Papers by Giuseppe Colonna
Journal of the American College of Cardiology, 2009
This study was designed to investigate whether an acute atorvastatin reload before percutaneous c... more This study was designed to investigate whether an acute atorvastatin reload before percutaneous coronary intervention (PCI) protects patients receiving chronic statin therapy from periprocedural myocardial damage. Background Previous ARMYDA (Atorvastatin for Reduction of Myocardial Damage During Angioplasty) studies demonstrated that short-term pre-treatment with atorvastatin reduces myocardial infarction during PCI in statin-naïve patients with both stable angina and acute coronary syndromes. Methods A total of 383 patients (age 66 Ϯ 10 years, 305 men) with stable angina (53%) or non-ST-segment elevation acute coronary syndromes (47%) and chronic statin therapy (55% atorvastatin) undergoing PCI were randomized to atorvastatin reload (80 mg 12 h before intervention, with a further 40-mg pre-procedural dose [n ϭ 192]) or placebo (n ϭ 191). All patients received long-term atorvastatin treatment thereafter (40 mg/day). The primary end point was 30-day incidence of major adverse cardiac events (cardiac death, myocardial infarction, or unplanned revascularization). Results The primary end point occurred in 3.7% of patients treated with atorvastatin reload and in 9.4% in the placebo arm (p ϭ 0.037); this difference was mostly driven by reduction in periprocedural myocardial infarction. There was lower incidence of post-procedural creatine kinase-myocardial band and troponin-I elevation greater than the upper limit of normal in the atorvastatin arm (13% vs. 24%, p ϭ 0.017, and 37% vs. 49%, p ϭ 0.021, respectively). Multivariable analysis identified atorvastatin reload as a predictor of decreased risk of 30-day incidence of major adverse cardiac events (odds ratio: 0.50, 95% confidence interval: 0.20 to 0.80; p ϭ 0.039), mainly in patients with acute coronary syndromes (82% relative risk reduction; p ϭ 0.027). Conclusions The ARMYDA-RECAPTURE trial suggests that reloading with high-dose atorvastatin improves the clinical outcome of patients on chronic statin therapy undergoing PCI. These findings may support a strategy of routine reload with high-dose atorvastatin early before intervention even in the background of chronic therapy.
Giornale italiano di cardiologia, 2015
European Heart Journal. Acute Cardiovascular Care, 2021
Aims To report the incidence, the predictors and clinical impact of device-related complications ... more Aims To report the incidence, the predictors and clinical impact of device-related complications (DRCs) in the IMP-IT (IMPella Mechanical Circulatory Support Device in Italy) registry. Impella is percutaneous left ventricular assist devices, which provides mechanical circulatory support both in cardiogenic shock (CS) and high-risk percutaneous coronary intervention (HR-PCI). The IMP-IT registry is a multicentre registry evaluating the trends in use and clinical outcomes of Impella in Italy. Methods and results A total of 406 patients have been included in this registry: 56.4% in the setting of CS, while 43.6% patients in the setting of HR-PCI. DRCs were defined as a composite endpoint of access-site bleeding, limb ischaemia, vascular complication requiring treatment, haemolysis, aortic injury, and left ventricular perforation. DRC incidence in the overall population was 25.6%, with significantly higher rate in the CS (37.1%) than in the HR-PCI (10.7%) group. The most frequent compli...
Heart, 2021
ObjectiveThe study was designed to: (1) confirm safety and feasibility of mini-invasive radial ba... more ObjectiveThe study was designed to: (1) confirm safety and feasibility of mini-invasive radial balloon aortic valvuloplasty (BAV); (2) assess its impact in terms of quality of life and frailty; and (3) evaluate whether changes in frailty after BAV are associated with death in patients undergoing transcatheter aortic valve implantation (TAVI).Methods330 patients undergoing BAV in 16 Italian centres were prospectively included. The primary endpoint was the occurrence of major and minor Valve Academic Research Consortium (VARC)-2 bleeding. Secondary endpoints were scales of quality of life, frailty, evaluated at baseline and 30 days, and their relationship with the occurrence of all-cause death.ResultsBAV was performed by radial access in 314 (95%) patients. No VARC-2 major and six (1.8%) VARC-2 minor bleedings occurred in the study population. Quality of life, as well as frailty status, significantly improved 30 days after BAV. At 1 year, patients undergoing TAVI with baseline essenti...
