Target Vessel Failure Research Articles

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

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

P5494Impact of the gender difference on long-term clinical outcomes in dyslipidemic South Korean AMI patients who underwent PCI with new-generation DES

Abstract Background There are limited comparative data concerning long-term major clinical outcomes between male and female in dyslipidemic AMI patients after PCI with new-generation DES. Purpose We thought to investigate the impact of gender difference on the 2-year clinical outcomes. Methods Finally, a total of 2403 eligible dyslipidemic AMI patients who underwent PCI with new-generation DES were enrolled and they were separated into two groups; the male group (n=1800) and the female group (n=603). The primary endpoint was major adverse cardiac events (MACE) defined as all-cause death, recurrent myocardial infarction (re-MI), target lesion revascularization (TLR), and target vessel revascularization (TVR). The secondary endpoints were the incidence of the individual components of MACE and target vessel failure (TVF), a composite of death related to the target vessel, re-MI, or clinically driven TVR Results Two propensity score-matched (PSM) groups (422 pairs, n=844, C-statistic = 0.850) were generated. In the total study population, the cumulative incidences of MACE, all-cause death, re-MI, and TVF were significantly higher in the female group compared with the male group. However, after propensity score-matched (PSM) analysis, the cumulative incidences of MACE (HR, 0.971; 95% CI, 0.628–1.501; p=0.895), all-cause death (HR, 1.061; 95% CI, 0.536–2.100; p=0.865), re-MI (HR, 1.212; 95% CI, 0.433–2.907; p=0.813), and TVF (HR, 0.764; 95% CI, 0.474–1.229; p=0.267) were similar between the two groups. In addition, the cumulative incidences of cardiac death, TLR, TVR were not significantly different between the two groups (Table 1). Outcomes Cumulative Events at 2-year (%) Hazard Ratio (95% CI) p value Male Female Log-rank Propensity score matched patients MACE 41 (10.4) 40 (10.3) 0.895 0.971 (0.628–1.501) 0.895 All-cause death 16 (4.0) 17 (4.2) 0.865 1.061 (0.536–2.100) 0.865 Cardiac death 13 (3.3) 9 (2.2) 0.391 0.691 (0.295–1.616) 0.393 Re-MI 8 (2.0) 9 (2.4) 0.813 1.212 (0.433–2.907) 0.813 TLR 7 (1.8) 6 (1.6) 0.781 0.857 (0.298–2.550) 0.781 TVR 16 (4.3) 10 (2.7) 0.236 0.623 (0.283–1.373) 0.241 TVF 39 (10.2) 30 (7.8) 0.265 0.764 (0.474–1.229) 0.267 Conclusion The gender difference was not apparent in these dyslipidemic South Korean AMI patients who underwent PCI with new-generation DES during 2-year follow-up period.

P6517Three-year clinical outcome of patients with abnormal glucose metabolism treated with contemporary drug-eluting stents

Abstract Background/Introduction Patients with coronary artery disease that have an abnormal glucose metabolism are known to have more extensive and complex atherosclerotic coronary disease. In patients without previously known diabetes, abnormal glucose metabolism was shown to be independently associated with an up to four-fold higher event risk during the first year after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Purpose To examine the 3-year clinical outcome after stenting with contemporary DES in patients with abnormal glucose metabolism, either detected by oral glucose tolerance testing (OGTT) or by glycated haemoglobin A1c (HbA1c) and fasting plasma glucose. Methods The present analysis is a local substudy of the BIO-RESORT randomised trial. OGTT and HbA1c with fasting plasma glucose were prospectively assessed in 988 trial participants without previously known diabetes. The main clinical endpoint was target vessel failure, a composite of cardiac death, target vessel-related myocardial infarction or target vessel revascularisation at 3-years. Results In one out of three study participants (330/988), abnormal glucose metabolism was detected by either OGTT or HbA1c and fasting plasma glucose. Three-year follow up was available in 99.8% of these patients. The rate of target vessel failure was significantly higher in patients with abnormal glucose metabolism versus normoglycaemic patients (8.8% vs. 5.5%, p=0.044; Figure). This difference was driven by the incidence of periprocedural myocardial infarction that was higher in patients with abnormal glucose metabolism than in patients with normoglycaemia (4.5% vs. 1.4%, p=0.002). Target vessel failure at 3-years Conclusion Abnormal glucose metabolism was associated with a significantly higher risk of target vessel failure at 3-years; this difference was driven by higher rates of periprocedural myocardial infarction. Acknowledgement/Funding The present substudy received no additional funding. The BIO-RESORT trial was equally funded by Biotronik, Boston Scientific, and Medtronic.

