258Use of low-dose prasugrel vs. clopidogrel in elderly patients undergoing complex or non-complex PCI for acute coronary syndromes: insights from the Elderly ACS 2 study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C Montalto ◽  
G Crimi ◽  
F Fortuni ◽  
A Mandurino Mirizzi ◽  
L Piatti ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Elderly Patients ◽  
Primary Endpoint ◽  
Acute Coronary Syndromes ◽  
Low Dose ◽  
P Value ◽  
Significant Difference ◽  
All Cause Mortality ◽  
Coronary Syndromes ◽  
The Impact

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

Interaction of ischaemic postconditioning and thrombectomy in patients with ST-elevation myocardial infarction

Heart ◽  
2019 ◽  
Vol 106 (1) ◽  
pp. 24-32 ◽  
Author(s):  
Lars Nepper-Christensen ◽  
Dan Eik Høfsten ◽  
Steffen Helqvist ◽  
Jens Flensted Lassen ◽  
Hans-Henrik Tilsted ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Heart Failure ◽  
Primary Endpoint ◽  
Coronary Intervention ◽  
Primary Pci ◽  
St Segment Elevation ◽  
Segment Elevation Myocardial Infarction ◽  
St Segment ◽  
Significant Difference ◽  
All Cause Mortality

ObjectiveThe Third Danish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction – Ischaemic Postconditioning (DANAMI-3-iPOST) did not show improved clinical outcome in patients with ST-segment elevation myocardial infarction (STEMI) treated with ischaemic postconditioning. However, the use of thrombectomy was frequent and thrombectomy may in itself diminish the effect of ischaemic postconditioning. We evaluated the effect of ischaemic postconditioning in patients included in DANAMI-3-iPOST stratified by the use of thrombectomy.MethodsPatients with STEMI were randomised to conventional primary percutaneous coronary intervention (PCI) or ischaemic postconditioning plus primary PCI. The primary endpoint was a combination of all-cause mortality and hospitalisation for heart failure.ResultsFrom March 2011 until February 2014, 1234 patients were included with a median follow-up period of 35 (interquartile range 28 to 42) months. There was a significant interaction between ischaemic postconditioning and thrombectomy on the primary endpoint (p=0.004). In patients not treated with thrombectomy (n=520), the primary endpoint occurred in 33 patients (10%) who underwent ischaemic postconditioning (n=326) and in 35 patients (18%) who underwent conventional treatment (n=194) (adjusted hazard ratio (HR) 0.55 (95%confidence interval (CI) 0.34 to 0.89), p=0.016). In patients treated with thrombectomy (n=714), there was no significant difference between patients treated with ischaemic postconditioning (n=291) and conventional PCI (n=423) on the primary endpoint (adjusted HR 1.18 (95% CI 0.62 to 2.28), p=0.62).ConclusionsIn this post-hoc study of DANAMI-3-iPOST, ischaemic postconditioning, in addition to primary PCI, was associated with reduced risk of all-cause mortality and hospitalisation for heart failure in patients with STEMI not treated with thrombectomy.Trial registration numberNCT01435408.

Ticagrelor versus Clopidogrel in high bleeding risk patients presenting with Acute Coronary Syndromes: insights from the multicenter START-ANTIPLATELET registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
F Gragnano ◽  
E Moscarella ◽  
P Calabro' ◽  
A Cesaro ◽  
P.C Pafundi ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Coronary Syndromes ◽  
Bleeding Risk ◽  
Coronary Intervention ◽  
P Value ◽  
Bleeding Events ◽  
P2y12 Inhibitors ◽  
Coronary Syndromes ◽  
High Bleeding Risk

