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Background The EXCEL trial reported similar five-year rates of the primary composite outcome of death, myocardial infarction (MI), or stroke after percutaneous coronary intervention (PCI) compared with coronary artery bypass grafting (CABG) for treatment of obstructive left main coronary artery disease (LMCAD). Aims We sought to determine whether these outcomes remained consistent regardless of geography of enrolment. Methods We performed a pre-specified subgroup analysis based on regional enrolment. Results Among 1,905 patients randomised to PCI (n=948) or CABG (n=957), 1,075 (56.4%) were recruited at 52 European Union (EU) centres, and 752 (39.5%) were recruited at 67 North American (NA) centres. EU versus NA patients varied according to numerous baseline demographics, anatomy, pharmacotherapy and procedural characteristics. Nonetheless, the relative rates of the primary endpoint after PCI versus CABG were consistent across EU versus NA centres at 30 days and 5 years. However, NA participants had substantially higher late rates of ischaemia-driven revascularisation (IDR) after PCI, driven predominantly by the need for greater target vessel and lesion revascularisation. This culminated in a significant difference in the relative risk of the secondary composite outcome of death, MI, stroke, or IDR at 5 years (pinteraction=0.02). Conclusions In the EXCEL trial, the relative risks for the 30-day and five-year primary composite outcome of death, MI or stroke after PCI versus CABG were consistent irrespective of geography. However, five-year rates of IDR after PCI were significantly higher in NA centres, a finding the Heart Team and patients should consider when making treatment decisions. ClinicalTrials.gov identifier: NCT01205776.

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

AIMS The aim of this study was to evaluate the accuracy of a continuous intracoronary (IC) adenosine infusion, administered through the novel HYPEREM™IC over-the-wire microcatheter, to measure fractional flow reserve (FFR). METHODS AND RESULTS The HYPEREMIC trial was a randomised, non-inferiority, crossover study in which patients with intermediate coronary lesions were enrolled for sequential pressure wire studies. FFR was measured using intravenous (IV) (140-180 mcg/kg/min) versus continuous non-weight-adjusted IC (360 mcg/min) adenosine. Patients were randomised and blinded to the order in which they received the adenosine, separated by a washout period. The primary endpoint was the mean hyperaemic FFR. Forty-one patients were enrolled at three UK sites between June and November 2016. The mean (standard deviation) FFR was 0.82 (±0.09) after IC versus 0.84 (±0.09) after IV adenosine. The difference of -0.02 (95% confidence interval [CI]: -0.03 to -0.01) confirmed the non-inferiority (margin

Background New‐generation drug‐eluting stents (DES) reduce target‐vessel revascularization compared with bare‐metal stents (BMS), and recent data suggest that DES have the potential to decrease the risk of myocardial infarction and cardiovascular mortality. We evaluated the treatment effect of DES versus BMS according to the target artery (left anterior descending [LAD] and/or left main [LM] versus other territories [no‐LAD/LM]). Methods and Results The Coronary Stent Trialist (CST) Collaboration gathered individual patient data of randomized trials of DES versus BMS for the treatment of coronary artery disease. The primary outcome was the composite of cardiac death or myocardial infarction. Hazard ratios (HRs) with 95% CIs were derived from a 1‐stage individual patient data meta‐analysis. We included 26 024 patients across 19 trials: 13 650 (52.4%) in the LAD/LM and 12 373 (47.6%) in the no‐LAD/LM group. At 6‐year follow‐up, there was strong evidence that the treatment effect of DES versus BMS depended on the target vessel ( P ‐interaction=0.024). Compared with BMS, DES reduced the risk of cardiac death or myocardial infarction to a greater extent in the LAD/LM (HR, 0.76; 95% CI, 0.68–0.85) than in the no‐LAD/LM territories (HR, 0.93; 95% CI, 0.83–1.05). This benefit was driven by a lower risk of cardiac death (HR, 0.83; 95% CI, 0.70–0.98) and myocardial infarction (HR, 0.74; 95% CI, 0.65–0.85) in patients with LAD/LM disease randomized to DES. An interaction ( P =0.004) was also found for all‐cause mortality with patients with LAD/LM disease deriving benefit from DES (HR, 0.86; 95% CI, 0.76–0.97). Conclusions As compared with BMS, new‐generation DES were associated with sustained reduction in the composite of cardiac death or myocardial infarction if used for the treatment of LAD or left main coronary stenoses. Registration URL: https://www.crd.york.ac.uk/PROSPERO ; Unique identifier: CRD42017060520.

Objectives The aim of this study was to evaluate all-cause mortality in patients aged greater than 80 years old with multi-vessel (MV) coronary artery disease (CAD) presenting with an acute ST segment elevation myocardial infarction (STEMI) and the impact of culprit only (CORV) versus full revascularisation (FRV). Background Current European Society of Cardiology (ESC) guidelines recommend FRV either during the index procedure or as a staged approach in patients presenting with STEMIs and found to have MV CAD. A recent meta-analysis demonstrated a 31% relative risk reduction in cardiovascular mortality in patients undergoing FRV. The average age of patients in the trials that have directed these guidelines is 61-65 and therefore their applicability to the elderly is questionable. Methods This is a retrospective cohort study of patients presenting with a STEMI to the Royal Sussex County Hospital between January 2009 and December 2019. Groups were defined as those less than or greater than 80 years old and subdivided into those with single vessel (SV) or MV CAD. Group baseline characteristics were compared and the time to all-cause mortality from index procedure was assessed for each group. Logrank tests / cox-regression models were used for survival analysis and chi-squared tests for categorical data. Significance level = Results 2809 eligible patients were identified during the study period. In those less than 80 years old (2418 patients) 1751 patients had SV CAD and 647 (26.8%) had MV CAD. Of those with MV CAD, 81 (12.5%) underwent FRV. In patients greater than 80 years old (391 patients) 247 patients had SV CAD and 144 (36.8%) had MV CAD of which 19 (13.2%) had FRV. Patients greater than 80 years old were significantly more likely to have MV CAD compared with patients less than 80 years old (p Conclusions The results show there is a mortality difference in patients with MV versus SV CAD in patients less than 80 years old, which is not seen in patients greater than 80 years old. There also does not appear to be a mortality benefit in FRV compared with CORV in the elderly. While a reduction in cardiovascular mortality with FRV has been demonstrated in a recent meta-analysis these results indicate that this benefit may be tempered in elderly patients. This is a single centre study with relatively small numbers, especially in those greater than 80 years old undergoing FRV. Given the uncertainty around FRV in the elderly, there remains a need for a randomised control trial to evaluate this question. Conflict of Interest None

Background Coronary collaterals are often seen supplying retrograde flow to an acutely occluded arterial territory. Whether this early collateralization offers prognostic benefit is not well established. Methods We analyzed data from all patients presenting to our regional cardiac unit with acute ST-elevation myocardial infarction requiring immediate angiography (years 1999-2017). Data on all patients is entered prospectively into a bespoke tailored database prior to knowledge of patient outcome. Only patients with TIMI 0 or 1 flow in the infarct-related vessel were included in the analysis. In-hospital and long-term outcome were assessed according to the presence or absence of angiographically visible collateral flow prior to treatment of the occluded vessel. Results Two thousand five hundred and forty-two patients were included in the analysis. 76% of these (n = 1944) had TIMI 0/1 flow at angiography. Angiographically-visible collateralization was seen in 17% (n = 322) and was more commonly observed in the right coronary artery (64%) than in the left anterior descending (25%) or Cx (6%). Cardiogenic shock (10.8%) and use of an intra-aortic balloon pump (5.4%) were more frequent in patients without coronary collateralisation (p = .04 and p = .02, respectively). The presence of collaterals improved long term survival (95% CI 11.4-18.7 months; p Conclusion One-sixth of patients with STEMI have angiographically visible collaterals to the infarcted territory. Patients without collaterals are more likely to present in cardiogenic shock. The presence of angiographically visible collaterals at the time of STEMI is associated with an improved long-term survival.

