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1.
EuroIntervention ; 20(7): e436-e444, 2024 Apr 01.
Article in English | MEDLINE | ID: mdl-38562070

ABSTRACT

BACKGROUND: The effect of administering a crushed prasugrel loading dose is uncertain in patients presenting with a large myocardial infarction and ST-segment elevation myocardial infarction (STEMI). AIMS: The aim of this study was to investigate if patients with a large myocardial infarction may benefit from prehospital administration of a crushed prasugrel loading dose. METHODS: Patients from the CompareCrush trial with an available ambulance electrocardiography (ECG) were included in the study. An independent core laboratory confirmed a prehospital large myocardial area. We compared pre- and postprocedural angiographic markers, including Thrombolysis in Myocardial Infarction (TIMI) 3 flow in the infarct-related artery, high thrombus burden, and myocardial blush grade 3, in STEMI patients with and without a prehospital large myocardial area. RESULTS: Ambulance ECG was available for 532 patients, of whom 331 patients were identified with a prehospital large myocardial area at risk. Crushed prasugrel significantly improved postprocedural TIMI 3 flow rates in STEMI patients with a prehospital large myocardial area at risk (92% vs 79%, odds ratio [OR] 3.00, 95% confidence interval [CI]: 1.50-6.00) but not in STEMI patients without a prehospital large myocardial area at risk (91% vs 95%, OR 0.47, 95% CI: 0.14-1.57; pinteraction=0.009). CONCLUSIONS: Administration of crushed prasugrel may improve postprocedural TIMI 3 flow in STEMI patients with signs of a large myocardial area at risk on the ambulance ECG. The practice of crushing tablets of prasugrel loading dose might, therefore, represent a safe, fast and cost-effective strategy to improve myocardial reperfusion in this high-risk STEMI subgroup undergoing primary percutaneous coronary intervention.


Subject(s)
Emergency Medical Services , Myocardial Infarction , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Humans , Myocardial Infarction/drug therapy , Percutaneous Coronary Intervention/adverse effects , Platelet Aggregation Inhibitors/therapeutic use , Prasugrel Hydrochloride/therapeutic use , ST Elevation Myocardial Infarction/drug therapy , Treatment Outcome
2.
J Clin Med ; 12(20)2023 Oct 20.
Article in English | MEDLINE | ID: mdl-37892785

ABSTRACT

BACKGROUND: Direct stenting (DS) compared with conventional stenting (CS) after balloon predilatation may reduce distal embolization during percutaneous coronary intervention (PCI), thereby improving tissue reperfusion. In contrast, DS may increase the risk of stent underexpansion and target lesion failure. METHODS: In this sub-study of the randomized COMPARE CRUSH trial (NCT03296540), we reviewed the efficacy of DS versus CS in a cohort of contemporary, pretreated ST-segment elevation myocardial infarction (STEMI) patients undergoing primary PCI. We compared DS versus CS, assessing (1) stent diameter in the culprit lesion, (2) thrombolysis in myocardial infarction (TIMI) flow in the infarct-related artery post-PCI and complete ST-segment resolution (STR) one-hour post-PCI, and (3) target lesion failure at one year. For proportional variables, propensity score weighting was applied to account for potential treatment selection bias. RESULTS: This prespecified sub-study included 446 patients, of whom 189 (42%) were treated with DS. Stent diameters were comparable between groups (3.2 ± 0.5 vs. 3.2 ± 0.5 mm, p = 0.17). Post-PCI TIMI 3 flow and complete STR post-PCI rates were similar between groups (DS 93% vs. CS 90%, adjusted OR 1.16 [95% CI, 0.56-2.39], p = 0.69, and DS 72% vs. CS 58%, adjusted OR 1.29 [95% CI 0.77-2.16], p = 0.34, respectively). Moreover, target lesion failure rates at one year were comparable (DS 2% vs. 1%, adjusted OR 2.93 [95% CI 0.52-16.49], p = 0.22). CONCLUSION: In this contemporary pretreated STEMI cohort, we found no difference in early myocardial reperfusion outcomes between DS and CS. Moreover, DS seemed comparable to CS in terms of stent diameter and one-year vessel patency.

