Publications by authors named "Roberto Diletti"

150 Publications

Impact of thrombus burden on long-term clinical outcomes in patients with either anterior or non-anterior ST-segment elevation myocardial infarction.

J Thromb Thrombolysis 2021 Nov 26. Epub 2021 Nov 26.

Department of Interventional Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, The Netherlands.

Large thrombus burden (LTB) during ST-segment elevation myocardial infarction (STEMI) could translate into worse clinical outcomes. The impact of a LTB in terms of long-term clinical outcomes on different myocardial infarct territories has not yet been fully evaluated. From April 2002 to December 2004, consecutive patients with STEMI undergoing percutaneous coronary intervention with drug eluting stent were evaluated. The study sample was stratified in two groups: anterior STEMI and non-anterior STEMI. LTB was considered as a thrombus larger than or equal to 2-vessel diameters, and small thrombus burden less than 2-vessel diameters. Major adverse cardiac events (MACE) were evaluated at 10-year and survival data were collected up to 15-year. A total of 812 patients were evaluated, 6 patients were excluded due to inadequate angiographic images, 410 (50.9%) had an anterior STEMI and 396 (49.1%) a non-anterior STEMI. Patients with LTB had higher rates of 10-year mortality (aHR 2.27, 95%CI 1.42-3.63; p = 0.001) and 10-year MACE (aHR 1.46, 95%CI 1.03-2.08; p = 0.033) in anterior STEMI, but not in non-anterior STEMI (aHR 0.78, 95%CI 0.49-1.24; p = 0.298; aHR 0.71, 95%CI 0.50-1.02; p = 0.062). LTB was associated with increased 30-day mortality (aHR 5.60, 95%CI 2.49-12.61; p < 0.001) and 30-day MACE (aHR 2.72, 95%CI 1.45-5.08; p = 0.002) in anterior STEMI, but not in non-anterior STEMI (aHR 0.39, 95%CI 0.15-1.06; p = 0.066; aHR 0.67, 95%CI 0.31-1.46; p = 0.316). Beyond 30-day, LTB had no impact on mortality and MACE in both groups. In anterior STEMI, LTB is associated with worse long-term clinical outcomes, this effect was driven by early events.
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http://dx.doi.org/10.1007/s11239-021-02603-3DOI Listing
November 2021

Ultra-Short Term Evaluation of Coronary Vessel Wall Changes in Reference Segments Adjacent to Culprit Lesions in ST-Segment Elevation Myocardial Infarction.

J Invasive Cardiol 2021 Nov 18. Epub 2021 Nov 18.

MedStar Washington Hospital Center, 110 Irving St NW, Washington DC USA.

Background: Culprit lesions of ST-segment elevation myocardial infarction (STEMI) patients are friable, soft, and prone to disruption during primary percutaneous coronary intervention (pPCI). The presence of dissections in reference vessel segments (RVSs), adjacent to stented culprit lesions, and dynamic luminal changes in proximal or distal RVSs have not yet been investigated. We therefore sought to assess the healing patterns of edge dissections and the changes of lumen area at RVSs within 1 week post stent implantation in patients with STEMI.

Methods: In the MATRIX trial (ClinicalTrials.gov NCT01433627), optical coherence tomography (OCT) was performed at the end of pPCI and within 1 week during staged PCI. The RVS dissection was defined as: type 1 = flap; type 2 = cavity; type 3 = double barrel; and type 4 = fissure. We compared separately the fate of residual dissection and luminal area/dimension by OCT in the target vessel between pPCI and staged PCI, including 1-year clinical outcomes.

Results: Out of 151 patients, 46 patients had dissections in 50 RVSs and did not experience worse clinical outcome. Dissections were 44% type 1, 28% type 2, 12% type 3, and 16% type 4. Overall, 18% of the dissections healed. The mean lumen area of the RVS enlarged in 82 patients (59%) from pPCI to staged PCI. Compared with the proximal RVS, there was a significant increase in the lumen diameter at the distal RVS (0.06 ± 0.25 mm vs -0.01 ± 0.21 mm; P=.01).

Conclusion: Dissections occur frequently after pPCI. One-fifth of them heal within 1 week and do not seem to negatively impact clinical outcomes. Distal RVS lumen area increased compared with proximal RVS, likely reflecting a different vasoconstriction pattern over time.
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November 2021

Impact of Large Thrombus Burden on Very Long-Term Clinical Outcomes in Patients Presenting With ST-Segment Elevation Myocardial Infarction.

J Invasive Cardiol 2021 Nov;33(11):E900-E909

Interventional Cardiology, Thoraxcenter, Erasmus MC, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands.

Objectives: The impact of large thrombus burden (LTB) on very long-term clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) is unknown. We compared very long-term clinical outcomes in STEMI patients with either LTB or small thrombus burden (STB).

Methods: Between 2002 and 2004, thrombus burden (TB) was evaluated in consecutive patients with STEMI undergoing percutaneous coronary intervention (PCI). In occluded infarct-related arteries, TB was reclassified after flow restoration. LTB was defined as thrombus ≥2 vessel diameters. Major adverse cardiac event (MACE) rate was evaluated at 10-year follow-up and survival data were collected up to 15 years post PCI.

Results: A total of 812 patients were enrolled, and TB assessment was available for 806 patients (99.3%); 580 patients (72.0%) had STB and 226 patients (28.0%) had LTB. Patients with LTB experienced more no reflow (4.0% vs 0.5%; P<.01) and distal embolization (17.3% vs 3.4%; P<.001) than STB patients. Ten-year MACE rate (42.5% vs 42.4%; P=.59), 10-year mortality rate (27.0% vs 26.4%; P=.75), and 15-year mortality rate (31.9% vs 35.9%; P=.29) were similar between STB and LTB groups, respectively. By landmark analysis, MACE rate was higher in the LTB group (15.9% vs 8.8%; P<.01) at 30 days, but not beyond (31.6% vs 36.9%; P=.28). There was no difference in mortality at any time point (at 30 days, 9.7% vs 6.2%; P=.08; beyond 30 days, 17.3% vs 20.5%; P=.48). LTB was an independent predictor of MACE at 30 days post PCI (hazard ratio, 1.60; 95% confidence interval, 1.01-2.51; P=.04).

Conclusions: In STEMI patients, LTB might identify a subpopulation at high risk of no-reflow, distal embolization, and early ischemic events, but is not associated with worse clinical outcomes at long-term follow-up.
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November 2021

Vessel fractional flow reserve (vFFR) for the assessment of stenosis severity: the FAST II study.

EuroIntervention 2021 Oct 14. Epub 2021 Oct 14.

Department of Cardiology, Erasmus Medical Center, Rotterdam, the Netherlands.

Background: Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) is superior to angiography-guided PCI. The clinical uptake of FFR has been limited, however, by the need to advance a wire in the coronary artery, the additional time required and the need for hyperaemic agents which can cause patient discomfort. FFR derived from routine coronary angiography eliminates these issues.

Aims: The aim of this study was to assess the diagnostic performance and accuracy of three-dimensional quantitative coronary angiography (3D-QCA)-based vessel FFR (vFFR) compared to pressure wire-based FFR (≤0.80).

Methods: The FAST II (Fast Assessment of STenosis severity) study was a prospective observational multicentre study designed to evaluate the diagnostic accuracy of vFFR compared to the reference standard (pressure wire-based FFR ≤0.80). A total of 334 patients from six centres were enrolled. Both site-determined and blinded independent core lab vFFR measurements were compared to FFR.

