P2808Absorb bioresorbable scaffold vs. Xience metallic stent: outcomes in the AIDA trial stratified by SYNTAX score

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
R Y G Tijssen ◽  
R P Kraak ◽  
I M Van Dongen ◽  
J Elias ◽  
S H Hofma ◽  
...  

Abstract Aims Extent of coronary artery disease (CAD) may affect outcomes after percutaneous coronary intervention (PCI). In this pre-specified subgroup analysis of the AIDA trial we evaluated the impact of SXscore on clinical outcomes Methods and results AIDA was a multicenter trial comparing Absorb with Xience. SX score was assessed using the baseline diagnostic angiograms. Each coronary lesion with diameter stenosis ≥50% in vessels ≥1.5 mm was scored. All lesion scores were combined to provide the overall SXscore. The angiographic SXscore calculations were performed by core laboratory analysts who were blinded for clinical events (Cardialysis B.V., Rotterdam, The Netherlands). Clinical outcomes were subsequently stratified according to SXscore tertiles: SXlow (SXcore ≤8), SXmid (SXscore >8 and ≤15) and SXhigh (>15). The primary endpoint of this AIDA-trial substudy was target vessel failure (TVF), defined as a composite of cardiac death, target vessel myocardial infarction and target vessel revascularization. The SXscore was prospectively calculated in 1661 of the 1845 patients (90%). The SXscore ranged from 1 to 57, with a mean±SD of 12.9±8.5 and a median of 11 (Q1-Q3 7–17). In this analysis the SXscore tertiles were defined as SXlow (SXcore ≤8) (n=589), SXmid (SXscore >8 and ≤15) (n=538), and SXhigh (>15) (n=534). Patients in the SXhigh group were older, had a more extensive medical history for previous revascularizations (both PCI and coronary artery bypass grafting), and were more likely to present with a ST-elevation myocardial infarction. At 2 follow-up the Kaplan-Meier estimates of TVF for the overall AIDA study population was 15.5% in the SXhigh tertile, 10.4% in the SXmid tertile and 4.7% in the SXlow tertile (hazard ratio (HR) 3.53 95% CI 2.28–5.45; P<0.001). The event rate of the primary endpoint of TVF was numerically lower in Absorb when compared to Xience (3.7% versus 5.6%; HR 0.64; 95% CI 0.29 - 1.40; p=0.257) in the SXlow tertile. Patients treated with Absorb and a SXscore >8 had significantly higher event rates as compared to patients with a SXscore ≤8. The rates of TVF in the Absorb BVS population are 15.5% (SXhigh), 11.4% (SXmid), and 3.7% (SXlow), with a significant difference between the SXlow versus SXmid (HR 3.27; 95% CI 1.61–6.68; p=0.001) and SXlow versus SXhigh (HR 4.57; 95% CI 2.29–9.10; p<0.001). Target Vessel Failure in Absorb BVS Conclusions This study demonstrates that implantation of the Absorb in patients with a SXscore ≤8 is associated with numerically lower TVF rates as compared to the Xience drug-eluting stent. The rate of scaffold thrombosis in this SXlow tertile, while still higher for Absorb, is more acceptable than in SXmid and SXhigh score tertiles. Higher SXscore (i.e. >8), both Sxmid and SXhigh, however, appears to be associated with markedly increased risk of device thrombosis, revascularization and myocardial infarction in patients treated with the Absorb. Acknowledgement/Funding The AIDA trial was financially supported by an unrestricted research grant from Abbott Vascular

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Pannipa Suwannasom ◽  
Siriporn Athiksakul ◽  
Tasalak Thonghong ◽  
Vorarit Lertsuwunseri ◽  
Jarkarpun Chaipromprasit ◽  
...  