3.
Am Heart J ; 258: 17-26, 2023 04.
Article in English | MEDLINE | ID: mdl-36596332

ABSTRACT

BACKGROUND: The mechanisms underlying the increased risk of bleeding that female patients with ST-segment Elevation Myocardial Infarction (STEMI) exhibit, remains unclear. The present report assessed sex-related differences in response to pre-hospital dual antiplatelet therapy (DAPT) initiation in patients with STEMI. METHODS: The COMPARE CRUSH trial randomized patients presenting with STEMI to receive a pre-hospital loading dose of crushed or integral prasugrel tablets in the ambulance. In this substudy, we compared platelet reactivity levels and the occurrence of high platelet reactivity (HPR; defined as platelet reactivity ≥208) between sexes at 4 prespecified time points after DAPT initiation, and evaluated post-PCI bleeding between groups. RESULTS: Out of 633 STEMI patients, 147 (23%) were female. Females compared with males presented with significantly higher levels of platelet reactivity and higher HPR rates at baseline (232 [IQR, 209-256] vs 195 [IQR, 171-220], P < .01, and 76% vs 41%, OR 4.58 [95%CI, 2.52-8.32], P < .01, respectively). Moreover, female sex was identified as the sole independent predictor of HPR at baseline (OR 5.67 [95%CI, 2.56-12.53], P < .01). Following DAPT initiation, levels of platelet reactivity and the incidence of HPR were similar between sexes. Post-PCI bleeding occurred more frequently in females compared with males (10% vs 2%, OR 6.02 [95%CI, 2.61-11.87], P < .01). Female sex was an independent predictor of post-PCI bleeding (OR 3.25 [95%CI, 1.09-9.72], P = .04). CONCLUSIONS: In this contemporary STEMI cohort, female STEMI patients remain at risk of bleeding complications after primary PCI. However, this is not explained by sex-specific differences in the pharmacodynamic response to pre-hospital DAPT initiation.


Subject(s)
Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Female , Humans , Male , Fibrinolytic Agents/therapeutic use , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Percutaneous Coronary Intervention/adverse effects , Platelet Aggregation Inhibitors/adverse effects , Prasugrel Hydrochloride/therapeutic use , ST Elevation Myocardial Infarction/therapy , Treatment Outcome
4.
Am Heart J ; 252: 26-30, 2022 10.
Article in English | MEDLINE | ID: mdl-35671829

ABSTRACT

The present research letter reports the 1-year clinical outcomes of the randomized COMPARE CRUSH trial, which allocated STEMI patients at first medical contact in the ambulance to receive either crushed or integral tablets of prasugrel loading dose. This trial aimed to investigate whether early enhanced antiplatelet effect constituted by the crushed potent oral P2Y12 inhibitor prasugrel could lead to improved early myocardial reperfusion and clinical outcomes.


Subject(s)
Emergency Medical Services , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Follow-Up Studies , Humans , Percutaneous Coronary Intervention/methods , Platelet Aggregation Inhibitors/therapeutic use , Prasugrel Hydrochloride/therapeutic use , Purinergic P2Y Receptor Antagonists/therapeutic use , ST Elevation Myocardial Infarction/drug therapy , Tablets , Treatment Outcome
5.
J Am Heart Assoc ; 11(2): e023691, 2022 01 18.
Article in English | MEDLINE | ID: mdl-35023343

ABSTRACT

Background The use of large-bore (LB) arterial access and guiding catheters has been advocated for complex percutaneous coronary intervention. However, the impact of LB transradial access (TRA) and transfemoral access (TFA) on extremity dysfunction is currently unknown. Methods and Results The predefined substudy of the COLOR (Complex Large-Bore Radial PCI) trial aimed to assess upper and lower-extremity dysfunction after LB radial and femoral access. Upper-extremity function was assessed in LB TRA-treated patients by the Quick Disabilities of the Arm, Shoulder, and Hand questionnaire and lower-extremity function in LB TFA-treated patients by the Lower Extremity Functional Scale questionnaire. Extremity pain and effect of access site complications and risk factors on extremity dysfunction was also analyzed. There were 343 patients who completed analyzable questionnaires. Overall, upper and lower-extremity function did not decrease over time when LB TRA and TFA were used for complex percutaneous coronary intervention, as represented by the median Quick Disabilities of the Arm, Shoulder, and Hand score (6.8 at baseline and 2.1 at follow-up, higher is worse) and Lower Extremity Functional Scale score (56 at baseline and 58 at follow-up, lower is worse). Clinically relevant extremity dysfunction occurred in 6% after TRA and 9% after TFA. A trend for more pronounced upper-limb dysfunction was present in female patients after LB TRA (P=0.05). Lower-extremity pain at discharge was significantly higher in patients with femoral access site complications (P=0.02). Conclusions Following LB TRA and TFA, self-reported upper and lower-limb function did not decrease over time in the majority of patients. Clinically relevant limb dysfunction occurs in a small minority of patients regardless of radial or femoral access. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03846752.


