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.).

Intracoronary imaging guided percutaneous coronary intervention outcomes among individuals with cardiogenic shock.

BACKGROUND: Limited data exist around the utility of intracoronary imaging (ICI) during percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS) and cardiogenic shock (CS), who are inherently at a high risk of stent thrombosis (ST). METHODS: All PCI procedures for ACS patients with CS in England and Wales between 2014 and 2020 were retrospectively analysed, stratified into two groups: ICI and angiography-guided groups. Multivariable logistic regression analyses were performed to examine odds ratios (OR) of in-hospital outcomes, including major adverse cardiovascular and cerebrovascular events (MACCE; composite of all-cause mortality, acute stroke/transient ischaemic attack (TIA), and reinfarction) and major bleeding, in the ICI-guided group compared with angiography-guided PCI. RESULTS: Of 15,738 PCI procedures, 1240(7.9%) were ICI-guided. The rate of ICI use amongst those with CS more than doubled from 2014 (5.7%) to 2020 (13.3%). The ICI-guided group were predominantly younger, males, with a higher proportion of non-ST-elevation ACS and ST. MACCE was significantly lower in the ICI-guided group compared with the angiography-guided group (crude: 29.8% vs. 38.2%, adjusted odds ratio (OR) 0.65 95% confidence interval [CI] 0.56-0.76), driven by lower all-cause mortality (28.6% vs. 37.0%, OR 0.65 95% CI 0.55-0.75). There were no differences in other secondary outcomes between groups. CONCLUSION: ICI use among CS patients has more than doubled over 6 years but remains significantly under-utilized, with less than 1-in-6 patients in receipt of ICI-guided PCI by 2020. ICI-guided PCI is associated with prognostic benefits in CS patients and should be more frequently utilized to increase their long-term survival.

Machine learning-based prediction of adverse events following an acute coronary syndrome (PRAISE): a modelling study of pooled datasets.

BACKGROUND: The accuracy of current prediction tools for ischaemic and bleeding events after an acute coronary syndrome (ACS) remains insufficient for individualised patient management strategies. We developed a machine learning-based risk stratification model to predict all-cause death, recurrent acute myocardial infarction, and major bleeding after ACS. METHODS: Different machine learning models for the prediction of 1-year post-discharge all-cause death, myocardial infarction, and major bleeding (defined as Bleeding Academic Research Consortium type 3 or 5) were trained on a cohort of 19 826 adult patients with ACS (split into a training cohort [80%] and internal validation cohort [20%]) from the BleeMACS and RENAMI registries, which included patients across several continents. 25 clinical features routinely assessed at discharge were used to inform the models. The best-performing model for each study outcome (the PRAISE score) was tested in an external validation cohort of 3444 patients with ACS pooled from a randomised controlled trial and three prospective registries. Model performance was assessed according to a range of learning metrics including area under the receiver operating characteristic curve (AUC). FINDINGS: The PRAISE score showed an AUC of 0·82 (95% CI 0·78-0·85) in the internal validation cohort and 0·92 (0·90-0·93) in the external validation cohort for 1-year all-cause death; an AUC of 0·74 (0·70-0·78) in the internal validation cohort and 0·81 (0·76-0·85) in the external validation cohort for 1-year myocardial infarction; and an AUC of 0·70 (0·66-0·75) in the internal validation cohort and 0·86 (0·82-0·89) in the external validation cohort for 1-year major bleeding. INTERPRETATION: A machine learning-based approach for the identification of predictors of events after an ACS is feasible and effective. The PRAISE score showed accurate discriminative capabilities for the prediction of all-cause death, myocardial infarction, and major bleeding, and might be useful to guide clinical decision making. FUNDING: None.

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.

Sex differences in high-risk but indicated coronary interventions (CHiP): National report from British Cardiovascular Intervention Society Registry.