Results: The core lab vFFR was 0.83±0.09 and pressure wire-based FFR 0.83±0.08. A good correlation was found between core lab vFFR and pressure wire-based FFR (R=0.74; p<0.001; mean bias 0.0029±0.0642). vFFR had an excellent diagnostic accuracy in identifying lesions with an invasive wire-based FFR ≤0.80 (AUC 0.93; 95% CI: 0.90-0.96; p<0.001). Positive predictive value, negative predictive value, diagnostic accuracy, sensitivity and specificity of vFFR were 90%, 90%, 90%, 81% and 95%, respectively.

Conclusions: 3D-QCA-based vFFR has excellent diagnostic performance to detect FFR ≤0.80. The study was registered on clinicaltrials.gov under identifier NCT03791320.
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http://dx.doi.org/10.4244/EIJ-D-21-00471DOI Listing
October 2021

Efficacy and Safety of Ticagrelor Monotherapy by Clinical Presentation: Pre-Specified Analysis of the GLOBAL LEADERS Trial.

J Am Heart Assoc 2021 09 17;10(18):e015560. Epub 2021 Sep 17.

Department of Medicine and Institute of Health Policy, Management and Evaluation Applied Health Research CentreLi Ka Shing Knowledge Institute of St. Michael's HospitalUniversity of Toronto Canada.

Background The optimal duration of dual antiplatelet therapy after coronary drug-eluting stent placement in adults with stable coronary artery disease (SCAD) versus acute coronary syndromes (ACS) remains uncertain. Methods and Results This was a prespecified subgroup analysis of the GLOBAL LEADERS trial. Participants were randomly assigned 1:1 to the experimental or reference strategy, stratified by ACS (experimental, n=3750; reference, n=3737) versus SCAD (experimental, n=4230; reference, n=4251). The experimental strategy was 75 to 100 mg aspirin daily plus 90 mg ticagrelor twice daily for 1 month, followed by 23 months of ticagrelor monotherapy. The reference strategy was 75 to 100 mg aspirin daily plus either 75 mg clopidogrel daily (for SCAD) or 90 mg ticagrelor twice daily (for ACS) for 12 months, followed by aspirin monotherapy for 12 months. The primary end point at 2 years was a composite of all-cause mortality or non-fatal centrally adjudicated new Q-wave myocardial infarction. The key secondary safety end point was site-reported Bleeding Academic Research Consortium grade 3 or 5 bleeding. The primary end point occurred in 147 (3.92%) versus 169 (4.52%) patients with ACS (rate ratio [RR], 0.86; 95% CI, 0.69-1.08; =0.189), and in 157 (3.71%) versus 180 (4.23%) patients with SCAD (RR, 0.87; 95% CI, 0.71-1.08; =0.221) with experimental and reference strategy, respectively (-interaction=0.926). Bleeding Academic Research Consortium grade 3 or 5 bleeding occurred in 73 (1.95%) versus 100 (2.68%) patients with ACS (RR, 0.73; 95% CI, 0.54-0.98; =0.037), and in 90 (2.13%) versus 69 (1.62%) patients with SCAD (RR, 1.32; 95% CI, 0.97-1.81; =0.081; -interaction=0.007). Conclusions While there was no evidence for differences in efficacy between treatment strategies by subgroup, the experimental strategy appeared to reduce bleeding risk in patients with ACS but not in patients with SCAD. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01813435.
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http://dx.doi.org/10.1161/JAHA.119.015560DOI Listing
September 2021

Pharmacodynamic Effects of Pre-Hospital Administered Crushed Prasugrel in Patients With ST-Segment Elevation Myocardial Infarction.

JACC Cardiovasc Interv 2021 06;14(12):1323-1333

Department of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands; Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands. Electronic address:

Objectives: This study sought to compare the pharmacodynamic effects of pre-hospitally administered P2Y inhibitor prasugrel in crushed versus integral tablet formulation in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI).

Background: Early dual antiplatelet therapy is recommended in STEMI patients. Yet, onset of oral P2Y inhibitor effect is delayed and varies according to formulation administered.

Methods: The COMPARE CRUSH (Comparison of Pre-hospital Crushed Versus Uncrushed Prasugrel Tablets in Patients With STEMI Undergoing Primary Percutaneous Coronary Interventions) trial randomized patients with suspected STEMI to crushed or integral prasugrel 60-mg loading dose in the ambulance. Pharmacodynamic measurements were performed at 4 time points: before antiplatelet treatment, at the beginning and end of pPCI, and 4 h after study treatment onset. The primary endpoint was high platelet reactivity at the end of pPCI. The secondary endpoint was impact of platelet reactivity status on markers of coronary reperfusion.

Results: A total of 441 patients were included. In patients with crushed prasugrel, the occurrence of high platelet reactivity at the end of pPCI was reduced by almost one-half (crushed 34.7% vs. uncrushed 61.6%; odds ratio [OR] = 0.33; 95% confidence interval [CI] = 0.22 to 0.50; p < 0.01). Platelet reactivity <150 P2Y reactivity units at the beginning of coronary angiography correlated with improved Thrombolysis In Myocardial Infarction flow grade 3 in the infarct artery pre-pPCI (OR: 1.78; 95% CI: 1.08 to 2.94; p = 0.02) but not ST-segment resolution (OR: 0.80; 95% CI: 0.48 to 1.34; p = 0.40).

Conclusions: Oral administration of crushed compared with integral prasugrel significantly improves platelet inhibition during the acute phase in STEMI patients undergoing pPCI. However, a considerable number of patients still exhibit inadequate platelet inhibition at the end of pPCI, suggesting the need for alternative agents to bridge the gap in platelet inhibition.
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http://dx.doi.org/10.1016/j.jcin.2021.04.022DOI Listing
June 2021

Transient ST-elevation myocardial infarction versus persistent ST-elevation myocardial infarction. An appraisal of patient characteristics and functional outcome.

Int J Cardiol 2021 08 15;336:22-28. Epub 2021 May 15.

Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081HV Amsterdam, the Netherlands; Department of Cardiology, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525GA Nijmegen, the Netherlands. Electronic address:

Background: Up to 24% of patients presenting with ST-elevation myocardial infarction (STEMI) show resolution of ST-elevation and symptoms before revascularization. The mechanisms of spontaneous reperfusion are unclear. Given the more favorable outcome of transient STEMI, it is important to obtain further insights in differential aspects.

Methods: We compared 251 patients who presented with transient STEMI (n = 141) or persistent STEMI (n = 110). Clinical angiographic and laboratory data were collected at admission and in subset of patients additional index hemostatic data and at steady-state follow-up. Cardiac magnetic resonance imaging (CMR) was performed at 2-8 days to assess myocardial injury.

Results: Transient STEMI patients had more cardiovascular risk factors than STEMI patients, including more arterial disease and higher cholesterol values. Transient STEMI patients showed angiographically more often no intracoronary thrombus (41.1% vs. 2.7%, P < 0.001) and less often a high thrombus burden (9.2% vs. 40.0%, P < 0.001). CMR revealed microvascular obstruction less frequently (4.2% vs. 34.6%, P < 0.001) and smaller infarct size [1.4%; interquartile range (IQR), 0.0-3.7% vs. 8.8%; IQR, 3.9-17.1% of the left ventricle, P < 0.001] with a better preserved left ventricular ejection fraction (57.8 ± 6.7% vs. 52.5 ± 7.6%, P < 0.001). At steady state, fibrinolysis was higher in transient STEMI, as demonstrated with a reduced clot lysis time (89 ± 20% vs. 99 ± 25%, P = 0.03).