Abstract Background Despite numerous studies supporting the outperformance of ultrathin-strut bioresorbable polymer sirolimus-eluting stent (Orsiro SES, Biotronik AG), the generalizability of the study results remains unclear in the Asian population. We sought to evaluate the clinical outcomes of the Orsiro SES in unselected Thai population. Methods The Thailand Orsiro registry was a prospective, open-label clinical study evaluating all patients with obstructive coronary artery disease implanted with Orsiro SES. The primary endpoint was target lesion failure (TLF) at 12 months. TLF is defined as a composite of cardiac death, target vessel myocardial infarction (TVMI), emergent coronary artery bypass graft (CABG), and clinically driven target lesion revascularization (CD-TLR). Patients with diabetes, small vessels (≤ 2.75 mm), chronic total occlusions (CTOs), and acute myocardial infarction (AMI) were pre-specified subgroups for statistical analysis. Result A total of 150 patients with 235 lesions were included in the analysis. Half of the patients (53.3%) presented with AMI, and 24% had diabetes. Among 235 lesions, 93(39.4%) were small vessels, and 24(10.2%) were chronic total occlusions. The primary endpoint, TLF at 12 months, occurred in eight patients (5.3%), predominately caused by cardiac death. By contrast, the incidences of TVMI and CD-TLR were null. The outcomes in pre-specified subgroup were not different from the overall population (all p > 0.05). One definite late stent thrombosis(0.7%) was incidentally observed during primary percutaneous coronary intervention to the non-target vessel. Conclusion The safety and efficacy of the ultrathin strut sirolimus-eluting stent in unselected cases are confirmed in the Thailand Orsiro registry. Despite the high proportion of pre-specified high-risk subgroups, the excellent stent performance was consistent with the overall population. Trial Registration TCTR20190325001.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Tomonori Akasaka ◽  
Seiji Hokimoto ◽  
Noriaki Tabata ◽  
Kenji Sakamoto ◽  
Kenichi Tsujita ◽  
...  

Background: Based on 2011 ACCF/AHA/SCAI PCI guideline, it is recommended that PCI should be performed at hospital with onsite cardiac surgery. But, recent data suggests that there is no significant difference in clinical outcomes following primary or elective PCI between hospitals with and without onsite cardiac surgery. The proportion of PCI centers without onsite cardiac surgery comprises approximately more than half of all PCI centers in Japan. We examined the impact of with or without onsite cardiac surgery on clinical outcomes following PCI to ACS. Methods: From Aug 2008 to March 2011, subjects (n=2288) were enrolled from the Kumamoto Intervention Conference Study (KICS), which is a multicenter registry, and enrolling consecutive patients undergoing PCI in 15 centers in Japan. Patients were assigned to two groups treated in hospitals with (n=1954) or without (n=334) onsite cardiac surgery. Clinical events were followed up for 12 months. Primary endpoint was in-hospital death, cardiovascular death, myocardial infarction, and stroke. And we monitored other events those were non-cardiovascular deaths, bleeding complications, revascularizations, and emergent CABG. Results: There was no overall significant difference in primary endpoint between hospitals with and without onsite cardiac surgery (9.6%vs9.5%; P=0.737). There was also no significant difference when events in primary endpoint were considered separately. In other events, only revascularization was more frequently seen in hospitals with onsite cardiac surgery (22.1%vs12.9%; P<0.001). Kaplan-Meier analysis for primary endpoint showed that there was no significant difference between two groups (Log Rank P=0.943). By cox proportional hazards model analysis for primary endpoint, without onsite cardiac surgery was not a predictive factor for primary endpoint (HR 0.969, 95%CI 0.704-1.333; P=0.845). We performed propensity score matching analysis to correct for the disparate patient numbers between two groups, and there was also no significant difference for primary endpoint (6.9% vs 8.0%; P=0.544). Conclusions: There is no significant difference in clinical outcomes following PCI for ACS between hospitals with and without onsite cardiac surgery backup in Japan.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Dariusz Dudek ◽  
Petr Widimsky ◽  
Leonardo Bolognese ◽  
Patrick Goldstein ◽  
Christian Hamm ◽  
...  

