Peter Ludman

Coronary artery bypass surgery versus percutaneous coronary intervention with stent implantation in patients with multivessel coronary artery disease (the Stent or Surgery trial): a randomised controlled trial

BACKGROUND: Results of trials, comparing percutaneous transluminal coronary angioplasty (PTCA) with coronary artery bypass grafting (CABG), indicate that rates of death or myocardial infarction are similar with either treatment strategy. Management with PTCA is, however, associated with an increased requirement for subsequent, additional revascularisation. Coronary stents, used as an adjunct to PTCA, reduce restenosis and the need for repeat revascularisation. The aim of the Stent or Surgery (SoS) trial was to assess the effect of stent-assisted percutaneous coronary intervention (PCI) versus CABG in the management of patients with multivessel disease. METHODS: In 53 centres in Europe and Canada, symptomatic patients with multivessel coronary artery disease were randomised to CABG (n=500) or stent-assisted PCI (n=488). The primary outcome measure was a comparison of the rates of repeat revascularisation. Secondary outcomes included death or Q-wave myocardial infarction and all-cause mortality. Analysis was by intention to treat. FINDINGS: All patients were followed-up for a minimum of 1 year and the results are expressed for the median follow-up of 2 years. 21% (n=101) of patients in the PCI group required additional revascularisation procedures compared with 6% (n=30) in the CABG group (hazard ratio 3.85, 95% CI 2.56-5.79, p<0.0001). The incidence of death or Q-wave myocardial infarction was similar in both groups (PCI 9% [n=46], CABG 10% [n=49]; hazard ratio 0.95, 95% CI 0.63-1.42, p=0.80). There were fewer deaths in the CABG group than in the PCI group (PCI 5% [n=22], CABG 2% [n=8]; hazard ratio 2.91, 95% CI 1.29-6.53, p=0.01). INTERPRETATION: The use of coronary stents has reduced the need for repeat revascularisation when compared with previous studies that used balloon angioplasty, though the rate remains significantly higher than in patients managed with CABG. The apparent reduction in mortality with CABG requires further investigation.BACKGROUND Results of trials, comparing percutaneous transluminal coronary angioplasty (PTCA) with coronary artery bypass grafting (CABG), indicate that rates of death or myocardial infarction are similar with either treatment strategy. Management with PTCA is, however, associated with an increased requirement for subsequent, additional revascularisation. Coronary stents, used as an adjunct to PTCA, reduce restenosis and the need for repeat revascularisation. The aim of the Stent or Surgery (SoS) trial was to assess the effect of stent-assisted percutaneous coronary intervention (PCI) versus CABG in the management of patients with multivessel disease. METHODS In 53 centres in Europe and Canada, symptomatic patients with multivessel coronary artery disease were randomised to CABG (n=500) or stent-assisted PCI (n=488). The primary outcome measure was a comparison of the rates of repeat revascularisation. Secondary outcomes included death or Q-wave myocardial infarction and all-cause mortality. Analysis was by intention to treat. FINDINGS All patients were followed-up for a minimum of 1 year and the results are expressed for the median follow-up of 2 years. 21% (n=101) of patients in the PCI group required additional revascularisation procedures compared with 6% (n=30) in the CABG group (hazard ratio 3.85, 95% CI 2.56-5.79, p<0.0001). The incidence of death or Q-wave myocardial infarction was similar in both groups (PCI 9% [n=46], CABG 10% [n=49]; hazard ratio 0.95, 95% CI 0.63-1.42, p=0.80). There were fewer deaths in the CABG group than in the PCI group (PCI 5% [n=22], CABG 2% [n=8]; hazard ratio 2.91, 95% CI 1.29-6.53, p=0.01). INTERPRETATION The use of coronary stents has reduced the need for repeat revascularisation when compared with previous studies that used balloon angioplasty, though the rate remains significantly higher than in patients managed with CABG. The apparent reduction in mortality with CABG requires further investigation.

Classification of coronary artery bifurcation lesions and treatments: Time for a consensus!