EuroIntervention, 2020
Aims: The aim of this study was to investigate nationwide trends and clinical outcomes of the Imp... more Aims: The aim of this study was to investigate nationwide trends and clinical outcomes of the Impella device for cardiogenic shock (CS) and high-risk percutaneous coronary intervention (HR-PCI). Methods and results: The IMP-IT study was a multicentre observational national registry which enrolled all patients treated with Impella 2.5, Impella CP, Impella 5.0 and Impella RP, both for CS and HR-PCI indications, across 17 Italian centres from 2004 to June 2018. A total of 406 patients were included: 229 had CS (56.4%) and 177 underwent HR-PCI (43.6%). The use of Impella increased significantly during the study period (average annual percent change 39.8%, 95% confidence interval: 30.4 to 49.9; p<0.0001) for both indications. The Impella 2.5 was the most commonly used device (N=242; 59.6%). Rates of in-hospital and one-year all-cause death in patients with CS were 46.9% and 57.0%, respectively; 18.5% underwent left ventricular assist device implantation or heart transplant at one year. Rates of in-hospital and one-year allcause death in patients who underwent HR-PCI were 5.7% and 15.6%, respectively. Rates of device-related complications were 37.1% and 10.7% in the setting of CS and HR-PCI, respectively. Conclusions: Use of the Impella for CS and HR-PCI is increasing substantially in Italy, despite relatively high rates of device-related complications.
Giornale italiano di cardiologia (2006), 2015
Giornale italiano di cardiologia, 1997
An abnormal stimulation of adenosine A1-receptors has been suggested to play a role in the pathog... more An abnormal stimulation of adenosine A1-receptors has been suggested to play a role in the pathogenesis of both chest pain and ischemia-like electrocardiographic changes in patients with syndrome X and a nonselective adenosine antagonist (theophylline) has been reported to be beneficial in these patients. In this study we investigated the acute effects of bamiphylline, a specific A1-receptor antagonist, in 16 patients with syndrome X (14 women, age 57 +/- 6 years), with both angina and ST-segment depression inducible during exercise testing. All patients underwent two treadmill exercise tests (Bruce modified protocol) on 2 separate days, 5 minutes after the end of randomized intravenous infusion of either placebo (saline solution) or bamiphylline (300 mg). Severity of chest pain was assessed by a 100 mm visual analogic scale. There were no significant differences in resting heart rate and blood pressure after bamiphylline or placebo. Rate-pressure product (20 600 +/- 5000 vs 20 200 ...
Journal of Cardiovascular Medicine, 2011
ARMYDA-2 (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) trial demon... more ARMYDA-2 (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) trial demonstrated improved clinical outcome in patients undergoing percutaneous coronary intervention (PCI) pretreated with 600 vs. 300 mg clopidogrel loading dose. ARMYDA-2 SELECT is a prospectively planned subanalysis to investigate the effects of those different loading regimens on P-selectin levels. From the ARMYDA-2 population, we investigated a subgroup of 84 patients (41 randomized to a 600 mg and 43 to a 300 mg clopidogrel loading dose given at a mean time of 6 h before PCI), in whom soluble P-selectin levels were measured at baseline (at the time of clopidogrel administration), immediately after the procedure, and after 8 and 24 h. In the overall study population, a significant decrease of P-selectin levels was observed from baseline to intervention (from 91 ± 10 to 53 ± 15 ng/ml; P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001). Baseline P-selectin levels were similar in the two groups, whereas at the time of intervention they were significantly lower in the high-dose arm (50 ± 13 vs. 58 ± 15 ng/ml; P = 0.048). P-selectin values between the two arms were not different at the subsequent determinations. The lowest procedural P-selectin levels were observed in patients of the 600 mg arm who had no postprocedural increase of troponin-I above normal limits (P ≤ 0.040). Pretreatment with clopidogrel before PCI decreases peri-procedural P-selectin levels; moreover, a 600 mg clopidogrel loading dose, compared with the 300 mg regimen, is associated with reduction of peri-procedural myocardial damage and significant attenuation of P-selectin levels at the time of intervention. These results may help in identifying mechanisms underlying clinical benefit of the high clopidogrel load in PCI.
