Colchicine in Patients With Acute Coronary Syndrome: The Australian COPS Randomized Clinical Trial.

BACKGROUND: Inflammation plays a crucial role in clinical manifestations and complications of acute coronary syndromes (ACS). Colchicine, a commonly used treatment for gout, has recently emerged as a novel therapeutic option in cardiovascular medicine owing to its anti-inflammatory properties. We sought to determine the potential usefulness of colchicine treatment in patients with ACS. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled trial involving 17 hospitals in Australia that provide acute cardiac care service. Eligible participants were adults (18-85 years) who presented with ACS and had evidence of coronary artery disease on coronary angiography managed with either percutaneous coronary intervention or medical therapy. Patients were assigned to receive either colchicine (0.5 mg twice daily for the first month, then 0.5 mg daily for 11 months) or placebo, in addition to standard secondary prevention pharmacotherapy, and were followed up for a minimum of 12 months. The primary outcome was a composite of all-cause mortality, ACS, ischemia-driven (unplanned) urgent revascularization, and noncardioembolic ischemic stroke in a time to event analysis. RESULTS: A total of 795 patients were recruited between December 2015 and September 2018 (mean age, 59.8±10.3 years; 21% female), with 396 assigned to the colchicine group and 399 to the placebo group. Over the 12-month follow-up, there were 24 events in the colchicine group compared with 38 events in the placebo group (P=0.09, log-rank). There was a higher rate of total death (8 versus 1; P=0.017, log-rank) and, in particular, noncardiovascular death in the colchicine group (5 versus 0; P=0.024, log-rank). The rates of reported adverse effects were not different (colchicine 23.0% versus placebo 24.3%), and they were predominantly gastrointestinal symptoms (colchicine, 23.0% versus placebo, 20.8%). CONCLUSIONS: The addition of colchicine to standard medical therapy did not significantly affect cardiovascular outcomes at 12 months in patients with ACS and was associated with a higher rate of mortality. Registration: URL: https://www.anzctr.org.au; Unique identifier: ACTRN12615000861550.

Performance and Safety of Transfemoral TAVI With SAPIEN XT in Australian Patients With Severe Aortic Stenosis at Intermediate Surgical Risk: SOLACE-AU Trial.

BACKGROUND: To determine the safety and performance of the SAPIEN XT transcatheter heart valve (THV) in Australian patients with severe aortic stenosis (AS) and intermediate surgical risk. METHODS: Eligible patients in this multi-centre, prospective, consecutively enrolled, non-randomised, clinical trial, received transcatheter aortic valve replacement via femoral artery access. Follow-up visits were at discharge, 30 days, and 6, 12, and 24 months. The primary endpoint was Valve Academic Research Consortium-2 composite safety at 30 days: all-cause mortality, all stroke, life-threatening bleeding, acute kidney injury-Stage 3, coronary artery obstruction requiring intervention, major vascular complication, and valve-related dysfunction requiring repeat procedure. Other endpoints were device success (successful vascular access, delivery, and deployment; correct position; intended performance mean aortic valve gradient <20 mmHg, mild or less paravalvular aortic regurgitation [PAR]; and only one valve implanted) and New York Heart Association functional class (NYHA). Kaplan-Meier (KM) estimates were calculated for the primary endpoint. RESULTS: At baseline, mean patient (N=199) age was 85.5 years, mean Society of Thoracic Surgeon score was 5.9, and 78.4% were in NYHA class III/IV. The primary composite endpoint KM estimate was 12.1%. Device success was 88.8%. SAPIEN XT was implanted in the proper location in 98.5% (n=2: valve-in-valve procedures, n=1: no implant due to left main coronary artery occlusion). No device malfunctions were reported. The post procedure PAR was mild or less in 93.8% of patients. Mean aortic gradient decreased from baseline (50.0 mmHg) to 2 years (10.3 mmHg). Most patients (90.9%) were in NYHA class I/II at 30 days. New permanent pacemaker rate was 8.1%. Stroke at 30 days was 3.5% (1.5% disabling). CONCLUSION: SAPIEN XT was safe and improved heart failure symptoms and valve haemodynamics in this cohort of Australian patients.

Medium-Term Bioresorbable Scaffold Outcomes Utilising Data From an Australian Clinical Quality Registry.

