Analysis of core outcome set reporting in coronary intervention trials.

BACKGROUND: This paper will focus on outcome reporting within percutaneous coronary intervention (PCI) trials. A core outcome set (COS) is a standardised set of outcomes that are recommended to be reported in every clinical trial. Using a COS can help to ensure that all relevant outcomes are consistently reported across clinical trials. In 2018, the European Society of Cardiology outlined the only COS published for PCI trials. METHODS: We searched the literature for all randomised controlled trials published between 2014 and 2022. PCI trials included were late-phase trials and must investigate coronary intervention. The primary outcome was the proportion of trials that reported all of the COS-defined outcomes within their publication as either a primary, secondary or safety endpoint. The secondary outcomes included; the number of primary outcomes reported per study, the proportion of studies which use patient and public involvement (PPI) during trial design, outcome variability and outcome consistency. RESULTS: 9580 trials were screened and 115 studies met inclusion/exclusion criteria. Our study demonstrated that 55% (34/62) of PCI trials used a COS when it was available, compared with 40% (21/53) before the availability of a PCI COS set, p=0.121. Fewer primary outcomes were reported after the implementation of the COS, 2 compared with 2.3, p=0.014. There was no difference in the use of PPI between either group. There was a higher level of variability in outcomes reported before the availability of the COS, while the consistency of outcome reporting remained similar. CONCLUSION: The use of a COS in PCI trials is low. This study provides evidence that there still is a lack of awareness of the COS among those who design clinical trials. We also presented the inconsistency and heterogenicity in reporting clinical trial outcomes. Finally, there was a clear lack of PPI utilisation in PCI trials.

Peer evaluation and feedback for invasive medical procedures: a systematic review.

BACKGROUND: There is significant variability in the performance and outcomes of invasive medical procedures such as percutaneous coronary intervention, endoscopy, and bronchoscopy. Peer evaluation is a common mechanism for assessment of clinician performance and care quality, and may be ideally suited for the evaluation of medical procedures. We therefore sought to perform a systematic review to identify and characterize peer evaluation tools for practicing clinicians, assess evidence supporting the validity of peer evaluation, and describe best practices of peer evaluation programs across multiple invasive medical procedures. METHODS: A systematic search of Medline and Embase (through September 7, 2021) was conducted to identify studies of peer evaluation and feedback relating to procedures in the field of internal medicine and related subspecialties. The methodological quality of the studies was assessed. Data were extracted on peer evaluation methods, feedback structures, and the validity and reproducibility of peer evaluations, including inter-observer agreement and associations with other quality measures when available. RESULTS: Of 2,135 retrieved references, 32 studies met inclusion criteria. Of these, 21 were from the field of gastroenterology, 5 from cardiology, 3 from pulmonology, and 3 from interventional radiology. Overall, 22 studies described the development or testing of peer scoring systems and 18 reported inter-observer agreement, which was good or excellent in all but 2 studies. Only 4 studies, all from gastroenterology, tested the association of scoring systems with other quality measures, and no studies tested the impact of peer evaluation on patient outcomes. Best practices included standardized scoring systems, prospective criteria for case selection, and collaborative and non-judgmental review. CONCLUSIONS: Peer evaluation of invasive medical procedures is feasible and generally demonstrates good or excellent inter-observer agreement when performed with structured tools. Our review identifies common elements of successful interventions across specialties. However, there is limited evidence that peer-evaluated performance is linked to other quality measures or that feedback to clinicians improves patient care or outcomes. Additional research is needed to develop and test peer evaluation and feedback interventions.

Impact of sex on outcomes of bifurcation lesion percutaneous coronary intervention: results from a single-centre prospective registry.

