Publications by authors named "Tullio Palmerini"

158 Publications

Long-term echocardiographic findings after TAVR: 5-year follow-up in 400 consecutive patients.

Intern Emerg Med 2021 Mar 26. Epub 2021 Mar 26.

Cardiology Unit, S. Orsola-Malpighi University Hospital, Bologna, Italy.

A little is known about long-term hemodynamic performance of the transcatheter heart valves (THVs). The aim of the present study was to assess hemodynamic outcome, structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) in patients treated with transcatheter aortic valve replacement (TAVR) five or more years ago. All consecutive patients treated at Bologna and Florence University Hospitals with TAVR between January 2008 and December 2013 were analyzed in a retrospective registry with regards to demographic, procedural and outcome data as well as follow-up data on mortality and echocardiographic characteristics. Standardized definitions were used to define outcomes and durability of the THVs. 400 patients were included in the study, mostly treated with transfemoral TAVR (71.8%), using first generation balloon-expandable (37%) or self-expanding (63%) devices. The 1-year mortality was 21.8% (87 patients) and 5-year mortality was 53.8% (215 patients). Median follow-up was 45.5 months (14.0-68.9) totaling 1516.7 patient/years, with the longest follow-up being 10.25 years. At least one follow-up echocardiogram was available for 320 patients (80%), SVD occurred in 19 of these patients (5.94%): moderate in 17 patients (5.31%) and severe in two patients (0.63%). The hemodynamic presentation was stenosis in most of the cases (12 patients). Late BVF was registered in 10 patients (3.13%) and this was mainly driven by transcatheter paravalvular leak closure (six patients) with subsequent good long-term outcome. Our results confirm that TAVR appears to be a long-lasting treatment strategy with low rates of structural valve degeneration and valve failure.
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http://dx.doi.org/10.1007/s11739-021-02689-wDOI Listing
March 2021

Pattern of arterial inflammation and inflammatory markers in people living with HIV compared with uninfected people.

J Nucl Cardiol 2021 Feb 10. Epub 2021 Feb 10.

Division of Cardiology, Department of Experimental Diagnostic and Specialty Medicine, IRCCS Policlinico di St.Orsola, Alma Mater Studiorum-University of Bologna, Via Massarenti 9, 40138, Bologna, Italy.

Study Design: To compare arterial inflammation (AI) between people living with HIV (PLWH) and uninfected people as assessed by F-Fluorodeoxyglucose (F-FDG)-positron emission tomography (PET).

Methods: We prospectively enrolled 20 PLWH and 20 uninfected people with no known cardiovascular disease and at least 3 traditional cardiovascular risk factors. All patients underwent F-FDG-PET/computed tomography (CT) of the thorax and neck. Biomarkers linked to inflammation and atherosclerosis were also determined. The primary outcome was AI in ascending aorta (AA) measured as mean maximum target-to-background ratio (TBR). The independent relationships between HIV status and both TBR and biomarkers were evaluated by multivariable linear regression adjusted for body mass index, creatinine, statin therapy, and atherosclerotic cardiovascular 10-year estimated risk (ASCVD).

Results: Unadjusted mean TBR in AA was slightly higher but not statistically different (P = .18) in PLWH (2.07; IQR 1.97, 2.32]) than uninfected people (2.01; IQR 1.85, 2.16]). On multivariable analysis, PLWH had an independent risk of increased mean log-TBR in AA (coef = 0.12; 95%CI 0.01,0.22; P = .032). HIV infection was independently associated with higher values of interleukin-10 (coef = 0.83; 95%CI 0.34, 1.32; P = .001), interferon-γ (coef. = 0.90; 95%CI 0.32, 1.47; P = .003), and vascular cell adhesion molecule-1 (VCAM-1) (coef. = 0.75; 95%CI: 0.42, 1.08, P < .001).

Conclusions: In patients with high cardiovascular risk, HIV status was an independent predictor of increased TBR in AA. PLWH also had an increased independent risk of IFN-γ, IL-10, and VCAM-1 levels.
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http://dx.doi.org/10.1007/s12350-020-02522-5DOI Listing
February 2021

Target Lesion Failure With Current Drug-Eluting Stents: Evidence From a Comprehensive Network Meta-Analysis.

JACC Cardiovasc Interv 2020 12;13(24):2868-2878

Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, IRCCS Policlinico di St. Orsola, Alma Mater Studiorum Università di Bologna, Bologna, Italy.

Objectives: The aim of this study was to investigate the efficacy and safety of currently used drug-eluting stents (DES).

Background: Head-to-head comparisons among newer DES have shown conflicting results.

Methods: For this network meta-analysis, randomized controlled trials comparing different types of currently used DES were searched in PubMed, Scopus, and proceedings of international meetings. The primary endpoint was target lesion failure (TLF) at 1 year and at long-term follow-up.

Results: Seventy-seven trials with 99,039 patients were selected for this network meta-analysis. Among the 10 DES included in the meta-analysis, 4 received the most extensive investigation: Orsiro, XIENCE, Nobori/BioMatrix, and Resolute. At 1 year, the Orsiro stent was associated with lower rates of TLF compared with XIENCE (odds ratio [OR]: 0.84; 95% confidence interval [CI]: 0.71 to 0.98; p = 0.03), Resolute (OR: 0.81; 95% CI: 0.68 to 0.95; p = 0.01), and Nobori/BioMatrix (OR: 0.81; 95% CI: 0.67 to 0.98; p = 0.03). Orsiro had the highest probability to be the best (70.8%), with a surface under the cumulative ranking curve value of 95.9%. However, after a median follow-up period of 50 months (range: 24 to 60 months), no significant difference was apparent in the rates of TLF between any DES, although Orsiro still ranked as the best stent (58.6% probability to be the best). In addition, Orsiro had a lower rate of long-term definite stent thrombosis compared with Nobori/BioMatrix (OR: 0.60; 95% CI: 0.36 to 0.98; p = 0.04) and lower rates of definite and probable stent thrombosis compared with Resolute (OR: 0.66; 95% CI: 0.45 to 0.99; p = 0.04). No differences in cardiac mortality between any DES were observed.

Conclusions: Orsiro is associated with a lower 1-year rate of TLF compared with XIENCE, Resolute, and Nobori/BioMatrix but with an attenuation of the efficacy signal at long-term follow-up.
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http://dx.doi.org/10.1016/j.jcin.2020.09.014DOI Listing
December 2020

Bleeding risk prediction in elderly patients managed invasively for acute coronary syndromes: External validation of the PRECISE-DAPT and PARIS scores.