BACKGROUND: Bioresorbable scaffolds (BRS) are a novel technology in coronary intervention. However, recent trials demonstrate higher rates of device failure compared to contemporary drug-eluting stents. This study sought to utilise a clinical quality registry to assess the medium-term safety of the Abbott Absorb BRS (Abbott Vascular, Santa Clara, CA, USA), in an Australian context. METHODS: A prospective, observational study of 192 BRS percutaneous coronary interventions (PCI) compared to 31,773 non-BRS PCIs entered in the Victorian Cardiac Outcomes Registry from 2013 to 2017. The main outcome measure was patient-oriented composite endpoint (POCE) events comprising all-cause mortality, any myocardial infarction (MI), and any revascularisation. RESULTS: Bioresorbable scaffolds patients (mean age 61.6±10.5 years, 79% male) were younger, had less comorbidity, less prior PCI, fewer ST elevation myocardial infarction (STEMI) presentations, lower rates of multi-lesion disease and more adjuvant devices compared to non-BRS PCI (all p<0.01). All-cause mortality was 2.1%, myocardial infarction (MI) 2.1%, scaffold thrombosis 3.1% and any revascularisation 14.1% (mean follow-up 27.4±8.9 months). POCE events occurred in 11.5% at 1 year and 16.9% at 2 years, comparable to pooled-trial data. Multivariate predictors of POCE were >1 scaffold used (odds ratio [OR] 4.6, 95% confidence interval [CI] 1.9-11.4, p<0.01) and scaffold diameter ≤2.5 mm (OR 3.3, 95% CI 1.4-7.6, p=0.02). Over 95% guideline adherence was achieved in six of eight patient selection criteria and four of six device deployment criteria. CONCLUSION: In an Australian setting, BRS were used in non-complex patients. Most guidelines for use were adhered to and outcomes were comparable to pooled trial data. Clinical quality registries are effective in assessing novel treatments and technologies when potential safety concerns develop.

Three-year clinical outcomes of patients treated with everolimus-eluting bioresorbable vascular scaffolds: Final results of the ABSORB EXTEND trial.

BACKGROUND: There is still limited data on the very long term clinical outcomes after ABSORB BRS in daily practice. We sought to evaluate the 3 year-performance of the Absorb bioresorbable vascular scaffolds for the treatment of low/moderate complexity patients enrolled in the ABSORB EXTEND trial. METHODS: ABSORB EXTEND is a prospective, single-arm, open-label clinical study in which 812 patients were enrolled at 56 sites. This study allowed the treatment of lesions ≤28 mm in length and reference vessel diameter of 2.0-3.8 mm (as assessed by on-line QCA). To determine the independent predictors of MACE, a multivariable logistic regression model was built using a stepwise (forward/backward) procedure. RESULTS: Average population age was 61 years and 26.5% had diabetes. Most patients had single target lesion (92.4%). Adequate scaffold deployment (PSP) was achieved in 14.2% of the cases. At three years, the composite endpoints of MACE and ischemia-driven target vessel failure were 9.2% and 10.6%, respectively. The cumulative rate of ARC definite/probable thrombosis was 2.2%, with 1.2% of the cases occurring after the 1st year. Independent predictors of MACE were hypertension and the need for "bail out" stent. CONCLUSION: At three-year follow-up, the use of ABSORB in low/moderate complex PCI was associated with low and acceptable rates of major adverse clinical events, despite the infrequent use of the recommended contemporary scaffold deployment technique. However, scaffold thrombosis rate was higher than reported with current generation of metallic DES. The study is registered on clinicaltrials.gov (unique identifier NCT01023789).

Contemporary review of severe aortic stenosis.