Item does not contain fulltext BACKGROUND: The Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial was a non-inferiority trial that compared percutaneous coronary intervention (PCI) using first-generation paclitaxel-eluting stents with coronary artery bypass grafting (CABG) in patients with de-novo three-vessel and left main coronary artery disease, and reported results up to 5 years. We now report 10-year all-cause death results. METHODS: The SYNTAX Extended Survival (SYNTAXES) study is an investigator-driven extension of follow-up of a multicentre, randomised controlled trial done in 85 hospitals across 18 North American and European countries. Patients with de-novo three-vessel and left main coronary artery disease were randomly assigned (1:1) to the PCI group or CABG group. Patients with a history of PCI or CABG, acute myocardial infarction, or an indication for concomitant cardiac surgery were excluded. The primary endpoint of the SYNTAXES study was 10-year all-cause death, which was assessed according to the intention-to-treat principle. Prespecified subgroup analyses were performed according to the presence or absence of left main coronary artery disease and diabetes, and according to coronary complexity defined by core laboratory SYNTAX score tertiles. This study is registered with ClinicalTrials.gov, NCT03417050. FINDINGS: From March, 2005, to April, 2007, 1800 patients were randomly assigned to the PCI (n=903) or CABG (n=897) group. Vital status information at 10 years was complete for 841 (93%) patients in the PCI group and 848 (95%) patients in the CABG group. At 10 years, 244 (27%) patients had died after PCI and 211 (24%) after CABG (hazard ratio 1.17 [95% CI 0.97-1.41], p=0.092). Among patients with three-vessel disease, 151 (28%) of 546 had died after PCI versus 113 (21%) of 549 after CABG (hazard ratio 1.41 [95% CI 1.10-1.80]), and among patients with left main coronary artery disease, 93 (26%) of 357 had died after PCI versus 98 (28%) of 348 after CABG (0.90 [0.68-1.20], pinteraction=0.019). There was no treatment-by-subgroup interaction with diabetes (pinteraction=0.66) and no linear trend across SYNTAX score tertiles (ptrend=0.30). INTERPRETATION: At 10 years, no significant difference existed in all-cause death between PCI using first-generation paclitaxel-eluting stents and CABG. However, CABG provided a significant survival benefit in patients with three-vessel disease, but not in patients with left main coronary artery disease. FUNDING: German Foundation of Heart Research (SYNTAXES study, 5-10-year follow-up) and Boston Scientific Corporation (SYNTAX study, 0-5-year follow-up).

BACKGROUND Transcatheter aortic valve implantation (TAVI) is maturing as a treatment option and is now often undertaken during an unscheduled index hospital admission. The aim of this study was to look at procedural and mid-term outcomes of patients undergoing elective versus urgent in-hospital transcatheter aortic valve implantation. METHODS We identified a total of 1,157 patients who underwent TAVI between November 2007 and November 2019 at the Sussex Cardiac Centre in the UK. We compared the demographics, procedural outcomes, 30-day and 1-year mortality between elective and urgent patients. Emergency and salvage TAVI cases were excluded. RESULTS Of the 1,157 patients who underwent the procedure, 975 (84.3%) had elective while 182 (15.7%) had urgent TAVI. Predominant aortic stenosis was more frequent in elective patients (91.7% vs. 77.4%); p

Objectives To determine whether a permanent pacemaker (PPM) in situ can enhance survival after transcatheter aortic valve implantation (TAVI), in a predominantly inoperable or high risk cohort. Background New conduction disturbances are the most frequent complication of TAVI, often necessitating PPM implantation before hospital discharge. Methods We performed an observational cohort analysis of the UK TAVI registry (2007-2015). Primary and secondary endpoints were 30-day post-discharge all-cause mortality and long-term survival, respectively. Results Of 8,651 procedures, 6,815 complete datasets were analyzed. A PPM at hospital discharge, irrespective of when implantation occurred (PPM 1.68% [22/1309] vs. no PPM 1.47% [81/5506], odds ratio [OR] 1.14, 95% confidence interval [CI] 0.71-1.84; p = .58), or a PPM implanted peri- or post-TAVI only (PPM 1.44% [11/763] vs. no PPM 1.47% [81/5506], OR 0.98 [0.51-1.85]; p = .95) did not significantly reduce the primary endpoint. Patients with a PPM at discharge were older, male, had right bundle branch block at baseline, were more likely to have received a first-generation self-expandable prosthesis and had experienced more peri- and post-procedural complications including bailout valve-in-valve rescue, bleeding and acute kidney injury. A Cox proportional hazards model demonstrated significantly reduced long-term survival in all those with a PPM, irrespective of implantation timing (hazard ratio [HR] 1.14 [1.02-1.26]; p = .019) and those receiving a PPM only at the time of TAVI (HR 1.15 [1.02-1.31]; p = .032). The reasons underlying this observation warrant further investigation. Conclusions A PPM did not confer a survival advantage in the first 30 days after hospital discharge following TAVI.

BACKGROUND: Historically the elderly have been under-represented in non-ST-elevation myocardial infarction (NSTEMI) management trials. AIMS: The aim of this trial was to demonstrate that an intervention-guided strategy is superior to optimal medical therapy (OMT) alone for treating NSTEMI in elderly individuals. METHODS: Patients (≥80 years, chest pain, ischaemic ECG, and elevated troponin) were randomised 1:1 to an intervention-guided strategy plus OMT versus OMT alone. The primary endpoint was a composite of all-cause mortality and non-fatal myocardial reinfarction at 1 year. Ethics approval was obtained by the institutional review board of every recruiting centre. RESULTS: From May 2014 to September 2018, 251 patients (n=125 invasive vs n=126 conservative) were enrolled. Almost 50% of participants were female. The trial was terminated prematurely due to slow recruitment. A Kaplan-Meier estimate of event-free survival revealed no difference in the primary endpoint at 1 year (invasive 18.5% [23/124] vs conservative 22.2% [28/126]; p=0.39). No significant difference persisted after Cox proportional hazards regression analysis (hazard ratio 0.79, 95% confidence interval 0.45-1.35; p=0.39). There was greater freedom from angina at 3 months (p

OBJECTIVES We sought to identify baseline demographics and procedural factors that might independently predict in-hospital stroke following transcatheter aortic valve implantation (TAVI). BACKGROUND Stroke is a recognized, albeit infrequent, complication of TAVI. Established predictors of procedure-related in-hospital stroke; however, remain poorly defined. METHODS We conducted an observational cohort analysis of the multicenter UK TAVI registry. The primary outcome measure was the incidence of in-hospital stroke. RESULTS A total of 8,652 TAVI procedures were performed from 2007 to 2015. There were 205 in-hospital strokes reported by participating centers equivalent to an overall stroke incidence of 2.4%. Univariate analysis showed that the implantation of balloon-expandable valves caused significantly fewer strokes (balloon-expandable 96/4,613 [2.08%] vs. self-expandable 95/3,272 [2.90%]; p = .020). After multivariable analysis, prior cerebrovascular disease (CVD) (odds ratio [OR] 1.51, 95% confidence interval [CI 1.05-2.17]; p = .03), advanced age at time of operation (OR 1.02 [0.10-1.04]; p = .05), bailout coronary stenting (OR 5.94 [2.03-17.39]; p = .008), and earlier year of procedure (OR 0.93 [0.87-1.00]; p = .04) were associated with an increased in-hospital stroke risk. There was a reduced stroke risk in those who had prior cardiac surgery (OR 0.62 [0.41-0.93]; p = .01) and a first-generation balloon-expandable valve implanted (OR 0.72 [0.53-0.97]; p = .03). In-hospital stroke significantly increased 30-day (OR 5.22 [3.49-7.81]; p

