Raffaele Piccolo

Echocardiographic Correlates of Acute Heart Failure, Cardiogenic Shock, and In-Hospital Mortality in Tako-Tsubo Cardiomyopathy

OBJECTIVESnThe purpose of this study was to determine clinical and echocardiographic correlates of acute heart failure, cardiogenic shock and in-hospital mortality in a large cohort of tako-tsubo cardiomyopathy (TTC) patients.nnnBACKGROUNDnDespite good long-term prognosis, life-threatening complications due to hemodynamic instability can occur early in TTC patients.nnnMETHODSnThe study population consisted of 227 patients (66.2 ± 12.2 years of age; females, 90.3%) enrolled in the Tako-tsubo Italian Network, undergoing transthoracic two-dimensional echocardiography on admission and at short-term follow-up (4.3 [4 to 6] weeks). Patients were divided into two groups according to the presence or absence of major adverse events, a composite of acute heart failure, cardiogenic shock, and in-hospital mortality.nnnRESULTSnMajor adverse events occurred in 59 patients (25.9%). The variables for elderly patients ≥ 75 years of age (42.4% vs. 23.8%; p = 0.011): left ventricular (LV) ejection fraction (35.1 ± 5.9% vs. 38.4 ± 4.6%, p < 0.001), wall motion score index (1.9 ± 0.2 vs. 1.7 ± 0.2, p < 0.001), E/e ratio (13.5 ± 4.3 vs. 9.9 ± 3.3 [where E/e is ratio of mitral E peak velocity and averaged e velocity], p < 0.001), LV outflow tract obstruction (23.7 vs. 8.9%, p = 0.006), pulmonary artery systolic pressure (47.4 ± 12.3 mm Hg vs. 38.0 ± 9.2 mm Hg; p < 0.001), right ventricular involvement (28.8 vs. 9.5%; p < 0.001), and reversible moderate-to-severe mitral regurgitation (49.1 vs. 11.9%; p < 0.001), were significantly different between groups and were associated with adverse events. At multivariate analysis, LV ejection fraction (HR: 0.92; 95% CI: 0.89 to 0.95; p < 0.001), E/e ratio (HR: 1.13; 95% CI: 1.02 to 1.24; p = 0.011), reversible moderate to severe mitral regurgitation (HR: 3.25; 95% CI: 1.16 to 9.10; p = 0.025), and age ≥ 75 years (HR: 2.81; 95% CI: 1.05 to 7.52; p = 0.039) were independent correlates of major adverse events.nnnCONCLUSIONSnEchocardiographic parameters provide additional information compared to other variables routinely used in clinical practice to identify patients at higher risk of hemodynamic deterioration and poor in-hospital outcome, allowing prompt institution of appropriate pharmacological treatment and adequate mechanical support.

Effect of drug-eluting stents in patients with acute ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention: a meta-analysis of randomised trials and an adjusted indirect comparison

AIMSnThe role of drug-eluting stent (DES) remains an unsettled issue in patients with ST-segment elevation myocardial infarction (STEMI). Therefore, we performed a meta-analysis of randomised trials to evaluate the clinical outcome of DES as compared with bare-metal stent (BMS) after percutaneous coronary intervention (PCI).nnnMETHODS AND RESULTSnWe undertook a literature search until July 2009. Thirteen clinical trials met inclusion criteria, with 7,244 patients enrolled. Up to 1-year, patients treated with DES as compared with BMS experienced less target-vessel revascularisation (TVR) (5.11% versus 11.19% respectively, p<0.00001) and recurrent myocardial infarction rates (3.03% versus 3.70% respectively, p=0.02). In addition, no significant differences were found in terms of cardiac death (2.80% versus 3.52%, p=0.21) and stent thrombosis (2.65% versus 2.76%, p=0.37). Using the adjusted indirect comparison, a significant difference between sirolimus- and paclitaxel-eluting stent was found when TVR was evaluated (OR [95% CI] =0.59 [0.40-0.89], p=0.01), without differences in other clinical outcomes.nnnCONCLUSIONSnIn patients undergoing PCI for STEMI, treatment with DES is associated with decreased TVR and myocardial infarction rates, without increasing cardiac death or stent thrombosis occurrence. Sirolimus-eluting stent is associated with a greater TVR reduction as compared to paclitaxel-eluting stent.

