Publications (13)22.85 Total impact
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Article: Characteristics and Outcomes of Patients With ST-Segment Elevation Myocardial Infarction Excluded from the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) Trial.
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ABSTRACT: Randomized controlled trials assessing new drugs and devices tend to exclude subjects who are at greatest risk. The Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial incorporated broader inclusion criteria in an attempt to include a more representative spectrum of patients presenting with ST-segment elevation myocardial infarction (STEMI). To identify the differences between this modern trial and the real world, we analyzed the characteristics and outcomes of patients with STEMI who were screened but not enrolled at a high-volume recruiting center. Of 318 consecutive patients with STEMI who were screened, 200 (62.9%) were randomized, and 118 (37.1%) were excluded. The baseline characteristics and 30-day and 1-year clinical outcomes were compared in the 2 groups. The excluded patients had numerous high-risk features compared to those randomized, including being older (67.0 ± 12.8 vs 63.0 ± 11.4 years, p = 0.004), more often had had a previous MI (34.7% vs 8.0%, p <0.001), Killip class III-IV (27.4% vs 4.0%, p <0.001), and lower hemoglobin (13.4 ± 2.3 vs 14.8 ± 1.5 g/dl, p <0.001). The excluded patients had markedly greater 30-day and 1-year rates of all-cause mortality (17.4% vs 2.0%, p <0.001, and 27.6% vs 2.5%, p <0.001, respectively), major adverse cardiovascular events (death, MI, ischemia-driven target vessel revascularization, and stroke), major bleeding, and net adverse clinical events (major adverse cardiovascular events or major bleeding). On multivariate analysis, Killip class III-IV at presentation, age, left ventricular ejection fraction, and final Thrombolysis In Myocardial Infarction flow grade 3 were independent predictors of outcome. In conclusion, despite the broadened entry criteria of the HORIZONS-AMI trial, 37.1% of all patients presenting with STEMI at a center with a high rate of enrollment were judged to be ineligible and were excluded. The excluded patients had a significantly greater risk profile and markedly increased mortality and adverse events compared to the trial-eligible group.The American journal of cardiology 10/2012; · 3.58 Impact Factor -
Article: Impact of different stent alloys on human vascular response to everolimus-eluting stent: An optical coherence tomography study: The OCTEVEREST.
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ABSTRACT: BACKGROUND: New generation drug-eluting stents (DES) incorporate thinner struts and novel alloys to improve clinical performance. Nevertheless, the impact of novel stent materials and designs on human vascular response to DES remains elusive. We sought to evaluate the in-vivo coronary artery response to platinum-chromium (PtCr) versus cobalt-chromium (CoCr) stents featuring the same durable polymer and antiproliferative drug by optical coherence tomography (OCT). METHODS AND RESULTS: A total of 42 patients with de novo lesions in native coronary vessels was treated with PtCr-everolimus eluting stent (EES; n = 21) or CoCr-EES (n = 21). Angiography, intravascular ultrasound, and OCT were performed at the index procedure and 6-month follow-up. PtCr-EES and CoCr-EES had similar concentric expansion (stent eccentricity index; median 0.91 vs. 0.90, respectively, P = 0.47) and very low rate of strut malapposition (median 1.15 vs. 1.80%, P = 0.92) at post implantation. Proportion of struts embedded in tissue was lower in PtCr-EES compared to CoCr-EES (median 2.67 vs. 15.23%, P < 0.001). The primary prespecified end point, the percentage of uncovered struts per patient at 6 months follow-up, was 8.46% [interquartile range (IQR) = 3.05-17.26] in PtCr-EES and 5.88% (IQR = 1.35-13.27) in CoCr-EES (P = 0.36), whereas malapposed struts were observed in 0.00% (IQR = 0.00-0.25) versus 0.48% (IQR = 0.00-1.44), respectively, (P = 0.10). Strut-level neointimal thickness did not differ between the two platforms (median 0.09 vs. 0.08 mm, P = 0.49). CONCLUSIONS: Acute and mid-term responses to EES using PtCr or CoCr platforms were similar, with concentric stent expansion, low malapposition, similar strut coverage and limited amount of neointima. Conversely, at postprocedure, PtCr-EES had fewer embedded struts compared with CoCr-EES. © 2012 Wiley Periodicals, Inc.Catheterization and Cardiovascular Interventions 03/2012; · 2.29 Impact Factor -
Article: Serial assessment of coronary artery response to paclitaxel-eluting stents using optical coherence tomography.
