Terry Levy

Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial

BACKGROUNDnSymptomatic relief is the primary goal of percutaneous coronary intervention (PCI) in stable angina and is commonly observed clinically. However, there is no evidence from blinded, placebo-controlled randomised trials to show its efficacy.nnnMETHODSnORBITA is a blinded, multicentre randomised trial of PCI versus a placebo procedure for angina relief that was done at five study sites in the UK. We enrolled patients with severe (≥70%) single-vessel stenoses. After enrolment, patients received 6 weeks of medication optimisation. Patients then had pre-randomisation assessments with cardiopulmonary exercise testing, symptom questionnaires, and dobutamine stress echocardiography. Patients were randomised 1:1 to undergo PCI or a placebo procedure by use of an automated online randomisation tool. After 6 weeks of follow-up, the assessments done before randomisation were repeated at the final assessment. The primary endpoint was difference in exercise time increment between groups. All analyses were based on the intention-to-treat principle and the study population contained all participants who underwent randomisation. This study is registered with ClinicalTrials.gov, number NCT02062593.nnnFINDINGSnORBITA enrolled 230 patients with ischaemic symptoms. After the medication optimisation phase and between Jan 6, 2014, and Aug 11, 2017, 200 patients underwent randomisation, with 105 patients assigned PCI and 95 assigned the placebo procedure. Lesions had mean area stenosis of 84·4% (SD 10·2), fractional flow reserve of 0·69 (0·16), and instantaneous wave-free ratio of 0·76 (0·22). There was no significant difference in the primary endpoint of exercise time increment between groups (PCI minus placebo 16·6 s, 95% CI -8·9 to 42·0, p=0·200). There were no deaths. Serious adverse events included four pressure-wire related complications in the placebo group, which required PCI, and five major bleeding events, including two in the PCI group and three in the placebo group.nnnINTERPRETATIONnIn patients with medically treated angina and severe coronary stenosis, PCI did not increase exercise time by more than the effect of a placebo procedure. The efficacy of invasive procedures can be assessed with a placebo control, as is standard for pharmacotherapy.nnnFUNDINGnNIHR Imperial Biomedical Research Centre, Foundation for Circulatory Health, Imperial College Healthcare Charity, Philips Volcano, NIHR Barts Biomedical Research Centre.

Myocardial iron loading by magnetic resonance imaging T2* in good prognostic myelodysplastic syndrome patients on long‐term blood transfusions

Magnetic resonance imaging (MRI) was used to quantify myocardial iron loading by T2* in 11 transfusion‐dependent good prognostic myelodysplastic syndrome (MDS) patients. Myocardial T2*, left ventricular function and hepatic T2* were measured simultaneously. Patients had been on transfusion therapy for 13–123u2003months and had serum ferritin levels of 1109–6148u2003μg/l at the time of study. Five patients had not commenced iron chelation and had been transfused with a median of 63 red cell units and had a median serum ferritin level of 1490u2003μg/l. Six patients were on iron chelation and had been transfused with a median of 112 red cell units and had a median serum ferritin level of 4809u2003μg/l. Hepatic iron overload was mild in two, moderate in seven and severe in two patients. The median liver iron concentration was 5·9u2003mg/g dry weight in chelated patients and 9·5u2003mg/g in non‐chelated patients (Pu2003=u20030·17; not significant). Myocardial T2* indicated absent iron loading in 10/11 patients (91%; 95% confidence interval 62–98%) and borderline‐normal in one patient. Left ventricular function was normal in all patients. No correlation was observed between increasing serum ferritin levels, hepatic iron overload and myocardial T2*. A long latent period relative to hepatic iron loading appears to predate the development of myocardial iron loading in transfusion‐dependent MDS patients.

Beyond the balloon: excimer coronary laser atherectomy used alone or in combination with rotational atherectomy in the treatment of chronic total occlusions, non-crossable and non-expansible coronary lesions.

AIMSnTo establish success and complication rates of excimer laser coronary atherectomy (ELCA) in a contemporary series of patients with balloon failure during percutaneous coronary intervention (PCI) of both chronic total occlusions (CTO) and lesions with distal TIMI 3 flow.nnnMETHODS AND RESULTSnWe identified 58 cases of balloon failure treated with ELCA±rotational atherectomy (RA) over four years, representing 0.84% of all PCI performed in our centre during this period. Balloon failures were classified according to: (i) mechanism of balloon failure; and (ii) whether this occurred in the context of treating a CTO. ELCA was performed following balloon failure using the CVX-300 Excimer Laser System and a 0.9 mm catheter with saline flush. For the entire cohort, procedure success was achieved in 91% (with ELCA successful: alone in 76.1%, after RA failure in 6.8% and in combination with RA for 8.6%). Only in one case did RA succeed where ELCA had failed. There were four procedure-related complications, including transient no-reflow, side branch occlusion and two coronary perforations, of which one was directly attributable to ELCA and led to subsequent mortality.nnnCONCLUSIONSnELCA provides safe and effective adjunctive therapy in contemporary PCI to treat lesions associated with balloon failure due to an inability either to cross the lesion or to expand a balloon sufficiently to permit stenting. ELCA was successful in the majority of these selected cases when used independently with further effectiveness achieved when combined with RA or after RA failure.