Objectives The authors report the incidence of pacemaker implantation up to hospital discharge and the factors influencing pacing rate following implantation of the LOTUS bioprosthesis (Boston Scientific, Natick, Massachusetts) in the United Kingdom. Background Transcatheter aortic valve replacement (TAVR) is associated with a significant need for permanent pacemaker implantation. Pacing rates vary according to the device used. The REPRISE II (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System) trial reported a pacing rate of 29% at 30 days after implantation of the LOTUS device. Methods Data were collected retrospectively on 228 patients who had the LOTUS device implanted between March 2013 and February 2015 across 10 centers in the United Kingdom. Twenty-seven patients (12%) had pacemakers implanted pre-procedure and were excluded from the analysis. Results Patients were aged 81.2 ± 7.7 years; 50.7% were male. The mean pre-procedural QRS duration was 101.7 ± 20.4 ms. More than one-half of the cohort (n = 111, 55%) developed new left bundle branch block (LBBB) following the procedure. Permanent pacemakers were implanted in 64 patients (32%) with a median time to insertion of 3.0 ± 3.4 days. Chief indications for pacing were atrioventricular (AV) block (n = 46, 72%), or LBBB with 1st degree AV block (n = 11, 17%). Amongst those who received a pacemaker following TAVR the pre-procedural electrocardiogram findings included: No conduction disturbance (n = 41, 64%); 1st degree AV block (n = 10, 16%); right bundle branch block (n = 6, 9%) and LBBB (n = 5, 8%). LBBB (but not permanent pacemaker) occurred more frequently in patients who had balloon aortic valvuloplasty before TAVR (odds ratio [OR]: 1.25; p = 0.03). Pre-procedural conduction abnormality (composite of 1st degree AV block, hemiblock, right bundle branch block, LBBB) was independently associated with the need for permanent pacemaker (OR: 2.54; p = 0.048). The absence of aortic valve calcification was also associated with a higher pacing rate (OR: 0.55; p = 0.031). Multivariate regression analysis did not show an independent association between depth of implant, valve oversizing, balloon post-dilatation, and the need for pacing post-procedure. Conclusions Following implantation of the repositionable LOTUS valve, 55% of patients developed LBBB and 32% of patients required a pacemaker during their index hospital admission. Patients with pre-procedural conduction disturbance and non-calcified aortic valves were more likely to need pacing. No other anatomic features were identified with increased pacing requirement with the LOTUS device.

Stent thrombosis (ST) is a potentially life-threatening complication of percutaneous coronary intervention (PCI). We aimed to develop a scoring system to predict the risk of ST following PCI.Odds ratios (ORs) for risk factors associated with ST were identified from a meta-analysis based on a systematic literature review, and through consensus expert opinion (Delphi-RAND method). The combined ORs were used to calculate risk scores for acute (within 24 hours), early (within 30 days) and late (31 days to 1 year) ST. Risk scores were validated against patient-level data from the TRITON-TIMI 38 study. Twenty risk factors were identified.The most highly predictive factor for early and late ST was "incomplete duration of dual antiplatelet therapy". Derived total risk scores ranged from 0 to 22 for acute and early ST, and from 0 to 20 for late ST. Increasing scores were associated with an increasing risk of ST when applied to trial data. Model discrimination was 0.60 (p = .0028), 0.67 (p .0001) and 0.66 (p .0001) for acute, early and late ST respectively, indicating good discriminatory power for predicting ST. Key limitations included a lack of published data on acute ST, resulting in a risk score for this time point being based predominantly on expert opinion, and that it was not possible to map all risk factors to variables collected in the TRITON-TIMI 38 study.Our weighted scoring system may help to stratify ST risk and individualize antiplatelet therapy in patients undergoing PCI.

Background The BASE ACS trial demonstrated an outcome of titanium–nitride–oxide-coated bioactive stents (BAS) that was non-inferior to everolimus-eluting stents (EES) in patients presenting with acute coronary syndrome (ACS). We performed a post hoc analysis of elderly versus non-elderly patients from the BASE ACS trial. Methods We randomized 827 patients (1:1) presenting with ACS to receive either BAS or EES. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR). Follow-up was planned at 12 months and yearly thereafter for up to 7 years. Elderly age was defined as ≥ 65 years. Results Of the 827 patients enrolled in the BASE ACS trial, 360 (43.5%) were elderly. Mean follow-up duration was 4.2 ± 1.9 years. MACE was more frequent in elderly versus younger patients (19.7% versus 12.0%, respectively, p = 0.002), probably driven by more frequent cardiac death and non-fatal MI events (5.3% versus 1.5%, and 9.7% versus 4.5%, p = 0.002 and p = 0.003, respectively). The rates of ischemia-driven TLR were comparable (p > 0.05). In propensity score-matched analysis (215 pairs), only cardiac death was more frequent in elderly patients (6% versus 1.4%, respectively, p = 0.01). Diabetes independently predicted both MACE and cardiac death in elderly patients. Conclusions Elderly patients treated with stent implantation for ACS had worse long-term clinical outcome, compared with younger ones, mainly due to a higher death rate.

Objectives We performed a post hoc analysis of outcome in patients with, versus those without, calcified target lesions from the BASE ACS trial. Background The outcome of contemporary stent implantation in patients with calcified lesions presenting with acute coronary syndrome is unknown. Methods The BASE ACS trial randomized 827 patients (1:1) presenting with acute coronary syndrome to receive either titanium-nitride-oxide-coated stents or everolimus-eluting stents. Calcified lesions were defined as moderate or severe calcification in the vessel wall by coronary angiography. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction or ischemia-driven target lesion revascularization. Follow-up was planned at 12 months, and yearly thereafter for up to 7 years. Results Of 827 patients enrolled in the trial, 352 (42.6%) had calcified target lesions. Median follow-up was 5.0 years. The incidence of MACE was higher in patients with, versus those without, calcified target lesions (19.6% vs. 12.2%, respectively, P = 0.004). This was driven by more frequent cardiac death and non-fatal myocardial infarction events (P 0.05). MACE and the other endpoints were comparable between the 2 propensity-score matched subgroups (P > 0.05 for all). Hypertension and smaller vessel size independently predicted MACE in patients treated for calcified lesions. Conclusions Patients presenting with acute coronary syndrome who were treated for calcified lesions had worse long-term clinical outcome, compared with those treated for non-calcified lesions, mainly due to more frequent safety events. In the propensity score-matched analysis, the outcome was comparable.

Introduction The XIMA trial was a randomised comparison of BMS or DES in patients undergoing stenting for CAD in patients aged 80 and over. Recruitment of 800 patients across 20 centres proved straightforward and timely with a high uptake rate in suitable patients. The RINCAL trial randomised patients to a conservative or an invasive approach for the management of NSTEMI in patients aged 80 and above. Recruitment of 250 patients across 10 sites was laboured and recruitment challenging with participation reluctance. We determined to understand the causes of this enrolment discrepancy. Methods Review of the RINCAL study screening log over an 18-month period at a single high recruiting site, and reasons tabulated for lack of enrolment. Results During an 18-month period within the RINCAL study at a single site, 102 out of 136 octogenarians with NSTEMI were eligible for inclusion. Of the 34 excluded patients, 14 were due to cognitive impairment [including dementia, lacking capacity to consent to participation, not understanding the patient information sheet], and 20 had concomitant medical comorbidities restricting invasive management. Of the 102 eligible patients, 24 [24%] patients participated. 37 [36%] eligible elderly patients declined to participate. The reasons for declining were: 1) patient declined invasive management, 2) patient wanted invasive management. In 41 [40%] eligible patients, the managing cardiologist decided that randomisation was not appropriate in one or other of the treatment arms. Conclusion Evidence is needed to guide management of acute anginal syndromes in older patients. Studies asking simple binary questions have been able to recruit reasonably well [as in the XIMA trial]. Trials asking more complex questions, including RINCAL, have observed high numbers of octogenarians declining to participate. This needs to be borne in mind when designing studies in the elderly, with a greater focus on supporting patients through the consent process. Conflict of Interest None

Background: New-generation drug-eluting stents (DES) have mostly been investigated in head-to-head non-inferiority trials against early-generation DES and have typically shown similar efficacy and superior safety. How the safety profile of new-generation DES compares with that of bare-metal stents (BMS) is less clear. Methods: We did an individual patient data meta-analysis of randomised clinical trials to compare outcomes after implantation of new-generation DES or BMS among patients undergoing percutaneous coronary intervention. The primary outcome was the composite of cardiac death or myocardial infarction. Data were pooled in a one-stage random-effects meta-analysis and examined at maximum follow-up and a 1-year landmark. Risk estimates are reported as hazard ratios (HRs) with 95% CIs. This study is registered in PROSPERO, number CRD42017060520. Findings: We obtained individual data for 26 616 patients in 20 randomised trials. Mean follow-up was 3·2 (SD 1·8) years. The risk of the primary outcome was reduced in DES recipients compared with BMS recipients (HR 0·84, 95% CI 0·78–0·90, p

Introduction and Method Transcatheter aortic valve implantation (TAVI) and balloon aortic valvuloplasty (BAV) are now well established percutaneous procedures. These procedures almost always require bursts of rapid ventricular pacing to temporarily reduce cardiac output to facilitate the procedure, usually done via a temporary pacing wire inserted into the right ventricle. We describe a case series of 132 cases of TAVI and 76 BAV done using ventricular pacing via the left ventricular lead by simply connecting one electrode to the patient's skin and one electrode through the left ventricular (LV) wire. Results All of the 132 TAVI cases (a mixture of Edwards Sapien, Medtronic CoreValve and Boston Scientific Lotus) and 76 BAV were successfully performed using pacing through the LV wire. No BAV patients required temporary pacing wire (TPW) or permanent pacemaker (PPM) insertion. Of the TAVI patients, 6 (4.5%) required TPW during the procedure due to complete heart block to facilitate removal of the LV wire. 1 patient (0.8%) required a PPM urgently due to complete heart block and haemodynamic instability. Twenty eight Patients (21.2%) required PPM following TAVI, 9 of which were within the first 24 hr. Average time to pacemaker implantation was 3.7 days. Conclusion Rapid ventricular pacing via the LV wire is a simple, safe and effective strategy for percutaneous aortic valve intervention and balloon aortic valvuloplasty. It eliminates the need for a temporary pacing wire with its attendant risks in the vast majority of cases. Furthermore, most pacemakers following TAVI are required late, after the first 24 hr period, by which time the TPW has already usually been removed. © 2016 Wiley Periodicals, Inc.

