Search PubMed⌕ Search

Biomedical subjects

Carlo Di Mario

Publications and source records attributed to Carlo Di Mario.

At least 19 recordsLinked to original sources
PubMed2007

Predictors of restenosis after treatment of bifurcational lesions with paclitaxel eluting stents: a multicenter prospective registry of 150 consecutive patients.

OBJECTIVES: The aim of the study was the assessment of the clinical, angiographic and procedural characteristics correlated with freedom from adverse events at 1 year in a real life setting of consecutive bifurcation lesions. BACKGROUND: Even if stent implantation has shown to be superior to conventional balloon angioplasty in most coronary lesions, bifurcation treatment with stent implantation both in main and in side branch (SB) still raises controversy. METHODS: We reviewed the results obtained in a prospective multicenter registry of 150 patients with 158 bifurcation lesions involving a SB of sufficient diameter to be treated, if necessary, with a polymer based paclitaxel eluting stent (PES, TAXUS). Two stents were used in 118 lesions (74.7%). Final kissing balloon inflation was performed in 87/118 lesions (73.7%) and in 30/40 lesions (75.0%) of the 2 and 1 stent group respectively. RESULTS: At 1-year clinical follow-up we observed 4 stent thromboses, all involving the SBs of the 2 stents group (2.7%). Unlike previous reports, revascularization involved the main vessel in the majority of patients (21/150, 14.0%). After an exploratory multivariable analysis the only parameter predictive of target lesion revascularization (TLR) (HR 0.52; CI 95% 0.11-0.86; p = 0.02) and target vessel revascularization (TVR) (HR 0.47; CI 95% 0.14-0.90; p = 0.03) was postprocedural main branch minimal lumen diameter (MB-MLD). CONCLUSIONS: In a real life setting of consecutive bifurcation lesions, thrombosis rate, concentrated in the SB and the 2-stents group, and need for target lesion revascularization remain higher than in less complex lesion subgroups treated with PES. No differences in immediate success and TLR were observed between 2 stents and 1 stent groups. The frequently observed suboptimal stent expansion and final MB-MLD predict 1 year revascularization.

Aged↗
PubMed2007

A new quantitative analysis system for the evaluation of coronary bifurcation lesions: comparison with current conventional methods.

BACKGROUND: Objective conventional quantitative angiographic systems are designed to automatically follow the contours of straight vascular segments and not of bifurcations. Recently a new analysis method was specifically developed for bifurcation lesions, able to automatically divide the lesion into three separate segments. In this study, we aimed to assess whether the smaller interaction required by the analyst could reduce the analysis time and inter and intra observer variability when compared with a conventional analysis. METHOD: We used a dedicated system (QVA-CMS V. 6.0 with the Bifurcation Module, MEDIS, Leiden, The Netherlands) applying a minimum cost algorithm tuned to detect the contours of the proximal main vessel (PMV), distal main vessel (DMV), and side-branch (SB). We assessed the intra- and the interobserver agreement in measurements of minimal lumen diameter (MLD) and percentage diameter stenosis (%DS) of the PMV and DMV, as well as of the SB ostium in 30 angiograms of patients before and after percutaneous coronary angioplasty with stenting of both branches. The consensus between measurements by two observers and by the same observer was analyzed using the intra- and interclass correlation coefficient and the reliability coefficients for all measurements. Bland-Altman plots before and after PCI were also generated to assess the relationship between variability and absolute measurements. RESULTS: Before PCI, intra- and interobserver variabilities were consistently lower for the new QVA system, with a significant difference for lesion length in the SB. Post-PCI data showed a greater variability in the assessment of diameter stenosis with both techniques. The time for analysis was significantly lower both before and after PCI for QVA compared with quantitative coronary angiography (QCA) (4.7 +/- 1.1 min versus 6.2 +/- 1.3 min, P < 0.0001). CONCLUSION: Our results demonstrate that this new quantitative bifurcation analysis system can be consistently applied to the analysis of bifurcation lesions before and after angioplasty, with an intra- and interobserver reproducibility equal to or better than the conventional analysis system with a significantly shorter analysis time.

Aged↗
PubMed2006

64-multislice computed tomography in consecutive patients with suspected or proven coronary artery disease: initial single center experience.