Abstract Background Optimal dual antiplatelet therapy in high bleeding risk (HBR) patients with acute coronary syndromes (ACS) remains debated. Although current guidelines recommend the use of potent P2Y12 inhibitors in these patients (according to the labeled indications), clopidogrel is frequently used in clinical practice based on a perceived advantage in terms of safety in the HBR population. Purpose We sought to investigate the use of clopidogrel versus ticagrelor in consecutive HBR ACS patients and their impact on ischemic and bleeding events at 1 year. Methods ACS patients enrolled in the START-ANTIPLATELET registry with at least 1 HBR criterion were included in the present analysis and stratified according to DAPT type (clopidogrel versus ticagrelor). The primary endpoint was net adverse clinical endpoint (NACE), defined as a composite of all-cause death, myocardial infarction, stroke, and major bleeding. The secondary endpoints were major adverse cardiac and cerebral events (MACE), defined as a composite of all-cause death, myocardial infarction and stroke, each individual component of NACE and MACE, and target vessel revascularization. Results Among a total of 1,209 patients with 1-year follow-up in the registry, 383 patients were considered at HBR, of whom 174 (45.4%) were on clopidogrel and 209 (54.6%) on ticagrelor. Clopidogrel was more likely to be administered in patients at increased ischemic and bleeding risk, while ticagrelor in those undergoing percutaneous coronary intervention. Mean DAPT duration was longer in the ticagrelor group than in the clopidogrel group (10.40±4.29 versus 9.35±5.4; p-value=0.03). At 1-year follow-up, the risk of NACE and MACE events was significantly higher in the clopidogrel than in the ticagrelor group (NACE: HR 1.82; 95% CI 1.07–3.09; p-value=0.02; MACE: HR 1.83; 95% CI 1.04–3.24; p-value=0.03) (Figure). After multivariate adjustment for clinical and procedural characteristics, no difference in NACEs nor MACEs was observed between patients on clopidogrel versus ticagrelor (NACE: adjusted HR 1.27; 95% CI 0.71–2.27; p-value=0.42; MACE: adjusted HR 1.19; 95% CI 0.63–2.24; p-value=0.59) (Figure). Age, number of HBR criteria, and mean DAPT duration were independent predictors of NACEs. Conclusions In a real-world ACS registry, approximately 50% of patients are at HBR and frequently treated with clopidogrel. In HBR ACS patients, no difference was observed in ischemic and bleeding events between clopidogrel and ticagrelor after adjustment for potential confounders. Kaplan-Meier curves at 1-year follow-up. Funding Acknowledgement Type of funding source: None

Abstract 3220: Bivalirudin Monotherapy Provides Similar One-Year Survival Compared to Heparin plus GP IIb/IIIa Inhibitors in Diabetic Patients with Acute Coronary Syndromes: Results from the Randomized ACUITY Trial

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Frederick Feit ◽  
Stuart V Manoukian ◽  
George D Dangas ◽  
A. M Lincoff ◽  
E. M Ohman ◽  
...  
Keyword(s):  
Treatment Group ◽  
High Risk ◽  
Major Bleeding ◽  
Acute Coronary Syndromes ◽  
Diabetic Patients ◽  
Significant Difference ◽  
Coronary Syndromes ◽  
One Year ◽  
The Impact ◽  
Ischemic Events

Background: Among diabetic patients with acute coronary syndromes (ACS) in the ACUITY trial, bivalirudin (Biv) monotherapy (Mono) provided similar survival and protection from ischemic events with significantly less major bleeding compared to heparin (unfractionated or enoxaparin) plus GP IIb/IIIa inhibitors (Hep+GPI) at 30 days. Whether this protection from ischemic events persists to one year is unknown. Methods: In the ACUITY trial, patients with moderate and high risk (ACS) were randomized to Hep+GPI, Biv+gPI, or Biv Mono. We evaluated the impact of treatment group on composite ischemia (death, MI, or unplanned revascularization) and mortality at one year in diabetic patients using Kaplan Meier survival analysis and log rank tests. Results: Of patients enrolled in the ACUITY trial, 3852 were diabetic (28.1%) and 9857 (71.9%) were non-diabetic. Compared with non-diabetics, diabetics had higher rates of mortality at one year (6.1% vs 3.4%, p<0.001). There was no significant difference in the rate of composite ischemia at one year for diabetic patients who received Biv Mono vs Hep+GPI (19.7% vs 18.9%, p=0.39) or Biv+GPI vs Hep+GPI (20.9% vs 18.9%, p=0.16). Mortality rates for diabetic patients by treatment group are shown below. Conclusions: In the ACUITY Trial, diabetic patients had lower survival rates at one year than non-diabetics. Among diabetic patients, treatment with Biv Mono resulted in similar rates of composite ischemia and survival at one year compared to those treated with Hep+GPI. Combined with the early reduction in major bleeding, these findings indicate that Biv Mono is a suitable alternative to Hep + GPI for diabetic patients with moderate and high risk ACS.

scholarly journals 342 Impact of temporary traffic bans on the risk of acute coronary syndromes in a large metropolitan area