Leaning objectives To date, there remains no universal definition for ‘elderly’, and indeed for some, biological age does not correspond with chronological age. However, most now consider elderly as those aged ≥80 years. Within the Western world, the general population is ageing; therefore, the proportion of octogenarians (defined as age >80 years) in the general population is expected to triple by the year 2050.1 Advanced age is associated with an increased incidence of coronary heart disease, with patients presenting with both stable and unstable (acute coronary syndromes (ACS)) symptoms.2 ,3 Hence, cardiovascular disease is a leading cause of morbidity and mortality in older people, and increasingly, elderly patients are referred for revascularisation. As such, they represent an important high-risk subgroup of patients. Myocardial revascularisation is appropriate when the expected benefits, in terms of survival or health outcomes (symptoms, functional status and/or quality of life (QoL)), exceed the expected negative consequences of the procedure.4 However, revascularisation in this high-risk population is not without risk. It can often be a very difficult clinical decision whether or not an elderly patient should undergo attempted revascularisation, irrespective of the modality, whether that be by coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). Many have significant comorbid pathology, and previous studies have shown that octogenarians experience increased in-hospital complications and mortality relative to younger patients.3 ,5 To date, many revascularisation trials have focused on a younger patient demographic, with octogenarians often under-represented, and with varying definitions. Therefore, the existing evidence and guidelines that exist are often extrapolated from trial based on a younger patient population into this rapidly growing …

The Comparison of Bioactive-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome (BASE-ACS) trial demonstrated an outcome of titanium-nitride-oxide-coated bioactive stents (BAS) non-inferior to everolimus-eluting stents (EES) in patients presenting with acute coronary syndrome (ACS). We performed a post hoc analysis of the BASE-ACS trial in patients with, versus those without, preexisting vascular disease. We randomized 827 patients (1:1) presenting with ACS to receive either BAS or EES. The primary end point was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR). A total of 169 (20.4%) patients had preexisting vascular disease. Median follow-up was 5.0 years. The incidence of MACE was higher in patients with, versus those without, preexisting vascular disease (22.5% vs 13.5%, respectively, P = .004). This was driven by more frequent cardiac death and non-fatal MI (5.9% vs 2.4% and 11.8% vs 5.5%, P = .02 and P = .003, respectively). The rates of ischemia-driven TLR were comparable ( P > .05). All events were comparable between the 2 matched-pair subgroups ( P > .05 for all). In patients treated with early percutaneous coronary intervention for ACS, the long-term outcome was worse in patients with, versus those without, preexisting vascular disease.

BACKGROUND Second-generation drug eluting stents (DES) may reduce costs and improve clinical outcomes compared to first-generation DES with improved cost-effectiveness when compared to bare metal stents (BMS). We aimed to conduct an economic evaluation of a cobalt-chromium everolimus eluting stent (Co-Cr EES) compared with BMS in percutaneous coronary intervention (PCI). OBJECTIVE To conduct a cost-effectiveness analysis (CEA) of a cobalt-chromium everolimus eluting stent (Co-Cr EES) versus BMS in PCI. METHODS A Markov state transition model with a 2-year time horizon was applied from a US Medicare setting with patients undergoing PCI with Co-Cr EES or BMS. Baseline characteristics, treatment effects, and safety measures were taken from a patient level meta-analysis of 5 RCTs (n = 4,896). The base-case analysis evaluated stent-related outcomes; a secondary analysis considered the broader set of outcomes reported in the meta-analysis. RESULTS The base-case and secondary analyses reported an additional 0.018 and 0.013 quality-adjusted life years (QALYs) and cost savings of $236 and $288, respectively with Co-Cr EES versus BMS. Results were robust to sensitivity analyses and were most sensitive to the price of clopidogrel. In the probabilistic sensitivity analysis, Co-Cr EES was associated with a greater than 99% chance of being cost saving or cost effective (at a cost per QALY threshold of $50,000) versus BMS. CONCLUSIONS Using data from a recent patient level meta-analysis and contemporary cost data, this analysis found that PCI with Co-Cr EES is more effective and less costly than PCI with BMS. © 2016 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc.

Background Redo surgery for degenerative bioprosthetic aortic valves is associated with significant morbidity and mortality. Report results of valve-in-valve therapy (ViV-TAVI) in failed supra-annular stentless Freedom Solo (FS) bioprostheses, which are the highest risk for coronary occlusion. Methods Six patients with FS valves (mean age 78.5 years, 50% males). Five had valvular restenosis (peak gradient 87.2 mm Hg, valve area 0.63 cm2), one had severe regurgitation (AR). Median time to failure was 7 years. Results Patients were high risk (mean STS/Logistic EuroScore 10.6 15.8, respectively). FS valves ranged from 21 to 25 mm. Successful ViV-TAVI was achieved in 4/6 patients (67%). Of the unsuccessful cases, (patient 1 and 2 of series) patient 1 underwent BAV with simultaneous aortography which revealed left main stem occlusion. The procedure was stopped and the patient went forward for repeat surgery. Patient 2 underwent successful ViV-TAVI with a 26-mm CoreValve with a guide catheter in the left main, but on removal coronary obstruction occurred, necessitating valve snaring into the aorta. Among the successful cases, (patients 3, 4, 5, 6) the TAVIs used were CoreValve Evolut R 23 mm (n = 3), and Lotus 23 mm (n = 1). In the successful cases the peak gradient fell from 83.0 to 38.3 mm Hg. No patient was left with >1+ AR. One patient had a stroke on Day 2, with full neurological recovery. Two patients underwent semi-elective pacing for LBBB and PR >280 ms. Conclusions ViV-TAVI in stentless Freedom Solo valves is high risk. The risk of coronary occlusion is high. The smallest possible prosthesis (1:1 sizing) should be used, and strategies to protect the coronary vessels must be considered. © 2016 Wiley Periodicals, Inc.

Objectives This study sought to present the U.K. experience to date with the second-generation LOTUS bioprosthesis (Boston Scientific, Natick, Massachusetts). Background First-generation transcatheter aortic valves have limitations. Second-generation repositionable valves may improve on some of those limitations. Methods Prospectively collected data relating to procedural and in-hospital outcome was analyzed from 10 implantation centers in the United Kingdom. Results Implants in 228 patients age 81.4 ± 7.6 years were studied; 53.5% were male. Mean logistic EuroScore was 17.5 ± 12.4. One hundred eighty-seven (82.0%) were undertaken for aortic stenosis, 7 (3.1%) for aortic regurgitation, and 34 (14.9%) for mixed aortic valve disease. A total of 67.1% of cases were done under local anesthetic and/or sedation with transfemoral access in 94.7% and transaortic in 5.3%. Three device sizes were used: 23 mm (n = 66, 28.9%), 25 mm (n = 39, 17.1%), and 27 mm (n = 123, 53.9%). The valve was successfully deployed in 99.1% of procedures. After implantation, the mean aortic gradient was 11.4 ± 5.4 mm Hg and aortic valve area 1.6 ± 0.5 cm 2 . In-hospital mortality was 1.8% (n = 4). Complications included cardiac tamponade (1.8%), conversion to sternotomy (1.3%), stroke (3.9%), vascular access-related (7.0%), and acute kidney injury (7.9%). The incidence of moderate/severe aortic regurgitation was 0.8% (n = 2). A total of 31.8% of patients required new permanent pacemaker implantation. Conclusions This analysis represents the largest published series on use of the LOTUS valve. Outcomes using this valve are excellent. In-hospital mortality is very low. Complication rates are low, and the LOTUS valve improves on first-generation valves, particularly with regard to residual aortic regurgitation.