Int J Cardiol 2021 Apr 3;328:22-28. Epub 2020 Dec 3.

University of Pavia, Pavia, Italy.

Background: We sought to assess and compare the prediction power of the PRECISE-DAPT and PARIS risk scores with regards to bleeding events in elderly patients suffering from acute coronary syndromes (ACS) and undergoing invasive management.

Methods: Our external validation cohort included 1883 patients older >74 years admitted for ACS and treated with PCI from 3 prospective, multicenter trials.

Results: After a median follow-up of 365 days, patients in the high-risk categories according to the PRECISE-DAPT score experienced a higher rate of BARC 3-5 bleedings (p = 0.002) while this was not observed for those in the high-risk category according to the PARIS risk score (p = 0.3). Both scores had a moderate discriminative power (c-statistics 0.70 and 0.64, respectively) and calibration was accurate for both risk scores (all χ > 0.05), but PARIS risk score was associated to a greater overestimation of the risk (p = 0.02). Decision curve analysis was in favor of the PRECISE-DAPT score up to a risk threshold of 2%.

Conclusions: In the setting of older adults managed invasively for ACS both the PARIS and the PRECISE-DAPT scores were moderately accurate in predicting bleeding risk. However, the use of the PRECISE-DAPT is associated with better performance.
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http://dx.doi.org/10.1016/j.ijcard.2020.11.065DOI Listing
April 2021

Antiplatelet strategies in acute coronary syndromes: design and methodology of an international collaborative network meta-analysis of randomized controlled trials.

Minerva Cardioangiol 2020 Dec 1. Epub 2020 Dec 1.

Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA -

Introduction: The optimal choice of oral P2Y12 receptor inhibitors has the potential to significantly influence outcomes. We seek to compare the safety and efficacy of the three most commonly used oral P2Y12 receptor inhibitors (clopidogrel, prasugrel, and ticagrelor) in acute coronary syndromes (ACS) via a comprehensive systematic review and network meta-analysis.

Evidence Acquisition: We will perform a comprehensive search for randomized clinical trials which compared cardiovascular and hemorrhagic outcomes after use of at least two of the distinct oral P2Y12 receptor inhibitors (i.e. clopidogrel, prasugrel, and ticagrelor). In addition, key inclusion criteria will be trial size of at least 100 patients and at least 1 month of follow-up time. Several pre-specified subgroups will be explored, including Asian patients, patients presenting with ST-elevation myocardial infarction, patients of advanced age, and others.

Evidence Synthesis: Exploratory frequentist pairwise meta-analyses will be based primarily on a random-effects method, relying on relative risks (RR) for short-term endpoints and incidence rate ratios (IRR) for long-term endpoints. Inferential frequentist network meta-analysis will be based primarily on a random-effects method, relying on RR and IRR as specified above. Results will be reported as point summary of effect, 95% CI, and p-values for effect, and graphically represented using forest plots.

Conclusions: An international collaborative network meta-analysis has begun to comprehensively analyze the safety and efficacy of prasugrel, ticagrelor and clopidogrel, each on a background of aspirin, for management of patients with ACS. It is our hope that the rigor and breadth of the undertaking described herein will provide novel insights that will inform optimal patient care for patients with ACS treated conservatively, or undergoing revascularization.
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http://dx.doi.org/10.23736/S0026-4725.20.05353-0DOI Listing
December 2020

Correlation between aortic root dimension and coronary ectasia.

Coron Artery Dis 2020 Oct 13. Epub 2020 Oct 13.

Department of Cardiology, University of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy.

Background: Aortic aneurysms are associated with coronary artery ectasia (CAE). However, the relation between the extent of CAE and the severity of aortic dilatation is not understood. This study was undertaken to investigate the relationship between angiographic extension of CAE and aortic dimension.

Patients And Methods: We retrospectively include 135 patients with angiographic diagnosis of CAE defined as dilatation of coronary segment more than 1.5 times than an adjacent healthy one. Study population was divided in four groups according to the maximum diameter of ascending aorta beyond sinus of Valsalva obtained in the parasternal long-axis view (group 1: <40 mm; group 2: 40-45 mm; group 3: 45-55 mm; group 4: >55 mm or previous surgery because of aortic aneurysm/dissection. The relationship between aortic dimension and the extension of CAE was investigated by means of multivariable linear regression, including variables selected at univariable analysis (P < 0.1). The total estimated ectatic area (EEA total) was used as dependent variable.

Results: Baseline characteristics of study groups were well balanced. Patients in group 4 were more likely to have both higher neutrophil count and neutrophil to lymphocyte ratio. On univariable analysis ascending aorta diameter [Coef. = 0.075; 95% confidence interval (CI) 0.052-0.103, P < 0.01] and c-reactive protein (CRP) values [Coef. = 0.033, 95% CI 0.003-0.174, P = 0.04] showed a linear association with total EEA. After adjustment for CRP values only the ascending aorta diameter was still associated with the extent of CAE (95% CI 0.025-0.063, P < 0.01).

Conclusion: In patients with diagnosis of CAE, a strong linear association between aortic dimension and coronary ectasia extent exists.
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http://dx.doi.org/10.1097/MCA.0000000000000977DOI Listing
October 2020

Routine minimalist transcatheter aortic valve implantation with local anesthesia only.

J Cardiovasc Med (Hagerstown) 2020 10;21(10):805-811

Cardiology Unit.

Aims: Conscious sedation instead of general anesthesia has been increasingly adopted in many centers for transfemoral transcatheter aortic valve replacement (TAVR). Improvement of materials and operators' experience and reduction of periprocedural complications allowed procedural simplification and adoption of a minimalist approach. With this study, we sought to assess the feasibility and safety of transfemoral TAVR routinely performed under local anesthesia without on-site anesthesiology support.

Methods: The routine transfemoral TAVR protocol adopted at our center includes a minimalist approach, local anesthesia alone with fully awake patient, anesthesiologist available on call but not in the room, and direct transfer to the cardiology ward after the procedure. All consecutive patients undergoing transfemoral TAVR between January 2015 and July 2018 were included. We assessed the rates of actual local anesthesia-only procedures, conversion to conscious sedation or general anesthesia and 30-day clinical outcomes.

