Publications by authors named "Sergio Buccheri"

58 Publications

Efficacy and safety of aspirin for cardiovascular risk prevention in younger and older age: an updated systematic review and meta-analysis.

Thromb Haemost 2021 Oct 12. Epub 2021 Oct 12.

Cardiology Unit, University of Catania, Catania, Italy.

Aims - The efficacy and safety of aspirin for primary cardiovascular disease (CVD) prevention is controversial. The aim of this study was to investigate the merits of aspirin in subjects with no overt CVD, with a focus on age as a treatment modifier. Methods and results - Randomized trials comparing aspirin use versus no aspirin use or placebo were included. The primary efficacy outcome was all-cause death. The primary safety outcome was major bleeding. Subgroups analyses were conducted to investigate the consistency of the effect sizes in studies including younger and older individuals, using a cut-off of 65 years. A total of 21 randomized trials including 173,810 individuals at a mean follow-up of 5.3 years were included. Compared with control, aspirin did not reduce significantly the risk of all-cause death (risk ratio 0.96, 95% CI 0.92-1.00, p=0.057). Major adverse cardiovascular events were significantly reduced by 11%, paralleled by significant reductions in myocardial infarction and transient ischemic attack. Major bleeding, intracranial hemorrhage, and gastrointestinal bleeding were significantly increased by aspirin. There was a significant age interaction for death (p for interaction=0.007), with aspirin showing a statistically significant 7% relative benefit on all-cause death in studies including younger patients. Conclusions - The use of aspirin in subjects with no overt cardiovascular disease was associated with a neutral effect on all-cause death and a modest lower risk of major cardiovascular events at the price of an increased risk in major bleeding. The benefit of aspirin might be more pronounced in younger individuals.
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http://dx.doi.org/10.1055/a-1667-7427DOI Listing
October 2021

Causes, Pattern, Predictors and Prognostic Implications of New Hospitalizations after TAVI: A Long-Term Nationwide Observational Study.

Eur Heart J Qual Care Clin Outcomes 2021 Apr 8. Epub 2021 Apr 8.

Department of Medical Sciences, Uppsala University, Uppsala, Sweden.

Aim: The aim of this study was to investigate the pattern, causes and predictors of all new hospitalizations in patients who underwent TAVI.

Methods And Results: The nationwide Swedish TAVI-registry was merged with other mandatory health care registries, which enabled the analysis of all TAVI-procedures, new hospital admissions and death between the years 2008 and 2017.A total of 2821 patients underwent TAVI with a mean of 2.5 hospitalizations during a mean Follow-up of 2.2 years. Hospitalizations were associated with worse prognosis. Heart failure (HF) was the most common cause of hospitalization with 19% having at least one hospitalization due to HF causing 16% of all-cause admissions and 50% of cardiovascular admissions. Male gender, age > 90 years, high Charlson Comorbidity Index, atrial fibrillation, present neurologic disease, severe renal impairment, peripheral vascular disease, New York Heart Association class IV, mild or moderate mean aortic valve gradients and pulmonary hypertension were associated with an increased risk for all-cause hospitalizations or death. For cardiovascular hospitalization or death, the pattern was similar, with the addition of impaired systolic left ventricular function as a predictor.

Conclusion: Multiple hospitalizations after TAVI are common, and are often caused by HF. Reducing the rate of HF hospitalizations is important to mitigate the burden on the health care system due to new hospitalizations after TAVI.
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http://dx.doi.org/10.1093/ehjqcco/qcab026DOI Listing
April 2021

Outcome of PCI with Xience versus other commonly used modern drug eluting stents: A SCAAR report.

Catheter Cardiovasc Interv 2021 08 15;98(2):E197-E204. Epub 2021 Mar 15.

Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.

Objectives: To analyze the clinical outcome of percutaneous coronary intervention (PCI) using the Xience drug eluting stent (DES) versus other modern DES.

Methods: This retrospective study based on the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) analyzed the outcome of PCI using Xience versus other commonly used modern DES, 2007 to 2017. The primary outcome measure was a combination of all-cause death, myocardial infarction (MI) and revascularisation with PCI. Angiographical outcome measures were in-stent restenosis (ISR) and stent thrombosis (ST).

Results: Rates of the primary outcome measure for Xience and other DES were 31.9% and 28.2% respectively, adjusted hazard ratio (HR) 0.99 (95% CI 0.95-1.03). Crude rates of ISR were 2.9% versus 2.1% over 4.3 and 2.9 years respectively, adjusted HR 0.93 (95% CI 0.81-1.06). Crude rates of ST were 0.9% versus 0.7%, adjusted HR 1.07 (95% CI 0.82-1.39). Results were consistent in all sensitivity analyses.

Conclusions: This nationally complete, real-world study confirms that Xience is a safe and effective DES with low-event rates of ISR and ST. Compared with a control group containing a large proportion of thinner strut stents and absorbable polymers, Xience exhibits similar results in all important clinical endpoints.
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http://dx.doi.org/10.1002/ccd.29641DOI Listing
August 2021

Patient-tailored antithrombotic therapy following percutaneous coronary intervention.

Eur Heart J 2021 03;42(10):1038-1046

Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.