Twelve-month clinical outcomes of everolimus-eluting stent as compared to paclitaxel- and sirolimus-eluting stent in patients undergoing percutaneous coronary interventions. A meta-analysis of randomized clinical trials

BACKGROUNDnIt is well established that both PES and SES reduce the need for reintervention as compared with bare-metal stents. Whether everolimus-eluting stent (EES) a second-generation drug-eluting stent, further improves clinical outcomes compared to PES and SES still remains uncertain. The aim of this study was to perform a meta-analysis of randomized trials evaluating safety and efficacy of EES compared with paclitaxel- (PES) and sirolimus-eluting stent (SES), in patients undergoing percutaneous coronary intervention (PCI).nnnMETHODSnWe undertook a literature search using Medline, EMBASE, the Cochrane Central Register of Controlled Trials, scientific session abstracts and relevant websites, until August 2010. Included studies comprised randomized trials evaluating EES vs PES/SES, in patients undergoing PCI, at 1-year follow-up.nnnRESULTSnFive studies, enrolling 8058 patients, were included. At 12-month follow-up, patients treated with EES, as compared with PES/SES, experienced lower target-lesion revascularization (OR [95% CI] = 0.56 [0.45-0.70], p<0.00001) and myocardial infarction rates (OR [95% CI] = 0.57 [0.43-0.77], p = 0.0002), without difference in mortality (OR [95% CI] = 0.88 [0.62-1.24], p = 0.46). A trend towards lower stent thrombosis rates in favour of EES vs PES/SES was found (OR [95% CI] = 0.45 [0.20-1.01], p = 0.05). However, after the exclusion of SES, EES significantly reduced stent thrombosis as compared with PES (OR [95% CI] = 0.35 [0.14-0.86], p = 0.02).nnnCONCLUSIONSnAt 12-month follow-up, treatment with EES is associated with decreased target-lesion revascularization and myocardial infarction rates, without differences in mortality, as compared with PES/SES. EES vs PES/SES use is associated with a trend towards lower stent thrombosis rates. Moreover, EES significantly reduce stent thrombosis with respect to PES.

Is direct stenting superior to stenting with predilation in patients treated with percutaneous coronary intervention? results from a meta-analysis of 24 randomised controlled trials

Background In the last decade, direct stenting has been proposed as an alternative strategy to conventional stenting with balloon predilation. The aim of this study was to perform a meta-analysis of randomised trials comparing a direct stenting strategy versus a conventional one. Methods A literature search was performed using Medline, EMBASE, the Cochrane Central Register of Controlled Trials, scientific session abstracts and relevant websites, from inception of each database to June 2009. Included studies comprised randomised controlled trials evaluating direct versus conventional stenting in patients undergoing percutaneous coronary intervention. Primary endpoint was the composite of death or myocardial infarction and secondary endpoints were myocardial infarction and target-vessel revascularisation occurrence. Results 24 trials met inclusion criteria, with 6803 patients enrolled (3412 or 50.15% randomised to direct stenting and 3391 or 49.85% randomised to conventional stenting). Up to 6-month follow-up, the composite of death or myocardial infarction was significantly reduced with direct stenting compared with conventional stenting (3.95% versus 5.10% respectively, OR=0.76 (95% CI 0.60 to 0.96), p=0.02). This reduction was primarily driven by a lower myocardial infarction occurrence (3.16% versus 4.04%, respectively, OR=0.77 (0.59 to 0.99), p=0.04). Furthermore, direct stenting was not associated with a reduction in target-vessel revascularisation (6.50% versus 6.96%, respectively, OR=0.92 (0.76 to 1.12), p=0.42). Conclusion This meta-analysis demonstrates that, in selected coronary lesions, direct stenting improves outcome in patients undergoing percutaneous coronary intervention, primarily reducing myocardial infarction incidence.

Effect of an Invasive Strategy on Outcome in Patients ≥75 Years of Age With Non-ST-Elevation Acute Coronary Syndrome

The Italian Elderly ACS study was the first randomized controlled trial comparing an early aggressive with an initially conservative strategy in patients with non-ST-segment elevation acute coronary syndromes aged ≥75 years, with the results showing no significant benefit of early aggressive therapy. The aim of this study was to evaluate the outcomes of trial patients, according to the treatment actually received during hospitalization. The trial enrolled 313 patients. The primary end point was the composite of death, myocardial infarction (MI), disabling stroke, and repeat hospital stay for cardiovascular causes or bleeding within 1 year. All patients in whom coronary angiography was performed during initial hospitalization were defined as having undergone invasive treatment (182 patients), whereas all patients who did not undergo coronary angiography were classified as medically managed (conservative treatment [CT] group, 131 patients). The primary end point occurred in 53 patients (40.5%) in the CT group and 45 patients (24.7%) in the invasive treatment group (hazard ratio 0.56, 95% confidence interval 0.37 to 0.83, pxa0= 0.003). The invasive treatment group showed significantly lower rates of MI (6% vs 13% in the CT group; hazard ratio 0.43, 95% confidence interval 0.20 to 0.92, pxa0= 0.034) and the aggregate of death and MI (14.3% vs 27.5% CT group; hazard ratio 0.48, 95% confidence interval 0.29 to 0.81, pxa0= 0.004). In conclusion, elderly patients with non-ST-segment elevation acute coronary syndromes treated invasively experienced significantly better survival free from the composite of all-cause mortality, nonfatal MI, disabling stroke, and repeat hospitalization for cardiovascular causes or bleeding.