Conclusions: Transient STEMI is a syndrome with less angiographic thrombus burden and spontaneous infarct artery reperfusion, resulting in less myocardial injury than STEMI. The presence of a more effective fibrinolysis in transient STEMI patients may explain these differences and might provide clues for future treatment of STEMI.
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http://dx.doi.org/10.1016/j.ijcard.2021.05.018DOI Listing
August 2021

Elastic stent recoil in coronary total occlusions: Comparison of durable-polymer zotarolimus eluting stent and ultrathin strut bioabsorbable-polymer sirolimus eluting stent.

Catheter Cardiovasc Interv 2021 May 7. Epub 2021 May 7.

Department of Interventional Cardiology, Thoraxcenter, Erasmus University Medical Centre, Rotterdam, The Netherlands.

Objectives: To compare stent recoil (SR) of the thin-strut durable-polymer Zotarolimus-eluting stent (dp-ZES) and the ultrathin-strut bioabsorbable-polymer Sirolimus-eluting stent (bp-SES) in chronic total occlusions (CTOs) and to investigate the predictors of high SR in CTOs.

Background: Newer ultrathin drug eluting stent might be associated with lower radial force and higher elastic recoil due to the thinner strut design, possibly impacting on the rate of in-stent restenosis and thrombosis.

Methods: Between January 2017 and November 2019, consecutive patients with CTOs undergoing percutaneous coronary intervention were evaluated. Only patients treated with dp-ZES or bp-SES were included and stratified accordingly. Quantitative coronary angiography analysis was used to assess absolute SR, relative SR, absolute focal SR, relative focal SR, high absolute, and high relative focal SR.

Results: A total of 128 lesions (67 treated with dp-ZES and 61 with bp-SES) in 123 patients were analyzed. Between bp-SES and dp-ZES no differences were found in absolute SR (p = .188), relative SR (p = .138), absolute focal SR (p = .069), and relative focal SR (p = .064). High absolute and high relative focal SR occurred more frequently in bp-SES than in dp-ZES (p = .004 and p = .015). Bp-SES was a predictor of high absolute focal SR (Odds ratio [OR] 3.29, 95% confidence interval [CI] 1.50-7.22, p = .003]. High-pressure postdilation and bp-SES were predictors of high relative focal SR (OR 2.22, 95% CI 1.01-4.86, p = .047; OR 2.74, 95% CI 1.24-6.02, p = .012, respectively).

Conclusions: Both stents showed an overall low SR. However, ultra-thin strut bp-SES was a predictor of high absolute and high relative focal SR.
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http://dx.doi.org/10.1002/ccd.29739DOI Listing
May 2021

Culprit lesion detection in patients presenting with non-ST elevation acute coronary syndrome and multivessel disease.

Cardiovasc Revasc Med 2021 Mar 30. Epub 2021 Mar 30.

Department of Interventional Cardiology, Thoraxcenter, Erasmus University Medical Centre, Rotterdam, the Netherlands. Electronic address:

Background/purpose: Identification of the culprit lesion in patients with non-ST elevation acute coronary syndrome (NSTE-ACS) allows appropriate coronary revascularization but may be unclear in patients with multivessel coronary disease (MVD). Therefore, we investigated the rate of culprit lesion identification during coronary angiography in NSTE-ACS and multivessel disease.

Methods/materials: Consecutive patients presenting with NSTE-ACS and MVD, between January 2012 and December 2016 were evaluated. Coronary angiograms, intravascular imaging, and ECGs were analyzed for culprit lesion identification. Long-term clinical outcomes in terms of major adverse cardiac events (MACE) and mortality were reported in patients with or without culprit identification.

Results: A total of 1107 patients with NSTE-ACS and MVD were included in the analysis, 310 (28.0%) with unstable angina and 797 (72.0%) with non-ST elevation myocardial infarction. The culprit lesion was angiographically identified in 952 (86.0%) patients, while no clear culprit lesion was found in 155 (14.0%) patients. ECG analysis allowed to predict the location of the culprit vessel with low sensitivity (range 28.4%-36.7%) and high specificity (range 90.6%-96.5%). Higher lesion complexity was associated with inability to identify the culprit. Intravascular imaging was applied in 55 patients and helped to identify the culprit lesion in 53 patients (96.4%). There was no difference in all-cause mortality (21.4% vs. 25.8%, p = 0.24) and MACE (39.2% vs. 47.6%, p = 0.07) between the cohorts with or without culprit lesion identification by angiography.

Conclusions: The culprit lesion appeared unclear by coronary angiography in >10% of patients with NSTE-ACS and MVD. Complementary invasive imaging substantially enhanced the diagnostic accuracy of culprit lesion detection.
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http://dx.doi.org/10.1016/j.carrev.2021.03.019DOI Listing
March 2021

Impact of Poststenting Fractional Flow Reserve on Long-Term Clinical Outcomes: The FFR-SEARCH Study.

Circ Cardiovasc Interv 2021 03 9;14(3):e009681. Epub 2021 Mar 9.

Department of Interventional Cardiology, Thoraxcenter, Erasmus University Medical Centre, Rotterdam, the Netherlands (R.D., K.M., J.D., L.J.C.v.Z., T.N., J.W., W.K.D.D., I.K., P.C., P.d.J., F.Z., N.M.V.M.).

[Figure: see text].
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.009681DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7982137PMC
March 2021

10-Year Follow-Up of Patients With Everolimus-Eluting Versus Bare-Metal Stents After ST-Segment Elevation Myocardial Infarction.

J Am Coll Cardiol 2021 03;77(9):1165-1178

International Center of Circulatory Health, Imperial College London, London, United Kingdom; Department of Cardiology, National University of Ireland, Galway, Galway, Ireland.

Background: Outcomes data for a durable-polymer everolimus-eluting stent (EES) at extended long-term follow-up in patients with ST-segment elevation myocardial infarction (STEMI) are unknown.

Objectives: The aim of this study was to assess the 10-year outcomes of patients enrolled in the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) trial.

Methods: The EXAMINATION-EXTEND (10-Years Follow-Up of the EXAMINATION Trial) study is an investigator-driven 10-year follow-up of the EXAMINATION trial, which randomly assigned 1,498 patients with STEMI in a 1:1 ratio to receive either EES (n = 751) or bare-metal stents (n = 747). The primary endpoint was a patient-oriented composite endpoint of all-cause death, any myocardial infarction, or any revascularization. Secondary endpoints included a device-oriented composite endpoint of cardiac death, target vessel myocardial infarction, or target lesion revascularization; the individual components of the combined endpoints; and stent thrombosis.

Results: Complete 10-year clinical follow-up was obtained in 94.5% of the EES group and 95.9% of the bare-metal stent group. Rates of the patient-oriented composite endpoint and device-oriented composite endpoint were significantly reduced in the EES group (32.4% vs. 38.0% [hazard ratio: 0.81; 95% confidence interval: 0.68 to 0.96; p = 0.013] and 13.6% vs. 18.4% [hazard ratio: 0.72; 95% confidence interval: 0.55 to 0.93; p = 0.012], respectively), driven mainly by target lesion revascularization (5.7% vs. 8.8%; p = 0.018). The rate of definite stent thrombosis was similar in both groups (2.2% vs. 2.5%; p = 0.590). No differences were found between the groups in terms of target lesion revascularization (1.4% vs. 1.3%; p = 0.963) and definite or probable stent thrombosis (0.6% vs. 0.4%; p = 0.703) between 5 and 10 years.

