A Placebo-Controlled Trial of Percutaneous Coronary Intervention for Stable Angina.

BACKGROUND: Percutaneous coronary intervention (PCI) is frequently performed to reduce the symptoms of stable angina. Whether PCI relieves angina more than a placebo procedure in patients who are not receiving antianginal medication remains unknown. METHODS: We conducted a double-blind, randomized, placebo-controlled trial of PCI in patients with stable angina. Patients stopped all antianginal medications and underwent a 2-week symptom assessment phase before randomization. Patients were then randomly assigned in a 1:1 ratio to undergo PCI or a placebo procedure and were followed for 12 weeks. The primary end point was the angina symptom score, which was calculated daily on the basis of the number of angina episodes that occurred on a given day, the number of antianginal medications prescribed on that day, and clinical events, including the occurrence of unblinding owing to unacceptable angina or acute coronary syndrome or death. Scores range from 0 to 79, with higher scores indicating worse health status with respect to angina. RESULTS: A total of 301 patients underwent randomization: 151 to the PCI group and 150 to the placebo group. The mean (±SD) age was 64±9 years, and 79% were men. Ischemia was present in one cardiac territory in 242 patients (80%), in two territories in 52 patients (17%), and in three territories in 7 patients (2%). In the target vessels, the median fractional flow reserve was 0.63 (interquartile range, 0.49 to 0.75), and the median instantaneous wave-free ratio was 0.78 (interquartile range, 0.55 to 0.87). At the 12-week follow-up, the mean angina symptom score was 2.9 in the PCI group and 5.6 in the placebo group (odds ratio, 2.21; 95% confidence interval, 1.41 to 3.47; P<0.001). One patient in the placebo group had unacceptable angina leading to unblinding. Acute coronary syndromes occurred in 4 patients in the PCI group and in 6 patients in the placebo group. CONCLUSIONS: Among patients with stable angina who were receiving little or no antianginal medication and had objective evidence of ischemia, PCI resulted in a lower angina symptom score than a placebo procedure, indicating a better health status with respect to angina. (Funded by the National Institute for Health and Care Research Imperial Biomedical Research Centre and others; ORBITA-2 ClinicalTrials.gov number, NCT03742050.).

Fractional Flow Reserve and Instantaneous Wave-Free Ratio as Predictors of the Placebo-Controlled Response to Percutaneous Coronary Intervention in Stable Coronary Artery Disease.

BACKGROUND: The Placebo-controlled Trial of Percutaneous Coronary Intervention for the Relief of Stable Angina (ORBITA-2) provided evidence for the role of percutaneous coronary intervention (PCI) for angina relief in stable coronary artery disease (CAD). Fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are often used to guide PCI, however their ability to predict placebo-controlled angina improvement is unknown. METHODS: Participants with angina, ischemia, and stable CAD were enrolled and antianginal medications were stopped. Participants reported angina episodes daily for 2 weeks using the ORBITA-app. At the research angiogram, FFR and iFR were measured. After sedation and auditory isolation, participants were randomized to PCI or placebo, before entering a 12-week blinded follow-up phase with daily angina reporting. The ability of FFR and iFR, analyzed as continuous variables, to predict the placebo-controlled effect of PCI, was tested using Bayesian proportional odds modelling. RESULTS: Invasive physiology data were available in 279 patients (140 PCI and 139 placebo). The median (IQR) age was 65 years (59.0 to 70.5) and 223 (79.9%) were male. Median FFR was 0.60 (0.46 to 0.73) and median iFR was 0.76 (0.50 to 0.86). The lower the FFR or iFR, the greater the placebo-controlled improvement with PCI across all endpoints. There was strong evidence that a patient with an FFR at the lower quartile would have a greater placebo-controlled improvement in angina symptom score with PCI than a patient at the upper quartile (FFR 0.46 vs. 0.73: OR 2.01, 95% CrI 1.79 to 2.26, Pr(Interaction)>99.9%). Similarly, there was strong evidence that a patient with an iFR at the lower quartile would have a greater placebo controlled improvement in angina symptom score with PCI than a patient with an iFR at the upper quartile (iFR 0.50 vs. 0.86: OR 2.13, 95% CrI 1.87 to 2.45, Pr(Interaction) >99.9%). The relationship between benefit and physiology was seen in both Rose angina and Rose nonangina. CONCLUSIONS: Physiological stenosis severity, as measured by FFR and iFR, predicts placebo-controlled angina relief from PCI. Invasive coronary physiology can be used to target PCI to those patients who are most likely to experience benefit.

