Rate Of Major Adverse Clinical Events Research Articles

Abstract 12870: Absence of LDL Measurement in Secondary Prevention is Associated With Increased Subsequent Major Adverse Clinical Event (MACE) That is Only Partially Mitigated by Statin Use

Introduction: There has been considerable discussion regarding the value of follow-up LDL-C measurements in secondary prevention of major adverse cardiac events (MACE). We therefore set out to determine in a large healthcare system whether measurement of LDL-C after an ASCVD event was associated with a difference in MACE during follow-up and whether differences in outcomes could be attributed to differences in statin use. Methods: The Intermountain Enterprise Data Warehouse was searched to identify all adults with a first encounter for ASCVD-including coronary artery disease (CAD), cerebrovascular disease (CVD), and peripheral arterial disease (PAD)—between January 1, 1995 and December 31, 2016 who survived the index event and were followed for ≥3 years or until death. Results: Patients (N=68,411) had an average age of 66±14 years; 65% were men; 70.3%, 21.0%, and 8.6% entered with CAD, CVD, and PAD, respectively. A statin was prescribed to 52% of patients during follow-up. A total of 33,698 (49%) did not have and 34,713 (51%) did have a follow-up LDL-C test prior to a subsequent MACE (death, MI, CVA, and revascularization) or end of follow-up. By 3 years, MACE occurred in 14,835 (37.4%) vs. 5,770 (20.1%) of those without vs. with an LDL-C measurement, respectively (Figure top). The multivariable hazard ratio for 3 year MACE based on measuring LDL-C was 0.47. The increased MACE rate associated with not measuring LDL-C was partially mitigated by statin use (Figure bottom). Only 44.7% vs. 58.9% of patients without vs. with LDL-C measurement were taking statins. Conclusion: These data indicate that there is a significant and clinically meaningful difference in MACE based on a follow-up measurement of LDL-C. Statin administration partially, but not completely mitigated the increased MACE rate. While these results are limited in that they are from a retrospective registry, they indicate that LDL-C should be measured, and statin should be administered after an initial ASCVD event.

Albumin-Bilirubin Score to Predict Outcomes in Patients with Idiopathic Dilated Cardiomyopathy.

ResumoFundamento:A disfunção hepática é uma variável postulada de prognóstico desfavorável na cardiomiopatia dilatada (CMD).Objetivo:Este estudo teve como objetivo investigar o valor prognóstico do escore albumina-bilirrubina (ALBI), um modelo relativamente novo para a avaliação da função hepática, em pacientes com CMD idiopática.Métodos:Um total de 1.025 pacientes com CMD idiopática foram incluídos retrospectivamente e divididos em três grupos com base nos escores de ALBI: grau 1 (≤ −2,60, n = 113), grau 2 (−2,60 a −1,39, n = 835) e grau 3 (> −1,39, n = 77). Foi analisada a associação do escore ALBI com eventos clínicos adversos maiores (ECAM) intra-hospitalares e mortalidade a longo prazo. Valor de p inferior a 0,05 foi considerado estatisticamente significativo.Resultados:A taxa de ECAM intra-hospitalares foi significativamente maior nos pacientes com grau 3 (2,7% versus 7,1% versus 24,7%, p < 0,001). A análise multivariada mostrou que o escore ALBI foi um preditor independente para ECAM intra-hospitalares (odds ratio ajustada = 2,80, IC 95%: 1,63 – 4,80, p < 0,001). Após seguimento mediano de 27 meses, 146 (14,2%) pacientes morreram. A curva de Kaplan-Meier indicou que a taxa cumulativa de sobrevida a longo prazo foi significativamente menor em pacientes com grau mais alto de ALBI (log-rank = 45,50, p < 0,001). O escore ALBI foi independentemente associado à mortalidade a longo prazo (hazard ratio ajustada = 2,84, IC 95%: 1,95 – 4,13, p < 0,001).Conclusão:O escore ALBI, como modelo de risco simples, pode ser considerado uma ferramenta de estratificação de risco para pacientes com CMD idiopática.

Clinical impact of FFR‐guided PCI compared to angio‐guided PCI from the France PCI registry

