Publications by authors named "Carmine Musto"

54 Publications

A Comparison Between Gore Cardioform and Amplatzer Septal Occluder for Percutaneous Closure of Patent Foramen Ovale Associated With Atrial Septal Aneurysm: Clinical and Echocardiographic Outcomes.

J Invasive Cardiol 2021 Nov 15;33(11):E857-E862. Epub 2021 Oct 15.

Interventional Cardiology Unit, San Camillo Hospital, Via Circonvallazione Gianicolense n. 87, 00152 Rome, Italy.

Objectives: To evaluate the short- and long-term clinical and echocardiographic outcomes of the percutaneous closure of the patent foramen ovale (PFO) with an atrial septal aneurysm (ASA) using 2 different devices.

Methods: We enrolled 100 patients with PFO and ASA. Fifty consecutive patients had transcatheter closure of the PFO with the Gore Cardioform septal occluder (GSO) (Gore Medical) and a second group of 50 consecutive patients with the Amplatzer PFO occluder (APO) (Abbott). A clinical and transthoracic echocardiographic follow-up was performed at 1, 3, 6, and 12 months after the implant procedure. The primary endpoint was the incidence of moderate-to-severe residual right-to-left shunting (rRLS) at the 6-month follow-up. The procedural results and the recurrence of embolic events at 1 year were also investigated.

Results: The procedure was successful in all patients. The immediate postprocedural moderate-to-severe rRLS incidence was similar between the 2 groups (GSO 14% vs APO 12%; P=NS) as well as the incidence of moderate-to-severe rRLS at the 6-month follow-up (GSO 4% vs APO 4%; P=non-significant). In only 1 patient of the GSO group, there was a persistent moderate rRLS at the 1-year follow-up. The 6-month and 1-year complete occlusion rate for all subjects was 93% and 96%, respectively. No devices embolized and no death or recurrent embolic events were observed during hospitalization through the 1-year follow-up.

Conclusions: GSO and APO devices appear to be safe and effective devices for the percutaneous closure of a PFO with ASA, showing similar results for the presence of rRLS at the 6-month follow-up, complete occlusion rate, and clinical embolic recurrences.
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November 2021

Gender Differences after Transcatheter Aortic Valve Replacement (TAVR): Insights from the Italian Clinical Service Project.

J Cardiovasc Dev Dis 2021 Sep 15;8(9). Epub 2021 Sep 15.

Division of Cardiology, Ospedale Carlo Poma, ASST Mantova, 46100 Mantova, Italy.

Background: TAVR is a safe alternative to surgical aortic valve replacement (SAVR); however, sex-related differences are still debated. This research aimed to examine gender differences in a real-world transcatheter aortic valve replacement (TAVR) cohort.

Methods: All-comer aortic stenosis (AS) patients undergoing TAVR with a Medtronic valve across 19 Italian sites were prospectively included in the Italian Clinical Service Project (NCT01007474) between 2007 and 2019. The primary endpoint was 1-year mortality. We also investigated 3-year mortality, and ischemic and hemorrhagic endpoints, and we performed a propensity score matching to assemble patients with similar baseline characteristics.

Results: Out of 3821 patients, 2149 (56.2%) women were enrolled. Compared with men, women were older (83 ± 6 vs. 81 ± 6 years, < 0.001), more likely to present severe renal impairment (GFR ≤ 30 mL/min, 26.3% vs. 16.3%, < 0.001) but had less previous cardiovascular events (all < 0.001), with a higher mean Society of Thoracic Surgeons (STS) score (7.8% ± 7.1% vs. 7.2 ± 7.5, < 0.001) and a greater mean aortic gradient (52.4 ± 15.3 vs. 47.3 ± 12.8 mmHg, < 0.001). Transfemoral TAVR was performed more frequently in women (87.2% vs. 82.1%, < 0.001), with a higher rate of major vascular complications and life-threatening bleeding (3.9% vs. 2.4%, = 0.012 and 2.5% vs. 1.4%, = 0.024). One-year mortality differed between female and male (11.5% vs. 15.0%, = 0.002), and this difference persisted after adjustment for significant confounding variables (Adj.HR1yr 1.47, 95%IC 1.18-1.82, < 0.001). Three-year mortality was also significantly lower in women compared with men (19.8% vs. 24.9%, < 0.001) even after adjustment for age, STS score, eGFR, diabetes and severe COPD (Adj.HR3yr 1.42, 95%IC 1.21-1.68, < 0.001). These results were confirmed in 689 pairs after propensity score matching.

Conclusion: Despite higher rates of peri-procedural complications, women presented better survival than men. This better adaptive response to TAVR may be driven by sex-specific factors.
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http://dx.doi.org/10.3390/jcdd8090114DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8472227PMC
September 2021

Platypnea and orthodeoxia syndrome as an uncommon clinical indication for a challenging percutaneous patent foramen ovale closure: a case report.

Eur Heart J Case Rep 2021 Apr 17;5(4):ytab029. Epub 2021 Apr 17.

Department of Cardiovascular Sciences, O.U. of Interventional Cardiology, San Camillo Hospital, Rome, Italy.

Background: Platypnea and Orthodeoxia Syndrome (POS) is a rare clinical condition characterized by positional dyspnoea and arterial desaturation. Various mechanisms are related to this syndrome. The simultaneous presence of abnormal anatomical findings [aortic root dilatation, atrial septal aneurysm (ASA), Lipomatous septum, and patent foramen ovale (PFO)] and an occurring ventilation/perfusion mismatch can modify intracardiac haemodynamics leading to POS in elderly patients.

Case Summary: A 70-year-old man was admitted to our emergency department suffering from neurological symptoms. A brain computed tomography scan showed a subdural haematoma and the patient underwent surgical evacuation. Some days later, he experienced an acute pulmonary insufficiency (SpO 63%) due to parenchymal basal pneumonia treated with endotracheal intubation. Two weeks later, despite pneumonia resolution, the patient's dyspnoea became worse, experiencing deep hypoxia as soon as the patient sat up with a partial resolution on recumbent position. A transoesophageal echocardiogram with bubble-test was performed showing aortic root dilatation and a lipomatous interatrial septum characterized by the presence of tunnel-like PFO with large ASA resulting in a big right to left shunt at rest with no signs of pulmonary hypertension. The patient underwent PFO percutaneous closure intervention and a few days later O therapy was reduced and the patient decannulated.

Discussion: This case illustrates how the presence of both intracardiac and extracardiac factors may facilitate the onset of POS in aged patients. Platypnea and Orthodeoxia Syndrome should be considered in patients with unexplained dyspnoea and arterial desaturation related to orthostatism. It has a good prognosis with an improvement of quality of life if the causal factor can be treated.
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http://dx.doi.org/10.1093/ehjcr/ytab029DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8188864PMC
April 2021

Instantaneous wave-free ratio-guided revascularization of non-culprit lesion in patients with ST-segment elevation myocardial infarction and multivessel coronary disease: design and rationale of the WAVE Registry.

Minerva Cardiol Angiol 2021 Jun 11;69(3):291-298. Epub 2021 Jan 11.