BACKGROUND: The improved accuracy of 64-multislice CT (MSCT) suggests that this technique may replace other non-invasive methods to detect clinically significant coronary atherosclerosis. The aim of the present study was to assess the clinical usefulness of in consecutive patients with suspected or proven coronary artery disease (CAD). METHODS: 64-MSCT was performed in 56 patients (age 56+/-16 years, 50 male) with suspected or proven CAD (35 patients with chest pain/positive provocative tests/risk factors), 18 with documented significant CAD, CABG surgery or stent implantation, 3 non-assessable with selective angiography because of peripheral vascular disease or large aneurysms of the ascending aorta. RESULTS: One patient was excluded because of contrast extravasation. In 30/55 patients (54%) 64-MSCT excluded significant coronary stenoses; in 13/55 patients (24%) angiography and/or angioplasty were recommended to treat (3) 50% diameter stenoses shown by MSCT, a diagnosis confirmed in 9 (81.8%) of the 11 patients who underwent further investigations; 12/55 patients (22%) needed angiography or other preliminary non-invasive tests because 64-MSCT was of insufficient diagnostic quality. Predictors of a poor diagnostic quality of 64-MSCT were older age (64+/-8 vs. 55+/-11 years, p<0.007), diabetes mellitus (42% vs. 9%, p=0.017), previous angiography, angioplasty or CABG surgery (83% vs. 26%, p<0.0001), Agatston score>400 (75% vs. 21%, p<0.002). CONCLUSION: 64-MSCT provided complete diagnostic coronary images sufficient for clinical decision making in the vast majority (78%) of a consecutive group of patients studied for suspected or proven CAD. Predictors of diagnostic failure were massive calcification, long-standing known coronary atherosclerosis or previous CABG/stent implantation, old age and diabetes mellitus.

Coronary Angiography↗
PubMed2006

Testing prospectively the effectiveness and safety of paclitaxel-eluting stents in over 1000 very high-risk patients: design, baseline characteristics, procedural data and in-hospital outcomes of the multicenter Taxus in Real-life Usage Evaluation (TRUE) Study.

BACKGROUND: Paclitaxel-eluting stents (PES) have been proved effective in randomized trials enrolling highly selected patients. Yet, given the uncertainty concerning results of PES implantation in very high-risk patients and lesions, we designed a prospective multicenter registry, the Taxus in Real-life Usage Evaluation (TRUE) Study. STUDY DESIGN, PATIENT CHARACTERISTICS AND IN-HOSPITAL OUTCOMES: Consecutive patients undergoing PES implantation were enrolled provided that the target lesion treated with PES was an unprotected left main (ULM), a true bifurcation, a chronic total occlusion (CTO), a long lesion (>28 mm), located in a small vessel (<2.75 mm), or the patient had diabetes mellitus. Clinical events will be adjudicated at 1, 7 and 12 months, with 4- to 8-month angiographic follow-up. The primary end-point will be the 7-month occurrence of major adverse cardiovascular events (MACE, i.e. the composite of cardiac death, non-fatal myocardial infarction [MI], coronary artery bypass grafting [CABG] and percutaneous target vessel revascularization [TVR]). To date, patient enrollment has been completed reaching the target of 1065 subjects. These included 322 (30.2%) diabetics, 115 (10.8%) subjects undergoing PES implantation for ULM, 229 (21.5%) in a bifurcation, 191 (17.9%) in a CTO, 430 (40.4%) in a small vessel, and 289 (27.1%) in a long lesion. An average of 1.5+/-0.6 vessels and 2.0+/-1.0 lesions were treated per patient, with 2.0+/-1.2 PES implanted per patient, and a 46+/-30 mm total PES length per patient. In-hospital MACE occurred in 39 (3.7%) patients, with 2 (0.2%) cardiac deaths, 32 (3.0%) MI, 5 (0.5%) TVR, no CABG, and 4 (0.4%) acute stent thromboses. IMPLICATIONS: Despite the availability of randomized trials, only carefully designed and prospective registries can provide timely and accurate assessment of the risk-benefit profile of PES in very high-risk patients. Indeed, the TRUE Study, including as much as 115 ULM and 229 bifurcation interventions, should give important insights into the outcome of PES in such an unprecedented and challenging context.