Journal of the American College of Cardiology, 2011
The purpose of this study was to compare 600-and 300-mg clopidogrel loading doses in patients wit... more The purpose of this study was to compare 600-and 300-mg clopidogrel loading doses in patients with STsegment elevation myocardial infarction (STEMI). Background Given the high thrombotic risk of patients with STEMI, greater platelet inhibition may improve outcome in those patients receiving percutaneous coronary intervention (PCI). Although observational data suggest that pretreatment with a 600-mg clopidogrel loading dose may be more effective than the 300-mg regimen in primary PCI, this hypothesis has never been tested in a randomized study. Methods A total of 201 patients undergoing primary PCI for STEMI randomly received a 600-mg (n ϭ 103) or 300-mg (n ϭ 98) clopidogrel loading dose before the procedure. The primary endpoint was the evaluation of the infarct size, defined as the area under the curve of cardiac markers. Results Infarct size was significantly lower in the high-dose regimen: median creatine kinase-myocardial band 2,070 ng/ml (interquartile range [IQR]: 815 to 2,847 ng/ml) versus 3,049 ng/ml (IQR: 1,050 to 7,031 ng/ml) in the 300-mg group, p ϭ 0.0001; troponin-I 255 ng/ml (IQR: 130 to 461 ng/ml) versus 380 ng/ml (IQR: 134 to 1,406 ng/ml), p Ͻ 0.0001. In the 600-mg arm, Thrombolysis In Myocardial Infarction flow grade Ͻ3 after PCI was less frequent (5.8% vs. 16.3%, p ϭ 0.031), left ventricular ejection fraction at discharge was improved (52.1 Ϯ 9.5% vs. 48.8 Ϯ 11.3%, p ϭ 0.026), 30-day major adverse cardiovascular events were fewer (5.8% vs. 15%, p ϭ 0.049), and bleeding/entry site complications were not increased (secondary endpoints). Conclusions In STEMI patients, pre-treatment with a 600-mg clopidogrel loading dose before primary PCI was associated with a reduction of the infarct size compared with a 300-mg loading dose, as well as with improvement of angiographic results, residual cardiac function, and 30-day major adverse cardiovascular events; further studies are warranted to evaluate impact of such strategy on survival.
Journal of the American College of Cardiology, 1995
Despite growing interest and a large body of studies on syndrome X (anginal chest pain and angiog... more Despite growing interest and a large body of studies on syndrome X (anginal chest pain and angiographically normal coronary arteries), there are no data concerning the respective diagnostic value of exercise testing (ExT) and ambulatory Holter monitoring (HM) in revealing ischemic ST-segment changes in these patients. To address this problem, we performed ExT and 24-hour HM, off therapy, in 38 syndrome X patients (27 women, age 54 ± 8 years). ExT showed ST-segment depression (STd) in 28 patients (74% Group 1), whereas it was normal in 10 patients (26%, Group 2). Anginal chest pain during ExT was reported by 10 patients (36%) of Group 1 and 9 patients (90%) of Group 2 (p l 0.01). On the other hand, STd episodes were detected on HM in 22 patients (59%), 17 (61%) of whom belonging to Group 1 and 5 (50%) to Group 2 (p = NS). On the whole, 129 STd episodes, 14 (11%) of which associated to anginal pain, were found in the 22 patients (mean 5.8 ± 4.6 episodes/patient). A total of 21 STd episodes (5 associated to anginal pain) were detected on HM in the 5 patients with negative ExT (mean 4.3 ± 3.5 episodes/patient, range 1–10). In these 5 patients, heart rate at 1 mm STd during HM was significantly lower than that achieved at peak exercise during ExT (111 ± 19 vs. 136 ± 22 bpm, p = 0.01). The prevalence of positive HM in patients with negative ExT in our syndrome X patients was significantly higher than that observed in an unselected group of 76 patients with stable angina, significant coronary artery disease and negative ExT (50% vs 8%, p l 0.01). Thus, our data show that HM, with respect to ExT, has a significant additional diagnostic value in revealing the occurrence of ischemic ST-segment changes in patients with syndrome X. These findings also support the hypothesis that a microvascular vasoconstriction, rather than an impaired vasodilation, plays a major role in the pathophysiologic mechanisms leading to transient ischemia in these patients.