2020 ◽  
Vol 22 (Supplement_N) ◽  
pp. N81-N82
Author(s):  
Alessandra De Luca ◽  
Igino Proietti ◽  
Carlo Trani ◽  
Andrea Berni ◽  
Sonia Cristina Sergi ◽  
...  
Keyword(s):  
Nitric Oxide ◽  
Myocardial Infarction ◽  
Metropolitan Area ◽  
Acute Coronary Syndromes ◽  
Coronary Intervention ◽  
St Elevation Myocardial Infarction ◽  
Large Metropolitan Area ◽  
Coronary Syndromes ◽  
St Elevation ◽  
The Impact

Abstract Aims Strong epidemiologic evidence has highlighted the role of pollution, on top of adverse climate features, as a novel cardiovascular risk factor. However, mechanistic proof that reducing pollution may be beneficial to prevent atherothrombotic events is limited. We aimed at appraising the impact of temporary traffic bans in a large metropolitan area on the risk of acute coronary syndromes. Methods and results Aggregate and anonymized data from 15 tertiary cardiac care centers were obtained detailing pre-coronarivus disease 2019 (COVID-19) daily cases of ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI), including those treated with percutaneous coronary intervention (PCI). Data on pollutants and climate were sought for the same days. Mixed level regression was used to compare the week before vs. after the traffic ban (Fortnight analysis), the 3 days before vs. after (Weekly analysis) and the Sunday before vs. after (Sunday analysis). A total of 8 days of temporary traffic bans were included, occurring between 2017 and 2020, totaling 802 STEMI and 1196 NSTEMI in the Fortnight analysis, 382 STEMI and 585 in the Weekly analysis, and 148 STEMI and 210 NSTEMI in the Sunday analysis. Fortnight and Sunday analysis did not disclose a significant impact of traffic ban on STEMI or NSTEMI (all P &gt; 0.05). Conversely, Weekly analysis showed non-significant changes for STEMI but a significant decrease in daily NSTEMI when comparing the 3 days before the traffic ban with the ban day (P = 0.043), as well as the 3 days before vs. the 3 days after the ban (P = 0.025). No statistically significant effect of traffic ban was found at Fortnight, Weekly or Sunday analyses for daily mean concentrations of benzene, carbon monoxide, nitric oxide, nitrogen dioxide, ozone, sulfur dioxide, particulate matter (PM) &lt;2.5 µm or PM &lt; 10 µm (all P &gt; 0.05). However, minimum daily concentrations showed a significant reduction of ozone during the ban in comparison to the week preceding it (P = 0.034), nitric oxide during the ban in comparison to the 3 days preceding it (P = 0.046), and an increase in benzene during the ban in comparison to the Sunday before (P = 0.039). Conclusion Temporary traffic bans may favorably reduce coronary atherothrombotic events, and in particular NSTEMI, even if not globally and immediately impacting on environmental pollution. Further controlled studies are required to confirm and expand this hypothesis-generating results.

scholarly journals 464Optimal timing of invasive coronary angiography following NSTEMI

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T Mahendiran ◽  
D Nanchen ◽  
D Meier ◽  
B Gencer ◽  
R Klingenberg ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Real World ◽  
Invasive Coronary Angiography ◽  
Cox Proportional Hazards ◽  
Major Adverse Cardiovascular Events ◽  
Significant Difference ◽  
All Cause Mortality ◽  
One Year ◽  
The Impact ◽  
Grace Score