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ABSTRACT: The paucity of longitudinal, serial high-resolution imaging studies has limited our understanding of in vivo arterial response to drug-eluting stents. We sought to investigate the human coronary response to paclitaxel-eluting stent implantation, using serial optical coherence tomography assessments. Thirty patients with at least 2 significant coronary lesions in different vessels were treated with a paclitaxel-eluting stent. The most severe stenosis (lesion A) was treated at the initial procedure, and the second target vessel (lesion B) was stented 3 months later. Optical coherence tomography was performed at baseline, 3-, and 9-month follow-up for lesions A and baseline and 6 months for lesions B. Prespecified end points were percent of uncovered and malapposed struts over time. In lesions A, uncovered struts were 3.77±4.94% and 3.02±4.35% at 3 versus 9 months (P=NS). Malapposed struts were 3.55±5.16% at post-procedure, 1.51±3.52% at 3 months, and 0.60±1.82% at 9 months (P<0.05, at 3 versus 9 months). Strut-level neointimal thickness was 0.19±0.09 mm and 0.20±0.11 mm (P=NS) over time. Newly acquired malapposition was detected in 10.4% and 3.3% of 2.5-mm segments at 3- and 9-month follow-up. In lesions B, uncovered struts were 2.91±5.47% at 6-months. Malapposed struts were 4.94±6.70% post-procedure and 1.01±3.11% at 6 months (P<0.01), with 0.19±0.09-mm neointimal thickness at follow-up. Optical coherence tomography imaging suggested the first 3 months to be the period with most biological activity after paclitaxel-eluting stent implantation, when the proliferative reaction mainly occurs and malapposition resolves. A less active, yet continuous, dynamic arterial response, with resolution and development of malapposition, occurs through 9 months post-treatment.Circulation Cardiovascular Interventions 02/2012; 5(1):30-8. · 6.06 Impact Factor -
Article: Impact of drug release kinetics on vascular response to different zotarolimus-eluting stents implanted in patients with long coronary stenoses: the LongOCT study (Optical Coherence Tomography in Long Lesions).
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ABSTRACT: We assessed the in vivo vascular response to a new generation of zotarolimus-eluting stents (ZES) with prolonged drug release (Resolute ZES-SR, Medtronic Vascular, Santa Rosa, California) compared with ZES with faster kinetics (Endeavor ZES-FR, Medtronic Vascular) by optical coherence tomography. Local drug release kinetics has been implicated with antirestenosis efficacy of drug-eluting stents. However, the impact of different release kinetics on vascular response of diseased human coronary arteries remains to be investigated. The study population consisted of 43 patients with long lesions in native coronary vessels treated with multiple overlapping ZES. Twenty-one patients treated with ZES-SR were compared with 22 patients treated with ZES-FR from the ODESSA (Optical coherence tomography for DES SAfety) study. The primary endpoint was in-stent neointimal hyperplasia as assessed by optical coherence tomography at 6-month follow-up. Coprimary endpoints were the percentage of uncovered and malapposed struts. Strut-level median neointimal thickness was 0.11 mm (interquartile range [IQR]: 0.07 to 0.15 mm) in ZES-SR and 0.31 mm (IQR: 0.27 to 0.42 mm) in ZES-FR, respectively (p < 0.001). The 6-month rate of uncovered struts per patient was 7.38% (IQR: 3.06% to 12.72%) in ZES-SR and 0.00% (IQR: 0.00% to 0.00%) in ZES-FR (p < 0.001); rate of malapposed and uncovered struts was 1.47% (IQR: 0.32% to 4.23%) in ZES-SR and 0.00% (IQR: 0.00% to 0.00%) in ZES-FR (p < 0.001). This study demonstrated the impact of different release kinetics on human in vivo vascular response to ZES implantation. The new generation of ZES-SR compared with ZES-FR had better suppression of the neointimal response but higher proportion of uncovered and malapposed struts at 6-month optical coherence tomography follow-up. (Optical Coherence Tomography in Long Lesions [LongOCT]; NCT01133925).07/2011; 4(7):778-85. · 1.07 Impact Factor -
Article: Optical coherence tomography in ST-elevation myocardial infarction treated with novel drug-eluting stent: preprocedural, postimplant and 2-month follow-up findings.