BACKGROUND: Coronary bifurcation lesions are technically and clinically more challenging compared to nonbifurcation lesions. Sex-related differences in diagnostic and invasive therapeutic coronary procedures have been described in the literature. Our objective was to assess the impact of sex on outcomes of bifurcation lesion percutaneous coronary intervention (PCI). METHODS: Our data were taken from a prospective registry of consecutive patients undergoing PCI for bifurcation lesions at our medical centre between 2004 and 2019. We compared rates of death and major adverse cardiac events (MACE) between men and women at 1 year and 3 years. MACE comprised cardiac death, myocardial infarction, target vessel revascularization or stroke. RESULTS: A total of 1209 patients were included, 948 (78.4%) were male and 261 (21.6%) were female. Women were older (mean age 69.7 ± 11 years vs. 63.1 ± 11 years, P < 0.01), and had more comorbidities than men. Female patients had more angiographically calcified (38.1% vs. 30.1%, P = 0.017) lesions. At 1-year follow up, there was no significant difference of MACE (18.8 vs. 15.2%, P = 0.183) or all-cause mortality (5.7% vs. 3.9%, P = 0.242) between sexes. At 3-year follow up, there was a significantly higher rate of MACE in women (29.1% vs. 22.5%, P = 0.026), this was driven by a significantly higher all-cause mortality (13.8% vs. 6.5%, P < 0.01). CONCLUSION: Women undergoing bifurcation PCI are older and have more comorbidities than their male counterparts. Intermediate term follow-up outcomes are similar between sexes. Poorer long-term outcomes of women are likely due to baseline higher risk profile.

Predictors of angina resolution after percutaneous coronary intervention in stable coronary artery disease.

BACKGROUND: Elective percutaneous coronary intervention (PCI) is performed to relieve symptoms of angina. Identifying patients who will benefit symptomatically after PCI would be clinically advantageous but robust predictors of symptom resolution are ill-defined. METHODS: Prospective indexing of baseline angina status, clinical, and procedural characteristics were collected over a 5-year period in a regional revascularization registry. At 1-year follow-up, angina resolution was assessed. We performed a stepwise selection algorithm to identify predictors of persistent angina at 1 year. RESULTS: A total of 777 patients were included in the analysis and the median follow-up was 387 days. Mean age of the cohort was 66.6 years, 23.8% were female and 23.3% had baseline Canadian Cardiovascular Society class 3 or 4 angina. Overall, 13.1% had persistent angina. The only predictor of persistent angina was the presence of a residual chronic total occlusion after PCI with odds ratio of 3.06 (95% confidence interval, 1.81-5.17). Residual stenoses 50-69%, 70-89%, and 90-99% were not associated with residual angina after PCI. CONCLUSION: Most patients achieved symptom resolution with PCI and optimal medical therapy. A residual chronic total occlusion after PCI was associated with persistent angina. Other degrees of stenoses were not associated with persistent angina.

Trends in ST-elevation myocardial infarction.

AIMS: Despite recent progress in coronary artery disease treatment, ST-segment elevation myocardial infarction (STEMI) remains a very high-risk medical condition. Whether recent patients' outcomes, following implementation of the 2012 European Society of Cardiology (ESC) STEMI guidelines have improved, is yet unclear. METHODS AND RESULTS: The study was based on a prospective detailed registry of 2004 consecutive patients with STEMI treated with primary percutaneous coronary intervention (pPCI). We compared trends during two different time periods (2006-2012 vs. 2012-2018). Endpoints included mortality and major adverse cardiac events (MACE: death, repeat myocardial infarction, target vessel revascularization and coronary artery bypass surgery) at 1 month, 1 and 2 years. Rates of transradial interventions have risen significantly (67.3 vs. 42.0%; P < 0.01), as have rates of prasugrel administration (69.8 vs. 4.5%; P < 0.01) and use of drug eluting stents (75.5 vs. 56.5%; P < 0.01). Both at 1 and at 2 years, MACE was significantly lower in the later period (11.6 vs. 20.9%; P < 0.01 and 18.9 vs. 25.4%; P < 0.01 respectively), whereas mortality was only significantly lower after 1 year (5.8 vs. 8.6%; P = 0.02). Cox regression identified the later period (2012-2018) to independently and favorably impact MACE (hazard ratio, -0.69; 95% CI, 0.56-0.85; P < 0.01) but not mortality (hazard ratio, -0.76; 95% CI, 0.54-1.05; P = 0.09). CONCLUSION: Among patients treated with pPCI for STEMI, adoption of the contemporary evidence-based treatments is associated with better MACE derived outcomes, following the inception of the 2012 ESC guidelines. Nonetheless, the long-term mortality was marginally (but not significantly) lower, which indicates an unmet need for further improvement.

White blood cell count and clinical outcomes after left main coronary artery revascularization: insights from the EXCEL trial.