Objectives: We evaluated the impact of prasugrel pretreatment and timing of coronary artery bypass grafting (CABG) on clinical outcomes of patients with non-ST-segment elevation myocardial infarction (NSTEMI) undergoing CABG based on data from ACCOAST. Methods: We evaluated the impact of troponin, prasugrel pretreatment and CABG timing on clinical outcomes of NSTEMI patients undergoing CABG through 30 days from ACCOAST. Results: CABG patients versus PCI or medically managed patients were more often male, diabetic, had peripheral arterial disease and a higher GRACE score. By randomization assignment, 157 patients received a 30-mg loading-dose of prasugrel before CABG; 157 patients did not. CABG patients were grouped by tertiles of time from randomization to CABG; baseline characteristics in the Table. Patients in the lowest tertile had significantly more events (cardiovascular death, MI, stroke, urgent revascularization or glycoprotein IIb/IIIa bailout) and all TIMI major bleeds than those in the other 2 groups (p<0.045, p<0.002 respectively), but the patients in the higher 2 groups were not significantly different from each other. No difference was detected in all cause death among the 3 groups (p>0.39). A multivariate model evaluated 5 possible predictors of the composite endpoint of all cause death, MI, stroke and TIMI major bleeding. Time from randomization to CABG (HR 0.84 for each 1 hour of delay), left main disease presence (HR 1.76), and region of enrollment (Eastern Europe vs other, HR 3.83) were significant predictors but not prasugrel pretreatment or baseline troponin level ≥3xULN. Conclusions: In this group of high-risk patients presenting with NSTEMI, early surgical revascularization carried an increased risk of bleeding and ischemic complications, without impact on all-cause mortality. No impact of baseline troponin or prasugrel pretreatment (important factors influencing time of CABG) on clinical outcomes was confirmed.


Open Heart ◽  
2021 ◽  
Vol 8 (2) ◽  
pp. e001726
Author(s):  
Anthony P Carnicelli ◽  
Ruth Owen ◽  
Stuart J Pocock ◽  
David B Brieger ◽  
Satoshi Yasuda ◽  
...  

ObjectiveAtrial fibrillation (AF) and myocardial infarction (MI) are commonly comorbid and associated with adverse outcomes. Little is known about the impact of AF on quality of life and outcomes post-MI. We compared characteristics, quality of life and clinical outcomes in stable patients post-MI with/without AF.Methods/resultsThe prospective, international, observational TIGRIS (long Term rIsk, clinical manaGement and healthcare Resource utilization of stable coronary artery dISease) registry included 8406 patients aged ≥50 years with ≥1 atherothrombotic risk factor who were 1–3 years post-MI. Patient characteristics were summarised by history of AF. Quality of life was assessed at baseline using EQ-5D. Clinical outcomes over 2 years of follow-up were compared. History of AF was present in 702/8277 (8.5%) registry patients and incident AF was diagnosed in 244/7575 (3.2%) over 2 years. Those with AF were older and had more comorbidities than those without AF. After multivariable adjustment, patients with AF had lower self-reported quality-of-life scores (EQ-5D UK-weighted index, visual analogue scale, usual activities and pain/discomfort) than those without AF. CHA2DS2-VASc score ≥2 was present in 686/702 (97.7%) patients with AF, although only 348/702 (49.6%) were on oral anticoagulants at enrolment. Patients with AF had higher rates of all-cause hospitalisation (adjusted rate ratio 1.25 [1.06–1.46], p=0.008) over 2 years than those without AF, but similar rates of mortality.ConclusionsIn stable patients post-MI, those with AF were commonly undertreated with oral anticoagulants, had poorer quality of life and had increased risk of clinical outcomes than those without AF.Trial registration numberClinicalTrials: NCT01866904.


2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Chan Soon Park ◽  
Eue-Keun Choi ◽  
Bongseong Kim ◽  
Kyung-Do Han ◽  
So-Ryoung Lee ◽  
...  