Mediterranea Cardiocentro, Naples, Italy.

Background: The optimal management of patients with ST-elevation acute coronary syndromes and multivessel coronary artery disease is challenging. There is a growing body of evidence supporting invasive functional evaluation of multivessel disease with FFR or iFR, which it has been added to the literature. In this regard, the WAVE Study recently demonstrated the diagnostic accuracy of instantaneous wave-free ratio (iFR) functional assessment of non-culprit lesions in multivessel patients with STEMI. However, no studies have still verified the long-term clinical impact of an iFR-guided revascularization in this setting of patients.

Methods: Patients undergoing primary PCI for STEMI and presenting multivessel disease will be enrolled. After the treatment of the culprit lesion, an iFR-guided functional assessment of non-culprit lesions will be done if iFR≤0.89 PCI will be performed during the index procedure or staged. Conversely, iFR>0.89 will direct the patient towards a conservative approach.

Results: The study start date was May 1, 2018. The enrollment phase was completed on March 30, 2020. The primary endpoint is the occurrence of target lesion failure (TLF), a composite of cardiovascular death, non-fatal myocardial infarction, and ischemia-driven revascularization of the vessel previously assessed with iFR. Secondary endpoints include MACE (cardiovascular death, non-fatal MI, any revascularization).

Conclusions: The aim of the present study was to evaluate the long-term clinical impact of an iFR-guided revascularization of the non-culprit lesions in STEMI patients with multivessel coronary artery disease.
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http://dx.doi.org/10.23736/S0026-4725.20.05229-9DOI Listing
June 2021

Interplay between COVID-19, pollution, and weather features on changes in the incidence of acute coronary syndromes in early 2020.

Int J Cardiol 2021 04 30;329:251-259. Epub 2020 Dec 30.

Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; Mediterranea Cardiocentro, Napoli, Italy. Electronic address:

Background: Coronavirus disease 2019 (COVID-19) has caused an unprecedented change in the apparent epidemiology of acute coronary syndromes (ACS). However, the interplay between this disease, changes in pollution, climate, and aversion to activation of emergency medical services represents a challenging conundrum. We aimed at appraising the impact of COVID-19, weather, and environment features on the occurrence of ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI) in a large Italian region and metropolitan area.

Methods And Results: Italy was hit early on by COVID-19, such that state of emergency was declared on January 31, 2020, and national lockdown implemented on March 9, 2020, mainly because the accrual of cases in Northern Italy. In order to appraise the independent contribution on changes in STEMI and NSTEMI daily rates of COVID-19, climate and pollution, we collected data on these clinical events from tertiary care cardiovascular centers in the Lazio region and Rome metropolitan area. Multilevel Poisson modeling was used to appraise unadjusted and adjusted effect estimates for the daily incidence of STEMI and NSTEMI cases. The sample included 1448 STEMI and 2040 NSTEMI, with a total of 2882 PCI spanning 6 months. Significant reductions in STEMI and NSTEMI were evident already in early February 2020 (all p<0.05), concomitantly with COVID-19 spread and institution of national countermeasures. Changes in STEMI and NSTEMI were inversely associated with daily COVID-19 tests, cases, and/or death (p<0.05). In addition, STEMI and NSTEMI incidences were associated with daily NO2, PM10, and O3 concentrations, as well as temperature (p<0.05). Multi-stage and multiply adjusted models highlighted that reductions in STEMI were significantly associated with COVID-19 data (p<0.001), whereas changes in NSTEMI were significantly associated with both NO2 and COVID-19 data (both p<0.001).

Conclusions: Reductions in STEMI and NSTEMI in the COVID-19 pandemic may depend on different concomitant epidemiologic and pathophysiologic mechanisms. In particular, recent changes in STEMI may depend on COVID-19 scare, leading to excess all-cause mortality, or effective reduced incidence, whereas reductions in NSTEMI may also be due to beneficial reductions in NO2 emissions in the lockdown phase.
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http://dx.doi.org/10.1016/j.ijcard.2020.12.059DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7833791PMC
April 2021

Impact of temporary traffic bans on the risk of acute coronary syndromes in a large metropolitan area.

Panminerva Med 2020 Dec 6;62(4):252-259. Epub 2020 Oct 6.

Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University, Rome, Italy -

Background: Strong epidemiologic evidence has highlighted the role of pollution, on top of adverse climate features, as a novel cardiovascular risk factor. However, mechanistic proof that reducing pollution may be beneficial to prevent atherothrombotic events is limited. We aimed at appraising the impact of temporary traffic bans in a large metropolitan area on the risk of acute coronary syndromes.

Methods: Aggregate and anonymized data from 15 tertiary cardiac care centers were obtained detailing precoronavirus disease 2019 (COVID-19) daily cases of ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI), including those treated with percutaneous coronary intervention (PCI). Data on pollutants and climate were sought for the same days. Mixed level regression was used to compare the week before vs after the traffic ban (Fortnight analysis), the 3 days before vs. after (Weekly analysis) and the Sunday before vs. after (Sunday analysis).

Results: A total of 8 days of temporary traffic bans were included, occurring between 2017 and 2020, totaling 802 STEMI and 1196 NSTEMI in the Fortnight analysis, 382 STEMI and 585 in the Weekly analysis, and 148 STEMI and 210 NSTEMI in the Sunday analysis.Fortnight and Sunday analyses did not disclose a significant impact of traffic ban on STEMI or NSTEMI (all P>0.05). Conversely, Weekly analysis showed non-significant changes for STEMI, but a significant decrease in daily NSTEMI when comparing the 3 days before the traffic ban with the ban day (P=0.043), as well as the 3 days before vs. the 3 days after the ban (P=0.025). No statistically significant effect of traffic ban was found at Fortnight, Weekly or Sunday analyses for daily mean concentrations of benzene, carbon monoxide, nitric oxide, nitrogen dioxide, ozone, sulfur dioxide, particulate matter (PM) <2.5 µm or PM <10 µm (all P>0.05). However, minimum daily concentrations showed a significant reduction of ozone during the ban in comparison to the week preceding it (P=0.034), nitric oxide during the ban in comparison to the 3 days preceding it (P=0.046), and an increase in benzene during the ban in comparison to the Sunday before (P=0.039).

Conclusions: Temporary traffic ban may favorably reduce coronary atherothrombotic events, and in particular NSTEMI, even if not globally and immediately impacting on environmental pollution. Further controlled studies are required to confirm and expand this hypothesis-generating results.
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http://dx.doi.org/10.23736/S0031-0808.20.04161-0DOI Listing
December 2020

Evaluation and Management of Nonculprit Lesions in STEMI.

JACC Cardiovasc Interv 2020 05;13(10):1145-1154

Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.

Nonculprit lesions are frequently observed in patients with ST-segment elevation myocardial infarction. Results from recent randomized clinical trials suggest that complete revascularization after ST-segment elevation myocardial infarction improves outcomes. In this state-of-the-art paper, the authors review these trials and consider how best to determine which nonculprit lesions require revascularization and when this should be performed.
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http://dx.doi.org/10.1016/j.jcin.2020.02.030DOI Listing
May 2020

Hutchinson-Gilford Progeria Syndrome and Severe Aortic Stenosis: A New Hope for Treatment.