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ABSTRACT: The use of drug-eluting stents (DES) allowed the reduction in the need for repeat revascularization. At the culprit site in acute myocardial infarction patients treated with first-generation DES, the interaction between the eluted drug and the underlying necrotic core may generate different patterns of pathologic vessel response and delayed healing. A new generation DES intrepide elutes trapidil. Its modes of action are neither cytotoxic nor cytostatic, and may promote normal re-endothelialization. Due to its high resolution, optical coherence tomography (OCT) allows accurate detection of thrombus deposition and stent strut coverage at follow-up. Intravascular ultrasound (IVUS) has enhanced tissue penetration and provides information on vessel remodeling. Using OCT and IVUS, we evaluated the intravascular morphology of the culprit vessel, the acute and intermediate result of novel DES implanted to treat an ST-segment elevation myocardial infarction.Journal of Cardiovascular Medicine 10/2010; 12(1):55-8. · 1.51 Impact Factor -
Article: Strut coverage and vessel wall response to a new-generation paclitaxel-eluting stent with an ultrathin biodegradable abluminal polymer: Optical Coherence Tomography Drug-Eluting Stent Investigation (OCTDESI).
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ABSTRACT: Polymer-coated drug-eluting stents are effective in preventing restenosis but have been associated with delayed healing and incomplete strut coverage. It is unknown whether paclitaxel-eluting stents (PES) with minimal biodegradable abluminal coating enhances strut coverage while preventing neointimal hyperplasia. Using optical coherence tomography (OCT) as a primary imaging modality, we assessed the proportion of uncovered struts at 6-month follow-up in PES coated with durable versus ultrathin (<1 microm) biodegradable abluminal polymers. In this pilot trial, 60 patients with de novo lesions (< or =25 mm) in native coronary vessels were randomly assigned to receive either TAXUS Liberté PES or JACTAX PES, a Liberté stent with polymer deposited abluminally as microdots (JACTAX HD: 9.2 microg each of polymer and paclitaxel per 16-mm stent; JACTAX LD: 5 microg each). OCT follow-up occurred at 6 months with clinical follow-up through 1 year. The primary end point was percent uncovered struts by OCT. An independent core laboratory blinded to stent assignment analyzed images. The 6-month rate of uncovered struts per patient was 5.3+/-14.7% for TAXUS Liberté, 7.0+/-12.2% for JACTAX HD, and 4.6+/-7.3% for JACTAX LD (P=0.81); percent malapposed struts was 1.4+/-4.4%, 0.8+/-1.9%, and 1.1+/-2.8%, respectively (P=0.86). Strut-level intimal thickness was 0.20+/-0.10, 0.22+/-0.15, and 0.24+/-0.15 mm (P=0.64); percent volume obstruction by OCT was 22.2+/-12.8, 22.5+/-16.2, and 25.8+/-15.2 (P=0.69). There were no deaths, Q-wave myocardial infarctions, or stent thromboses through 1 year. JACTAX PES with an ultrathin microdot biodegradable abluminal polymer did not result in improved strut coverage at 6 months compared with TAXUS Liberté. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00776204.Circulation Cardiovascular Interventions 08/2010; 3(4):367-75. · 6.06 Impact Factor -
Article: Failure of transradial approach during coronary interventions: anatomic considerations.