Intracoronary versus intravenous bolus abciximab administration in patients undergoing primary percutaneous coronary intervention with acute ST-elevation myocardial infarction: a pooled analysis of individual patient data from five randomised controlled trials

AIMSnIn recent years, intracoronary bolus abciximab has emerged as an alternative to the standard intravenous route in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). The aim of the current study was to perform an individual patient-level pooled analysis of randomised trials, comparing intracoronary versus intravenous abciximab bolus use in STEMI patients undergoing primary PCI.nnnMETHODS AND RESULTSnIndividual data of 3,158 patients enrolled in five trials were analysed. Reperfusion endpoints were: post-procedural Thrombolysis in Myocardial Infarction (TIMI) 3 flow, myocardial blush grade (MBG) 2/3 and complete ST-segment resolution. The primary clinical endpoint of interest was the composite of death and reinfarction at 30 days. Compared with the intravenous route, intracoronary abciximab bolus administration did not improve TIMI 3 flow (odds ratio [OR] 1.19; 95% confidence interval [CI]: 0.90-1.59; p=0.23) and complete ST-segment resolution (OR 1.22, 95% CI: 0.92-1.63, p=0.17), but increased MBG 2/3 occurrence (OR 1.83, 95% CI: 1.05-3.18, p=0.03). At 30-day follow-up, intracoronary bolus abciximab did not reduce the risk of death and reinfarction (OR 0.78, 95% CI: 0.55-1.10, p=0.16), death (OR 0.77, 95% CI: 0.51-1.17, p=0.22), reinfarction (OR 0.79, 95% CI: 0.46-1.33, p=0.38) and stent thrombosis (OR 0.77, 95% CI: 0.43-1.35, p=0.36) as compared with intravenous administration.nnnCONCLUSIONSnIn STEMI patients undergoing primary PCI, intracoronary abciximab does not provide additional benefits as compared with standard intravenous treatment and, therefore, it should not be recommended as the default route of administration in this setting.

Antiplatelet theRapy after Genous EPC-capturing coroNary stenT implantatiOn The ARGENTO Study: a prospective, multicenter registry

BACKGROUNDnTo investigate the safety and efficacy of Genous Bio-engineered R stent (GRS) with ≤ 15-day or >15-day dual antiplatelet therapy (DAT), in patients undergoing percutaneous coronary intervention (PCI), with known or expected low compliance to long-term DAT (Antiplatelet theRapy after Genous EPC-capturing coroNary stenT implantatiOn--ARGENTO study).nnnMETHODSnConsecutive patients without ≤ 12-month revascularization history, known statins allergy, known hypersensitivity reaction or previous or concomitant monoclonal and/or recombinant antibodies therapy, treated with single- or multivessel PCI plus GRS, were prospectively enrolled, at four PCI centers. Major adverse cardiac events (MACEs), the composite of cardiac death, any myocardial infarction (MI) and target vessel revascularization (TVR), and stent thrombosis (ST) cumulative incidences were evaluated.nnnRESULTSnBetween March 2008 and March 2010, 384 patients (70.3% male, 423 lesions) were enrolled. At follow-up (22.8 ± 13.6 months), 8.6% MACEs, 3.4% cardiac death, 3.4% any MI, 4.7% TVR and 2.3% overall ST (definite/probable ST 1.3%) rates were reported, without differences between ≤ 15-day and >15-day DAT groups. At Cox multivariable-adjusted regression analysis (Hosmer-Lemeshow statistic, p=0.50) female sex, diabetes, previous PCI history, <45% left ventricular ejection fraction at admission and lesion length were identified as independent MACE predictors. DAT time duration (hazard ratio 1.98; 95% confidence interval 0.57-6.80, p=0.27) was not independent risk factor for MACEs.nnnCONCLUSIONSnIn consecutive, prospectively enrolled patients with PCI indication and known or supposed low compliance to long-term DAT, GRS implantation might be a safe and effective option regardless of DAT duration after stenting (≤ 15 days or >15 days).