BACKGROUND: Prior studies have reported an association between elevated white blood cell count (WBCc) and worse clinical outcomes after coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI). We assessed the prognostic impact of WBCc in patients undergoing revascularization for left main coronary artery disease (LMCAD). METHODS: In Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL), 1905 patients with LMCAD and low or intermediate SYNTAX scores were randomized to PCI with everolimus-eluting stents versus CABG. The 1895 patients with baseline WBCc available were grouped in tertiles of WBCc (mean 5.6 ± 0.8, 7.5 ± 0.5, and 10.1 ± 1.6 × 109/L). RESULTS: Five-year rates of the primary endpoint (death, myocardial infarction or stroke) were similar across increasing WBCc tertiles (21.2, 18.9, and 21.6%; P = 0.46). Individual components of the primary endpoint, Bleeding Academic Research Consortium (BARC) 3-5 bleeding, stent thrombosis or graft occlusion and ischemia-driven revascularization were all similar across WBCc tertiles. By multivariable analysis, WBCc as a continuous variable was not an independent predictor of adverse events (hazard radio per 1 × 109/L: 1.02; 95% CI, 0.97-1.08; P = 0.43). Results were consistent in the PCI and CABG arms individually. CONCLUSION: There was no association between baseline WBCc and 30-day or 5-year clinical outcomes after PCI or CABG. The absence of a clear incremental increase in events with increasing WBCc in the current analysis indicates that WBCc should not routinely be used as a prognostic marker or to guide revascularization decisions in patients with LMCAD.

A meta-analysis of optimal medical therapy with or without percutaneous coronary intervention in patients with stable coronary artery disease.

BACKGROUND: Whether percutaneous coronary intervention (PCI) improves clinical outcomes in patients with chronic angina and stable coronary artery disease (CAD) has been a continuing area of investigation for more than two decades. The recently reported results of the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches, the largest prospective trial of optimal medical therapy (OMT) with or without myocardial revascularization, provides a unique opportunity to determine whether there is an incremental benefit of revascularization in stable CAD patients. METHODS: Scientific databases and websites were searched to find randomized clinical trials (RCTs). Pooled risk ratios were calculated using the random-effects model. RESULTS: Data from 10 RCTs comprising 12 125 patients showed that PCI, when added to OMT, were not associated with lower all-cause mortality (risk ratios, 0.96; 95% CI, 0.87-1.08), cardiovascular mortality (risk ratios, 0.91; 95% CI, 0.79-1.05) or myocardial infarction (MI) (risk ratios, 0.90; 95% CI, 0.78-1.04) as compared with OMT alone. However, OMT+PCI was associated with improved anginal symptoms and a lower risk for revascularization (risk ratios, 0.52; 95% CI, 0.37-0.75). CONCLUSIONS: In patient with chronic stable CAD (without left main disease or reduced ejection fraction), PCI in addition to OMT did not improve mortality or MI compared to OMT alone. However, this strategy is associated with a lower rate of revascularization and improved anginal symptoms.

2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

AIM: The executive summary of the American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions coronary artery revascularization guideline provides the top 10 items readers should know about the guideline. In the full guideline, the recommendations replace the 2011 coronary artery bypass graft surgery guideline and the 2011 and 2015 percutaneous coronary intervention guidelines. This summary offers a patient-centric approach to guide clinicians in the treatment of patients with significant coronary artery disease undergoing coronary revascularization, as well as the supporting documentation to encourage their use. METHODS: A comprehensive literature search was conducted from May 2019 to September 2019, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, CINHL Complete, and other relevant databases. Additional relevant studies, published through May 2021, were also considered. Structure: Recommendations from the earlier percutaneous coronary intervention and coronary artery bypass graft surgery guidelines have been updated with new evidence to guide clinicians in caring for patients undergoing coronary revascularization. This summary includes recommendations, tables, and figures from the full guideline that relate to the top 10 take-home messages. The reader is referred to the full guideline for graphical flow charts, supportive text, and tables with additional details about the rationale for and implementation of each recommendation, and the evidence tables detailing the data considered in the development of this guideline.

Contemporary Management of Cardiogenic Shock: A RAND Appropriateness Panel Approach.