P974Efficacy of plaque debulking for bifurcated or ostial lesion by directional coronary atherectomy before 2nd generation drug eluting stent (PERFECT2)

Abstract Objectives We sought to evaluate the efficacy of plaque debulking by directional coronary atherectomy (DCA) before 2nd generation drug-eluting stent (DES) implantation for bifurcated coronary lesions. Background Percutaneous coronary intervention (PCI) for bifurcated lesions still remains complex and challenging in terms of restenosis or stent thrombosis regardless of whether simple or complex stenting used. Methods Patients with bifurcated lesions were enrolled in this prospective multicenter registry. Pre-2nd generation DES plaque debulking with a novel DCA was conducted. All patients were scheduled to perform a follow up (9–12 months) angiography (coronary angiography or coronary computed tomography). The primary end point was the target vessel failure (TVF) at follow-up. Secondary end points were procedure-related events and major adverse cardiac events at 1 year. Results A total of 77 patients with bifurcated lesions were enrolled. PCI with DCA was performed successfully in all without any major procedure-related event and only 1 case needed complex stenting. TVF rate at 9–12 months follow up was 3.9% (3 of 77) and those were all associated with revascularization of the target vessel. Restenosis was only observed at ostial of main-branch in 3cases. No death, no coronary artery bypass grafting, and no myocardial infarction were reported in the patients within the first year. Figure1 Conclusion DCA before 2nd generation DES implantation can possibly avoid complex stenting and provide a good mid-term outcome in patients with bifurcated lesions. Acknowledgement/Funding None

P833Two-year clinical outcomes between statin with ACE inhibitor or ARB in patients with ST-segment elevation myocardial infarction after successful PCI with DES

Abstract Background Limited comparative data are available. Purpose We decided to compare 2-year major clinical outcomes between statin with ACEI and statin ARB therapy in patients with STEMI after PCI with drug-eluting stents (DES). Methods A total 11706 STEMI patients who underwent PCI with DES and who prescribed statin were enrolled and they were divided into two groups, the statin with ACEI group (n=8705) and the statin with ARB group (n=3001). The primary endpoint was the major adverse cardiac events (MACE) defined as all-cause death, recurrent myocardial infarction (re-MI), target lesion revascularization (TLR), target vessel revascularization (TVR), non-TVR. The secondary endpoints were the cumulative incidences of individual components of MACE and target vessel failure (TVF), a composite of death related to the target vessel, re-MI, or clinically driven TVR. Results Two PSM groups (2835 pairs, n=5670, C-statistic = 0.680) were generated. The relative risk of MACE was higher in the statin with ARB group compared to statin with ACEI groups after propensity score-matched (PSM) analysis (hazard ratio [HR]: 1.323, 95% confidence interval [CI]: 1.085–1.613, p=0.006). The relative risks of cardiac death (HR: 1.831, 95% CI: 1.199–2.740, p=0.005), total repeat revascularization (HR: 1.487, 95% CI: 1.133–1.950, p=0.004), and non-TVR (HR: 1.696, 95% CI: 1.122–2.564, p=0.012) were also higher in the statin with ARB group after PSM. Outcomes Cumulative Events at 2-year (%) Hazard Ratio (95% CI) p value Statin + ACEI Statin + ARB Log-rank Propensity score matched Patients MACE 173 (6.5) 225 (8.5) 0.006 1.323 (1.085–1.613) 0.006 All-cause death 58 (2.2) 80 (3.0) 0.054 1.391 (0.992–1.950) 0.056 Cardiac death 35 (1.3) 63 (2.3) 0.004 1.831 (1.199–2.740) 0.005 Re-MI 39 (1.5) 44 (1.7) 0.548 1.141 (0.742–1.756) 0.548 Total repeat revascularization 88 (3.4) 128 (4.9) 0.004 1.487 (1.133–1.950) 0.004 TLR 26 (1.0) 40 (1.5) 0.075 1.561 (0.953–2.558) 0.077 TVR 53 (2.0) 71 (2.8) 0.086 1.364 (0.955–1.946) 0.088 Non-TVR 36 (1.4) 60 (2.3) 0.011 1.696 (1.122–2.564) 0.012 TVF 140 (5.3) 173 (6.6) 0.050 1.249 (1.000–1.561) 0.050 Conclusions In this study, we suggest that the combination of statin with ACEI may be beneficial for reducing the cumulative incidences of MACE, total repeat revascularization rate, and non-TVR rather than the statin with ARB after PCI with DES in STEMI patients.