The BASE ACS trial demonstrated an outcome of titanium-nitride-oxide-coated bioactive stents (BAS) that was non-inferior to everolimus-eluting stents (EES) in patients with acute coronary syndrome (ACS). We performed a post-hoc analysis of diabetic versus non-diabetic patients from the trial.We randomised 827 patients (1:1) with ACS to receive either BAS or EES. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction (MI) or ischaemia-driven target lesion revascularisation (TLR). Follow-up was planned yearly through 7 years.Of 827 patients, 140 (16.9%) were diabetic; of these, 36 (25.7%) were insulin-treated. Mean follow-up duration was 4.2 ± 1.9 years. MACE was more frequent in diabetics versus non-diabetics (23.6% versus 13.7%, respectively, p = 0.003), mainly driven by more frequent cardiac death (7.9% versus 2.2%, respectively, p = 0.002). The rates of non-fatal MI, ischaemia-driven TLR were comparable (p 0.05 for all). In diabetic patients, MACE was comparable between the two stent arms (18.5% versus 28.0%, for BAS versus EES, respectively, p = 0.18).Diabetic patients treated with early percutaneous coronary intervention for ACS had worse long-term outcome, compared with non-diabetics, mainly driven by more frequent cardiac death. The long-term outcome of BAS was comparable to EES in diabetics. Key Messages Diabetic patients presenting with acute coronary syndrome who were treated with early percutaneous coronary intervention had worse long-term clinical outcome, compared with non-diabetics, mainly driven by a high incidence of cardiac death. Age independently predicted both major adverse cardiac events and cardiac death in diabetic patients. The long-term clinical outcome of titanium-nitride-oxide-coated bioactive stents was comparable to that of everolimus-eluting stents in the diabetic, as well as in the non-diabetic subgroup.

The BASE-ACS trial demonstrated non-inferiority of titanium-nitride-oxide-coated bioactive stents (BAS), versus everolimus-eluting stents (EES), for major adverse cardiac events (MACE) at 1- and 2-year follow-up, in patients with acute coronary syndrome (ACS). We presented the 4-year outcome of the BASE-ACS trial.We randomized 827 patients with ACS to receive either BAS (417) or EES (410). MACE was a composite of cardiac death, non-fatal myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR) at 12-month follow-up. Analyses were performed by intention to treat. Follow-up was planned at 12 months, and yearly thereafter for 5 years.Four-year clinical follow-up was completed in 753 (91.1%) patients. At 4 years, BAS were non-inferior to EES for MACE (14.7% versus 17.8%, respectively; p = 0.24 for superiority; p = 0.001 for non-inferiority). Non-fatal MI was less frequent with BAS (5.0% versus 9.2%, respectively; p = 0.025). Cardiac death and ischemia-driven TLR were comparable (2.9% versus 3.5%, and 8.6% versus 9.2%; p = 0.62 and p = 0.80, respectively). Independent predictors of MACE were calcified lesions (HR 1.54, p = 0.021), the number of vessels treated (HR 1.53, p = 0.025), and reference vessel diameter (HR 0.54, p = 0.006).In patients presenting with ACS, BAS was associated with a clinical outcome non-inferior to EES at 4-year follow-up.

As many people are living longer, much older patients are now commonly being seen in clinical practice. The management of coronary disease in this group presents formidable challenges. We review the epidemiology of coronary disease in this population and report on the burden of comorbidity, influence of frailty, problems with polypharmacy, interactions and compliance for the older patient. We discuss the management of stable and acute coronary syndromes, the specific anatomical challenges of the older coronary artery, the outcomes of the limited number of trials involving older patients, and review the guidelines available.

Rotational atherectomy (RA) or rotablation is a highly specialized technique used to treat coronary atherosclerosis. A diamond/nickel-coated burr rotating at high speeds driven by compressed air allows vessel modification and ablates atherosclerotic plaque. The burr pulverizes calcific tissue to particulate matter, smaller than red blood cells, which are then processed by the reticulo-endothelial system. RA was developed to complement balloon-only angioplasty, which suffered significant restenosis rates. RA use was rationalized for debulking lesions, although not particularly selective regarding their complexity, but no clinical benefit was found using this approach. RA was rapidly recognized as an excellent tool for dealing with calcified plaques but, unfortunately, restenosis rates persisted with the use of bare-metal stents. The development of drug-eluting stents to tackle restenosis has contributed to the re-emergence and rising popularity of RA. When correctly used with modern techniques and appropriate training, RA offers a powerful tool in the arsenal against calcified disease, offering similar complication rates as conventional angioplasty. There has been an increase in demand for RA as the aging population is presenting with mature calcified coronary disease. RA offers a less invasive approach than coronary artery bypass graft surgery for treating these patients.

Vaccinations, nutritional and medical advances have increased the longevity of life—the proportion of octogenarians is expected to triple by 2050. This has opened a new chapter in clinical cardiology—angina management of the very elderly is now daily clinical fodder. Nearly a quarter of the patients presenting with acute coronary syndromes (ACS) and undergoing angiography will have diabetes mellitus (DM). With the advent of poor lifestyle choices such as unhealthy diets and reduction in exercise, DM is likely to increase further. Chronic kidney disease (CKD), defined as an estimated glomerular filtration rate (eGFR)

Background Surgical risk scoring systems are poor at predicting outcome in patients undergoing transcatheter aortic valve implantation (TAVI). Frailty indices might more accurately predict outcome. Aims: To examine multiple frailty indices as markers of performance to see whether they predict outcomes both in the shorter (30 days) and longer terms (5 years) in patients who have undergone TAVI. Methods Frailty indices (Mobility; Brighton Mobility Index, New York Heart Association (NYHA), Karnofsky Performance Index, Canadian Study Health Association (CSHA) clinical frailty scale, and Katz Index of Dependence) were assessed in 312 consecutive TAVI patients. Mortality tracking was obtained from the Office of National Statistics as of May 2014. Results Mean age was 81.2 ± 7.0 years; 53.2% were male. Mean Logistic EuroSCORE and STS were 17.4 ± 9.4 and 4.6 ± 2.8, respectively. Mean peak aortic valve gradient and aortic valve area were 79.1 ± 28.0 mm Hg and 0.72 ± 0.25 cm2, respectively. 30-day mortality was 4.8%; long-term mortality (maximum 5.8 years, mean 2.2 ± 1.5 years) was 25.3%. Both univariate and multivariate analyses confirmed poor mobility (defined as severe impairment of mobility secondary to musculoskeletal or neurological dysfunction (Euroscore II risk)), as the best predictor of adverse outcome over both the short-term (OR 4.03, 95% CI (1.36–11.96), P = 0.012 (30 days)) and longer term (OR 2.15, 95% CI (1.33–3.48), P = 0.002, (2.2 ± 1.5 years.)). Conclusion Poor mobility predicts worse survival among patients undergoing TAVI, both in the shorter and longer terms. Our data suggest that mobility impairment, of either neurological or musculoskeletal etiology, is an appropriate screening measure when considering patients for TAVI. © 2015 Wiley Periodicals, Inc.