BACKGROUND: Current practice in cardiogenic shock is guided by expert opinion in guidelines and scientific statements from professional societies with limited high quality randomized trial data to inform optimal patient management. An international panel conducted a modified Delphi process with the intent of identifying aspects of cardiogenic shock care where there was uncertainty regarding optimal patient management. METHODS: An 18-person multidisciplinary panel comprising international experts was convened. A modified RAND/University of California Los Angeles appropriateness methodology was used. A survey comprising 70 statements was completed. Participants anonymously rated the appropriateness of each statement on a scale of 1 to 9: 1 to 3 inappropriate, 4 to 6 uncertain, and 7 to 9 appropriate. A summary of the results was discussed as a group, and the survey was iterated and completed again before final analysis. RESULTS: There was broad alignment with current international guidelines and consensus statements. Overall, 44 statements were rated as appropriate, 19 as uncertain, and 7 as inappropriate. There was no disagreement with a disagreement index <1 for all statements. Routine fluid administration was deemed to be inappropriate. Areas of uncertainty focused panel on pre-PCI interventions, the use of right heart catheterization to guide management, routine use of left ventricular unloading strategies, and markers of futility when considering escalation to mechanical circulatory support. CONCLUSIONS: While there was broad alignment with current guidance, an expert panel found several aspects of care where there was clinical equipoise, further highlighting the need for randomized controlled trials to better guide patient management and decision making in cardiogenic shock.

P2Y12 inhibitor monotherapy or dual antiplatelet therapy after coronary revascularisation: individual patient level meta-analysis of randomised controlled trials.

OBJECTIVE: To assess the risks and benefits of P2Y12 inhibitor monotherapy compared with dual antiplatelet therapy (DAPT) and whether these associations are modified by patients' characteristics. DESIGN: Individual patient level meta-analysis of randomised controlled trials. DATA SOURCES: Searches were conducted in Ovid Medline, Embase, and three websites (www.tctmd.com, www.escardio.org, www.acc.org/cardiosourceplus) from inception to 16 July 2020. The primary authors provided individual participant data. ELIGIBILITY CRITERIA: Randomised controlled trials comparing effects of oral P2Y12 monotherapy and DAPT on centrally adjudicated endpoints after coronary revascularisation in patients without an indication for oral anticoagulation. MAIN OUTCOME MEASURES: The primary outcome was a composite of all cause death, myocardial infarction, and stroke, tested for non-inferiority against a margin of 1.15 for the hazard ratio. The key safety endpoint was Bleeding Academic Research Consortium (BARC) type 3 or type 5 bleeding. RESULTS: The meta-analysis included data from six trials, including 24 096 patients. The primary outcome occurred in 283 (2.95%) patients with P2Y12 inhibitor monotherapy and 315 (3.27%) with DAPT in the per protocol population (hazard ratio 0.93, 95% confidence interval 0.79 to 1.09; P=0.005 for non-inferiority; P=0.38 for superiority; τ2=0.00) and in 303 (2.94%) with P2Y12 inhibitor monotherapy and 338 (3.36%) with DAPT in the intention to treat population (0.90, 0.77 to 1.05; P=0.18 for superiority; τ2=0.00). The treatment effect was consistent across all subgroups, except for sex (P for interaction=0.02), suggesting that P2Y12 inhibitor monotherapy lowers the risk of the primary ischaemic endpoint in women (hazard ratio 0.64, 0.46 to 0.89) but not in men (1.00, 0.83 to 1.19). The risk of bleeding was lower with P2Y12 inhibitor monotherapy than with DAPT (97 (0.89%) v 197 (1.83%); hazard ratio 0.49, 0.39 to 0.63; P<0.001; τ2=0.03), which was consistent across subgroups, except for type of P2Y12 inhibitor (P for interaction=0.02), suggesting greater benefit when a newer P2Y12 inhibitor rather than clopidogrel was part of the DAPT regimen. CONCLUSIONS: P2Y12 inhibitor monotherapy was associated with a similar risk of death, myocardial infarction, or stroke, with evidence that this association may be modified by sex, and a lower bleeding risk compared with DAPT. REGISTRATION: PROSPERO CRD42020176853.

Standardizing the Definition and Analysis Methodology for Complete Coronary Artery Revascularization.