OBJECTIVE: To assess sex-based differences in clinical outcomes following complex and high-risk but indicated percutaneous coronary intervention (CHiP). BACKGROUND: CHiP is increasingly common in contemporary percutaneous coronary intervention (PCI) practice. Data on sex differences in the type of CHiP procedures undertaken or their associated clinical outcomes are limited. METHODS: Patients with stable coronary artery disease who underwent CHiP between January 1, 2006, and December 31, 2017, were included. All procedures were stratified by sex. Multivariate logistic regression analyses were performed to investigate the sex-specific adjusted odds ratios (aOR) of in-hospital outcomes. RESULTS: Out of 424,290 PCI procedures, 141,610 (33.37%) were CHiP procedures. Overall, 32,129 (23%) of CHiP were undertaken in females. Females were older than males (median: 74.8 vs. 69.1 years). Males had a higher prevalence of previous myocardial infarction (MI) (44.6% vs. 35.6%) and previous PCI (40% vs. 32.5%). The most common variable observed in female patients undergoing CHiP was age >80 (35.4%), followed by prior coronary artery bypass graft (CABG) (24.3%) and severe coronary calcification (22.6%). In contrast, the most common variable in male patients was prior CABG (36%), followed by chronic thrombus occlusion (CTO) PCI (34.4%) and severe coronary calcification (22%). Females had higher odds (aOR) for mortality (aOR: 1.78, 95% CI: [1.4, 2.2]), bleeding (aOR: 1.99, 95% CI: [1.72, 3.2]), and major adverse cardiovascular and cerebral events (aOR: 1.23, 95% CI: [1.09, 1.38]) compared to males. CONCLUSION: In this national analysis of CHiP procedures over 12 years, there were significant sex differences in the type of CHiP procedures undertaken, with females at increased odds for mortality and in-hospital adverse outcomes.

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.

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.

The Impact of Intracoronary Imaging on PCI Outcomes in Cases Utilising Rotational Atherectomy: An Analysis of 8,417 Rotational Atherectomy Cases from the British Cardiovascular Intervention Society Database.

Introduction: There is increasing evidence supporting the use of intracoronary imaging to optimize the outcomes of percutaneous coronary intervention (PCI). However, there are no studies examining the impact of imaging on PCI outcomes in cases utilising rotational atherectomy (RA-PCI). Our study examines the determinants and outcomes of using intracoronary imaging in RA-PCI cases including 12-month mortality. Methods: Using the British Cardiac Intervention Society database, data were analysed on all RA-PCI procedures in the UK between 2007 and 2014. Descriptive statistics and multivariate logistic regressions were used to examine baseline, procedural, and outcome associations with intravascular imaging. Results: Intracoronary imaging was used in 1,279 out of 8,417 RA-PCI cases (15.2%). Baseline covariates associated with significantly more imaging use were number of stents used, smoking history, previous CABG, pressure wire use, proximal LAD disease, laser use, glycoprotein inhibitor use, cutting balloons, number of restenosis attempted, off-site surgery, and unprotected left main stem (uLMS) PCI. Adjusted rates of in-hospital major adverse cardiac/cerebrovascular events (IH-MACCE), its individual components (death, peri-procedural MI, stroke, and major bleed), or 12-month mortality were not significantly altered by the use of imaging in RA-PCI. However, subgroup analysis demonstrated a signal towards reduction in 12-month mortality in uLMS RA-PCI cases utilising intracoronary imaging (OR 0.67, 95% CI 0.44-1.03). Conclusions: Intracoronary imaging use during RA-PCI is associated with higher risk of baseline and procedural characteristics. There were no differences observed in IH-MACCE or 12-month mortality with intracoronary imaging in RA-PCI.

Percutaneous coronary intervention in octogenarians: A risk scoring system to predict 30-day outcomes in the elderly.

OBJECTIVE: Octogenarians are a high-risk group presenting for percutaneous coronary intervention (PCI). We aimed to create a 30-day mortality risk model for octogenarians presenting with both acute coronary syndrome (ACS) and chronic stable angina (CSA), using comprehensive mandatory UK data submissions to the UK National database. BACKGROUND: Octogenarians are a high-risk group presenting for percutaneous coronary intervention, and decisions on whether or not to undertake intervention in this cohort can be challenging. The increasing number of octogenarians in the general population means they represent an important high-risk subgroup of patients. METHODS: The data group consisted of 425,897 PCI procedures undertaken in the UK between 2008 and 2012 during which time there was comprehensive data linkage to mortality via the Office of National Statistics. Of these procedures, 44,221 (10.4%) were in patients aged ≥80. These comprised the model group. Logistic regression was used to create a predictive score which ultimately consisted of the following weightings: age 80-89 (n = 1); age > 90 (n = 2); unstable angina/non-ST-elevation myocardial infraction (NSTEMI) (n = 1); STEMI (n = 2); creatinine >200 mmol/L (n = 1); preprocedural ventilation (n = 1); left ventricular ejection fraction <30% (n = 1); cardiogenic shock (n = 2). Multiple imputation was used to account for missing data. RESULTS: The patient cohort was divided into a derivation (n = 22,072) and a validation dataset (n = 22,071). Receiver operating characteristic analyses were used to derive the area-under-the-curve to assess properties of the score. The scoring system generated an AUC 0.83, (95% CI 0.80-0.85) suggesting high sensitivity and specificity. Scores of 1-4 were associated with good survival but scores ≥5 were associated with an estimated likelihood of death within 30 days of ≥40%. CONCLUSIONS: This octogenarian risk score maybe a useful tool to determine the chance of a successful outcome in elderly patients presenting for PCI.