We sought to compare, in a national French registry (FrancePCI), the clinical impact of fractional flow reserve(FFR)-guided percutaneous coronary intervention(PCI) compared with angio-guided PCI at 1year. FFRhas become the invasive gold standard to quantify myocardial ischemia generated by a coronary stenosis in patients with chronic coronary syndrome, but in clinical practice it is still underutilised to guide PCIcompared to angiography (angio). We extracted from the FrancePCI database all chronic coronary syndrome patients treated with PCI for coronary stenosis <90% between 2014 and 2019. Our composite clinical endpoint was the rate of major adverse clinical events (MACE). Fourteen thousand three hundred eighty-fourpatients with 1-year clinical follow-up were included. Among them, 13,125 had angio-guided PCI (91%) and 1259 (9%) had FFR-guided PCI. We observed a significantly higher rate of MACE in the angio-guided group versus the FFR-guided group: 1478 (11.3%) versus 100 (7.9%) (p < 0.0001), respectively, with hazard ratio (HR) of 1.440, 95% confidence interval (CI) [1.211-1.713] (p = 0.0004). This result was driven by the higher occurrence of death in the angio-guided group versus the FFR-guided-group: 506 (3.9%) versus 17 (1.4%) (p < 0.0001), respectively, with HR of 2.845, 95% CI [2.099-3.856] (p < 0.0001). After adjustment for potential confounding factors, HRs were 1.287, 95% CI [1.028-1.613] (p = 0.028) for MACE and 2.527, 95% CI [1.452-4.399] (p = 0.001) for death. No significant differences between angio-guided PCI and FFR-guided PCI were observed for other clinical endpoints. FFR-guided PCI improves outcome at 1year compared to angio-guided PCI with a reduction of 64% of death.

Percutaneous Intramyocardial Septal Radiofrequency Ablation in Patients With Drug-Refractory Hypertrophic Obstructive Cardiomyopathy

Patients with hypertrophic obstructive cardiomyopathy (HOCM) and drug-refractory symptoms and outflow gradients have limited nonsurgical treatment options. The feasibility of percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) has been reported previously; however, procedural and medium-term outcomes are unknown. To describe the safety and medium-term outcomes of PIMSRA in a large patient cohort with drug-refractory HOCM. This was a single-arm, open-label study of PIMSRA in patients with drug-refractory HOCM. Patients presenting to the Xijing Hospital in Xi'an, China, between October 2016 to June 2020 with hypertrophic cardiomyopathy. Of 1314 patients presenting with HOCM, 244 fulfilled inclusion criteria of severe resting/provoked outflow gradients of 50 mm Hg or higher, and symptoms of New York Heart Association functional class of II or higher refractory to maximum tolerated medications. After discussion among the heart team, 40 patients underwent surgical or alcohol septal reduction therapy and 4 required treatment of significant coronary artery disease. PIMSRA performed in patients. The primary outcome was 30-day major adverse clinical events: death, emergency surgery, severe effusion requiring intervention, procedure-related stroke, bleeding, and stroke. Secondary outcomes included 30-day technical success and 90-day improvement in outflow obstruction. The mean (SD) age of 200 patients was 46.9 (14.0) years, and 125 (62.5%) were men. Resting or provoked left ventricular outflow tract gradients were 50 mm Hg or higher. The median (IQR) follow-up for all patients was 19 (6-50) months. Thirty-day major adverse clinical events rate was 10.5% (n = 21): there were 2 in-hospital/30-day deaths (1.0%), 7 patients (3.5%) with pericardial effusion requiring mini-thoracotomy, 12 patients (6%) with pericardial effusion requiring pericardiocentesis, and no bleeding or strokes. Other periprocedural complications included permanent right bundle branch block in 5 patients (2.5%), resuscitated ventricular fibrillation in 2 (1.0%), and septal branch aneurysm in 2 (1.0%). There were no permanent pacemaker implantations. At follow-up, maximum septal thickness was reduced from a mean (SD) of 24.0 (5.1) mm to 17.3 (4.4) mm (P < .001), and left ventricular outflow tract gradient was decreased from a mean (SD) of 79.0 (53.0) mm Hg to 14.0 (24.0) mm Hg (P < .001). Overall, 190 patients (96%) with HOCM were in New York Heart Association functional class I or II at last follow-up. This study found that PIMSRA in patients with drug-refractory HOCM may be an effective procedure for relief of left ventricular outflow tract obstruction and symptoms with acceptable complication rates. These results are encouraging and support the design of a randomized clinical trial against well-established septal reduction therapies.

The monocyte to high-density lipoprotein cholesterol ratio and outcomes in type 2 diabetes mellitus patients with non-ST-segment elevation acute coronary syndrome.

BackgroundThe monocyte to high-density lipoprotein cholesterol ratio (MHR) has been demonstrated as a new marker of inflammation. However, at present, the prognostic value of MHR in type 2 diabetes mellitus (T2DM) accompanied with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) undergoing percutaneous coronary intervention (PCI) is unclear.MethodsT2DM patients with NSTE-ACS undergoing PCI were consecutively enrolled from January 1, 2010 to December 31, 2014 and divided according to MHR value tertiles. Baseline, procedural, and follow-up data were collected. The primary outcomes were in-hospital major adverse clinical events (MACE). The prespecified secondary outcomes included any bleeding [as indicated by Bleeding Academic Research Consortium definition (BARC) grades 1–5] and death during follow-up.ResultsOf the 1,405 enrolled patients, the rates of in-hospital MACE (0.2%, 0.2%, and 1.3%, P=0.043) and bleeding (12.4%, 12.2%, and 17.1%, P=0.048) increased significantly in high MHR tertiles. After 1 year of follow-up, the rates of bleeding (15.0%, 14.5%, and 22.2%, P=0.002) and all-cause death (1.5%, 1.7%, and 4.3%, P=0.010) were higher in higher MHR tertiles. Our results also suggested that MHR was an independent predictor of in-hospital MACE [adjusted odds ratio =8.36; 95% confidence interval (CI): 1.57–44.47; P=0.013] and long-term bleeding (adjusted hazard ratio =1.21; 95% CI: 1.07–1.37; P=0.002). Receiver-operating characteristic curve analysis indicated that MHR >0.022 had a sensitivity of 75.0% and specificity of 72.7% for predicting in-hospital MACE [area under the curve (AUC) =0.722; 95% CI: 0.51–0.933; P=0.040]. Furthermore, Kaplan-Meier curves showed that a higher risk of all-cause death in long-term follow-up was prevalent in patients with high MHR (P=0.033).ConclusionsThe increased level of MHR was related to in-hospital MACE and long-term bleeding events in T2DM patients with NSTE-ACS undergoing PCI.