126Clinical outcomes at two years of the Absorb BRS vs. the Xience metallic DES in patients presenting with ACS vs. stable coronary disease - AIDA trial substudy

Abstract AIMS Patients with acute coronary syndrome (ACS) might represent a specific subgroup, in which bioresorbable scaffold implantation in percutaneous coronary intervention, might lead to better outcomes when compared to conventional treatment. ACS patients (STE-ACS patients in particular) are generally younger, and most often have lesions with softer plaques, a lower plaque burden and less extensive coronary artery disease. In this pre-specified subgroup analysis of the AIDA trial, we evaluated the clinical outcomes of Absorb BVS versus Xience EES treated patients presenting with or without ACS. Methods and results This analysis includes the 2-year outcomes of all 1845 patients randomized in the AIDA trial subdivided by clinical presentation, a pre-specified subgroup analysis. We compared patients presenting with ACS with those presenting without ACS (ACS versus no-ACS patients). Patients presenting with ACS were further sub-categorized according to the presence or absence of ST-segment elevation at presentation (STE-ACS versus NSTE-ACS patients). Baseline status by clinical presentation was known in all patients, and 842 (45.6%) patients presented with ACS, 456 (25.2%) with STE-ACS and 377 (20.4%) with NSTE-ACS.The rate of the 2-year primary endpoint of target vessel failure (TVF) was similar after treatment with Absorb BVS or Xience EES in ACS patients (10.2% versus 9.0% respectively; p=0.49) and in no-ACS patients (11.7% versus 10.7% respectively; p=0.67) Definite or probable device thrombosis occurred more frequently with Absorb BVS compared to Xience EES in ACS patients (4.3% versus 1.7% respectively, p=0.03) as well as in no-ACS patients (2.4% versus 0.2% respectively; p=0.002). There were no statistically significant interactions between clinical presentation and randomized device modality for TVF (p=0.80) and for the endpoint of definite or probable device thrombosis (p=0.17). Conclusions In ACS patients within AIDA, we found no difference in rates of target vessel failure between the Absorb BVS and Xience EES groups. Rates of definite or definite/probable device thrombosis were higher in the Absorb BVS group throughout all clinical presentations. No significant interaction between ACS and no-ACS patients and the occurrence of TVF Acknowledgement/Funding The AIDA trial was financially supported by an unrestricted research grant from Abbott Vascular.