Subject(s)
Catheterization, Peripheral , Percutaneous Coronary Intervention , Catheterization, Peripheral/adverse effects , Catheterization, Peripheral/methods , Female , Femoral Artery , Humans , Lower Extremity , Pain/etiology , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , Radial Artery , Treatment Outcome , Upper Extremity
7.
JACC Cardiovasc Interv ; 14(12): 1323-1333, 2021 06 28.
Article in English | MEDLINE | ID: mdl-34167672

ABSTRACT

OBJECTIVES: This study sought to compare the pharmacodynamic effects of pre-hospitally administered P2Y12 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 P2Y12 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 P2Y12 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.


Subject(s)
Myocardial Infarction , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Hospitals , Humans , Myocardial Infarction/drug therapy , Percutaneous Coronary Intervention/adverse effects , Platelet Aggregation Inhibitors/adverse effects , Prasugrel Hydrochloride/adverse effects , Purinergic P2Y Receptor Antagonists/adverse effects , ST Elevation Myocardial Infarction/diagnostic imaging , ST Elevation Myocardial Infarction/drug therapy , Treatment Outcome
8.
Circulation ; 142(24): 2316-2328, 2020 12 15.
Article in English | MEDLINE | ID: mdl-33315489

ABSTRACT

BACKGROUND: Early treatment with a potent oral platelet P2Y12 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 P2Y12 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], P=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], P=0.55). Platelet reactivity at the beginning of pPCI, measured as P2Y12 reactivity unit, differed significantly between groups (crushed, 192 [132-245] versus integral, 227 [184-254], P≤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.


Subject(s)
Blood Platelets/drug effects , Emergency Medical Services , Percutaneous Coronary Intervention , Platelet Aggregation Inhibitors/administration & dosage , Prasugrel Hydrochloride/administration & dosage , Purinergic P2Y Receptor Antagonists/administration & dosage , ST Elevation Myocardial Infarction/therapy , Aged , Ambulances , Blood Platelets/metabolism , Drug Administration Schedule , Female , Hemorrhage/chemically induced , Humans , Male , Middle Aged , Netherlands , Percutaneous Coronary Intervention/adverse effects , Platelet Aggregation Inhibitors/adverse effects , Prasugrel Hydrochloride/adverse effects , Prospective Studies , Purinergic P2Y Receptor Antagonists/adverse effects , ST Elevation Myocardial Infarction/diagnosis , Tablets , Time Factors , Time-to-Treatment , Treatment Outcome
9.
Am Heart J ; 224: 10-16, 2020 06.
Article in English | MEDLINE | ID: mdl-32272255

ABSTRACT

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 P2Y12 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.


Subject(s)
Percutaneous Coronary Intervention , Prasugrel Hydrochloride/administration & dosage , ST Elevation Myocardial Infarction/therapy , Administration, Oral , Aged , Coronary Angiography , Dose-Response Relationship, Drug , Female , Humans , Male , Middle Aged , Platelet Aggregation Inhibitors/administration & dosage , Preoperative Period , ST Elevation Myocardial Infarction/diagnosis , Treatment Outcome
11.
EuroIntervention ; 16(7): 591-599, 2020 Sep 18.
Article in English | MEDLINE | ID: mdl-31085504