Severe aortic stenosis (AS) is the most common form of valvular heart disease in the developed world, with a rising prevalence due to an ageing Australian population. Transcatheter aortic valve implantation (TAVI) offers a less invasive option for the treatment of severe AS, with evidence supporting TAVI compared with medical therapy in inoperable patients and superior with surgical aortic valve replacement (SAVR) in high-risk patients. Equal outcomes have been observed in all-comer intermediate-risk populations. The Heart Team utilises a shared decision-making approach between physicians and surgeons in risk-stratifying patients and reduces the intrinsic bias that may occur if decisions are made in isolation. Geriatric assessment is useful for identifying preoperative frailty, a major risk factor for death post-aortic valve intervention. In severe AS, a decision can be made collaboratively to pursue TAVI, SAVR, a Ross Procedure or conservative management. The learning curve associated with TAVI has improved markedly, with overall complication rates decreasing around the world. Contemporary changes in practice, such as conscious sedation without general anaesthesia, expedited recovery and early discharge, will likely improve cost-effectiveness. In 2018, TAVI is a well-established procedure in Australia that has revolutionised the management of severe AS. In the future, with an expanding elderly population, the number of patients to benefit from transcatheter therapies for severe AS is hypothesised to increase 4-10-fold. Heart Team assessment is crucial in patients with severe AS to direct appropriate management.

Transcatheter aortic valve implantation for severe aortic stenosis in the Australian regional population.

OBJECTIVE: To compare clinical and functional outcomes of regional and urban patients after transcatheter aortic valve implantation for severe aortic stenosis. METHODS: Data were collected at patient follow-up post-transcatheter aortic valve implantation at 30 days and 12 months. Patients were stratified by residential postcodes into remoteness areas using the Australian Statistical Geography Standard. DESIGN: Retrospective cohort study. SETTING: Single-centre tertiary referral hospital. PARTICIPANTS: Patients undergoing transcatheter aortic valve implantation (n = 142) from 2009 to 2018 were analysed, with 77 patients (54.2%) residing in regional Victoria and New South Wales. MAIN OUTCOME MEASURES: Procedural success, adverse event rates, readmission rates, mortality rates, loss to follow-up and functional improvement. RESULTS: Patients residing in regional areas had a lower mean age (81.8 vs 83.7 years) and proportion of Stage 4 or 5 chronic kidney disease (1.3% vs 9.2%), compared with urban patients. Procedural characteristics and immediate post-procedural outcomes were similar between both groups. There was no statistically significant difference in mortality, readmission rates or loss to follow-up between the two cohorts. Regional patients demonstrated poorer rates of functional improvement at 30 days (50.7% vs 67.7%); however, this difference was not sustained at 12 months (79.2% vs 71.0%). Frailty was demonstrated to be an independent predictor of poor 30-day functional improvement. CONCLUSION: Regional patients treated with transcatheter aortic valve implantation for severe aortic stenosis have non-inferior 30-day and 12-month outcomes, when compared with urban patients. Frailty is a predictor of poor functional improvement post-transcatheter aortic valve implantation.

Two-year clinical outcomes of patients treated with overlapping absorb scaffolds: An analysis of the ABSORB EXTEND single-arm study.

BACKGROUND: Preclinical data showed that overlapping (OVP) scaffolds might result in delayed healing and strut coverage compared to nonOVP scaffold segments. Furthermore, OVP in patients could result in increased periprocedure myocardial infarction (MI) rate secondary to side branch occlusion; however, little is known whether this may have an impact on long-term clinical outcomes. METHODS: ABSORB EXTEND is a prospective, single-arm, open-label clinical study in which 812 patients were enrolled at 56 sites. In this study, we compared the immediate and 2-year clinical outcomes of patients with OVP scaffolds (n = 115) to those of patients with nonOVP scaffolds (n = 697). The primary objective was the comparison of major adverse cardiac event (MACE) (cardiac death, MI and ischemic-driven target lesion revascularization [TLR]) and scaffold thrombosis (ST) rates up to 2 years. RESULTS: Baseline clinical and angiographic characteristics were comparable between cohorts except for longer lesions in the OVP patients as expected (16.7 ± 7.3 vs. 11.6 ± 4.4 mm, P < 0.0001), higher lesion complexity (B2) and numerically smaller vessel size. In-hospital, there was a marked increase in MACE in the OVP cohort (7.0 vs. 0.9%, P = 0.002), exclusively driven by a higher rate of periprocedure MI (7.0 vs. 0.9%, P = 0.002). Long-term MACE did not significantly differ between groups (10.4% in the OVP cohort vs. 6.6% in the no-OVP group, P = 0.1) with comparable rates of cardiac death (0.9 vs. 1.2%, P = 1.0) and ischemia-driven TLR (1.7 vs. 2.5%, P = 1.0). Cumulative incidence of MI was higher in the OVP cohort (7.8 vs. 3.0%, P = 0.02). Of note, the rate of MI between hospital discharge and 2-year follow-up was lower in the OVP cohort (0.8 vs. 2.1%, P = 0.04). Cumulative incidence of definite/probable ST was relatively low and comparable between groups (1.8 vs. 1.5%, P = 0.7). CONCLUSIONS: In this low-to-moderate complex population treated with the ABSORB scaffold the OVP group showed a higher incidence of periprocedure MI with no immediate or long-term increase in cardiac death, TLR or ST.