105Calcified nodule in coronary artery: clinical features and prognosis with optical coherence tomography-guided percutaneous coronary intervention

Abstract Background Calcified nodule (CN) in coronary artery is known to be a significant factor for stent underexpansion, however, its baseline characteristics and long-term prognosis is unclear. Method 421 consecutive severe calcified lesions (Defined as maximum calcium arc >180 degrees) which underwent optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) were analyzed between January 2013 and December 2017. We investigated baseline characteristics and OCT parameter (maximum arc of calcium, maximum thickness of calcium, and length of calcium) and long-term clinical outcome (Major adverse cardiac event (MACE), any cause of death, acute myocardial infarction (AMI) and target vessel failure (TVF)). Median follow up period was 33.7 months. Result CN was seen in 22.3% (94 lesions) of all severe calcified lesions. Baseline characteristics and OCT parameters were significantly different in CN and non-CN groups (Hemodialysis; 23.6% vs. 14.1%, p=0.03, Multivessel Disease; 57.4% vs. 44.6, p=0.03, maximum arc of calcium; 305.4 vs. 286.1, p=0.02, maximum thickness of calcium (μm); 1206.2 vs 1123.8, p=0.01, length of calcium (mm); 24.6 vs. 19.0, p=0.01). CN lesions was strongly associated poor long-term clinical outcome (MACE; 50.5% vs. 25.7%, p<0.01), any cause of death; 18.1% vs. 9.5%, p=0.02, AMI; 7.4% vs. 2.4%, p=0.02, TVF; 38.3% vs. 19.2%, p<0.01). Conclusion Hemodialysis, multivessel disease and abundant calcium component may have accompanied with CN which may result in poor long-term prognosis.

P2809Comparison between treatment of “established” versus complex “off-label” coronary lesions with Absorb bioresorbable scaffold implantation: results from the GABI-R registry

Abstract Objectives The purpose of this study was to compare the clinical outcomes of patients treated with bioresorbable scaffold (BRS) for off-label versus approved indications. Background The BRS promised some advantages in terms of complete biodegradation, however, the implication of BRS for off-label indications is not well described. Methods The short- and long-term outcome after implantation of a bioresorbable scaffold system (ABSORB, Abbott Vascular, USA) was evaluated in the prospective, non-interventional, multicenter real-world German-Austrian ABSORB RegIstRy (GABI-R). Results A total of 3,188 patients were enrolled. Patients were divided into two groups: on-label BRS use (33.0%) and off-label use (66.9%) if at least one off-label use criteria was met. The incidence of scaffold thrombosis in confirmed cases was significantly higher in off-label group (1.36% vs. 0.57%, p=0.04; OR 2.41 (95% CI: 1.00–5.82) with also a trend towards higher myocardial infarction rate (2.39% vs. 1.42%, p=0.077; OR 1.70 (95% CI: 0.95–3.03) and cardiovascular death (1.27% vs. 1.14%, p=0.76, OR 1.11 (95% CI: 0.56–2.21) at 6 months follow up. Clinical outcome at 6 months Total Off-label On-label p-value* OR (95%-CI) Patients with 6m FU record 99.0% 99.0% 99.1% 0.82 0.92 (0.43–1.95) Confirmed cardiovascular death 1.22% 1.27% 1.14% 0.76 1.11 (0.56–2.21) Confirmed non-cardiovascular death 0.22% 0.14% 0.38% 0.18 0.37 (0.08–1.66) Cause unknown 0.22% 0.28% 0.09% 0.29 2.97 (0.36–24.73) Hospitalisation 27.5% 27.9% 26.7% 0.51 1.06 (0.89–1.27) MI 2.07% 2.39% 1.42% 0.07 1.70 (0.95–3.03) ARC definite scaffold thrombosis 1.10% 1.36% 0.57% 0.04 2.41 (1.00–5.82) TLF 2.70% 3.00% 2.09% 0.13 1.45 (0.89–2.37) TVF 3.98% 4.31% 3.32% 0.18 1.31 (0.88–1.95) MACE 4.33% 4.64% 3.70% 0.22 1.27 (0.87–1.85) Values are mean ± standard deviation (SD) or number and percentage (n, %). *Comparison between off-label and on-label use. The p-values are from Chi-squared test or Mann-Whitney-Wilcoxon test. ARC, academic research consortium; FU, follow up; MACE, major adverse cardiac events; PCI, percutaneous coronary intervention; TLF, target lesion failure; TVF, target vessel failure. Kaplan-Meyer curve stent thrombosis Conclusions The off-label use of BRS compared to confirmed indications appears to be associated with a higher rate of clinical endpoints considering more complex lesions and higher morbidity in this patients' group. Acknowledgement/Funding This research was supported by a grant from Abbott Vascular.