Guideline-based medical therapy is the foundation of treatment for individuals with coronary artery disease. However, revascularization with either percutaneous coronary intervention or coronary artery bypass grafting may be beneficial in patients with acute coronary syndromes, refractory symptoms, or in other specific scenarios (eg, left main disease and heart failure). While the goal of percutaneous coronary intervention and coronary artery bypass grafting is to achieve complete revascularization, anatomical and ischemic definitions of complete revascularization and their methodology for assessment remain highly variable. Such lack of consensus invariably contributes to the absence of standardized approaches for invasive treatment of coronary artery disease. Herein, we propose a novel, comprehensive, yet pragmatic algorithm with both anatomical and ischemic parameters that aims to provide a systematic method to assess complete revascularization after percutaneous coronary intervention or coronary artery bypass grafting in both clinical practice and clinical trials.

Examining the Timeliness of ST-elevation Myocardial Infarction Transfers.

INTRODUCTION: Despite large-scale quality improvement initiatives, substantial proportions of patients with ST-elevation myocardial infarction (STEMI) transferred to percutaneous coronary intervention centers do not receive percutaneous coronary intervention within the recommended 120 minutes. We sought to examine the contributory role of emergency medical services (EMS) activation relative to percutaneous coronary intervention center activation in the timeliness of care for patients transferred with STEMI. METHODS: We conducted a retrospective analysis of interfacility transfers from emergency departments (ED) to a single percutaneous coronary intervention center between 2011-2014. We included emergency department (ED) patients transferred to the percutaneous coronary intervention center and excluded scene transfers and those given fibrinolytics. We calculated descriptive statistics and used multivariable linear regression to model the association of variables with ED time intervals (arrival to electrocardiogram [ECG], ECG-to-EMS activation, and ECG-to-STEMI alert) adjusting for patient age, gender, mode of arrival, weekday hour presentation, facility transfers in the past year, and transferring facility distance. RESULTS: We identified 159 patients who met inclusion criteria. Subjects were a mean of 59 years old (standard deviation 13), 22% female, and 93% White; 59% arrived by private vehicle, and 24% presented after weekday hours. EDs transferred a median of 9 STEMIs (interquartile range [IQR] 3, 15) in the past year and a median of 65 miles (IQR 35, 90) from the percutaneous coronary intervention center. Median ED length of stay was 65 minutes (IQR 51, 85). Among component intervals, arrival to ECG was 6%, ECG-to-EMS activation 32%, and ECG-to-STEMI alert was 49% of overall ED length of stay. Only 18% of transfers had EMS activation earlier than STEMI alert. ECG-to-EMS activation was shorter in EDs achieving length of stay ≤60 minutes compared to those >60 minutes (12 vs 31 minutes, P<0.001). Multivariable modeling showed that after-hours presentation was associated with longer ECG-to-EMS activation (adjusted relative risk [RR] 1.05, P<0.001). Female gender (adjusted RR 0.81, P<0.001), prior facility transfers (adjusted RR 0.84, P<0.001), and initial ambulance presentation (adjusted RR 0.93, P = 0.02) were associated with shorter ECG-to-EMS activation. CONCLUSION: In STEMI transfers, faster EMS activation was more likely to achieve a shorter ED length of stay than a rapid, percutaneous coronary intervention center STEMI alert. Large-scale quality improvement efforts such as the American Heart Association's Mission Lifeline that were designed to regionalize STEMI have improved the timeliness of reperfusion, but major gaps, particularly in interfacility transfers, remain. While the transferring EDs are recognized as the primary source of delay during interfacility STEMI transfers, the contributions to delays at transferring EDs remain poorly understood.

In-hospital outcomes of patients with chronic kidney disease undergoing percutaneous coronary intervention for chronic total occlusion: a systematic review and meta-analysis.