ABSTRACT

AIMS: The aim of this study was to validate novel software to calculate vessel fractional flow reserve (vFFR) based on 3D-QCA and to assess inter-observer variability in patients who underwent routine preprocedural FFR assessment for intermediate coronary artery stenosis. METHODS AND RESULTS: In vitro validation was performed in an experimental model. Clinical validation was performed in an observational, retrospective, single-centre cohort study. A total of 100 patients presenting with stable angina or non-ST-segment elevation myocardial infarction and an indication to perform FFR between January 2016 and October 2016 were included. vFFR was calculated based on the aortic root pressure along with two angiographic projections and validated against pressure wire-derived FFR. Mean FFR and vFFR were 0.82±0.08 and 0.84±0.07, respectively. A good linear correlation was found between FFR and vFFR (r=0.89; p<0.001). Assessment of vFFR had a low inter-observer variability (r=0.95; p<0.001). The diagnostic accuracy of vFFR in identifying lesions with an FFR ≤0.80 was higher as compared with 3D-QCA: AUC 0.93 (95% CI: 0.88-0.97) vs 0.66 (95% CI: 0.55-0.77), respectively. CONCLUSIONS: The 3D-QCA-derived vFFR has a high linear correlation to invasively measured FFR, a high diagnostic accuracy to detect FFR ≤0.80 and a low inter-observer variability.


Subject(s)
Coronary Stenosis/diagnostic imaging , Fractional Flow Reserve, Myocardial , Cohort Studies , Coronary Angiography , Humans , Predictive Value of Tests , Retrospective Studies , Severity of Illness Index , Software
12.
Am Heart J ; 213: 66-72, 2019 07.
Article in English | MEDLINE | ID: mdl-31128504

ABSTRACT

BACKGROUND: Post percutaneous coronary intervention (PCI) fractional flow reserve (FFR) is a significant predictor of major adverse cardiac events (MACE). The rationale for low post procedural FFR values often remains elusive based on angiographic findings alone, warranting further assessment using an FFR pullback or additional intravascular imaging. It is currently unknown if additional interventions intended to improve the PCI, decrease MACE rates. STUDY DESIGN: The FFR REACT trial is a prospective, single-center randomized controlled trial in which 290 patients with a post PCI FFR <0.90 will be randomized (1:1) to either standard of care (no additional intervention) or intravascular ultrasound (IVUS)-directed optimization of the FFR (treatment arm). Eligible patients are those treated with angiographically successful PCI for (un)stable angina or non-ST elevation myocardial infarction (MI). Assuming 45% of patients will have a post PCI FFR <0.90, approximately 640 patients undergoing PCI will need to be enrolled. Patients with a post PCI FFR ≥ 0.90 will be enrolled in a prospective registry. The primary end point is defined as a composite of cardiac death, target vessel MI and clinically driven target vessel revascularisation (target vessel failure) at 1 year. Secondary end points will consist of individual components of the primary end point, procedural success, stent thrombosis and correlations on clinical outcome, changes in post PCI Pd/Pa and FFR and IVUS derived dimensions. All patients will be followed for 3 years. CONCLUSION: The FFR-REACT trial is designed to explore the potential benefit of HD-IVUS-guided PCI optimization in patients with a post PCI FFR <0.90 (Dutch trial register: NTR6711).


Subject(s)
Angina, Stable/therapy , Endosonography/methods , Fractional Flow Reserve, Myocardial , Non-ST Elevated Myocardial Infarction/therapy , Percutaneous Coronary Intervention/methods , Randomized Controlled Trials as Topic , Angina, Stable/physiopathology , Humans , Myocardial Revascularization , Non-ST Elevated Myocardial Infarction/physiopathology , Prospective Studies , Standard of Care
13.
Circ Cardiovasc Interv ; 12(5): e007428, 2019 05.
Article in English | MEDLINE | ID: mdl-31018666

ABSTRACT

BACKGROUND: Fractional flow reserve (FFR) is the current gold standard to determine hemodynamic severity of angiographically intermediate coronary lesions. Much less is known about the prognostic effects of FFR measured directly after percutaneous coronary intervention (PCI). The aims of this study were to evaluate post-PCI FFR values, identify predictors for a low post-PCI FFR, and to investigate whether a relationship between postprocedural FFR and outcome during 30-day follow-up exists. METHODS AND RESULTS: The FFR-SEARCH (Fractional Flow Reserve-Stent Evaluated at Rotterdam Cardiology Hospital) is a prospective registry in which FFR measurements were performed after PCI in 1000 consecutive patients. All FFR measurements were performed under maximum hyperemia with intravenous adenosine with the Navvus RXi system (ACIST Medical Systems, Eden Prairie, MN). The clinical end point was defined as a composite of death, target vessel revascularization, or nonfatal myocardial infarction at 30-day follow-up. Measurement of post-PCI FFR was successful in 959 patients (96%), and a total of 1165 lesions were assessed. There were no complications related to the microcatheter. A total of 322 ST-segment-elevation myocardial infarction patients with 371 measured lesions were excluded leaving 637 patients with 794 measured lesions for the final analysis. Overall post-PCI FFR was 0.90±0.07. In 396 lesions (50%), post-PCI FFR was >0.90. A total of 357 patients (56%) had ≥1 lesion(s) with a post-PCI FFR ≤0.90, and 73 patients (11%) had ≥1 lesion(s) with a post-PCI FFR ≤0.80 with post-PCI FFR ≤0.80 in 78 lesions (9.8%). Complex lesion characteristics, use of multiple stents and smaller reference vessel diameter was associated with post-PCI FFR ≤0.90. During follow-up, 11 patients (1.8%) reached the clinical end point. There was no significant relationship between post-PCI FFR and the clinical end point at 30-day follow-up ( P=0.636). CONCLUSIONS: Routine measurement of post-PCI FFR using a monorail microcatheter is safe and feasible. Several lesion and patient characteristics were associated with a low post-PCI FFR. Post-PCI FFR did not correlate with clinical events at 30 days.