Percutaneous coronary intervention is currently the most common form of revascularization for symptomatic coronary artery disease. In elderly, diabetic and renal patients, there is an increased prevalence of calcified coronary disease. Rotational atherectomy (RA) can be useful in the treatment of these lesions.Plaque removal was initially proposed as an alternative to balloon angioplasty, hence RA required high-velocity protocols with large-sized burrs (over 2.0 mm). With a high incidence of acute complications and disappointing restenosis rates, the use of RA dwindled. However, the advent of drug-eluting stents, which significantly decreased the rate of restenosis, led to the repositioning of RA as an adjunctive technique in the preparation of densely calcified lesions, improving stent delivery and expansion.In recent years, a better understanding of the mechanism of action of RA has changed it from a plaque debulking to a compliance modifying technique. As a result, RA has become less aggressive, using smaller size burrs and lower rotational speeds. This conservative approach has improved immediate results, with increased safety and better long-term outcomes.In this review paper, the technique of RA is explained in the light of current knowledge. Resumo: A angioplastia coronária tornou-se a forma mais habitual de revascularização miocárdica na doença coronária sintomática. Na população mais idosa, nos diabéticos e nos doentes com insuficiência renal crónica, a prevalência de lesões calcificadas tende a aumentar. A aterectomia rotacional (AR) é uma técnica de grande utilidade no tratamento destas situações.Tendo-se considerado inicialmente que a erosão da placa podia constituir uma alternativa à angioplastia de balão, a técnica de aterectomia rotacional utilizava protocolos de alta velocidade com olivas que ultrapassavam os 2,0 mm de diâmetro. A ocorrência de complicações agudas e resultados insuficientes a longo prazo limitaram a sua difusão. O aparecimento dos stents com fármaco com redução significativa das taxas de reestenose, levou ao reposicionamento da aterectomia rotacional como técnica adjuvante na preparação das lesões permitindo uma melhor entrega e expansão dos stents, no contexto de doença aterosclerótica calcificada.Nos últimos anos, tem-se assistido a uma melhor compreensão do mecanismo de acção da aterectomia rotacional que passou de debulking para modificação de compliance da placa. Consequentemente, a técnica tem-se tornado menos agressiva: utilizam-se olivas de menor calibre, com menor velocidade de rotação, alcançando-se elevadas taxas de sucesso e de segurança no procedimento.Neste artigo procuramos reunir o conhecimento atual sobre como executar a técnica de aterectomia rotacional. Keywords: Rotational atherectomy, Rotational atherectomy technique, Percutaneous coronary intervention, Coronary calcification, Palavras-chave: Aterectomia rotacional, Técnica de aterectomia rotacional, Intervenção coronária percutânea, Calcificação coronária

The interest in rotational atherectomy (RA) has increased over the past decade as a consequence of more complex and calcified coronary stenoses being attempted with percutaneous coronary interventions. Yet adoption of RA is hampered by several factors: amongst others, by the lack of a standardised protocol. This European expert consensus document stems from the awareness of the large heterogeneity in the protocols adopted to perform rotational atherectomy. The objective of the present document is to provide some points of consensus among highly experienced operators on the most controversial steps of RA in an attempt to build the basis of a standardised and universally accepted protocol. © Europa Digital & Publishing 2015. All rights reserved.

Aims The aim of this registry was to monitor practice patterns and outcomes in patients treated with Absorb bioresorbable vascular scaffolds (BVS) during the early phase of usage in the UK. Methods and results A total of 1,005 patients with de novo coronary lesions were treated using careful implantation techniques at 24 centres. Follow-up at one year was obtained in 99%. An independent clinical events committee and angiographic core lab adjudicated all events. Patient age was 52 years and 46% presented with acute coronary syndromes. Lesion complexity was B2/C in 47.4%, with an average of 1.4±0.6 BVS implanted and a BVS length of 28±14.3 mm. A single BVS was implanted in 71.3%. High pressure post-dilatation was performed in 94.9%, with 50% using intravascular imaging. Device success was achieved in 98.7% and procedure success in 97.3% of patients. At one year, the device-oriented endpoint target lesion failure was 3.2%, and the patient-oriented endpoint major adverse cardiac events was 3.4%. Definite ST occurred in 1.4%. By multivariable analysis, scaffold size of 2.5 mm predicted ST at one year (OR 3.27, 95% CI: 1.28-8.37; p=0.014). Conclusions With careful patient selection and technique, TLF rates following BVS implantation in real-world practice are comparable with contemporary drug-eluting stents. ST rates remain high, with small vessel size identified as a contributory factor.

Learning objectives The generation of mineralised matrix within arterial conduits is common (see Figure 1). About 10%–20% of atherosclerotic vessels contain architecturally complete trabecular bone with fully formed marrow cavities with haematopoietic cells and vascular sinusoids. Although it is recognised that bone formation and arterial vessel calcification have common biochemical pathways, this so-called vascular calcification is a complex and incompletely understood phenomenon, which has proved difficult to prevent and treat.1 The process of extraskeletal ossification is not unlike embryonic ossification pathways which can be triggered by a variety of metabolic, inflammatory and genetic factors. For example, it is likely that proteins that normally restrict biomineralisation to skeletal bone are diminished (eg, fetuin A, matrix GIa, among others), and raise the prospect of identifying targets for therapeutic intervention. The two types of calcification—atherosclerotic (intimal calcification) and medial artery calcification—have different mechanisms, but both affect arterial stiffness and physiology, and increase the risk of adverse cardiovascular events.2 Figure 1 Three-dimensional reconstruction showing extensive aortic and coronary calcification (image courtesy of Dr V Parish). ### Vascular calcification: therapeutic targets Vascular calcification is more common with ageing, patients with diabetes mellitus, hypertension, renal dysfunction, hypercalcaemia and hyperphosphataemia, but can occur in patients without any of these characteristics. Patients with a high calcium diet do not have an increased risk of coronary calcification, suggesting that the pathogenesis lies in dysfunctional regulatory pathways. There is a substantial literature on the potential genetic and acquired mechanisms for this process, but specific mechanisms leading to therapeutic prevention have proved elusive. For example, small studies using statins, calcium blockers, hormonal therapies, phosphate …

Background Chronic total occlusion (CTO) is common, being reported in 18% to 30% of patients undergoing coronary angiography. Percutaneous coronary intervention (PCI) is usually performed to relieve anginal symptoms, but data are emerging to suggest that there may also be a mortality benefit. Objectives This study aimed to compare outcomes of patients with successful versus unsuccessful PCI to a CTO. Methods We analyzed the U.K. Central Cardiac Audit Database for all CTO PCI cases carried out in England and Wales between January 1, 2005, and December 31, 2009. Vital status in September 2010 was obtained from the Medical Research Information Service. Results A total of 13,443 patients (78.8% male) had a mean age of 63.5 years and underwent 14,439 CTO procedures. CTO PCI was successful in 10,199 cases (70.6%). During follow-up of 2.65 years (interquartile range: 1.59 to 3.83 years), successful PCI of at least 1 CTO was associated with improved survival (hazard ratio [HR]: 0.72; 95% CI: 0.62 to 0.83; p Conclusions Successful CTO PCI was associated with improved long-term survival. The improvement was greatest in patients when complete revascularization was achieved. The identity of the successfully treated occluded vessel was not associated with differences in outcome.

Introduction Duration of dual antiplatelet therapy (DAPT) following drug eluting stent (DES) implantation remains poorly defined. Endothelialisation of biodegradable polymer biolimus-eluting stents occurs early, and 6 months DAPT may be adequate. Aims We evaluated long term outcome in patients treated with biolimus-eluting stents who were treated with 6 months DAPT. Endpoints included cardiac death and non-fatal stent thrombosis occurring 6 to 12 months after stent implantation. Methods 692 patients (77.2% male), aged 65.6±12.5years received biolimus-eluting DES (March 2008 –November 2011). Vital status was tracked through the Medical Research Information Service. Episodes of non-fatal stent thrombosis, (Academic Research Consortium definition) between months 6 and 12 were tracked via systematic database searches (5 PCI centres). Results Presentations included acute coronary syndrome (47.2%) and stable coronary disease (52.8%). Vessels treated included left main stem (6.8%), left anterior descending (37.4%), circumflex (19.1%), right coronary artery (34.5%) and saphenous vein graft (2.1%) respectively. High-risk subsets included diabetes (15.6%); AHA type C lesions (35.1%) and chronic total occlusions (12.8%). During median follow-up of 700 days (0 to 1392) there were 42 deaths (6.1%); 4.2% at 0–6months, 1.0% at 6–12months and 0.9% at >12months. Of the 7 deaths between 6 and 12months, one death was adjudicated as possible stent thrombosis. There were no cases of non-fatal known stent thrombosis. All cause mortality accrued with smooth decremental incidence. Statistical examination showed no evidence of event clustering between 6 and 12 months. Conclusions After implantation of biodegradable polymer biolimus-eluting coronary stents, 6 months DAPT appears to be adequate, safe and effective.