Abstract NTM infection demonstrates an increasing incidence and prevalence. We studied the impact of NTM in cardiovascular events. Using the Korean nationwide database, we included newly diagnosed 1,730 NTM patients between 2005 and 2008 and followed up for new-onset atrial fibrillation (AF), myocardial infarction (MI), heart failure (HF), ischemic stroke (IS), and death. Covariates-matched non-NTM subjects (1:5, n = 8,650) were selected and analyzed. Also, NTM infection was classified into indolent or progressive NTM for risk stratification. During 4.16 ± 1.15 years of the follow-up period, AF, MI, HF, IS, and death were newly diagnosed in 87, 125, 121, 162, and 468 patients. In multivariate analysis, NTM group showed an increased risk of AF (hazard ratio [HR] 2.307, 95% confidence interval [CI] 1.560–3.412) and all-cause death (HR 1.751, 95% CI 1.412–2.172) compared to non-NTM subjects, whereas no significant difference in MI (HR 0.868, 95% CI 0.461–1.634), HF (HR 1.259, 95% CI 0.896–2.016), and IS (HR 1.429, 95% CI 0.981–2.080). After stratification, 1,730 NTM patients were stratified into 1,375 (79.5%) indolent NTM group and 355 (20.5%) progressive NTM group. Progressive NTM showed an increased risk of AF and mortality than indolent NTM group. Screening for AF and IS prevention would be appropriate in these high-risk patients.


2020 ◽  
Vol 52 (12) ◽  
pp. 861-868
Author(s):  
Otto Mayer ◽  
Jitka Seidlerová ◽  
Jan Bruthans ◽  
Julius Gelžinský ◽  
Martina Rychecká ◽  
...  

AbstractAdiponectin has several beneficial properties, namely, on the level of glucose metabolism, but paradoxically, its high concentrations were associated with increased mortality. We aimed to clarify the impact of high serum adiponectin on mortality and morbidity in patients with stable coronary artery heart disease (CAD). A total of 973 patients after myocardial infarction and/or coronary revascularization were followed in a prospective cohort study. All-cause and cardiovascular (CV) death, non-fatal cardiovascular events, and hospitalizations for heart failure (HF) were registered as outcomes. High serum adiponectin levels (≥8.58 ng/ml, i. e., above median) were independently associated with increased risk of 5-year all-cause, CV mortality or HF [with HRR 1.57 (95% CI: 1.07–2.30), 1.74 (95% CI: 1.08–2.81) or 1.94 (95% CI: 1.20–3.12), respectively] when adjusted just for conventional risk factors. However, its significance disappeared if brain natriuretic peptide (BNP) was included in a regression model. In line with this, we observed strong collinearity of adiponectin and BNP. Additionally, major adverse cardiovascular event (i. e., CV death, non-fatal myocardial infarction or stroke, coronary revascularization) incidence risk was not associated with high adiponectin. In conclusion, the observed inverse association between adiponectin concentrations and mortality risk seems to be attributable to concomitantly increased BNP, rather than high adiponectin being a causal factor.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T Niida ◽  
T Yonetsu ◽  
T Lee ◽  
M Nakao ◽  
S Nakagama ◽  
...  