In-hospital outcomes of ad hoc versus planned PCI for unprotected left-main disease: An analysis of 8574 cases from British Cardiovascular Intervention Society database 2006-2018.

BACKGROUND: Although data suggests ad hoc percutaneous coronary intervention (PCI) results in similar patient outcomes compared to planned PCI in nonselected patients, data for ad hoc unprotected left main stem PCI (uLMS-PCI) are lacking. AIM: To determine if in-hospital outcomes of uLMS-PCI vary by ad hoc versus planned basis. METHODS: Data were analyzed from all patients undergoing uLMS-PCI in the United Kingdom 2006-2018, and patients grouped into uLMS-PCI undertaken on an ad hoc or a planned basis. Patients who presented with ST-segment elevation, cardiogenic shock, or with an emergency PCI indication were excluded. RESULTS: In total, 8574 uLMS-PCI procedures were undertaken with 2837 (33.1%) of procedures performed on an ad hoc basis. There was a lower likelihood of intervention for stable angina (28.8% vs. 53.8%, p < 0.001) and a higher rate of potent P2Y12 inhibitor use (16.4% vs. 12.1%, p < 0.001) in the ad hoc PCI group compared to the planned PCI group. Patients undergoing uLMS-PCI on an ad hoc basis tended to undergo less complex procedures. Acute procedural complications including slow flow (odds ratio [OR]: 1.70, 95% confidence interval [CI]: 1.01-2.86), coronary dissection (OR: 1.41, 95% CI: 1.12-1.77) and shock induction (OR: 2.80, 95% CI: 1.64-4.78) were more likely in the ad hoc PCI group. In-hospital death (OR: 1.65, 95% CI: 1.19-2.27) and in-hospital major adverse cardiac or cerebrovascular events (OR: 1.50, 95% CI: 1.13-1.98) occurred more frequently in the ad hoc group. In sensitivity analyses, these observations did not differ when several subgroups were separately examined. CONCLUSIONS: Ad hoc PCI for uLMS disease is associated with adverse outcomes compared to planned PCI. These data should inform uLMS-PCI procedural planning.

Phenogrouping heart failure with preserved or mildly reduced ejection fraction using electronic health record data.

BACKGROUND: Heart failure (HF) with preserved or mildly reduced ejection fraction includes a heterogenous group of patients. Reclassification into distinct phenogroups to enable targeted interventions is a priority. This study aimed to identify distinct phenogroups, and compare phenogroup characteristics and outcomes, from electronic health record data. METHODS: 2,187 patients admitted to five UK hospitals with a diagnosis of HF and a left ventricular ejection fraction ≥ 40% were identified from the NIHR Health Informatics Collaborative database. Partition-based, model-based, and density-based machine learning clustering techniques were applied. Cox Proportional Hazards and Fine-Gray competing risks models were used to compare outcomes (all-cause mortality and hospitalisation for HF) across phenogroups. RESULTS: Three phenogroups were identified: (1) Younger, predominantly female patients with high prevalence of cardiometabolic and coronary disease; (2) More frail patients, with higher rates of lung disease and atrial fibrillation; (3) Patients characterised by systemic inflammation and high rates of diabetes and renal dysfunction. Survival profiles were distinct, with an increasing risk of all-cause mortality from phenogroups 1 to 3 (p < 0.001). Phenogroup membership significantly improved survival prediction compared to conventional factors. Phenogroups were not predictive of hospitalisation for HF. CONCLUSIONS: Applying unsupervised machine learning to routinely collected electronic health record data identified phenogroups with distinct clinical characteristics and unique survival profiles.

Clinical decision aids and computed tomography coronary angiography in patients with suspected acute coronary syndrome.