Risk and timing of clinical events according to diabetic status of patients treated with everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting stent: 2-year results from a propensity score matched comparison of ABSORB EXTEND and SPIRIT trials.

OBJECTIVES: to compare the occurrence of clinical events in diabetics treated with the Absorb bioresorbable vascular scaffold (Absorb BVS; Abbott Vascular, Santa Clara, CA) versus everolimus-eluting metal stents (EES; XIENCE V; Abbott Vascular, Santa Clara, CA) BACKGROUND: There are limited data dedicated to clinical outcomes of diabetic patients treated with bioresorbable scaffolds (BRS) at 2-year horizon. METHODS: The present study included 812 patients in the ABSORB EXTEND study in which a total of 215 diabetic patients were treated with Absorb BVS. In addition, 882 diabetic patients treated with EES in pooled data from the SPIRIT clinical program (SPIRIT II, SPIRIT III and SPIRIT IV trials) were used for comparison by applying propensity score matching using 29 different variables. The primary endpoint was ischemia driven major adverse cardiac events (ID-MACE), including cardiac death, myocardial infarction (MI), and ischemia driven target lesion revascularization (ID-TLR). RESULTS: After 2 years, the ID-MACE rate was 6.5% in the Absorb BVS vs. 8.9% in the Xience group (P = 0.40). There was no difference for MACE components or definite/probable device thrombosis (HR: 1.43 [0.24,8.58]; P = 0.69). The occurrence of MACE was not different for both diabetic status (insulin- and non-insulin-requiring diabetes) in all time points up to the 2-year follow-up for the Absorb and Xience groups. CONCLUSION: In this largest ever patient-level pooled comparison on the treatment of diabetic patients with BRS out to two years, individuals with diabetes treated with the Absorb BVS had a similar rate of MACE as compared with diabetics treated with the Xience EES. © 2017 Wiley Periodicals, Inc.

Different patients, different outcomes: A case-control study of spontaneous coronary artery dissection versus acute coronary syndrome.

INTRODUCTION: There is progressive interest worldwide in spontaneous coronary artery dissection (SCAD). To identify a SCAD cohort and compare risk factors, presentation, and management outcomes compared to acute coronary syndrome (ACS) matched controls. METHODS: Retrospective analysis was performed from 2000 to 2015. Clinical data included a neuropsychiatric history, with management and clinical outcomes assessed at 12 months. Patients were matched on a 1:3 case-control basis according to type of ACS. Twenty-two SCAD patients were matched to 66 controls by ACS type (ST-elevation myocardial infarction 45%, Non-ST-elevation myocardial infarction 41%, unstable angina 14%). RESULTS: The SCAD group were more likely female (77.3% vs 19.7%, P < 0.0001), of younger age (48.7 ± 10.7 years vs 61.3 ± 10.6 years, P < 0.0001) with no cases of diabetes (0% vs 33.3%, P = 0.002), compared to controls. SCAD patients had a high prevalence of anxiety, depression or previous neuropsychiatric history (52.4% SCAD vs 1.5% ACS, P < 0.0001). A conservative revascularization strategy with stenting was performed in a minority of SCAD patients (13.6% SCAD vs 83.3% ACS, P < 0.0001), with no significant difference in cumulative major adverse cardiac or cerebrovascular events (MACCE) of death, stroke, re-admission, or repeat angiography rates between both groups (13.6% SCAD vs 27.3% ACS P = NS). CONCLUSION: SCAD affects young females with a paucity of cardiovascular risk factors. The major risk factor for SCAD was a history of anxiety, depression, or neuropsychiatric illness. A conservative approach to SCAD revascularization led to similar MACCE when compared to ACS controls undergoing guideline revascularization at 12 months.