Subject(s)
Acute Coronary Syndrome/therapy , Angina, Stable/therapy , Cardiac Catheterization , Coronary Artery Disease/therapy , Fractional Flow Reserve, Myocardial , Percutaneous Coronary Intervention , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/mortality , Acute Coronary Syndrome/physiopathology , Adenosine/administration & dosage , Aged , Angina, Stable/diagnosis , Angina, Stable/mortality , Angina, Stable/physiopathology , Coronary Angiography , Coronary Artery Disease/diagnosis , Coronary Artery Disease/mortality , Coronary Artery Disease/physiopathology , Female , Humans , Hyperemia/physiopathology , Male , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/instrumentation , Percutaneous Coronary Intervention/mortality , Predictive Value of Tests , Prospective Studies , Recurrence , Registries , Risk Factors , Stents , Time Factors , Treatment Outcome , Vasodilator Agents/administration & dosage
14.
Circ Cardiovasc Interv ; 12(2): e007030, 2019 02.
Article in English | MEDLINE | ID: mdl-30732469

ABSTRACT

BACKGROUND: Fractional flow reserve (FFR) after percutaneous coronary intervention is a predictor of adverse cardiovascular events during follow-up. However, the rationale for low post procedural FFR values remains often elusive based on angiographic findings alone. METHODS AND RESULTS: FFR SEARCH (Stent Evaluated at Rotterdam Cardiology Hospital) is a prospective single-center registry in which post-percutaneous coronary intervention FFR was assessed in 1000 consecutive all-comer patients. FFR measurements were performed with a microcatheter ±20 mm distal to the most distal stent edge. In 100 vessels with a post procedural FFR ≤0.85, and 20 vessels >0.85 high definition intravascular ultrasound analysis was performed. In 100 vessels with a post-percutaneous coronary intervention FFR ≤0.85, mean post procedural FFR was 0.79±0.05. Minimal lumen area was 2.19 (1.81-3.19) mm2, mean lumen area was 5.95 (5.01-7.03) mm2, and minimal stent area was 4.01 (3.09-5.21) mm2. Significant residual focal proximal lesions were found in 29% of the assessed vessels whereas, focal distal lesions were found in 30% of the vessels. Stent underexpansion and malapposition were found in 74% and 22% of vessels, respectively. Clear focal signs of luminal narrowing were found in 54% of the vessels analyzed. Although incidences of focal lesions, underexpansion, and malapposition were similar between both cohorts, minimal stent area was significantly smaller in vessels with a post-percutaneous coronary intervention FFR ≤0.85 as compared with those with an FFR >0.85. CONCLUSIONS: In patients with a post procedural FFR ≤0.85, intravascular ultrasound revealed focal signs of luminal narrowing in a significant number of cases.