BACKGROUND: The HEART score, the T-MACS model and the GRACE score support early decision-making for acute chest pain, which could be complemented by CT coronary angiography (CTCA). However, their performance has not been directly compared. METHODS: In this secondary analysis of a multicentre randomised controlled trial of early CTCA in intermediate-risk patients with suspected acute coronary syndrome, C-statistics and performance metrics (using the predefined cut-offs) of clinical decision aids and CTCA, alone and then in combination, for the index hospital diagnosis of acute coronary syndrome and for 30-day coronary revascularisation were assessed in those who underwent CTCA and had complete data. RESULTS: Among 699 patients, 358 (51%) had an index hospital diagnosis of acute coronary syndrome, for which the C-statistic was higher for CTCA (0.80), followed by the T-MACS model (0.78), the HEART score (0.74) and the GRACE score (0.60). The negative predictive value was higher for the absence of coronary artery disease on CTCA (0.90) or a T-MACS estimate of <0.05 (0.83) than a HEART score of <4 (0.81) and a GRACE score of <109 (0.55). For 30-day coronary revascularisation, CTCA had the greatest C-statistic (0.80) with a negative predictive value of 0.96 and 0.92 in the absence of coronary artery disease and obstructive coronary artery disease, respectively. The combination of the T-MACS estimates and the CTCA findings was most discriminative for the index hospital diagnosis of acute coronary syndrome (C-statistic, 0.88) and predictive of 30-day coronary revascularisation (C-statistic, 0.85). No patients with a T-MACS estimate of <0.05 and normal coronary arteries had acute coronary syndrome during index hospitalisation or underwent coronary revascularisation within 30 days. CONCLUSIONS: In intermediate-risk patients with suspected acute coronary syndrome, the T-MACS model combined with CTCA improved discrimination of the index hospital diagnosis of acute coronary syndrome and prediction of 30-day coronary revascularisation. TRIAL REGISTRATION NUMBER: NCT02284191.

Routine Pressure Wire Assessment Versus Conventional Angiography in the Management of Patients With Coronary Artery Disease: The RIPCORD 2 Trial.

BACKGROUND: Measurement of fractional flow reserve (FFR) has an established role in guiding percutaneous coronary intervention. We tested the hypothesis that, at the stage of diagnostic invasive coronary angiography, systematic FFR-guided assessment of coronary artery disease would be superior, in terms of resource use and quality of life, to assessment by angiography alone. METHODS: We performed an open-label, randomized, controlled trial in 17 UK centers, recruiting 1100 patients undergoing invasive coronary angiography for the investigation of stable angina or non-ST-segment-elevation myocardial infarction. Patients were randomized to either angiography alone (angiography) or angiography with systematic pressure wire assessment of all epicardial vessels >2.25 mm in diameter (angiography+FFR). The coprimary outcomes assessed at 1 year were National Health Service hospital costs and quality of life. Prespecified secondary outcomes included clinical events. RESULTS: In the angiography+FFR arm, the median number of vessels examined was 4 (interquartile range, 3-5). The median hospital costs were similar: angiography, £4136 (interquartile range, £2613-£7015); and angiography+FFR, £4510 (£2721-£7415; P=0.137). There was no difference in median quality of life using the visual analog scale of the EuroQol EQ-5D-5L: angiography, 75 (interquartile range, 60-87); and angiography+FFR, 75 (interquartile range, 60-90; P=0.88). The number of clinical events was as follows: deaths, 5 versus 8; strokes, 3 versus 4; myocardial infarctions, 23 versus 22; and unplanned revascularizations, 26 versus 33, with a composite hierarchical event rate of 8.7% (48 of 552) for angiography versus 9.5% (52 of 548) for angiography+FFR (P=0.64). CONCLUSIONS: A strategy of systematic FFR assessment compared with angiography alone did not result in a significant reduction in cost or improvement in quality of life. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01070771.

Early computed tomography coronary angiography and preventative treatment in patients with suspected acute coronary syndrome: A secondary analysis of the RAPID-CTCA trial.

BACKGROUND: Computed tomography coronary angiography (CTCA) offers detailed assessment of the presence of coronary atherosclerosis and helps guide patient management. We investigated influences of early CTCA on the subsequent use of preventative treatment in patients with suspected acute coronary syndrome. METHODS: In this secondary analysis of a multicenter randomized controlled trial of early CTCA in intermediate-risk patients with suspected acute coronary syndrome, prescription of aspirin, P2Y12 receptor antagonist, statin, renin-angiotensin system blocker, and beta-blocker therapies from randomization to discharge were compared within then between those randomized to early CTCA or to standard of care only. Effects of CTCA findings on adjustment of these therapies were further examined. RESULTS: In 1,743 patients (874 randomized to early CTCA and 869 to standard of care only), prescription of P2Y12 receptor antagonist, dual antiplatelet, and statin therapies increased more in the early CTCA group (between-group difference: 4.6% [95% confidence interval, 0.3-8.9], 4.5% [95% confidence interval, 0.2-8.7], and 4.3% [95% confidence interval, 0.2-8.5], respectively), whereas prescription of other preventative therapies increased by similar extent in both study groups. Among patients randomized to early CTCA, there were additional increments of preventative treatment in those with obstructive coronary artery disease and higher rates of reductions in antiplatelet and beta-blocker therapies in those with normal coronary arteries. CONCLUSIONS: Prescription patterns of preventative treatment varied during index hospitalization in patients with suspected acute coronary syndrome. Early CTCA facilitated targeted individualization of these therapies based on the extent of coronary artery disease.

