Intracoronary Stenting Research Articles

Giant Coronary Artery Aneurysm Associated with Extraluminal Migration of Stent: Role of Multimodal Imaging

Abstract Extraluminal migration of a drug-eluting intracoronary stent into pericardial space with or without aneurysm formation is a rare complication. It is usually symptomatic although rare asymptomatic cases have been described. Herein, we report a 49-year-old male who presented with atypical chest pain 9 years after intracoronary stent implantation in the right coronary artery and the ramus intermediate branch. Echocardiographic examination showed a 7.4 cm × 3.8 cm large oblong cystic mass along the lateral wall of the left ventricle with inward bulging of the adjacent segments. Computed tomography and invasive coronary angiography showed this mass to be a partly thrombosed giant oblong coronary aneurysm arising from the bifurcation of the left main coronary artery with extraluminal migration of the stent from the ramus branch.

Second-generation everolimus-eluting intracoronary stents: a comprehensive review of the clinical evidence.

Percutaneous coronary intervention with implantation of second-generation drug-eluting stents (DES) has emerged as a mainstay for the treatment of obstructive coronary artery disease given its beneficial impact on clinical outcomes in these patients. Everolimus-eluting stents (EES) are one of the most frequently implanted second-generation DES; their use for the treatment of a wide range of patients including those with complex coronary lesions is supported by compelling evidence. Although newer stent platforms such as biodegradable polymer DES may lower local vessel inflammation, their efficacy and safety have not yet surpassed that of Xience stents. This articlesummarizes the properties of theXience family of EES and the evidence supporting their use across diverse patient demographics and coronary lesion morphologies.

Preprocedural physiological assessment of coronary disease patterns to predict haemodynamic outcomes post-PCI.

Even with intracoronary imaging-guided stent optimisation, suboptimal haemodynamic outcomes post-percutaneous coronary intervention (PCI) can be related to residual lesions in non-stented segments. Preprocedural assessment of pathophysiological coronary artery disease (CAD) patterns could help predict the physiological response to PCI. The aim of this study was to assess the relationship between preprocedural pathophysiological haemodynamic patterns and intracoronary imaging findings, as well as their association with physiological outcomes immediately post-PCI. Data from 206 patients with chronic coronary syndrome enrolled in the ASET-JAPAN study were analysed. Pathophysiological CAD patterns were characterised using Murray law-based quantitative flow ratio (μQFR)-derived indices acquired from pre-PCI angiograms. The diffuseness of CAD was defined by the pullback pressure gradient (PPG) index. Intracoronary imaging in stented segments after stent optimisation was also analysed. In the multivariable analysis, diffuse disease - defined by the pre-PCI μQFR-PPG index - was an independent factor for predicting a post-PCI μQFR <0.91 (per 0.1 decrease of PPG index, odds ratio 1.57, 95% confidence interval: 1.07-2.34; p=0.022), whereas the stent expansion index (EI) was not associated with a suboptimal post-PCI μQFR. Among vessels with an EI ≥80% and post-PCI μQFR <0.91, 84.0% of those vessels had a diffuse pattern preprocedure. There was no significant difference in EI between vessels with diffuse disease and those with focal disease. The average plaque burden in the stented segment was significantly larger in vessels with a preprocedural diffuse CAD pattern. A physiological diffuse pattern preprocedure was an independent factor in predicting unfavourable immediate haemodynamic outcomes post-PCI, even after stent optimisation using intracoronary imaging. Preprocedural assessment of CAD patterns could identify patients who are likely to exhibit superior immediate haemodynamic outcomes following PCI.