Prospective evaluation of an ultrathin strut biodegradable polymer-coated sirolimus-eluting stent: 12 months’ results from the S-FLEX UK registry

ObjectiveTo prospectively evaluate safety and efficacy of the ultrathin strut biodegradable polymer-coated Supraflex sirolimus-eluting stent (S-SES) in ‘real world’ patient population requiring percutaneous coronary intervention (PCI).MethodsNational, prospective, multicentre, single-arm, all-comers,...

P3385Difference of vascular healing after percutaneous coronary intervention between 4 kinds of new generation drug-eluting stents: an optical coherence tomography analysis

Abstract Background New generation drug eluting stents (DES) have improved target vessel failure as compared with early generation DES and bare metal stent. Contemporary several new generation DES are different each other regarding strut thickness and drug and polymer type. A little is known about which stent induces a more favorable vascular healing at follow up. Purpose In this study, we compared the vascular healing at 8-month follow up by optical coherence tomography (OCT) between 4 different kinds of new generation DES. Methods We enrolled 112 consecutive patients (121 lesions) who underwent PCI using 4 kinds of new generation DES including biodegradable-polymer everolimus-eluting stents (BP-EES), biodegradable-polymer sirolimus-eluting stents (BP-SES), durable-polymer everolimus-eluting stents (DP-EES) and durable-polymer zotarolimus-eluting stents (DP-ZES) and who underwent 8-month follow up angiogram and OCT between July 2016 and April 2018. We compared the OCT parameters including percentage of covered struts, uncovered struts, well-apposed and uncovered struts, malapposed strut and mean neointimal hyperplasia (NIH) thickness between them. Results BP-EES consisted of 29 lesions, BP-SES consisted of 25 lesions, DP-EES consisted of 38 lesions and DP-ZES consisted of 29 lesions. A total of 734 frames with 5163 struts in BP-EES, 481 frames with 4214 struts in BP-SES, 783 frames with 6119 struts in DP-EES and 583 frames with 4708 struts in DP-ZES were analyzed. As shown in a table, mean NIH thickness was significantly higher in BP-EES and BP-SES. Thus, we compared the OCT parameters between durable-polymer (DP) group including DP-ZES and DP-EES and biodegradable-polymer (BP) group including BP-EES and BP-SES. The percentage of uncovered struts was significantly lower and mean NIH thickness was significantly higher in BP group than DP group. Results of OCT parameters BP-EES (n=29) BP-SES (n=25) DP-EES (n=38) DP-ZES (n=29) P value BP group (n=54) DP group (n=67) P value Covered struts (%) 89.5±13.6 92.4±8.6 85.5±17.5 85.0±17.7 0.29 90.9±11.6 85.3±17.4 0.08 Uncovered struts (%) 8.8±10.8 7.1±8.7 14.5±17.5 15.0±17.7 0.14 8.0±9.9 14.7±17.4 0.03 Well-apposed and uncovered struts (%) 7.9±9.9 5.9±7.7 11.7±13.1 12.3±14.0 0.15 7.0±8.9 11.9±13.4 0.04 Malapposed struts (%) 0.8±1.6 1.3±2.2 2.7±5.8 2.7±4.7 0.33 1.0±1.9 2.7±5.3 0.07 Mean NIH thickness (μm) 102±57 121±48 78±28 88±33 <0.01 111±53 82±31 <0.01 Conclusion The present OCT study demonstrated that delayed neointimal healing characterized by the presence of uncovered struts and lower mean NIH thickness was less common in BP group than DP gruop. Biodegradable-polymer may be more favorable than durable-polymer from the point of view of vascular healing.

Coronary artery perforation during chronic total occlusion percutaneous coronary intervention: epidemiology, mechanisms, management, and outcomes.