Modified Thromboelastography for Peri-interventional Assessment of Platelet Function in Cardiology Patients: A Narrative Review.

Viscoelastic testing (VET), such as thromboelastography, can measure whole blood coagulation dynamics in real time and is used across a range of clinical settings, including cardiac surgery, liver transplant, and trauma. The use of modified thromboelastography with platelet function assessment (TEG(R) PlateletMapping(R) Assay) can provide an analysis of platelet contribution to hemostasis, including the contribution of the P2Y12 receptor and thromboxane pathway to platelet function. The TEG PlateletMapping Assay has shown high correlation with the current gold standard test of platelet function, light transmission aggregometry, to measure arachidonic acid and adenosine diphosphate agonist-induced platelet activation. Studies have also shown comparable results with other whole blood platelet function tests. In this review, we explore the clinical applications of modified thromboelastography with platelet function assessment. This includes guiding dual antiplatelet therapy in relation to cardiac procedures, such as percutaneous coronary interventions, transcatheter aortic valve replacement, and left atrial appendage closure. We also explore the developing use of thromboelastography in the emergency care setting of coronavirus disease 2019, which is commonly associated with a hypercoagulable and hypofibrinolytic state. Despite a general lack of high-quality, grade 1 evidence regarding the use of modified thromboelastography with platelet function assessment in these disease areas, the ability of the TEG PlateletMapping Assay to measure global hemostasis and platelet reactivity rapidly and to view and evaluate results at the point of care makes it a promising area for further study for managing patient treatment and optimizing hemostatic therapy.

Timing of invasive strategy in non-ST-elevation acute coronary syndrome: a meta-analysis of randomized controlled trials.

AIMS: The optimal timing of an invasive strategy (IS) in non-ST-elevation acute coronary syndrome (NSTE-ACS) is controversial. Recent randomized controlled trials (RCTs) and long-term follow-up data have yet to be included in a contemporary meta-analysis. METHODS AND RESULTS: A systematic review of RCTs that compared an early IS vs. delayed IS for NSTE-ACS was conducted by searching MEDLINE, Embase, and Cochrane Central Register of Controlled Trials. A meta-analysis was performed by pooling relative risks (RRs) using a random-effects model. The primary outcome was all-cause mortality. Secondary outcomes included myocardial infarction (MI), recurrent ischaemia, admission for heart failure (HF), repeat re-vascularization, major bleeding, stroke, and length of hospital stay. This study was registered with PROSPERO (CRD42021246131). Seventeen RCTs with outcome data from 10 209 patients were included. No significant differences in risk for all-cause mortality [RR: 0.90, 95% confidence interval (CI): 0.78-1.04], MI (RR: 0.86, 95% CI: 0.63-1.16), admission for HF (RR: 0.66, 95% CI: 0.43-1.03), repeat re-vascularization (RR: 1.04, 95% CI: 0.88-1.23), major bleeding (RR: 0.86, 95% CI: 0.68-1.09), or stroke (RR: 0.95, 95% CI: 0.59-1.54) were observed. Recurrent ischaemia (RR: 0.57, 95% CI: 0.40-0.81) and length of stay (median difference: -22 h, 95% CI: -36.7 to -7.5 h) were reduced with an early IS. CONCLUSION: In all-comers with NSTE-ACS, an early IS does not reduce all-cause mortality, MI, admission for HF, repeat re-vascularization, or increase major bleeding or stroke when compared with a delayed IS. Risk of recurrent ischaemia and length of stay are significantly reduced with an early IS.

The Direct and Indirect Effects of COVID-19 on Acute Coronary Syndromes.

The novel SARS-CoV-2 has directly and indirectly impacted patients with acute coronary syndrome (ACS). The onset of the COVID-19 pandemic correlated with an abrupt decline in hospitalizations with ACS and increased out-of-hospital deaths. Worse outcomes in ACS patients with concomitant COVID-19 have been reported, and acute myocardial injury secondary to SARS-CoV-2 infection is recognized. A rapid adaptation of existing ACS pathways has been required such that overburdened health care systems may manage both a novel contagion and existing illness. As SARS-CoV-2 is now endemic, future research is required to better define the complex interplay of COVID-19 infection and cardiovascular disease.

Ten-Year All-Cause Death According to Completeness of Revascularization in Patients With Three-Vessel Disease or Left Main Coronary Artery Disease: Insights From the SYNTAX Extended Survival Study.