The Index of Microcirculatory Resistance Postpercutaneous Coronary Intervention Predicts Left Ventricular Recovery in Patients With Thrombolyzed ST-Segment Elevation Myocardial Infarction.

BACKGROUND: The index of microcirculatory resistance (IMR), an invasive measure of microvascular function, has been shown to correlate with clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI). The aim of this study is to evaluate the predictive value of IMR on left ventricular recovery in patients undergoing a pharmacoinvasive strategy for STEMI. METHODS: The index of microcirculatory resistance was assessed following percutaneous coronary intervention (PCI) in 31 patients with STEMI who were initially managed with thrombolysis. Other markers of microvascular function such as coronary flow reserve (CFR), TIMI flow grade, corrected TIMI frame count (cTFC), and ST-segment resolution were also recorded. All indices were evaluated against measures of left ventricular function and recovery 3 months postindex event. RESULTS: The IMR correlated with left ventricular function, as assessed by wall motion score and ejection fraction at 3-month follow-up (r = 0.652, P = 0.005; r = -0.452, P = 0.011, respectively). The traditional methods of assessing microvascular function, such as CFR, TIMI flow grade, cTFC, and ST-segment resolution did not correlate with wall motion score and ejection fraction at 3 months. Post-PCI IMR was significantly lower in those patients with left ventricular recovery at 3 months (18 U vs 39 U, P < 0.001). The optimal cut-off value for post-PCI IMR and left ventricular recovery was 32 U. In patients in whom the IMR was greater than 32 U, the percent change in ejection fraction was significantly lower than in those patients in whom the IMR was less than 32 U (2 ± 11 vs 12 ± 8, P = 0.012). CONCLUSIONS: In patients presenting with STEMI initially managed with thrombolysis and subsequently undergoing PCI, IMR correlates with measures of left ventricular function and has the potential to predict left ventricular recovery at 3 months.

An Australian longitudinal pilot study examining health determinants of cardiac outcomes 12 months post percutaneous coronary intervention.

BACKGROUND: Percutaneous coronary intervention (PCI) is a very common revascularisation procedure for coronary artery disease (CAD). The purpose of this study was to evaluate cardiac outcomes, health related quality of life (HRQoL), resilience and adherence behaviours in patients who have undergone a PCI at two time points (6 and 12 months) following their procedure. METHODS: A longitudinal pilot study was conducted to observe the cardiac outcomes across a cohort of patients who had undergone a percutaneous coronary intervention (PCI). Participants who had undergone PCI 6 months prior were invited. Those participants who met the inclusion criteria and provided consent then completed a telephone survey (time point 1). These participants were then contacted 6 months later (i.e. 12 months post-intervention, time point 2) and the measures were repeated. RESULTS: All patients (n = 51) were recorded as being alive at time point 1. The multiple model indicated that controlling for other factors, gender was significantly associated with a linear combination of outcome measures (p = 0.004). The effect was moderate in magnitude (partial-η(2) = 0.303), where males performed significantly better than females 6 months after the PCI procedure physically and with mood. Follow-up univariate ANOVAs indicated that gender differences were grounded in the scale measuring depression (PHQ9) (p = 0.005) and the physical component score of the short form measuring HRQoL (SF12-PCS) (p = 0.003). Thirteen patients were lost to follow-up between time points 1 and 2. One patient was confirmed to have passed away. The pattern of correlations between outcome measures at time point 2 revealed statistically significant negative correlation between the PHQ instrument and the resilience scale (CD-RISC) (r = -0.611; p < 0.001); and the physical component score of the SF-12 instrument (r = -0.437; p = 0.054). CONCLUSIONS: Men were performing better than women in the 6 months post-PCI, particularly in the areas of mood (depression) and physical health. This pilot results indicate gender-sensitive practices are recommended particularly up to 6 months post-PCI. Any gender differences observed at 6 month appear to disappear at 12 months post-PCI. Further research into the management of mood particularly for women post-PCI is warranted. A more detailed inquiry related to access/attendance to secondary prevention is also warranted.

Transcatheter versus Surgical Aortic Valve Replacement in High-risk Patients: A propensity-score matched analysis.

