culprit STEMI lesions, and the remaining 10 (36%) were deployed at non-culprit sites. The distribution of clinical and procedural variables in DES and CCS as well as in culprit and non-culprit sites was not different. In total, 27,019 struts were analysed in 28 stents. The percentage of stent uncoverage in the overall analysis was 11.7%, while the percentage of malapposition and that of struts covered with thrombus were 4.8% and 2.2%, respectively. A low percentage of strut uncoverage was found in all the four studied subgroups: DES 12.8%, CCS 10.9%, stents deployed in culprit lesions 13.2% and stents deployed in non-culprit lesions 8.7%. CONCLUSIONS: In conclusion, our data show that in patients with STEMI, a very high percentage of stent struts is covered by an early thin rim of tissue within 7 days after stent positioning. The present data bring new insights in the mechanism and timing of strut coverage.

Percutaneous coronary intervention of unprotected left main coronary artery disease as culprit lesion in patients with acute myocardial infarction.

OBJECTIVES: This study sought to evaluate short- and long-term outcomes of patients undergoing emergency percutaneous coronary intervention (PCI) for acute myocardial infarction due to a culprit lesion in an unprotected left main coronary artery. METHODS: In this retrospective, 2-center, international observational study, 5,261 patients were admitted between February 2005 and December 2008 with acute myocardial infarction and treated with PCI; of these, 1,277 were ST-segment elevation myocardial infarction and 3,984 non-ST-segment elevation myocardial infarction. We identified 48 patients among this cohort who underwent emergency PCI to an unprotected left main coronary artery culprit lesion. RESULTS: Mean age was 70 ± 12.5 years, and 45% of the patients presented with ST-segment elevation myocardial infarction or new left bundle branch block. Cardiogenic shock was present in 45%, and distal left main coronary artery disease was present in 71% of patients. Angiographic procedural success was achieved in 92% of patients. Overall in-hospital mortality was 21%, due in all cases to refractory, multiorgan failure. Twenty-five percent experienced major adverse cardiac events, defined as death, myocardial infarction, stent thrombosis, and target vessel revascularization. In patients presenting in cardiogenic shock, in-hospital mortality was 32%. At 1-year follow-up, in-hospital survivors had a mortality rate of 10.5%, whereas 18.4% experienced subsequent major adverse cardiac events. Long-term prognosis was excellent in hospital survivors with a 1-year survival rate of 89.5%. CONCLUSIONS: Patients with acute myocardial infarction and thrombosis of the unprotected left main coronary artery are a high-risk subgroup with a substantial mortality, particularly if they present in cardiogenic shock. We demonstrate that in these patients, PCI is a feasible treatment option associated with reasonably good outcomes. Long-term prognosis is excellent in hospital survivors with an 89.5% survival rate at 1 year.

Safety and feasibility of frequency domain optical coherence tomography to guide decision making in percutaneous coronary intervention.

AIMS: The purpose of this single centre registry is to assess safety and feasibility of the frequency domain optical coherence tomography (FD-OCT) system during coronary interventions. METHODS AND RESULTS: Ninety patients with unstable or stable coronary artery disease were included in this study. OCT imaging was performed in a first group of 40 patients (group 1), to evaluate ambiguous/intermediate lesions (24 patients in group 1 had OCT also done post-PCI, for assessment of stent deployment); and in a second group of 50 patients (group 2), to address the adequacy of stent deployment. Therefore, 74 patients underwent FD-OCT after stent implantation. A complex-lesion population was studied (B2 type lesion=72.2% and C type lesion=20.3%). The mean time of a FD-OCT pull-back (from the set up to the completion of the pull back) was 2.1 min and in all but one (99.1%) the procedure was successful. No patients experienced major complications in terms of death, myocardial infarction, emergency revascularisation, embolisation, life-threatening arrhythmia, coronary dissection, prolonged and severe vessel spasm and contrast induced nephropathy. In the ambiguous lesion group, 60% of patients were treated with PCI, whilst in the others, PCI were deferred. In total, 113 deployed stents (33,6% chromium cobalt stent, 66,4% drug eluting stent) were imaged with OCT. OCT findings led to additional interventions in 24 out of 74 patients (32%): 15 had further balloon inflations, nine had additional stent deployment whilst two had both treatments. At clinical follow-up, (4.6 ± 3.,2 months), there were no death, acute myocardial infarctions and cases of stent thrombosis, whilst two patients underwent revascularisation for recurrence of angina. CONCLUSIONS: The present registry shows that FD-OCT is a feasible and safe technique for guidance of coronary interventions. Randomised studies will confirm whether the use of FD-OCT will improve the clinical outcome.

Evaluation of infarct-related coronary artery patency and microcirculatory function after facilitated percutaneous primary coronary angioplasty: the FINESSE-ANGIO (Facilitated Intervention With Enhanced Reperfusion Speed to Stop Events-Angiographic) study.