Ann Thorac Surg 2020 11 28;110(5):e365-e367. Epub 2020 Apr 28.

Department of Cardiac Surgery, Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.

Hutchinson-Gilford progeria syndrome is an autosomal dominant, rare, fatal pediatric segmental premature aging disease. Cardiovascular and cerebrovascular diseases constitute the major cause of morbidity and mortality. Patients with the syndrome and severe aortic valve stenosis have been described in the literature, and for all of them a strategy of conservative management has been followed. We describe the first successful treatment of a 23-year-old Hutchinson-Gilford progeria syndrome patient with severe aortic stenosis who underwent transapical transcatheter aortic valve replacement.
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http://dx.doi.org/10.1016/j.athoracsur.2020.03.067DOI Listing
November 2020

Long-term clinical outcome and performance of transcatheter aortic valve replacement with a self-expandable bioprosthesis.

Eur Heart J 2020 05;41(20):1876-1886

Department of Cardiology, IRCCS Policlinico S. Donato, San Donato Milanese, 20149 Milan, Italy.

Aims: In the last decade, transcatheter aortic valve (TAV) replacement determined a paradigm shift in the treatment of patients with severe symptomatic aortic stenosis. Data on long-term TAV performance are still limited. We sought to evaluate the clinical and haemodynamic outcomes of the CoreValve self-expandable valve up to 8-year follow-up (FU).

Methods And Results: Nine hundred and ninety inoperable or high-risk patients were treated with the CoreValve TAV in eight Italian Centres from June 2007 to December 2011. The median FU was 4.4 years (interquartile range 1.4-6.7 years). Longest FU reached 11 years. A total of 728 died within 8-year FU (78.3% mortality from Kaplan-Meier curve analysis). A significant functional improvement was observed in the majority of patients and maintained over time, with 79.3% of surviving patients still classified New York Heart Association class ≤ II at 8 years. Echocardiographic data showed that the mean transprosthetic aortic gradient remained substantially unchanged (9 ± 4 mmHg at discharge, 9 ± 5 mmHg at 8 years, P = 0.495). The rate of Grade 0/1 paravalvular leak was consistent during FU with no significant change from post-procedure to FU ≥5 years in paired analysis (P = 0.164). Structural valve deterioration (SVD) and late bioprosthetic valve failure (BVF) were defined according to a modification of the 2017 EAPCI/ESC/EACTS criteria. In cumulative incidence functions at 8 years, moderate and severe SVD were 3.0% [95% confidence interval (CI) 2.1-4.3%] and 1.6% (95% CI 0.6-3.9%), respectively, while late BVF was 2.5% (95% CI 1.2-5%).

Conclusion: While TAVs are questioned about long-term performance and durability, the results of the present research provide reassuring 8-year evidence on the CoreValve first-generation self-expandable bioprosthesis.
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http://dx.doi.org/10.1093/eurheartj/ehz925DOI Listing
May 2020

Five-year clinical outcome of multicenter randomized trial comparing amphilimus - with paclitaxel-eluting stents in de novo native coronary artery lesions.

Int J Cardiol 2020 02 15;301:50-55. Epub 2019 Nov 15.

Medical Care Center, Hamburg University Cardiovascular Center, Hamburg, Germany.

Objectives: Long-term data from randomized studies on polymer-free stents are scarce. Long-term data of Cre8 amphilimus eluting stent are still not available. We sought to investigate contribution of a polymer-free design versus a permanent-polymer one on the long-term.

Methods And Results: Patients undergoing percutaneous coronary intervention for de novo lesions were randomized 1:1 to Cre8 or Taxus Liberté (323 overall, 126 Cre8). Original primary endpoint (6-month angiographic in-stent late lumen loss) already demonstrated the superiority of Cre8 vs Taxus (0.14 + 0.36 mm vs. 0.34 + 0.40 mm; p < 0.001). Secondary endpoints were the device oriented composite endpoint (DOCE), patient oriented composite endpoint (POCE) up to 5-year. Long-term follow-up data confirmed the superiority shown by Cre8 in the analysis of the angiographic endpoint at 6-month, especially in the diabetic patients, where the device strongly reduced the clinical difference with non-diabetic. Landmark analysis demonstrated that the incidence of DOCE after 1-year and up to 5-year follow up was significantly lower in patients implanted with Cre8 AES (2.1% Cre8 vs. 9.3% Taxus, p = 0.009). While no differences were found in terms of DOCE rate among diabetic and non-diabetic patients treated with the Cre8 AES (HR 1.039; 95%CI 0.320-3.374), this was not true for Taxus (HR 2.64; 95%CI 1.112-6.278).

Conclusions: Cre8 showed favourable safety and efficacy results versus Taxus at 5-years follow-up, with a superior clinical performance for the DOCE endpoint from 1 to 5 years. Cre8, differently from Taxus, has been able to strongly reduce the differences in clinical outcome between diabetic and non-diabetic up to 5 years, suggesting the higher efficacy of Cre8 in the treatment of diabetic patients.
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http://dx.doi.org/10.1016/j.ijcard.2019.10.058DOI Listing
February 2020

Efficacy and Safety of Stents in ST-Segment Elevation Myocardial Infarction.

J Am Coll Cardiol 2019 11;74(21):2572-2584

Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium; Cardialysis Clinical Trials Management and Core Laboratories, Rotterdam, the Netherlands. Electronic address:

Background: To date, no specific drug-eluting stent (DES) has fully proven its superiority over others in patients with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention.

Objectives: The purpose of this study was to compare the safety and efficacy of coronary artery stents in STEMI patients in a patient-level network meta-analysis.

Methods: Eligible studies were dedicated randomized controlled trials comparing different stents in STEMI patients undergoing percutaneous coronary intervention with at least 12 months of clinical follow-up. Of 19 studies identified from the published data, individual patient data were collected in 15 studies with 10,979 patients representing 87.7% of patients in the overall network of evidence. The primary endpoint was the composite of cardiac death, reinfarction, or target lesion revascularization.

Results: Overall, 8,487 (77.3%) of 10,979 STEMI patients were male and the mean age was 60.7 years. At a median follow-up of 3 years, compared with bare-metal stents (BMS), patients treated with paclitaxel-, sirolimus-, everolimus-, or biolimus-eluting stents had a significantly lower risk of the primary endpoint (adjusted hazard ratios [HRs]: 0.74 [95% confidence interval (CI): 0.63 to 0.88], 0.65 [95% CI: 0.49 to 0.85], 0.70 [95% CI: 0.53 to 0.91], and 0.66 [95% CI: 0.49 to 0.88], respectively). The risk of primary endpoint was not different between patients treated with BMS and zotarolimus-eluting stents (adjusted HR: 0.83 [95% CI: 0.51 to 1.38]). Among patients treated with DES, no significant difference in the risk of the primary outcome was demonstrated. Treatment with second-generation DES was associated with significantly lower risk of definite or probable stent thrombosis compared with BMS (adjusted HR: 0.61 [95% CI: 0.42 to 0.89]) and first-generation DES (adjusted HR: 0.56 [95% CI: 0.36 to 0.88]).