Journal of the American College of Cardiology, 2010
This study sought to evaluate safety and effectiveness of in-laboratory (in-lab) 600-mg clopidogr... more This study sought to evaluate safety and effectiveness of in-laboratory (in-lab) 600-mg clopidogrel loading prepercutaneous coronary intervention (PCI) versus routine 6-h pre-load.
Journal of the American College of Cardiology, 1998
i or1 gr2 p early repedusion (%) 100 70 NS lime ol CK pock (h,)ur~) 10 S I 3 tl t. 3 N8 CK po~k (... more i or1 gr2 p early repedusion (%) 100 70 NS lime ol CK pock (h,)ur~) 10 S I 3 tl t. 3 N8 CK po~k (UI/I) 4307 t 3471 2449 t: 2137-0,05 vlllbltity (%) 3S L 20 40 .t 20% 0:07 recovrm/(%) 16 :I: 20 03 ± 20%-;0,05 Conch~,,~ions: Pie elected to PTCA have a granter likelihood of achieving early repodtmlen, However, In spite of that, percent mducllon of Infaml site ~nd the early recovery wore significantly lose tl~nn in pie undergoing thmmbolysls, Furthermore, we observed n trend towards lesser residual vl~bllty, The dol~y of treatment anent Is n critical factor which has to be carefully c0ostdomd bolero choosing dPTCA, A greater mpedusioo damage caused by abrupt mfl~w may also piny n role,
Journal of the American College of Cardiology, 2013
Benefits of high clopidogrel reloading in patients with acute coronary syndrome (ACS) on patients... more Benefits of high clopidogrel reloading in patients with acute coronary syndrome (ACS) on patients undergoing percutaneous coronary intervention (PCI) in the setting of chronic clopidogrel therapy are not well established. 242 patients on chronic clopidogrel therapy with non-ST-segment elevation
International Journal of Cardiology, 2014
International Journal of Cardiology, 2009
Background: Transradial access (RA) is associated with less complications and is preferred by pat... more Background: Transradial access (RA) is associated with less complications and is preferred by patients. Vascular closure devices (VCDs) may improve discomfort and may reduce complications associated with transfemoral access. Aim was to evaluate complications and discomfort associated with percutaneous coronary procedures employing RA or VCDs. Methods: We enrolled 1492 consecutive patients who underwent percutaneous coronary procedures with RA (604 procedures), femoral approach with manual compression (MC) (276 procedures), or with either Angioseal™ (311 procedures) or Starclose™ (301 procedures) closure device. Discomfort was assessed using procedure-specific questions. Major vascular complications were evaluated during hospitalization. Results: RA significantly reduced major complications (0.7%) compared to either the MC (2.9%, p = 0.03) or the VCDs (Starclose™ 2.7%, Angioseal™ 3.9%, p = 0.003). There were no significant differences in major complications between MC and either the Angioseal™ or the Starclose™. At multivariate analysis the RA was predictor of reduced complications (OR 0.26, 95% CI 0.08-0.85, p = 0.03 vs MC, and OR 0.19, 95% CI 0.07-0.57, p = 0.003 vs VCDs). The RA was associated with a significant reduction in procedural discomfort with 44.2% of patients referring no discomfort (p b 0.0001). Starclose™ and Angioseal™ were better tolerated than MC (27.8%, 29.3% and 8.9% patients respectively without discomfort, p b 0.0001). Conclusions: RA is associated with a significant reduction in major vascular complications compared to femoral approach even if two different VCDs are employed. VCDs are better tolerated than MC but the RA was associated with the lowest discomfort.
Circulation, 2005
Background— Aggressive platelet inhibition is crucial to reduce myocardial injury and early cardi... more Background— Aggressive platelet inhibition is crucial to reduce myocardial injury and early cardiac events after coronary intervention. Although observational data have suggested that pretreatment with a high loading dose of clopidogrel may be more effective than a conventional dose, this hypothesis has never been tested in a randomized trial. Methods and Results— A total of 255 patients scheduled to undergo percutaneous coronary intervention were randomized to a 600-mg (n=126) or 300-mg (n=129) loading regimen of clopidogrel given 4 to 8 hours before the procedure. Creatine kinase MB, troponin I, and myoglobin levels were measured at baseline and at 8 and 24 hours after intervention. The primary end point was the 30-day occurrence of death, myocardial infarction (MI), or target vessel revascularization. The primary end point occurred in 4% of patients in the high loading dose versus 12% of those in the conventional loading dose group ( P =0.041) and was due entirely to periprocedur...