Results: Among 321 patients, 6 received general anesthesia upfront and 315 (98.1%) local anesthesia only. Mean age of the local anesthesia group was 83.2 ± 6.9 years, Society of Thoracic Surgery score 5.8 ± 4.8%. A balloon-expandable valve was used in 65.7%. Four patients (1.3%) shifted to conscious sedation because of pain or anxiety; 6 patients (1.9%) shifted to general anesthesia because of procedural complications. Hence, local anesthesia alone was possible in 305 patients (96.8% of the intended cohort, 95% of all transfemoral procedures). At 30 days, in the intended local anesthesia group, mortality was 1.6%, stroke 0.6%, major vascular complications 2.6%. Median hospital stay was 4 days (IQR 3-7).

Conclusion: Transfemoral TAVR can be safely performed with local anesthesia alone and without an on-site anesthesiologist in the vast majority of patients.
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http://dx.doi.org/10.2459/JCM.0000000000001030DOI Listing
October 2020

Impact of Elective, Uncomplicated Target Lesion Revascularization on Cardiac Mortality After Elective Percutaneous Coronary Intervention of Unprotected Left Main Coronary Artery Disease.

Am J Cardiol 2020 08 13;128:94-100. Epub 2020 May 13.

Cardiology Unit, Cardio-Thoraco-Vascular Department, University Hospital of Bologna, Bologna, Italy.

This study sought to investigate the impact of elective, uncomplicated target lesion revascularization (TLR) on long-term cardiac mortality after percutaneous coronary intervention (PCI) of unprotected left main coronary artery (ULMCA) disease. Consecutive patients undergoing PCI for ULMCA disease between January 2003 and December 2015 in 1 interventional center in Northern Italy were included. Patients presenting with cardiogenic shock, ST-segment elevation myocardial infarction (MI), as well as those undergoing urgent or complicated TLR were excluded. The primary endpoint of the study was cardiac mortality. Among the 418 patients fulfilling the study criteria, 79 (18.46%) underwent elective, uncomplicated TLR. After a median follow-up of 5.5 years, there were 23 cardiac deaths among patients undergoing elective, uncomplicated TLR versus 50 in patients not undergoing TLR. After adjusting for possible confounders, TLR was an independent predictor of cardiac mortality (Hazard ratio [HZ] = 1.92, 95% confidence interval [CI]: 1.05 to 3.49; p = 0.03). Patients undergoing TLR had also significantly higher rates of the composite of cardiac death, MI and stroke compared with the no TLR group (adjusted HR = 1.76, 95% CI 1.14 to 2.72). In conclusion, elective, uncomplicated TLR after PCI of ULMCA disease is associated with increased risk of long-term cardiac mortality. Reducing the risk of TLR after PCI of ULMCA disease may potentially improve the survival of these patients.
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http://dx.doi.org/10.1016/j.amjcard.2020.04.053DOI Listing
August 2020

Long-term outcome of prosthesis-patient mismatch after transcatheter aortic valve replacement.

Int J Cardiol 2020 Nov 5;318:27-31. Epub 2020 Jul 5.

Interventional Cardiology Unit, Cardio-Thoracic-Vascular Department, University Hospital of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy. Electronic address:

Background: Incidence and long-term clinical consequences of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) are still unclear.

Methods: We enrolled 710 consecutive patients who underwent TAVR. PPM was defined as absent if the index orifice area (iEOA) was >0.85 cm2/m2, moderate if the iEOA was between 0.65 and 0.85 cm2/m2 or severe if the iEOA was <0.65 cm2/m2.

Results: Among the 566 patients fulfilling the study criteria, the distribution of PPM was as follows: 50.5% none (n = 286), 43% moderate PPM (n = 243) and 6.5% severe PPM (n = 37). At 5-year follow-up, patients with severe PPM had a significantly higher incidence of the combined endpoint of cardiovascular death, acute myocardial infarction and stroke (p = .025) compared with the other patients. After adjusting the results for possible confounders, severe PPM remained an independent predictor of long-term adverse outcome (HR: 2.46; 95% Confidence Interval: 1.10-5.53). The independent predictors of severe PPM were valve-in-valve procedure and body mass index. Balloon-expandable valves were not associated with higher rates of severe PPM in comparison with self-expandable valves (8% vs. 5%, respectively, p = .245).

Conclusions: In our study severe PPM emerged as a risk factor for long-term major adverse cardiac and cerebrovascular events.
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http://dx.doi.org/10.1016/j.ijcard.2020.06.033DOI Listing
November 2020

Predicting and improving outcomes of transcatheter aortic valve replacement in older adults and the elderly.

Expert Rev Cardiovasc Ther 2020 Oct 18;18(10):663-680. Epub 2020 Jun 18.

Cardiology Unit, Cardio-Thorax-Vascular Department, University Hospital of Bologna , Bologna, Italy.

Introduction: Indications for transcatheter aortic valve replacement (TAVR) are progressively extending to younger and lower risk patients. In this scenario, minimizing periprocedural complications and optimizing procedural result are both crucial to achieve an excellent long-term outcome.

Areas Covered: In this review, we summarize the main strategies that can be adopted before, during, and after TAVR to predict and prevent complications, to optimize procedural results and ultimately improve outcomes, with an emphasis on more recent evidence, new devices, and new techniques.

Expert Opinion: In the next future TAVR will probably represent the first treatment option for patients affected by aortic valve stenosis who are candidates to receive a biological valve. Continuous refinement of TAVR devices has been key to allow safer and most effective procedures and further progress is expected. Development of new techniques and devices, such as ultrasound-guided puncture and intravascular lithotripsy, will expand safety and eligibility to transfemoral procedures. Effective preemptive measures for coronary occlusion have been developed. Open issues include cerebral protection, re-access to coronary arteries, post-procedural management, and therapy.
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http://dx.doi.org/10.1080/14779072.2020.1778465DOI Listing
October 2020

Long-term percentage of ventricular pacing in patients requiring pacemaker implantation after transcatheter aortic valve replacement: A multicenter 10-year experience.

Heart Rhythm 2020 11 5;17(11):1897-1903. Epub 2020 Jun 5.

Cardiac Intensive Care Unit, Arrhythmia and Electrophysiology and Experimental Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

Background: Recent studies suggest that atrioventricular (AV) conduction may recover after pacemaker (PM) implantation following transcatheter aortic valve replacement (TAVR), but little is known about long-term follow-up of such patients.

Objective: The purpose of this study was to evaluate the long-term percentage of right ventricular pacing in patients who underwent TAVR and required PM implantation stratified based on the indication for permanent pacing.