Background: Percutaneous coronary intervention (PCI) of coronary bifurcation lesions remains a subject of debate. Many studies have been published in this setting. They are often small scale and display methodological flaws and other shortcomings such as inaccurate designation of lesions, heterogeneity, and inadequate description of techniques implemented. Methods: The aim is to propose a consensus established by the European Bifurcation Club (EBC), on the definition and classification of bifurcation lesions and treatments implemented with the purpose of allowing comparisons between techniques in various anatomical and clinical settings. Results: A bifurcation lesion is a coronary artery narrowing occurring adjacent to, and/or involving, the origin of a significant side branch. The simple lesion classification proposed by Medina has been adopted. To analyze the outcomes of different techniques by intention to treat, it is necessary to clearly define which vessel is the distal main branch and which is (are) the side branche(s) and give each branch a distinct name. Each segment of the bifurcation has been named following the same pattern as the Medina classification. The classification of the techniques (MADS: Main, Across, Distal, Side) is based on the manner in which the first stent has been implanted. A visual presentation of PCI techniques and devices used should allow the development of a software describing quickly and accurately the procedure performed. Conclusion: The EBC proposes a new classification of bifurcation lesions and their treatments to permit accurate comparisons of well described techniques in homogeneous lesion groups.

The 2011-12 pilot European Sentinel Registry of Transcatheter Aortic Valve Implantation: in-hospital results in 4,571 patients.

AIMS The aim of this prospective multinational registry is to assess and identify predictors of in-hospital outcome and complications of contemporary TAVI practice. METHODS AND RESULTS The Transcatheter Valve Treatment Sentinel Pilot Registry is a prospective independent consecutive collection of individual patient data entered into a web-based case record form (CRF) or transferred from compatible national registries. A total of 4,571 patients underwent TAVI between January 2011 and May 2012 in 137 centres of 10 European countries. Average age was 81.4±7.1 years with equal representation of the two sexes. Logistic EuroSCORE (20.2±13.3), access site (femoral approach: 74.2%), type of anaesthesia and duration of hospital stay (9.3±8.1 days) showed wide variations among the participating countries. In-hospital mortality (7.4%), stroke (1.8%), myocardial infarction (0.9%), major vascular complications (3.1%) were similar in the SAPIEN XT and CoreValve (p=0.15). Mortality was lower in transfemoral (5.9%) than in transapical (12.8%) and other access routes (9.7%; p<0.01). Advanced age, high logistic EuroSCORE, pre-procedural ≥grade 2 mitral regurgitation and deployment failure predicted higher mortality at multivariate analysis. CONCLUSIONS Increased operator experience and the refinement of valve types and delivery catheters may explain the lower rate of mortality, stroke and vascular complications than in historical studies and registries.

Reperfusion therapy for ST elevation acute myocardial infarction 2010/2011: current status in 37 ESC countries

AIMS Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion therapy in ST-elevation myocardial infarction (STEMI). We conducted this study to evaluate the contemporary status on the use and type of reperfusion therapy in patients admitted with STEMI in the European Society of Cardiology (ESC) member countries. METHODS AND RESULTS A cross-sectional descriptive study based on aggregated country-level data on the use of reperfusion therapy in patients admitted with STEMI during 2010 or 2011. Thirty-seven ESC countries were able to provide data from existing national or regional registries. In countries where no such registries exist, data were based on best expert estimates. Data were collected on the use of STEMI reperfusion treatment and mortality, the numbers of cardiologists, and the availability of PPCI facilities in each country. Our survey provides a brief data summary of the degree of variation in reperfusion therapy across Europe. The number of PPCI procedures varied between countries, ranging from 23 to 884 per million inhabitants. Primary percutaneous coronary intervention and thrombolysis were the dominant reperfusion strategy in 33 and 4 countries, respectively. The mean population served by a single PPCI centre with a 24-h service 7 days a week ranged from 31 300 inhabitants per centre to 6 533 000 inhabitants per centre. Twenty-seven of the total 37 countries participated in a former survey from 2007, and major increases in PPCI utilization were observed in 13 of these countries. CONCLUSION Large variations in reperfusion treatment are still present across Europe. Countries in Eastern and Southern Europe reported that a substantial number of STEMI patients are not receiving any reperfusion therapy. Implementation of the best reperfusion therapy as recommended in the guidelines should be encouraged.