Abstract Introduction Current guidelines recommend angiography within 24 hours of hospitalisation for patients with non-ST elevation myocardial infarction (NSTEMI). The recent VERDICT study found that angiography within 12 hours of hospitalisation was associated with improved cardiovascular outcomes among high-risk patients. We aimed to obtain a real-world perspective of the impact of angiography timing on one-year outcomes of patients admitted with NSTEMI. Methods Data was obtained from the SPUM-ACS registry, a cohort of consecutive patients hospitalised with acute coronary syndromes in four university hospitals in Switzerland between 2009 and 2017. Patients without a door-to-catheter (DTC) time and those with life-threatening features were excluded. Cox proportional hazards models evaluated the impact of DTC time on the primary endpoint, defined as one-year major adverse cardiovascular events (MACE: cardiovascular mortality, myocardial infarction, stroke), and on one-year all-cause mortality. Results Of 2,672 NSTEMI patients, 1,832 met the inclusion criteria. Among them, 1,464 patients underwent angiography within 12 hours of admission (12h group) while 368 patients underwent angiography between 12 and 24 hours (12–24h group). After 2:1 propensity score matching, 736 patients from the 12h group and 368 patients from the 12–24h group were deemed equivalent in terms of main baseline clinical characteristics. Multiple logistic regression identified admission out-of-hours (night or weekend) as the most significant factor associated with delayed angiography. Cox models found no significant association between early angiography and one-year MACE (12h group: n=57 (7.7%) vs. 12–24h group: n=27 (7.3%), HR: 1.050, 95% CI 0.637- 1.733, p=0.847), or one-year all-cause mortality (12h group: n=25 (3.4%) vs. 12–24h group: n=17 (4.6%), HR: 1.514, 95% CI 0.774- 2.962, p=0.225) (Figure 1A). After stratification based on GRACE score (>140 vs. ≤140), there was no significant difference in one-year MACE or one-year all-cause mortality in the 12h group compared with the 12–24h group (p for interaction=0.601 and 0.463, respectively) (Figure 1A + 1B). Figure 1 Conclusion In an unselected real-world cohort of NSTEMI patients, angiography within 12 hours of hospitalisation was not associated with improved one-year outcomes when compared with angiography between 12 and 24 hours, even among patients with an elevated GRACE score.

P1781Burden of significant valvular heart disease in elderly patients presenting with acute coronary syndromes

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C Montalto ◽  
G Crimi ◽  
F Fortuni ◽  
A Mandurino Mirizzi ◽  
L A Ferri ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Heart Disease ◽  
Elderly Patients ◽  
Primary Endpoint ◽  
Valvular Heart Disease ◽  
Acute Coronary Syndromes ◽  
Left Ventricular Ejection ◽  
History Of ◽  
Coronary Syndromes ◽  
History Of Cancer

Abstract Background Elderly patients with acute coronary syndromes (ACS) represent a group seldom included in clinical trials and in whom robust data regarding mid-term impact of significant concomitant valvular heart disease are lacking. Purpose Our aim was to evaluate the impact of moderate-to-severe mitral regurgitation (MR), moderate-to-severe aortic stenosis (AS), or both conditions combined on a primary composite endpoint of mortality, myocardial infarction, disabling stroke and re-hospitalization for cardiovascular causes or bleeding within one year in a population of ACS patients included in the Elderly ACS 2 trial. Methods In the multicenter Elderly II ACS Study, 1,443 patients aged >74 y undergoing percutaneous coronary intervention (PCI) for ACS, were randomly assigned to receive prasugrel (5 mg) or clopidogrel (75 mg) and were prospectively followed for 1 year. Amongst these, 1,102 patients received full echocardiographic assessment and were included in the post-hoc analysis (Table 1). Results Survival analysis showed that patients presenting with moderate-to-severe MR, AS or both (Figure 1A), had worse outcome in terms of primary endpoint (p<0.001) as compared to no valve disease. A multivariable Cox regression model revealed that the presence of moderate-to-severe MR, AS or both were independent predictors of primary endpoint (HR 1.84; HR 2.8; HR 2.9 and p<0.001; p=0.004; p=0.01, respectively), regardless of age, gender, left ventricular ejection fraction, diabetes mellitus, history of cancer and total number of diseased vessels (Figure 1B). Table 1 Overall No residual valvular heart disease Moderate-to-severe MR Moderate-to-severe AS Both Age (y) 80.68±4.50 80.40±4.42 81.47±4.45 82.92±5.42 83.23±5.42 Male gender 652 (59.2) 538 (61.6) 92 (48.4) 19 (73.1) 3 (23.1) STE-ACS 420 (38.1) 319 (36.5) 91 (47.9) 6 (23.1) 4 (30.8) Diabetes mellitus 203 (18.4) 158 (18.1) 35 (18.4) 5 (19.2) 5 (38.5) LVEF (%) 48.30±9.58 49.26±9.27 44.61±9.45 48.50±11.22 38.31±10.87 History of cancer 32 (2.9) 26 (3.0) 3 (1.6) 2 (7.7) 1 (7.7) Tot number of diseased vessel 2.31±1.05 2.28±1.04 2.49±1.05 2.04±0.87 2.54±1.13 Data are expressed as mean ± SD or count (valid %). Figure 1 Conclusions Moderate-to-severe MR and AS represent significant predictors of 1-year outcome in elderly patients hospitalized for ACS, even when other well-established prognostic factors are taken into account and after revascularization with PCI. Therefore, these patients should be carefully screened for the presence of valvular heart disease at the time of presentation and the need for surgical or percutaneous correction should be assessed accordingly. Acknowledgement/Funding None