Conclusions: At 10-year follow-up, EES demonstrated confirmed superiority in combined patient- and device-oriented composite endpoints compared with bare-metal stents in patients with STEMI requiring primary percutaneous coronary intervention. Between 5- and 10-year follow-up, a low incidence of adverse cardiovascular events related to device failure was found in both groups. (10-Years Follow-Up of the EXAMINATION Trial; NCT04462315).
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http://dx.doi.org/10.1016/j.jacc.2020.12.059DOI Listing
March 2021

Comparison of Investigator-Reported and Clinical Event Committee-Adjudicated Outcome Events in GLASSY.

Circ Cardiovasc Qual Outcomes 2021 02 4;14(2):e006581. Epub 2021 Feb 4.

Institute of Social and Preventive Medicine and Clinical Trials Unit (D.H.), University of Bern, Switzerland.

Background: Event adjudication by a clinical event committee (CEC) provides a standardized, independent outcome assessment. However, the added value of CEC to investigators reporting remains debated. GLASSY (GLOBAL LEADERS Adjudication Sub-Study) implemented, in a subset of the open-label, investigator-reported (IR) GLOBAL LEADERS trial, an independent adjudication process of reported and unreported potential outcome events (triggers). We describe metrics of GLASSY feasibility and efficiency, diagnostic accuracy of IR events, and their concordance with corresponding CEC-adjudicated events.

Methods: We report the proportion of myocardial infarction, bleeding, stroke, and stent thrombosis triggers with sufficient evidence for assessment (feasibility) that were adjudicated as outcome events (efficiency), stratified by source (IR or non-IR). Using CEC-adjudicated events as criterion standard, we describe sensitivity, specificity, positive and negative predictive value, and global diagnostic accuracy of IR events. Using Gwet AC coefficient, we examine the concordance between IR- and corresponding CEC-adjudicated triggers. There was sufficient evidence for assessment for 2592 (98.3%) of 2636 triggers.

Results: Overall, the adjudicated end point-to-trigger ratio was high and similar between IR- (88%) and non-IR-reported (87%) triggers. The global diagnostic accuracy and concordance between IR-reported and CEC-adjudicated outcome events was 0.70 (95% CI, 0.65-0.74) and 0.54 (95% CI, 0.45-0.62), respectively, for myocardial infarction; 0.77 (95% CI, 0.75-0.79) and 0.71 (95% CI, 0.68-0.74) for bleeding; 0.70 (95% CI, 0.62-0.79) and 0.59 (95% CI, 0.43-0.74) for stroke; 0.59 (95% CI, 0.52-0.66) and 0.39 (95% CI, 0.25-0.53) for stent thrombosis. For IR bleedings, the concordance with the CEC on type of events was generally weak.

Conclusions: Implementing CEC adjudication in a pragmatic open-label trial with IR events is feasible and efficient. Our findings of modest global diagnostic accuracy for IR events and generally weak concordance between investigators and CEC support the role for CEC adjudication in such settings. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03231059.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.120.006581DOI Listing
February 2021

Cardiac Catheterizations in Patients With Prior Coronary Bypass Surgery: Impact of Access Strategy on Short-Term Safety and Long-Term Efficacy Outcomes.

Angiology 2021 May 19;72(5):465-473. Epub 2021 Jan 19.

Department of Cardiology, Thoraxcenter, 6993Erasmus University Medical Center, Rotterdam, the Netherlands.

Little data are available on access strategy outcomes for cardiac catheterizations in patients with prior coronary artery bypass graft surgery (CABG). We investigated the effect of transradial access (TRA) and transfemoral access (TFA) on short-term major vascular complications (MVC) and long-term major adverse cardiovascular events (MACE). In this single-center, retrospective cohort study, 1084 patients met our inclusion criteria (TRA = 469; TFA = 615). The cumulative incidence for the primary safety endpoint MVC at 30 days (a composite of major bleeding, retroperitoneal hematoma, dissection, pseudoaneurysm, and arteriovenous fistula) was lower with TRA (0.7% vs 3.0%, < .01) and this difference remained significant after propensity score adjustment (odds ratio: 0.24; 95% CI, 0.07-0.83; = .024). The cumulative incidence for the primary efficacy endpoint MACE at 36 months (a composite of all-cause mortality, myocardial infarction, stroke, and urgent target vessel revascularization) was 28.6% with TRA and 27.6% with TFA, respectively. Kaplan-Meier curves showed no difference for the primary efficacy endpoint ( = .65). Contrast use (mL) was significantly lower with TRA (130 [100-180] vs 150 [100-213], < .01). In conclusion, in patients with prior CABG, TRA was associated with significantly fewer short-term MVC and contrast use, but not with a difference in long-term MACE, compared with TFA.
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http://dx.doi.org/10.1177/0003319720987351DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8044620PMC
May 2021

Effect of Prehospital Crushed Prasugrel Tablets in Patients With ST-Segment-Elevation Myocardial Infarction Planned for Primary Percutaneous Coronary Intervention: The Randomized COMPARE CRUSH Trial.

Circulation 2020 12 14;142(24):2316-2328. Epub 2020 Oct 14.

Maasstad Hospital, Rotterdam, The Netherlands (G.J.V., V.P., P.C.S.).

Background: Early treatment with a potent oral platelet P2Y inhibitor is recommended in patients presenting with ST-segment-elevation myocardial infarction scheduled to undergo primary percutaneous coronary intervention (pPCI). The impact on coronary reperfusion of crushed P2Y inhibitor tablets, which lead to more prompt and potent platelet inhibition, is unknown.

Methods: We conducted a randomized controlled, multicenter trial in the Netherlands, enrolling patients with ST-segment-elevation myocardial infarction scheduled to undergo pPCI. Patients were randomly allocated to receive in the ambulance, before transfer, a 60-mg loading dose of prasugrel either as crushed or integral tablets. The independent primary end points were thrombolysis in myocardial infarction (TIMI) 3 flow in the infarct-related artery at initial coronary angiography, and complete (≥70%) ST-segment resolution 1 hour after pPCI. The safety end points were TIMI major and Bleeding Academic Research Consortium ≥3 bleedings. Secondary end points included platelet reactivity and ischemic outcomes.

Results: A total of 727 patients were assigned to either crushed or integral tablets of prasugrel loading dose. The median time from study treatment to wire-crossing during pPCI was 57 (47-70) minutes. The primary end point TIMI 3 flow in the infarct-related artery before pPCI occurred in 31.0% in the crushed group versus 32.7% in the integral group (odds ratio, 0.92 [95% CI, 0.65-1.30], =0.64). Complete ST-segment resolution 1 hour after pPCI was present in 59.9% in the crushed group versus 57.3% in the integral group (odds ratio, 1.11 [95% CI, 0.78-1.58], =0.55). Platelet reactivity at the beginning of pPCI, measured as P2Y reactivity unit, differed significantly between groups (crushed, 192 [132-245] versus integral, 227 [184-254], ≤0.01). TIMI major and Bleeding Academic Research Consortium ≥3 bleeding occurred in 0% in the crushed group versus 0.8% in the integral group, and in 0.3% in the crushed group versus 1.1% in the integral group, respectively. There were no differences observed between groups regarding ischemic events at 30 days.