BACKGROUND: Ten-year all-cause death according to incomplete (IR) versus complete revascularization (CR) has not been fully investigated in patients with 3-vessel disease and left main coronary artery disease undergoing percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG). METHODS: The SYNTAX Extended Survival study (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]) evaluated vital status up to 10 years in patients who were originally enrolled in the SYNTAX trial. In the present substudy, outcomes of the CABG CR group were compared with the CABG IR, PCI CR, and PCI IR groups. In addition, in the PCI cohort, the residual SYNTAX score (rSS) was used to quantify the extent of IR and to assess its association with fatal late outcome. The rSS of 0 suggests CR, whereas a rSS>0 identifies the degree of IR. RESULTS: IR was more frequently observed in patients with PCI versus CABG (56.6% versus 36.8%) and more common in those with 3-vessel disease than left main coronary artery disease in both the PCI arm (58.5% versus 53.8%) and the CABG arm (42.8% versus 27.5%). Patients undergoing PCI with CR had no significant difference in 10-year all-cause death compared with those undergoing CABG (22.2% for PCI with CR versus 24.3% for CABG with IR versus 23.8% for CABG with CR). In contrast, those with PCI and IR had a significantly higher risk of all-cause death at 10 years compared with CABG and CR (33.5% versus 23.7%; adjusted hazard ratio, 1.48 [95% CI, 1.15-1.91]). When patients with PCI were stratified according to the rSS, those with a rSS≤8 had no significant difference in all-cause death at 10 years as the other terciles (22.2% for rSS=0 versus 23.9% for rSS>0-4 versus 28.9% for rSS>4-8), whereas a rSS>8 had a significantly higher risk of 10-year all-cause death than those undergoing PCI with CR (50.1% versus 22.2%; adjusted hazard ratio, 3.40 [95% CI, 2.13-5.43]). CONCLUSIONS: IR is common after PCI, and the degree of incompleteness was associated with 10-year mortality. If it is unlikely that complete (or nearly complete; rSS<8) revascularization can be achieved with PCI in patients with 3-vessel disease, CABG should be considered. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00114972. URL: https://www.clinicaltrials.gov; Unique identifier: NCT03417050.

Angiography-derived physiology guidance vs usual care in an All-comers PCI population treated with the healing-targeted supreme stent and Ticagrelor monotherapy: PIONEER IV trial design.

BACKGROUND: Current ESC guidelines recommend the use of intra-coronary pressure guidewires for functional assessment of intermediate-grade coronary stenoses. Angiography-derived quantitative flow ratio (QFR) is a novel method of assessing these stenoses, and guiding percutaneous coronary intervention (PCI). METHODS/DESIGN: The PIONEER IV trial is a prospective, all-comers, multi-center trial, which will randomize 2,540 patients in a 1:1 ratio to PCI guided by angiography-derived physiology or usual care, with unrestricted use in both arms of the Healing-Targeted Supreme sirolimus-eluting stent (HT Supreme). The stent's fast, biologically healthy, and robust endothelial coverage allows for short dual-antiplatelet therapy (DAPT); hence the antiplatelet regimen of choice is 1-month DAPT, followed by ticagrelor monotherapy. In the angiography-derived physiology guided arm, lesions will be functionally assessed using on-line QFR, with stenting indicated in lesions with a QFR ≤0.80. Post-stenting, QFR will be repeated in the stented vessel(s), with post-dilatation or additional stenting recommended if the QFR<0.91 distal to the stent, or if the delta QFR (across the stent) is >0.05. Usual care PCI is performed according to standard clinical practice. The primary endpoint is a non-inferiority comparison of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, any myocardial infarction, or any clinically, and physiologically driven revascularization with a non-inferiority risk-difference margin of 3.2%, at 1-year post-procedure. Clinical follow-up will be up to 3 years. SUMMARY: The PIONEER IV trial aims to demonstrate non-inferiority of QFR-guided PCI to usual care PCI with respect to POCE at 1-year in patients treated with HT Supreme stents and ticagrelor monotherapy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov UNIQUE IDENTIFIER: NCT04923191 CLASSIFICATIONS: Interventional Cardiology.

What is the Role of Coronary Physiology in the Management of Patients with Chronic Coronary Syndromes?

The use of coronary physiology in patients with chronic coronary syndromes is highly variable, and the evidence base complex. Tests of coronary physiology have traditionally been invasive (e.g., fractional flow reserve), but novel non-invasive methods are now available which provide additional anatomical information (e.g., computed tomography-based fractional flow reserve and angiogram-derived physiology). This review summarises the evidence for and against the relative value of these tests for patients being investigated for chest pain that may represent chronic coronary syndromes, and for those triaged to percutaneous coronary intervention.