Thin-cap fibroatheroma predicts clinical events in diabetic patients with normal fractional flow reserve: the COMBINE OCT-FFR trial.

The aim of this study was to understand the impact of optical coherence tomography (OCT)-detected thin-cap fibroatheroma (TCFA) on clinical outcomes of diabetes mellitus (DM) patients with fractional flow reserve (FFR)-negative lesions. COMBINE OCT-FFR study was a prospective, double-blind, international, natural history study. After FFR assessment, and revascularization of FFR-positive lesions, patients with ≥1 FFR-negative lesions (target lesions) were classified in two groups based on the presence or absence of ≥1 TCFA lesion. The primary endpoint compared FFR-negative TCFA-positive patients with FFR-negative TCFA-negative patients for a composite of cardiac mortality, target vessel myocardial infarction, clinically driven target lesion revascularization or unstable angina requiring hospitalization at 18 months. Among 550 patients enrolled, 390 (81%) patients had ≥1 FFR-negative lesions. Among FFR-negative patients, 98 (25%) were TCFA positive and 292 (75%) were TCFA negative. The incidence of the primary endpoint was 13.3% and 3.1% in TCFA-positive vs. TCFA-negative groups, respectively (hazard ratio 4.65; 95% confidence interval, 1.99-10.89; P < 0.001). The Cox regression multivariable analysis identified TCFA as the strongest predictor of major adverse clinical events (MACE) (hazard ratio 5.12; 95% confidence interval 2.12-12.34; P < 0.001). Among DM patients with ≥1 FFR-negative lesions, TCFA-positive patients represented 25% of this population and were associated with a five-fold higher rate of MACE despite the absence of ischaemia. This discrepancy between the impact of vulnerable plaque and ischaemia on future adverse events may represent a paradigm shift for coronary artery disease risk stratification in DM patients.

Clinical Impact of FFR-Guided PCI Compared to Angio-Guided PCI From the France PCI Registry

Background: Fractional Flow Reserve (FFR) has become the invasive gold standard to quantify myocardial ischemia generated by a coronary stenosis in patients with chronic coronary syndrome, but in clinical practice it is still underutilised to guide percutaneous coronary intervention (PCI) compared to angiography (angio). Methods: We sought to compare, in a national French registry (France PCI), the clinical impact of FFR-guided PCI compared with angio-guided PCI at one year. We extracted from the France PCI database all chronic coronary syndrome patients treated with PCI for coronary stenosis <90% between 2014 and 2019. Our composite clinical endpoint was the rate of major adverse clinical events (MACE) defined as the composite of the following endpoints: rates of death, myocardial infarction, stent thrombosis, revascularisation, stroke, and bleeding with a BARC score ≥ 3. Findings: 14384 patients with one-year clinical follow-up were included. Among them, 13125 had angio-guided PCI (91%) and 1259 (9%) had FFR-guided PCI. We observed a significantly higher rate of MACE in the angio-guided group versus the FFR-guided group: 1478 (11·3%) versus 100 (7·9%) (p<0·0001), respectively, with Hazard Ratio (HR) of 1·440, 95% confidence Interval (CI) [1·211-1·713] (p=0·0004). This result was driven by the higher occurrence of death in the angio-guided group versus the FFR-guided-group: 506 (3·9%) versus 17 (1·4%) (p<0·0001), respectively, with HR of 2·845, 95% CI [2·099-3·856] (p<0·0001). After adjustment for potential confounding factors, HRs were 1·287, 95% CI [1·028-1·613] (p=0·028) for MACE and 2·527, 95% CI [1·452-4·399] (p=0·001) for death. No significant differences between angio-guided PCI and FFR-guided PCI were observed for other clinical endpoints. Interpretation: Our study showed that FFR was the most important predictor of death after adjustment for confounding factors. PCI guided with FFR improves outcome at one year compared to angio-guided PCI with a reduction of 64M of death at one year. Funding: None Declaration of Interest: The authors do not have any conflict of interest to report related to this manuscript. Ethical Approval: The French Persons Protection Committee (IR3888) approved the study protocol (no. 15-231). Data file collection and storage were approved by the French National Commission for Data Protection and Liberties (no. 2014-073).