Intracoronary abciximab in diabetic patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention

BACKGROUNDnAlthough intracoronary abciximab failed to improve prognosis compared with intravenous route in unselected ST-segment elevation myocardial infarction (STEMI) patients, little is known about the role of intracoronary abciximab in diabetic patients.nnnOBJECTIVESnTo evaluate the efficacy of intracoronary abciximab administration in diabetic patients with STEMI undergoing primary percutaneous coronary intervention (PCI).nnnMETHODSnReperfusional and clinical outcomes of intracoronary abciximab compared with intravenous bolus abciximab according to diabetic status were evaluated in a pooled analysis of five randomized trials including 3158 STEMI patients. The primary clinical endpoint of the study was the composite of death or reinfarction at 30-day follow-up.nnnRESULTSnAmong 584 diabetic patients (18.5%), the composite of death or reinfarction was significantly reduced with intracoronary abciximab compared to intravenous abciximab (4.7% vs. 8.8%; rate ratio [RR], 0.50; 95% confidence intervals [CI], 0.26-0.99; p=0.04), driven by numerically lower deaths (3.7% vs. 6.4%; RR, 0.56; 95% CI, 0.26-1.20; p=0.13). Moreover, a significant reduction in definite or probable stent thrombosis was observed in patients receiving intracoronary abciximab (1% vs. 3.5%; RR, 0.27; 95% CI, 0.07-0.99; p=0.04). Although formal tests for interaction were not significant, no clinical benefit was apparent in the cohort of STEMI patients without diabetes (n=2574).nnnCONCLUSIONSnIn diabetic patients with STEMI undergoing primary PCI, intracoronary abciximab may improve clinical outcomes as compared with standard intravenous use. These findings require confirmation in a dedicated randomized trial.

Everolimus- versus first generation drug-eluting stents: the never-ending story of searching for a winner in the “limus family”

We read with great interest the Letter to the Editor by Kun Liu and Honglin Chen [1] aiming to update the study-level meta-analysis reporting of 1-year clinical outcomes of everolimus-eluting stent (EES) as compared to paclitaxeland sirolimus-eluting stent (PES/ SES) in patients undergoing percutaneous coronary interventions, that we recently published on the International Journal of Cardiology [2]. Even we recognize the relevance of the comments received, there are several issues that need to be pointed out. As first, we disagree regarding the “heterogeneity” among clinical outcomes of the selected trials that would contraindicate the combined SES/PES evaluation as compared to EES. Consistently with the supplementary data (Table 1) embedded with the published meta-analysis [2], primary endpoints were considered according to per protocol definitions that were substantially identical for all trials. Furthermore, the risk of bias assessing the reproducibility of the data analyses and interpretation (including the incomplete data outcome or the selective outcome reporting), as well as the interobserver agreement in trials selection, were carefully described in accordance with the Cochrane Collaboration methods [3]. We previously reported of SES and PES outcomes, both atmidand long-term follow-up, in a different clinical setting [4– 7]. In this respect, although SES and PES may perform differently, we defined SES/PES as a control arm aiming to highlight difference among EES and firstly marketed drug-eluting stents as a “class-effect”. Second, “subgroup analyses” addressing separate SES and PES contribute on endpoints occurrence, would represent a “nonsense”, since there were no prespecified subgroups that could be adequately included in this study and therefore compared. The sensitivity analysis performed instead, revealed the importance of omitting SES for outcome evaluation. As a consequence, we clearly stated that EES superiority as compared with SES in terms of myocardial infarction (MI) and stent thrombosis (ST) occurrence cannot be assessed since data and longer follow-up, focusing on these specific issues, are scanty. Third, to the best of our knowledge, only one new randomized trial [8] investigating of EES versus SES outcome at 12-month followup has been published. In this respect, since the last search was run on August 2010, trials published beyond this specified time point cannot be included. The latter, Kun Liu and coworker erroneously included in their update the X-SEARCH registry [9] that was interpreted as “randomized”: this was a prospective single-center registry evaluating the safety and efficacy of EES implantation in consecutive unselected patients. Thus, its inclusion in the analysis seems to be incorrect. Taking in consideration the paucity of data regarding EES versus SES performance with respect to target lesion revascularization, mortality, MI, or ST, statements such as those reported from the Authors look like quite hazardous, and need further investigations by mean of ongoing well designed and powered randomized trials. The Authors of this manuscript have certified that they comply with the Principles of Ethical Publishing in the International Journal of Cardiology [10].

Multi-slice computed tomography assessment of stent position in a patient with acute coronary syndrome and anomalous origin of the coronary arteries : online article - case report

We describe the case of a woman with acute coronary syndrome who was treated by percutaneous coronary intervention (PCI) and stenting of the proximal right coronary artery, which shared its short origin with the left anterior descending artery. A multi-slice computed tomography study of the patients coronary tree, performed after percutaneous treatment, played a fundamental role in obtaining a clearer view of the coronary anatomy, as well as of stent positioning in this particular anatomy, eliminating any doubt about the PCI result.