Combined Modality Therapy↗
PubMed2006

Comparison of ticlopidine vs. clopidogrel in addition to aspirin after paclitaxel-eluting stent implantation: insights from the TRUE (Taxusin Real-life Usage Evaluation) Study.

Thienopyridines and aspirin are beneficial in patients undergoing bare-metal stent implantation, and aspirin and clopidogrel treatment have also been proved effective after drug-eluting stent (DES) implantation. However, despite the common substitution of clopidogrel with ticlopidine because of cost or patient intolerance, there are no data on the comparison of ticlopidine vs. clopidogrel after DES implantation. We hereby compare ticlopidine vs. clopidogrel after paclitaxel-eluting stent implantation in subjects enrolled in the prospective multicenter Taxus in Real-life Usage Evaluation (TRUE) Study. Across the 505 analyzed patients (112 treated with ticlopidine and 393 with clopidogrel), similar rates of early and mid-term (7 months) adverse thrombotic events were found with either antiplatelet regimen, with the notable exception of 2 cases of late stent thrombosis in patients who had prematurely withdrawn ticlopidine treatment just 3 months after the procedure. These findings thus support the overall safety and effectiveness of ticlopidine after DES implantation, and also confirm the increased risk of late thrombosis when premature withdrawal of thienopyridines occurs.

Aspirin↗
PubMed2006

Cellular immunostaining of angiotensin-converting enzyme in human coronary atherosclerotic plaques.

OBJECTIVES: The aim of this study was to determine the cellular localization of angiotensin I-converting enzyme (ACE) in the atherosclerotic plaque and its correlation with inflammation and cellular proliferation. BACKGROUND: Angiotensin I-converting enzyme inhibitors reduce the incidence of vascular events; therefore, tissue ACE may play a determinant role in the pathophysiology of the atherosclerotic plaque. METHODS: Histology and immunocytochemistry of de novo coronary plaques retrieved with directional coronary atherectomy from 141 patients were analyzed: 87 with stable angina, 39 with subacute unstable angina, and 15 with acute unstable angina. RESULTS: Compared with stable patients, unstable patients showed more thrombotic lesions (72% vs. 27%, p < 0.0001), smaller areas of fibrous plaque (2.3 +/- 1.2 mm2 vs. 2.8 +/- 1.1 mm2, p = 0.02), higher cellular proliferative score (0.78 +/- 0.9 vs. 0.27 +/- 0.6, p = 0.003), larger content of ACE-stained cells (26.3 +/- 23% vs. 12.6 +/- 15%, p = 0.005) and larger areas of inflammation as identified by CD68 immunostaining (29.5 +/- 22% vs. 20.2 +/- 19%, p = 0.02). A significant linear correlation was found between CD68- and ACE-stained areas (mm2) among unstable patients (r = 0.6, p = 0.0001), but it was absent among stable patients (r = 0.006, p = 0.9). Co-localization of ACE, CD68, and alpha-actin was confirmed by double immunostaining. Patients with Ki-67-positive staining as an index of cell proliferation showed also significantly larger areas of ACE immunoactivity (p = 0.004). CONCLUSIONS: Our data demonstrate ACE immunoactivity in inflammatory and proliferative cells of coronary atherosclerotic plaques. In particular, patients with unstable angina showed larger areas of ACE immunoactive tissue and proliferating cells compared with stable patients. These observations support a role of the enzyme in the pathophysiology of coronary unstable plaques and suggest potentially different effects of ACE inhibitors according to clinical presentation.

Coronary Artery Disease↗
PubMed2006

Which strategy should be used for acute ST-elevation myocardial infarction in patients aged more than 75 years?

The optimal management of acute myocardial infarction in elderly people (>or= 75 years) is controversial because elderly patients have been excluded or are under-represented in most acute myocardial infarction trials. Randomized studies show that, also in the elderly, thrombolytic therapy is effective in reducing mortality after acute myocardial infarction but the benefit in terms of mortality, recurrent infarction and stroke is smaller compared to primary percutaneous coronary intervention. Among the available mechanical therapeutic strategies, stenting is found to be superior to balloon angioplasty, whereas the role of drug-eluting stents in this setting still remains to be evaluated. The standard use of intravenous unfractionated heparin is still recommended because of the increased risk of intracranial haemorrhage by a combination of low molecular weight heparin or IIb/IIIa inhibitors and thrombolytic agents. Dedicated randomized clinical trials are needed to establish the best reperfusion therapy for this expanding population, especially in patients admitted to hospitals without percutaneous coronary intervention facilities and in patients developing cardiogenic shock.