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ABSTRACT: The anatomy of the radial artery has yet to be systematically studied from the perspective of using it as a route for catheter access. We prospectively performed angiography of the arteries of the upper limb to delineate the anatomic features of the radial artery as a way to determine the feasibility of using it as a route for coronary intervention. We studied 2,211 consecutive patients submitted to transradial cardiac catheterization. In all patients, an angiography of the upper limb arteries was performed before and after procedure. Radial puncture was successful in 98.9% of patients. At angiography, anatomic variations of upper limb arteries were noted in 505 patients (22.8%) and included tortuous configurations (3.8%), stenosis (1.7%), hypoplasias (7.7%), radioulnar loop (0.8%), abnormal origin of the radial artery (8.3%), and lusoria subclavian artery (0.45%). Overall procedural success by transradial approach was 97.5%. Patients with anatomic variations of radial artery had a significantly lower puncture (96.2% vs 99.7%, P < 0.0001) and procedural (93.1% vs 98.8%, P < 0.0001) success. The procedure was successfully performed by radial approach in 98.8% of patients with tortuous configurations, 91.9% of radial stenosis, 93.9% of hypoplastic radial artery, 83.3% of radioulnar loop, 96.7% of radial axillary origin, and 60% of lusoria subclavian artery setting. Anatomic variations of the radial artery are not rare. However, they do not represent an important limitation in transradial approach if they are well documented previously.Catheterization and Cardiovascular Interventions 07/2006; 67(6):870-8. · 2.29 Impact Factor -
Article: Safety and feasibility of transradial coronary angioplasty in elderly patients.
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ABSTRACT: The aim of this study was to assess the safety, feasibility and efficacy of transradial coronary angioplasty in elderly (> or = 70 years) vs younger patients (< 70 years). We studied 1125 consecutive patients submitted to transradial coronary angioplasty by a single operator. An angiography of the arteries of the upper limbs was performed before and after the procedure. The presence of the radial pulse was assessed at 1 month of follow-up. At angiography, elderly patients (n = 323) were found to have a higher incidence of radial and brachiocephalic trunk anatomical tortuosity compared to younger subjects (35.3 vs 17.3%, p < 0.05; 10.5 vs 5.3%, p < 0.05, respectively). Radial access was successful in 98.8% of elderly and in 99% of younger patients (p = NS). The procedural success by radial access did not significantly differ between the two groups (97.5 vs 98.7%; p = NS). The cannulation time (from skin anesthesia to arterial cannulation) and the total procedure time (from patient arrival at the catheterization room to the completion of the procedure) were not significantly different between the two groups (1.5 +/- 0.8 vs 1.6 +/- 0.4 min, p = NS; 57 +/- 23 vs 56 +/- 12 min, p = NS, respectively). There were no access site bleeding complications in younger and only one (0.4%) such a complication in elderly patients. In all patients, there was no case of forearm ischemia and the incidence of asymptomatic loss of the radial pulse during the 30-day follow-up period was not different between the two groups (1.5 vs 1.4%, p = NS). Performed by experienced operators, transradial access constitutes a safe and feasible approach for coronary angioplasty in elderly patients. The results are similar to those observed in younger patients.Italian heart journal: official journal of the Italian Federation of Cardiology 01/2005; 5(12):926-31. -
Article: Safety, feasibility and efficacy of transradial primary angioplasty in patients with acute myocardial infarction.