BACKGROUND: There is limited data from Australia and New Zealand comparing transcatheter aortic valve implantation (TAVI) with conventional surgical aortic valve replacement (sAVR). METHODS: Between 2009 and 2015, 64 patients underwent TAVI and 669 underwent sAVR at a single centre. Patients' peri-operative details were analysed and compared between groups. Propensity-score matching was performed for risk adjustment. RESULTS: Patients receiving TAVI were older (mean age in years TAVI: 83.9±4.6 vs. sAVR: 71±9.9, P<0.001), and were more likely to be female (TAVI: 67%, 43/64, vs. sAVR: 32%, 217/669, P <0.001). Unadjusted 30-day mortality was comparable between groups (2/64, 3% vs. 22/669, 3%, P >0.99). The matched analysis revealed comparable 30-day mortality (TAVI: 2/44, 5% vs. sAVR: 2/44, 5%, P > 0.99). New atrial arrhythmia occurred more frequently within the sAVR cohort (TAVI: 1/44, 2% vs. sAVR 18/44, 41%, P <0.001). Complete heart block requiring permanent pacemaker was more frequent amongst the TAVI cohort (TAVI: 10/44, 23% vs. sAVR 2/44, 5%, P=0.039). At two years, survival was comparable between groups (TAVI: 74±1.7 vs. sAVR: 80±0.1%, P=0.65). CONCLUSION: This single centre experience suggests that TAVI is a valuable treatment option for high-risk surgical patients with comparable survival.

Mid-term outcomes in patients following transcatheter aortic valve implantation in the CoreValve Australia and New Zealand Study.

BACKGROUND: Although numerous studies have reported the safety and effectiveness of transcatheter aortic valve implantation (TAVI), integration of this therapy into standard of care varies widely by region. We evaluated mid-term follow-up in 540 patients with severe symptomatic AS at high risk of surgical AV replacement, enrolled in the ongoing Medtronic CoreValve Australia-New Zealand Study. METHODS: Between August 2008 and July 2013, 10 centres in Australia/New Zealand enrolled 540 patients, which includes initial use of the CoreValve System for all investigators. Patients were deemed suitable for TAVI based on consensus of a multidisciplinary Heart Team. Primary endpoints were cardiovascular death and major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days. Data were fully monitored, and an independent Clinical Events Committee employed. RESULTS: Baseline characteristics include; 45% female, mean age 84 years, EuroSCORE 17.3±10.7%, and 74.9% had New York Heart Association III/IV symptoms. At 30 days, all deaths were cardiovascular (4.1%); MACCE was 11.5%. At one and two years, all-cause mortality was 11.9% and 21.2%; cardiovascular mortality, 9.9% and 15.2%; and stroke, 8.2% and 10.1%, respectively. CONCLUSIONS: Early experience with the CoreValve System in a large cohort of fully-monitored patients was associated with good early- and mid-term safety outcomes.

Intravascular ultrasound analysis of small vessel lesions treated with the Sparrow coronary stent system: results of the CARE II trial.

OBJECTIVES: The aim of this study was to evaluate the Sparrow sirolimus-eluting stent (Sparrow-SES) against the Sparrow bare-metal stent (Sparrow-BMS) and conventional balloon-expandable bare-metal stent (BMS: Driver/Micro-Driver stent, Medtronic Vascular, Santa Rosa, CA). BACKGROUND: The Sparrow stent (Biosensors International, Singapore) consists of a guide wire-based, self-expandable, ultra-thin nitinol stent. The performance of this device with sirolimus in a fully biodegradable polymer has not been determined. METHODS: A total of 74 patients were included in this intravascular ultrasound (IVUS) sub-study of the CARE II trial, which was a prospective, randomized, multicenter trial in the treatment of single de novo native coronary artery lesions in vessels ranging from 2.0 mm to 2.75 mm in diameter (Sparrow-SES: n = 31, Sparrow-BMS: n = 22, BMS: n = 21). RESULTS: Stent volume index (VI) was significantly increased 8-month later in Sparrow-SES and Sparrow-BMS, but not in BMS (4.0 ± 1.0 to 4.6 ± 1.0 mm(3) /mm, p<0.0001, 4.0 ± 0.6 to 4.4 ± 0.8 mm(3) /mm, p<0.05, and 5.2 ± 1.0 to 5.1 ± 0.9 mm(3) /mm, p=0.421, respectively). % neointimal obstruction in Sparrow-SES was significantly smaller than those in Sparrow-BMS and BMS at follow-up (17.6 ± 9.4 vs. 36.2 ± 13.8 and 39.9 ± 11.1%, p<0.001). Sparrow-SES showed a mean 15% stent expansion and good suppression of neointimal proliferation, resulting in a significantly lower percentage of change in lumen VI during follow-up period (Sparrow-SES: -6.2 ± 16.2%, Sparrow-BMS: -30.4 ± 11.6%, BMS: -40.4 ± 10.0%, p<0.001). CONCLUSIONS: The self-expanding Sparrow-SES demonstrated chronic stent expansion, good suppression of neointimal proliferation and resulted in a more preserved lumen in stented small vessels compared with the Sparrow-BMS and conventional balloon expandable BMS.