A Case Report of Kounis Syndrome Developing Anaphylaxis Secondary to Vitamin B and C Infusion

Kounis syndrome is a condition characterized by temporary coronary spasm, reduction in coronary blood flow and myocardial ischemia by activated mast cells as a result of an abnormal immune reaction to a drug or molecule. It is also called allergic angina and allergic myocardial infarction. It was first described by Kounis and Zarvas in 1991. (1) Kounis syndrome can be observed in all age groups regardless of the history of coronary artery disease. Kounis syndrome may occur due to environmental factors such as drugs, intracoronary stent implantation, foods, insect bites, bee stings, pollen, latex exposure etc. In our case report, acute coronary syndrome occurring during anaphylaxis secondary to vitamin B and C infusion, which is frequently used in clinical practice, will be explained.

Successful simultaneous retrieval of two dislodged and entangled intracoronary stents using distal balloon inflating technique

Stent loss in coronary arteries is a rare complication of coronary intervention. Furthermore, the entanglement of a lost stent with a second previously deployed stent leading to a very complicated scenario has not been reported previously. In this case, we are presenting the first case report of a stent loss due to the entanglement of a stent with the ostial part of the second already deployed side branch stent leading to distortions of the second stent and entrapment. This is also the first case report describing the successful and simultaneous retrieval of both the lost and entangled deployed stents percutaneously using the distal inflating balloon technique.

Coronary Syndromes and High-Altitude Exposure—A Comprehensive Review

The aim of this review is to identify a preventive strategy in order to minimize the risk of adverse events in patients with coronary syndromes and acute exposure to high-altitude. For this purpose we searched the electronic database of PubMed, EMBASE, and Web of Science for studies published in the last 30 years in this field. The conclusions of this review are: patients with stable coronary artery disease on optimal treatment and in a good physical condition can tolerate traveling to high altitude up to 3500 m; on the other hand, patients with unstable angina or recent myocardial infarction no older than 6 months should take less interest in hiking or any activity involving high altitude. Air-traveling is contraindicated for patients with myocardial infarction within previous 2 weeks, angioplasty or intracoronary stent placement within previous 2 weeks, and unstable angina or coronary artery bypass grafting within previous 3 weeks. The main trigger for sudden cardiac death is the lack of gradual acclimatization to high-altitude and to the exercise activity, and the most important risk factor is prior myocardial infarction.

Risk investigation of in-stent restenosis after initial implantation of intracoronary drug-eluting stent in patients with coronary heart disease.

To analyze the risk factors of in-stent restenosis (ISR) after the first implantation of drug-eluting stent (DES) patients with coronary heart disease (CHD) and to establish a nomogram model to predict the risk of ISR. This study retrospectively analyzed the clinical data of patients with CHD who underwent DES treatment for the first time at the Fourth Affiliated Hospital of Zhejiang University School of Medicine from January 2016 to June 2020. Patients were divided into an ISR group and a non-ISR (N-ISR) group according to the results of coronary angiography. The least absolute shrinkage and selection operator (LASSO) regression analysis was performed on the clinical variables to screen out the characteristic variables. Then we constructed the nomogram prediction model using conditional multivariate logistic regression analysis combined with the clinical variables selected in the LASSO regression analysis. Finally, the decision curve analysis, clinical impact curve, area under the receiver operating characteristic curve, and calibration curve were used to evaluate the nomogram prediction model's clinical applicability, validity, discrimination, and consistency. And we double-validate the prediction model using ten-fold cross-validation and bootstrap validation. In this study, hypertension, HbA1c, mean stent diameter, total stent length, thyroxine, and fibrinogen were all predictive factors for ISR. We successfully constructed a nomogram prediction model using these variables to quantify the risk of ISR. The AUC value of the nomogram prediction model was 0.806 (95%CI: 0.739-0.873), indicating that the model had a good discriminative ability for ISR. The high quality of the calibration curve of the model demonstrated the strong consistency of the model. Moreover, the DCA and CIC curve showed the model's high clinical applicability and effectiveness. Hypertension, HbA1c, mean stent diameter, total stent length, thyroxine, and fibrinogen are important predictors for ISR. The nomogram prediction model can better identify the high-risk population of ISR and provide practical decision-making information for the follow-up intervention in the high-risk population.