Aged↗
PubMed2005

17-beta-estradiol eluting stent versus phosphorylcholine-coated stent for the treatment of native coronary artery disease.

In this study we randomly compared the estradiol eluting stent (17-beta-E) with phosphorylcholine (PC)-coated stents in native coronary arteries. The incidence of angiographic restenosis was 23% in the 17-beta-E group and 31% in the PC group (p = 0.34). The major adverse cardiovascular event rates were also similar in the 2 groups (17% in the 17-beta-E group vs 22% in the PC group, p = 0.47). The mid-term clinical and angiographic outcomes did not indicate superiority of the 17-beta-E eluting stent over the control PC stent.

Angioplasty, Balloon, Coronary↗
PubMed2005

Percutaneous left atrial appendage transcatheter occlusion (PLAATO system) to prevent stroke in high-risk patients with non-rheumatic atrial fibrillation: results from the international multi-center feasibility trials.

OBJECTIVES: These studies were conducted to evaluate the feasibility of percutaneous left atrial appendage (LAA) occlusion using the PLAATO system (ev3 Inc., Plymouth, Minnesota). BACKGROUND: Patients with atrial fibrillation (AF) have a five-fold increased risk for stroke. Other studies have shown that more than 90% of atrial thrombi in patients with non-rheumatic AF originate in the LAA. Transvenous closure of the LAA is a new approach in preventing embolism in these patients. METHODS: Within two prospective, multi-center trials, LAA occlusion was attempted in 111 patients (age 71 +/- 9 years). All patients had a contraindication for anticoagulation therapy and at least one additional risk factor for stroke. The primary end point was incidence of major adverse events (MAEs), a composite of stroke, cardiac or neurological death, myocardial infarction, and requirement for procedure-related cardiovascular surgery within the first month. RESULTS: Implantation was successful in 108 of 111 patients (97.3%, 95% confidence interval [CI] 92.3% to 99.4%) who underwent 113 procedures. One patient (0.9%, 95% CI 0.02% to 4.9%) experienced two MAEs within the first 30 days: need for cardiovascular surgery and in-hospital neurological death. Three other patients underwent in-hospital pericardiocentesis due to a hemopericardium. Average follow-up was 9.8 months. Two patients experienced stroke. No migration or mobile thrombus was noted on transesophageal echocardiogram at one and six months after device implantation. CONCLUSIONS: Closing the LAA using the PLAATO system is feasible and can be performed at acceptable risk. It may become an alternative in patients with AF and a contraindication for lifelong anticoagulation treatment.

Aged↗
PubMed2005

Normal coronary physiology assessed by intracoronary Doppler ultrasound.

There is a natural need to measure flow in normal as well as diseased coronary arteries since the reestablishment of normal flow is the aim of most coronary interventions. Miniaturization has enabled positioning both proximal and distal within the coronary anatomy and improved accuracy of Doppler velocity measurements. Measurement of coronary flow reserve adds functional data to coronary angiographic anatomic description, and quantitation of flow, achieved by combining Doppler velocity. Although new techniques involving transthoracic Doppler and magnetic resonance imaging are currently being developed and refined to measure coronary flow velocity and volume flow noninvasively, the role of intracoronary Doppler remains secure particularly for the coronary interventional physician.

Blood Flow Velocity↗
PubMed2005

Treatment of unprotected left main coronary artery stenosis in the drug-eluting stent era.