Dual antiplatelet therapy has long been the standard of care in preventing coronary and cerebrovascular thrombotic events in patients with chronic coronary syndrome and acute coronary syndrome undergoing percutaneous coronary intervention, but choosing the optimal treatment duration and composition has become a major challenge. Numerous studies have shown that certain patients benefit from either shortened or extended treatment duration. Furthermore, trials evaluating novel antithrombotic strategies, such as P2Y12 inhibitor monotherapy, low-dose factor Xa inhibitors on top of antiplatelet therapy, and platelet function- or genotype-guided (de-)escalation of treatment, have shown promising results. Current guidelines recommend risk stratification for tailoring treatment duration and composition. Although several risk stratification methods evaluating ischaemic and bleeding risk are available to clinicians, such as the use of risk scores, platelet function testing , and genotyping, risk stratification has not been broadly adopted in clinical practice. Multiple risk scores have been developed to determine the optimal treatment duration, but external validation studies have yielded conflicting results in terms of calibration and discrimination and there is limited evidence that their adoption improves clinical outcomes. Likewise, platelet function testing and genotyping can provide useful prognostic insights, but trials evaluating treatment strategies guided by these stratification methods have produced mixed results. This review critically appraises the currently available antithrombotic strategies and provides a viewpoint on the use of different risk stratification methods alongside clinical judgement in current clinical practice.
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http://dx.doi.org/10.1093/eurheartj/ehaa1097DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8244639PMC
March 2021

Clinical outcomes with unselected use of an ultrathin-strut sirolimus-eluting stent: a report from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR).

EuroIntervention 2021 04;16(17):1413-1421

Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.

Aims: The aim of this study was to assess the real-world clinical performance of a sirolimus-eluting ultrathin-strut drug-eluting stent (DES) (Orsiro) in a large nationwide cohort of patients undergoing percutaneous coronary intervention (PCI).

Methods And Results: From the Swedish Coronary Angiography and Angioplasty Registry, the two-year outcomes of 4,561 patients implanted with Orsiro (Orsiro group) and 69,570 receiving other newer-generation DES (n-DES group) were analysed. The rate of definite stent thrombosis was low in both groups (0.67% and 0.83% for Orsiro and n-DES, respectively; adjusted hazard ratio [HR] 0.90, 95% confidence interval [CI]: 0.55-1.46, p-value 0.66). Restenosis was also infrequent (1.5% vs 2.0% with Orsiro and n-DES, adjusted HR 0.81, 95% CI: 0.63-1.03, p-value=0.09). The risk of target lesion revascularisation by PCI was lower in the Orsiro group (1.6% vs 2.3%, adjusted HR 0.75, 95% CI: 0.60-0.94, p-value=0.013). All-cause mortality and myocardial infarction did not show a statistically significant difference between the two groups (mortality of 7.5% in both groups, adjusted HR 0.99, 95% CI: 0.72-1.35, p-value=0.94; 6.0% vs 5.2% for myocardial infarction, adjusted HR 1.19, 95% CI: 1.00-1.43, p-value=0.06).

Conclusions: In a nationwide scenario, the use of a sirolimus-eluting ultrathin-strut DES portended favourable clinical outcomes.
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http://dx.doi.org/10.4244/EIJ-D-20-00429DOI Listing
April 2021

Epicardial fat study-AG: relationship between echocardiographic epicardial fat and coronary artery disease in patients after invasive coronary artery angiography.

Future Cardiol 2020 11 10;16(6):635-643. Epub 2020 Jun 10.

Interventional Cardiology, San Giovanni di Dio Hospital, Agrigento, Italy.

Epicardial fat increase has not yet a clear correlation with coronary artery disease (CAD). This study had as goal to demonstrate a relationship between an increase of epicardial fat thickness (EFT) and CAD. In this observational study, we included 234 patients who underwent invasive coronary angiography. Before invasive coronary angiography, all patients underwent echocardiographic-2D for evaluation of EFT and they were divided into groups based on Gensini score and also on Syntax score. EFT was significantly correlated to the presence and severity of CAD assessed by Gensini score with a cut-off value of 5.2 mm (sensitivity of 90.9%-specificity of 87.3%- area under the ROC curve = 92.1%). EFT increase (fat index ≥5.2 mm) evaluated by echocardiographic-2D could be considered as a risk factor for predicting CAD.
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http://dx.doi.org/10.2217/fca-2020-0025DOI Listing
November 2020

Comparative Efficacy and Safety of Oral P2Y Inhibitors in Acute Coronary Syndrome: Network Meta-Analysis of 52 816 Patients From 12 Randomized Trials.

Circulation 2020 07 29;142(2):150-160. Epub 2020 May 29.

Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University Hospital, Sweden (S.B., L.W., S.J.).

Background: New randomized, controlled trials have become available on oral P2Y inhibitors in acute coronary syndrome. We aimed to evaluate current evidence comparing the efficacy and safety profile of prasugrel, ticagrelor, and clopidogrel in acute coronary syndrome by a meta-analysis of randomized controlled trials.

Methods: We performed a network meta-analysis and direct pairwise comparison analysis of efficacy and safety outcomes from 12 randomized controlled trials including a total of 52 816 patients with acute coronary syndrome.