Transcatheter Aortic Valve Implantation in the United Kingdom Temporal Trends, Predictors of Outcome, and 6-Year Follow-Up: A Report From the UK Transcatheter Aortic Valve Implantation (TAVI) Registry, 2007 to 2012

Background— We assessed trends in the performance of transcatheter aortic valve implantation in the United Kingdom from the first case in 2007 to the end of 2012. We analyzed changes in case mix, complications, outcomes to 6 years, and predictors of mortality. Methods and Results— Annual cohorts were examined. Mortality outcomes were analyzed in the 92% of patients from England and Wales for whom independent mortality tracking was available. A total of 3980 transcatheter aortic valve implantation procedures were performed. In successive years, there was an increase in frequency of impaired left ventricular function, but there was no change in Logistic EuroSCORE. Overall 30-day mortality was 6.3%; it was highest in the first cohort (2007–2008), after which there were no further significant changes. One-year survival was 81.7%, falling to 37.3% at 6 years. Discharge by day 5 rose from 16.7% in 2007 and 2008 to 28% in 2012. The only multivariate preprocedural predictor of 30-day mortality was Logistic EuroSCORE ≥40. During long-term follow-up, multivariate predictors of mortality were preprocedural atrial fibrillation, chronic obstructive pulmonary disease, creatinine >200 μmol/L, diabetes mellitus, and coronary artery disease. The strongest independent procedural predictor of long-term mortality was periprocedural stroke (hazard ratio=3.00; P <0.0001). Nonfemoral access and postprocedural aortic regurgitation were also significant predictors of adverse outcome. Conclusions— We analyzed transcatheter aortic valve implantation in an entire country, with follow-up over 6 years. Although clinical profiles of enrolled patients remained unchanged, longer-term outcomes improved, and patients were discharged earlier. Periprocedural stroke, nonfemoral access, and postprocedural aortic regurgitation are predictors of adverse outcome, along with intrinsic patient risk factors. # CLINICAL PERSPECTIVE {#article-title-29}Background— We assessed trends in the performance of transcatheter aortic valve implantation in the United Kingdom from the first case in 2007 to the end of 2012. We analyzed changes in case mix, complications, outcomes to 6 years, and predictors of mortality. Methods and Results— Annual cohorts were examined. Mortality outcomes were analyzed in the 92% of patients from England and Wales for whom independent mortality tracking was available. A total of 3980 transcatheter aortic valve implantation procedures were performed. In successive years, there was an increase in frequency of impaired left ventricular function, but there was no change in Logistic EuroSCORE. Overall 30-day mortality was 6.3%; it was highest in the first cohort (2007–2008), after which there were no further significant changes. One-year survival was 81.7%, falling to 37.3% at 6 years. Discharge by day 5 rose from 16.7% in 2007 and 2008 to 28% in 2012. The only multivariate preprocedural predictor of 30-day mortality was Logistic EuroSCORE ≥40. During long-term follow-up, multivariate predictors of mortality were preprocedural atrial fibrillation, chronic obstructive pulmonary disease, creatinine >200 &mgr;mol/L, diabetes mellitus, and coronary artery disease. The strongest independent procedural predictor of long-term mortality was periprocedural stroke (hazard ratio=3.00; P<0.0001). Nonfemoral access and postprocedural aortic regurgitation were also significant predictors of adverse outcome. Conclusions— We analyzed transcatheter aortic valve implantation in an entire country, with follow-up over 6 years. Although clinical profiles of enrolled patients remained unchanged, longer-term outcomes improved, and patients were discharged earlier. Periprocedural stroke, nonfemoral access, and postprocedural aortic regurgitation are predictors of adverse outcome, along with intrinsic patient risk factors.

British Cardiovascular Intervention Society Registry for audit and quality assessment of percutaneous coronary interventions in the United Kingdom