scholarly journals Prognostic value of BNP in STEMI patients

2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
I Almeida ◽  
H Miranda ◽  
H Santos ◽  
M Santos ◽  
J Chin ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Coronary Syndromes ◽  
Prognostic Value ◽  
Composite Endpoint ◽  
Multivessel Disease ◽  
All Cause Mortality ◽  
Coronary Syndromes ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Abstract Funding Acknowledgements Type of funding sources: None. OnBehalf Portuguese Registry of Acute Coronary Syndromes (ProACS) Introduction Brain natriuretic peptide (BNP) is a highly sensitive and specific biomarker on the extension of myocardial infarction, strongly related to short and long-term prognosis in patients with ST elevation myocardial infarction (STEMI). Objective To evaluate diagnostic and prognostic value of BNP levels in a Portuguese cohort of STEMI patients. Material and methods Retrospective analysis of patients admitted with STEMI included in the Portuguese Registry of Acute Coronary Syndromes between 2010-19. Patients were divided in three groups regarding BNP: Group 1 if BNP &lt;100 pg/ml; Group 2 100 ≤ BNP &lt; 400 pg/ml and Group 3 ≥400 pg/ml. Independent predictors of a composite of all-cause mortality and rehospitalization for cardiovascular causes were assessed by multivariate logistic regression. Results 1650 patients were included, mean age 64 ± 13 years, 75.4% male. 39.0% (n = 643) integrated group 1, 39.5% (n = 652) group 2 and 21.5% (n = 355) group 3. Group 3 patients were significantly older (58 ± 11 vs 66 ± 13 vs 72 ± 12 years, p &lt; 0.001), had more classic cardiovascular risk factors, except for smoker status, and more previous history of cardiovascular disease, chronic kidney disease, chronic obstructive pulmonary disease and cancer. Anterior STEMI was the most frequent location (51.1%), however group 3 patients presented with lower systolic blood pressure (136 ± 30 vs 140 ± 31 vs 131 ± 28 mmHg, p &lt; 0.001) and higher heart rate (76 ± 17 vs 77 ± 19 vs 84 ± 26 bpm, p &lt; 0.001) and KK class (KK class &gt; I 5.6 vs 9.5 vs 28.5%, p &lt; 0.001). They also presented higher levels of creatinine (1 ± 0.5 vs 1.2 ± 0.9 vs 1.5 ± 1 mg/dl, p &lt; 0.001) and the lowest levels of hemoglobin (13.5 ± 1.6 vs 12.6 ± 1.9 vs 11.7 ± 2.1 g/dl, p &lt; 0.001). Mean ejection fraction (EF) was lower in group 3 (58 ± 11 vs 53 ± 12 vs 44 ± 13%, p &lt; 0.001). Multivessel disease was more common in group 3 (34.8 vs 44.8 vs 51.3%, p &lt; 0.001), where a higher percentage was proposed to medical therapy (2.8 vs 3.5 vs 8.5%, p &lt; 0.001). In the patients proposed to revascularization, although not statistically significant, there was a trend towards surgical revascularization or hybrid approach. In-hospital complications were more frequent in group 3, especially heart failure (HF) (18.9% mean vs 45.4%, p &lt; 0.001), and mortality was seven times superior in group 3 versus group 1 (1.2% vs. 8.5%, p &lt; 0.001). The composite endpoint of 1-year mortality and cardiovascular rehospitalization occurred in 12%. After propensity score application, the 1-year endpoint total mortality rate and cardiovascular readmission was 20.3%, and higher BNP was associated with higher rates (p &lt; 0.001). Predictor factors for the composite endpoint, evaluated through Cox multivariate regression were previous HF, multivessel disease, EF &lt; 30% and the use of nitrates and aldosterone antagonists. The use of aspirin was a protector factor. Conclusion BNP levels during index hospitalization were a powerful prognostic biomarker for all-cause mortality MACE in patients admitted with STEMI.

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 ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Coronary Artery ◽  
Clinical Outcomes ◽  
Primary Endpoint ◽  
Metallic Stent ◽  
Target Vessel ◽  
Increased Risk ◽  
Significant Difference ◽  
Absorb Bvs ◽  
The Impact

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

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