Impact of extracardiac vascular disease on outcomes of 1.4 million patients undergoing percutaneous coronary intervention.

OBJECTIVES: Extracardiac vascular disease (ECVD) is increasingly recognized as a cardiovascular risk factor, but its association with outcomes after percutaneous coronary intervention (PCI) has not been well characterized. METHODS: Using the National Inpatient Sample database, all patients undergoing PCI between October 2015 and December 2018 were stratified by the presence and organ-specific extent of extracardiac vascular comorbidity (cerebrovascular disease (CeVD), renovascular, aortic and peripheral arterial disease (PAD)). Primary outcome was all-cause mortality and secondary outcomes were (a) major adverse cardiovascular and cerebrovascular events (MACCE), (b) acute ischemic stroke and (c) major bleeding. Multivariable logistic regression was used to determine the adjusted odds ratios (aOR) and 95% confidence interval (95% CI). RESULTS: Of a total of 1,403,505 patients undergoing PCI during the study period, 199,470 (14.2%) had ECVD. Patients with ECVD were older (median of 72 years vs. 70 years, p < 0.001) and had higher comorbidity burden that their counterparts. All cause-mortality was 22% higher in patients with any ECVD compared to those without ECVD. PAD patients had the highest odds of all-cause mortality (aOR 1.48, 95% CI 1.40-1.56), followed by those with CeVD (aOR 1.15, 95% CI 1.10-1.19). Patients with extracardiac disease had increased odds of MACCE, ischemic stroke and bleeding, irrespective of the nature or extent (p < 0.05), compared to patients without ECVD. CONCLUSION: ECVD is associated with worse outcomes in patients undergoing PCI including significantly higher rates of death and stroke. These data should inform our shared decision-making process with our patients.

Variation in practice for out-of-hospital cardiac arrest treated with percutaneous coronary intervention in England and Wales.

OBJECTIVES: We assessed the association between total center volume, operator volume, and out-of-hospital cardiac arrest (OHCA) percutaneous coronary intervention (PCI) volume. BACKGROUND: Variations between OHCA PCI volume, hospital total PCI, and primary PCI volume are not well studied and are unlikely to be clinically justifiable. METHODS: Patients undergoing PCI for the acute coronary syndrome (ACS) between January 1, 2014, and March 31, 2019, in England and Wales were grouped as OHCA PCI and non-OHCA PCI. Spearman's correlation was used to determine the degree of correlation between each hospital PCI volume and OHCA PCI volume. RESULTS: Out of 250,088 PCI procedures undertaken for ACS, 12,016 (4.8%) were performed for OHCA, and 238,072 (95.2%) were non-OHCA PCI procedures. The OHCA PCI group were younger [mean age (SD) 63.2 (12.3) and 65.6 (12.5, p < 0.001)], less likely to be female (20.2% vs. 26.9%, p < 0.001) or Black, Asian, and Minority Ethnicity (11.5% vs. 14.8%, p < 0.001) compared to the non-OHCA PCI group. Although there was a degree of correlation between total PCI and OHCA PCI, there was wide variation for both ACS cohort (Spearman correlation R2 = 0.50) and total PCI volume (Spearman correlation R2 = 0.60). Furthermore, the correlation between primary PCI volume and OHCA PCI within centers was weak (R2 = 0.10). Similarly, wide variations between operator PCI volume and OHCA PCI volume were observed. CONCLUSION: These national data demonstrate wide variation in the practice of OHCA PCI both between centers and individuals. These variations are not expected according to clinical factors and require further investigation.

Clinical outcomes of percutaneous coronary intervention for chronic total occlusion by treated segment length.