Results: In comparison with clopidogrel, ticagrelor significantly reduced cardiovascular mortality (hazard ratio [HR], 0.82 [95% CI, 0.72-0.92]) and all-cause mortality (HR, 0.83 [95% CI, 0.75-0.92]), whereas there was no statistically significant mortality reduction with prasugrel (HR, 0.90 [95% CI, 0.80-1.01] and HR, 0.92 [95% CI, 0.84-1.02], respectively). In comparison with each other, there were no significant differences in mortality (HR prasugrel versus ticagrelor, 1.10 [95% CI, 0.94-1.29] and 1.12 [95% CI, 0.98-1.28]). In comparison with clopidogrel, prasugrel reduced myocardial infarction (HR, 0.81 [95% CI, 0.67-0.98]), whereas ticagrelor showed no risk reduction (HR, 0.97 [95% CI, 0.78-1.22]). Differences between prasugrel and ticagrelor were not statistically significant. Stent thrombosis risk was significantly reduced by both ticagrelor and prasugrel versus clopidogrel (28%-50% range of reduction). In comparison with clopidogrel, both prasugrel (HR, 1.26 [95% CI, 1.01-1.56]) and ticagrelor (HR, 1.27 [95% CI, 1.04-1.55]) significantly increased major bleeding. There were no significant differences between prasugrel and ticagrelor for all outcomes explored.

Conclusions: Prasugrel and ticagrelor reduced ischemic events and increased bleeding in comparison with clopidogrel. A significant mortality reduction was observed with ticagrelor only. There was no efficacy and safety difference between prasugrel and ticagrelor. Registration: URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD42019155648.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.046786DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7489363PMC
July 2020

Measuring Thrombogenicity in ST-Elevation Myocardial Infarction - Mechanistic Insights and Future Directions.

Authors:
Sergio Buccheri

Circ J 2020 05 9;84(6):885-887. Epub 2020 May 9.

Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University.

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http://dx.doi.org/10.1253/circj.CJ-20-0256DOI Listing
May 2020

Percutaneous Treatment and Outcomes of Small Coronary Vessels: A SCAAR Report.

JACC Cardiovasc Interv 2020 04 12;13(7):793-804. Epub 2020 Feb 12.

Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. Electronic address:

Objectives: The aim of this study was to investigate the outcomes of patients with de novo lesions in small coronary vessels undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCBs) or newer-generation drug-eluting stents (n-DES).

Background: Notwithstanding the available evidence from a few randomized clinical trials and meta-analyses, the best device for PCI in patients with small-vessel coronary artery disease is not yet established.

Methods: The study included all consecutive patients with de novo lesions in small coronary vessels undergoing PCI in Sweden from April 2009 to July 2017. A small coronary vessel was defined by a device diameter ≤2.5 mm. The primary outcomes were restenosis and definite target lesion thrombosis at 3-year follow-up. The secondary outcomes were the occurrence of all-cause death and myocardial infarction.

Results: The study population included 14,788 patients: 1,154 treated with DCBs and 13,634 with n-DES. Overall, 35,541 PCIs were performed using 2,503 DCBs and 33,038 n-DES. The propensity score-adjusted regression analysis showed a significantly higher risk for restenosis in the DCB group compared with the n-DES group (adjusted hazard ratio [HR]: 2.027; 95% confidence interval [CI]: 1.537 to 2.674). Conversely, no difference in the risk for target lesion thrombosis (adjusted HR: 0.741; 95% CI: 0.412 to 1.331) was detected. The risk for all-cause death (adjusted HR: 1.178; 95% CI: 0.992 to 1.399) and myocardial infarction (adjusted HR: 1.251; 95% CI: 0.960 to 1.629) was comparable between groups.

Conclusions: Because of the significantly higher risk for restenosis up to 3 years, this research suggests that DCBs are not an equally effective alternative to n-DES for percutaneous treatment of small coronary vessels.
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http://dx.doi.org/10.1016/j.jcin.2019.10.062DOI Listing
April 2020

Individualized Duration of Dual Antiplatelet Therapy Guided by Risk Scores - Ready for Prime Time?

Circ J 2020 01 15;84(2):153-155. Epub 2020 Jan 15.

Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University.

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http://dx.doi.org/10.1253/circj.CJ-19-1149DOI Listing
January 2020

Time-based measures of comparative efficacy and safety in ARISTOTLE: Methodological remarks and clinical implications.

Authors:
Sergio Buccheri

Eur J Prev Cardiol 2020 08 17;27(12):1307-1310. Epub 2019 Dec 17.

Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Sweden.

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http://dx.doi.org/10.1177/2047487319894876DOI Listing
August 2020

Evolving paradigms in antithrombotic therapy for anticoagulated patients undergoing coronary stenting.

Ther Adv Cardiovasc Dis 2019 Jan-Dec;13:1753944719891688

Division of Cardiology, C.A.S.T., P.O. 'G. Rodolico,' Azienda Ospedaliero-Universitaria 'Policlinico-Vittorio Emanuele,' P.O. Rodolico, Ed. 8, Via Santa Sofia 78, Catania, Sicilia, Italy.