Impact of metabolic syndrome on short-term outcome of carotid revascularization: a large sample size study in Chinese population.

BackgroundMetabolic syndrome (MetS) is relatively common worldwide and an important risk factor for cardiovascular diseases. It is closely linked to arterial stiffness of the carotid artery. However, the association of MetS with the safety of carotid revascularization has been rarely studied. The aim of this study was to observe the current status of MetS and its components in Chinese carotid revascularized patients, and investigate the impact on major adverse clinical events (MACEs) after carotid endarterectomy (CEA) or carotid artery stenting (CAS).MethodsFrom January 2013 to December 2017, patients undergoing CEA or CAS in the Neurosurgery Department of Xuanwu Hospital were retrospectively recruited. The changes in prevalence of MetS and each component with time were investigated. The primary outcome was 30-day post-operative MACEs. Univariable and multivariable analyses were performed to identify the impact of MetS on CEA or CAS.ResultsA total of 2068 patients who underwent CEA (766 cases) or CAS (1302 cases) were included. The rate of MetS was 17.9%; the prevalence rate of MetS increased with time. The occurrence rate of MACEs in CEA was 3.4% (26 cases) and in CAS, 3.1% (40 cases). There was no statistical difference between the two groups (3.4% vs. 3.1%, P = 0.600). For CEA patients, univariate analysis showed that the MACE (+) group had increased diabetes history (53.8% vs. 30.9%, P = 0.014) and MetS (34.6% vs. 15.8%, P = 0.023). For CAS patients, univariate analysis showed that the MACE (+) group had increased coronary artery disease history (40.0% vs. 21.6%, P = 0.006) and internal carotid artery tortuosity (67.5%% vs. 37.6%, P < 0.001). Furthermore, the MACE (+) group had higher systolic blood pressure (143.38 ± 22.74 vs. 135.42 ± 17.17 mmHg, P = 0.004). Multivariable analysis showed that the influencing factors for MACEs in CEA included history of diabetes (odds ratio [OR] = 2.345; 95% confidence interval [CI] = 1.057–5.205; P = 0.036) and MetS (OR = 2.476; 95% CI = 1.065–5.757; P = 0.035). The influencing factors for MACEs in CAS included systolic blood pressure (OR = 1.023; 95% CI = 1.005–1.040; P = 0.010), coronary artery disease (OR = 2.382; 95% CI = 1.237–4.587; P = 0.009) and internal carotid artery tortuosity (OR = 3.221; 95% CI = 1.637–6.337; P = 0.001).ConclusionsThe prevalence rate of MetS increased with time in carotid revascularized patients. MetS is a risk for short-term MACEs after CEA, but not CAS.

P1898Prevalence and risk of DOACs inappropriate dosing in atrial fibrillation. An analysis of the Swiss-AF and BEAT-AF registries

Abstract Background Direct oral anticoagulants (DOACs) have a similar efficacy in terms of stroke and mortality reduction as compared to Vitamin K-Antagonists (VKAs) and improved safety with regards to intracranial haemorrhage in patients with non-valvular atrial fibrillation (AF). Dose of DOACs needs to be adjusted according to age, weight, renal function and concomitant medication. Yet, off-label dosages have been reported in 11 - 45% of patients (on average 20%). Purpose To assess the prevalence of inappropriate DOAC-dosing according to the official prescribing information in two large prospective Swiss AF cohorts (Swiss-AF and BEAT-AF) and to evaluate its correlation with adverse clinical outcomes. Methods All 3267 patients taking oral anticoagulants were stratified at baseline as receiving DOACs (adequately dosed, under- or overdosed) or VKAs. Appropriateness of DOAC dosing was assessed based on age (≥80 years), weight (≤60kg) and renal function (serum creatinine ≥133μmol/l [apixaban]; creatinine clearence ≤50ml/min [all other DOACs]). Clinical outcomes were collected during a median follow-up of 2.96 years. Major adverse clinical events (MACE) consisted of a combination of myocardial infarction, cardiac death, ischemic stroke and systemic embolism. Safety was assessed by occurrence of any bleeding event. Results 1902 patients (58%) were on VKAs and 1365 on DOACs (42%). In the DOAC group, 1149 patients received a dose consistent with drug labelling (84%), 133 (10%) received an inappropriately high and 83 (6%) an inappropriately low dose. Overdosed patients were older than those adequately treated and more likely female, had a lower BMI and a higher CHA2DS2-VASc score (4 vs. 3 points) (p&lt;0.001 for all). Underdosed patients were more likely to have concomitant antiplatelet therapy (p&lt;0.001). Both off-label groups were more likely to have a history of coronary artery disease, heart failure and chronic kidney disease (p&lt;0.001). Kaplan-Meier cumulative incidence rates for the first occurrence of MACE or bleedings are provided in Figure 1. Overdosed patients had an almost two-fold higher risk of bleeding (9.0 vs. 5.0 events per 100 patient-years compared to correctly dosed DOACs and to VKAs) and a higher rate of MACE (5.1 vs. 2.3 events per 100 patient years compared to correctly dosed DOACs and 5.1 vs. 3.4 compared to VKAs). Underdosing did not seem to be associated with a relevant increase in ischemic or bleeding events as compared to correctly dosed DOACs and VKAs (see Figure 1). Figure 1. Kaplan-Meier incidence curves Conclusion Inadequate DOACs dosing was found in 1 in 6 patients and correlated with a higher burden of comorbidities at baseline. Underdosing correlated with concomitant antiplatelet therapy. Overdosing was associated with adverse clinical outcome for ischemic and bleeding events.