Abstract Background Previous studies revealed that the morphological substrates of the culprit lesion assessed by optical coherence tomography (OCT) in acute coronary syndrome (ACS), which includes ruptured plaque (RP) and intact fibrous cap (IFC) plaque, are associated with subsequent clinical outcomes. Nevertheless, the impact of culprit morphology on clinical outcomes has not been evaluated in patients with diabetes mellitus (DM), which is one of the major determinants of clinical prognosis. Purpose We sought to investigate the association of the culprit lesion morphology with clinical outcomes in patients with DM and those without DM. Methods We retrospectively investigated a total of 508 patients with acute myocardial infarction (AMI) experiencing their first episode of ACS in whom OCT-guided, primary percutaneous coronary intervention (PCI) was performed and a culprit lesion was observed by OCT with sufficient image quality. Patients were divided into two groups according to the culprit lesion morphology into patients with RP (RP group) and those without RP (IFC group). The rate of major adverse cardiac events (MACE) including death, myocardial infarction, target or non-target lesion revascularizations were compared between RP and IFC groups in patients with DM (DM) and those without DM (non-DM), separately. Results MACE was captured in 80 patients during the median follow-up of 505 (IQR 274–1300) days. In non-DM, RP group showed significantly worse MACE-free rate than in IFC group (Figure), In DM, there was no significant difference between RP and IFC groups (Figure). Figure 1 Conclusion Culprit lesion morphology assessed by OCT was not associated with clinical outcomes in DM patients unlike non-DM patients. Distinct strategy for secondary prevention may be required for DM patients.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C Montalto ◽  
G Crimi ◽  
F Fortuni ◽  
A Mandurino Mirizzi ◽  
L Piatti ◽  
...  

Abstract Background Prasugrel was superior to clopidogrel in the setting of acute coronary syndromes (ACS) and recent data highlighted its possible role in the setting of complex percutaneous coronary intervention (PCI). Nonetheless, evidence supporting its use in high bleeding risk population are lacking. Purpose The aim of this post-hoc subgroup analysis was to evaluate the impact of prasugrel administration in elderly patients undergoing complex PCI for ACS. A primary composite endpoint of composite of mortality, myocardial infarction, disabling stroke and re-hospitalization for cardiovascular causes or bleeding within one year and secondary endpoints of all-cause mortality and any bleeding at 1 year were analyzed. Methods In the multicenter Elderly ACS 2 Study 1,443 patients aged >74 y were randomly assigned to receive low-dose prasugrel (5 mg) or clopidogrel (75 mg) and were prospectively followed for 1 year (Table 1). Complex PCI was defined if ≥3 lesions were treated, if ≥3 stents were deployed, or if any bifurcation, trifurcation, chronic total obstruction or moderate-to-severe calcified lesions were treated. Results Patients undergoing complex PCI (n=607) did not experience worse outcome, as compared to those with simpler PCI, in terms of primary endpoint (p=0.21, Figure 1A). Furthermore, in this subgroup, no significant difference was observed with prasugrel vs clopidogrel with regard to the primary endpoint (HR 1.17; CI 0.819–1.67; p=0.39, Figure 1A), all-cause death and bleeding (Figure 1C and 1D). No significant interaction was observed between treatment and PCI complexity (interaction p=0.34). Table 1 Overall Non-complex PCI Complex PCI p value Age (y) 80.60±4.46 80.00 [77.00, 84.00] 80.00 [77.00, 83.00] 0.215 STE-ACS 595 (41.2) 272 (32.5) 323 (53.4) <0.001 Diabetes mellitus 253 (17.5) 159 (19.0) 94 (15.5) 0.104 LVEF 48.27±9.59 49.08±9.55 47.26±9.54 0.002 Total number of diseased vessels 2.29±1.06 2.22±1.06 2.38±1.05 0.005 Previous Myocardial Infarction 274 (19.0) 171 (20.4) 103 (17.0) 0.122 Randomized to prasugrel 713 (49.4) 404 (48.2) 404 (48.2) 0.307 Data are expressed as mean ± SD or [IQR] and count/valid %). Figure 1 Conclusions In elderly patients presenting with ACS low-dose prasugrel was comparable to clopidogrel in terms of all-cause mortality and any bleeding at 1 year. Acknowledgement/Funding None


2018 ◽  
Vol 23 (suppl_1) ◽  
pp. e29-e30
Author(s):  
Steffany Poupart ◽  
Audrey Dionne ◽  
Cathie-Kim Le ◽  
Léamarie Meloche-Dumas ◽  
Jean Turgeon ◽  
...  