The Role of Oxidants in Percutaneous Coronary Intervention-Induced Endothelial Dysfunction: Can We Harness Redox Signaling to Improve Clinical Outcomes?

Significance: Coronary artery disease (CAD) is commonly treated using percutaneous coronary interventions (PCI). However, PCI with stent placement damages the endothelium, and failure to restore endothelial function may result in PCI failure with poor patient outcomes. Recent Advances: Oxidative signaling is central to maintaining endothelial function. Potentiation of oxidant production, as observed post-PCI, results in endothelial dysfunction (ED). This review delves into our current understanding of the physiological role that endothelial-derived oxidants play within the vasculature and the effects of altered redox signaling during dysfunction. We then examine the impact of PCI and intracoronary stent placement on oxidant production in the endothelium, which can culminate in stent failure. Finally, we explore how recent advances in PCI and stent technologies aim to mitigate PCI-induced oxidative damage and improve clinical outcomes. Critical Issues: Current PCI technologies exacerbate cellular oxidant levels, driving ED. If left uncontrolled, oxidative signaling leads to increased intravascular inflammation, restenosis, and neoatherosclerosis. Future Directions: Through the development of novel biomaterials and therapeutics, we can limit PCI-induced oxidant production, allowing for the restoration of a healthy endothelium and preventing CAD recurrence.

Management of Guidewire Entrapment and Fracture During Percutaneous Coronary Intervention: When All Bailout Techniques Fail!

A 55-year-old man presented with chest pain and was diagnosed with non-ST-segment elevation myocardial infarction. Coronary angiography revealed a 95% eccentric lesion in the mid-right coronary artery. After 3 intracoronary stents were placed, the guidewire became entrapped in 1 of the stents; multiple attempts at retrieval were unsuccessful. Ultimately, the guidewire fractured, and a coronary artery bypass graft surgery was performed to remove the guidewire fragments. This report reviews the procedural steps for wire retrieval that are critical for operators to avoid coronary artery bypass surgery.

High on-aspirin treatment platelet reactivity and restenosis after percutaneous coronary intervention: results of the Intracoronary Stenting and Antithrombotic Regimen-ASpirin and Platelet Inhibition (ISAR-ASPI) Registry

ObjectiveThe aim of this study was to assess the association between high on-aspirin treatment platelet reactivity (HAPR) and the subsequent risk of restenosis after percutaneous coronary intervention (PCI) with predominantly drug-eluting stents.BackgroundThe association between HAPR and subsequent risk of restenosis after PCI is unclear.MethodsThis study included 4839 patients undergoing PCI (02/2007–12/2011) in the setting of the Intracoronary Stenting and Antithrombotic Regimen-ASpirin and Platelet Inhibition (ISAR-ASPI) registry. Platelet function was assessed with impedance aggregometry using the multi-plate analyzer immediately before PCI and after intravenous administration of aspirin (500 mg). The primary outcome was clinical restenosis, defined as target lesion revascularization at 1 year. Secondary outcomes included binary angiographic restenosis and late lumen loss at 6- to 8-month angiography.ResultsThe upper quintile cut-off of platelet reactivity measurements (191 AU × min) was used to categorize patients into a group with HAPR (platelet reactivity > 191 AU × min; n = 952) and a group without HAPR (platelet reactivity ≤ 191 AU × min; n = 3887). The primary outcome occurred in 94 patients in the HAPR group and 405 patients without HAPR (cumulative incidence, 9.9% and 10.4%; HR = 0.96, 95% CI 0.77–1.19; P = 0.70). Follow-up angiography was performed in 73.2% of patients. There was no difference in binary restenosis (15.2% vs. 14.9%; P = 0.79) or late lumen loss (0.32 ± 0.57 vs. 0.32 ± 0.59 mm; P = 0.93) between patients with HAPR versus those without HAPR.ConclusionsThis study did not find an association between HAPR, measured at the time of PCI, and clinical restenosis at 1 year after PCI.Graphical abstract

Prior Myocardial Infarction and Treatment Effect of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndromes - A Post-hoc Analysis of the ISAR-REACT 5 Trial.