IP127. Risk Factors for Major Adverse Clinical Events After Carotid Endarterectomy Based on Patient Age and Symptoms

Carotid endarterectomy (CEA) is a well-established surgical procedure in the treatment of symptomatic and asymptomatic carotid atherosclerosis. We reviewed the American College of Surgeons National Surgical Quality Improvement Program database to assess which factors contribute to major adverse clinical events (MACEs) in the 30-day postoperative period. The American College of Surgeons National Surgical Quality Improvement Program database was queried among all participating institutions for CEAs performed in 2011 to 2015. Patients’ demographic data, comorbid conditions, preprocedure medication use, and operative variables were analyzed using multivariate logistic regression analysis to determine predictors of postoperative MACEs. There were 17,888 patients who underwent CEA analyzed; the patients were grouped by age (<75 and ≥75 years old) and whether they presented symptomatically (SYM) or asymptomatically (AS) before the procedure. For AS patients <75 years, the rate of stroke, myocardial infarction (MI), death, and MACEs was 1.8%, 1.6%, 0.4%, and 3.6%, respectively; for patients ≥75 years, rates were 1.7%, 2.3%, 0.7%, and 4.3%. The rate of MI was significantly higher in older patients (P = .0133). The odds of postoperative stroke was 73% higher (P < .0011) in diabetics, 57% higher (P = .0109) with American Society of Anesthesiologists (ASA) score 4 or 5, and 34% higher with operative time >2.5 hours (P = .0189). SYM patients ≥75 years had 1.1 times higher risk of postoperative stroke if they had insulin-dependent diabetes (P = .0148). Reintubation and reoperation were associated with increased risk of postoperative stroke in both age groups, whether SYM or AS (P < .0001), as well as postoperative MI (P < .0001). AS patients <75 years had higher likelihood of postoperative MI if they had history of congestive heart failure (P = .0257) and operative time >2.5 hours (P = .0033). SYM patients ≥75 years had 46% higher likelihood of postoperative MI if operative time >2.5 hours (P = .0023). Mortality was higher in AS patients <75 years with ASA score 4 or 5 (P = .0006) and those ≥75 years (P = .0072) and in patients who were reintubated (P < .0001). In SYM patients <75 years, the rate of stroke, MI, death, and MACEs was 4.8%, 1.4%, 0.9%, and 6.3%, respectively. In those ≥75 years, rates were 4.9%, 2.6%, 1.6%, and 7.8%. Older patients had higher rates of MI and MACEs (P = .001 and P= .0103). SYM patients <75 years had higher mortality if they had chronic obstructive pulmonary disease (P = .0002) and diabetes (P = .0062). SYM patients of all ages had higher mortality with postoperative stroke or MI (P < 0.0001). Patients 75 years or older are at increased risk of postoperative MI after CEA regardless of symptomatic status. Diabetes, increased operative time, and ASA score 4 or 5 were associated with higher MACE rates among all age groups.

High-volume forced diuresis with matched hydration using the RenalGuard System to prevent contrast-induced nephropathy: A meta-analysis of randomized trials.

Contrast-induced nephropathy (CIN) is a well-recognized complication of coronary angiography that is associated with poor outcomes. Several small randomized controlled trials (RCTs) have recently shown that in patients with chronic kidney disease (CKD), furosemide-induced forced diuresis with matched hydration using the RenalGuard system can prevent its occurrence. However, individual studies have been underpowered and thus cannot show significant differences in major clinical endpoints. Forced diuresis with matched hydration using the RenalGuard system improves clinical outcomes in patients undergoing coronary angiography. Scientific databases and websites were searched for relevant RCTs. The pooled risk ratios were calculated using random-effects models. The primary endpoint was CIN, and the secondary endpoints were major adverse clinical events (MACEs) and the need for renal replacement therapy. Data from 3 trials including 586 patients were analyzed. High-volume forced diuresis with matched hydration using the RenalGuard system decreased risk of CIN by 60% (risk ratio: 0.40, 95% confidence interval: 0.25 to 0.65, P < 0.001), MACE rate by 59%, and the need for renal replacement therapy by 78%, compared with the standard of care. In patients with CKD undergoing coronary angiography, high-volume forced diuresis with matched hydration using the RenalGuard system significantly reduces the risk of CIN, MACE rate, and the need for renal replacement therapy. Larger RCTs with sufficient power are needed to confirm these findings.