Abstract BACKGROUND Kawasaki disease (KD) is a paediatric systemic vasculitis that can be associated with concomitant viral or bacterial infections. Patients with persistent or recurrent fever 36 hours after the end of intravenous immunoglobulin (IVIG) are considered to be resistant to treatment and are at increased risk for coronary complications. OBJECTIVES However, it is unknown how concomitant infection influences the response to IVIG treatment. The aim of this study was to determine the impact of concurrent infection on the prevalence of IVIG resistance and coronary outcome. DESIGN/METHODS Retrospective study of 154 children (mean age at diagnosis: 3.4 ± 2.8 years) diagnosed with KD, between 2008–2016 in a tertiary paediatric university hospital, of which 59 (38%) had concomitant infection. RESULTS Delay in diagnosis (>10 days of fever) was similar between patients with and without concomitant infection (7% vs 7%, p=0.89). Patients with concomitant infection were more likely to have fever 48 hours after initial treatment (36% vs 20%, p=0.05) and to be treated with a second dose of IVIG (33% vs 18%, p=0.04). Patients with infection had higher C-reactive protein at the time of diagnosis (148 vs 112 mg/L, p=0.04), which persisted after IVIG administration (111 vs 59 mg/L at 48 hours, p=0.003). However, there was no statistically significant difference in the prevalence of coronary artery (CA) complications (coronary artery Z-score > 2.5) between patients with and without concomitant infection (36% vs 39%, p=0.68). CONCLUSION Children with KD and concomitant infection are more likely to have persistent fever and elevated inflammatory markers after treatment requiring a second dose of IVIG. Nevertheless, this is not associated with an increased risk of CA complications. Larger scale studies are needed to help distinguish IVIG resistance from infection in children with persistent fever and guide management of this population. Table/Chart or graphic upload


2020 ◽  
Author(s):  
Xuhe Gong ◽  
Li Zhou ◽  
Xiaosong Ding ◽  
Hui Chen ◽  
Hongwei Li

Abstract Background: Coronary chronic total occlusions (CTOs) are correlated with increased risk of adverse clinical outcomes. The optimal treatment strategy for CTO has not been well established. We sought to examine the impact of CTO percutaneous coronary intervention (PCI) on long-term clinical outcome in the real world.Methods: A total of 592 consecutive patients with CTO in Beijing Friendship Hospital from June 2017 to December 2019 were enrolled, 29 patients were excluded due to Coronary artery bypass grafting (CABG). After exclusion, 563 patients were divided into the no-revascularized group (CTO-NR group, n=263) and successful revascularized group (CTO-R group, n=300). The primary endpoint was cardiac death; Secondary endpoint was major adverse cardiac and cerebrovascular events (MACCE), a composite of all-cause death, cardiac death, recurrent myocardial infarction, target lesion revascularization, re-hospitalization, heart failure, and stroke.Results: Percent of Diabetes mellitus (53.2% vs 39.7), Chronic kidney disease (8.7% vs 3.7%), CABG history (7.6% vs 1%), three vessel disease(96.2% vs 90%) and left main coronary artery disease (25.1% vs 13.7%) was significantly higher in the CTO-NR group than in success PCI group (all P<0.05). Moreover, the CTO-NR group has lower EF (0.58±0.11 vs 0.61±0.1, p=0.001) and FS (0.31±0.07 vs 0.33±0.07, p=0.002). At a median follow-up of 12 months, CTO revascularization was superior to CTO no-revascularization in terms of cardiac death (adjusted hazard ratio [HR]: 0.27, 95% conference interval [CI] 0.11-0.64). The superiority of CTO revascularization was consistent for MACCE (HR: 0.55, 95% CI 0.35-0.79). At multivariable Cox hazards regression analysis, CTO revascularization remains one of the independent predictors of lower risk of cardiac death and MACCE.Conclusions: Successful revascularization by PCI may bring more clinical benefits. The presence of LVEF<0.5 and LM-disease was associated with an incidence of cardiac death; CTO revascularization was a protected predictor of cardiac death.


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