Conclusions: Prehospital administration of crushed prasugrel tablets does not improve TIMI 3 flow in the infarct-related artery before pPCI or complete ST-segment resolution 1 h after pPCI in patients presenting with ST-segment-elevation myocardial infarction scheduled for pPCI. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03296540.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.051532DOI Listing
December 2020

Impact of optical coherence tomography findings on clinical outcomes in ST-segment elevation myocardial infarction patients: a MATRIX (Minimizing Adverse Hemorrhagic Events by Trans-radial Access Site and angioX) OCT sub-study.

Int J Cardiovasc Imaging 2021 Apr 22;37(4):1143-1150. Epub 2020 Nov 22.

Swiss Cardiovascular Center, University of Bern, Bern, Switzerland.

Purpose: To investigate the association of the degree of stent expansion, as assessed by optical coherence tomography (OCT), following stent implantation, and clinical outcomes in ST-segment elevation myocardial infarction (STEMI) patients.

Methods: STEMI patients from the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) OCT study were selected; Clinical outcomes were collected through 1 year. Stent expansion index is a minimum stent area (MSA) divided by average lumen area (average of proximal and distal reference lumen area). The following variables were measured: MSA (< 4.5mm), dissection (> 200 µm in width and < 5 mm from stent segment), malapposition (> 200 µm distance of stent from vessel wall), a thrombus (area > 5% of lumen area) were compared.

Results: A total of 151 patients were included; after excluding patients with suboptimal OCT quality, the population with available OCT was classified into 2 groups: under-expanded < 90% (N = 72, 51%) and well-expanded ≥ 90% (N = 67, 49%). In the well-expanded group, a significant number of the proximal vessels had a lumen area < 4.5mm (16.1%, p < 0.001) and a greater thrombus burden within stent (56.7%, p = 0.042). The overall 30 day and 1 year major adverse cardiovascular event (MACE) rates were 5% and 6.1%, respectively.

Conclusion: Irrespective of the degree of stent expansion, the OCT findings, in STEMI patients, and the MACE at 30 days and one year follow up was low; further, well-expanded stents led to a more significant residual thrombotic burden within the stent but seemed to have insignificant clinical impact. Acknowledged stent optimization criteria, traditionally related to worse outcomes in stable patients, do not seem to be associated with worse outcomes in this STEMI population.
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http://dx.doi.org/10.1007/s10554-020-02098-8DOI Listing
April 2021

Patient perspectives on left main stem revascularization strategies, the OPINION-2 study.

J Cardiol 2021 03 8;77(3):271-278. Epub 2020 Oct 8.

Department of Cardiology, Erasmus University Medical Center, Rotterdam, The Netherlands.

Background: Treatment preferences in patients with left main (LM) stem disease and no prior revascularization are unknown. The objectives of this study were to determine (i) patient-reported importance ratings of particular features related to percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery, (ii) how these features determine treatment preference, and (iii) how educational and psychosocial background influence this preference.

Methods: In this prospective, multicenter study a total of 500 patients without previous revascularization who underwent diagnostic angiography for suspected coronary disease were asked to complete a case-vignette on a (hypothetical) LM stenosis qualifying for both PCI and CABG, in addition to 6 validated questionnaires to assess the influence of psychosocial factors on treatment preference.

Results: Overall, 90% favored PCI over CABG because of the lower bleeding and stroke risk despite a higher likelihood for repeat revascularization. By multivariable regression, the only independent determinant of treatment preference for CABG was lower educational level (14% in low vs. 8% in higher educated patients, OR: 3.22, CI: 1.16-8.95, p=0.025) while psychosocial variables were not associated. Compared to higher educated patients, those with lower educational level suffered more from depression, anxiety, loneliness, and uncertainty.

Conclusions: Overall, patients who are informed about risk and benefits of each treatment modality clearly favor PCI over CABG and particularly value lower short-term morbidity while being aware of higher risk of repeat revascularization. Lower educational level was associated with a higher prevalence of psychosomatic phenotypes and a 14% preference for CABG. Educational and psychosocial background matter in the revascularization strategy decision-making process.
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http://dx.doi.org/10.1016/j.jjcc.2020.09.009DOI Listing
March 2021

Validation of novel 3-dimensional quantitative coronary angiography based software to calculate fractional flow reserve post stenting.

Catheter Cardiovasc Interv 2021 10 6;98(4):671-677. Epub 2020 Oct 6.

Department of cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.

Objectives: To validate novel dedicated 3D-QCA based on the software to calculate post PCI vessel-FFR (vFFR) in a consecutive series of patients, to assess the diagnostic accuracy, and to assess inter-observer variability.

Background: Low post percutaneous coronary intervention (PCI) fractional flow reserve (FFR) predicts future adverse cardiac events. However, FFR assessment requires the insertion of a pressure wire in combination with the use of a hyperemic agent.

Methods: FAST POST study is an observational, retrospective, single-center cohort study. One hundred patients presenting with stable angina or non ST-elevation myocardial infarction, who underwent post PCI FFR assessment using a dedicated microcatheter were included. Two orthogonal angiographic projections were acquired to create a 3D reconstruction of the coronary artery using the CAAS workstation 8.0. vFFR was subsequently calculated using the aortic root pressure.

Results: Mean age was 65±12 years and 70% were male. Mean microcatheter based FFR and vFFR were 0.91±0.07 and 0.91±0.06, respectively. A good linear correlation was found between FFR and vFFR (r = 0.88; p <.001). vFFR had a higher accuracy in the identification of patients with FFR values <0.90, AUC 0.98 (95% CI: 0.96-1.00) as compared with 3D-QCA AUC 0.62 (95% CI: 0.94-0.74). Assessment of vFFR had a low inter-observer variability (r = 0.95; p <.001).

Conclusion: 3D-QCA derived post PCI vFFR correlates well with invasively measured microcatheter based FFR and has a high diagnostic accuracy to detect FFR <0.90 with low inter-observer variability.
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http://dx.doi.org/10.1002/ccd.29311DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8519140PMC
October 2021

PRECISE-DAPT score for bleeding risk prediction in patients on dual or single antiplatelet regimens: insights from the GLOBAL LEADERS and GLASSY.

Eur Heart J Cardiovasc Pharmacother 2020 Sep 17. Epub 2020 Sep 17.

Hôpital Bichat, AP-HP, Université Paris-Diderot, Paris, France.

Aims: The 5-item PRECISE-DAPT, integrating age, haemoglobin, white-blood-cell count, creatinine clearance, and prior bleeding, predicts bleeding risk in patients on dual antiplatelet therapy (DAPT) after stent implantation. We sought to assess whether the bleeding risk prediction offered by the PRECISE-DAPT remains valid among patients receiving ticagrelor monotherapy from 1 month onwards after coronary stenting instead of standard DAPT and having or not having centrally-adjudicated bleeding endpoints.

