Publications (9)102 Total impact
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Article: Does the site of bleeding matter? A stratified analysis on location of TIMI-graded bleedings and their impact on 12-month outcome in patients with ST-segment elevation myocardial infarction.
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ABSTRACT: While bleeding in patients with STEMI undergoing primary percutaneous coronary intervention (pPCI) is known to be associated with poor outcomes, the differential prognostic impact of access-site related versus non access-site related bleedings is unknown. We aimed to assess the relative impact of access-site related bleeding, as compared to non access-site related, on 12-month clinical outcome in patients undergoing intervention for STEMI. Thirty-day bleeding endpoints, stratified into access-site versus non access-site, were examined according to the TIMI scale in 744 patients with STEMI enrolled in the MULTISTRATEGY trial. TIMI major or minor bleeding complications occurred in 56 (7.5%) patients within 30 days, 46% had an access-site related bleed and 34% required blood transfusion. Bleeding severity and the need for transfusion were equally distributed between site access- versus non-site access-related bleeds. After adjustment, patients with any TIMI rated bleed were more likely to die or develop recurrent MI within 12 months (HR 2.1 [95% CI: 1.13-3.8]; p=0.02). This ratio was entirely driven by non-site access-related bleeds (adjusted HR: 2.66 [95% CI: 1.21-5.8]; p=0.007), whereas site-access bleeds were not associated with worse outcomes (HR: 0.74 [95% CI: 0.16-3.4]; p=0.70). While bleeds of any TIMI severity within 30 days were independently associated with worse cardiovascular outcomes at 12 months, thus confirming previous analyses, this relationship was entirely driven in our study by non access-site related haemorrhagic events. Investigation on whether the site of bleeding complications may preferentially impact cardiovascular outcomes is warranted.EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 02/2012; 8(1):71-8. · 3.29 Impact Factor -
Article: Sex-specific benefits of sirolimus-eluting stent on long-term outcomes in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: insights from the Multicenter Evaluation of Single High-Dose Bolus Tirofiban Versus Abciximab With Sirolimus-Eluting Stent or Bare-Metal Stent in Acute Myocardial Infarction Study trial.
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ABSTRACT: We assessed the relation between female sex and sirolimus-eluting stent (SES) use on long-term outcomes in acute myocardial infarction. There are no data on sex-specific differences in long-term benefit of SES use compared with bare-metal stent (BMS) use among patients undergoing primary percutaneous coronary interventions. We performed a post hoc analysis of the MULTISTRATEGY trial. Hazard ratios (HRs) of events with 95% CI for sex and stent type were computed using Cox proportional regression with adjustment for confounders. A total of 744 patients, 64 years old (55-73 years old), 179 (24.1%) women, were enrolled. After a follow-up of 1,080 days, SES use was associated with a significant reduction of major adverse cardiovascular events, that is, the composite of all-cause death, reinfarction, or clinically driven target vessel revascularization (TVR) (13.9% vs 23.6%, adjusted HR 0.62, 95% CI 0.41-0.94, P = .026) and of TVR (6.1% vs 15.1%, adjusted HR 0.35, 95% CI 0.19-0.63, P < .001) in men. Conversely, SES use was not associated to a better outcome among women (major adverse cardiovascular events 21.9% in SES vs 18.2% in the BMS group, adjusted HR 1.27, 95% CI 0.53-3.02, P = .59; TVR 6.6% vs 9.1%, adjusted HR 0.62, 95% CI 0.17-2.21, P = .46). In this analysis, the clinical benefit of SES use, over BMS, at 3-year follow-up was restricted to men and was not observed among women.American heart journal 01/2012; 163(1):104-11. · 4.65 Impact Factor -
Article: Three-year follow-up of the MULTIcentre evaluation of Single high-dose Bolus TiRofiban versus Abciximab with Sirolimus-eluting STEnt or Bare-Metal Stent in Acute Myocardial Infarction StudY (MULTISTRATEGY).