A sizable proportion of coronary artery disease (CAD) patients undergoing percutaneous coronary intervention (PCI) with stent implantation have an indication for treatment with oral anticoagulant therapy (OAC). The coexistence of atrial fibrillation (AF) and the need for PCI expose patients to a higher risk of developing thrombotic complications, and a multitargeted antithrombotic treatment strategy, addressing both platelet- and coagulation-mediated triggering mechanisms of thrombosis, is necessary for ensuring full protection from ischemic hazards. The increased bleeding risk identified with triple antithrombotic therapy has driven the search for alternative treatment modalities and pharmacological combination strategies aimed at achieving an optimal balance between safety and efficacy in this complex clinical scenario. Over a short time period, the paradigms surrounding the management of patients undergoing PCI who require OAC have substantially evolved. In this review, we summarize and critically evaluate the results of recent randomized clinical trials investigating the pharmacological management of patients who, in addition to antiplatelet therapy, have an indication for OAC treatment before or at the time of a PCI procedure.
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http://dx.doi.org/10.1177/1753944719891688DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6902384PMC
December 2019

Bleeding after antiplatelet therapy for the treatment of acute coronary syndromes: a review of the evidence and evolving paradigms.

Expert Opin Drug Saf 2019 Dec 25;18(12):1171-1189. Epub 2019 Oct 25.

Division of Cardiology, University of Florida College of Medicine, Jacksonville, FL, USA.

: Potent platelet inhibition reduces the risk of thrombotic complications including myocardial infarction and death in patients with acute coronary syndrome (ACS). Targeting different pathways involved in thrombotic processes have synergistic effects and more effectively counteract thrombosis both in the acute and long-term following an ACS. Unavoidably, more potent platelet inhibition increases the risk of bleeding. In light of the adverse prognostic implications associated with bleeding, including increased mortality, safety aspects with antiplatelet therapy have gained increased importance.: This review aims at describing the safety of different antiplatelet agents, particularly with regards to the risk of bleeding complications, used in the management of ACS patients. New bleeding reduction strategies to enhance the safety of antiplatelet therapy are also reviewed.: The final goal of a well-structured antiplatelet treatment strategy is that of tackling the spectrum of ischemic risk without compromising patient safety. A simple mnemonic rule for guiding therapeutic decisions in this complex clinical scenario can be summarized with the acronym 'ABC', meaning the sequential process of assessing, balancing and customizing treatment strategies in individual patients on the tradeoff between bleeding and ischemic risk. This approach is recommended for maximizing the ischemic benefits, while preserving safety, with the use of antiplatelet therapy.
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http://dx.doi.org/10.1080/14740338.2019.1680637DOI Listing
December 2019

Outcomes of three different new generation transcatheter aortic valve prostheses.

Catheter Cardiovasc Interv 2020 02 14;95(3):398-407. Epub 2019 Oct 14.

Division of Cardiology, CAST, Policlinico G. Rodolico-Vittorio Emanuele Hospital, University of Catania, Catania, Italy.

Aims: To evaluate outcomes of transfemoral transcatheter aortic valve implantation (TF-TAVI) using three different new-generation devices.

Background: Although new generation transcatheter aortic valves (TAVs) have demonstrated to improve procedural outcomes, to date few head-to-head comparisons are available among these devices.

Methods: This is a single center, retrospective study. From September 2014 to February 2018, 389 patients underwent elective TF-TAVI for native, severe aortic stenosis using a new-generation transcatheter aortic valve (TAV) with a preprocedural multi-detector computed tomography assessment. Among these, 346 patients received an Edwards SAPIEN 3 (n = 134), Medtronic Evolut R (n = 111), or Boston ACURATE neo (n = 101) prosthesis. Differences in baseline clinical characteristics between groups were accounted using the propensity score weighting method.

Results: The mean age for the entire study cohort was 81.4 ± 5.2 years while the Society of Thoracic Surgery predicted risk of mortality was 4.0 ± 2.5%. After propensity score weighting adjustment, TAVs did not differently impact on 30-day all-cause and cardiovascular mortality. Evolut R device showed an increased risk of permanent pacemaker implantation (PPI) after the procedure (8.3% for SAPIEN 3 vs. 16.7% for Evolut R vs. 2.1% for ACURATE neo, p < .05). At 30 days, patients treated with SAPIEN 3 valve showed a higher mean transvalvular gradient (9.7 ± 7.5 mmHg vs. 6.1 ± 2.4 mmHg vs. 8.4 ± 3.5 mmHg for SAPIEN 3, Evolut R, and ACURATE neo, respectively, p < .01) and a lower rate of more-than-trace paravalvular regurgitation (PVR) (18.8 vs. 47.9 vs. 45.8%, for SAPIEN 3, Evolut R, and ACURATE neo, respectively, p < .01). At 1 year, SAPIEN 3, Evolut R, and ACURATE neo TAVs showed excellent and comparable outcomes with no difference in terms of freedom from major adverse cardiovascular and cerebrovascular event (MACCE) (p = 0.534).

Conclusions: TAVI using new-generation prostheses was associated with high device success (97.0% vs. 92.8% vs. 95.0% for SAPIEN 3, Evolut R and ACURATE neo, respectively) and low complications rates up to 1 year. Evolut R valve was associated with a higher rate of PPI whereas SAPIEN 3 valve was associated with a higher mean transvalvular gradient and lower rate of more-than-trace PVR. At 1-year, MACCE rates were similar among the three groups.
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http://dx.doi.org/10.1002/ccd.28524DOI Listing
February 2020

Clinical and angiographic outcomes of bioabsorbable vs. permanent polymer drug-eluting stents in Sweden: a report from the Swedish Coronary and Angioplasty Registry (SCAAR).

Eur Heart J 2019 08;40(31):2607-2615

Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center, Uppsala University, Dag Hammarskjölds Väg 38, Uppsala, Sweden.