Evaluation of therapy management and outcome in Takotsubo syndrome

BackgroundTo date there is no validated evidence for standardized treatment of patients with Takotsubo syndrome (TTS). Medication therapy after final TTS diagnosis remains unclear. Previous data on patient outcome is ambivalent. Aim of this study was to evaluate medication therapy in TTS and to analyze patient outcome.MethodsWithin an observational retrospective cohort study we analyzed our medical records and included 72 patients with TTS that underwent cardiovascular magnetic resonance imaging (CMR) after a median of 2 days interquartile range (IQR 1–3.5). We investigated medication therapy at discharge. Medication implementation and major adverse clinical events (MACE) were prospectively evaluated after a median follow-up of 24 months (IQR 6–43). Left ventricular function, myocardial oedema and late gadolinium enhancement were analyzed in a CMR follow-up if available.ResultsAntithrombotic therapy was recommended in 69 (96%) patients including different combinations. Antiplatelet monotherapy was prescribed in 28 (39%) patients. Dual antiplatelet therapy was recommended in 29 (40%) patients. Length of therapy duration varied from one to twelve months. Only in one case oral anticoagulation was prescribed due to apical ballooning with a left ventricular ejection fraction <30%. In all other cases oral anticoagulation was recommended due to other indications. ß-adrenoceptor antagonists and ACE inhibitors were recommended in 63 (88%), mineralocorticoid receptor antagonists were prescribed in 31 (43%) patients. After a median of 2 months (IQR 1.3–2.9) left ventricular function significantly recovered (49.1% ± 10.1 vs. 64.1% ± 5.7, P < 0.001) and myocardial oedema significantly decreased (13.5 ± 11.3 vs. 0.6% ± 2.4, P = <0.001) in the CMR follow-up. The 30-day mortality was 1%. MACE rate after 24 months was 12%.ConclusionAlthough therapy guidelines for TTS currently do not exist, we found that the majority of patients were treated with antithrombotic and heart failure therapy for up to twelve months. Left ventricular function and myocardial oedema recovered rapidly within the first two months. Outcome analysis showed a low bleeding rate and a high short-term survival. Therefore, TTS patients might benefit from antithrombotic and heart failure therapy at least for the first two months.

Efficacy of everolimus-eluting stent implantation in patients with small coronary arteries (≤2.5 mm): outcomes of 3-year clinical follow-up

Previous studies have demonstrated that patients with small coronary artery lesions are at increased risk for late cardiac events after percutaneous coronary intervention. It remains uncertain whether second-generation drug-eluting stents have an advantage over first-generation drug-eluting stents in patients with small vessel lesions. Our aim was to compare in the 3-year clinical impact between second-generation everolimus-eluting stents (EES) and first-generation sirolimus-eluting stents (SES) in small vessel lesions. Four-hundred forty-four patients with small vessel lesions defined as reference diameter <2.5mm were treated with EES (237 patients, 265 lesions) or SES (207 patients, 220 lesions) and completed 3-year follow-up. We compared the major adverse clinical events (MACE) between the two groups. EES had no significant impact on the MACE rate compared with SES (4.6 vs. 7.2%, p=0.14). No significant differences were observed in the individual components of cardiac death (1.7 vs. 1.9%, p=0.78), myocardial infarction (1.3 vs. 3.4%, p=0.12), and ischemia-driven target lesion revascularization (2.3 vs. 4.6%, p=0.13) in EES and SES, respectively. Stent thrombosis, however, was significantly less in the EES group than in the SES group (0.7 vs. 3.4%, HR: 0.53, 95% CI 0.38-0.88, p<0.05). EES implantation did not significantly impact 3-year MACE rates compared to SES implantation in small vessel lesions. A significant reduction in the overall rate of stent thrombosis was observed in recipients of EES. While the SES group showed increasing rates of late and very late thrombosis, the EES group did not. EES offers a safe and effective treatment for small vessel lesions.