BACKGROUND: Long lesions are known to have worse outcomes following percutaneous coronary intervention (PCI), but there are limited data assessing the association between lesion length and clinical outcomes in PCI procedures undertaken in chronic total occlusions (CTO). METHODS AND RESULTS: We formed a longitudinal cohort (2006-2018, n = 27,205) of stable angina patients who underwent PCI to CTO in the British Cardiovascular Intervention Society (BCIS) database. Clinical, demographical, procedural, and outcome data were analyzed in three groups by treated segment length, < 30 mm (n = 11,782), 30-59 mm (n = 10,415), ≥ 60 mm (n = 5008). Prevalence of previous myocardial infarction and PCI were higher in patients in 30-59 mm group or ≥ 60 mm group compared with < 30 mm group. Following multivariable analysis, no significant difference was observed in in-patient death (OR = 30-59 mm group = 1.10, CI:0.55-2.19, p = 0.78) (OR ≥ 60 mm group = 0.82, CI: 0.33-2.05, p = 0.67), and 1-year death (OR = 30-59 mm group = 1.06, CI: 0.81-1.37, p = 0.69) (OR ≥ 60 mm group =1.01, CI: 0.70-1.43, p = 0.99) (< 30 mm group = reference) but in-patient MACE was higher in > = 60 mm group (OR: 1.52, CI: 1.15-2.01, p = 0.06) but similar in 30-59 mm group (OR: 1.16, CI: 0.91-1.48, p = 0.22) compared with < 30 mm group. The adjusted rates of procedural complications were higher in ≥ 60 mm group (OR: 1.61, CI: 1.40-1.85, p < 0.001) but were similar in 30-59 mm group (OR: 1.06, CI: 0.94-1.20, p < 0.31) compared with < 30 mm group. For every 10 mm increase, there was an increased adjusted risk of in-patient procedural complications and coronary perforation but not in-patient MACE or death. CONCLUSION: Patients with very long CTO lesions have higher risk of procedural complications and in-patient MACE but similar risk of short or long-term mortality compared with short CTO lesions.

Clinical outcomes of percutaneous coronary intervention for chronic total occlusion in prior coronary artery bypass grafting patients.

OBJECTIVE: To compare the clinical characteristics and outcomes in patients with stable angina who have undergone chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in native arteries with or without prior coronary artery bypass grafting (CABG) surgery in a national cohort. BACKGROUND: There are limited data on outcomes of patients presenting with stable angina undergoing CTO PCI with previous CABG. METHODS: We identified 20,081 patients with stable angina who underwent CTO PCI between 2007-2014 in the British Cardiovascular Intervention Society database. Clinical, demographical, procedural and outcome data were analyzed in two groups; group 1-CTO PCI in native arteries without prior CABG (n = 16,848), group 2-CTO PCI in native arteries with prior CABG (n = 3,233). RESULTS: Patients in group 2 were older, had more comorbidities and higher prevalence of severe left ventricular systolic dysfunction. Following multivariable analysis, no significant difference in mortality was observed during index hospital admission (OR:1.33, CI 0.64-2.78, p = .44), at 30-days (OR: 1.28, CI 0.79-2.06, p = .31) and 1 year (OR:1.02, CI 0.87-1.29, p = .87). Odds of in-hospital major adverse cardiovascular events (MACE) (OR:1.01, CI 0.69-1.49, p = .95) and procedural complications (OR:1.02, CI 0.88-1.18, p = .81) were similar between two groups but procedural success rate was lower in group 2 (OR: 0.34, CI 0.31-0.39, p < .001). The adjusted risk of target vessel revascularization (TVR) remained similar between the two groups at 30-days (OR:0.68, CI 0.40-1.16, P-0.16) and at 1 year (OR:1.01, CI 0.83-1.22, P-0.95). CONCLUSION: Patients with prior CABG presenting with stable angina and treated with CTO PCI in native arteries had more co-morbid illnesses but once these differences were adjusted for, prior CABG did not independently confer additional risk of mortality, MACE or TVR.

Outcomes following PCI in CABG candidates during the COVID-19 pandemic: The prospective multicentre UK-ReVasc registry.

OBJECTIVES: To describe outcomes following percutaneous coronary intervention (PCI) in patients who would usually have undergone coronary artery bypass grafting (CABG). BACKGROUND: In the United Kingdom, cardiac surgery for coronary artery disease (CAD) was dramatically reduced during the first wave of the COVID-19 pandemic. Many patients with "surgical disease" instead underwent PCI. METHODS: Between 1 March 2020 and 31 July 2020, 215 patients with recognized "surgical" CAD who underwent PCI were enrolled in the prospective UK-ReVasc Registry (ReVR). 30-day major cardiovascular event outcomes were collected. Findings in ReVR patients were directly compared to reference PCI and isolated CABG pre-COVID-19 data from British Cardiovascular Intervention Society (BCIS) and National Cardiac Audit Programme (NCAP) databases. RESULTS: ReVR patients had higher incidence of diabetes (34.4% vs 26.4%, P = .008), multi-vessel disease with left main stem disease (51.4% vs 3.0%, P < .001) and left anterior descending artery involvement (94.8% vs 67.2%, P < .001) compared to BCIS data. SYNTAX Score in ReVR was high (mean 28.0). Increased use of transradial access (93.3% vs 88.6%, P = .03), intracoronary imaging (43.6% vs 14.4%, P < .001) and calcium modification (23.6% vs 3.5%, P < .001) was observed. No difference in in-hospital mortality was demonstrated compared to PCI and CABG data (ReVR 1.4% vs BCIS 0.7%, P = .19; vs NCAP 1.0%, P = .48). Inpatient stay was half compared to CABG (3.0 vs 6.0 days). Low-event rates in ReVR were maintained to 30-day follow-up. CONCLUSIONS: PCI undertaken using contemporary techniques produces excellent short-term results in patients who would be otherwise CABG candidates. Longer-term follow-up is essential to determine whether these outcomes are maintained over time.