Coronary angiography is often inadequate for estimating the severity of ambiguous left main coronary artery (LMCA) stenoses. Our assessment of these lesions can be improved by the techniques of intravascular ultrasound and fractional flow reserve which provide indices of stenosis severity to enable the prediction of future events and planning of treatment. For patients requiring LMCA revascularization, coronary artery bypass graft (CABG) surgery has been gold standard for decades. However, this technique continues to be limited by factors such as periprocedural mortality, prolonged hospital stay and rehabilitation, and long-term graft patency. LMCA stenosis remains one of the few serious challenges for the interventional cardiologists and, in the bare metal stent era, the long-term results were not sufficient to replace CABG surgery, mainly because of the high restenosis rate. Drug-eluting stents (DES) have dramatically reduced the restenosis rate and early results in small series (approximately 300 patients in total) treated with DES in LMCA have been encouraging, especially for lesions at the ostium and in the left main shaft. Before changes are made in the guidelines for treatment, we must wait for a refinement in the technique and stent design used for bifurcational left main lesion and the results of randomized, specific multicenter studies (SYNTAX trial). It is likely that, for selected patients, LMCA stenosis will be regarded as an indication for PCI.

Angioplasty, Balloon, Coronary↗
PubMed2005

Proximal endovascular flow blockage for cerebral protection during carotid artery stenting: results from a prospective multicenter registry.

PURPOSE: To evaluate the feasibility of cerebral protection during carotid artery stenting (CAS) using the Mo.Ma device, which prevents cerebral embolization by proximal endovascular blockage of blood flow in the internal and external carotid arteries. METHODS: In 14 European centers, 157 patients (121 men; mean age 68.0+/-8.3 years) were enrolled in a prospective registry between March 2002 and March 2003. Eligible patients had a symptomatic (>50%) or asymptomatic (>70%) stenosis of the internal carotid artery suitable for carotid stenting. Protected carotid stenting was performed with the Mo.Ma system, which occludes both the common and external carotid arteries via 2 independently inflatable compliant low-pressure balloons before any device is advanced across the lesion. Blood is aspirated through the catheter intermittently or at the end of the procedure. RESULTS: The device was successfully positioned and stents were implanted in all cases. Diameter stenosis was reduced from 84.1%+/-7.8% to 6.7%+/-5.1%. The mean duration of flow blockage was 7.6+/-5.9 minutes. In 12 (7.6%) patients, transient intolerance to flow blockade was observed, but the procedures were completed successfully. In 124 (79.6%) cases, there was macroscopic evidence of debris after filtering the aspirated blood. In-hospital complications included 4 (2.5%) minor strokes, 8 (5.1%) transient ischemic attacks, no deaths, and no major strokes, resulting in a 2.5% death/stroke rate at discharge. At 30-day follow-up, there was 1 cardiac death, 1 major stroke, and 3 minor strokes, for an overall 5.7% 30-day death/stroke rate and a 30-day major stroke and death rate of 1.3%. CONCLUSIONS: Cerebral protection with proximal endovascular blood flow blockage during CAS is feasible, with a high procedural success rate.

Aged↗
PubMed2004

High-dose 7-hexanoyltaxol-eluting stent with polymer sleeves for coronary revascularization: one-year results from the SCORE randomized trial.

OBJECTIVES: The Study to COmpare REstenosis Rate between QueST and QuaDDS-QP2 (SCORE) trial was a multicenter, randomized, open-label trial comparing the safety and performance of 13- and 17-mm QuaDDS stents (n = 126) (Quanam Medical Corp., Santa Clara, California/Boston Scientific Corp., Natick, Massachusetts) versus uncoated control stents (n = 140) in focal, de novo coronary lesions. BACKGROUND: The pioneering drug-delivery QuaDDS stent used four to six acrylate polymer sleeves, each loaded with 800 microg of the paclitaxel derivative 7-hexanoyltaxol. METHODS: Clinical end points were assessed at 1, 6, and 12 months post procedure. Quantitative coronary angiography and intravascular ultrasound were performed post procedure and at six-month follow-up. RESULTS: In the QuaDDS group, early stent thrombosis and myocardial infarction (MI) rates were significantly higher, leading to premature cessation of enrollment. For the QuaDDS group, the stent thrombosis rate increased from 3.2% to 10.3% between 1 and 12 months, associated with increased non-Q-wave MI and death rates. The angiographic restenosis rate at six months was reduced from 32.7% (control) to 7.4% (p < 0.0001). However, the primary end point was not met with six-month target vessel revascularization (TVR) rate as well as the composite major adverse cardiac event rates (cardiac death, MI, and TVR) comparable between groups. CONCLUSIONS: Despite angiographic indications of potential anti-restenotic benefit, increased rates of stent thrombosis, MI, and cardiac death associated with the QuaDDS stent show an unacceptable safety profile.