Subject(s)
Coronary Artery Disease/therapy , Fractional Flow Reserve, Myocardial , Percutaneous Coronary Intervention/adverse effects , Aged , Cardiac Catheterization , Coronary Angiography , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/physiopathology , Female , Humans , Male , Middle Aged , Netherlands , Percutaneous Coronary Intervention/instrumentation , Predictive Value of Tests , Prospective Studies , Registries , Risk Factors , Stents , Treatment Outcome , Ultrasonography, Interventional
15.
Catheter Cardiovasc Interv ; 93(2): 233-238, 2019 02 01.
Article in English | MEDLINE | ID: mdl-30260080

ABSTRACT

BACKGROUND: Angiographic assessment of left main coronary artery (LMCA) lesions remains challenging and limited data is available on reference diameters and length of nonobstructive LMCA dimensions. Our aim was to provide insights in the dimensions of nonobstructive LMCA and to find a possible correlation with gender and patient habitus. METHODS: This retrospective single center study was performed in a consecutive cohort of patients who underwent Intravascular Ultrasound (IVUS) guided percutaneous coronary interventions of the left coronary system including complete pullbacks of a non-obstructive LMCA (n = 254). RESULTS: Mean LMCA length as measured with IVUS was 7.37 ± 4.2 mm and mean lumen area (LA) was 15.63 ± 4.76 mm2 corresponding to a mean lumen diameter (LD) of 4.41 ± 0.67 mm. An IVUS derived mean LD of >4 mm was present in 71.7%, >4.5 mm in 43% and > 5 mm in 19% of patients. LMCA mean LA was significantly smaller in women as compared to men (14.1 ± 4.1 mm2 and 16.2 ± 4.8 mm2 , P < 0.01). Multivariable analysis identified weight of the patient as the sole significant predictor for LMCA length while height of the patient and LMCA length were predictors of LMCA mean LA. Correlation coefficients of determination for all independent predictors were low (R2 < 0.1 for all). CONCLUSION: This study demonstrated that the mean LD of a non-obstructive LMCA is 4 mm or greater in the majority of patients, with a mean LMCA length of 7.4 mm. Women have smaller luminal dimension than men. No clinically relevant predictors were found for both LMCA length and mean LA.


Subject(s)
Coronary Vessels/diagnostic imaging , Ultrasonography, Interventional , Aged , Body Height , Body Weight , Female , Humans , Male , Middle Aged , Predictive Value of Tests , Reference Values , Retrospective Studies , Sex Factors , Ultrasonography, Interventional/standards
16.
Circ Cardiovasc Interv ; 11(12): e006911, 2018 12.
Article in English | MEDLINE | ID: mdl-30562091

ABSTRACT

BACKGROUND: Instantaneous wave-free ratio (iFR) offers a reliable non-hyperemic assessment of coronary physiology but requires dedicated proprietary software with a fully automated algorithm. We hypothesized that dPR (diastolic pressure ratio), calculated with novel universal software, has a strong correlation with iFR, similar diagnostic accuracy relative to resting distal coronary artery pressure/aortic pressure and fractional flow reserve (FFR). METHODS AND RESULTS: The dPR study is an observational, retrospective, single-center cohort study including patients who underwent iFR or FFR. Dedicated software was used to calculate the dPR from Digital Imaging and Communications in Medicine (DICOM) pressure waveforms. The flat period on the pressure difference between sample (dP) to the time difference between the same sample points (dt) signal was used to detect automatically the period, where the resistance is low and constant, and to calculate the dPR, which is an average over 5 consecutive heartbeats. The software was validated by correlating iFR results with dPR. Software validation was done by comparing 78 iFR measurements in 44 patients who underwent iFR. Mean iFR and dPR were 0.91±0.10 and 0.92±0.10, respectively, with a significant linear correlation ( R=0.997; P<0.001). Diagnostic accuracy was tested in 100 patients who underwent FFR. Mean FFR, resting distal coronary artery pressure/aortic pressure, and dPR were 0.85±0.09, 0.94±0.05, and 0.93±0.07, respectively. There was a significant linear correlation between dPR and FFR ( R=0.77; P<0.001). Both distal coronary artery pressure/aortic pressure and dPR had good diagnostic accuracy in the identification of lesions with an FFR ≤0.80 (area under the curve, 0.84; 95% CI, 0.76-0.92 and 0.86; 95% CI, 0.78-0.93, respectively). CONCLUSIONS: dPR, calculated by a novel validated software tool, showed a strong linear correlation with iFR. dPR correlated well with FFR with a good diagnostic accuracy to identify positive FFR.