Aims: Randomized clinical trials have consistently demonstrated the non-inferiority of bioabsorbable polymer drug-eluting stents (BP-DES) with respect to DES having permanent polymers (PP-DES). To date, the comparative performance of BP- and PP-DES in the real world has not been extensively investigated.

Methods And Results: From October 2011 to June 2016, we analysed the outcomes associated with newer generation DES use in Sweden. After stratification according to the type of DES received at the index procedure, a total of 16 504 and 79 106 stents were included in the BP- and PP-DES groups, respectively. The Kaplan-Meier estimates for restenosis at 2 years were 1.2% and 1.4% in BP- and PP-DES groups, respectively. Definite stent thrombosis (ST) was low in both groups (0.5% and 0.7% in BP- and PP-DES groups, respectively). The adjusted hazard ratio (HR) for either restenosis or definite ST did not differ between BP- and PP-DES [adjusted HR 0.95, 95% confidence interval (CI) 0.74-1.21; P = 0.670 and adjusted HR 0.79, 95% CI 0.57-1.09; P = 0.151, respectively]. Similarly, there were no differences in the adjusted risk of all-cause death and myocardial infarction (MI) between the two groups (adjusted HR for all-cause death 1.01, 95% CI 0.82-1.25; P = 0.918 and adjusted HR for MI 1.05, 95% CI 0.93-1.19; P = 0.404).

Conclusion: In a large, nationwide, and unselected cohort of patients, percutaneous coronary intervention with BP-DES implantation was not associated with an incremental clinical benefit over PP-DES use at 2 years follow-up.
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http://dx.doi.org/10.1093/eurheartj/ehz244DOI Listing
August 2019

Bioabsorbable stents: only bad news?

Eur Heart J Suppl 2019 Mar 29;21(Suppl B):B28-B30. Epub 2019 Mar 29.

Department of General Surgery and Medical-Surgical Specialties, Università degli Studi di Catania, Italy.

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http://dx.doi.org/10.1093/eurheartj/suz009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6439901PMC
March 2019

Assessing the Nationwide Impact of a Registry-Based Randomized Clinical Trial on Cardiovascular Practice.

Circ Cardiovasc Interv 2019 03;12(3):e007381

Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center, Uppsala University, Sweden (S.B., G.S., B.L., D.L., S.J.).

Background: Registry-based randomized clinical trials have emerged as useful tools to provide evidence on the comparative efficacy and safety of different therapeutic strategies. However, it remains unknown whether the results of registry-based randomized clinical trials have a sizable impact on daily clinical practice. We sought, therefore, to describe the temporal trends in thrombus aspiration (TA) use in Sweden before, during, and after dissemination of the TASTE trial (Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia) results.

Methods And Results: From January 1, 2006, to December 31, 2017, we included all consecutive patients with ST-segment-elevation myocardial infarction undergoing percutaneous revascularization in Sweden. All patients were registered in the Swedish Coronary Angiography and Angioplasty Registry. A total of 55 809 ST-segment-elevation myocardial infarction patients were included. TA use in Sweden substantially decreased after dissemination of TASTE results (from 39.8% to 11.8% during and after TASTE, respectively). Substantial variability in TA use across treating centers was observed before TASTE (TA use ranging from 0% to 70%), but after TASTE both the interhospital variability and the frequency of TA use were markedly reduced. A constant shift in medical practice was seen about 4 months after dissemination of the TASTE trial results. Time trends for all-cause mortality and definite stent thrombosis at 30 days were not associated with variations in TA use ( P values >0.05 using the Granger test).

Conclusions: In Sweden, the results of the TASTE trial were impactful in daily clinical practice and led to a relevant decrease in TA use in ST-segment-elevation myocardial infarction patients undergoing percutaneous revascularization.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.118.007381DOI Listing
March 2019

Risk Stratification in Patients with Coronary Artery Disease: A Practical Walkthrough in the Landscape of Prognostic Risk Models.

Interv Cardiol 2018 Sep;13(3):112-120

CAST, AOU. Policlinico-Vittorio Emanuele, University of Catania Catania, Italy.

Although a combination of multiple strategies to prevent and treat coronary artery disease (CAD) has led to a relative reduction in cardiovascular mortality over recent decades, CAD remains the greatest cause of morbidity and mortality worldwide. A variety of individual factors and circumstances other than clinical presentation and treatment type contribute to determining the outcome of CAD. It is increasingly understood that personalised medicine, by taking these factors into account, achieves better results than "one-size-fitsall" approaches. In recent years, the multiplication of risk scoring systems for CAD has generated some degree of uncertainty regarding whether, when and how predictive models should be adopted when making clinical decisions. Against this background, this article reviews the most accepted risk models for patients with evidence of CAD to provide practical guidance within the current landscape of tools developed for prognostic risk stratification.
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http://dx.doi.org/10.15420/icr.2018.16.2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6234492PMC
September 2018

Incidence of Long-Term Structural Valve Dysfunction and Bioprosthetic Valve Failure After Transcatheter Aortic Valve Replacement.

