Duration of triple antithrombotic therapy and clinical outcomes after percutaneous coronary intervention in atrial fibrillation.

BACKGROUND: Triple antithrombotic therapy (TAT) with aspirin, a P2Y12 inhibitor, and oral anticoagulation in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) raises concerns about increased bleeding. Regimens incorporating more potent P2Y12 inhibitors over clopidogrel have not been investigated adequately. RESEARCH DESIGN AND METHODS: A retrospective observational study was performed on 387 patients with AF receiving TAT for 1 month (n = 236) or ≤1 week (n = 151) after PCI. Major and clinically relevant non-major bleeding and major adverse cardiac and cerebrovascular events (MACCE) were assessed up to 30 days post-procedure. RESULTS: Bleeding was less frequent with ≤1 week versus 1 month of TAT (3.3 vs 9.3%; p = 0.025) while MACCE were similar (4.6 vs 4.7%; p = 0.998). No differences in bleeding or MACCE were observed between ticagrelor/prasugrel and clopidogrel regimens. For patients receiving ≤1 week of TAT, no excess of MACCE was seen in the subgroup given no further aspirin post-PCI compared with those given aspirin for up to 1 week (3.6 vs 5.2%). CONCLUSIONS: TAT post-PCI for ≤1 week was associated with less bleeding despite greater use of ticagrelor/prasugrel but similar MACCE versus 1-month TAT. These findings support further studies on safety and efficacy of dual therapy with ticagrelor/prasugrel immediately after PCI.

Modelled impact of virtual fractional flow reserve in patients undergoing coronary angiography (VIRTU-4).

BACKGROUND: The practical application of 'virtual' (computed) fractional flow reserve (vFFR) based on invasive coronary angiogram (ICA) images is unknown. The objective of this cohort study was to investigate the potential of vFFR to guide the management of unselected patients undergoing ICA. The hypothesis was that it changes management in >10% of cases. METHODS: vFFR was computed using the Sheffield VIRTUheart system, at five hospitals in the North of England, on 'all-comers' undergoing ICA for non-ST-elevation myocardial infarction acute coronary syndrome (ACS) and chronic coronary syndrome (CCS). The cardiologists' management plan (optimal medical therapy, percutaneous coronary intervention (PCI), coronary artery bypass surgery or 'more information required') and confidence level were recorded after ICA, and again after vFFR disclosure. RESULTS: 517 patients were screened; 320 were recruited: 208 with ACS and 112 with CCS. The median vFFR was 0.82 (0.70-0.91). vFFR disclosure did not change the mean number of significantly stenosed vessels per patient (1.16 (±0.96) visually and 1.18 (±0.92) with vFFR (p=0.79)). A change in intended management following vFFR disclosure occurred in 22% of all patients; in the ACS cohort, there was a 62% increase in the number planned for medical management, and in the CCS cohort, there was a 31% increase in the number planned for PCI. In all patients, vFFR disclosure increased physician confidence from 8 of 10 (7.33-9) to 9 of 10 (8-10) (p<0.001). CONCLUSION: The addition of vFFR to ICA changed intended management strategy in 22% of patients, provided a detailed and specific 'all-in-one' anatomical and physiological assessment of coronary artery disease, and was accompanied by augmentation of the operator's confidence in the treatment strategy.

Association between operator volume and mortality in primary percutaneous coronary intervention.

BACKGROUND: There is a paucity of real-world data assessing the association of operator volumes and mortality specific to primary percutaneous coronary intervention (PPCI). METHODS: Demographic, clinical and outcome data for all patients undergoing PPCI in Leeds General Infirmary, UK, between 1 January 2009 and 31 December 2011, and 1 January 2013 and 31 December 2013, were obtained prospectively. Operator volumes were analysed according to annual operator PPCI volume (low volume: 1-54 PPCI per year; intermediate volume: 55-109 PPCI per year; high volume: ≥110 PPCI per year). Cox proportional hazards regression analyses were undertaken to investigate 30-day and 12-month all-cause mortality, adjusting for confounding factors. RESULTS: During this period, 4056 patients underwent PPCI, 3703 (91.3%) of whom were followed up for a minimum of 12 months. PPCI by low-volume operators was associated with significantly higher adjusted 30-day mortality (HR 1.48 (95% CI 1.05 to 2.08); p=0.02) compared with PPCI performed by high-volume operators, with no significant difference in adjusted 12-month mortality (HR 1.26 (95% CI 0.96 to 1.65); p=0.09). Comparisons between low-volume and intermediate-volume operators, and between intermediate and high-volume operators, showed no significant differences in 30-day and 12-month mortality. CONCLUSIONS: Low operator volume is independently associated with higher probability of 30-day mortality compared with high operator volume, suggesting a volume-outcome relationship in PPCI at a threshold higher than current recommendations.

Real-world comparison of clopidogrel, prasugrel and ticagrelor in patients undergoing primary percutaneous coronary intervention.