Rotational atherectomy (RA) is widely used for treating calcified coronary lesions. Clinical data however remain limited.We assessed outcome and survival among patients undergoing percutaneous coronary intervention (PCI) with or without RA in the UK between September 2007 and March 2011.Data from 221,669 percutaneous coronary intervention (PCI) procedures were analysed; 2152 patients (0.97%) underwent RA (RA+); the remainder underwent conventional PCI (RA-). RA+ patients were older (71.7±9.6 vs. 64.1±12.8 year; p0.001), and had a higher incidence of diabetes (26.4% vs. 18.0%; p0.001), hypertension, (61.9% vs. 49.4%; p0.001), peripheral vascular disease (9.9% vs. 4.2%, p0.001), cerebrovascular disease (5.5% vs. 3.4%, p0.001), renal impairment (3.4% vs. 1.5%, p0.001) and poor left ventricular function (11.4% vs. 4.3%,p0.001). Procedural success was lower among RA+ patients (90.3% vs 94.6%; p0.001) and procedural complications were more frequent (9.7% vs 5.4%; p0.001). After 2.4±1.2 years follow-up, unadjusted Cox proportional hazard modeling demonstrated poorer survival for RA+ patients (HR 2.21, 95%CI 1.97-2.49; p0.0001). This disadvantage remained after adjustment for adverse variables (HR 1.26, 95%CI 1.11-1.44; p=0.0004) and following propensity analysis. There was evidence however of improved survival for RA+ patients with left main stem disease (HR 0.52, 95%CI 0.35-0.75, p0.0001), and peripheral vascular disease (HR 0.65, 95%CI 0.43-0.98, p0.0005).Rotational atherectomy was undertaken in patients with higher pre-procedural risk. Medium term survival was worse among patients undergoing rotational atherectomy, and this survival disadvantage remained after correction for available adverse factors. Rotational atherectomy however remains clinically useful for patients with calcified coronary lesions.

Background New-generation drug-eluting stents (DES) have mostly been investigated in head-to-head non-inferiority trials against early-generation DES and have typically shown similar efficacy and superior safety. How the safety profile of new-generation DES compares with that of bare-metal stents (BMS) is less clear. Methods We did an individual patient data meta-analysis of randomised clinical trials to compare outcomes afterimplantation of new-generation DES or BMS among patients undergoing percutaneous coronary intervention. The primary outcome was the composite of cardiac death or myocardial infarction. Data were pooled in a one-stage random-effects meta-analysis and examined at maximum follow-up and a 1-year landmark. Risk estimates are reported as hazard ratios (HRs) with 95% CIs. This study is registered in PROSPERO, number CRD42017060520. Findings We obtained individual data for 26616 patients in 20 randomised trials. Mean follow-up was 3·2 (SD 1·8)years. The risk of the primary outcome was reduced in DES recipients compared with BMS recipients (HR 0·84,95% CI 0·78–0·90, p

Introduction Percutaneous coronary intervention (PCI) has historically required cardiothoracic backup in the event of ischemic complications. However, many complications occurring during PCI can now be effectively treated at the time of the indexed procedure. Equally, ischemic complications, which occur following coronary artery bypass grafting (CABG), which were previously treated medically or with reoperation, may now also be effectively treated by acute PCI. Aims and Methods To identify the rate, cause, treatment, and outcomes of ischemic complications from PCI or isolated CABG procedures undertaken from January 2004 to January 2011 where there was immediate crossover from PCI to CABG or vice versa, and to determine from the indexed revascularization procedure, whether or not the ischemic complications were rectified by either CABG with respect to PCI or PCI with respect to CABG. Results Three hundred fifty-six PCI major ischemic complications were identified. Three hundred forty-seven (97.5%) were rectified percutaneously and 9 (2.5%) required emergency CABG. The commonest reason for emergency CABG was occlusive dissection (n = 7). Of the 9 patients that underwent emergency CABG, 3 patients (33.3%) died. Forty CABG major ischemic complications were identified. Twenty-seven (67.5%) were treated medically. Thirteen (32.5%) underwent diagnostic angiography. The etiology of the ischemia was found in all cases. Consequently, 2 underwent reoperation, one was treated medically, and 10 underwent acute PCI. Conclusion Acute coronary ischemia remains a small but significant complication of both PCI and CABG. Resolution of ischemia requires prompt diagnosis and early discussion between cardiothoracic surgeon and cardiac interventionalist to determine the safest and therefore most appropriate way to resolve the problem.

Objectives This study sought to assess the impact of coronary bifurcation stenting on health-related functional status, using the Seattle Angina Questionnaire (SAQ), for participants in the BBC ONE (British Bifurcation Coronary; Old, New, and Evolving Strategies) trial and to compare simple versus complex bifurcation stenting strategies in this regard. Background Large randomized studies have examined outcomes from bifurcation stenting with drug-eluting stents. They have reported on major adverse cardiovascular events and angiographic follow-up. However, a principal goal of percutaneous coronary intervention is symptom control and improvement in quality of life, yet there are no published data from these trials on this aspect. Furthermore, it is unknown whether simple versus complex stenting strategies have different effects on angina control and quality of life. Methods The BBC ONE study randomized 500 subjects to bifurcation stenting using either a simple (provisional T) or complex (crush or culotte) approach. Subjects completed the SAQ at baseline and at 9 months after percutaneous coronary intervention. Canadian Cardiovascular Society class and antianginal drug use were also evaluated. Results Bifurcation stenting was associated with significant improvements on SAQ scales and in Canadian Cardiovascular Society class (baseline: 5.3% subjects were class 0; follow-up: 64.0% were class 0; p Conclusions Regardless of chosen strategy, bifurcation stenting produced significant functional improvements in angina-related health. No significant difference between simple and complex strategies was found in this regard.

Objectives: We sought to characterize UK-wide balloon aortic valvuloplasty (BAV) experience in the TAVI era. Background: BAV for acquired calcific aortic stenosis is in a phase of renaissance, largely due to the development of transcatheter aortic valve implantation (TAVI). Methods: Data from 423 patients at 14 centers across the UK were analyzed. Results: Patients were aged 80.9 6 9.5 years; 52.5% were male. Mean logistic EuroScore was 27.3% 6 16.8%. Mean peak transaortic gradient fell from 62.0 6 26.3 to 28.3 6 16.2 mm Hg. Aortic valve area increased from 0.58 6 0.19 to 0.80 6 0.25 cm 2 echocardiographically. Procedural complication rate was 6.3%, comprising death (2.4%), blood transfusion � 2 U (1.2%), cardiac tamponade (1.0%), stroke (1.0%), vascular surgical repair (1.0%), coronary embolism (0.5%), and permanent pacemaker (0.2%). Mortality was 13.8% at 30 days and 36.3% at 12 months. Subsequently, 18.3% of patients underwent TAVI and 7.0% sAVR, with improved survival compared to those who had no further intervention (logrank < 0.0001). Multivariate Cox proportional hazard analysis demonstrated that survival was adversely effected by the presence of coronary artery disease (HR 1.53, 95%CI 1.08‐2.17, P 5 0.018), poor LV function (HR 1.54, 95%CI 1.09‐2.16, P 5 0.014), and either urgent (HR 1.70, 95%CI 1.18‐2.45; P 5 0.004) or emergent presentation (HR 3.72, 95%CI 2.27‐6.08; P < 0.0001). Conclusion: Balloon aortic valvuloplasty offers good immediate hemodynamic efficacy at an acceptable risk of major complications. Medium-term prognosis is poor in the absence of definitive therapy. V C 2013 Wiley Periodicals, Inc.

The BASE ACS randomized trial demonstrated non-inferiority of titanium-nitride-oxide-coated bioactive stents (BAS), compared with everolimus-eluting stents (EES), for the primary endpoint of major adverse cardiac events (MACE) in patients presenting with acute coronary syndrome (ACS) at 12-month follow-up. We report the final long-term clinical outcome of the trial.We randomly assigned 827 patients with ACS to receive either BAS (417) or EES (410). The primary endpoint was MACE: a composite of cardiac death, non-fatal myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR) at 12-month follow-up. Analysis was performed by intention to treat. Follow-up was planned at 12months, and yearly thereafter through 7years.Mean follow-up duration was 4.2±1.9years (median 5.0years). At 5-year follow-up, BAS was non-inferior to EES for the primary endpoint of MACE (14.4% versus 17.8%, respectively; hazard ratio for BAS versus EES, 0.82; 95% confidence interval, 0.58-1.16; p=0.26 for superiority; p0.001 for non-inferiority). The rate of non-fatal MI was lower in the BAS group (5.9% versus 9.7%, respectively, p=0.028). The rates of cardiac death and ischemia-driven TLR were comparable (2.8% versus 3.8%, and 8.3% versus 9.9%; p=0.76 and p=0.58, respectively).In the current final report of the randomized BASE ACS trial in patients with ACS, BAS implantation was associated with a rate of cumulative MACE at long-term follow-up that was statistically non-inferior to EES.