J Am Heart Assoc 2018 08;7(15):e008440

1 Division of Cardiology Ferrarotto Hospital University of Catania Catania, Italy.

Background Long-term data on durability of currently available transcatheter heart valves are sparse. We sought to assess the incidence of long-term (8-year) structural valve dysfunction and bioprosthetic valve failure in a cohort of patients with transcatheter aortic valve replacement ( TAVR ) who reached at least 5-year follow-up. Methods and Results Consecutive patients with at least 5-year follow-up available undergoing TAVR from June 4, 2007 to March 30, 2012 were included. Structural valve dysfunction and bioprosthetic valve failure were defined according to newly standardized European Association of Percutaneous Cardiovascular Interventions/ European Society of Cardiology/European Association for Cardio-Thoracic Surgery criteria and reported as cumulative incidence function to account for the competing risk of death. A total of 288 consecutive patients with a mean age of 80.7±5.3 years and with a mean Society of Thoracic Surgery mortality score of 8.1±5.1% were analyzed. Survival rate at 8 years was 29.8%. Mean pressure gradients decreased from 53.3±15.9 mm Hg (pre- TAVR ) to 10.5±4.5 mm Hg (in-hospital post- TAVR ) ( P<0.001). There was a small, not significant, increase in the transaortic gradient throughout follow-up. Bioprosthetic valve failure was observed in a total of 11 patients (8-year cumulative incidence function: 4.51%; 95% confidence interval , 1.95%-8.76%). Severe and moderate structural valve dysfunctions were reported in 7 patients (8-year cumulative incidence function: 2.39%; 95% confidence interval, 0.77%-5.71%) and 13 patients (8-year cumulative incidence function: 5.87%; 95% confidence interval , 3.06%-9.96%), respectively. Aortic valve reintervention (redo TAVR ) was successfully performed in 2 patients (0.7%) presenting with symptomatic severe restenosis and intraprosthetic regurgitation subsequent to endocarditis. Conclusions In an aged population of patients with symptomatic severe aortic stenosis treated with first-generation bioprostheses, TAVR was associated with a survival rate of 30% but low rates of bioprosthetic valve failure and structural valve dysfunction at 8 years.
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http://dx.doi.org/10.1161/JAHA.117.008440DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6201462PMC
August 2018

Gender differences on benefits and risks associated with oral antithrombotic medications for coronary artery disease.

Expert Opin Drug Saf 2018 10 23;17(10):1041-1052. Epub 2018 Sep 23.

a Division of Cardiology , CAST, P.O. "Rodolico", Azienda Ospedaliero-Universitaria "Policlinico-Vittorio Emanuele", University of Catania , Catania , Italy.

Introduction: Despite the significant advances in the pharmacological and interventional management of patients with cardiovascular disease (CVD) over the last decades, cardiovascular mortality remains the leading cause of death. Large randomized clinical trials have investigated the efficacy and safety of different antithrombotic medications in patients with CVD. Although female gender is generally underrepresented in these clinical trials, most analyses clearly indicate that both men and women may accrue therapeutic benefits from antithrombotic management strategies.

Areas Covered: This review aims to provide a comprehensive and focused update on gender-related comparative clinical studies of antithrombotic therapies in patients suffering from CVD.

Expert Opinion: Current evidence supports the understanding of a similar therapeutic effect between genders with signals of an increased risk of bleeding in women. However, important gaps in evidence exist due to the overall limited percentage of women that have been enrolled in randomized controlled trials. A greater awareness of gender-related issues in antithrombotic therapy should be promoted among physicians and further evidence from large clinical trials looking at the safety and efficacy balance of different antithrombotic strategies in women is warranted.
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http://dx.doi.org/10.1080/14740338.2018.1524869DOI Listing
October 2018

Transcatheter or surgical treatment of severe aortic stenosis and coronary artery disease: A comparative analysis from the Italian OBSERVANT study.

Int J Cardiol 2018 Nov 7;270:102-106. Epub 2018 Jun 7.

National Centre for Global Health - Istituto Superiore di Sanità, Rome, Italy.

Background: To assess clinical outcomes of patients with concomitant severe aortic stenosis (AS) and coronary artery disease (CAD) who underwent transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) or surgical aortic valve replacement (SAVR) and coronary artery bypass grafting (CABG).

Methods: Data were extracted from the multicenter OBSERVANT study. For the purposes of the present analysis, we included only patients with established stable CAD meeting any of the following inclusion criteria: 1) TAVI patients with CAD undergoing staged PCI or TAVI and PCI in the same session; 2) SAVR patients undergoing combined SAVR and CABG in the same session.

Results: After propensity-score matching, a total of 472 patients (236 per group) were identified. Among TAVI patients, PCI was performed prior to the procedure in 217 patients (92.0%), whereas concomitant TAVI and PCI were performed in 19 patients (8.0%). At 3-year, there was no difference in survival between the two groups (KM estimate of freedom from death for SAVR and TAVI patients of 0.742 and 0.650, respectively; log-rank p-value of 0.105). The rate of MACCE was comparable between the two groups (KM estimate of freedom from MACCE for SAVR and TAVI patients of 0.683 and 0.582, respectively; log-rank p-value of 0.115).

Conclusions: In patients with associated severe AS and CAD, percutaneous treatment (TAVR and staged or concomitant PCI) was comparable to surgical treatment (SAVR and concomitant CABG) with respect to the early and mid-term risk of death from any cause, myocardial infarction, stroke and unplanned revascularization.
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http://dx.doi.org/10.1016/j.ijcard.2018.06.011DOI Listing
November 2018

Bioabsorbable polymer everolimus-eluting stents in patients with acute myocardial infarction: a report from the Swedish Coronary Angiography and Angioplasty Registry.