BACKGROUND: The relative safety and efficacy of percutaneous coronary intervention (PCI) for chronic total occlusions (CTO) in patients with chronic kidney disease (CKD) have not been well defined. We performed a systematic review and meta-analysis of observational studies to assess in-hospital outcomes in this population. METHODS: We searched MEDLINE, EMBASE, and Cochrane Library databases from inception to April 2020 for all clinical trials and observational studies. Five observational studies with a total of 6769 patients met our inclusion criteria. Patients were divided into two groups based on estimated glomerular filtration rate (eGFR <60 ml/min/1.73m2 in CKD group and ≥ 60 ml/min/1.73m2 in non-CKD group). The primary outcome was in-hospital mortality. Secondary outcomes were acute kidney injury, coronary injury (perforation, dissection or tamponade), stroke and procedural success. Mantel-Haenszel random-effects model was used to calculate the odds ratio (OR) and 95% confidence intervals (CI). RESULTS: In-hospital mortality was significantly higher among patients with CKD undergoing PCI for CTO (OR: 5.16, 95% CI: 2.60-10.26, P < 0.00001). Acute kidney injury (OR: 2.54, 95% CI: 1.89-3.40, P < 0.00001) and major bleeding (OR: 2.58, 95% CI: 1.20-5.54, P < 0.01) were also more common in the CKD group. No significant difference was observed in the occurrence of stroke (OR: 2.36, 95% CI: 0.74-7.54, P < 0.15) or coronary injury (OR: 1.38, 95% CI: 0.98-1.93, P < 0.06) between the two groups. Non-CKD patients had a higher likelihood of procedural success compared to CKD patients (OR: 0.66, 95% CI: 0.57-0.77, P < 0.00001). CONCLUSION: Patients with CKD undergoing PCI for CTO have a significantly higher risk of in-hospital mortality, acute kidney injury and major bleeding when compared to non-CKD patients. They also have a lower procedural success rate.

One-year clinical outcome and predictors of ischemic and hemorrhagic events after percutaneous coronary intervention in elderly and very elderly patients.

BACKGROUND: Elderly constitute a high-risk subset of patients but are under-represented in clinical revascularization trials. Our aim was to investigate clinical outcomes and prognosis predictors after percutaneous coronary intervention (PCI) in this population. METHODS: Unrestricted consecutive patients with ≥75 years who underwent PCI from 2012 to 2015 were enrolled. The primary ischemic endpoint was the composite of 1-year myocardial infarction, definite/probable stent thrombosis and target vessel revascularization. The primary bleeding endpoint was defined according to the Bleeding Academic Research Consortium (BARC) classification as BARC ≥ 2. RESULTS: We enrolled 708 patients (mean age 80 ± 4): 14% were very elderly patients (≥85 years), 27% of patients were diabetic, 23% had chronic kidney disease (CKD), 17% atrial fibrillation and 37% presented acute coronary syndrome. The primary ischemic endpoint was reported in 67 patients (12%): 29 had myocardial infarction (5%), 25 had definite/probable stent thrombosis (4.4%) and 44 had target vessel revascularization (8%). BARC ≥ 2 bleeding was reported in 43 patients (8%). No differences were found in terms of both ischemic and bleeding events between patients with <85 and ≥85 years. Three-vessel disease and use of bare metal stent were independent predictors of the primary ischemic endpoint. Triple antithrombotic therapy and CKD were the only independent predictors of BARC ≥ 2 bleedings. CONCLUSIONS: In our experience, elderly patients reported reassuring efficacy and safety outcomes after PCI, even if ischemic and bleeding events were frequent. Three-vessel disease and the use of bare metal stent were the only predictors of primary ischemic endpoint. Triple antithrombotic therapy and CKD were the only predictors of BARC ≥ 2 bleedings.

Predictive value of LncRNA on coronary restenosis after percutaneous coronary intervention in patients with coronary heart disease: A protocol for systematic review and meta-analysis.

BACKGROUND: Evidence shows that long-stranded non-coding RNA (LncRNA) can predict coronary artery restenosis in patients suffering from coronary heart disease after percutaneous coronary intervention, suggesting that LncRNA may become a promising biomarker for the diagnosis of coronary artery restenosis after percutaneous coronary intervention. However, its accuracy has not been systematically evaluated. Therefore, it is necessary to perform meta-analysis to certify the diagnostic value of LncRNA on coronary artery restenosis after percutaneous coronary intervention. METHODS: PubMed, EMBASE, Cochrane Library, and Web of Science were searched for relevant studies to explore the potential diagnostic values of LncRNA on coronary artery restenosis after percutaneous coronary intervention from inception to December 2020. Data were extracted by two experienced researchers independently. The risk of bias about the meta-analysis was confirmed by the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2). Data was synthesized and heterogeneity was investigated as well. All of the above statistical analysis was carried out with Stata 14.0. RESULTS: This study proved the pooled diagnostic performance of LncRNA on coronary artery restenosis after percutaneous coronary intervention. CONCLUSION: This study clarified confusions about the specificity and sensitivity of LncRNA on coronary artery restenosis after percutaneous coronary intervention, thus further guiding their promotion and application. ETHICS AND DISSEMINATION: Ethical approval is not required for this study. The systematic review will be published in a peer-reviewed journal, presented at conferences, and shared on social media platforms. This review would be disseminated in a peer-reviewed journal or conference presentations. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/4QT2P.