Methods: Retrospective analysis of all consecutive patients who underwent TAVR from February 2008 to August 2019 at 3 centers was performed. Patients already implanted with a PM/implantable cardioverter-defibrillator (ICD) before TAVR, implanted with a cardiac resynchronization therapy device, or implanted >30 days after TAVR were excluded. Eligible patients were divided into 2 groups based on the presence (persistent atrioventricular block [AVB] group) or absence (nonpersistent AVB group) of persistent third-degree AVB after TAVR.

Results: A total of 1594 patients underwent TAVR. Two hundred four patients were implanted with a PM or ICD after TAVR and 32 met exclusion criteria, so 172 patients were eligible (median time TAVR-PM implant 4 days) for a total of 352 follow-up visits analyzed. A significant difference in the percentage of ventricular pacing was observed at follow-up performed 7-90 days after implantation (98% persistent AVB group vs 8% nonpersistent AVB group; P <.001). This difference remained significant at follow-up performed 91-270 days (95% vs 3.5%; P <.001), 271-540 days (95.5% vs 3%; P = .006), and 541-900 days (97.4% vs 2.2%; P <.001) after implantation.

Conclusion: Patients requiring PM implantation due to persistent third-degree AVB after TAVR were less likely to show AV conduction recovery, whereas patients implanted for other indications showed a low percentage of pacing during follow-up.
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http://dx.doi.org/10.1016/j.hrthm.2020.05.040DOI Listing
November 2020

Coronary Protection to Prevent Coronary Obstruction During TAVR: A Multicenter International Registry.

JACC Cardiovasc Interv 2020 03 12;13(6):739-747. Epub 2020 Feb 12.

Cedars-Sinai Medical Center, Los Angeles, California.

Objectives: The aim of this study was to investigate the safety and efficacy of coronary protection by preventive coronary wiring and stenting across the coronary ostia in patients at high risk for coronary obstruction after transcatheter aortic valve replacement (TAVR).

Background: Coronary obstruction following TAVR is a life-threatening complication with high procedural and short-term mortality.

Methods: Data were collected retrospectively from a multicenter international registry between April 2011 and February 2019.

Results: Among 236 patients undergoing coronary protection with preventive coronary wiring, 143 had eventually stents implanted across the coronary ostia after valve deployment. At 3-year follow-up, rates of cardiac death were 7.8% in patients receiving stents and 15.7% in those not receiving stents (adjusted hazard ratio: 0.42; 95% confidence interval: 0.14 to 1.28; p = 0.13). There were 2 definite stent thromboses (0.9%) in patients receiving stents, both occurring after TAVR in "valve-in-valve" procedures. In patients not receiving stents, there were 4 delayed coronary occlusions (DCOs) (4.3%), occurring from 5 min to 6 h after wire removal. Three cases occurred in valve-in-valve procedures and 1 in a native aortic valve procedure. Distance between the virtual transcatheter valve and the protected coronary ostia <4 mm was present in 75.0% of patients with DCO compared with 30.4% of patients without DCO (p = 0.19).

Conclusions: In patients undergoing TAVR at high risk for coronary obstruction, preventive stent implantation across the coronary ostia is associated with good mid-term survival rates and low rates of stent thrombosis. Patients undergoing coronary protection with wire only have a considerable risk for DCO.
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http://dx.doi.org/10.1016/j.jcin.2019.11.024DOI Listing
March 2020

Stent-Related Adverse Events >1 Year After Percutaneous Coronary Intervention.

J Am Coll Cardiol 2020 02;75(6):590-604

Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address:

Background: The majority of stent-related major adverse cardiovascular events (MACE) after percutaneous coronary intervention (PCI) are believed to occur within the first year. Very-late (>1-year) stent-related MACE have not been well described.

Objectives: The purpose of this study was to assess the frequency and predictors of very-late stent-related events or MACE by stent type.

Methods: Individual patient data from 19 prospective, randomized metallic stent trials maintained at a leading academic research organization were pooled. Very-late MACE (a composite of cardiac death, myocardial infarction [MI], or ischemia-driven target lesion revascularization [ID-TLR]), and target lesion failure (cardiac death, target-vessel MI, or ID-TLR) were assessed within year 1 and between 1 and 5 years after PCI with bare-metal stents (BMS), first-generation drug-eluting stents (DES1) and second-generation drug-eluting stents (DES2). A network meta-analysis was performed to evaluate direct and indirect comparisons.

Results: Among 25,032 total patients, 3,718, 7,934, and 13,380 were treated with BMS, DES1, and DES2, respectively. MACE rates within 1 year after PCI were progressively lower after treatment with BMS versus DES1 versus DES2 (17.9% vs. 8.2% vs. 5.1%, respectively, p < 0.0001). Between years 1 and 5, very-late MACE occurred in 9.4% of patients (including 2.9% cardiac death, 3.1% MI, and 5.1% ID-TLR). Very-late MACE occurred in 9.7%, 11.0%, and 8.3% of patients treated with BMS, DES1, and DES2, respectively (p < 0.0001), linearly increasing between 1 and 5 years. Similar findings were observed for target lesion failure in 19,578 patients from 12 trials. Findings were confirmed in the network meta-analysis.

Conclusions: In this large-scale, individual patient data pooled study, very-late stent-related events occurred between 1 and 5 years after PCI at a rate of ∼2%/year with all stent types, with no plateau evident. New approaches are required to improve long-term outcomes after PCI.
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http://dx.doi.org/10.1016/j.jacc.2019.11.058DOI Listing
February 2020

Impact of coronary bypass or stenting on mortality and myocardial infarction in stable coronary artery disease.

Int J Cardiol 2020 06 23;309:63-69. Epub 2020 Jan 23.

Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Alma Mater Studiorum Università di Bologna, Italy.

Background: To assess whether coronary bypass (CABG) or stenting reduce the risk of mortality and myocardial infarction (MI) compared with optimal medical therapy (OMT) in stable coronary artery disease (CAD).

Methods: We performed a systematic review and network meta-analysis of contemporary randomized controlled trials comparing OMT, CABG and different stent types in stable CAD. All-comer trials were included if the rate of patients with acute myocardial infarction (AMI) was≤20%. Endpoints were all-cause mortality and MI.