Conclusions: In STEMI patients, DES were superior to BMS with respect to long-term efficacy. No difference in long-term efficacy and safety was observed among specific DES. Second-generation were superior to first-generation DES in reducing stent thrombosis. (Clinical Outcomes After Primary Percutaneous Coronary Intervention [PCI] Using Contemporary Drug-Eluting Stent [DES]: Evidence From the Individual Patient Data Network Meta-Analysis; CRD42018104053).
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http://dx.doi.org/10.1016/j.jacc.2019.09.038DOI Listing
November 2019

Percutaneous Aortic Valve Closure in Patient With Left Ventricular Assist Device and Dilated Aortic Annulus.

Ann Thorac Surg 2020 01 14;109(1):e25-e27. Epub 2019 Jun 14.

Department of Cardiac Surgery and Transplantation, S. Camillo Hospital, Rome, Italy.

Percutaneous transcatheter intervention for aortic regurgitation secondary to implantation of a continuous-flow left ventricular assist device remains challenging, because of the minimal global experience with these procedures. Two treatment options are available: transcatheter aortic valve replacement, which is not always feasible when a dilated aortic annulus is present, and percutaneous aortic valve occlusion. We report a successful percutaneous closure of the aortic valve using an oversized Amplatzer patent foramen ovale multifenestrated device (St Jude Medical, Saint Paul, MN) to treat aortic regurgitation associated with dilated aortic annulus in a patient with a continuous-flow left ventricular assist device.
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http://dx.doi.org/10.1016/j.athoracsur.2019.04.081DOI Listing
January 2020

RARE CO-EXISTENCE OF CORONARY ANOMALIES: ANOMALY OF ORIGIN AND DISTRIBUTION TOGETHER WITH ANOMALY OF INTRINSIC CORONARY ARTERY ANOMALY.

Ethiop Med J 2017 Jan;55(1):73-6

We describe a 63 year old Romanian female patient admitted to our institution with complaints of typical angina and a diagnosis of non ST-elevation myocardial infarction. Coronary arteriography unveiled anomalous origin of a left circumflex coronary artery from the right coronary sinus of Valsalva near the right coronary ostium and a hyperdominant left anterior descending coronary artery giving off a posterior descending coronary artery with small distal-posterolateral left ventricular branch. The co-existence of a left circumflex coronary artery originating ectopically from the right sinus of Valsalva together with a posterior descending coronary artery originating from the distal end of the anterior descending artery is important to keep in mind especially by those doing coronary angiography in the cardiac catheterization laboratory.
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January 2017

Instantaneous wave-free ratio and fractional flow reserve for the assessment of nonculprit lesions during the index procedure in patients with ST-segment elevation myocardial infarction: The WAVE study.

Am Heart J 2017 Nov 3;193:63-69. Epub 2017 Aug 3.

Interventional Cardiology Unit-San Camillo Hospital, Rome.

Background: Functional assessment of non-infarct-related artery lesions during primary percutaneous coronary intervention (PCI) might be useful to avoid revascularization of nonsignificant stenosis and staged procedures, thus reducing hospital stay. We aimed to assess the diagnostic performance of instantaneous wave-free ratio (iFR) as compared with fractional flow reserve (FFR) in this setting.

Methods: In the WAVE study, a prospective, observational, single-center registry (NCT02869906), paired iFR and FFR measurements were performed at the level of non-IRA lesions in patients with ST-segment elevation myocardial infarction both during primary PCI and during staged procedures (5-8 days after).

Results: Paired iFR and FFR measurements were available for 66 non-IRA lesions in 50 patients. The iFR and FFR values of non-IRA lesions did not change significantly between the index and staged procedure. Bland-Altman analysis did not show systematic bias for either iFR or FFR repeated measures. Receiver operating characteristic curve analysis showed high accuracy of iFR to identify positive (≤0.80) FFR measurements in the index procedure with an area under the curve of 0.95. A cutoff of ≤0.89 for iFR in the index procedure had the best combination of sensitivity (95%) and specificity (90%) with positive and negative predictive values of 86% and 97%, respectively. Finally, iFR measured during the index procedure was significantly correlated with FFR (r=0.71, r=0.51; P<.0001).

Conclusions: The WAVE study shows that iFR yields similar diagnostic accuracy to FFR in functional evaluation of non-IRA stenosis in patients with STEMI and multivessel CAD, with the advantage of being adenosine free.
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http://dx.doi.org/10.1016/j.ahj.2017.07.017DOI Listing
November 2017

"Life hanging by a thread".

Kardiol Pol 2016 ;74(10):1188

Department of Heart and Vessels, Cardiac Surgery Unit and Heart Transplantation Centre, "S. Camillo-Forlanini" Hospital, Rome, Italy.

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http://dx.doi.org/10.5603/KP.2016.0142DOI Listing
April 2017

Noncompaction and embolic myocardial infarction: the importance of oral anticoagulation.

Rev Port Cardiol 2015 Jul-Aug;34(7-8):497.e1-4. Epub 2015 Jul 7.

Cardiology 1/CCU, S. Camillo Hospital, Rome, Italy.

Left ventricular noncompaction (LVNC) is characterized by left ventricular (LV) hypertrabeculations and is associated with heart failure, arrhythmias and embolism. We report the case of a 67-year-old LVNC patient, under oral anticoagulation (OAC) therapy for apical thrombosis. After she discontinued OAC, the thrombus involved almost the whole of the left ventricle; in a few months her condition worsened, requiring hospitalization, and despite heparin infusion she experienced myocardial infarction (MI), caused by embolic occlusion of the left anterior descending artery. Although infrequent as a complication of LVNC, and usually attributable to microvascular dysfunction, in this case MI seems due to coronary thromboembolism from dislodged thrombotic material in the left ventricle.
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http://dx.doi.org/10.1016/j.repc.2015.01.014DOI Listing
July 2017

Effect of Abciximab Therapy in Patients Undergoing Coronary Angioplasty for Acute ST-Elevation Myocardial Infarction Complicated by Cardiogenic Shock.

Circ J 2015 24;79(7):1568-74. Epub 2015 Apr 24.

Interventional Cardiology Unit, S. Camillo Forlanini Hospital.

Background: The effect of abciximab on survival in patients with ST-elevation myocardial infarction (STEMI) complicated by cardiogenic shock (CS) undergoing primary percutaneous coronary intervention (PCI) is not clear. METHODS AND RESULTS: We evaluated outcome in 410 consecutive patients with STEMI and CS who underwent PCI treated without (n=123) or with (n=287) abciximab. The endpoint was survival at 1-year follow-up. The predictors of death at 1 year were also investigated. The groups with and without abciximab had similar survival at 1-year follow-up. Propensity score-adjusted Cox proportional hazards model identified age (adjusted hazard ratio [HR], 1.02; 95% confidence interval [95% CI]: 1.01-1.03, P=0.001), oro-tracheal intubation (HR, 1.49; 95% CI: 1.12-1.96, P=0.05), post-PCI TIMI flow grade 0-1 (HR, 2.08; 95% CI: 1.52-2.83, P=0.0001) but not abciximab use (HR, 1.08; 95% CI: 0.70-1.60, P=0.60) as independent predictors of death at 1-year follow-up. Cox adjusted 1-year survival rates were 42.8% and 51.6%, (P=0.56) in patients treated without vs. with abciximab, respectively.