Background The efficacy and safety of ticagrelor versus prasugrel in patients with acute coronary syndrome and prior myocardial infarction (MI) remain unstudied. We aimed to assess the treatment effect of ticagrelor versus prasugrel according to prior MI status in patients with ACS. Methods and Results Patients with acute coronary syndrome planned for an invasive strategy and randomized to ticagrelor or prasugrel in the ISAR-REACT (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment) 5 trial were included. The primary end point was the composite of 1-year all-cause death, MI, or stroke; the secondary safety end point was the composite of 1-year Bleeding Academic Research Consortium type 3 to 5 bleeding. The study included 4015 patients (prior MI=631 patients; no prior MI=3384 patients). As compared with patients without prior MI, the primary end point occurred more frequently in patients with prior MI (12.6% versus 7.2%; hazard ratio [HR], 1.78 [95% CI, 1.38-2.29]); the secondary safety end point appears to differ little between patients with and without prior MI (5.8% versus 5.7%, respectively; HR, 1.02 [95% CI, 0.71-1.45]). With regard to the primary end point, ticagrelor versus prasugrel was associated with an HR of 1.62 (95% CI, 1.03-2.55) in patients with prior MI and an HR of 1.28 (95% CI, 0.99-1.65) in patients without prior MI (Pint=0.37). With regard to the secondary safety end point, ticagrelor versus prasugrel was associated with an HR of 1.28 (95% CI, 0.56-2.91) in patients with prior MI and an HR of 1.13 (95% CI, 0.82-1.55) in patients without prior MI (Pint=0.79). Conclusions Patients with acute coronary syndrome and prior MI are at higher risk for recurrent ischemic but not bleeding events. Prasugrel is superior to ticagrelor in reducing the risk of ischemic events without a tradeoff in bleeding regardless of prior MI status. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01944800.

In Silico Modelling to Assess the Electrical and Thermal Disturbance Provoked by a Metal Intracoronary Stent during Epicardial Pulsed Electric Field Ablation.

Background: Pulsed Electric Field (PEF) ablation has been recently proposed to ablate cardiac ganglionic plexi (GP) aimed to treat atrial fibrillation. The effect of metal intracoronary stents in the vicinity of the ablation electrode has not been yet assessed. Methods: A 2D numerical model was developed accounting for the different tissues involved in PEF ablation with an irrigated ablation device. A coronary artery (with and without a metal intracoronary stent) was considered near the ablation source (0.25 and 1 mm separation). The 1000 V/cm threshold was used to estimate the ‘PEF-zone’. Results: The presence of the coronary artery (with or without stent) distorts the E-field distribution, creating hot spots (higher E-field values) in the front and rear of the artery, and cold spots (lower E-field values) on the sides of the artery. The value of the E-field inside the coronary artery is very low (~200 V/cm), and almost zero with a metal stent. Despite this distortion, the PEF-zone contour is almost identical with and without artery/stent, remaining almost completely confined within the fat layer in any case. The mentioned hot spots of E-field translate into a moderate temperature increase (<48 °C) in the area between the artery and electrode. These thermal side effects are similar for pulse intervals of 10 and 100 μs. Conclusions: The presence of a metal intracoronary stent near the ablation device during PEF ablation simply ‘amplifies’ the E-field distortion already caused by the presence of the vessel. This distortion may involve moderate heating (<48 °C) in the tissue between the artery and ablation electrode without associated thermal damage.