Results: Ninety-seven trials including 75,754 patients were analyzed at a weighted mean follow up of 42.5 months. Compared to OMT, CABG was associated with a lower risk of death (OR = 0.84; 95%CI:0.71-0.97). After exclusion of trials in left main and/or multivessel disease(LM/MVD) this benefit was not statistically significant (OR = 0.89; 95%CI:0.74-1.06). CABG was associated with a lower risk of MI (OR = 0.67;95%CI: 0.49-0.91) showing, however, a certain degree of inconsistency (p=0.10). None of the stent types included was associated with a lower risk of death. However, durable-polymer-CoCr-everolimus-eluting stent, by mixed evidence, after exclusion of either LM/MVD (OR = 0.73;95%CI: 0.54-0.98) or all-comer/post-MI trials (OR = 0.62;95%CI:0.39-0.98) was associated with a lower risk of MI than OMT. Similar findings, by indirect evidence, were confirmed for bio-absorbable-polymer-CoCr-sirolimus eluting stent (LMV/MVD trials excluded OR = 0.46; 95%CI = 0.29-0.74, all-comer/post-MI trials excluded: OR = 0.41;95%CI:0.22-0.79).

Conclusions: In stable CAD, CABG reduces the risk of mortality and MI compared to OMT, especially in patients with higher extent of CAD. Our study suggests that some of second and latest-generation drug-eluting stents may reduce the risk of MI. Future research should confirm these latter findings.
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http://dx.doi.org/10.1016/j.ijcard.2020.01.054DOI Listing
June 2020

In-hospital and thirty-day outcomes of the SAPIEN 3 Ultra balloon-expandable transcatheter aortic valve: the S3U registry.

EuroIntervention 2020 Feb;15(14):1240-1247

Cardiology unit, Cardio-Thoracic-Vascular Department, University Hospital of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy.

Aims: The aim of this study was to evaluate 30-day safety and efficacy outcomes of transcatheter aortic valve implantation (TAVI) performed with the SAPIEN 3 Ultra system.

Methods And Results: The S3U registry is a physician-led, post-approval, multicentre, observational registry of transfemoral TAVI with the SAPIEN 3 Ultra. New features include an improved sealing skirt, a 14 Fr expandable sheath and a new delivery catheter. Overall, 139 consecutive patients at nine participating centres were enrolled. Mean age was 81.4±8.3 years, average STS score 3.8±2.4%. The vast majority (97.2%) underwent TAVI with local anaesthesia (28.8%) or conscious sedation (68.3%). Balloon predilatation was performed in 30 patients (21.6%), post-dilatation in three (2.2%). In-hospital, there were no cases of death, stroke, or conversion to open heart surgery. Major vascular complications occurred in three patients (2.2%), as well as major or life-threatening bleedings in three patients (2.2%). There were two moderate (1.4%) and no moderate/severe paravalvular leaks. Median length of stay after TAVI was three days (IQR 3-5 days). At 30 days, there were no deaths, MI, or strokes, and the incidence of new permanent pacemaker implantation was 4.4%.

Conclusions: This first multicentre international experience of transfemoral TAVI with the SAPIEN 3 Ultra transcatheter heart valve shows good in-hospital and 30-day clinical outcomes.
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http://dx.doi.org/10.4244/EIJ-D-19-00541DOI Listing
February 2020

In vitro thrombogenicity of drug-eluting and bare metal stents.

Thromb Res 2020 01 14;185:43-48. Epub 2019 Nov 14.

Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY, United States.

Aims: We sought to investigate the thrombogenicity of different DES and BMS in an in vitro system of stent perfusion.

Material And Methods: The experimental model consisted of a peristaltic pump connected to 4 parallel silicone tubes in which different stents were deployed. Blood was drawn from healthy volunteers and the amount of stent surfaced-induced thrombus deposition was determined using I-fibrinogen.

Results: Compared to Resolute, Biomatrix and Vision, Xience was associated with the lowest amount of stent surface-induced thrombus formation, with a significant difference compared to Vision (I-fibrinogen median value deposition [IQ range]: 50 ng [25-98] versus 560 ng [320-1520], respectively, p < 0.05), but not to other DES. In the second set of experiments Fluoropolymer-coated BMS not eluting drug was associated with a significant 3-fold reduction in I-fibrinogen deposition (245 ng [80-300]) compared to Vision (625 ng [320-760], p < 0.05), but a 7-fold increase compared to Xience (35 ng [20-60], p < 0.05). Finally Xience was associated with a significantly greater absorption of albumin compared to BMS.

Conclusions: In an in vitro system of stent perfusion, Xience was associated with the lowest amount of stent surface-induced thrombus formation compared with Resolute, Biomatrix and Vision, with a noted synergistic effect between the fluoropolymer and the drug.
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http://dx.doi.org/10.1016/j.thromres.2019.11.016DOI Listing
January 2020

Surgical Risk Scores Applied to Transcatheter Aortic Valve Implantation: Friends or Foes? Short-Term and Long-Term Outcomes From a Single-Center Registry.

J Invasive Cardiol 2019 Oct;31(10):E282-E288

Interventional Cardiology Unit, Cardio-Thoracic-Vascular Department, Policlinico S.Orsola-Malpighi (Pavilion 23), Via Massarenti 9, 40138 Bologna, Italy.

Background: Transcatheter aortic valve implantation (TAVI) is a valid alternative to surgical aortic valve replacement for the treatment of symptomatic aortic stenosis. The EuroScore (ES) II, logistic EuroScore (log ES), and the Society of Thoracic Surgeons (STS) score are the most applied scores for surgical risk stratification. However, their predictive value for patients undergoing TAVI is still unclear.

Aim: To evaluate the performance of STS, log ES and ES II as predictors of short-term and long-term mortality in patients undergoing TAVI.

Methods: Between February 2008 and October 2017, a total of 384 patients underwent transfemoral TAVI at our institution and constituted the study population. Patients were divided into three groups based on the class of risk (low, intermediate, and high) calculated by each score. In-hospital complications, 30-day outcomes, and 5-year outcomes were assessed.

Results: In-hospital mortality rate was 2.6% (n = 10). All scores over-estimated the risk of 30-day mortality, especially for the highest risk classes. At the end of follow-up (5 years), STS risk stratification was able to stratify all-cause and cardiovascular (CV) mortality (P<.01 and P=.02, respectively). Patients with intermediate ES II risk showed a lower survival rate (P=.04) while CV deaths did not differ between classes of risk. All-cause mortality and CV mortality curves did not diverge according to the patients' risk profiles derived from log ES.