Methods And Results: The PRECISE-DAPT was calculated in 14,928 and 7,134 patients from GLOBAL LEADERS and GLASSY trials, respectively. The ability of the score to predict BARC 3 or 5 bleeding was assessed and compared among patients on ticagrelor monotherapy (experimental strategy) or standard DAPT (reference strategy) from 1 month after drug-eluting stent implantation. Bleeding endpoints were investigator-reported or centrally-adjudicated in GLOBAL LEADERS and GLASSY, respectively.At 2 years, the c-indexes for the score among patients treated with the experimental or reference strategy were 0.67 (95% confidence interval [CI]:0.63-0.71) vs. 0.63 (95% CI:0.59-0.67) in GLOBAL LEADERS (p = 0.27), and 0.67 (95% CI:0.61-0.73) vs. 0.66 (95% CI:0.61-0.72) in GLASSY (p = 0.88). Decision curve analysis showed net benefit using the PRECISE-DAPT to guide bleeding risk assessment under both treatment strategies. Results were consistent between investigator-reported and adjudicated endpoints and using the simplified 4-item PRECISE-DAPT.

Conclusions: The PRECISE-DAPT offers a prediction model that proved similarly effective to predict clinically-relevant bleeding among patients on ticagrelor monotherapy from 1 month after coronary stenting compared with standard DAPT and appears to be unaffected by the presence or absence of adjudicated bleeding endpoints.
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http://dx.doi.org/10.1093/ehjcvp/pvaa106DOI Listing
September 2020

Percutaneous complete revascularization strategies using sirolimus-eluting biodegradable polymer-coated stents in patients presenting with acute coronary syndrome and multivessel disease: Rationale and design of the BIOVASC trial.

Am Heart J 2020 09 15;227:111-117. Epub 2020 Jun 15.

Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands.

Background: Complete revascularization in patients with an acute coronary syndrome and multivessel disease is superior compared to culprit-only treatment. However, it is unknown whether direct complete or staged complete revascularization should be pursued.

Methods: The BIOVASC study is an investigator-initiated, prospective, multicenter, randomized, 2-arm, international, open-label, noninferiority trial. We will randomize 1,525 patients 1:1 to immediate complete revascularization (experimental arm) or culprit-only plus staged complete revascularization (control arm). Patients will be enrolled in approximately 30 sites in Belgium, Italy, the Netherlands, and Spain. The primary end point is a composite of all-cause mortality, nonfatal myocardial infarction, any unplanned ischemia-driven revascularization (excluding staged procedures in the control arm at the predetermined time), and cerebrovascular events (MACCE) at 1 year post index procedure.

Conclusions: The BIOVASC study aims to further refine the treatment algorithm for acute coronary syndrome patients with multivessel disease in terms of optimal timing for complete revascularization (Clinicaltrials.gov NCT03621501).
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http://dx.doi.org/10.1016/j.ahj.2020.06.006DOI Listing
September 2020

Correlation between 3D-QCA based FFR and quantitative lumen assessment by IVUS for left main coronary artery stenoses.

Catheter Cardiovasc Interv 2021 03 29;97(4):E495-E501. Epub 2020 Jul 29.

Department of Cardiology, Erasmus Medical Center, University Medical Center Rotterdam, Thorax Centre, Rotterdam, The Netherlands.

Objectives: We aimed to evaluate the feasibility of using three dimensional-quantitative coronary angiography (3D-QCA) based fractional flow reserve (FFR) (vessel fractional flow reserve [vFFR], CAAS8.1, Pie Medical Imaging) and to correlate vFFR values with intravascular ultrasound (IVUS) for the evaluation of intermediate left main coronary artery (LMCA) stenosis.

Background: 3D-QCA derived FFR indices have been recently developed for less invasive functional lesion assessment. However, LMCA lesions were vastly under-represented in first validation studies.

Methods: This observational single-center cohort study enrolled consecutive patients with stable angina, unstable angina, or non-ST-segment elevation myocardial infarction and nonostial, intermediate grade LMCA stenoses who underwent IVUS evaluation. vFFR was computed based on two angiograms with optimal LMCA stenosis projection and correlated with IVUS-derived minimal lumen area (MLA).

Results: A total of 256 patients with intermediate grade LMCA stenosis evaluated with IVUS were screened for eligibility; 147 patients met the clinical inclusion criteria and had a complete IVUS LMCA footage available, of them, 63 patients (63 lesions) underwent 3D-QCA and vFFR analyses. The main reason for screening failure was insufficient quality of the angiogram (51 patients,60.7%). Mean age was 65 ± 11 years, 75% were male. Overall, mean MLA within LMCA was 8.77 ± 3.17 mm , while mean vFFR was 0.87 ± 0.09. A correlation was observed between vFFR and LMCA MLA (r = .792, p = .001). The diagnostic accuracy of vFFR ≤0.8 in identifying lesions with MLA < 6.0 mm (sensitivity 98%, specificity 71.4%, area under the curve (AUC) 0.95, 95% confidence interval (CI) 0.89-1.00, p = .001) was good.

Conclusions: In patients with good quality angiographic visualization of LMCA and available complete LMCA IVUS footage, 3D-QCA based vFFR assessment of LMCA disease correlates well to LMCA MLA as assessed by IVUS.
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http://dx.doi.org/10.1002/ccd.29151DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7984347PMC
March 2021

Vulnerability for ventricular arrhythmias in patients with chronic coronary total occlusion.

Expert Rev Cardiovasc Ther 2020 Aug 1;18(8):487-494. Epub 2020 Aug 1.

Department of Cardiology, Erasmus MC, University Medical Center Rotterdam , Rotterdam, The Netherlands.

Introduction: The presence of a chronic total occlusion (CTO) is associated with an increased risk of ventricular arrhythmias.

Areas Covered: This review provides an overview of the relationship between CTO and ventricular arrhythmias, arrhythmogenic mechanisms, and the effect of revascularization.

Expert Opinion: Studies in recipients of an implantable cardioverter-defibrillator (ICD) have shown that a CTO is an independent predictor of appropriate ICD therapy. The myocardial territory supplied by a CTO is a pro-arrhythmogenic milieu characterized by scar tissue, large scar border zone, hibernating myocardium, residual ischemia despite collaterals, areas of slow conduction, and heterogeneity in repolarization. Restoring coronary flow by revascularization might be associated with electrical homogenization as reflected by a decrease in QT(c) dispersion, decrease in T wave peak-to-end interval, reduction of late potentials, and decrease in scar border zone area. Future research should explore whether CTO revascularization results in a lower burden of ventricular arrhythmias. Furthermore, risk stratification of CTO patients without severe LV dysfunction is interesting to identify potential ICD candidates. Potential tools for risk stratification are the use of electrocardiographic parameters, body surface mapping, electrophysiological study, and close rhythm monitoring using an insertable cardiac monitor.
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http://dx.doi.org/10.1080/14779072.2020.1793671DOI Listing
August 2020

Impact of intravascular ultrasound findings in patients with a post PCI fractional flow reserve ≤0.85 on 2 year clinical outcome.

Int J Cardiol 2020 Oct 18;317:33-36. Epub 2020 May 18.

Department of Cardiology, Erasmus MC, Rotterdam, the Netherlands. Electronic address:

Background: Patients with a low post PCI fractional flow reserve (FFR) are at increased risk for future adverse cardiac events. The aim of the present study was to assess the impact of specific intravascular ultrasound (IVUS) findings in patients with a low post percutaneous coronary intervention (PCI) FFR on long-term clinical outcome.

Methods: In a subgroup analysis, 100 vessels with an FFR value ≤0.85 underwent post PCI IVUS to further assess the potential determinants for low post PCI FFR. No further action was taken to improve post PCI FFR. The primary endpoint of this study was the event free survival of target vessel failure (TVF) at two years in patients with a post PCI FFR ≤0.85, which was defined as a composite of cardiac death, target vessel myocardial infarction or target vessel revascularization.