EuroIntervention 2018 Aug 3;14(5):e562-e569. Epub 2018 Aug 3.

Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.

Aims: The clinical performance of the SYNERGY drug-eluting stent (DES) in patients with acute myocardial infarction (MI) has not been investigated in detail. We sought to report on the outcomes after SYNERGY DES (Boston Scientific, Marlborough, MA, USA) implantation in patients with MI undergoing percutaneous revascularisation (PCI).

Methods And Results: We included all consecutive patients with MI undergoing PCI with the SYNERGY DES and newer-generation DES (n-DES group) in Sweden. From March 2013 to September 2016, a total of 36,292 patients, of whom 39.7% presented with ST-elevation MI, were included. As compared to patients in the n-DES group (n=31,403), patients in the SYNERGY group (n=4,889) were older and presented more often with left main or three-vessel disease involvement, as well as with restenotic lesions (p<0.001 for all parameters). The Kaplan-Meier estimates of ST at two years in the SYNERGY and n-DES groups were 0.69% and 0.81%, respectively (adjusted HR 1.00, 95% CI: 0.69-1.46; p=0.99). Clinically relevant restenosis was encountered in 1.48% and 1.25% of patients in the SYNERGY and n-DES groups, respectively (adjusted HR 1.05, 95% CI: 0.81-1.37; p=0.72). No differences in the risk of all-cause death and recurrent MI were found between the two groups after adjustment (adjusted HR 1.12, 95% CI: 0.98-1.28; p=0.10, and adjusted HR 0.95, 95% CI: 0.82-1.10; p=0.49, respectively).

Conclusions: In a large and unselected cohort of patients with MI undergoing percutaneous revascularisation with the SYNERGY DES, stent performance and clinical outcomes did not differ compared with other n-DES up to two years.
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http://dx.doi.org/10.4244/EIJ-D-18-00392DOI Listing
August 2018

Incidence, Timing, Causes and Predictors of Early and Late Re-Hospitalization in Patients Who Underwent Percutaneous Mitral Valve Repair With the MitraClip System.

Am J Cardiol 2018 05 12;121(10):1253-1259. Epub 2018 Feb 12.

Cardiac-Thoracic-Vascular Department, Azienda Ospedaliero-Universitaria "Policlinico-Vittorio Emanuele," University of Catania, Catania, Italy.

The pattern and reasons for re-hospitalization (RH) after MitraClip implantation are not well characterized. A total of 322 consecutive MitraClip patients were included, with data stratified by RH status. Multivariate analyses were conducted to identify predictors of early (30-day) and late (30-day to 12-month) RH. Eighty-nine patients (27.6%) were readmitted to hospital during the study period and early RH occurred in 27%. The median time from MitraClip to RH was 99 days. RH was mostly related to cardiovascular causes (66.3%). Anemia and gastrointestinal bleeding were the most frequent noncardiovascular causes. Independent predictors of early RH were length of stay ≥3 days during the index procedure (odds ratio [OR] 4.13, 95% confidence interval [CI] 1.32 to 12.91), reduction of left ventricular ejection fraction ≥5% after MitraClip implantation (OR 4.88, 95% CI 1.36 to 18.91), and severe systolic pulmonary artery pressure ≥60 mm Hg at discharge (OR 3.72, 95% CI 1.23 to 11.26). Conversely, the independent predictors of late RH were device failure (OR 4.02, 95% CI 1.22 to 13.25) and systolic pulmonary artery pressure ≥60 mm Hg at discharge (OR 2.34, 95% CI 1.01 to 5.44). In patients with early RHs, survival was significantly worse at 12 months compared with patients with late RH and no-RH (69.3% vs 82.6% vs 86%, p <0.001). In conclusion, RH is not uncommon after MitraClip implantation and cardiovascular causes represent its most frequent etiology. Clinical and echocardiographic predictors of early and late RH can be identified at discharge. Early RH carries a worse prognosis than late RH.
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http://dx.doi.org/10.1016/j.amjcard.2018.01.047DOI Listing
May 2018

Operator volume and mortality in percutaneous coronary intervention: a call for better competency metrics.

Eur Heart J 2018 05;39(18):1635-1637

Centro Alte Specialità e Trapianti, Azienda Ospedaliero-Universitaria, "Policlinico-Vittorio Emanuele", Presidio Ospedaliero Rodolico, Ed. 8, Via Santa Sofia 78, Catania, Sicily, Italy.

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http://dx.doi.org/10.1093/eurheartj/ehy144DOI Listing
May 2018

Statistical primer: methodology and reporting of meta-analyses.

Eur J Cardiothorac Surg 2018 04;53(4):708-713

Cardio-Thoracic-Vascular Department, Azienda Ospedaliero-Universitaria 'Policlinico-Vittorio Emanuele', University of Catania, Catania, Italy.