The American Journal of Cardiology, 2012
Bivalirudin, a direct thrombin inhibitor, is as effective as unfractionated heparin (UFH), with d... more Bivalirudin, a direct thrombin inhibitor, is as effective as unfractionated heparin (UFH), with decreased bleeding in patients with acute coronary syndromes who undergo percutaneous coronary intervention (PCI). The aim of this study was to evaluate the effectiveness of bivalirudin versus UFH in selected PCI patients at high bleeding risk. Four hundred one consecutive patients who underwent PCI fulfilling >1 enrollment criterion (age >75 years, chronic renal failure, and diabetes mellitus) were randomized to bivalirudin (bolus 0.75 mg/kg followed by infusion during the procedure; n ؍ 198) or UFH (75 IU/kg; n ؍ 203). In the overall population, 39% were aged >75 years, 22% had renal failure, 63% had diabetes, and 29% had acute coronary syndromes. The primary efficacy end point was the 30-day incidence of major adverse cardiac events (cardiac death, myocardial infarction, stent thrombosis, or target vessel revascularization). The primary safety end point was the occurrence of any bleeding or entry-site complications after PCI. All patients were preloaded with clopidogrel 600 mg. Glycoprotein IIb/IIIa inhibitors were used at the operators' discretion. Thirty-day major adverse cardiac event rates were 11.1% in the bivalirudin group and 8.9% in the UFH group (p ؍ 0.56); the primary efficacy end point was reached mainly because of periprocedural myocardial infarction; 1 patient in the bivalirudin group had stent thrombosis. Occurrence of the primary safety end point was 1.5% in the bivalirudin group and 9.9% in the UFH group (p ؍ 0.0001); this benefit was essentially driven by the prevention of entry-site hematomas >10 cm (0.5% vs 6.9%, p ؍ 0.002). In conclusion, Anti-Thrombotic Strategy for Reduction of Myocardial Damage During Angioplasty-Bivalirudin vs Heparin (ARMYDA-7 BIVALVE) indicates that bivalirudin, compared with UFH, causes significantly lower bleeding and has a similar incidence of major adverse cardiac events in patients with older age, diabetes mellitus, or chronic renal failure who undergo PCI.
The American Journal of Cardiology, 2013
Whether an additional clopidogrel load in patients receiving chronic clopidogrel therapy and unde... more Whether an additional clopidogrel load in patients receiving chronic clopidogrel therapy and undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) is associated with clinical benefit has not been well characterized. The aim of the present study was to evaluate, in a randomized protocol, the safety and effectiveness of clopidogrel reload for patients with ACS undergoing PCI in the background of chronic clopidogrel therapy. A total of 242 patients with non-ST-segment elevation ACS with &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;10 days of clopidogrel therapy randomly received a 600-mg loading dose of clopidogrel 4 to 8 hours before PCI (n = 122) or placebo (n = 120). The primary end point was the 30-day incidence of major adverse cardiac events (death, myocardial infarction, target vessel revascularization). The primary end point occurred in 4.1% of patients in the reload arm versus 14.1% in the placebo arm (odds ratio 0.26, 95% confidence interval 0.10 to 0.73, p = 0.013). This benefit in the reload arm was mainly from the prevention of periprocedural myocardial infarction (4.1% vs 13%, p = 0.02) and was paralleled by lower periprocedural platelet reactivity. The aggregometry data were consistent with the clinical outcome. No difference was found in the bleeding outcomes between the 2 groups. In conclusion, the results from the Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty (ARMYDA-8 RELOAD-ACS) trial have shown a significant clinical benefit from reloading patients with ACS receiving chronic clopidogrel therapy before PCI. These data might be relevant in clinical practice, given the large number of patients with ACS who are still currently treated with clopidogrel during PCI.
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Papers by Giuseppe Colonna