Background Surgical risk scoring systems are of modest value in predicting outcome following transcatheter aortic valve implantation (TAVI). There is no consensus as to which scoring system is the most useful. We examined the efficacy of all four currently available global scorings systems (Additive EuroScore [aES], Logistic EuroScore [LES], EuroScore II [ES II], Society of Thoracic Surgeons [STS] Score) in predicting outcome, both in the short (30 day) and longer term, in patients undergoing TAVI. Methods Additive EuroScore (aES), Logistic EuroScore (LES), EuroScore II (ES II), and Society of Thoracic Surgeons (STS) score were assessed in 312 consecutive TAVI patients. Mortality tracking was obtained from the Office of National Statistics as of May 2014. Results Mean age was 81.2±7.0 years; 53.2% were male. Mean aES, LES, ESII and STS were 9.7±1.9, 17.4±9.4, 6.1±4.3 and 4.6±2.8, respectively. Thirty-day mortality was 4.8%; long-term mortality (maximum 5.8 years, mean 2.2±1.5 years) was 25.3%. Using both univariate and multivariate modelling all four scoring systems failed to predict outcomes in the short term. In the longer term, univariable analysis demonstrated that higher aES and LES scores were associated with higher mortality (aES P=0.0048, LES P=0.054, respectively). After multivariable analysis, only higher aES remained significant. Conclusions Surgical risk scores are poor at predicting outcomes in patients undergoing TAVI, particularly in the short term.

AIMS: Randomized trials of coronary bifurcation stenting have shown better outcomes from a simple (provisional) strategy rather than a complex (planned two-stent) strategy in terms of short-term efficacy and safety. Here, we report the 5-year all-cause mortality based on pooled patient-level data from two large bifurcation coronary stenting trials with similar methodology: the Nordic Bifurcation Study (NORDIC I) and the British Bifurcation Coronary Study: old, new, and evolving strategies (BBC ONE).METHODS AND RESULTS: Both multicentre randomized trials compared simple (provisional T-stenting) vs. complex (culotte, crush, and T-stenting) techniques, using drug-eluting stents. We analysed all-cause death at 5 years. Data were collected from phone follow-up, hospital records, and national mortality tracking. Follow-up was complete for 890 out of 913 patients (97%). Both Simple and Complex groups were similar in terms of patient and lesion characteristics. Five-year mortality was lower among patients who underwent a simple strategy rather than a complex strategy [17 patients (3.8%) vs. 31 patients (7.0%); P = 0.04].CONCLUSION: For coronary bifurcation lesions, a provisional single-stent approach appears to be associated with lower long-term mortality than a systematic dual stenting technique.

Introduction: An optimal fluoroscopic working view projection (OP) with all three aortic sinuses aligned is crucial during trans-catheter aortic valve implantation (TAVI). The aim of this study was to identify simple reference projection angles, which would act as a starting point for the operator to help determine OP for patients undergoing TAVI. Methods: During the period under consideration, 50 patients underwent TAVI. Procedural data and outcomes were collected prospectively on a dedicated database. Optimal angiographic deployment angles were achieved for all patients by starting in an anteroposterior caudal 15 degrees projection and then adjusting according to the initial image, with multiple small volume contrast injections undertaken to determine when all three aortic cusps were aligned (OP). Results: OP angles for the 50 cases were plotted on a graph. After normality testing confirmed that all angles were normally distributed, regression analysis enabled a regression line to be calculated. The equation for the regression line was defined as cranial/caudal intercept −16.4 ± 1.5 (SE of the coefficient), P < 0.0001, slope of regression line LAO/RAO + 0.53 ± 0.1 (SE of the coefficient SE), P < 0.0001). Conclusions: As the regression line and its equation represents an acceptable estimate of the true relationship between Cranial/Caudal and LAO/RAO, to determine OP while remaining close to the regression line we suggest starting in LAO = 8.9, Caudal = −11.4 (which represent the mean values of these two variables), and then increasing the caudal angle by approximately 0.5 degrees for every increase of 1 degree of the LAO angle or decreasing the caudal angle by 0.53 degrees for every decrease of 1 degree in LAO until all three aortic sinuses are in line which represents OP. © 2012 Wiley Periodicals, Inc.

Background Periprocedural myocardial infarction (PMI; ESC/ACC type 4a) is diagnosed on the basis of elevation of cardiac enzymes more than three times the 99th centile upper reference limit. Recent guidelines recommend the use of troponin instead of creatine kinase (CK) to diagnose PMI, but this assay increases diagnostic sensitivity, while the clinical significance of small increases in troponin remains undetermined. We examined the effects of using the new definition on the incidence of a composite endpoint (previously defined by CK) in a contemporary clinical randomised trial—the British Bifurcation Coronary Study (BBC ONE). Methods The BBC ONE trial randomly allocated 500 patients with coronary bifurcation lesions to either a simple or complex stenting strategy. The composite primary endpoint (CPEP) included death, myocardial infarction (MI) (PMI plus subsequent MI) and target vessel failure, at 9 months. Results In BBC ONE the CPEP occurred in 8% versus 15.2% in the simple and complex groups, respectively (HR 2.02, 95% CI 1.17 to 3.47, p=0.009). This difference was largely driven by PMI, which occurred in nine (3.6%) versus 28 (11.2%) patients (HR 3.24, 95% CI 1.53 to 6.86, p=0.001). Using troponin, PMI would have occurred in 71 (28.4%) versus 114 (45.6%) patients, respectively (HR 1.61, 95% CI 1.27 to 2.05, p=0.001), and the CPEP in 32% versus 48% of patients (HR 1.50, 95% CI 1.2 to 1.87, p=0.001). Use of troponin increased MI detection fivefold, from 7.4% to 37.0% overall. Conclusions Use of troponin would have led to a fivefold increase in diagnosis of PMI in the BBC ONE trial. Incorporation of PMI into a composite endpoint may no longer be justified in many interventional trials.

Transcatheter aortic valve implantation (TAVI) is an effective way to treat patients with symptomatic aortic stenosis when open surgical repair is not feasible or considered too high risk. Large bore vascular access is required (18F–24F), and successful management of this arterial access is the key to overall procedural success. We review the current state of play with regard to vascular closure following retrograde transfemoral TAVI. (J Interven Cardiol 2012;25:526–532)

Background: : Percutaneous aortic valve treatments, balloon aortic valvuloplasty (BAV) and transcatheter aortic valve implantation (TAVI), are effective ways to treat patients with symptomatic aortic stenosis when open surgical repair is not feasible or considered too high risk. Large bore vascular access is required, and successful management of this arterial access is key to overall procedural success. We report outcomes and complications using the Prostar vascular closure device following BAV and TAVI. Methods: : During the period under consideration, 54 patients underwent BAV and 64 patients underwent TAVI (n = 118). Procedural data and outcomes were collected prospectively on a dedicated database. Results: : Patients were aged 80 ± 6.9 years (BAV) and 80.8 ± 6.1 years (TAVI) and 46.2% (BAV) and 46.8% (TAVI) were male, respectively. Primary success (hemostasis achieved immediately after deployment of the Prostar system on the table and persisting for a minimum of 24 hr in the absence of major or minor bleeding complications) was achieved in 94.4% (n = 54) of the patients undergoing BAV and 92.2% (n = 64) of the patients undergoing TAVI, respectively. The combined success rate was 93.3%. Major bleeding (see definitions section) was seen in 1.9% of cases in the BAV group and 4.7% of cases in the TAVI group. Minor bleeding (see definitions section) was seen in 3.7% of cases in the BAV group and 3.1% of cases in the TAVI group. Conclusions: : Use of the Prostar vascular closure system to achieve hemostasis following percutaneous aortic valve interventions is associated with a high primary success rate and acceptable level of bleeding complications. © 2011 Wiley Periodicals, Inc

The international, randomized EXCEL trial reported similar 3-year rates of the primary endpoint of death, stroke or MI after PCI with everolimus-eluting stents vs. CABG in pts with left main coronary artery disease (LMCAD) and low or intermediate SYNTAX scores. Whether geographical differences in