Friday, June 17, 202210:00 AM - 12 PMPO01: Intravascular Brachytherapy of the Coronary Arteries for In Stent In Stent Restenosis: Sicker Patients, but Just as Safe

<h3>Purpose</h3> More than 20 years ago prophylactic intravascular brachytherapy burst into the radiation oncology lexicon, only to be replaced within a few years by the introduction of drug eluting stents. However, restenosis still occurs in 5- 15% of high risk patients with two or more layers of drug eluting stents. We examined our experience in patients with in stent in stent restenosis who have no options for durable revascularization and therefore are forced to lead a shortened and sedentary life, comparing this to our historic control group. <h3>Materials and Methods</h3> A retrospective cohort of 134 patients treated with angioplasty followed by intracoronary brachytherapy was compared to a current high risk group of 122 patients with in stent in stent restenosis. All patients had a minimum 6 month follow up post brachytherapy. None of the original cohort had stenting performed at the time of brachytherapy, while all patients in the restenosis cohort had placement of at least 2 layers of intracoronary stents prior to repeat angioplasty and IVBT. <h3>Results</h3> In the original cohort, there were no intraprocedural deaths, while the high risk cohort had a single intraprocedural death due to intracoronary thrombosis. No high risk patient developed any significant cardiovascular event otherwise at 6 months post-procedure. <h3>Conclusions</h3> Intravascular brachytherapy for in stent in stent restenosis is equally safe compared to the historic post angioplasty IBVT safety profile, despite the fragile nature and relatively high risk disease status of these patients with limited options.

Predictors of Stent Restenosis in Han and Uygur Patients with Coronary Heart Disease after PCI in the Xinjiang Region.

Background Stent restenosis after PCI seriously affects the efficacy and prognosis; therefore, the study of ISR risk factors has become an urgent topic to be solved. Objective To investigate the risk factors for in-stent restenosis (ISR) after percutaneous coronary intervention (PCI) in Han and Uygur patients with coronary heart disease. Methods The clinical data of 345 Han and 127 Uygur patients who underwent intracoronary stent implantation were divided into an ISR group and a non-ISR group. The general clinical data, laboratory indicators, and coronary artery lesions were compared. Results Age (OR = 1.040, 95% CI: 1.006∼1.075), triglycerides (OR = 1.440, 95% CI: 1.050∼1.973), total cholesterol (OR = 5.256, 95% CI: 2.826∼9.773), and ApoB (OR = 137.540, 95% CI: 11.364∼899.455) were independent risk factors for ISR after PCI in the Han patients, while ApoAI (OR = 0.002, 95% CI: 0.001∼0.011), MCV (OR = 0.824, 95% CI: 0.744∼0.911), MCH (OR = 0.421, 95% CI: 0.324∼0.548), and MCHC (OR = 0.934, 95% CI: 0.903∼0.965) were protective factors of ISR after PCI in Han patients, and the logistic regression equation composed of various factors predicted that the area under the ROC curve of ISR was 0.905. ApoB (OR = 11.571, 95% CI: 1.667∼80.340), Gensini score (OR = 1.017, 95% CI: 1.003∼1.031), and diabetes history (OR = 3.474, 95% CI: 1.189∼10.151) were independent risk factors for ISR after PCI in Uygur patients, and the area under ROC curve of ISR predicted by logistic regression equation is 0.807. The predictive efficiency of the Gensini score and ApoB level for ISR in Uygur patients was higher than that in Han, while the predictive efficiency of levels of ApoAI and MCH for ISR in Han patients was higher than that in Uygur (P < 0.05). Conclusion The independent risk factors for ISR after PCI in Han and Uygur patients in Xinjiang are different.