Combined use of rotational and excimer lASER coronary atherectomy (RASER) during complex coronary angioplasty-An analysis of cases (2006-2016) from the British Cardiovascular Intervention Society database.

INTRODUCTION: Combining rotational (RA) and excimer laser coronary atherectomy (ELCA)-RASER atherectomy-is technique utilized in the percutaneous management of calcific coronary disease. The evidence base examining its safety and utility is sparse and limited to small case-series. This study examines the patterns and outcomes of RASER atherectomy use in the largest cohort to date. METHODS: Using the British Cardiac Intervention Society database, data were analyzed on all PCI procedures in the UK between 2006 and 2016. Descriptive statistics and multivariate logistic regressions were used to examine baseline, procedural, and outcome associations with RASER. RESULTS: We identified 153 (0.02%) RASER atherectomy cases out of 686,358 PCI procedures. Baseline covariates associated with RASER use were age, BMI, diabetes, stable coronary disease, and previous CABG. Procedural co-variates associated with RASER were CTO-PCI, the use of more/longer stents, intravascular imaging, cutting balloons, and microcatheters. Adjusted rates of in-hospital major adverse cardiac/cerebrovascular events (MACCE) were not significantly different with RASER. However, there were higher odds of arterial complications (OR 3.23, 95% CI: 1.58-6.61), slow flow (OR 3.50, 95% CI: 1.29-9.55), and shock induction (OR 9.66, 95% CI: 3.44-27.06). CONCLUSIONS: RASER atherectomy use in complex PCI is associated with higher risk baseline and procedural characteristics. Although increased rates of shock induction, slow flow, and arterial complications were observed, RASER does not increase the likelihood of in-hospital MACCE, major bleeding, or death.

Cost of coronary syndrome treated with percutaneous coronary intervention and 30-day unplanned readmission in the United States.

OBJECTIVES: This study aimed to examine the cost of coronary syndrome treated with percutaneous coronary intervention (PCI) and 30-day unplanned readmissions. BACKGROUND: There is limited understanding of the hospital cost of index PCI and 30-day unplanned readmissions. METHODS: Patients undergoing PCI between 2010 and 2014 in the U.S. Nationwide Readmission Database were included. The primary outcome was total cost defined by cost of index PCI and first unplanned readmission within 30 days. RESULTS: This analysis included 2,294,244 patients who underwent PCI, and the mean cost was $23,541 ± $20,730 (~$10.8 billion/year). There was a modest increase in cost over the study years of 17.5%. Of the 9.4% with an unplanned readmission within 30 days, the mean total cost was $35,333 ± 24,230 versus $22,323 ± 19,941 for those not readmitted. The variables most strongly associated with the highest quartile of cost were heart failure (adjusted odds ratio (aOR) 25.60 [95% CI 21.59-30.35]), need for circulatory support (aOR 11.62 [10.13-13.32]), periprocedural coronary artery bypass graft (CABG, aOR 585.08 [357.85-956.58]), and readmission within 30 days (aOR 24.49 [22.40-26.77]). An acute kidney injury (AKI; 8.5%), major bleed (0.8%), vascular injury (0.8%), or need for periprodedural CABG (1.4%) had an average increased cost of $21,935; $30,898; $27,875; and $43,005, respectively, compared to PCI without adverse outcome. CONCLUSIONS: The annual 30-day hospital cost of PCI is approximately $10.8 billion, and the costs associated with in-hospital adverse events, particularly the need for AKI and periprocedural CABG, were significant.