Conclusions: Patients with STEMI complicated by CS undergoing PCI treated with or without abciximab have similar 1-year survival rates; age, final TIMI 0-1 and oro-tracheal intubation are predictors of death.
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http://dx.doi.org/10.1253/circj.CJ-15-0053DOI Listing
April 2016

Impact of hypertension on clinical outcome in STEMI patients undergoing primary angioplasty with BMS or DES: insights from the DESERT cooperation.

Int J Cardiol 2014 Jul 26;175(1):50-4. Epub 2014 Apr 26.

Columbia University Medical Center, New York City, NY, USA; Cardiovascular Research Foundation, New York City, NY, USA.

Background: Hypertension is a well known risk factor for atherosclerosis. However, data on the prognostic impact of hypertension in patients with ST elevation myocardial infarction (STEMI) are inconsistent and mainly related to studies performed in the thrombolytic era, with very few data in patients undergoing primary angioplasty. Therefore, the aim of the current study was to evaluate the impact hypertension on clinical outcome in STEMI patients undergoing primary PCI with BMS or DES.

Methods: Our population is represented by 6298 STEMI patients undergoing primary angioplasty included in the DESERT database from 11 randomized trials comparing DES vs BMS for STEMI.

Results: Hypertension was observed in 2764 patients (43.9%), and associated with ageing (p<0.0001), female gender (p<0.001), diabetes (p<0.0001), hypercholesterolemia (p<0.0001), previous MI (p=0.002), previous revascularization (p=0.002), longer time-to-treatment (p<0.001), preprocedural TIMI 3 flow, and with a lower prevalence of smoking (41% vs 53.9%, p<0.001) and anterior MI (42% vs 45.9%, p=0.002). Hypertension was associated with impaired postprocedural TIMI 0-2 flow (Adjusted OR [95% CI]=1.22 [1.01-1.47], p=0.034). At a follow-up of 1,201 ± 440 days, hypertension was associated with higher mortality (adjusted HR [95% CI]=1.24 [1.01-1.54], p=0.048), reinfarction (adjusted HR [95% CI]=1.31 [1.03-1.66], p=0.027), stent thrombosis (adjusted HR [95% CI]=1.29 [0.98-1.71], p=0.068) and TVR (adjusted HR [95% CI]=1.22 [1.04-1.44], p=0.013).

Conclusions: This study showed that among STEMI patients undergoing primary angioplasty with DES or BMS, hypertension is independently associated with impaired epicardial reperfusion, mortality, reinfarction and TVR, and a trend in higher ST.
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http://dx.doi.org/10.1016/j.ijcard.2014.04.180DOI Listing
July 2014

Drug-eluting stents in patients with anterior STEMI undergoing primary angioplasty: a substudy of the DESERT cooperation.

Clin Res Cardiol 2014 Sep 1;103(9):685-99. Epub 2014 Apr 1.

Division of Cardiology, Ospedale "Maggiore della Carità", Eastern Piedmont University, C.so Mazzini, 18, 24100, Novara, Italy,

Background: Several concerns have emerged on the higher risk of in-stent thrombosis after drug-eluting stent (DES) implantation, especially in the setting of STEMI patients. Few data have even been reported in high-risk patients, such as those with anterior MI. Therefore this represents the aim of the current study.

Methods: The literature was scanned by formal searches of electronic databases (MEDLINE and CENTRAL). We examined all completed randomized trials of DES for STEMI. The following key words were used for study selection: randomized trial, myocardial infarction, reperfusion, primary angioplasty, stenting, DES, sirolimus-eluting stent (SES), Cypher, paclitaxel-eluting stent (PES), Taxus. No language restrictions were enforced.

Results: Individual patient's data were obtained from 11 out of 13 trials, including a total of 2,782 patients with anterior MI [1,739 or 62.5% randomized to DES and 1,043 or 37.5% randomized to bare-metal stent (BMS)]. At long-term follow-up, no significant benefit was observed with DES as compared to BMS in terms of mortality [9.8 vs 10.9%, HR (95% CI) = 0.81 (0.61, 1.07), p = 0.13, p heterogeneity = 0.18], reinfarction [8.8 vs 6.4%, respectively; HR (95% CI) = 1.14 (0.80, 1.61), p = 0.47, p heterogeneity = 0.82], and stent thrombosis [5.6 vs 5%, OR (95% CI) = 0.88 (0.59, 1.30), p = 0.51, p heterogeneity = 0.65], whereas DES was associated with a significant reduction in terms of target-vessel revascularization (TVR) [13.7 vs 23.4%; OR (95% CI) = 0.56 (0.46, 0.69), p < 0.0001, p het = 0.81] that was observed at both early (within 1 year) [7 vs 14.7%, HR (95% CI) = 0.56 (0.46, 0.69), p < 0.0001, p het = 0.81] and late (>1 year) follow-up [7.2 vs 9%, HR (95% CI) = 0.67 (0.47, 0.96), p = 0.03, p het = 0.96].

Conclusions: This study showed that among patients with anterior STEMI undergoing primary angioplasty, SES and PES, as compared to BMS, are associated with a significant reduction in TVR at long-term follow-up. No concerns were found with the use of first-generation DES in terms of mortality.
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http://dx.doi.org/10.1007/s00392-014-0702-6DOI Listing
September 2014

One-year clinical outcome of elderly patients undergoing angioplasty for ST-elevation myocardial infarction complicated by cardiogenic shock: the importance of 3-vessel disease and final TIMI-3 flow grade.

J Invasive Cardiol 2014 Mar;26(3):114-8

UO Cardiologia Interventistica, Azienda ASL S. Camillo Forlanini, Circonvallazione Gianicolense n 87, 00152 Roma, Italy.

Background: The influence of age on clinical results of primary percutaneous coronary intervention (PCI) in patients with ST-elevation myocardial infarctions (STEMI) complicated by cardiogenic shock (CS) is poorly investigated.

Methods: In this study, we evaluated the outcome of 216 consecutive all-comer patients with STEMI and CS undergoing PCI who were divided into 2 groups according to age: <75 years (n = 131) or ≥75 years (n = 81). The study endpoint was the incidence of death at 1-year follow-up. The predictors of mortality at 1 year were also investigated.