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ABSTRACT: In recent years the transradial approach has been increasingly employed as an alternative approach to percutaneous coronary intervention. The aim of this study was to investigate the safety, feasibility and efficacy of transradial primary angioplasty. We studied 726 patients (552 males, 174 females, mean age 61.5 +/- 12 years) with a diagnosis of acute myocardial infarction (< 12 hours after onset; Killip class 1-3) who underwent primary percutaneous coronary intervention. The transradial approach (group A) was used in 163 consecutive patients (126 males, 37 females, mean age 61.5 +/- 12 years) with a negative Allen test by a single experienced operator. The transfemoral approach (group B) was used for vascular access in the remaining patients (n = 563). No significant differences in baseline characteristics were observed between the two groups. The radial access was achieved in all patients of group A, but 9 who were switched to either left radial (n = 7) or right femoral approaches (n = 2). The time of radial artery cannulation was in all cases < 2 min. The cannulation time (from skin anesthesia to the time of arterial cannulation) and the total procedure time (from patient arrival at the catheterization room to the completion of the procedure) did not significantly differ between group A and group B (1.7 +/- 0.4 vs 1.6 +/- 0.6 min, p = 0.8; 62 +/- 23 vs 61 +/- 22 min, p = 0.7, respectively). In 71.1% of cases of group A, a single catheter (Sones type I or II) was employed for diagnostic angiography of the right and left coronary arteries and of the left ventricle. Only balloon angioplasty was performed in 6.1% of group A patients vs 9.9% of group B patients (p = NS). The primary success rate was identical: 96.9% in the radial and 95.5% in the femoral group. There were no major bleeding complications in group A as opposed to 7 (1.2%) in group B (p = 0.04). In the radial group patients during the 30-day follow-up period there was no forearm ischemia or loss of the radial pulse. The total length of hospitalization was slightly shorter in the radial group, although this difference was not statistically significant (5.9 +/- 2 vs 6.4 +/- 2.8 days, p = 0.1). Provided it is performed by experienced operators, the transradial approach can represent a safe and feasible method for performing primary angioplasty with similar results to those of the transfemoral approach.Italian heart journal: official journal of the Italian Federation of Cardiology 06/2003; 4(5):329-34. -
Article: Through the drug-eluting stent labyrinth.
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ABSTRACT: For interventional cardiologists restenosis has represented the main limit for the successful long-term treatment of coronary artery disease. The past 2 years witnessed the extraordinary results of drug-eluting stents (DES), putting this technique at the center stage. The safety and efficacy of sirolimus and paclitaxel-eluting stents have been proved in large prospective, multicenter, randomized trials (RAVEL, SIRIUS, TAXUS II). It is possible that the introduction of DES will lead to substantial changes in the therapeutic and/or the economic strategies of the treatment of ischemic coronary artery disease (increase in the complexity of patients treated, reduction in surgical indications, growing costs). Realizing the potential value of this technology will require the successful management of more complex coronary situations (for lesions and patients characteristics). Many extreme situations are still unexplored, although for some of them studies are currently in progress or already being planned.Italian heart journal: official journal of the Italian Federation of Cardiology 05/2003; 4(4):236-45. -
Article: In-hospital clinical outcome in elderly patients with acute myocardial infarction treated with primary angioplasty.
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ABSTRACT: The aim of the present study was to assess the early clinical outcome following primary coronary angioplasty in elderly patients (aged > or = 75 years) compared to younger patients (< 75 years). The study population included 655 consecutive patients (mean age 61.5 +/- 12.4 years) with acute ST-elevation myocardial infarction (MI) who underwent primary percutaneous coronary intervention (PCI) within 12 hours of symptom onset. Elderly patients accounted for 14.5% (96 of 655) of all patients. Primary PCI was performed using a balloon and/or coronary stent as well as glycoprotein IIb/IIIa inhibitors. The primary endpoint was the in-hospital incidence of major adverse cardiac events (including death, stroke, reinfarction, target vessel revascularization and new onset of heart failure). Elderly patients were more frequently female (48 vs 20%, p < 0.001) and had more comorbid disease (prior stroke 7.2 vs 2.5%, p < 0.05) and more extensive cardiovascular disease (previous acute MI 13.5 vs 5.5%, p < 0.05; multivessel disease 71.8 vs 44.6%, p < 0.0005) and a