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ABSTRACT: BACKGROUND: The Multicentre Evaluation of Single high-dose Bolus TiRofiban versus Abciximab with Sirolimus-eluting Stent or Bare Metal Stent in Acute Myocardial Infarction Study [MULTISTRATEGY]) randomised 745 patients with ST-elevation myocardial infarction to receive high-dose bolus (HDB) tirofiban or abciximab infusion and sirolimus-eluting (SES) or uncoated-stent (BMS) implantation. Tirofiban was non-inferior to abciximab in terms of ST-segment resolution after intervention, whereas 8 month-major adverse cardiac events occurred in 14.5% in the BMS and 7.8% in the SES groups (P=0.0039), reflecting a reduction of reintervention rates (10.2% vs. 3.2%). A three-year follow-up was performed to extend previous short- to mid-term findings. METHODS AND RESULTS: Complete data at 3years was available for 736 patients (99%). All-cause mortality was 6.7% in the tirofiban and 7.8% in the abciximab (P=0.56) and 7.5% in the BMS vs 7.0 in the SES groups, P=0.79. The composite of all-cause death or MI was identical at 12.9% in tirofiban and abciximab groups, P=0.99 and it occurred in 13.2% in the BMS vs. 12.6% in the SES groups (P=0.83). The need for reintervention remained more than twice as common with BMS (13.7%; versus 6.2%, P=0.0006). The cumulative rate of stent thrombosis (ST) did not differ. This is inspite of a higher very late definite, probable or possible ST thrombosis rate in the SES group. CONCLUSIONS: The 3-year follow-up of MULTISTRATEGY demonstrated comparable outcomes with HDB Tirofiban or abciximab and a sustained efficacy of SES to reduce reintervention with no difference in death, repeat MI or ST.International journal of cardiology 08/2011; · 7.08 Impact Factor -
Article: Metabolic syndrome does not increase angiographic restenosis rates after drug-eluting stent implantation.
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ABSTRACT: Metabolic syndrome (MS) is associated with an increased risk of coronary heart disease, stroke, and cardiovascular mortality; but its effect on patients undergoing cardiac revascularization is still unclear. Robust evidence demonstrates that diabetes mellitus and insulin resistance are among the main risk factors for restenosis in patients requiring percutaneous myocardial revascularization. The recent advent of drug-eluting stents (DESs) has significantly reduced the incidence of restenosis compared with bare-metal stents, both in nondiabetic and in diabetic patients. The aim of the study was to evaluate the effect of MS on the risk of binary restenosis in DES implant recipients. One hundred eighty-nine recipients of successful DES implants performed between January and March 2005 for stable coronary artery disease underwent 1-year clinical and angiographic follow-up. Body mass index (BMI), blood pressure, fasting blood glucose, and lipid profile were determined. Metabolic syndrome was defined according to the National Cholesterol Education Program Adult Treatment Panel III criteria, with the waist criterion being substituted by a BMI>or=28.8 kg/m2. Metabolic and anthropometric information for MS diagnosis was available for 148 of 189 patients; 87 of 148 patients (58%) had MS. Patients with MS had higher BMI (28.4+/-3.8 vs 26+/-2.7 kg/m2, P<.0001), systolic blood pressure (133+/-14 vs 124+/-14 mm Hg, P=.0004), and fasting glucose (113+/-37 vs 92+/-17 mg/dL, P<.0001). They also had higher serum triglycerides (154+/-94 vs 113+/-43, P=.0018) and lower high-density lipoprotein cholesterol levels (39+/-9 vs 46+/-10, P<.0001). Rates of restenosis (10.5% vs 8.1%, P=not significant [NS]), target vessel revascularization (10.5% vs 11.3%, P=NS), and major adverse cardiac events (11.6% vs 14.5%, P=NS) were not significantly different in patients with MS compared with those without MS, nor was any association found between increased end point risk and presence of MS. When patients were subdivided into 6 subgroups by the presence of 0, 1, 2, 3, 4, or 5 of the MS components, restenosis rates were not significantly different among subgroups. In conclusion, MS is not associated with higher rates of restenosis, target vessel revascularization, or major adverse cardiac events; and no additional MS feature was associated with an increased risk.Metabolism 06/2008; 57(5):593-7. · 2.66 Impact Factor -
Article: Comparison of angioplasty with infusion of tirofiban or abciximab and with implantation of sirolimus-eluting or uncoated stents for acute myocardial infarction: the MULTISTRATEGY randomized trial.