Association of Pretreatment With P2Y12 Receptor Antagonists Preceding Percutaneous Coronary Intervention in Non-ST-Segment Elevation Acute Coronary Syndromes With Outcomes.

Importance: Pretreatment of patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) with P2Y12 receptor antagonists is a common practice despite the lack of definite evidence for its benefit. Objective: To investigate the association of P2Y12 receptor antagonist pretreatment vs no pretreatment with mortality, stent thrombosis, and in-hospital bleeding in patients with NSTE-ACS undergoing percutaneous coronary intervention (PCI). Design, Setting, and Participants: This cohort study used prospective data from the Swedish Coronary Angiography and Angioplasty Registry of 64 857 patients who underwent procedures between 2010 and 2018. All patients who underwent PCI owing to NSTE-ACS in Sweden were stratified by whether they were pretreated with P2Y12 receptor antagonists. Associations of pretreatment with P2Y12 receptor antagonists with the risks of adverse outcomes were investigated using instrumental variable analysis and propensity score matching. Data were analyzed from March to June 2019. Exposures: Pretreatment with P2Y12 receptor antagonists. Main Outcomes and Measures: The primary end point was all-cause mortality within 30 days. Secondary end points were 1-year mortality, stent thrombosis within 30 days, and in-hospital bleeding. Results: In total, 64 857 patients (mean [SD] age, 64.7 [10.9] years; 46 809 [72.2%] men) were included. A total of 59 894 patients (92.4%) were pretreated with a P2Y12 receptor antagonist, including 27 867 (43.7%) pretreated with clopidogrel, 34 785 (54.5%) pretreated with ticagrelor, and 1148 (1.8%) pretreated with prasugrel. At 30 days, there were 971 deaths (1.5%) and 101 definite stent thromboses (0.2%) in the full cohort. Pretreatment was not associated with better survival at 30 days (odds ratio [OR], 1.17; 95% CI, 0.66-2.11; P = .58), survival at 1 year (OR, 1.34; 95% CI, 0.77-2.34; P = .30), or decreased stent thrombosis (OR, 0.81; 95% CI, 0.42-1.55; P = .52). However, pretreatment was associated with increased risk of in-hospital bleeding (OR, 1.49; 95% CI, 1.06-2.12; P = .02). Conclusions and Relevance: This cohort study found that pretreatment of patients with NSTE-ACS with P2Y12 receptor antagonists was not associated with improved clinical outcomes but was associated with increased risk of bleeding. These findings support the argument that pretreatment with P2Y12 receptor antagonists should not be routinely used in patients with NSTE-ACS.

Temporal Trends in X-Ray Exposure during Coronary Angiography and Percutaneous Coronary Intervention.

BACKGROUND: Percutaneous coronary intervention exposes patient and staff to ionizing radiation. Although staff only receive a small fraction of patient dose through scatter radiation, there are concerns about the potential health effects of repeated exposure. Minimizing both patient and occupational exposure is needed. OBJECTIVE: This article investigates patient and operator X-ray exposure over time in coronary intervention in relation to upgraded X-ray equipment, improved shielding, and enhanced operator awareness. MATERIALS AND METHODS: Data regarding irradiation time, patient dose, and patient characteristics were extracted from the Norwegian Registry for Invasive Cardiology (NORIC) for procedures performed from 2013 to mid-2019. Personal operator dosimetry records were provided by the Norwegian Radiation and Nuclear Safety Authority. Improved operator shielding and awareness measures were introduced in 2018. RESULTS: In the period 2013 through June 2019, 21499 procedures were recorded in our institution. Mean dose area product (DAP) for coronary angiography decreased 37% from 2981 µGy·m2 in 2013 to 1891 µGy·m2 in 2019 (p < 0.001). For coronary intervention, DAP decreased 39% from 8358 µGy·m2 to 5055 µGy·m2. Personal dosimetry data indicate a 70% reduction in operator dose per procedure in 2019 compared to 2013. The most pronounced reduction occurred after improved radiation protection measures were implemented in 2018 (-48%). CONCLUSIONS: This study shows a temporal trend towards considerable reduction in X-ray doses received by the patient and operator during cardiac catheterization. Upgraded X-ray equipment, improved shielding, and enhanced operator awareness are likely contributors to this development.