The impact of coronary perforation in percutaneous interventions involving the left main stem coronary artery in the United Kingdom 2007-2014: Insights from the British Cardiovascular Intervention Society database.

BACKGROUND: Percutaneous coronary intervention (PCI) is increasingly utilized for treatment of coronary disease involving the unprotected left main stem (ULMS). However, no studies to date have examined the outcomes of such interventions when complicated by coronary perforation (CP). METHODS: Using the British Cardiovascular Intervention society (BCIS) database, data were analyzed on all ULMS-PCI procedures complicated by CP in England and Wales between 2007 and 2014. Multivariate logistic regressions were used to identify predictors of ULMS CP and to evaluate the association between this complication and outcomes. RESULTS: During 10,373 ULMS-PCI procedures, CP occurred more frequently than in non-ULMS-PCI (0.9 vs. 0.4%, p < .001) with a stable annual incidence. Covariates associated with CP included number of stents used, female gender, use of rotational atherectomy and chronic total occlusion (CTO) intervention. Adjusted odds of adverse outcomes for ULMS-PCI complicated by CP were higher for peri-procedural complications including cardiogenic shock, tamponade, side-branch loss, DC cardioversion, in-hospital major bleeding, transfusion requirement, and peri-procedural myocardial infarction. There were also significantly increased odds for in-hospital major adverse cardiac events (MACCE, OR 8.961, 95% CI [4.902-16.383]) and 30-day mortality (OR 5.301, 95% CI [2.741-10.251]). CONCLUSIONS: CP is an infrequent event during ULMS-PCI and is predicted by female gender, rotational atherectomy, CTO interventions or number of stents used. CP was associated with significantly higher odds of mortality and morbidity, but at rates similar to previously published all-comer PCI complicated by CP.

Rotational atherectomy and same day discharge: Safety and growth from a national perspective.

OBJECTIVES: We explore whether same day discharge (SDD) is a feasible and safe practice following rotational atherectomy (ROTA) treatment during elective percutaneous coronary intervention (PCI), and examine which baseline characteristics are independently associated with SDD. BACKGROUND: SDD following elective ROTA PCI is not recommended as per the recent SCAI consensus. However, reports show it is practiced and no previous study has evaluated its safety and feasibility. METHODS: Our dataset included 4,591 patients undergoing elective ROTA PCI in England & Wales within an 8-years period. Independent associations with SDD were quantified via a multiple logistic regression model and the BCIS 30-day mortality risk model was used to evaluate the safety of SDD. RESULTS: The majority of elective ROTA PCI cases remain at the hospital for overnight (ON) observation, although SDD rates increased substantially from 6.7% in 2007 to 35.5% in 2014. The use of glycoprotein IIb/IIIa antagonists, Q wave AMI, left main PCI and valvular heart disease were independently associated with ON, while patients operated underwent transradial PCI were more likely to be SDD (OR = 1.77, 95% CI [1.45-2.15]). Over the study period, observed mortality rates were not significantly higher than those expected from the BCIS risk model. CONCLUSIONS: Our findings did not show superiority of the ON strategy over SDD for higher risk cases undergoing elective ROTA PCI, in terms of 30-day mortality. This is the first study to examine the safety of SDD after elective ROTA PCI and more should follow.

Vascular complications associated with intraaortic balloon pump supported percutaneous coronary intervention (PCI) and clinical outcomes from the British Cardiovascular Intervention Society National PCI Database.