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ABSTRACT: Abciximab infusion and uncoated-stent implantation is a complementary treatment strategy to reduce major adverse cardiac events in patients undergoing angioplasty for ST-segment elevation myocardial infarction (STEMI). It is uncertain whether there may be similar benefits in replacing abciximab with high-dose bolus tirofiban. Similarly, the use of drug-eluting stents in this patient population is currently discouraged because of conflicting results on efficacy reported in randomized trials and safety concerns reported by registries. To evaluate the effect of high-dose bolus tirofiban and of sirolimus-eluting stents as compared with abciximab infusion and uncoated-stent implantation in patients with STEMI undergoing percutaneous coronary intervention. An open-label, 2 x 2 factorial trial of 745 patients presenting with STEMI or new left bundle-branch block at 16 referral centers in Italy, Spain, and Argentina between October 2004 and April 2007. High-dose bolus tirofiban vs abciximab infusion and sirolimus-eluting stent vs uncoated stent implantation. For drug comparison, at least 50% ST-segment elevation resolution at 90 minutes postintervention with a prespecified noninferiority margin of 9% difference (relative risk, 0.89); for stent comparison, the rate of major adverse cardiac events, defined as the composite of death from any cause, reinfarction, and clinically driven target-vessel revascularization within 8 months. ST-segment resolution occurred in 302 of 361 patients (83.6%) who had received abciximab infusion and 308 of 361 (85.3%) who had received tirofiban infusion (relative risk, 1.020; 97.5% confidence interval, 0.958-1.086; P < .001 for noninferiority). Ischemic and hemorrhagic outcomes were similar in the tirofiban and abciximab groups. At 8 months, major adverse cardiac events occurred in 54 patients (14.5%) with uncoated stents and 29 (7.8%) with sirolimus stents (P = .004), predominantly reflecting a reduction of revascularization rates (10.2% vs 3.2%). The incidence of stent thrombosis was similar in the 2 stent groups. In patients with STEMI undergoing percutaneous coronary intervention, compared with abciximab, tirofiban therapy was associated with noninferior resolution of ST-segment elevation at 90 minutes following coronary intervention, whereas sirolimus-eluting stent implantation was associated with a significantly lower risk of major adverse cardiac events than uncoated stents within 8 months after intervention. clinicaltrials.gov Identifier: NCT00229515.JAMA The Journal of the American Medical Association 05/2008; 299(15):1788-99. · 30.03 Impact Factor -
Article: Impact of transverse aortic arch hypoplasia after surgical repair of aortic coarctation: an exercise echo and magnetic resonance imaging study.
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ABSTRACT: We sought to assess the impact of persistent hypoplasia of the transverse aortic arch (TAA) after repair of aortic coarctation (AoC), on blood pressure response to exercise, left ventricular (LV) hypertrophy and presence of collateral circulation. 34 consecutive patients with end-to-end repair of AoC (age at repair 3.2+/-2.5 years) underwent exercise echocardiography and magnetic resonance imaging (MRI) at 24+/-7 years of age (range 11.3 to 44.6 years). Systolic Doppler pressure gradient (SPG) across the descending aorta and blood pressure at the right arm were measured at baseline and every minute throughout all exercise. Magnetic resonance imaging was used to measure LV mass index, presence and amount of collateral flow, and the diameters of the aortic isthmus and TAA indexed to the diameter of the diaphragmatic. Aortic isthmus index was higher than that of the TAA (p=0.006). We observed LV hypertrophy in 15 patients (45%) and presence of collateral circulation in 14 (41%). Eighteen patients (53%) had an abnormal blood pressure response to exercise. Patients with abnormal pressure response to exercise had smaller TAA index (p=0.0005), but similar aortic isthmus index (p=0.09). They also had higher exercise SPG (p<0.0001), higher LV mass index (p<0.0001) and prevalence of LV hypertrophy (p=0.007), higher prevalence of collateral circulation (p<0.0001) and a higher amount of collateral flow (p<0.0001). TAA index, but not aortic isthmus index, correlated with exercise blood pressure (r=-0.59, p=0.003), exercise SPG (r=-0.70, p=0.0005), amount of collateral flow (r=-0.74, p=0.0002) and LV mass index (r=-0.68, p=0.0007). After repair of AoC, hypoplasia of the TAA may be responsible for abnormal blood pressure response to exercise, persistence of collateral circulation and LV hypertrophy.International journal of cardiology 07/2007; 119(1):21-7. · 7.08 Impact Factor -
Article: Transesophageal echocardiography-guided algorithm for stent-graft implantation in aortic dissection.