Results: The group <75 years had a significantly lower incidence of death compared with the group ≥75 years at 30 days (39% vs 69%; P=.01) and 1 year (51% vs 79%; P<.001). Cox proportional hazards model identified: age (adjusted hazard ratio [HR] = 1.02; 95% confidence interval [CI], 1.00-1.03; P=.02), 3-vessel disease (HR = 1.47; 95% CI, 1.00-2.17; P=.05), post-PCI TIMI flow grade 0-1 (HR = 2.48; 95% CI, 1.66-3.70; P=.01) and grade 2 (HR = 1.68; 95% CI, 1.01-2.80; P=.05) after PCI as independent predictors of death at 1-year follow-up.

Conclusions: Patients ≥75 years with STEMI complicated by CS and treated by PCI have higher 1-year mortality compared with younger counterparts. Final TIMI 0-2 and 3-vessel disease are strong predictors of death. This finding may be valuable in risk stratification of these patients.
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March 2014

Comparison between the new Gore septal and Amplatzer devices for transcatheter closure of patent foramen ovale. Short- and mid-term clinical and echocardiographic outcomes.

Circ J 2013 3;77(12):2922-7. Epub 2013 Sep 3.

Interventional Cardiology Unit, San Camillo Hospital.

Background: The ideal device for percutaneous patent foramen ovale (PFO) occlusion should provide effective closure with long-term biocompatibility and it should have a low profile without interfering with adjacent cardiac structures. Long-term data regarding safety and efficacy of the GORE Septal Occluder (GSO) are lacking. The aim of this study was to investigate the short- and mid-term clinical and echocardiographic outcomes of this device.

Methods And Results: Forty-five consecutive patients with clinically significant PFO were treated with GSO and their results were compared with those of 45 consecutive patients treated with Amplatzer PFO device (APO). Primary endpoint was the incidence of 6-month residual right-to-left shunting (rRLS). The procedural results and the recurrence of embolic events (REE) at 1 year were also investigated. No differences in terms of embolic risk profile and echocardiographic parameters were observed between the 2 groups. GSO was successfully implanted in all patients without device-related complication. In 2 patients for whom device position was not optimal, the GSO was easily retrieved and a new GSO was successfully repositioned. Immediate moderate-severe rRLS was similar in 2 groups. No cases of severe 6-month rRLS were registered. Two patients (4%) and 1 patient (2%) had moderate 6-month rRLS in the GSO and APO group, respectively (P=NS). No cases of REE were registered at 1-year follow-up.

Conclusions: GSO appears a valuable alternative to Amplatzer device for PFO occlusion.
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http://dx.doi.org/10.1253/circj.cj-13-0565DOI Listing
July 2014

Gender-related differences in outcome after BMS or DES implantation in patients with ST-segment elevation myocardial infarction treated by primary angioplasty: insights from the DESERT cooperation.

Atherosclerosis 2013 Sep 27;230(1):12-6. Epub 2013 Jun 27.

Division of Cardiology, Ospedale "Maggiore della Carità", Eastern Piedmont University, Novara, Italy.

Background: Several studies have found that among patients with ST-segment elevation myocardial infarction (STEMI) treated by thrombolysis, female sex is associated with a worse outcome. However, still controversial is the prognostic impact of gender in primary angioplasty, especially in the era of drug-eluting stents (DES). Therefore, the aim of this study was to investigate sex-related differences in clinical outcome in patients with STEMI treated with primary angioplasty with Bare-Metal Stent (BMS) or DES.

Methods: Our population is represented by 6298 STEMI patients undergoing primary angioplasty and stent implantation included in the DESERT database. Follow-up data were collected from 3 to 6 years after primary angioplasty.

Results: Female gender was observed in 1466 (23.2%) out of 6298 STEMI patients. Women were older (65.3 ± 12.4 vs 59.3 ± 11.4 years, p < 0.001), with higher prevalence of diabetes (18.6% vs 14.5%, p < 0.001), hypertension (52.4% vs 41.4%, p < 0.001), slightly longer ischemia time (272 ± 247 vs 258 ± 220 min, p = 0.06). No difference was observed in terms of angiographic and procedural characteristics. Follow-up data were available at a mean of 1201 ± 441 days. At long-term follow-up female gender was associated with a significantly higher rate of death (11.7% vs 8.5%, HR [95% CI] = 1.45 [1.18-1.78], p < 0.001), while no difference was observed in terms of reinfarction (HR [95% CI] = 1.14 [0.89-1.45], p = 0.3), ST (HR [95% CI] = 1.12 [0.85-1.48], p = 0.4), with similar temporal distribution (acute, subacute, late and very late) between male and female patients, and no difference in TVR (HR [95% CI] = 1.11 [0.95-1.3], p = 0.2, p = 0.2). These results were confirmed in both patients receiving BMS or DES. The impact of female gender on mortality disappeared after correction for baseline confounding factors (HR [95% CI] = 0.88 [0.71-1.09], p = 0.25).

Conclusions: This study shows that in patients with STEMI treated by primary angioplasty, female gender is associated with higher mortality rate in comparison with men, and this is mainly due to their higher clinical and angiographic risk profiles. In fact, female sex did not emerge as an independent predictor of mortality.
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http://dx.doi.org/10.1016/j.atherosclerosis.2013.05.024DOI Listing
September 2013

Time course, predictors and clinical implications of stent thrombosis following primary angioplasty. Insights from the DESERT cooperation.

Thromb Haemost 2013 Oct 18;110(4):826-33. Epub 2013 Jul 18.

Giuseppe De Luca, MD, PhD, Aggregate Professor of Cardiology, Chief Interventional Cardiology, Ospedale "Maggiore della Carità", Eastern Piedmont University, C.so Mazzini, 18, 24100 Novara, Italy, Tel.: +39 0321 3733141, Fax: +39 0321 3733407, E-mail:

Primary percutaneous coronary intervention (pPCI) has improved survival as compared to thrombolysis. Concerns still remain regarding the risk of stent thrombosis in the setting of STEMI, especially after drug-eluting stent (DES) implantation. Therefore, the aim of this study was to report on the timing of stent thrombosis (ST) with both DES and bare metal stents (BMS) and its prognostic significance in patients undergoing pPCI. The Drug-Eluting Stent in Primary Angioplasty (DESERT) cooperation is based on a pooled database including individual data of randomised trials that evaluate the long-term safety and effectiveness of DES as compared to BMS in patients undergoing pPCI for STEMI. Follow-up data were collected for 3-6 years after the procedure. ST was defined as definite or probable, based on the ARC definition. The study population consists of 6,274 STEMI patients undergoing primary angioplasty with BMS or DES. At 1201 ± 440 days, ST occurred in 267 patients (4.25%). Most of the events were acute or subacute (within 30 days) and very late (> 1 years), with different distribution between DES vs BMS. Patients with ST were more often diabetic (21.7% vs 15.1%, p=0.005), more frequently had post-procedural TIMI 0-2 flow (14.0% vs 9.3%, p = 0.01), and were less often treated with dual antiplatelet therapy at one year follow-up. Diabetes (p = 0.036), post-procedural TIMI 0-2 Flow (p = 0.013) and ischaemia time > 6 hours (p = 0.03) were independent predictors of ST. Post-procedural TIMI 0-2 flow (p = 0.001) and ischaemia time > 6 hours (p < 0.001) were independent predictors of early ST, ischaemia time > 6 hours (p = 0.05) was independent predictor of late ST, whereas diabetes (p = 0.022) and use of DES (p = 0.002) were independent predictors of very late ST. ST was associated with a significantly higher mortality (23.6% vs 6%, p < 0.001). The greatest impact on mortality was observed with subacute (40.4%) and late (20.9%) ST, as compared to acute (12.5%) and very late (9.1%) ST. ST was an independent predictor of mortality (HR [95%CI] = 3.73 [2.75-5.07], p < 0.001). In conclusion, ST occurs relatively frequently also beyond the first year for up to six years after pPCI in STEMI, with higher late occurrence rates among patients treated with first generation DES. ST after pPCI is a powerful predictor of mortality, especially subacute ST.
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http://dx.doi.org/10.1160/TH13-02-0092DOI Listing
October 2013

Impact of age on long-term outcome after primary angioplasty with bare-metal or drug-eluting stent (from the DESERT cooperation).