Conclusion: Conventional surgical risk scores are not appropriate to predict 30-day mortality in patients undergoing transfemoral TAVI. STS assessment was the only risk score able to stratify long-term all-cause and CV mortality.
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October 2019

Coronary artery disease and reasonably incomplete coronary revascularization in high-risk patients undergoing transcatheter aortic valve implantation.

Catheter Cardiovasc Interv 2020 01 27;95(1):19-27. Epub 2019 Mar 27.

Cardiology Unit, Cardio-Thoracic-Vascular Department, University Hospital of Bologna, Bologna, Italy.

Objectives: To evaluate the long-term impact of coronary artery disease (CAD) and heart team-guided incomplete coronary revascularization in patients undergoing transcatheter aortic valve implantation (TAVI).

Background: Revascularization strategy of CAD diagnosed with routine coronary angiography before TAVI is uncertain.

Methods: Five hundred and forty consecutive TAVI patients were classified as having CAD or normal coronary arteries (no-CAD). Within the CAD group, patients were further classified as those with complete (CR) versus incomplete revascularization (IR). Revascularization strategy was guided by the Heart Team following an algorithm largely based on current guidelines. Main outcome of interest was the incidence of 5-year cardiovascular (CV) death.

Results: Prevalence of CAD was 53.9%. CAD patients showed significantly lower left ventricular ejection fraction (LVEF: 55.8 ± 13.4% CAD vs. 61.4% ± 12.1 no-CAD, p < .0001), lower gradients, and larger ventricular volumes in comparison with the no-CAD group. Within the CAD group, 138 patients (47.4%) received CR and 153 (52.6%) IR. In-hospital mortality was 3.9%, without significant difference between groups (4.0% no-CAD vs. 3.8% CAD, p = .88; 2.9% CR vs. 4.6% IR, p = .45). Median follow-up was 57.8 months. Five-year survival free from CV death was 79.6% in the CAD versus 77.9% in the no-CAD group (p = .98), and 84.3% in the CR versus 74.3% in the IR groups (p = .25). These results were confirmed excluding patients with previous revascularization. At multivariable analyses, presentation with acute coronary syndrome (ACS) was significantly associated with 5-year CV death.

Conclusions: CAD is frequent in patients undergoing TAVI but portends an adverse prognosis only when presenting with ACS. Heart-team directed complete or reasonably incomplete revascularization was associated with comparable outcomes.
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http://dx.doi.org/10.1002/ccd.28211DOI Listing
January 2020

Risk-Benefit Profile of Longer-Than-1-Year Dual-Antiplatelet Therapy Duration After Drug-Eluting Stent Implantation in Relation to Clinical Presentation.

Circ Cardiovasc Interv 2019 03;12(3):e007541

Cardiovascular Research Foundation, New York, NY (P.G., T.P.V., G.W.S.).

Background: We sought to determine whether the risks and benefits of prolonging dual-antiplatelet therapy (DAPT) beyond 1 year after drug-eluting stent implantation depend on clinical presentation in a meta-analysis of randomized controlled trials.

Methods And Results: Randomized controlled trials comparing ≤1- versus >1-year DAPT after drug-eluting stent placement were searched through MEDLINE, EMBASE, Cochrane databases, and proceedings of international meetings. The primary efficacy end point was myocardial infarction, whereas the primary safety end point was major bleeding. Net clinical benefit was defined as the composite of myocardial infarction or major bleeding. Outcomes were analyzed according to patient presentation with stable ischemic heart disease versus acute coronary syndromes. The meta-analysis included 6 trials with a total of 21 457 patients, including 14 132 with stable ischemic heart disease and 7325 with acute coronary syndrome. After a median follow-up of 19.5 months, ≤1-year DAPT was associated with higher rates of myocardial infarction compared with >1-year DAPT (hazard ratio [HR], 1.63; 95% CI, 1.37-1.95), with no interaction apparent between treatment effect and clinical presentation. Shorter DAPT was associated with reduced rates of major bleeding compared with longer DAPT (HR, 0.64; 95% CI, 0.42-0.99) with no significant interaction between treatment effect and clinical presentation. However, a net clinical benefit of >1-year DAPT was present in patients with acute coronary syndrome (HR of shorter versus longer DAPT, 1.59; 95% CI, 1.24-2.02) but not in those with stable ischemic heart disease (HR, 1.15; 95% CI, 0.89-1.51; P=0.04). Shorter DAPT was also associated with lower rates of noncardiac mortality compared with longer DAPT (HR, 0.71; 95% CI, 0.52-0.96), with no significant interaction between treatment effect and clinical presentation ( P=0.12).

Conclusions: Compared with ≤1-year DAPT, >1-year DAPT reduces the risk of myocardial infarction but increases the risk of major bleeding and noncardiac mortality. A net clinical benefit of extended DAPT was apparent for patients with acute coronary syndrome but not for those with stable ischemic heart disease.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.118.007541DOI Listing
March 2019

Racial Differences in Ischaemia/Bleeding Risk Trade-Off during Anti-Platelet Therapy: Individual Patient Level Landmark Meta-Analysis from Seven RCTs.

Thromb Haemost 2019 Jan 31;119(1):149-162. Epub 2018 Dec 31.

Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.

Background:  Prolonged dual anti-platelet therapy (DAPT) is intended to reduce ischaemic events, at the cost of an increased bleeding risk in patients undergoing percutaneous coronary intervention (PCI). In this study, we evaluated whether race influences the ischaemia/bleeding risk trade-off.

Methods:  We searched for randomized clinical trials (RCTs) comparing DAPT duration after PCI. To compare the benefit or harm between DAPT duration by race, individual patient-level landmark meta-analysis was performed after discontinuation of the shorter duration DAPT group in each RCT. The primary ischaemic endpoint was major adverse cardiac events (MACEs), and the primary bleeding endpoint was major bleeding events (clinicaltrials.gov NCT03338335).

Results:  Seven RCTs including 16,518 patients (8,605 East Asians, 7,913 non-East Asians) were pooled. MACE occurred more frequently in non-East Asians (0.8% vs. 1.8%,  < 0.001), while major bleeding events occurred more frequently in East Asians (0.6% vs. 0.3%,  = 0.001). In Cox proportional hazards model, prolonged DAPT significantly increased the risk of major bleeding in East Asians (hazard ratio [HR], 2.843, 95% confidence interval [CI], 1.474-5.152,  = 0.002), but not in non-East Asians (HR, 1.375, 95% CI, 0.523-3.616,  = 0.523). East Asians had a higher median probability risk ratio of bleeding to ischaemia (0.66 vs. 0.15), and the proportion of patients with higher probability of bleeding than ischaemia was significantly higher in East Asians (32.3% vs. 0.4%,  < 0.001).