Aims To create an inclusive and accurate registry of all percutaneous coronary intervention (PCI) procedures performed in the UK for audit to assess quality of care, drive improvements in this care and to provide data for research. Interventions Feedback to PCI centres with ‘live’ online data analysis and structured monthly and quarterly reports of PCI activity, including process of care measures and assessment of risk-adjusted outcome. Annual national reports focused on the structure of the provision of PCI across the UK, the appropriateness and process of its delivery and outcomes. Setting All hospitals performing PCI in the UK. Years 1994 to present. Population Consecutive patients treated by PCI. Approximately 80 000 new procedures each year in recent years. Startpoints All attempts to perform a PCI procedure. This is defined as when any coronary device is used to approach, probe or cross one or more coronary lesions, with the intention of performing a coronary intervention. Baseline data 113 variables defining patient demographic features, indications for PCI, procedural details and outcomes up to time of hospital discharge. Data capture Data entry into local software systems by caregivers and data clerks, with subsequent encryption and internet transfer to central data servers. Data quality Local validation, range checks and consistency assessments during upload. No external validation. Feedback of data completeness to all units. Access to data Available for research by application to British Cardiovascular Intervention Society using a data sharing agreement which can be obtained at http://www.bcis.org.uk.

Influence of Arterial Access Site Selection on Outcomes in Primary Percutaneous Coronary Intervention : Are the Results of Randomized Trials Achievable in Clinical Practice?

OBJECTIVES This study sought to investigate the influence of access site utilization on mortality, major adverse cardiac and cardiovascular events (MACCE), bleeding, and vascular complications in a large number of patients treated by primary percutaneous coronary intervention (PPCI) in the United Kingdom over a 5-year period, through analysis of the British Cardiovascular Intervention Society database. BACKGROUND Despite advances in antithrombotic and antiplatelet therapy, bleeding complications remain an important cause of morbidity and mortality in patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing PPCI. A significant proportion of such bleeding complications are related to the access site, and adoption of radial access may reduce these complications. These benefits have not previously been studied in a large unselected national population of PPCI patients. METHODS Mortality (30-day), MACCE (a composite of 30-day mortality and in-hospital myocardial re-infarction, target vessel revascularization, and cerebrovascular events), and bleeding and access site complications were studied based on transfemoral access (TFA) and transradial access (TRA) site utilization in PPCI STEMI patients. The influence of access site selection was studied in 46,128 PPCI patients; TFA was used in 28,091 patients and TRA in 18,037. Data were adjusted for potential confounders using Cox regression that accounted for the propensity to undergo radial or femoral approach. RESULTS TRA was independently associated with a lower 30-day mortality (hazard ratio [HR]: 0.71, 95% confidence interval [CI]: 0.52 to 0.97; p < 0.05), in-hospital MACCE (HR: 0.73, 95% CI: 0.57 to 0.93; p < 0.05), major bleeding (HR: 0.37, 95% CI: 0.18 to 0.74; p < 0.01), and access site complications (HR: 0.38, 95% CI: 0.19 to 0.75; p < 0.01). CONCLUSIONS This analysis of a large number of PPCI procedures demonstrates that utilization of TRA is independently associated with major reductions in mortality, MACCE, major bleeding, and vascular complication rates.

Access Site Practice And Procedural Outcomes In Relation To Clinical Presentation In 439,947 Patients Undergoing Percutaneous Coronary Intervention In The United Kingdom

OBJECTIVES This study sought to determine the relationships among access site practice, clinical presentation, and procedural outcomes in a large patient population. BACKGROUND Transradial access (TRA) has been associated with improved patient outcomes in selected populations in randomized trials. It is unclear whether these outcomes are achievable in clinical practice. METHODS Using the BCIS (British Cardiovascular Intervention Society) database, we investigated outcomes for percutaneous coronary intervention procedures undertaken between 2007 and 2012 according to access site practice. Patients were categorized as stable, non-ST-segment elevation acute coronary syndrome (NSTEACS) and ST-elevation acute coronary syndrome (STEACS). The impact of access site on 30-day mortality, major adverse cardiac events, bleeding, and arterial access site complications was studied. RESULTS Data from 210,260 TRA and 229,687 transfemoral access procedures were analyzed. Following multivariate analysis, TRA was independently associated with a reduction in bleeding in all presenting syndromes (stable odds ratio [OR]: 0.24, p < 0.001; NSTEACS OR: 0.35, p < 0.001; STEACS OR: 0.47, p < 0.001) as well as access site complications (stable OR: 0.21, p < 0.001; NSTEACS OR: 0.19; STEACS OR: 0.16, p < 0.001). TRA was associated with reduced major adverse cardiac events only in patients with unstable syndromes (stable OR: 1.08, p = 0.25; NSTEACS OR: 0.72, p < 0.001; STEACS OR: 0.70, p < 0.001). TRA was associated with improved outcomes compared with a transfemoral access (TFA) with a vascular closure device in a propensity matched cohort. CONCLUSIONS In this large study, TRA is associated with reduced percutaneous coronary intervention-related complications in all patient groups and may reduce major adverse cardiac events and mortality in ACS patients. TRA is superior to transfemoral access with closure devices. Use of TRA may lead to important patient benefits in routine practice. TRA should be considered the preferred access site for percutaneous coronary intervention.