Cardiac mortality in patients randomised to elective coronary revascularisation plus medical therapy or medical therapy alone: a systematic review and meta-analysis.

AIMS: The value of elective coronary revascularisation plus medical therapy over medical therapy alone in managing stable patients with coronary artery disease is debated. We reviewed all trials comparing the two strategies in this population. METHODS AND RESULTS: From inception through November 2020, MEDLINE, EMBASE, Google Scholar, and other databases were searched for randomised trials comparing revascularisation against medical therapy alone in clinically stable coronary artery disease patients. Treatment effects were measured by rate ratios (RRs) with 95% confidence intervals, using random-effects models. Cardiac mortality was the pre-specified primary endpoint. Spontaneous myocardial infarction (MI) and its association with cardiac mortality were secondary endpoints. Further endpoints included all-cause mortality, any MI, and stroke. Longest follow-up data were abstracted. The study is registered with PROSPERO (CRD42021225598). Twenty-five trials involving 19 806 patients (10 023 randomised to revascularisation plus medical therapy and 9783 to medical therapy alone) were included. Compared with medical therapy alone, revascularisation yielded a lower risk of cardiac death [RR 0.79 (0.67-0.93), P < 0.01] and spontaneous MI [RR 0.74 (0.64-0.86), P < 0.01]. By meta-regression, the cardiac death risk reduction after revascularisation, compared with medical therapy alone, was linearly associated with follow-up duration [RR per 4-year follow-up: 0.81 (0.69-0.96), P = 0.008], spontaneous MI absolute difference (P = 0.01) and percentage of multivessel disease at baseline (P = 0.004). Trial sequential and sensitivity analyses confirmed the reliability of the cardiac mortality findings. All-cause mortality [0.94 (0.87-1.01), P = 0.11], any MI (P = 0.14), and stroke risk (P = 0.30) did not differ significantly between strategies. CONCLUSION: In stable coronary artery disease patients, randomisation to elective coronary revascularisation plus medical therapy led to reduced cardiac mortality compared with medical therapy alone. The cardiac survival benefit after revascularisation improved with longer follow-up times and was associated with fewer spontaneous MIs.

Fractional flow reserve derived from computed tomography coronary angiography in the assessment and management of stable chest pain: the FORECAST randomized trial.

AIMS: Fractional flow reserve (FFRCT) using computed tomography coronary angiography (CTCA) determines both the presence of coronary artery disease and vessel-specific ischaemia. We tested whether an evaluation strategy based on FFRCT would improve economic and clinical outcomes compared with standard care. METHODS AND RESULTS: Overall, 1400 patients with stable chest pain in 11 centres were randomized to initial testing with CTCA with selective FFRCT (experimental group) or standard clinical care pathways (standard group). The primary endpoint was total cardiac costs at 9 months. Secondary endpoints were angina status, quality of life, major adverse cardiac and cerebrovascular events, and use of invasive coronary angiography. Randomized groups were similar at baseline. Most patients had an initial CTCA: 439 (63%) in the standard group vs. 674 (96%) in the experimental group, 254 of whom (38%) underwent FFRCT. Mean total cardiac costs were higher by £114 (+8%) in the experimental group, with a 95% confidence interval from -£112 (-8%) to +£337 (+23%), though the difference was not significant (P = 0.10). Major adverse cardiac and cerebrovascular events did not differ significantly (10.2% in the experimental group vs. 10.6% in the standard group) and angina and quality of life improved to a similar degree over follow-up in both randomized groups. Invasive angiography was reduced significantly in the experimental group (19% vs. 25%, P = 0.01). CONCLUSION: A strategy of CTCA with selective FFRCT in patients with stable angina did not differ significantly from standard clinical care pathways in cost or clinical outcomes, but did reduce the use of invasive coronary angiography.