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ABSTRACT: Endovascular stent-graft placement is replacing traditional surgery in type B aortic dissection. Usually stent-graft implantation is performed under fluoroscopic and angiographic guidance, but this relatively new procedure is still burdened with some complications. We investigated the value of a developed algorithm based on transesophageal echocardiography (TEE) for guiding stent-graft implantation in type B aortic dissection. Forty-two patients with type B aortic dissection (chronic in 28 patients with aneurysmal dilatation of the false lumen, and acute complicated in 14 patients) underwent endovascular stent-graft reconstruction of the descending thoracic aorta. TEE was always performed after angiography. TEE-induced variations of the procedure, based on the algorithm, were compared with initial angiography-based decisions. TEE was decisive for guidewire repositioning (not possible with fluoroscopy) from the false to the true lumen in 3 patients and for correct guidewire entrance in an elephant trunk prosthesis in another patient. After stent-graft implantation color Doppler TEE enabled detection of proximal peri-stent leaks in 13 patients, whereas only 6 (46%) of the 13 leaks were detectable at angiography (P = .008). Most leaks were subsequently eliminated with balloon dilation or further stent grafting. Pulsed Doppler TEE was also useful for differentiating true leaks (13 patients) from Dacron porosity (7 patients). A pulsed-Doppler velocity cutoff value of 50 cm/s enabled differentiation of Dacron porosity (characterized by slow blood flow) from true peri-stent leak (fast flow). After stent-graft implantation TEE demonstrated new intimal tears in the thoracic aorta in 7 patients, whereas only 2 of the 7 new tears were detectable at angiography (P = .024); in 6 of 7 patients the new distal tears were subsequently resolved with placement of additional stents, whereas in a patient with Marfan syndrome new proximal tears determined a type I endoleak, which could not be resolved. Overall, TEE furnished decisive information additional to angiography in determining successful procedural changes in 16 of 42 patients (38%). There were no in-hospital deaths, and pre-discharge spiral computed tomograms showed a good outcome of stent-graft implantation in 37 of 42 patients (88%), with 5 residual type I endoleaks, all previously detected with TEE but impossible to eliminate with either balloon molding or further stent implantation. All but 2 patients (95%) are currently alive at mean follow-up of 30 +/- 18 months. TEE algorithm is an easy and useful tool in the operating room to guide correct stent-graft positioning in type B aortic dissection.Journal of Vascular Surgery 12/2004; 40(5):880-5. · 3.21 Impact Factor -
Article: Descending thoracic aortic diseases: stent-graft repair.