INTRODUCTION: The impact of a vascular complication (VC) in the setting of intraaortic balloon pump (IABP) supported PCI on clinical outcomes is unclear. METHODS: Using data from the BCIS National PCI Database, multivariate logistic regression was used to identify independent predictors of a VC. Propensity scoring was used to quantify the association between a VC and outcomes. RESULTS: Between 2007 and 2014, 9,970 PCIs in England and Wales were supported by IABP (1.6% of total PCI), with 224 femoral VCs (2.3%). Annualized rates of a VC reduced as the use of radial access for PCI increased. The independent predictors of a VC included a procedural complication (odds ratio [OR] 2.9, p < .001), female sex (OR 2.3, p < .001), PCI for stable angina (OR 3.47, p = .028), and use of a glycoprotein inhibitor (OR 1.46 [1.1:2.5], p = .04), with a lower likelihood of a VC when radial access was used for PCI (OR 0.48, p = .008). A VC was associated with a higher likelihood of transfusion (OR 5.7 [3.5:9.2], p < .0001), acute kidney injury (OR 2.6 [1.2:6.1], p = .027), and periprocedural MI (OR 3.2 [1.5:6.7], p = .002) but not with adjusted mortality at discharge (OR 1.2 [0.8:1.7], p = .394) or 12-months (OR 1.1 [0.76:1.56], p = .639). In sensitivity analyses, there was a trend towards higher mortality in patients experiencing a VC who underwent PCI for stable angina (OR 4.1 [1.0:16.4], p value for interaction .069). Discussion and Conclusions Although in-hospital morbidity was observed to be adversely affected by occurrence of a VC during IABP-supported PCI, in-hospital and 1-year survival were similar between groups.

Revascularisation strategies in patients with significant left main coronary disease during the COVID-19 pandemic.

BACKGROUND: There are limited data on the impact of the COVID-19 pandemic on left main (LM) coronary revascularisation activity, choice of revascularisation strategy, and post-procedural outcomes. METHODS: All patients with LM disease (≥50% stenosis) undergoing coronary revascularisation in England between January 1, 2017 and August 19, 2020 were included (n = 22,235), stratified by time-period (pre-COVID: 01/01/2017-29/2/2020; COVID: 1/3/2020-19/8/2020) and revascularisation strategy (percutaneous coronary intervention (PCI) vs. coronary artery bypass grafting (CABG). Logistic regression models were performed to examine odds ratio (OR) of 1) receipt of CABG (vs. PCI) and 2) in-hospital and 30-day postprocedural mortality, in the COVID-19 period (vs. pre-COVID). RESULTS: There was a decline of 1,354 LM revascularisation procedures between March 1, 2020 and July 31, 2020 compared with previous years' (2017-2019) averages (-48.8%). An increased utilization of PCI over CABG was observed in the COVID period (receipt of CABG vs. PCI: OR 0.46 [0.39, 0.53] compared with 2017), consistent across all age groups. No difference in adjusted in-hospital or 30-day mortality was observed between pre-COVID and COVID periods for both PCI (odds ratio (OR): 0.72 [0.51. 1.02] and 0.83 [0.62, 1.11], respectively) and CABG (OR 0.98 [0.45, 2.14] and 1.51 [0.77, 2.98], respectively) groups. CONCLUSION: LM revascularisation activity has significantly declined during the COVID period, with a shift towards PCI as the preferred strategy. Postprocedural mortality within each revascularisation group was similar in the pre-COVID and COVID periods, reflecting maintenance in quality of outcomes during the pandemic. Future measures are required to safely restore LM revascularisation activity to pre-COVID levels.

Excimer laser coronary atherectomy during complex PCI: An analysis of 1,471 laser cases from the British Cardiovascular Intervention Society database.

INTRODUCTION: Excimer laser coronary atherectomy (ELCA) is a recognized adjunctive therapy utilized in the percutaneous management of complex coronary lesions. Studies examining its safety and utility have been limited by small sample sizes. Our study examines the determinants and outcomes of ELCA. METHODS: Using the British Cardiac Intervention Society database, data were analyzed on all PCI procedures in the UK between 2006-2016. Descriptive statistics and multivariate logistic regressions were used to examine baseline, procedural and outcome associations with ELCA. RESULTS: We identified 1,471 (0.21%) ELCA cases out of 686,358 PCI procedures. Baseline covariates associated with ELCA use were age, BMI, number of lesions, CTO or restenosis attempted and history of prior MI, CABG or PCI. Procedural co-variates associated with ELCA were the use of glycoprotein inhibitors, intravascular imaging, rotational atherectomy, cutting balloons, microcatheters and intra-aortic balloon pumps. Adjusted rates of in-hospital major adverse cardiac/cerebrovascular events (MACCE) or its individual components (death, peri-procedural MI, stroke and major bleed) were not significantly altered by the use of ELCA. However, there were higher odds of dissection (OR 1.52, 95% CI 1.17-1.98), perforation (OR 2.18, 95% CI 1.44-3.30), slow flow (OR: 1.67, 95% CI 1.18-2.36), reintervention (OR: 2.12, 95% CI 1.14-3.93) and arterial complications (OR: 1.63, 95% CI 1.21-2.21). CONCLUSIONS: ELCA use during complex PCI is associated with higher risk baseline and procedural characteristics. Although increased rates of acute procedural complications were observed, ELCA does not increase likelihood of in-hospital MACCE or its individual components.