OBJECTIVES: The FINESSE-ANGIO (Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events-Angiographic) study evaluated acute treatment effects on infarct-related artery (IRA) patency and angiographic correlates of coronary microcirculatory function. BACKGROUND: The FINESSE trial evaluated the effects on clinical outcomes of primary percutaneous coronary intervention (PCI) facilitated with pre-catheterization laboratory administration of abciximab with half-dose reteplase (combination-facilitated group), abciximab alone (abciximab-facilitated group), or with abciximab administered immediately before the procedure (primary PCI). METHODS: The FINESSE-ANGIO substudy compared the effects of the 3 treatment strategies on patency (TIMI [Thrombolysis In Myocardial Infarction] flow grade 2/3) of the IRA at basal coronary angiography. The secondary efficacy end points were corrected TIMI frame count, percentage of patients achieving TIMI flow grade 3, and the percentage achieving myocardial blush grade 2/3 of the IRA at post-PCI angiography. All angiographies were evaluated at a central core laboratory. RESULTS: Of the 2,452 FINESSE patients, 637 were included in the FINESSE-ANGIO substudy. Patients in the combination-facilitated group exhibited significantly higher rates of baseline IRA patency compared with the abciximab-facilitated and the primary PCI groups (76.1% vs. 43.7% and 32.7%, respectively; p < 0.0001 for both; p = 0.025 abciximab-facilitated vs. primary PCI). There were no significant differences in the post-PCI corrected TIMI frame count (17.1 ± 15.8, 17.4 ± 17.3, and 15.8 ± 14.1) or the rates of post-PCI TIMI flow grade 3 (79.8%, 77.7%, and 76.6%), myocardial blush grade 2/3 (85.6%, 79.5%, and 86.4%), respectively. CONCLUSIONS: Pre-catheterization laboratory administration of abciximab alone and especially in combination with half-dose reteplase resulted in higher rates of IRA patency at baseline coronary angiography compared with no pre-treatment. However, post-procedural angiographic and microcirculatory variables were unaffected by facilitation therapy.

Randomized evaluation of intracoronary nitroprusside vs. adenosine after thrombus aspiration during primary percutaneous coronary intervention for the prevention of no-reflow in acute myocardial infarction: the REOPEN-AMI study protocol.

BACKGROUND: Thrombus aspiration improves microvascular obstruction in patients with acute myocardial infarction treated by percutaneous coronary intervention. However, drugs such as nitroprusside and adenosine have not yet been tested as adjuncts to thrombus aspiration. Therefore, we designed a placebo-controlled, randomized, open-label, blind-examination, multicenter trial assessing the effects of intracoronary nitroprusside or adenosine on microvascular obstruction in patients undergoing primary or rescue percutaneous coronary intervention and thrombus aspiration. METHODS AND RESULTS: Six hospitals in Italy participate in the REOPEN-AMI study. Two hundred and forty consecutive patients with acute myocardial infarction undergoing primary or rescue percutaneous coronary intervention and thrombus aspiration are randomly allocated 1: 1: 1 to receive either intracoronary nitroprusside, adenosine or placebo. The primary end-point is the incidence of ST resolution greater than 70% on surface ECG at 90 min after the procedure. Secondary end-points are: incidence of angiographic no-reflow (thrombolysis in myocardial infarction flow < or =2 or 3 with a myocardial blush grade <2); changes of left ventricular volumes at follow-up (at bidimensional echocardiography); rate of major adverse cardiac events (cardiac death, myocardial infarction, target lesion revascularization and heart failure requiring hospitalization). CONCLUSIONS: REOPEN-AMI will provide important data on the efficacy and safety of intracoronary nitroprusside and adenosine as an adjunctive treatment to percutaneous coronary intervention after thrombus aspiration for patients with acute myocardial infarction.

From bench to bedside: a novel technique of acquiring OCT images.

BACKGROUND: Optical coherence tomography (OCT), a high resolution intravascular imaging technique, requires blood displacement for reliable image acquisition and the current technique uses a soft occlusion balloon plus saline injection in the coronary artery. A non-occlusive technique based on manual infusion of a viscous iso-osmolar solution has been developed and tested and validated through a 2-phase study. METHODS AND RESULTS: OCT assessment was performed with the M2 LightLab OCT (LightLab Imaging, Westford, MA, USA) image-wire in 3 swine by infusing 30 ml of each of 3 solutions differing in viscosity, osmolarity and electrolytic composition (A: iodixanol 320 and Lactated Ringer's; B: iodixanol 320 and 50% albumin; C: iodixanol 320). Image quality and adverse effects were evaluated. The solution with the best image quality/side-effect ratio was tested in 44 patients. The best image quality/side-effect ratio was obtained in the swine model with solution C, which enabled the study of arterial segments of 29.8+/-2.1 mm in length. The results were confirmed in the human study (average length of 28.3+/-2.5 mm and absence of major complications and/or major arrhythmias). Repeated OCT pull-back in the first 10 patients enabled comparison of 1,572 matched cross-sections with an excellent correlation for reproducibility (R=0.96; p<0.001). CONCLUSIONS: The non-occlusive technique using iodixanol 320 has an excellent ratio of safety, feasibility and efficacy.

The RESTART project: high-dose atorvastatin helps control RESTenosis AfteR sTenting procedures at high risk for restenosis. Results from a prospective study and a matched control group comparison.