Subject(s)
Algorithms , Aorta/physiopathology , Arterial Pressure , Cardiac Catheterization , Coronary Artery Disease/diagnosis , Coronary Vessels/physiopathology , Fractional Flow Reserve, Myocardial , Aged , Aged, 80 and over , Cardiac Catheterization/instrumentation , Cardiac Catheters , Coronary Angiography , Coronary Artery Disease/physiopathology , Coronary Vessels/diagnostic imaging , Diastole , Feasibility Studies , Female , Humans , Male , Middle Aged , Predictive Value of Tests , Reproducibility of Results , Retrospective Studies , Software Validation , Time Factors , Transducers, Pressure
17.
Am Heart J ; 204: 83-91, 2018 10.
Article in English | MEDLINE | ID: mdl-30081277

ABSTRACT

BACKGROUND: Dedicated data on the prevalence of incidental findings (IF) stratified according to overall clinical relevance and their subsequent correlation to outcome are lacking. The aim of the present study was to describe the prevalence and consequences of noncardiac IF on computed tomography or magnetic resonance imaging in the workup for interventional cardiovascular procedures. METHODS: A total of 916 patients underwent preprocedural computed tomography or magnetic resonance imaging in the workup for transcatheter aortic valve implantation (TAVI), renal sympathetic denervation (RDN), or MitraClip implantation. RESULTS: IF were found in 395 of 916 patients (43.1%), with an average of 1.8 IF per patient. Classifying the IF resulted in 155 patients with minor, 171 patients with moderate, and 69 patients with major IF. The intended procedure was delayed or canceled in only 15 of 916 (1.6%) of the patients because of the presence of potential malignant IF. In patients that did undergo the intended procedure (n = 774), the presence of a moderate or major IF (23.8%) did not impact 1-year mortality compared to no or minor IF (adjusted HR 0.90, 95% CI 0.56-1.44, P value = .65). These findings were consistent among patients referred for TAVI, RDN, or MitraClip. CONCLUSIONS: IF are frequent in patients referred for cardiovascular procedures. IF did not result in a delay or cancellation of the intended procedure in the vast majority of cases, irrespective of their clinical relevance. The presence of a major or moderate IF did not significantly impact 1-year mortality.


Subject(s)
Asymptomatic Diseases/epidemiology , Cardiac Surgical Procedures/instrumentation , Incidental Findings , Mitral Valve Insufficiency/surgery , Sympathectomy , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Female , Humans , Magnetic Resonance Imaging , Male , Mitral Valve Insufficiency/diagnostic imaging , Prevalence , Surgical Instruments , Tomography, X-Ray Computed
18.
Int J Cardiol ; 271: 240-246, 2018 Nov 15.
Article in English | MEDLINE | ID: mdl-29885829

ABSTRACT

BACKGROUND: The presence of reperfusion ventricular arrhythmias (VA) has been shown to correlate with larger infarct size (IS). However it is unclear whether the initial area at risk (AAR), also a determining factor for IS, is responsible for this correlation. We hypothesized that IS would be significantly larger in the presence of VA, while AAR would not differ. METHODS: 68 STEMI patients from the MAST study with 24-hour, continuous, 12­lead Holter monitoring initiated prior to primary percutaneous coronary intervention (PCI) resulting in TIMI 3 flow post PCI were included. VA bursts were identified against subject-specific background VA rates using a previously validated statistical outlier method. IS, and infarct endocardial surface area (ESA) were obtained using CMR at mean 4.9 days after admission. Holter and CMR results were determined in core laboratories blinded to all other data. RESULTS: VA bursts were present in 69% (45/65) of patients. No significant differences were found for demographic characteristics, comorbidities, infarct location, number of diseased coronary vessels, or duration of ischemia between groups with and without VA burst. IS was significantly smaller in the group without VA bursts (median 9.3% vs 17.0%; p = 0.025). Infarct ESA did not significantly differ between the population with and without VA burst; median 24.3% vs 20.0%; p = 0.15. CONCLUSION: VA bursts are a marker for larger IS independent of AAR, assessed by surrogate markers. These findings support the hypothesis that VA bursts are a marker of reperfusion damage occurring downstream at myocellular level.