Am J Cardiol 2013 Jul 7;112(2):181-6. Epub 2013 May 7.

Division of Cardiology, Ospedale Maggiore della Carità, Eastern Piedmont University, Novara, Italy.

Despite mechanical reperfusion, elderly patients with ST-segment elevation myocardial infarction (STEMI) still experience unsatisfactory outcomes. Drug-eluting stents (DES) have significantly reduced target-vessel revascularization (TVR), but concerns have emerged about the higher risk of late stent thrombosis, which may be more pronounced in elderly patients. Therefore, the aim of this study was to evaluate the impact of age on outcome in patients with STEMI who underwent primary angioplasty with bare-metal stents (BMS) or DES. Our population comprised 6,298 patients who underwent primary angioplasty and stent implantation included in the Drug-Eluting Stent in Primary Angioplasty (DESERT) Cooperation database. Age was significantly associated with female gender (p <0.001), diabetes (p <0.001), hypertension (p <0.001), previous myocardial infarction (MI; p <0.001), ischemia time (p <0.001), and anterior MI (p <0.001) but inversely related to smoking (p <0.001). Elderly patients most often had infarct-related artery located in the descending artery (p = 0.014) and impaired postprocedural thrombolysis in myocardial infarction flow (p <0.001). Elderly patients were less often on clopidogrel at follow-up. At long-term follow-up, age was associated with a higher rate of death (hazard ratio [95% confidence interval] = 2.17 [1.97 to 2.39], p <0.0001), whereas no impact was observed on reinfarction (p = 0.36), stent thrombosis (p = 0.84), and TVR (p = 0.54). These results were confirmed in patients receiving both BMS and DES. The impact of age on mortality was confirmed after correction for baseline confounding factors (gender, diabetes hypertension, hypercholesterolemia, smoking, ischemia time, anterior MI, infarct-related artery location, and postprocedural thrombolysis in myocardial infarction 3 flow; adjusted hazard ratio [95% confidence interval] = 2.13 [1.78 to 2.56], p <0.001). In conclusion, this study shows that in patients with STEMI who underwent primary angioplasty, age is independently associated with higher mortality, observed with both BMS and DES, whereas no impact was observed on the rate of reinfarction, stent thrombosis, and TVR.
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http://dx.doi.org/10.1016/j.amjcard.2013.03.012DOI Listing
July 2013

Response letter to "Quality of evidence for multivariate analysis to keep stable estimates".

Int J Cardiol 2013 Oct 4;168(4):4266. Epub 2013 May 4.

UO Cardiologia Interventistica, Azienda ASL S. Camillo Forlanini, Circonvallazione Gianicolense, 87, Roma, Italy. Electronic address:

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http://dx.doi.org/10.1016/j.ijcard.2013.04.124DOI Listing
October 2013

Meta-analysis comparing efficacy and safety of first generation drug-eluting stents to bare-metal stents in patients with diabetes mellitus undergoing primary percutaneous coronary intervention.

Am J Cardiol 2013 May 12;111(9):1295-304. Epub 2013 Mar 12.

Division of Cardiology, Ospedale Maggiore Della Carità, Eastern Piedmont University, Novara, Italy.

Several concerns have emerged regarding the higher risk for stent thrombosis (ST) after drug-eluting stent (DES) implantation, especially in the setting of ST-segment elevation myocardial infarction (STEMI). Few data have been reported so far in patients with diabetes mellitus, which is associated with high rates of target vessel revascularization after bare-metal stent (BMS) implantation but also higher rates of ST after DES implantation. Therefore, the aim of this study was to perform a meta-analysis of individual patients' data to evaluate the long-term safety and effectiveness of DES compared with BMS in patients with diabetes who undergo primary percutaneous coronary intervention for STEMI. Published reports were scanned by formal searches of electronic databases (MEDLINE and CENTRAL). All completed randomized trials of DES for STEMI were examined. No language restrictions were enforced. Individual patients' data were obtained from 11 of 13 trials, including a total of 972 patients with diabetes (616 [63.4%] randomized to DES and 356 [36.6%] to BMS). At long-term follow-up (median 1,095 days, interquartile range 1,087 to 1,460), DES significantly reduced the occurrence of target vessel revascularization (hazard ratio 0.42, 95% confidence interval 0.29 to 0.59, p <0.0001), without any significant difference in terms of mortality, late reinfarction, and ST (>1 year) with DES. In conclusion, this meta-analysis, based on individual patients' data from 11 randomized trials, showed that among patients with diabetes with STEMIs who undergo primary percutaneous coronary intervention, sirolimus-eluting stents and paclitaxel-eluting stents, compared with BMS, are associated with a significant reduction in target vessel revascularization at long-term follow-up, without any apparent concern in terms of mortality, despite the trend toward higher rates of reinfarction and ST.
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http://dx.doi.org/10.1016/j.amjcard.2013.01.281DOI Listing
May 2013

Effect of multivessel coronary artery disease with or without a concomitant chronic total occlusion on 1-year survival in patients treated with rescue angioplasty.

J Invasive Cardiol 2013 Feb;25(2):64-8

Cardiologia Interventistica Ospedale S. Camillo Roma, Cardiologia Interventistica Ospedale S. Camillo, C.ne Gianicolense n 87, Rome 00152, Italy.

Background: The effect of multivessel disease (MVD) with or without a concomitant chronic total occlusion (CTO) has never been investigated in patients treated with rescue percutaneous coronary intervention (PCI).

Objectives: This study evaluates whether there is an increased rate of death at 1-year follow-up in patients undergoing rescue PCI with angiographic pattern of MVD and a concurrent CTO in comparison with single-vessel disease (SVD) and MVD without CTO.

Methods: Among 551 consecutive patients undergoing rescue PCI, we compared the 1-year survival rates of 361 patients with SVD, 137 with MVD without a CTO, and 53 with MVD and a CTO.