Results: In patients with a post PCI FFR ≤0.85, TVF free survival rates were 88.5% vs. 95.5% for patients with versus without residual proximal lesions and 88.2% vs. 95.5% for patients with versus without residual distal lesions respectively (HR = 2.53, 95% confidence interval (CI) 0.52-12.25, p = .25 and HR = 2.60, 95% CI 0.54-12.59, p = .24 respectively). TVF free survival was 92.8% vs. 93.5% in patients with versus without stent underexpansion >20% (HR = 1.01, 95% CI 0.21-4.88, p = .99) and 89.3% vs. 97.8% in patients with versus without any residual focal lesion including lumen compromising hematoma (HR = 4.64, 95% CI 0.55-39.22, p = .18).

Conclusion: Numerically higher TVF rates were observed in patients with a post PCI FFR ≤0.85 and clear focal residual disease as assessed with IVUS.
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http://dx.doi.org/10.1016/j.ijcard.2020.05.027DOI Listing
October 2020

Management of Septal Branch Perforation and Septal Hematoma During Retrograde Treatment of Coronary Chronic Total Occlusion Using Fat Embolization.

Can J Cardiol 2020 06 17;36(6):966.e15-966.e17. Epub 2019 Dec 17.

Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. Electronic address:

Septal vessel perforation followed by septal hematoma is a rare complication of retrograde approach for treatment of coronary chronic total occlusions, possibly leading to septal rupture. We report 2 cases of patients with septal vessel perforation and subsequent hematoma successfully treated with autologous fat embolization. Such technique is inexpensive, omnipresent, and relatively easy to perform.
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http://dx.doi.org/10.1016/j.cjca.2019.12.012DOI Listing
June 2020

COMPARison of pre-hospital CRUSHed vs. uncrushed Prasugrel tablets in patients with STEMI undergoing primary percutaneous coronary interventions: Rationale and design of the COMPARE CRUSH trial.

Am Heart J 2020 06 11;224:10-16. Epub 2020 Mar 11.

Maasstad Hospital, Rotterdam.

Background: Dual antiplatelet therapy constitutes the cornerstone of medical treatment in patients with ST elevation myocardial infarction (STEMI). However, oral antiplatelet agents, such as prasugrel or ticagrelor, are characterized by slow gastrointestinal drug absorption in the acute phase of STEMI, leading to decreased bioavailability and therefore delayed onset of platelet inhibition. Evidence suggests that administration of crushed tablets of the P2Y inhibitor prasugrel improves drug absorption and achieves earlier antiplatelet effects in STEMI patients undergoing primary percutaneous coronary intervention (PCI). However, the clinical implications of these pharmacokinetic and pharmacodynamic findings are unknown.

Hypothesis: The present study is designed to test the hypothesis that patients presenting with STEMI planned for primary PCI will have improved markers of optimal reperfusion and clinical outcomes by prehospital administration of crushed tablets of prasugrel loading dose.

Study Design: COMPARE CRUSH (NCT03296540) is a randomized trial in a regionally organized ambulance care setting evaluating the efficacy and safety of pre-hospital loading dose with prasugrel crushed tablets versus integral tablets in approximately 674 patients presenting with STEMI planned for primary PCI. The independent primary endpoints are percentage of patients reaching thrombolysis in myocardial infarction (TIMI) flow grade 3 in the infarct-related artery at initial angiography, or achieving ≥70% ST-segment elevation resolution at 1 hour post-PCI. Secondary clinical endpoints are death, myocardial infarction, revascularization, and stent thrombosis followed up to 1 year. Moreover, the primary safety endpoint is bleeding events assessed at 48 hours.

Conclusions: The COMPARE CRUSH trial will assess whether prehospital administration of loading dose prasugrel in form of crushed tablets - which is expected to provide faster platelet inhibition compared to standard treatment with integral tablets - results in improved reperfusion and clinical outcomes. RCT# NCT03296540.
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http://dx.doi.org/10.1016/j.ahj.2020.03.005DOI Listing
June 2020

Revascularization Strategies in Patients Presenting With ST-Elevation Myocardial Infarction and Multivessel Coronary Disease.

Am J Cardiol 2020 05 19;125(10):1486-1491. Epub 2020 Feb 19.

Department of Cardiology, Erasmus University Medical Centre, Rotterdam, The Netherlands. Electronic address:

The optimal revascularization strategy for residual coronary stenosis following primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD) remains controversial. This is a retrospective single-centre study including patients with STEMI and MVD. Based on the revascularization strategy, 3 groups were identified: (1) culprit only (CO), (2) ad hoc multivessel revascularization (MVR), and (3) staged MVR. Clinical outcomes were compared in terms of major adverse cardiac events (MACE), a composite of cardiac death, any myocardial infarction, and any unplanned revascularization at a long-term follow-up. A total of 958 patients were evaluated, 489 in the CO, 254 in the ad hoc, and 215 in the staged group. In the staged group, 65.6% of the patients received planned percutaneous coronary intervention, 9.7% coronary artery bypass grafting, 8.4% no further intervention after lesion reassessment, and in 16.3% an event occurred before the planned procedure. At 1,095 days, MACE was 36.1%, 16.7%, and 31% for CO, ad hoc, and staged groups, respectively. A MVR strategy was associated with lower rate of all-cause death compared with CO (HR 0.50; 95%CI [0.31 to 0.80]; p = 0.004). Complete revascularization reduced the rate of MACE (HR 0.30 [0.21 to 0.43] p < 0.001) compared with incomplete revascularization. Ad hoc MVR had lower rate of MACE compared with staged MVR (HR 0.61 [0.39 to 0.96] p = 0.032) mainly driven by less unplanned revascularizations. In conclusion, in patients with STEMI and MVD, complete revascularization reduced the risk of MACE. Ad hoc MVR appeared a reasonable strategy with lower contrast and stent usage and costs.
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http://dx.doi.org/10.1016/j.amjcard.2020.01.050DOI Listing
May 2020

Platelet Inhibition, Endothelial Function, and Clinical Outcome in Patients Presenting With ST-Segment-Elevation Myocardial Infarction Randomized to Ticagrelor Versus Prasugrel Maintenance Therapy: Long-Term Follow-Up of the REDUCE-MVI Trial.

J Am Heart Assoc 2020 03 3;9(5):e014411. Epub 2020 Mar 3.

Department of Cardiology Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.