Subject(s)
Arrhythmias, Cardiac/physiopathology , Electrocardiography/trends , Myocardial Reperfusion Injury/physiopathology , ST Elevation Myocardial Infarction/physiopathology , Aged , Arrhythmias, Cardiac/diagnostic imaging , Databases, Factual/trends , Electrocardiography/methods , Electrocardiography, Ambulatory/methods , Electrocardiography, Ambulatory/trends , Female , Humans , Male , Middle Aged , Myocardial Reperfusion Injury/diagnostic imaging , Risk Factors , ST Elevation Myocardial Infarction/diagnostic imaging
19.
J Cardiol ; 72(2): 149-154, 2018 08.
Article in English | MEDLINE | ID: mdl-29478878

ABSTRACT

BACKGROUND AND AIMS: Significant left main (LM) stem disease is potentially life-threatening and mandates revascularization. This study aimed to assess how patients rate the importance of particular features of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI), how this determines their preference for a particular treatment strategy, and whether particular personality characteristics influence this preference. METHODS AND RESULTS: In total, 1145 patients who visited the outpatient clinic of the Erasmus Medical Center for stable coronary artery disease were asked to complete a case vignette-questionnaire on a hypothetical significant LM stenosis amenable to PCI or CABG. To assess the individual's personality disposition and general distress level, each patient had to complete a set of 3 standardized, validated questionnaires with satisfactory psychometric properties. Overall 89% of patients preferred PCI to CABG. PCI was the preferred strategy despite a higher risk for repeat revascularization and need for more medication. Remarkably, the fact that a risk for repeat revascularization is more common in the PCI group is less important for the patients who opt for PCI. Risk for stroke and bleeding were the most important arguments to opt for PCI over CABG. Type D personality, depression, and anxiety were all associated with a relatively higher preference for CABG as revascularization strategy. CONCLUSION: Overall, when given the choice patients seem to have a clear preference for PCI over CABG and consider stroke and bleeding important procedure-related complications. Patients with Type D personality, depression, or anxiety favor CABG.


Subject(s)
Coronary Artery Bypass , Coronary Artery Disease/surgery , Patient Preference , Percutaneous Coronary Intervention , Adult , Aged , Aged, 80 and over , Anxiety , Coronary Artery Bypass/adverse effects , Depression , Female , Hemorrhage/etiology , Humans , Male , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Risk , Stroke/etiology , Surveys and Questionnaires , Treatment Outcome , Type D Personality
20.
Catheter Cardiovasc Interv ; 91(3): E21-E28, 2018 02 15.
Article in English | MEDLINE | ID: mdl-28500738

ABSTRACT

OBJECTIVES: To compare the occurrence of acute stent recoil in two different stent types (platinum chromium and cobalt chromium) and identify the potential predictors of significant acute stent recoil. BACKGROUND: Acute stent recoil is frequently observed after percutaneous coronary intervention and has been associated with in-stent restenosis and in-stent thrombosis. Different stent designs may result in varying degrees of stent recoil. METHODS: From a registry of "all-comers" treated with either the Xience Prime Cobalt Chromium or Promus Premier Platinum Chromium stent, a random sample of 100 patients was drawn. Acute stent recoil was defined as the minimal luminal diameter (MLD) of the last inflated balloon minus the MLD after, divided by the MLD of the last inflated balloon. Significant acute stent recoil was defined as recoil ≥10%. RESULTS: A total of 123 lesions (61 Xience Prime vs 62 Promus Premier) in 100 patients were analyzed. Acute stent recoil of 8.6 ± 4.9% was observed in the Xience Prime group versus 8.7 ± 4.2% in the Promus Premier group, P = 0.970. In a multivariate model for significant acute stent recoil, a stent/vessel ratio ≥1 (hazard ratio 4.64 [1.94-11.12], P = 0.001), a balloon/stent ratio >1 (hazard ratio 3.83 [1.12-13.14], P = 0.032) and direct stenting (hazard ratio 0.42 [0.18-0.96], P = 0.039) were identified as predictors. CONCLUSIONS: No significant differences were observed in the extent of acute stent recoil between the Xience Prime and the Promus Premier stent. A larger stent/vessel ratio, a larger balloon/stent ratio, and direct stenting were associated with significant acute stent recoil ≥10%. © 2017 Wiley Periodicals, Inc.


Subject(s)
Angioplasty, Balloon, Coronary/instrumentation , Chromium Alloys , Coronary Artery Disease/surgery , Coronary Stenosis/surgery , Platinum , Prosthesis Failure , Stents , Aged , Aged, 80 and over , Angioplasty, Balloon, Coronary/adverse effects , Coronary Angiography , Coronary Artery Disease/diagnostic imaging , Coronary Stenosis/diagnostic imaging , Female , Humans , Male , Middle Aged , Prosthesis Design , Registries , Retrospective Studies , Risk Factors , Severity of Illness Index , Treatment Outcome
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