Ticagrelor or Clopidogrel After an Acute Coronary Syndrome in the Elderly: A Propensity Score Matching Analysis from 16,653 Patients Treated with PCI Included in Two Large Multinational Registries.

PURPOSE: Higher risk of bleeding with ticagrelor over clopidogrel in elderly patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI) has been suggested. We assessed the incidence of major bleedings (MB), reinfarction (re-MI), and all-cause death to evaluate safety and efficacy of ticagrelor versus clopidogrel in such population. METHODS: Real-world registries RENAMI and BleeMACS were merged. The pooled cohort was divided into two groups, clopidogrel versus ticagrelor. Statistical analysis considered patients <75 versus ≥75 years old. Endpoints were BARC 3-5 MB, re-MI, and all-cause death at 1-year follow-up. The study included 16,653 patients (13,153 < 75 and 3500 ≥ 75 years). Ticagrelor was underused in elderly patients (16.3% versus 20.8%, P < 0.001). Using propensity score matching (PSM), two treatment groups of 1566 patients were included in the final analysis. RESULTS: Ticagrelor was able to prevent re-MI (hazard ratio [HR], 0.31; 95% confidence interval [CI], 0.2-0.6; P < 0.001) and all-cause death (HR, 0.60; 95% CI, 0.4-0.9; P = 0.026) irrespective of age. In patients ≥75 years, ticagrelor reduced all-cause death (HR, 0.32; 95% CI, 0.1-0.8; P = 0.012) and re-MI (HR, 0.25; 95% CI, 0.1-1.1, P = 0.072). Moreover, even with the limit of the low number of events, ticagrelor did not significantly increase the incidence of MB (HR, 1.49; 95% CI, 0.70-3.0; P = 0.257). At multiple Cox regression, age (HR, 1.03; 95% CI, 1.02-1.05; P < 0.001) resulted an independent risk factor for bleeding. CONCLUSION: In our study, reflecting the results from two large retrospective, real-world registries, Ticagrelor did not significantly increase MB compared with clopidogrel in elderly patients with ACS treated with PCI, while significantly improving 1-year survival. Further studies on elderly patients are suggested.

Complex high-risk and indicated percutaneous coronary intervention for stable angina: Does operator volume influence patient outcome?

BACKGROUND: Complex high-risk and indicated revascularization using percutaneous coronary intervention (CHIP-PCI) is an emerging concept that is poorly studied. OBJECTIVE: To define temporal changes in CHIP-PCI volumes, and the relationship between operator CHIP-PCI volume and patient outcomes. METHODS AND RESULTS: Data were analyzed on all CHIP-PCI procedures undertaken for stable angina in England and Wales between 2007 and 2014. Operator volume data was available for 2012-14. CHIP-PCI was defined by patient characteristics (age ≥80years, left ventricular (LV) ejection fraction <30%, previous CABG, or chronic renal failure) and/or by procedural characteristics (left main PCI, chronic total occlusion PCI, LV support, use of rotational atherectomy or laser atherectomy). CHIP-PCI as a percentage of total PCI increased from 28.1% in 2007 to 36.2% in 2014 (P < .001). Between 2012 and 2014, a total of 30,268 CHIP-PCI cases were performed. Total operator volume varied from 1 to 580 cases with median total operator volume of 29 cases. Higher operator volumes were associated with a greater degree of patient comorbidity and increasing procedural complexity. After adjustment for baseline difference, in-hospital major bleeding (P < .001 for trend), access site complications (P < .001) and coronary perforation (P = .002) were associated with increasing operator CHIP-PCI volumes. However, the frequency of in-hospital death (P = .394) and 12-month mortality (P = .638) were similar across the volume quartiles. Higher volumes quartiles were associated with a greater likelihood of same day discharge (P < .001). CONCLUSIONS: CHIP-PCI cases are an increasingly large population in contemporary PCI practice. Higher operator volumes were not associated with improved 12-month survival. CONDENSED ABSTRACT: Data were analyzed on all complex high-risk and indicated revascularization using percutaneous coronary intervention (CHIP-PCI) procedures in England and Wales between 2007 and 2014. CHIP-PCI as a percentage of total PCI increased from 28.1% in 2007 to 36.2% in 2014 (P < .001). Median total operator volume was 29 cases with higher volumes associated with more patient comorbidity and increasing procedural complexity. In-hospital major bleeding (P < .001 for trend), access site complications (P < .001) and coronary perforation (P = .002) all associated with increasing operator CHIP-PCI volumes. However, trends for in-hospital death (P = .394), and 12-month mortality (P = .638) were similar across the volume quartiles.