Background Off-target properties of ticagrelor might reduce microvascular injury and improve clinical outcome in patients with ST-segment-elevation myocardial infarction. The REDUCE-MVI (Evaluation of Microvascular Injury in Revascularized Patients with ST-Segment-Elevation Myocardial Infarction Treated With Ticagrelor Versus Prasugrel) trial reported no benefit of ticagrelor regarding microvascular function at 1 month. We now present the follow-up data up to 1.5 years. Methods and Results We randomized 110 patients with ST-segment-elevation myocardial infarction to either ticagrelor 90 mg twice daily or prasugrel 10 mg once a day. Platelet inhibition and peripheral endothelial function measurements including calculation of the reactive hyperemia index and clinical follow-up were obtained up to 1.5 years. Major adverse clinical events and bleedings were scored. An intention to treat and a per-protocol analysis were performed. There were no between-group differences in platelet inhibition and endothelial function. At 1 year the reactive hyperemia index in the ticagrelor group was 0.66±0.26 versus 0.61±0.28 in the prasugrel group (=0.31). Platelet inhibition was lower at 1 month versus 1 year in the total study population (61% [42%-81%] versus 83% [61%-95%]; <0.001), and per-protocol platelet inhibition was higher in patients randomized to ticagrelor versus prasugrel at 1 year (91% [83%-97%] versus 82% [65%-92%]; =0.002). There was an improvement in intention to treat endothelial function in patients randomized to ticagrelor (=0.03) but not in patients randomized to prasugrel (=0.88). Major adverse clinical events (10% versus 14%; =0.54) and bleedings (47% versus 63%; =0.10) were similar in the intention-to-treat analysis in both groups. Conclusions Platelet inhibition at 1 year was higher in the ticagrelor group, without an accompanying increase in bleedings. Endothelial function improved over time in ticagrelor patients, while it did not change in the prasugrel group. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique Identifier: NCT02422888.
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http://dx.doi.org/10.1161/JAHA.119.014411DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7335553PMC
March 2020

Predictors for Clinical Outcome of Untreated Stent Edge Dissections as Detected by Optical Coherence Tomography.

Circ Cardiovasc Interv 2020 03 24;13(3):e008685. Epub 2020 Feb 24.

Department of Cardiology, Erasmus MC, Rotterdam, the Netherlands (L.J.C.v.Z., M.T., M.N.T.F., K.M., L.V., K.W., J.L., I.K., M.E.L., R.D., J.W., P,d.J., F.Z., N.M.V.M., J.D.).

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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.119.008685DOI Listing
March 2020

Assessment of residual thrombus burden in patients with ST-segment elevation myocardial infarction undergoing bivalirudin versus unfractionated heparin infusion: The MATRIX (minimizing adverse hemorrhagic events by transradial access site and angioX) OCT study.

Catheter Cardiovasc Interv 2020 11 28;96(6):1156-1171. Epub 2019 Dec 28.

Swiss Cardiovascular Center Bern, University of Bern, Bern, Switzerland.

Background: Residual stent strut thrombosis after primary percutaneous coronary intervention (PCI), negatively affects myocardial perfusion, may increase stent thrombosis risk, and it is associated with neointima hyperplasia at follow-up.

Objectives: To study the effectiveness of any bivalirudin infusion versus unfractionated heparin (UFH) infusion in reducing residual stent strut thrombosis in patients with ST-elevation myocardial infarction (STEMI).

Methods: Multi-vessel STEMI patients undergoing primary PCI and requiring staged intervention were selected among those randomly allocated to two different bivalirudin infusion regimens in the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) Treatment-Duration study. Those receiving heparin only were enrolled into a registry arm. Optical coherence tomography (OCT) of the infarct-related artery was performed at the end of primary PCI and 3-5 days thereafter during a staged intervention. The primary endpoint was the change in minimum flow area (ΔMinFA) defined as (stent area + incomplete stent apposition [ISA] area) - (intraluminal defect + tissue prolapsed area) between the index and staged PCI.

Results: 123 patients in bivalirudin arm and 28 patients in the UFH arm were included. Mean stent area, percentage of malapposed struts, and mean percent thrombotic area were comparable after index or staged PCI. The ΔMinFA in the bivalirudin group was 0.25 versus 0.05 mm in the UFH group, which resulted in a between-group significant difference of 0.36 [95% CI: (0.05, 0.71); p = .02]. This was mostly related to a decrease in tissue protrusion in the bivalirudin group (p = .03). There was a trend towards more patients in the bivalirudin group who achieved a 5% difference in the percentage of OCT frames with the area >5% (p = .057).

Conclusions: The administration of bivalirudin after primary PCI significantly reduces residual stent strut thrombosis when compared to UFH. This observation should be considered hypothesis-generating since the heparin-treated patients were not randomly allocated.
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http://dx.doi.org/10.1002/ccd.28661DOI Listing
November 2020

Ticagrelor Alone Versus Dual Antiplatelet Therapy From 1 Month After Drug-Eluting Coronary Stenting.

J Am Coll Cardiol 2019 11;74(18):2223-2234

Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland.

Background: The GLOBAL LEADERS (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation) study randomly assigned 15,991 patients undergoing percutaneous coronary intervention to 1-month dual antiplatelet therapy (DAPT) followed by 23-month ticagrelor monotherapy or conventional 12-month DAPT followed by 12-month aspirin. Apart from Q-wave myocardial infarction (MI), all study endpoints were analyzed as investigator reported.

Objectives: This was a pre-specified ancillary study assessing whether experimental therapy is noninferior, and if met, superior, to conventional treatment for the coprimary efficacy endpoint of all-cause death, nonfatal MI, nonfatal stroke, or urgent target vessel revascularization and superior in preventing BARC 3 (Bleeding Academic Research Consortium) or 5 bleeding (coprimary safety endpoint) at 2 years with a 0.025 significance level to preserve nominal 5% alpha error.

Methods: An independent clinical event committee adjudicated investigator-reported and eventually unreported events of 7,585 patients from the 20 top-enrolling participating sites.

Results: The 2-year coprimary efficacy endpoint occurred in 271 (7.14%) and in 319 (8.41%) patients in the experimental and conventional groups, respectively (rate ratio [RR]: 0.85; 95% confidence interval [CI]: 0.72 to 0.99), fulfilling noninferiority (p noninferiority <0.001), but not superiority (p superiority = 0.0465). The rates of BARC 3 or 5 bleeding did not differ (RR: 1.00; 95% CI: 0.75 to 1.33; p = 0.986). A time-dependent treatment effect was observed with the experimental strategy being associated with a lower risk of MI (RR: 0.54; 95% CI: 0.33 to 0.88; p interaction = 0.062) and definite stent thrombosis (RR: 0.14; 95% CI: 0.03 to 0.63; p interaction = 0.007) after 1-year post-percutaneous coronary intervention.

Conclusions: Ticagrelor monotherapy after 1-month DAPT was noninferior, but not superior, to conventional treatment in the prevention of ischemic events, and it did not decrease major bleeding risk as compared with conventional treatment. (GLOBAL LEADERS Adjudication Sub-Study [GLASSY]; NCT03231059).
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http://dx.doi.org/10.1016/j.jacc.2019.08.1038DOI Listing
November 2019

Current approaches for treatment of coronary chronic occlusions.

Expert Rev Med Devices 2019 Nov 21;16(11):941-954. Epub 2019 Oct 21.

Department of Interventional Cardiology, Thoraxcenter, Erasmus University Medical Centre, Rotterdam, The Netherlands.

: Coronary chronic total occlusions (CTO) represent a challenging subset in interventional cardiology.: During the last decade, improvements in materials, techniques, and meticulous pre-procedural lesion assessment have increased the success rate in CTO lesions. Several scores have been developed to address overall lesion evaluation and help select the most appropriate treatment strategy. In addition, specific algorithms such as the hybrid algorithm have been introduced to provide a framework for CTO operators and a rapid management of the various challenging aspects of the procedure. The hybrid approach requires operator's ability to switch from one treatment strategy to another when the first one appears to be unsuccessful. Adequate training and operators' experience remain crucial to improve the likelihood of success.: The aim of this review is to provide insights and guidance for operators on current approaches for treatment of CTO and complication management.
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http://dx.doi.org/10.1080/17434440.2019.1676729DOI Listing
November 2019
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