significantly lower ejection fraction (48 vs 50%, p < 0.05). Despite a similar rate of TIMI 0-1 flow at presentation (69 vs 74%, p = NS), a similar use of stents (84 vs 86%, p = 0.3) and of glycoprotein IIb/IIIa inhibitor infusion (19.8 vs 22.1%, p = 0.3) and a comparable angiographic residual stenosis (21 vs 19%, p = NS), the final rate of TIMI 3 flow was significantly lower in the elderly population (77.8 vs 91.4%, p < 0.001). Although the in-hospital ischemic event rates for all ages were not significantly different, the in-hospital mortality was higher in the elderly as compared with younger patients (9.3 vs 3.2%, p < 0.0001), even when the patients with cardiogenic shock at the time of admission were excluded (4.4 vs 0.9%, p < 0.0001). Furthermore, more patients aged > or = 75 had in-hospital heart failure (5.2 vs 1.8%, p < 0.05). In the whole population, multivariate analysis identified baseline Killip class III-IV as the only independent predictor of events. In elderly patients, multivariate analysis identified baseline Killip class III-IV and the time from the onset of chest pain to PCI as independent predictors of events. Our data suggest that in elderly patients with acute ST-elevation MI primary PCI yields positive results: successful reperfusion can be achieved in a high proportion of elderly patients and the mortality rates are lower, than those reported in non-PCI registries. A high Killip class and late reperfusion therapy predict an unfavorable outcome in elderly patients treated with primary PCI.Italian heart journal: official journal of the Italian Federation of Cardiology 04/2003; 4(3):193-8. -
Article: Radial artery: how many times?
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ABSTRACT: Transradial approach for diagnostic and interventional procedures is becoming common practice. It has not been well determined how many times the same radial artery can be cannulated without complications. Aim of the study was to evaluate safety, feasibility and efficacy of repeat transradial procedures. From May 1998 to March 2009 we studied 4818 consecutive patients (75.44% male; age 64.02 +/- 11.6 Years) via radial artery by a single experienced operator. A repeat transradial procedure through the same radial artery was performed in 670 patients: twice in 514 cases, three times in 119, four times in 25 patients, five times in 7 patients, six times in 3 patients and seven times in one patient. Repeat PCI was performed in 412 patients. 6F catheters were used in 98.11%. There was no significant difference in radial puncture success rate and vascular access time: puncture success rate was 99.23% in the initial procedure and 98.11% (5 puncture failure) in repeated transradial artery procedures, and vascular access time was 1.5 +/- 2.1 min at the initial procedure and 2.2 +/- 3.1 min at repeat (p = ns). Failure of repeat puncture may be due to thickening of the tunica intima resulting from sheath insertion injuries or because of periarterial fibrosis at the prior radial puncture site. We believe that repeated use of the same radial artery is effective in considering its high procedural success and low complication rates in majority of patients in the hands of experienced operators.Indian heart journal 62(3):226-9. -
Article: Safety and feasibility of selective angiography of left internal mammary artery grafts via right transradial approach.
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ABSTRACT: Right transradial approach (TRA) for cardiovascular procedures is becoming common practice, but angiography and PCI of left mammary artery by-pass graft (LIMA) via the right radial artery is still technically challenging. Aim of the study was to evaluate the possibility to put a stable catheter in left mammary from right radial approach. From June 2002 to March 2009, 246 consecutive patients (88% male; age 67.7 +/- 7.8 years) with previous CABG underwent LIMA graft angiography via right TRA by a single experienced operator. An adequate radial access was obtained in all patients. Selective angiography of LIMA was successfully performed in 218 patients (89.1%). In the remaining 28 (10.9%) the LIMA approach from right radial failed because of severe tortuosity of brachiocephalic trunk or severe calcified and tortuous left subclavian artery. 13 patients underwent PCI and stentingon mid-distal native LAD trough LIMA using 6FIM4 guiding catheter. No periprocedural cerebro-vascular complications, no vascular injury at the LIMA takeoff as a result of selective canulation, no injury of the left subclavian artery were observed In patients with previous CABG, the presence of LIMA grafts is not a limitation to successfully perform diagnostic and interventional procedures via the right radial approach with experienced operators.Indian heart journal 62(3):255-7.
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2006
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Ospedali Riuniti di Bergamo
Bergamo, Lombardy, Italy
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