Renal artery sympathetic denervation: observations from the UK experience

BackgroundRenal denervation (RDN) may lower blood pressure (BP); however, it is unclear whether medication changes may be confounding results. Furthermore, limited data exist on pattern of ambulatory blood pressure (ABP) response—particularly in those prescribed aldosterone antagonists at the time of RDN.MethodsWe examined all patients treated with RDN for treatment-resistant hypertension in 18 UK centres.ResultsResults from 253 patients treated with five technologies are shown. Pre-procedural mean office BP (OBP) was 185/102xa0mmHg (SD 26/19; nxa0=xa0253) and mean daytime ABP was 170/98xa0mmHg (SD 22/16; nxa0=xa0186). Median number of antihypertensive drugs was 5.0: 96xa0% ACEi/ARB; 86xa0% thiazide/loop diuretic and 55xa0% aldosterone antagonist. OBP, available in 90xa0% at 11xa0months follow-up, was 163/93xa0mmHg (reduction of 22/9xa0mmHg). ABP, available in 70xa0% at 8.5xa0months follow-up, was 158/91xa0mmHg (fall of 12/7xa0mmHg). Mean drug changes post RDN were: 0.36 drugs added, 0.91 withdrawn. Dose changes appeared neutral. Quartile analysis by starting ABP showed mean reductions in systolic ABP after RDN of: 0.4; 6.5; 14.5 and 22.1xa0mmHg, respectively (pxa0<xa00.001 for trend). Use of aldosterone antagonist did not predict response (pxa0>xa00.2).ConclusionIn 253 patients treated with RDN, office BP fell by 22/9xa0mmHg. Ambulatory BP fell by 12/7xa0mmHg, though little response was seen in the lowermost quartile of starting blood pressure. Fall in BP was not explained by medication changes and aldosterone antagonist use did not affect response.

A novel strategy for managing clopidogrel-induced adverse skin reactions.

AIMSnWe conducted a prospective observational study using a course of steroids and antihistamines to treat a cohort of patients who developed skin reactions to clopidogrel, to assess whether dual antiplatelet therapy could be continued in an outpatient setting.nnnMETHODS AND RESULTSnThis study included 2,701 patients who underwent percutaneous coronary intervention (PCI) at our centre over a 23 month period. Patients with skin reactions to clopidogrel were identified and then commenced on five days oral prednisolone (30 mg/od) and chlorpheniramine (4 mg/tds) for seven days. A subsequent telephone survey was performed to evaluate a number of variables. The probability of the adverse reaction being secondary to clopidogrel was assessed using the Naranjo adverse drug reaction probability scale. Twenty (0.7%) patients were identified who developed adverse skin reactions to clopidogrel. There was complete resolution seen in the majority (89%) of patients within an average of 3.2 days following treatment. One patient had partial resolution, and one had no response to treatment, but both were able to continue clopidogrel.nnnCONCLUSIONSnWe propose a novel, safe and effective way of managing clopidogrel-induced skin reactions using a short course of prednisolone and chlorpheniramine, without stopping or substituting clopidogrel.

Feasibility and Efficacy of Herculink Elite ((TM)) Biliary Stent Implantation in Large Coronary Arteries (≥ 5 mm) and Venous Conduits: An Observational Study.

BACKGROUND AND OBJECTIVESnPercutaneous coronary intervention (PCI) in patients with lesions of large calibre coronary arteries (≥ 5 mm) and saphenous venous grafts (≥ 5 mm) can be challenging. There are no separate guidelines available to treat these vessels with PCI. Standard coronary stents of 4 mm diameter are used to treat these lesions conventionally but carry the risk of under deployment, distortion of stent architecture and future stent thrombosis even if they are subsequently expanded beyond 5 mm.nnnMETHODS AND RESULTSnBiliary stents (Herculink Elite™) provide a better alternative to standard coronary stents in these patients. These stents are of larger diameter (5-7 mm) and can be safely delivered over a 6 French sheath. In our case series, we demonstrate the use of intravascular ultrasound examination to confirm that biliary stents provide improved stent strut apposition within the coronary artery associated with extremely low repeat revascularisation rates.nnnCONCLUSIONnOur paper highlights that PCI of lesions in patients with large calibre coronary arteries can successfully be achieved using biliary stents.

67 Is it Safe to Send Patients Home for Staged Percutaneous Coronary Intervention (SPCI) to Non-culprit Stenoses Following Primary PCI (PPCI)?