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ABSTRACT: To evaluate endovascular treatment of descending thoracic aorta with commercially available self-expanding stent-grafts. Seventy patients with aortic dissection, intramural hemorrhage, degenerative and posttraumatic aneurysm, penetrating atherosclerotic ulcer, and pseudoaneurysm underwent endovascular treatment. Eleven patients had impending rupture and were treated on an emergency basis. Stent-grafts were customized or selected on the basis of spiral computed tomographic (CT) or magnetic resonance (MR) imaging measurements. Preprocedure diagnostic angiography was performed in patients with aortic dissection and in other selected patients. All procedures were performed in an operating room and monitored with digital subtraction angiography (DSA) and transesophageal echocardiography (TEE). Follow-up was at 1, 3, 6, and 12 months after treatment and yearly thereafter. Stent positioning was technically successful in 68 cases. At DSA and TEE, complete aneurysm or false-lumen exclusion was achieved in 66 (97%) cases. No intraoperative mortality or complications occurred. In-hospital complications included transient monoparesis (one patient) and extension of dissection into ascending aorta (one patient) that was repaired surgically. Early endoleak was observed in five (7%) patients: In three (type 2), endoleak resolved spontaneously; in one (type 1), it was persistent; and in one (type 1), treatment was converted to surgery. At long term, one (1%) patient died of aortic rupture; another, of respiratory insufficiency. Five (7%) late endoleak (type 1, one caused by migration of the stent) cases were observed. In three (4%), endovascular treatment was successful; in two (3%), surgery was performed. In one patient with persistent postimplantation syndrome, treatment was converted to surgery after successful aneurysm sealing. Procedure failure (ie, aortic disease-related mortality or conversion to surgery) occurred in six (9%) patients. Endovascular stent-graft repair is less invasive in patients with chronic and acute descending thoracic aortic aneurysm and dissection.Radiology 11/2003; 229(1):176-83. · 5.73 Impact Factor -
Article: Drug-eluting stents in vascular intervention.
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ABSTRACT: CONTEXT: Restenosis is the most important long-term limitation of stent implantation for coronary artery disease, occurring in 15-60% of patients. In-stent restenosis, a refractory coronary lesion resulting from neointimal hyperplasia, challenges both vascular biologist and interventional cardiologist. Various drugs and devices have been used tried to overcome restenosis but are not particularly successful. Over 1500000 percutaneous coronary interventions are done annually. Restenosis is not only important clinically but also for its impact on health-care costs. STARTING POINT: Growth and migration of vascular smooth-muscle cells result in neointimal proliferation after vascular injury and are the key mechanism of in-stent restenosis. The rationale of the most recent approaches to restenosis (eg, brachytherapy and immunosuppressive agents) arises from the similarity between tumour-cell growth and the benign tissue proliferation which characterises intimal hyperplasia. Several immunosuppressants have been tested for their potential to inhibit restenosis, with the novel strategy of administering the drug via a coated stent platform. Local drug delivery achieves higher tissue concentrations of drug without systemic effects, at a precise site and time. The first multicentre trial with stents coated with sirolimus was by Marie-Claude Morice and colleagues (N Engl J Med 2002; 346: 1773-80). In a trial of 238 patients, restenosis of 50% or more at 6 months was 0% and 27% with sirolimus or normal stents (p<0.001), respectively, after percutaneous revascularisation. Muzaffer Degertekin and colleagues (Circulation 2002; 106: 1610-13) present data on 2-year follow-up of 15 patients who had been implanted with the sirolimus stent in another study, and confirm persistent inhibition of restenosis and an absence of unexpected adverse events. WHERE NEXT? Local application of antiproliferative agents is a promising technique and research is developing. Other agents with potential benefits (eg, statins, local gene-therapy, adenovirus-mediated arterial gene-transfer, L-arginine, abciximab, angiopeptin, recombinant pegylated hirudin, and hiloprost) as well as improvements in polymer technology (biodegradable smart polymers, coatings for multiple-drug release) are under evaluation. The clinical impact of the elimination of restenosis may influence the approach to coronary artery disease, the future of cardiac surgery, and health-care economics in cardiology.The Lancet 01/2003; 361(9353):247-9. · 38.28 Impact Factor
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- International journal of cardiology (2)
- Metabolism (1)
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- The Lancet (1)
- Journal of Vascular Surgery (1)
Institutions
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2003
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University of Bologna
- Institute of Cardiology
Bologna, Emilia-Romagna, Italy
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