Dexmedetomidine and the Combination of Benzodiazepine and Fentanyl in Elective Endovacular Stenting of the Coronary Arteries. Comparative Analysis

The optimal method of anesthetic management in percutaneous coronary interventions (PCI) is procedural analgosedation that in most cases is provided by the combination of benzodiazepine and an opioid analgesic. However, there are no protocols and recommendations for its implementation at this time.The objective: to choose an adequate and safe method of analgosedation for elective endovascular stenting of coronary arteries.Subjects and Methods. A randomized study was conducted from September 2021 to January 2022. The group where analgosedation with fentanyl and sibazon was used included 33 patients. 30 patients were enrolled in the group of analgosedation with dexmedetomidine. A comparison was made in terms of the level of sedation (RASS scale), hemodynamic parameters, blood oxygen saturation (SpO2), the incidence of anginal pain at the stage of stenting and the need for additional analgesia, and the level of serum troponin T.Results. Dexmedetomidine significantly induces a deeper level of sedation (RASS -2) compared to the combination of benzodiazepine and fentanyl (RASS -1) at the stage of intracoronary stent placement (p &lt; 0.001). In the group of analgosedation with dexmedetomidine, there was a statistically significant decrease in blood pressure and heart rate versus the group of analgosedation with fentanyl and sibazon (p &lt; 0.05). Analgesia with narcotic analgesics was required 9.1 times lower (p =0.028) at the stage of installation of intracoronary stents in the group of dexmedetomidine analgosedation versus the group of fentanyl and sibazon analgosedation (OR 0.11; 95% CI 0.13–0.92).Conclusion. Anesthesia for elective percutaneous coronary interventions with dexmedetomidine may be more adequate and safer than the combination of a benzodiazepine and an opioid analgesic. At the stage of coronary artery stenting, dexmedetomidine provides deeper sedation, significant prevention of the development of anginal pain, a pronounced hypotensive and negative chronotropic effect compared to analgosedation with fentanyl and sibazon.

ANMCO position paper on antithrombotic treatment of patients with atrial fibrillation undergoing intracoronary stenting and/or acute coronary syndromes.

Patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) with or without acute coronary syndromes (ACS) represent a subgroup with a challenging pharmacological management. Indeed, if on the one hand, antithrombotic therapy should reduce the risk related to recurrent ischaemic events and/or stent thrombosis; on the other hand, care must be taken to avoid major bleeding events. In recent years, several trials, which overall included more than 12 000 patients, have been conducted demonstrating the safety of different therapeutic combinations of oral antiplatelet and anticoagulant agents. In the present ANMCO position paper, we propose a decision-making algorithm on antithrombotic strategies based on scientific evidence and expert consensus to be adopted in the periprocedural phase, at the time of hospital discharge, and in the long-term follow-up of patients with AF undergoing PCI with/without ACS.

ANMCO Position paper: Antithrombotic treatment of patients with atrial fibrillation undergoing intracoronary stenting and/or acute coronary syndromes

Patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) with or without acute coronary syndromes (ACS) represent a subgroup with a challenging pharmacological management. Indeed, if on the one hand antithrombotic therapy should reduce the risk related to recurrent ischemic events and/or stent thrombosis, on the other hand care should be taken to avoid major bleeding events. In recent years, several trials, which overall included more than 12 000 patients, have been conducted demonstrating the safety of different therapeutic combinations of oral antiplatelet and anticoagulant agents. In the present ANMCO position paper we propose a decision-making algorithm on antithrombotic strategies based on scientific evidence and expert consensus to be adopted in the periprocedural phase, at the time of hospital discharge and in the long-term follow-up of patients with AF undergoing PCI with/without ACS.

PThe Case of Removal of Intracoronary Broken Stent Catheter’s Shaft and Its Balloon Trough Femoral Sheat During Primer PTCA

In the time of invasive area, catheter based complications is getting more frequent and interventionist deals with this kind of complications’ management more than vascular surgeons. Regardless of complication’s nature commonly management of complications are successful and requirements of surgery are needless. But the patient stability deteriorates the time of complications especially result of intracoronary foreign bodies. Quick Removal of these foreign bodies from coronary circulation can stabilize patient condition. After that externalization of these kind remnants from patient body is the final step of successfully management of complications. . We herein present an acute inferior ST elevation myocardial infarction (MI) with hemodynamic disturbance because of total obstruction of RCA with broken stent balloon shaft. After successfully catch and removal of broken part of stent catheter, patient’s situation was going well and discharged with medical therapy shortly after intervention