29 Outcomes of PCI versus medical therapy in a surgically ineligible cohort from a single centre

Introduction There are limited data describing outcomes in patients who have been turned down for surgical revascularisation (CABG) on the basis of prohibitive risk. Methods We analysed cardiovascular outcomes (composite major adverse clinical event rate, MACE: all cause mortality; cardiac death, myocardial infarction, MI; repeat revascularisation; and stroke) in a retrospective cohort of patients turned down for elective CABG who were treated with PCI or medical therapy in a single centre over a 4 year period. Results Higher rates of cognitive impairment, chronic total occlusion, peripheral vascular disease (PVD) and atrial fibrillation were seen in the medical treatment group (n = 117). There was no difference between MACE rates in the PCI (n = 131) and medical groups at 30d however a significant difference emerged in MACE at 1 year, 2 year and 3 years due to a reduction in all cause death, cardiac death and MI in the PCI group. There was no difference between MACE rates in the high SYNTAX tertile, unless cases where residual SYNTAX was greater than 22 were excluded from the analysis. Independent predictors of MACE within the PCI group were SYNTAX score and diabetes, whereas peripheral vascular disease, haemodialysis and left main involvement were all associated with negative outcomes in the medical group. Conclusion Our data suggests a benefit from PCI revascularisation in patients ineligible for surgery at 1 year and a MACE-free survival benefit from PCI up to 3 years in patients within low and intermediate SYNTAX tertiles compared to medical therapy.

Impact of side branch stenting on five-year long-term clinical outcome with the bifurcation-dedicated Axxess Biolimus A9-eluting stent system.

Our aim was to evaluate the five-year clinical impact of side branch (SB) stenting with a drug-eluting stent (DES) following Axxess stent implantation in coronary bifurcation lesions. Four hundred patients treated with Axxess were pooled from the AXXESS Plus and DIVERGE five-year follow-up studies. We compared unadjusted and propensity-adjusted major adverse clinical events (MACE) between Axxess with no SB stenting ("Axxess provisional") versus Axxess with SB stenting ("Axxess additional"). "Axxess additional" had no impact on the MACE rate, with unadjusted and adjusted HR 1.59 (95% CI: 0.95-2.64) and 1.37 (95% CI: 0.88-2.13), respectively. No differences were seen in the individual components of death, myocardial infarction and ischaemia-driven target lesion revascularisation, respectively, both in unadjusted (HR 0.92 [95% CI: 0.38-2.19]; HR 1.73 [95% CI: 0.78-3.82]; HR 1.65 [95% CI: 0.84-3.26]) and adjusted analysis (HR 0.92 [95% CI: 0.41-2.09]; HR 1.13 [95% CI: 0.59-2.17]; HR 1.31 [95% CI: 0.74-2.31]). No differences in definite stent thrombosis were seen with unadjusted HR 2.1 (95% CI: 0.45-9.88) and adjusted HR 1.0 (95% CI: 0.32-3.1). Stenting the SB following Axxess implantation does not impact on long-term clinical outcomes compared to MV stenting only. The Axxess stent system offers a safe and tailored alternative for the treatment of coronary bifurcation lesions.

Abstract 9381: Comparison of Clinical Characteristics and Adverse Outcomes in Pregnant Women with Cardiomyopathy Subtypes at the Time of Delivery in the US: 2006-2010

Introduction: Investigation of patient characteristics and outcomes in women with cardiomyopathy (CDM) at the time of delivery has been limited. The aim of this study was to determine the clinical characteristics and outcomes in women with peripartum (PCDM) and hypertrophic cardiomyopathy (HCDM), and the predictors for adverse clinical outcomes in pregnant women at the time of delivery. Methods and Results: The Healthcare Cost and Utilization Project’s National Inpatient Sample was screened for hospital admissions for delivery in pregnant women with CDM subtypes (peripartum, hypertrophic and all others) from 2006-2010. Clinical characteristics and maternal outcomes were identified in women with subtypes of CDM and without. The primary outcome of interest was major adverse clinical events (MACE), a composite of in-hospital death, acute myocardial infarction, heart failure, arrhythmia, cerebrovascular event, or embolic event. Our study population consisted of 2,078 patients with CDM and 4,438,439 patients without CDM. Of those with CDM, 52 (2.5%) had HCDM, 1039 (50.0%) had PCDM, and 987 (47.5%) were classified as other CDM (OCDM). PCDM cohort was more likely to be insured by Medicaid and the HCDM patients were more likely to deliver at a teaching hospital (p&lt;0.01 for all). The PCDM and all OCDM cohorts had a larger proportion of black patients and most were from the South. PCDM patients experienced the highest rates of MACE (46%), compared with HCDM (23%) or OCDM (38.9%), mainly driven by heart failure and arrhythmia. Maternal mortality in all CDM subgroups was extremely low (&lt; 0.5%). Significant predictors of MACE in the PCDM cohort were the presence of valvular heart disease (OR 2.16, 95% CI 1.49-3.14), severe pre-eclampsia (OR 1.54, 95% CI: 1.08-2.21), and Cesarean delivery (OR 1.36, 95% CI: 1.04-1.78); delivery at a teaching hospital was associated with a reduction in MACE. In multivariable analysis, the presence of PCDM (OR 2.22, 95% CI 1.07-4.55) was independently predictive of MACE. Conclusions: Peripartum CDM patients had the highest likelihood of MACE compared to hypertrophic and all other CDM subtypes.