In modern medicine, the results of a comprehensive and methodologically sound meta-analysis bring the most robust, high-quality information to support evidence-based decision-making. With recent developments in newer meta-analytic approaches, iteration of statistical paradigms and software implementations, network and patient-level meta-analyses have recently gained popularity alongside conventional pairwise study-level meta-analyses. However, pitfalls are common in this challenging and rapidly evolving field of statistics. In this regard, guidelines have been introduced to standardize, strengthen and homogenize different aspects of conducting and reporting the results of a meta-analysis. Current recommendations advise a careful selection of the individual studies to be pooled, mainly based on the methodological quality and homogeneity in study designs. Indeed, even if a reasonable degree of variability across study results (namely, heterogeneity) can be accounted for with proper statistics (i.e. random-effect models), no adjustment can be performed in meta-analyses violating the issue of clinical validity and similarity across the included studies. In this context, this statistical primer aims at providing a conceptual framework, complemented by a practical example, for conducting, interpreting and critically evaluating meta-analyses.
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http://dx.doi.org/10.1093/ejcts/ezy004DOI Listing
April 2018

Decision Analytic Markov Model Weighting Expected Benefits and Current Limitations of First-Generation Bioresorbable Vascular Scaffolds: Implications for Manufacturers and Next Device Iterations.

Circ Cardiovasc Interv 2018 01;11(1):e005768

From the Cardiac-Thoracic-Vascular Department, Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele Presidio Ferrarotto, Catania, Italy (D.C., S.B., S.R., P.C., B.F., C.T.); and Department of General Surgery and Medical-Surgical Specialties, University of Catania, Italy (D.C., P.C., C.T.).

Background: Relative benefits of bioresorbable vascular scaffolds (BVS) compared with everolimus-eluting stents (EES) are expected to accrue after complete bioresorption.

Methods And Results: We built a decision analytic Markov model comparing BVS and EES for a contemporary percutaneous coronary intervention population. Procedure-related morbidity and outcome data from the available literature were used to derive model probabilities. The net benefit of BVS and EES was estimated in terms of quality-adjusted life expectancy. Under the assumption of no risk for device thrombosis and target lesion revascularization with BVS beyond 3 years, the equipoise in quality-adjusted life expectancy (12.86) between BVS and EES was achieved 19 years after implantation. The maximum tolerable excess risk of 3-year BVS thrombosis equalizing the model-predicted quality-adjusted life expectancy of BVS and EES at 10 years was 1.40, corresponding to an absolute tolerable rate of 1.45%.

Conclusions: At the currently observed relative increase in device thrombosis and under the extreme hypothesis of no scaffold thrombosis and target lesion revascularization beyond 3 years, the incremental benefit of BVS over EES becomes apparent only after 19 years. This simulation suggests that there is a small degree of benefit that clinicians and decision-makers may expect from the first-generation BVS at the current risk of device thrombosis. Manufacturers should target scaffold thrombosis rates <1.45% at 3 years to make their technologies attractive during a 10-year horizon.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.117.005768DOI Listing
January 2018

Clinical Outcomes Following Intravascular Imaging-Guided Versus Coronary Angiography-Guided Percutaneous Coronary Intervention With Stent Implantation: A Systematic Review and Bayesian Network Meta-Analysis of 31 Studies and 17,882 Patients.

JACC Cardiovasc Interv 2017 12 15;10(24):2488-2498. Epub 2017 Nov 15.

Division of Cardiology, Cardio-Thoracic-Vascular Department, Azienda Ospedaliero-Universitaria "Policlinico-Vittorio Emanuele", University of Catania, Catania, Italy. Electronic address:

Objectives: The authors sought to explore the comparative clinical efficacy of different imaging modalities for guiding percutaneous coronary interventions (PCI).

Background: Coronary angiography (CA) is the standard imaging modality for intraprocedural guidance of PCI. Intracoronary imaging techniques, including intravascular ultrasound (IVUS) and optical coherence tomography (OCT), can overcome some limitations of CA.

Methods: Comprehensive hierarchical Bayesian network meta-analysis of randomized clinical trials and adjusted observational studies comparing clinical outcomes of PCI with stent implantation guided by CA, IVUS, or OCT.

Results: A total of 31 studies encompassing 17,882 patients were included. Compared with CA guidance, the risks of all-cause death (odds ratio [OR]: 0.74; 95% credible interval [CrI]: 0.58 to 0.98), myocardial infarction (OR: 0.72; 95% CrI: 0.52 to 0.93), target lesion revascularization (OR: 0.74, 95% CrI: 0.58 to 0.90) and stent thrombosis (OR: 0.42; 95% CrI: 0.20 to 0.72) were significantly reduced by IVUS guidance. PCI guidance using either IVUS or OCT was associated with a significant reduction of major adverse cardiovascular events (OR: 0.79; 95% CrI: 0.67 to 0.91 and OR: 0.68; 95% CrI: 0.49 to 0.97, respectively) and cardiovascular death (OR: 0.47; 95% CrI: 0.32 to 0.66 and OR: 0.31; 95% CrI: 0.13 to 0.66, respectively). No differences in terms of comparative clinical efficacy were found between IVUS and OCT for all the investigated outcomes. Pooled estimates were consistent across several sensitivity analyses. However, the treatment effect of IVUS on all-cause death was neutralized in the analysis restricted to randomized clinical trials (OR: 1.03; 95% CrI: 0.41 to 2.14).

Conclusions: Compared with CA, the use of intravascular imaging techniques for PCI guidance reduces the risk of cardiovascular death and adverse events.
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http://dx.doi.org/10.1016/j.jcin.2017.08.051DOI Listing
December 2017
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