Baseline Bleeding Risk and Arterial Access Site Practice in Relation to Procedural Outcomes After Percutaneous Coronary Intervention

BACKGROUND Transradial access (TRA) has been associated with reduced access site-related bleeding complications and mortality after percutaneous coronary intervention (PCI). It is unclear, however, whether these observed benefits are influenced by baseline bleeding risk. OBJECTIVES This study investigated the relationship between baseline bleeding risk, TRA utilization, and procedure-related outcomes in patients undergoing PCI enrolled in the British Cardiovascular Intervention Society database. METHODS Baseline bleeding risk was calculated by using modified Mehran bleeding risk scores in 348,689 PCI procedures performed between 2006 and 2011. Four categories for bleeding risk were defined for the modified Mehran risk score (MMRS): low (<10), moderate (10 to 14), high (15 to 19), and very high (≥20). The impact of baseline bleeding risk on 30-day mortality and its relationship with access site were studied. RESULTS TRA was independently associated with a 35% reduction in 30-day mortality risk (odds ratio [OR]: 0.65 [95% confidence interval (CI): 0.59 to 0.72]; p < 0.0001), with the magnitude of mortality reduction related to baseline bleeding risk (MMRS <10, OR: 0.73 [95% CI: 0.62 to 0.86]; MMRS ≥20, OR: 0.53 [95% CI: 0.47 to 0.61]). In patients with an MMRS <10, TRA was used in 71,771 (43.2%) of 166,083 PCI procedures; TRA was used in 8,655 (40.1%) of 21,559 PCI procedures in patients with an MMRS ≥20, illustrating that TRA was used less in those at highest risk from bleeding complications (p < 0.0001). CONCLUSIONS TRA was independently associated with reduced 30-day mortality, and the magnitude of this effect was related to baseline bleeding risk; those at highest risk of bleeding complications gained the greatest benefit from adoption of TRA during PCI.

Major bleeding after percutaneous coronary intervention and risk of subsequent mortality: a systematic review and meta-analysis

Objectives To examine the relationship between periprocedural bleeding complications and major adverse cardiovascular events (MACEs) and mortality outcomes following percutaneous coronary intervention (PCI) and study differences in the prognostic impact of different bleeding definitions. Methods We conducted a systematic review and meta-analysis of PCI studies that evaluated periprocedural bleeding complications and their impact on MACEs and mortality outcomes. A systematic search of MEDLINE and EMBASE was conducted to identify relevant studies. Data from relevant studies were extracted and random effects meta-analysis was used to estimate the risk of adverse outcomes with periprocedural bleeding. Statistical heterogeneity was assessed by considering the I2 statistic. Results 42 relevant studies were identified including 533 333 patients. Meta-analysis demonstrated that periprocedural major bleeding complications was independently associated with increased risk of mortality (OR 3.31 (2.86 to 3.82), I2=80%) and MACEs (OR 3.89 (3.26 to 4.64), I2=42%). A differential impact of major bleeding as defined by different bleeding definitions on mortality outcomes was observed, in which the REPLACE-2 (OR 6.69, 95% CI 2.26 to 19.81), STEEPLE (OR 6.59, 95% CI 3.89 to 11.16) and BARC (OR 5.40, 95% CI 1.74 to 16.74) had the worst prognostic impacts while HORIZONS-AMI (OR 1.51, 95% CI 1.11 to 2.05) had the least impact on mortality outcomes. Conclusions Major bleeding after PCI is independently associated with a threefold increase in mortality and MACEs outcomes. Different contemporary bleeding definitions have differential impacts on mortality outcomes, with 1.5–6.7-fold increases in mortality observed depending on the definition of major bleeding used.