87 Outcomes of PCI Versus Medical Therapy in a Surgical Turndown Cohort from a Single Centre

Background:There is limited data describing outcomes in patients undergoing percutaneous coronary intervention (PCI) or medical therapy who have been turned down for surgical revascularisation (CABG) on the basis of prohibitive...

Long-Term Clinical Outcome of a Single Stent Approach With and Without a Final Kissing Balloon Technique for Coronary Bifurcation

The advantages of the final kissing balloon technique (FKB) in a provisional 1-stent approach are under debate. Long-term clinical outcomes remain unclear due to limited data. Of 2,132 patients (2,502 lesions) enrolled in the TAXUS Japan Postmarket Surveillance Study at 56 centers between July 2007 and December 2008, patients having coronary bifurcation treated with a single cross-over stenting with FKB (FKB-group: 132 patients/137 lesions) were compared to those treated without FKB (no-FKB-group: 121 patients/124 lesions). The no-FKB-group was also compared with non-bifurcation patients who had a single-stent implantation (814 patients/937 lesions). The primary outcome was MACE (major adverse clinical events), defined as cardiac death, myocardial infarction and target vessel revascularization (TVR) at 3 years. Higher late loss and binary restenosis were found in the main vessel (MV) of the FKB-group at the 9-month angiogram compared to the no-FKB-group. At 3 years, MACE was numerically higher (14.6% vs. 6.9%, P=0.07) and TVR was significantly higher (14.6% vs. 5.9%, P<0.05) in the FKB-group compared with the no-FKB-group. The rate of MACE (6.9% vs. 10.4%, P=0.34) and TVR (5.9% vs. 7.7%, P=0.57) were similar between the no-FKB and non-bifurcation patients. In a 1-stent approach, FKB was associated with worse angiographic outcomes in the MV, and did not demonstrate any clinical benefit over the long-term follow-up period. Cross-over stenting without FKB showed similar clinical outcomes to patients without bifurcation.

Dynamic annuloplasty for mitral regurgitation

The MiCardia DYANA annuloplasty system (MiCardia Corp, Irvine, Calif) is a nitinol-based dynamic complete ring that allows modification of the septal-lateral diameter under transesophageal echocardiography guidance in the loaded beating heart after mitral valve repair. Shape alteration is induced by radiofrequency via detachable activation wires. This multicenter study reports the first human experience with this device. Patients (n = 35, 67 ± 8 years) with degenerative (n = 29), functional/ischemic (n = 5), or rheumatic (n = 1) mitral regurgitation underwent mitral valve repair using the new device. We analyzed the occurrence of death, endocarditis, ring dehiscence, systolic anterior motion, thromboembolism, pulmonary edema, heart block, ventricular arrhythmia, hemolysis, or myocardial infarction at 30 days (primary end point) and 6 months (secondary end point) postprocedure. All patients exhibited mitral regurgitation of 2 or less early postoperatively and at 6 months follow-up. In 29 patients, the initial mitral valve repair result was satisfactory and no ring activation was required. In 6 patients, the nitinol-based ring was deformed intraoperatively postrepair with further improvement of mitral regurgitation in all cases (preactivation: 0.9 ± 0.2, postactivation: 0.2 ± 0.3; P = .001). One death (2.9%, multisystem organ failure, non-device related), 2 ventricular arrhythmias (5.7%), and 1 heart block (2.9%) occurred, all in the first 30 days after surgery. No additional major adverse clinical events occurred later than 1 month postprocedure (total observed major adverse clinical event rate 11.5%). The implantation of the new dynamic annuloplasty ring allows for safe mitral valve repair. The option of postrepair modification of the septal-lateral diameter by radiofrequency may further optimize repair results.

Endothelial progenitor cell capturing stent and short dual antiplatelet therapy in patients on chronic anti-vitamin k regimen undergoing percutaneous coronary interventions: long-term outcomes of a single centre registry

To evaluate outcomes of the endothelial progenitor cell (EPC) capture stent in patients on chronic anti-vitamin K (AVK) regimen, requiring percutaneous coronary intervention (PCI). Between February 2007 and February 2008, 78 consecutive patients under chronic AVK treatment undergoing PCI were enrolled in the registry and received an EPC capture stent. The incidence of comorbid conditions was analysed by the Charlson index. Dual antiplatelet therapy (DAT, aspirin and clopidogrel) was prescribed for one month only together with the AVK treatment, after PCI. Major adverse clinical events (MACE) rate, included death, acute myocardial infarction (MI) or target lesion revascularisation (TLR), incidence of stent thrombosis and rate of haemorrhagic events were collected. A?Charlson index >3 was present in 89% of patients. At 14±8 months the cumulative rate of MACE was 22%: 10 deaths (six cardiac deaths), and six TLR. No MI or definitive/probable stent thromboses occurred during follow-up. Four major haemorrhagic episodes occurred during follow-up, all of them after the first month. Patients on AVK treatment represent a highly comorbid population with a high event rate after PCI. The strategy of PCI with an EPC capture stent and short duration of DAT may be used in patients who need a short-term DAT.