AIMS: The long-term results of bare stenting in complex procedures are troubled by a high incidence of restenosis. The use of drug-eluting stents lead to excellent long-term angiographic results, but require, long-term antithrombotic treatment to prevent stent thrombosis. We evaluated the efficacy of high-dose atorvastatin as an adjuvant in limiting clinical and angiographic restenosis after bare stenting procedures which carry an high risk of restenosis. METHODS AND RESULTS: Between November 2003 and February 2004, 91 consecutive patients (with 152 target lesions) underwent successful interventional procedures with bare stents (158 stents; 1.7 stent/patient). The patients were included in the study in the presence of at least one of the following criteria: diabetes mellitus (14.6%); acute myocardial infarction (8.8%); lesion length >15 mm (27.5%); lesion in vessels with a reference diameter of <2.5 mm (24.2%); >2 treated lesions (58.2%); side-branch lesions (3.3%). All patients were started on atorvastatin (80 mg/day) on the day of the procedure, and continued receiving it for at least nine months.Six of the 91 patients (6.5%) experienced a clinical restenosis and underwent target lesion revascularisation; a further two underwent re-PTCA due to progressive atherosclerosis in untreated sites. Seventy-one patients (78.0%; 125 stents) were followed up with angiography after a mean 8.5 months (7-10 months): binary angiographic restenosis was observed in 18/71 patients (25.3%) (in-stent restenosis 21.1%; in-segment restenosis 4.2%), and 17/125 stents (13.6%).We matched 122 lesions (125 stents) from the present population with a reference group of 600 consecutive lesions treated at the Ospedale Maggiore della Carità in Novara during the same period of time, but without high-dose statin treatment: 88 lesions (94 stents) were successfully matched on the basis of the clinical and angiographic variables of diabetes, acute myocardial infarction, treated vessel, reference diameter and lesion length. The incidence of late loss was significantly lower in the atorvastatin group (p=0.027). CONCLUSIONS: The RESTART prospective study showed that the adjunct of atorvastatin 80 mg leads to excellent clinical and angiographic outcomes. These results were confirmed in a matched lesion comparison.

Safety and feasibility of a new non-occlusive technique for facilitated intracoronary optical coherence tomography (OCT) acquisition in various clinical and anatomical scenarios.

AIMS: To facilitate OCT images acquisition we developed a novel, simplified, non-occlusive technique based on manual infusion of a viscous isosmolar solution. The aims of the present study was to address the safety and efficacy of non-occlusive OCT images acquisition modality in a patient population with complex coronary lesions, and in various clinical scenarios. METHODS AND RESULTS: OCT assessment was performed with the LightLab OCT Imagewire in 64 patients. The imaging acquisition technique was aimed at target lesion and proximal and distal reference segments. OCT images were deemed of good quality if they allowed both an accurate measurement of luminal area and a qualitative classification of the superficial plaque components.In 60 patients (93.7%), the procedure was successful. The mean images acquisition time was 5.3+/-1.4 minutes. No major complications such as death, myocardial infarction or major arrhythmias were recorded. The average length of imaged segments was 28.6+/-6.1 mm and 95.1% of the imaged segments were deemed of sufficient quality to evaluate luminal area and plaque morphology (intra-observer and inter-observer variability 0.71, p<0.0001 and 0.68, p<0.0001 respectively).Conclusions. The non-occlusive modality of OCT image acquisition is safe and effective, and promises to simplify the complex current occlusive technique, leading to a marked reduction of procedural time.

Use of abciximab prevents microcirculatory impairment in patients treated with coronary angioplasty for unstable angina: results of a prospective randomized study.

The use of abciximab during percutaneous coronary angioplasty (PTCA) in patients with unstable angina (UA) prevents the postintervention enzyme surge and improves clinical outcomes, possibly by improving microcirculatory function. The aim of this quantitative myocardial blush grade (MBG) study was to verify whether abciximab improves postintervention microcirculation in patients with UA. This prospective randomized open-label study involved 140 UA patients scheduled to undergo PTCA of the target coronary lesion: 140 patients were randomized to receive either abciximab during PTCA (group 1, 70 patients) or conventional treatment without GP IIb/IIIa inhibitor (group 2, 70 patients). The exclusion criteria included above normal CK-MB levels. MBG was calculated by means of quantitative software that evaluates video intensity in a given region of interest: assuming that greater peak video intensity reflects a larger myocardial blood volume, a perfusion scale of 1-6 points (poor to optimal) was devised. The groups were homogeneous in terms of their demographic, procedural, and angiographic characteristics. Stents were used in 98% of the patients in both groups. The MBG score significantly increased in group 1 from 3.04 +/- 2.17 to 3.71 +/- 2.02 (P = 0.045) and slightly decreased in group 2 from 3.13 +/- 2.07 to 2.93 +/- 2.03 (P = 0.42). Consequently, group 1 showed a significantly greater postintervention MBG score (3.71 +/- 2.02 vs. 2.93 +/- 2.03; P = 0.022) and had a significantly greater MBG score change (P = 0.025). The results of this randomized study show that the administration of abciximab prevents microcirculatory impairment in patients undergoing angioplasty for acute coronary syndromes.