A randomized, controlled, multicenter trial to evaluate the safety and efficacy of Zotarolimus- vs. Paclitaxel-eluting stents in de novo occlusive lesions in coronary arteries: five-year results from the ZOMAXX I trial.

BACKGROUND: The ZOMAXX I trial tested the noninferiority of a zotarolimus-eluting coronary stent (ZoMaxx(™) ) when compared with a paclitaxel-eluting coronary stent (Taxus(™) Express(2™) ) in a randomized trial of percutaneous intervention for de novo coronary artery stenosis. Angiographic analysis at the primary endpoint of 9 months has been reported previously. The purpose of this follow-on analysis was to describe the clinical results of the ZoMaxx and Taxus cohorts of the ZOMAXX I trial after 5 years. METHODS AND RESULTS: In the ZOMAXX I trial, 199 patients received a ZoMaxx stent and 197 patients received a Taxus stent at 29 investigative sites in Europe, Australia, and New Zealand. The two groups were generally well matched with respect to both clinical and lesional characteristics, including the incidence of diabetes (ZoMaxx 22% vs. Taxus 26%; P = 0.29), reference vessel diameter (ZoMaxx 2.79 ± 0.43 mm vs. Taxus 2.81 ± 0.46 mm; P = 0.65), and lesion length (ZoMaxx 14.9 ± 5.7 mm vs. Taxus 14.6 ± 5.5; P = 0.61). Through 5 years of follow-up, a total of 21 patients had died, six patients had withdrawn, nine had been lost to follow-up, and 13 missed their 5-year visit, leaving a total of 347 patients for analysis (169 ZoMaxx and 178 Taxus). At the 5-year time point, there were no significant differences in any clinical metric including ischemia-driven target lesion revascularization (TLR; ZoMaxx 10.6% vs. Taxus 7.1%; P = 0.29), Q-wave myocardial infarction (ZoMaxx 1.5% vs. Taxus 1.0%; P = 0.99), definite/probable stent thrombosis (ZoMaxx 1.5% vs. Taxus 3.0%; P = 0.34), and cardiac death (ZoMaxx 3.0% vs. Taxus 1.0%; P = 0.28). CONCLUSIONS: After 5 years, the differences in clinical outcome between patients treated with ZoMaxx vs. Taxus stents did not reach statistical significance. However, the nominally higher rate of ischemia-driven TLR (10.6 vs. 7.1%) and the previously reported higher rate of restenosis after 9 months suggest that the ZoMaxx stent afforded less neointimal inhibition when compared with Taxus. © 2013 Wiley Periodicals, Inc.

Renal sympathetic nerve denervation for the treatment of resistant hypertension.

Improvements in BP control with pharmacotherapy undoubtedly translate into significant individual and population health benefits. RDN results in impressive reductions in BP, which are likely to be associated with further improvements in clinical outcomes. With more clinical trials and concurrent development of new devices, we hope that RDN holds up to its current accolades.

Proximal and distal maximal luminal diameters as a guide to appropriate deployment of the ABSORB everolimus-eluting bioresorbable vascular scaffold: a sub-study of the ABSORB Cohort B and the on-going ABSORB EXTEND Single Arm Study.