Conclusion:  We suggest that the ischaemia/bleeding trade-off may be different between East Asians and non-East Asians. In East Asians, prolonged DAPT may have no effect in reducing the ischaemic risk, while significantly increases the bleeding risk.
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http://dx.doi.org/10.1055/s-0038-1676545DOI Listing
January 2019

Response to Letter of Li et al.: How to select antiplatelet therapy in patients with acute coronary syndrome, according to platelet function testing or pharmacogenomic testing?

Int J Cardiol 2018 11;271:30

Department of Cardiology, San Giovanni di Dio e Ruggi d'Aragona University Hospital, Salerno, Italy. Electronic address:

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http://dx.doi.org/10.1016/j.ijcard.2018.06.048DOI Listing
November 2018

Impact of percutaneous coronary intervention extent, complexity and platelet reactivity on outcomes after drug-eluting stent implantation.

Int J Cardiol 2018 Oct;268:61-67

Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, NY, USA.

Background: Risk stratification after percutaneous coronary intervention (PCI) is mainly based on demographics and clinical presentation (stable coronary artery disease [CAD] vs. acute coronary syndromes [ACS]). We investigated the impact of PCI extent and complexity on 2-year clinical outcomes after successful implantation of drug-eluting stents (DES) and whether this effect is influenced by clinical presentation and/or high platelet reactivity (HPR) on clopidogrel.

Methods And Results: Patients from the prospective, multicenter Assessment of Dual Antiplatelet Therapy with Drug-Eluting Stents study were stratified according to PCI complexity, with complex PCI (C-PCI) defined as ≥3 stents implanted, bifurcation PCI with 2 stents, rotational atherectomy use for severely calcified lesions, or left main or saphenous vein graft (SVG) PCI. Major adverse cardiac events (MACE; cardiac death, myocardial infarction, and stent thrombosis) were compared at 2-year follow-up in patients with and without C-PCI. Successful DES PCI was performed in 8582 patients-2255 (26.3%) with C-PCI. C-PCI was independently associated with higher 2-year risk of MACE (adjusted HR [adjHR]: 1.56; 95%CI: 1.29-1.89; p<0.0001), MI (adjHR: 1.71; 95%CI: 1.37-2.14; p<0.0001), and ST (adjHR: 2.26; 95%CI: 1.42-3.59; p=0.0006). The association between C-PCI vs. non-C-PCI and the risk of MI and ST was greater in stable CAD than in ACS (P=0.04 and 0.03, respectively). SVG PCI, 2-stent bifurcation treatment, and implantation of ≥3 stents were independently associated with MACE.

Conclusions: Patients undergoing extensive and more complex PCI experienced worse outcomes after successful PCI. Considering the extent and complexity of PCI revascularization may improve risk stratification.
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http://dx.doi.org/10.1016/j.ijcard.2018.03.103DOI Listing
October 2018

Mortality Following Nonemergent, Uncomplicated Target Lesion Revascularization After Percutaneous Coronary Intervention: An Individual Patient Data Pooled Analysis of 21 Randomized Trials and 32,524 Patients.

JACC Cardiovasc Interv 2018 05 18;11(9):892-902. Epub 2018 Apr 18.

NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. Electronic address:

Objectives: This study sought to investigate the impact of nonemergent, uncomplicated target lesion revascularization (TLR) on the risk of long-term mortality after percutaneous coronary intervention (PCI).

Background: Restenosis requiring TLR after PCI is generally considered a benign event.

Methods: The study pooled patient-level data from 21 randomized trials. Subjects dying the same day as or the day after the TLR procedure as well as those with myocardial infarction (MI) the day before, the same day as or the day after TLR were excluded. The primary endpoint of the study was all-cause mortality.

Results: The dataset included 32,524 patients who were stratified according to whether repeat TLR was performed during follow-up. During a median follow-up of 37 months, 2,330 (7.2%) patients underwent a nonemergent, uncomplicated TLR procedure. After adjusting for potential confounders, TLR was an independent predictor of mortality (hazard ratio: 1.23, 95% confidence interval: 1.04 to 1.45; p = 0.02). Patients undergoing nonemergent, uncomplicated TLR had significantly higher rates of non-procedure-related MI compared with those without TVR. Among patients undergoing elective TLR, MI occurring after TLR was an independent predictor of mortality (hazard ratio: 3.82; 95% confidence interval: 2.44 to 5.99; p < 0.0001).

Conclusions: Nonemergent, uncomplicated TLR after PCI is an independent predictor of long-term mortality, an association in part explained by higher rates of MI occurring after TLR. Efforts aimed at reducing TLR risk may translate into prognostic benefits including reduced rates of MI and survival.
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http://dx.doi.org/10.1016/j.jcin.2018.01.277DOI Listing
May 2018

Systemic inflammatory status is associated with increased platelet reactivity in the early period after acute coronary syndromes.

Platelets 2018 Jul 4;29(5):528-530. Epub 2018 Apr 4.

f IRCCS Multimedica, Sesto San Giovanni , Milano , Italy.

Systemic inflammation measured by high-sensitivity C reactive protein (CPR) is associated with increased risk of major adverse cardiovascular events (MACE). Recent clinical trials targeting CPR showed a reduction in MACE after an acute coronary syndrome (ACS). Inflammation could be linked to high platelet reactivity (HPR), which is an independent predictor of MACE in patients with ACS. We aimed to evaluate the impact of 1-month C-reactive Protein (CRP) levels on HPR in patients enrolled in the GEPRESS study. We measured CRP and platelet reactivity index (PRI) at 30 days follow-up. PRI was assessed with vasodilator stimulated phosphoprotein (VASP) phosphorylation assay at the same timepoint. HPR was defined as PRI >50%. Of the 1042 patients included in the GEPRESS study, 756 (75%) had both VASP and CRP data at 30 days follow-up. HPR was found in 61 (49.1%) patients with CRP >1 mg/L and 233 (36.4%) patients with CRP ≤1 mg/L, p = 0.012. After adjustment for covariates, we found a direct gradient of effect between CRP and HPR; the inclusion of CRP significantly increased the discrimination of HPR regression model. This is the first study showing that residual HPR is more likely to occur in patients with CRP >1 mg/L at 1 month after non-ST elevation-ACS and this may contribute to the unfavorable outcome observed in such patients.
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http://dx.doi.org/10.1080/09537104.2018.1457782DOI Listing
July 2018

High on-treatment platelet reactivity and outcome in elderly with non ST-segment elevation acute coronary syndrome - Insight from the GEPRESS study.