Average daily ischemic versus bleeding risk in patients with ACS undergoing PCI: Insights from the BleeMACS and RENAMI registries.

BACKGROUND: The risk of recurrent ischemia and bleeding after percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) may vary during the first year of follow-up according to clinical presentation, and medical and interventional strategies. METHODS: BleeMACS and RENAMI are 2 multicenter registries enrolling patients with ACS treated with PCI and clopidogrel, prasugrel, or ticagrelor. The average daily ischemic and bleeding risks (ADIR and ADBR) in the first year after PCI were the primary end points. The difference between ADBR and ADIR was calculated to estimate the potential excess of bleeding/ischemic events in a given period or specific subgroup. RESULTS: A total of 19,826 patients were included. Overall, in the first year after PCI, the ADBR was 0.008085%, whereas ADIR was 0.008017% (P = .886). In the first 2 weeks ADIR was higher than ADBR (P = .013), especially in patients with ST-segment elevation myocardial infarction or incomplete revascularization. ADIR continued to be, albeit non-significantly, greater than ADBR up to the third month, whereas ADBR became higher, although not significantly, afterward. Patients with incomplete revascularization had an excess in ischemic risk (P = .003), whereas non-ST-segment elevation ACS patients and those on ticagrelor had an excess of bleeding (P = .012 and P = .022, respectively). CONCLUSIONS: In unselected ACS patients, ADIR and ADBR occurred at similar rates within 1 year after PCI. ADIR was greater than ADBR in the first 2 weeks, especially in ST-segment elevation myocardial infarction patients and those with incomplete revascularization. In the first year, ADIR was higher than ADBR in patients with incomplete revascularization, whereas ADBR was higher in non-ST-segment elevation ACS patients and in those discharged on ticagrelor.

In-hospital gastrointestinal bleeding following percutaneous coronary intervention.

OBJECTIVES: This study aims to examine in-hospital gastrointestinal (GI) bleeding, its predictors and clinical outcomes, including long-term outcomes, in a national cohort of patients undergoing percutaneous coronary intervention (PCI) in England and Wales. BACKGROUND: GI bleeding remains associated with significant morbidity, mortality, and socioeconomic burden. METHODS: We examined the temporal changes in in-hospital GI bleeding in a national cohort of patients undergoing PCI between 2007 and 2014 in England and Wales, its predictors and prognostic consequences. Multivariate analysis was performed to identify independent risk factors between GI bleeding and 30-day mortality. Survival analysis was performed comparing patients with, and without, GI bleeding. RESULTS: There were 480 in-hospital GI bleeds in 549,298 patients (0.09%). Overall, rates of GI bleeding remained stable over time but a significant decline was observed for patients with ST segment elevation myocardial infarction (STEMI). The strongest predictors of bleeding events were STEMI-odds ratio (OR) 7.28 (95% confidence interval [95% CI] 4.82-11.00), glycoprotein IIb/IIIa inhibitor use OR 3.42 (95% CI 2.76-4.24) and use of circulatory support OR 2.65 (95% CI 1.90-3.71). Antiplatelets/coagulants (clopidogrel, prasugrel, and warfarin) were not independently associated with GI bleeding. GI bleeding was independently associated with a significant increase in all-cause 30-day mortality (OR 2.08 [1.52-2.83]). Patients with in-hospital GI bleed who survived to 30-days had increased all-cause mortality risk at 1 year compared to non-bleeders (HR 1.49 [1.07-2.09]). CONCLUSIONS: In-hospital GI bleeding following PCI is rare but is a clinically important event associated with increased 30-day and long-term mortality.