OBJECTIVES: Due to the limited distensibility of the everolimus-eluting bioresorbable vascular scaffold (ABSORB) compared to metallic platform stents, quantitative coronary arteriography (QCA) is a mandatory requirement for ABSORB deployment in the on-going ABSORB EXTEND Single-Arm Study. Visual assessment of vessel size in the ABSORB Cohort B study often lead to under and over-sizing of the 3 mm ABSORB in coronary vessels (recommended range of the vessel diameter ≥ 2.5 mm and ≤ 3.3 mm), with an increased risk of spontaneous incomplete scaffold apposition post ABSORB deployment. We report whether mandatory QCA assessment of vessel size pre-implantation, utilizing the maximal luminal diameter (Dmax) and established interpolated reference vessel diameter (RVD) measurements, has improved device/vessel sizing. METHODS: Pre-implantation post-hoc QCA analyses of all 101 patients from ABSORB Cohort B (102 lesions) and first consecutive 101 patients (108 lesions) from ABSORB EXTEND were undertaken by an independent core-laboratory; all patients had a 3 mm ABSORB implanted. Comparative analyses were performed. RESULTS: Within ABSORB Cohort B, a greater number of over-sized vessels (> 3.3 mm) were identified utilizing the Dmax compared to the interpolated RVD (17 vessels, 16.7% vs. 3 vessels, 2.9%; P = 0.002). Comparative analyses demonstrated a greater number of appropriate vessel-size selection (75 vessels, 69.4% vs. 48 vessels, 47.1%; P = 0.001), a trend towards a reduction in implantation in small (< 2.5 mm) vessels (29 vessels, 26.9% vs. 40 vessels, 39.2%; P = 0.057) and a significant decrease in the implantation in large (> 3.3 mm) vessels (4 vessels, 3.7% vs. 17 vessels, 16.7%; P = 0.002) in ABSORB EXTEND. Bland-Altman plots suggested a good agreement between operator and core-laboratory calculated Dmax measurements. CONCLUSIONS: The introduction of mandatory Dmax measurements of vessel size prior to ABSORB implantation significantly reduced the under-sizing of the 3.0 mm scaffold in large vessels validating the use of this technique in vessel sizing prior to ABSORB implantation.

A comparative assessment by optical coherence tomography of the performance of the first and second generation of the everolimus-eluting bioresorbable vascular scaffolds.

AIMS: The first generation of the everolimus-eluting bioresorbable vascular scaffold (BVS 1.0) showed an angiographic late loss higher than the metallic everolimus-eluting stent Xience V due to scaffold shrinkage. The new generation (BVS 1.1) presents a different design and manufacturing process than the BVS 1.0. This study sought to evaluate the differences in late shrinkage, neointimal response, and bioresorption process between these two scaffold generations using optical coherence tomography (OCT). METHODS AND RESULTS: A total of 12 lesions treated with the BVS 1.0 and 12 selected lesions treated with the revised BVS 1.1 were imaged at baseline and 6-month follow-up with OCT. Late shrinkage and neointimal area (NIA) were derived from OCT area measurements. Neointimal thickness was measured in each strut. Strut appearance has been classified as previously described. Baseline clinical, angiographic, and OCT characteristics were mainly similar in the two groups. At 6 months, absolute and relative shrinkages were significantly larger for the BVS 1.0 than for the BVS 1.1 (0.98 vs. 0.07 mm² and 13.0 vs. 1.0%, respectively; P = 0.01). Neointimal area was significantly higher in the BVS 1.0 than in the BVS 1.1 (in-scaffold area obstruction of 23.6 vs. 12.3%; P < 0.01). Neointimal thickness was also larger in the BVS 1.0 than in the BVS 1.1 (166.0 vs. 76.4 µm; P < 0.01). Consequently, OCT, intravascular ultrasound, and angiographic luminal losses were higher with the BVS 1.0 than with the BVS 1.1. At 6 months, strut appearance was preserved in only 2.9% of the BVS 1.0 struts, but remained unchanged with the BVS 1.1 indicating different state of strut microstucture and/or their reflectivity. CONCLUSION: The BVS 1.1 has less late shrinkage and less neointimal growth at 6-month follow-up compared with the BVS 1.0. A difference in polymer degradation leading to changes in microstructure and reflectivity is the most plausible explanation for this finding.