Introduction and aIms PPCI for acute ST-segment elevation myocardial infarction (STEMI) is the gold-standard treatment. Current guidelines recommend treatment of the culprit vessel only in the acute setting, with elective outpatient sPCI of non-culprit vessels. However, recently published data suggests better outcomes with total revascularisation at the time of PPCI versus culprit vessel revascularisation alone. This total revascularisation strategy has not been compared to a staged approach. We aimed to review the safety and outcomes of our patients undergoing outpatient (OPD) sPCI for non-culprit coronary stenosis following PPCI. Methods Using our cardiac database, we identified all patients who had a PPCI and subsequently underwent sPCI.Patient letters and hospital databases were searched to identify firstly, how the clinical decision was made to perform sPCI, secondly, if there were any hospital admissions or cardiac events between discharge from PPCI and admission for OPD sPCI and thirdly, eventual outcomes at sPCI. Patients were excluded if enrolled in any clinical trial evaluating PPCI or if they had in-patient sPCI. Results 153 patients had a planned sPCI, 11 (7%) were excluded as they underwent in-patient revascularisation for critical or prognostically significant non-culprit disease on PPCI admission. For the remaining 142 patients (16% of PPCI population) the clinical decision pathway for planning sPCI is shown in Table 1. In the majority (80%) this was based primarily on angiographic findings at the time of PPCI. Abstract 67 Table 1 How the clinical decision was made to perform staged PCI No. patients (%) Direct Staged PCI (decision made at time of PPCI) 113 (80%) Cardiac MRI alone 13 (9%) Cardiac MRI/Stress testing + Clinical assessment 7 (5%) Clinic assessment for symptoms 9 (6%) Cardiac events occurred in 15 patients (11%, all hospital readmissions) prior to sPCI. Five had a new infarct (1 STEMI, 4 NSTEMI) and 10 had troponin negative chest pain. All underwent ‘early’ sPCI. Furthermore, there were no cardiovascular deaths prior to sPCI. Staged PCI outcomes are shown in Table 2. At sPCI, 114 (80%) patients underwent further PCI/stenting, with 21 patients (15%) requiring treatment of 2 non-culprit vessels. Pressure wire assessment (PW), used to guide intervention in a total of 71 vessels, was negative in 32 vessels thereby preventing unnecessary stenting in 24 patients. Abstract 67 Table 2 Outcome of sPCI No. patients (%) PCI/ Stenting 114 (80%) PW with –ve FFR, no stents 24 (17%) Clinical review; asymptomatic-no intervention 4 (3%) Conclusion Our data demonstrates that a strategy of elective sPCI following culprit vessel revascularisation in the setting of acute STEMI is associated with a MACE (major adverse cardiac events) of 3.5% (5/142) and a readmission rate of 11% between discharge post PPCI and planned admission for sPCI. Furthermore, at the time of sPCI, 20% of patients required no further intervention potentially avoiding unnecessary stenting compared to a strategy of total revascularisation at time of PPCI where PW was not used and clinical review not possible. Randomised controlled trials, comparing elective sPCI to total revascularisation at the time of PPCI, are required to determine which of these two strategies are best.

86 The Incidence of Cardiac Surgery Following Percutaneous Coronary Intervention: Insights from a High-volume Single-centre in the UK

Introduction Percutaneous coronary intervention (PCI) has established itself as an effective alternative to coronary artery bypass grafting (CABG) in appropriate patients. However, the proportion of patients that undergo CABG and or valve surgery (VS) following PCI in the short- and long-term is currently unknown. Methods We conducted a single-centre retrospective study examining the indications and number of patients requiring CABG and or VS following a successful PCI over a 4 year period 2009–2012. The surgical procedure was categorised as acute (referred within one month of the index PCI), sub-acute (referred between one month and one year of the index PCI) and remote (referred more than one year and up to 4 years following the index PCI). The denominator used for acute and sub-acute was PCI cases performed over a 3 year period 2009–2011, whilst for remote it was 2008–2010. Results During each 3-year period (2008–2010, 2009–2011), 5244 PCIs were performed at our centre. The total number of patients referred for cardiac surgery post-PCI was 63 (1.2%). Furthermore, the number of patients referred for acute, sub-acute and remote cardiac surgery was 21 (0.4%), 14 (0.26%) and 28 (0.53%) respectively. Within the acute surgery group, 8 patients had extensive 3 vessel disease stabilised with emergency/urgent PCI to allow subsequent CABG, 6 STEMI (1.6% of all primary PCI cases), 2 acute coronary syndromes (ACS) (0.08% of all ACS stented cases). Also within the acute group 10 underwent unsuccessful attempt of a chronic total occlusions (3.3% of all CTOs) and 3 had other technical PCI failures. In the sub-acute group, main reason for surgery was rapid progression in coronary disease to left main equivalent in 8 patients, restenosis in 5 patients (1.6% of all restenosis treated), and 1 missed severe valve disease at initial PCI. Finally, in the remote group, 19 patients underwent VS for progression of their valve disease, 6 progression in coronary disease, 2 restenosis and 1 stent misplaced at a ostium causing chronic valve damage. Conclusion Our data suggest that the number of patients requiring CABG and or valve surgery following PCI either short- or long-term is very small and the reasons differ with time from the PCI. We hope that these results will provide reassurance and interest to our interventional colleagues.