Background: There is a paucity of real-world outcome data comparing clopidogrel, prasugrel and ticagrelor in primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI). We sought to assess the association of choice of oral P2Y12-receptor inhibitor with clinical outcomes following PPCI for STEMI in a large consecutive patient series. Methods: Demographic, procedural and 12-month outcome data were prospectively collected for all patients undergoing PPCI in Leeds, UK, between 01 January 2009 and 31 December 2011, and 01 January 2013 and 31 December 2013. Clinical endpoints were 30-day and 12-month all-cause mortality, recurrent MI and 30-day HORIZONS-major bleeding. Logistic regression analyses were undertaken to adjust for confounding factors. Results: Prasugrel (n=1244) was associated with lower adjusted 30-day (OR 0.53 (0.34-0.85)) and 12-month (OR 0.55 (0.38-0.78)) mortality, and 12-month MI (OR 0.63 (0.42-0.94)) compared with clopidogrel (n=1648). Importantly, prasugrel was associated with lower adjusted 30-day mortality (OR 0.51 (0.29-0.91)) compared with ticagrelor (n=811). Lower 30-day (OR 0.40 (0.17-0.94)) and 12-month (OR 0.54 (0.32-0.93)) MI were observed in ticagrelor compared with clopidogrel, an association absent in comparison with prasugrel. Adjusted bleeding were not statistically significantly different among the P2Y12-receptor inhibitors. Conclusion: In this large consecutive real-world series, prasugrel was associated with lower adjusted 30-day mortality compared with ticagrelor and clopidogrel, and lower adjusted 12-month mortality compared with clopidogrel. Both prasugrel and ticagrelor were associated with lower recurrent MI following PPCI compared with clopidogrel, with no overall increase in adjusted bleeding.

Clinical outcomes following primary percutaneous coronary intervention for ST-elevation myocardial infarction according to sex and race.

BACKGROUND: Female sex and South Asian race have been associated with poor clinical outcomes following primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI) but remain understudied in large real-world series. We therefore investigated the association of sex and race with clinical outcomes following PPCI. METHODS: We conducted a prospective study of all patients undergoing PPCI for STEMI between January 2009 and December 2011 at a large UK cardiac centre. Clinical characteristics and outcomes were compared according to sex and race using Chi-square test, independent samples Student's t-test and Mann-Whitney U-test. Primary and secondary outcomes were 12-month major adverse cardiovascular events (MACEs) - defined as all-cause mortality, myocardial infarction and unplanned revascularization, analysed using Cox proportional hazard models adjusting for cardiovascular risk factors. RESULTS: Three thousand and forty-nine patients were included. Women ( n=826) were older than men ( n=2223) (median age 69 vs. 60 years, p <0.01). Mortality (hazard ratio 1.48 (1.15-1.90)) and MACE (hazard ratio 1.40 (1.14-1.72)) were higher in women in univariable analysis. However, there were no significant sex-differences in mortality or MACE after age-stratification alone. Multivariable analysis also showed no significant differences in outcomes between sexes. South Asians ( n=297) were younger but had a higher prevalence of most risk factors than White patients ( n=2570). Mortality and MACE did not differ significantly between South Asian and White patients in univariable or multivariable analysis. CONCLUSION: MACE and mortality was not greater in women, or in South Asian patients following PPCI after adjustment for cardiovascular risk factors including age, which was most strongly associated with both outcomes.

Conduction Abnormalities and Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement Using the Repositionable LOTUS Device: The United Kingdom Experience.

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.

Transcatheter Aortic Valve Replacement Using the Repositionable LOTUS Valve: United Kingdom Experience.

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.

Mineralocorticoid receptor antagonist pretreatment to MINIMISE reperfusion injury after ST-elevation myocardial infarction (the MINIMISE STEMI Trial): rationale and study design.

Novel therapies capable of reducing myocardial infarct (MI) size when administered prior to reperfusion are required to prevent the onset of heart failure in ST-segment elevation myocardial infarction (STEMI) patients treated by primary percutaneous coronary intervention (PPCI). Experimental animal studies have demonstrated that mineralocorticoid receptor antagonist (MRA) therapy administered prior to reperfusion can reduce MI size, and MRA therapy prevents adverse left ventricular (LV) remodeling in post-MI patients with LV impairment. With these 2 benefits in mind, we hypothesize that initiating MRA therapy prior to PPCI, followed by 3 months of oral MRA therapy, will reduce MI size and prevent adverse LV remodeling in STEMI patients. The MINIMISE-STEMI trial is a prospective, randomized, double-blind, placebo-controlled trial that will recruit 150 STEMI patients from four centers in the United Kingdom. Patients will be randomized to receive either an intravenous bolus of MRA therapy (potassium canrenoate 200 mg) or matching placebo prior to PPCI, followed by oral spironolactone 50 mg once daily or matching placebo for 3 months. A cardiac magnetic resonance imaging scan will be performed within 1 week of PPCI and repeated at 3 months to assess MI size and LV remodeling. Enzymatic MI size will be estimated by the 48-hour area-under-the-curve serum cardiac enzymes. The primary endpoint of the study will be MI size on the 3-month cardiac magnetic resonance imaging scan. The MINIMISE STEMI trial will investigate whether early MRA therapy, initiated prior to reperfusion, can reduce MI size and prevent adverse post-MI LV remodeling.

Transient right-to-left intracardiac shunt following a right ventricular myocardial infarction.

A 56-year-old smoker presented with a 3-day history of intermittent chest pain. Cardiovascular examination on admission was normal. ECG showed minimal (<1 mm) ST elevation in lead III, and right-sided leads revealed similar mild ST-elevation. Troponin I was elevated at 10.91. He was managed as a delayed-presentation ST-elevation myocardial infarction case. 12 h following admission, he developed oxygen-resistant hypoxia and hypotension. There were no clinical or radiological signs of pulmonary congestion. CT pulmonary angiogram revealed no pulmonary embolus. A bubble-contrast echocardiogram confirmed an active interatrial right-to-left shunt without Valsalva provocation. His hypoxia steadily improved over the following 24 h and he did not require any shunt closure. A repeat bubble contrast echocardiogram showed that the shunt was now only active following a Valsalva manoeuvre. Transoesophageal echocardiography confirmed a patent foramen ovale. This is a rare but important cause of resistant hypoxia following a right-heart infarct.