Int J Cardiol 2018 05;259:20-25

Department of Cardiology, San Giovanni di Dio e Ruggi d'Aragona University Hospital, Salerno, Italy.

Background: Elderly treated with dual antiplatelet therapy after percutaneous coronary intervention (PCI) represent a challenging population because of increased risk of both ischemic and bleeding events. We aimed to investigate the association between high on-treatment platelet reactivity (HPR) and long-term outcome in elderly with non-ST-elevated acute coronary syndromes (NSTE-ACS) undergoing PCI.

Methods: Platelet reactivity was measured by vasodilator-stimulated phosphoprotein (VASP) assay at three time-points (baseline, discharge, 1 month after PCI) in 1053 NSTE-ACS patients (311 elderly) treated with clopidogrel. Major adverse cardiac events (MACE) were assessed up to 1 year-follow-up.

Results: Elderly with HPR at discharge showed a significantly higher incidence of overall MACE (13 vs 4%, p = .006), cardiac death (6 vs 0.7%, p = .020), myocardial infarction (MI, 12 vs 4%, p = .031) and a trend for higher stent-thrombosis (5 vs 0.7%, p = .068). Similarly, elderly with 1-month-HPR showed between 1 month and 1 year significantly higher incidence of MACE (10 vs 4%, p = .012), cardiac death (6 vs 0.7%, p = .019) and composite cardiac death/MI (11 vs 4%, p = .014). Up to 1 year, elderly with HPR showed a 4-fold increased risk of MACE compared to both elderly without HPR (for discharge-HPR: p = .005; for 1-month-HPR: p = .01) and non-elderly with HPR (for discharge-HPR: p < .001; for 1-month-HPR: p < .0001). At multivariable analysis, HPR could independently predict 1-year-MACE in elderly (for discharge-HPR: HR = 3.191, CI: 1.373-7.417, p = .007; for 1-month-HPR: HR = 3.542, CI: 1.373-9.137, p = .009).

Conclusions: In elderly with NSTE-ACS undergoing PCI and treated with clopidogrel, HPR was independently associated with an increased risk of MACE up to 1 year.
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http://dx.doi.org/10.1016/j.ijcard.2018.01.057DOI Listing
May 2018

Short-Term Versus Long-Term Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Elderly Patients: A Meta-Analysis of Individual Participant Data From 6 Randomized Trials.

JACC Cardiovasc Interv 2018 03 14;11(5):435-443. Epub 2018 Feb 14.

Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York.

Objectives: This study sought to evaluate the optimal duration of dual antiplatelet therapy (DAPT) after the implantation of a drug-eluting stent (DES) in elderly patients.

Background: Qualified studies to evaluate the optimal duration of DAPT in elderly patients have been very limited.

Methods: Using 6 randomized trials that compared short-term (≤6 months) and long-term (12 months) DAPT, individual participant data meta-analysis was performed in elderly patients (≥65 years of age). The primary study outcome was the 12-month risk of a composite of myocardial infarction, definite or probable stent thrombosis, or stroke. The major secondary outcome was the 12-month risk of major bleeding.

Results: The primary outcome risk did not significantly differ between patients receiving short-term and long-term DAPT (hazard ratio [HR]: 1.12; 95% confidence interval [CI]: 0.88 to 1.43; p = 0.3581) in the overall group of study participants. In subgroup analysis, a significant interaction between age and DAPT duration was observed for primary outcome risk (p for interaction = 0.0384). In the subset of younger patients (<65 years of age, n = 6,152), short-term DAPT was associated with higher risk of primary outcome (HR: 1.67; 95% CI: 1.14 to 2.44; p = 0.0082). In elderly patients (n = 5,319), however, the risk of primary outcome did not significantly differ between patients receiving short-term and long-term DAPT (HR: 0.84; 95% CI: 0.60 to 1.16; p = 0.2856). Short-term DAPT was associated with a significant reduction in major bleeding compared with long-term DAPT (HR: 0.50; 95% CI: 0.30 to 0.84; p = 0.0081) in the overall group, and particularly in elderly patients (HR: 0.46; 95% CI: 0.24-0.88; p = 0.0196).

Conclusions: Short-term DAPT after new-generation DES implantation may be more beneficial in elderly patients than in younger patients.
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http://dx.doi.org/10.1016/j.jcin.2017.10.015DOI Listing
March 2018

Efficacy and safety of dual antiplatelet therapy after coronary stenting in patients with chronic kidney disease.

Am Heart J 2018 03 6;197:103-112. Epub 2017 Dec 6.

Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.

Background: We compared efficacy and safety of short- (3 or 6 months) versus long-term (≥12 months) dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation, according to the presence of chronic kidney disease (CKD).

Methods: Patient-level pooled analysis was performed with 7242 patients (87.2% with 2nd generation DES) from 5 randomized controlled trials.

Results: In both CKD (1273 patients) and non-CKD (5969 patients) population, the rates of patient-oriented composite outcomes at 1-year (POCO, all-cause death, any myocardial infarction [MI], stroke and TIMI major bleeding) were not different between the short- and long-term DAPT (hazard ratio [HR] 1.19, 95% confidence interval [CI] 0.76-1.86, P=.449 in CKD population; HR 1.14, 95% CI 0.83-1.56, P=.434 in non-CKD population). The rates of coronary thrombotic events (any MI and definite/probable stent thrombosis) also did not differ between short- and long-term DAPT in either CKD or non-CKD population. As for bleeding events, long-term DAPT increased the TIMI major bleeding (HR 2.91, 95% CI 1.31-6.48, P=.009) in non-CKD population. The similar trend was observed with long-term DAPT in CKD population. But it did not reach statistical significance (HR 3.15, 95% CI 0.64-15.63, P=.160).

Conclusions: The rates of POCO and coronary thrombotic events were significantly higher in patients with CKD compared with those without CKD, which were not affected by short- or long-term DAPT. Higher bleeding incidence by long-term DAPT was only observed in non-CKD patients but not in CKD patients. Further large scale studies are warranted to confirm our findings.
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http://dx.doi.org/10.1016/j.ahj.2017.11.013DOI Listing
March 2018