Peter O'Kane

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

BACKGROUND Symptomatic 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. METHODS ORBITA 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. FINDINGS ORBITA 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. INTERPRETATION In 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. FUNDING NIHR Imperial Biomedical Research Centre, Foundation for Circulatory Health, Imperial College Healthcare Charity, Philips Volcano, NIHR Barts Biomedical Research Centre.

A Prospective Randomized Trial of Everolimus-Eluting Stents Versus Bare-Metal Stents in Octogenarians: The XIMA Trial (Xience or Vision Stents for the Management of Angina in the Elderly)

OBJECTIVES The aim of this study was to determine whether drug-eluting stents (DES) are superior to bare-metal stents (BMS) in octogenarian patients with angina. BACKGROUND Patients ≥80 years of age frequently have complex coronary disease warranting DES but have a higher risk of bleeding from prolonged dual antiplatelet therapy. METHODS This multicenter randomized trial was conducted in 22 centers in the United Kingdom and Spain. Patients ≥80 years of age underwent stent placement for angina. The primary endpoint was a 1-year composite of death, myocardial infarction, cerebrovascular accident, target vessel revascularization, or major hemorrhage. RESULTS In total, 800 patients (83.5 ± 3.2 years of age) were randomized to BMS (n = 401) or DES (n = 399) for treatment of stable angina (32%) or acute coronary syndrome (68%). Procedural success did not differ between groups (97.7% for BMS vs. 95.4% for DES; p = 0.07). Thirty-eight percent of patients had ≥2-vessel percutaneous coronary intervention, and 66% underwent complete revascularization. Patients who received BMS had shorter stent implants (24.0 ± 13.4 mm vs. 26.6 ± 14.3 mm; p = 0.01). Rates of dual antiplatelet therapy at 1 year were 32.2% for patients in the BMS group and 94.0% for patients in the DES group. The primary endpoint occurred in 18.7% of patients in the BMS group versus 14.3% of patients in the DES group (p = 0.09). There was no difference in death (7.2% vs. 8.5%; p = 0.50), major hemorrhage (1.7% vs. 2.3%; p = 0.61), or cerebrovascular accident (1.2% vs. 1.5%; p = 0.77). Myocardial infarction (8.7% vs. 4.3%; p = 0.01) and target vessel revascularization (7.0% vs. 2.0%; p = 0.001) occurred more often in patients in the BMS group. CONCLUSIONS BMS and DES offer good clinical outcomes in this age group. DES were associated with a lower incidence of myocardial infarction and target vessel revascularization without increased incidence of major hemorrhage. (Xience or Vision Stent-Management of Angina in the Elderly [XIMA]; ISRCTN92243650).

Impact of age on the prognostic value of left ventricular function in relation to procedural outcomes following percutaneous coronary intervention: insights from the British Cardiovascular Intervention Society.

Around one third of patients undergoing percutaneous coronary intervention (PCI) have left ventricular (LV) dysfunction. Whilst the prevalence of LV dysfunction is known to increase with age, the prevalence of LV dysfunction in different age groups in the PCI setting is not known and the effect of age on the prognostic value of LV function in the PCI setting has not been examined.

Type 1 Brugada ECG unmasked by intracoronary contrast media

A 48-year-old man was admitted with chest discomfort. His ambulance electrocardiograph (ECG) documented ST-segment elevation in V1–V3. Immediate coronary angiography demonstrated smooth, normal, coronary arteries with no evidence of thrombus, plaque disease or coronary spasm. It was noted that injection of contrast medium (Omnipaque) resulted in further ST-segment deviation. The changes resembled those seen in a type 1 Brugada pattern. Subsequent Cardiac MRI scanning …

A 56-year-old woman with breathlessness

Clinical introduction A 56-year-old female with adult-onset asthma was admitted to the cardiology service with intermittent left-sided chest pain and progressive dyspnoea. Twelve months prior to this admission, she had received a course of prednisolone for bilateral anterior uveitis. Physical examination was unremarkable with blood sampling revealing a marked eosinophilia (eosinophil count 17.3×109/L) and a perinuclear antineutrophil cytoplasmic antibody staining pattern on indirect immunofluorescence microscopy (myeloperoxidase antibodies 83 IU/mL). ECG demonstrated anterolateral T-wave inversion (see online supplementary figure S1). High-sensitivity troponin T was elevated at 100 ng/L. Invasive coronary angiography showed unobstructed coronary arteries. Echocardiography and cardiac magnetic resonance (CMR) were performed (figure 1). Figure 1 (A) Two-chamber echocardiogram. (B) Four-chamber steady-state free precession cardiac MRI

Ajuvent Interventional techniques for the treatment of Intra-coronary thrombus

The Authors’ reply We thank Glenie et al for their correspondence.1 We agree with the points raised and reiterate the importance of recognising obstruction of a catheter by proximal thrombus. Massive intracoronary thrombus is a rare occurrence during PCI and is often associated with significant major adverse clinical events. Managing this condition will often demand a more sophisticated device other than a simple aspiration catheter. There …

Contemporary clot busting in ST-elevation myocardial infarction: beware of the embolus

A 65-year-old man presented with an acute inferior ST-elevation myocardial infarction (STEMI) 2 h after the onset of pain. After pre-treatment with aspirin, prasugrel and bivalirudin (bolus and infusion), the patient underwent percutaneous coronary intervention (PCI). The right coronary artery (RCA) was occluded proximally (figure 1A) and it was re-cannulised with the …

Acute Myocardial Infarction: STEMI and NSTEMI

Abstract The pathogenesis that underlies acute myocardial infarction (MI) is complex and multifactorial. One of the most important components, however, is the role of thrombus formation following atherosclerotic plaque rupture, leading to sudden coronary occlusion and subsequent ischemia and infarction. The management of the atherothrombotic cascade in the setting of acute MI, both ST-elevated and non-ST-elevated MI, is an evolving field that includes management with pharmacotherapy and also mechanical techniques to reduce thrombus burden and improve percutaneous coronary intervention results, with the aim of improving coronary and myocardial perfusion. This chapter will discuss the current methods of managing acute coronary syndrome patients who often present with angiographic evidence of thrombus, with particular insights into strategies that can be adopted to improve outcomes in this setting.

Twelve-month outcomes of patients unsuitable for prolonged DAPT presenting with an acute coronary syndrome and treated with polymer-free biolimus A9 drug-coated stents.

Prolonged dual anti‐platelet therapy (DAPT) is undesirable in certain patients. The biolimus‐A9 drug‐coated stent (BA9‐DCS) has a rapid drug‐elution profile allowing shortened DAPT.

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

BACKGROUND AND OBJECTIVES Percutaneous 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. METHODS AND RESULTS Biliary 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. CONCLUSION Our paper highlights that PCI of lesions in patients with large calibre coronary arteries can successfully be achieved using biliary stents.