Results: The 1-year mortality rates of patients with SVD, MVD without CTO, and MVD with CTO were 5%, 13%, and 27%, respectively (P<.001). The Cox proportional hazard model identified the presence of MVD with CTO as a strong predictor of death at 1-year follow-up (hazard ratio [HR], 3.4; 95% confidence interval [CI], 1.6-7.1; P=.001), while MVD alone did not result as a predictor of outcome (HR, 1.9; 95% CI, 0.9-3.8; P=.064). Adjusted 1-year overall survival rates were 96%, 91.4%, and 83.4% (P=.001) in the groups with SVD, MVD without CTO, and MVD with CTO, respectively.

Conclusion: Patients with MVD and concurrent CTO have higher mortality rates than those with SVD or MVD without CTO at 1-year follow-up after rescue PCI. MVD with CTO and not MVD alone is a predictor of death at 1-year follow-up.
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February 2013

Head-to-head comparison of sirolimus-eluting stent versus bare metal stent evaluation of the coronary endothelial dysfunction in the same patient presenting with multiple coronary artery lesions: the CREDENTIAL study.

Catheter Cardiovasc Interv 2013 Sep 5;82(3):E184-91. Epub 2013 Mar 5.

U.O. Cardiologia Interventistica, Ospedale San Camillo, C.ne Gianicolense n. 87, 00152, Roma, Italy; Department of Cardiology, "Bagdasar-Arseni" Emergency Hospital, 12 Berceni Street, 4th Sector, 041915, Bucharest, Romania.

Objectives: To assess the endothelial dysfunction (ED) after bare metal stents (BMS) and sirolimus eluting stents (SES) implantation in the same patient, overcoming the confounding role of individual variables.

Background: SES reduce restenosis rate compared to BMS but causes more ED. ED is a potentially unsafe phenomenon, since it is the first step in the cascade of atherosclerosis. Studies showing more pronounced ED with drug eluting stents than BMS involved different series of patients, making the comparison difficult because endothelial function (EF) is responsive to many risk factors.

Methods: we designed a prospective comparison of 6 months post-deployment EF of SES versus BMS implanted in the same patient, but in different coronary segments. Forty-eight lesions were randomly assigned on a 1:1 allocation using block sizing of 4 according to a computer-generated sequence (SAS System, Version 9.1) basis to treatment with SES or BMS. The EF was evaluated by measuring vessel diameter variation in the stented segment, before and after selective intracoronary infusion of acetylcholine (iiAch).

Results: In eligible patients, the relative magnitudes of major vasoconstriction were 2.6, 2.9, 4.6, and 3.1 at 5 mm proximal and 5, 10 and 20 mm distal to the stent edge. Overall, a 3.5-fold major distal vasoconstriction after iiAch of SES vs. BMS was calculated.

Conclusions: in the same patients, but treating different coronary segments, SES implantation induces a higher rate of vasoconstriction compared to BMS. The increased vasoconstriction after iiAch is an indicator of ED.
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http://dx.doi.org/10.1002/ccd.24844DOI Listing
September 2013

Impact of diabetes on long-term outcome after primary angioplasty: insights from the DESERT cooperation.

Diabetes Care 2013 Apr 28;36(4):1020-5. Epub 2012 Dec 28.

Division of Cardiology, Ospedale Maggiore della Carità, Eastern Piedmont University, Novara, Italy.

Objective: Diabetes has been shown to be associated with worse survival and repeat target vessel revascularization (TVR) after primary angioplasty. The aim of the current study was to evaluate the impact of diabetes on long-term outcome in patients undergoing primary angioplasty treated with bare metal stents (BMS) and drug-eluting stents (DES).

Research Design And Methods: Our population is represented by 6,298 ST-segment elevation myocardial infarction (STEMI) patients undergoing primary angioplasty included in the DESERT database from 11 randomized trials comparing DES with BMS.

Results: Diabetes was observed in 972 patients (15.4%) who were older (P < 0.001), more likely to be female (P < 0.001), with higher prevalence of hypertension (P < 0.001), hypercholesterolemia (P < 0.001), and longer ischemia time (P < 0.001), and without any difference in angiographic and procedural characteristics. At long-term follow-up (1,201 ± 441 days), diabetes was associated with higher rates of death (19.1% vs. 7.4%; P < 0.0001), reinfarction (10.4% vs. 7.5%; P < 0.001), stent thrombosis (7.6% vs. 4.8%; P = 0.002) with similar temporal distribution--acute, subacute, late, and very late--between diabetic and control patients, and TVR (18.6% vs. 15.1%; P = 0.006). These results were confirmed in patients receiving BMS or DES, except for TVR, there being no difference observed between diabetic and nondiabetic patients treated with DES. The impact of diabetes on outcome was confirmed after correction for baseline confounding factors (mortality, P < 0.001; repeat myocardial infarction, P = 0.006; stent thrombosis, P = 0.007; TVR, P = 0.027).

Conclusions: This study shows that among STEMI patients undergoing primary angioplasty, diabetes is associated with worse long-term mortality, reinfarction, and stent thrombosis in patients receiving DES and BMS. DES implantation, however, does mitigate the known deleterious effect of diabetes on TVR after BMS.
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http://dx.doi.org/10.2337/dc12-1507DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3609523PMC
April 2013

Five-year outcomes in patients with chronic total coronary occlusion treated with drug-eluting vs bare-metal stents: a case-control study.

Can J Cardiol 2013 Aug 21;29(8):945-50. Epub 2012 Dec 21.

UO Cardiologia Interventistica Azienda Ospedaliera S. Camillo Forlanini, Roma, Italy.

Background: Limited data exist on long-term safety and effectiveness of drug-eluting stents (DESs) in true chronic total coronary occlusion (CTO) settings. We evaluated 5-year clinical outcomes of patients with CTO treated successfully with DES vs bare-metal stent (BMS).

Methods: We compared the 5-year clinical outcomes of 156 patients treated with DES implantation with outcomes of a historical cohort of 159 patients treated with BMS. Primary end point was freedom from major adverse cardiac events (MACEs; defined as death, myocardial infarction [MI], and target lesion revascularization [TLR]); secondary end points were freedom from target vessel failure (TVF; combination of target vessel revascularization, MI, and cardiac death) and TLR at 5 years.

Results: After 5 years, the DES group had significantly superior event-free survival from MACE (84% vs 69%; log rank P < 0.001), TVF (71% vs 84%; P = 0.002), and TLR (77% vs 92%; P = 0.0001), compared with the BMS group. The Cox proportional hazards model identified BMS vs DES (adjusted hazard ratio [HR] = 3.37; 95% confidence interval [CI], 1.85-6.17; P = 0.001), final minimal lumen diameter (HR, 0.27; 95% CI, 0.14-0.52; P = 0.0001), and stent length (HR, 1.01; 95% CI, 1.00-1.03; P = 0.03) as independent predictors of MACE at 5-year follow-up. Twelve (7%) and 7 (4%) stent thromboses occurred in the DES and BMS groups (P = 0.23), respectively.

Conclusions: After 5 years, DESs were superior to BMSs in reducing MACE, TVF, and TLR in patients with CTO and should be the preferred strategy.
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http://dx.doi.org/10.1016/j.cjca.2012.10.002DOI Listing
August 2013
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