The diagnostic accuracy of coronary computed tomography angiography in patients with and without previous coronary interventions

BackgroundInvasive coronary angiography (ICA) is the gold standard for imaging coronary arteries and the severity of coronary artery disease (CAD). Coronary computed tomography angiography (CCTA) has undergone remarkable progress in the diagnosis of CAD. ObjectivesTo evaluate the effect of prior vs no previous coronary interventions on the diagnostic accuracy of CCTA as an alternative to ICA to improve health outcomes for patients with suspected CAD. MethodsA prospective cohort study was carried out among patients suspected of CAD and for evaluation of grafts and stents to investigate recurrent ischemic symptoms. 120 patients imaged by CCTA were then referred to ICA, which is considered the gold standard. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of CCTA were assessed relative to ICA. ResultsBased on a per-patient analysis, the comparison with ICA reveals variations in sensitivity, specificity, PPV, NPV and accuracy of CCTA. In patients without any previous coronary interventions, the sensitivity was 97.8%, and specificity was 95.6%. The PPV and NPV were 97.8% and 95.5%, respectively. Regarding patients with coronary artery bypass grafts (CABG), the sensitivity was 95% and specificity 100%. The PPV and NPV were 100% and 90.9%, respectively. Regarding patients with prior percutaneous coronary intervention (PCI), the results were a sensitivity of 84.6%, specificity of 77.8%, PPV of 84.6% and NPV of 77.8%. ConclusionCCTA is a powerful diagnostic tool, especially for the evaluation of the major coronary arteries and evaluation of patients with prior CABG. ICA is recommended for evaluation of patients with an intracoronary stent.

Assessment of Impact of Patient Recruitment Volume on Risk Profile, Outcomes, and Treatment Effect in a Randomized Trial of Ticagrelor Versus Prasugrel in Acute Coronary Syndromes.

BACKGROUNDWhether there are differences in the risk profile and treatment effect in patients recruited in a low recruitment center (LRC) versus patients recruited in a high recruitment center (HRC) in a randomized multicenter trial remains unknown.METHODS AND RESULTSThis study included 4018 patients with acute coronary syndrome recruited in the ISAR‐REACT 5 (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 5) trial. The primary end point was a composite of all‐cause death, myocardial infarction, or stroke. Overall, 3011 patients (75%) were recruited in the HRCs (7 centers recruiting 258 to 628 patients; median, 413 patients) and 1007 patients (25%) were recruited in the LRCs (16 centers recruiting 5 to 201 patients; median, 52 patients). Patients recruited in the LRCs had more favorable cardiovascular risk profiles than patients recruited in the HRCs. The primary end point occurred in 72 patients in the LRCs and 249 patients in the HRCs (cumulative incidence, 7.3% and 8.4%; P=0.267). All‐cause mortality was lower among patients recruited in the LRCs (n=29) than among patients recruited in the HRCs (n=134; cumulative incidence 2.9% versus 4.5%; P=0.031). There was no significant interaction between the treatment effect of ticagrelor versus prasugrel and patient recruitment category (LRC versus HRC) regarding the primary efficacy end point (LRC: hazard ratio [HR], 1.42 [95% CI, 0.89–2.28]; HRC: HR, 1.33 [95% CI, 1.04−1.72]; P for interaction=0.800).CONCLUSIONSPatients with acute coronary syndrome recruited in a LRC appear to have more favorable cardiovascular risk profiles and lower 1‐year mortality rates compared with patients recruited in a HRC. The recruitment volume did not interact with the treatment effect of ticagrelor versus prasugrel.REGISTRATIONURL: https://www.clinicaltrials.gov; Unique identifier: NCT01944800.