The impact of a dedicated coronavirus disease 2019 primary angioplasty protocol on time components related to ST­segment elevation myocardial infarction management in a 24/7 primary percutaneous coronary intervention-capable hospital.

BACKGROUND: Primary percutaneous coronary intervention (PPCI) as the treatment of choice for ST­segment elevation myocardial infarction (STEMI) should be rapidly performed. It is necessary to use preventive strategies during the coronavirus disease 2019 (COVID­19) outbreak, which is an ongoing global concern. However, critical times in STEMI management may be influenced by the implementation of infection control protocols. AIMS: We aimed to investigate the impact of our dedicated COVID­19 PPCI protocol on time components related to STEMI care and catheterization laboratory personnel safety. A subendpoint analysis to compare patient outcomes at a median time of 70 days during the pandemic with those of patients treated in the preceding year was another objective of our study. METHODS: Patients with STEMI who underwent PPCI were included in this study. Chest computed tomography (CT) and real­time reverse transcriptase-polymerase chain reaction (rRT­PCR) tests were performed in patients suspected of having COVID­19. A total of 178 patients admitted between February 29 and April 30, 2020 were compared with 146 patients admitted between March 1 and April 30, 2019. RESULTS: Severe acute respiratory syndrome coronavirus 2 infection was confirmed by rRT­PCR in 7 cases. In 6 out of 7 patients, CT was indicative of COVID­19. There were no differences between the study groups regarding critical time intervals for reperfusion in STEMI. The 70­day mortality rate before and during the pandemic was 2.73% and 4.49%, respectively (P = 0.4). CONCLUSIONS: The implementation of the dedicated COVID­19 PPCI protocol in patients with STEMI allowed us to achieve similar target times for reperfusion, short­term clinical outcomes, and staff safety as in the prepandemic era.

Comparative Trends in Percutaneous Coronary Intervention in Japan and the United States, 2013 to 2017.

BACKGROUND: Adoption of the results of large-scale randomized controlled trials in percutaneous coronary intervention (PCI) may differ internationally, yet few studies have described the potential variations in PCI practice patterns. OBJECTIVES: Using representative national registries, we compared temporal trends in procedural volume, patient characteristics, pre-procedural testing, procedural characteristics, and quality metrics in the United States and Japan. METHODS: The National Cardiovascular Data Registry CathPCI was used to describe care in the United States, and the J-PCI was used to assess practice patterns in Japan (numbers of participating hospitals: 1,752 in the United States and 1,108 in Japan). Both registries were summarized between 2013 and 2017. RESULTS: PCI volume increased by 15.8% in the United States from 550,872 in 2013 to 637,650 in 2017, primarily because of an increase in nonelective PCIs (p for trend <0.001). In Japan, the volume of PCIs increased by 36%, from 181,750 in 2013 to 247,274 in 2017, primarily because of an increase in elective PCIs (p for trend <0.001). The proportion of PCI cases for elective conditions was >2-fold greater in Japan (72.7%) than in the United States (33.8%; p < 0.001). Overall, the ratio of nonelective PCI (vs. elective PCI; 27.3% vs. 66.2%; p < 0.001) and the performance of noninvasive stress testing in patients with stable disease (15.2% vs. 55.3%; p < 0.001) was lower in Japan than in the United States. Computed tomography angiography was more commonly used in Japan (22.3% vs. 2.0%; p < 0.001). CONCLUSIONS: Elective PCI is more than twice as common in Japan as in the United States in contemporary practice. Computed tomography angiography is much more frequently used pre-procedurally in Japan than in the United States.