Aged↗
PubMed2004

Cutting balloon versus conventional balloon angioplasty for the treatment of in-stent restenosis: results of the restenosis cutting balloon evaluation trial (RESCUT).

OBJECTIVES: The aim of this trial was to compare cutting balloon angioplasty (CBA) with conventional balloon angioplasty (i.e., percutaneous transluminal coronary angioplasty [PTCA]) for the treatment of patients with coronary in-stent restenosis (ISR). BACKGROUND: Retrospective studies suggest CBA might be superior to conventional PTCA in the treatment of ISR. METHODS: The Restenosis Cutting Balloon Evaluation Trial (RESCUT) is a multicenter, randomized, prospective European trial including 428 patients with all types of ISR (e.g., focal, multifocal, diffuse, proliferative). RESULTS: In both groups, the majority of ISR lesions were shorter than 20 mm. The length of restenotic stents was similar (CBA: 18.6 +/- 9.7 mm; PTCA: 18.3 +/- 8.7 mm). The number of balloons used to treat ISR was lower in the CBA group: only one balloon was used in 82.3% of CBA cases, compared with 75% of PTCA procedures (p = 0.03). Balloon slippage was less frequent in the CBA group (CBA 6.5%, PTCA 25%; p < 0.01). There was a trend toward a lower need for additional stenting in the CBA group (CBA 3.9%, PTCA 8.0%; p = 0.07). At seven-month angiographic follow-up, the binary restenosis rate was not different between the groups (CBA 29.8%, PTCA 31.4%; p = 0.82), with a similar pattern of recurrent restenosis. Clinical events at seven months were also similar. CONCLUSIONS: Cutting balloon angioplasty did not reduce recurrent ISR and major adverse cardiac events, as compared with conventional PTCA. However, CBA was associated with some procedural advantages, such as use of fewer balloons, less requirement for additional stenting, and a lower incidence of balloon slippage.

Angioplasty, Balloon↗
PubMed2004

Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions.

BACKGROUND: A sirolimus-eluting stent (Cypher, Cordis Corp) has been reported to markedly decrease restenosis in selected lesions; higher-risk lesions, including coronary bifurcations, have not been studied. METHODS AND RESULTS: This prospective study evaluated the safety and efficacy of sirolimus-eluting stents for treatment of coronary bifurcation lesions. Patients were randomly assigned to either stenting of both branches (group A) or stenting of the main branch with provisional stenting of the side branch (SB) (group B). Eighty-five patients (86 lesions) were enrolled. There was 1 case of unsuccessful delivery of any device at the bifurcation site. Given the high crossover, more lesions were treated with 2 stents (n=63) than with stent/balloon (n=22). Clinical follow-up at 6 months was completed in all patients and angiographic follow-up in 53 patients in group A (85.5%) and 21 in group B (95.4%). One patient died suddenly 4.5 months after the procedure. There were 3 cases of stent thrombosis (3.5%). The total restenosis rate at 6 months was 25.7%, and it was not significantly different between the double-stenting (28.0%) and the provisional SB-stenting (18.7%) groups. Fourteen of the restenosis cases occurred at the ostium of the SB and were focal. Target lesion revascularization was performed in 7 cases; target vessel failure occurred in 15 cases (17.6%). CONCLUSIONS: These results are an improvement compared with historical controls using bare metal stents. Restenosis at the SB remains a problem. At this time, no statement can be made regarding the most appropriate technique to use when treating bifurcations with the Cypher stent.

Aged↗
PubMed2004

Comparison of diamond-like carbon-coated stents versus uncoated stainless steel stents in coronary artery disease.

Stainless steel (SS) and carbon-coated (CC) stents were randomly compared in 347 patients (520 lesions). No differences were observed in in-hospital major adverse cardiac events: 2.8% in the CC group and 4.5% in the SS group (p = 0.286). The 6-month follow-up showed similar rates of binary restenosis (31.8% in the CC group vs 35.9% in the SS group; p = 0.448) and of cumulative major adverse cardiac events (30.5% in the CC group vs 32.7% in the SS group; p = 0.675). In unselected patients and lesions, carbon coating does not provide significant improvements over SS stents with the same design.

Carbon↗