The aim of this study was to describe the epidemiology, mechanisms, management, and outcomes of coronary artery perforation during chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We included 1,811 consecutive patients undergoing CTO PCI at five centres between 2011 and 2018. Coronary perforation was observed in n=99 (5.5%). Patients with perforation were older, had a higher J-CTO score, more often required antegrade dissection/re-entry and the retrograde approach, and had lower success rates. The frequency of Ellis type I, II, III and III "cavity spilling" perforations was 11%, 46%, 28%, and 14%, respectively. In 48% of cases, perforation involved the CTO vessel, while the retrograde approach was responsible for 46% of cases. In 53% of cases perforations required intervention. The most frequently applied management strategies included clinical observation (47%), covered stent implantation (25%), balloon occlusion (9%), and coil/fat embolisation (9%). Tamponade was observed in 20/99 (20%) perforation cases. Ellis type III perforations were most frequently observed at the CTO site. These were accountable for 16/20 tamponades and 3/5 deaths. In-hospital mortality was 5.1% vs 0.3% in patients with versus those without perforation (p<0.001). Older age, occlusion length >20 mm, rotational atherectomy, antegrade dissection/re-entry, and the retrograde approach were independently associated with coronary perforation. Patients with perforation suffered an increased incidence of target vessel failure on short-term follow-up. Coronary perforation is observed in a non-negligible proportion of CTO PCIs, often requires intervention, and is associated with tamponade and mortality in a minority of patients. CTO vessel-related perforations are associated with the highest burden of morbidity and mortality.

TCT-67 Predictors and Outcomes After Stent Failure Is Treated With Either CABG or PCI: An Individual Patient-Data Pooled Analysis From 32,880 Patients

When target vessel failure occurs after stent implantation, patients are treated with either repeat percutaneous coronary intervention (PCI-TVR) or coronary artery bypass graft (CABG-TVR); however, the subsequent outcome after repeat revascularization has not been well studied. Individual patient

Clinical outcomes of contemporary drug-eluting stents in patients with and without diabetes mellitus: Multigroup propensity-score analysis using data from stent-specific, multicenter, prospective registries.

Whether the diabetic status differentially affects the clinical outcomes with different drug-eluting stents (DES) has been controversial. From stent-specific, prospective DES registries, we evaluated 17,184 patients (11,428 in non-diabetics and 5,756 in diabetics) who received several contemporary DES: 3570 sirolimus-eluting stents (SES), 5,023 cobalt-chromium everolimus-eluting stents (CoCr-EES), 2,985 platinum-chromium EES (PtCr-EES), 2,913 Resolute zotarolimus-eluting stents (Re-ZES), and 2,693 biodegradable-polymer biolimus-eluting stents (BP-BES). The primary outcome was patient-oriented composite endpoint (POCE, a composite of all-cause death, any myocardial infarction, and any revascularization) at 3-year follow-up and target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization) at 3 years was also evaluated. In non-diabetics, the rates of POCE were not significantly different (CoCr-EES 14.3%, PtCr-EES 13.0%, Re-ZES 14.3%, BP-BES 13.4%, and SES 14.6%; overall p = .39). In diabetics, similar results were revealed (CoCr-EES 18.4%, PtCr-EES 20.3%, Re-ZES 17.3%, BP-BES 17.7%, and SES 17.8%; overall p = .44). In multiple treatment propensity-score weighting analysis, regardless of the diabetic status, the hazard ratios for POCE between-individual comparison were similar. Target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization) was also comparable except the higher ratio of Re-ZES than PtCr-EES (hazard ratio 1.25, 1.26, 95% confidence interval 1.00-1.55, p = .048) in patients without diabetes. In this clinical-practice registry study, regardless the diabetic status, the 3-year rates of the primary outcome were similar among different types of DES, suggesting no differential clinical response between contemporary DES in patients with or without diabetes.

A paradox in sex-specific clinical outcomes after bioresorbable scaffold implantation: 2-year results from the AIDA trial

BackgroundFemales are underrepresented in clinical trials evaluating new stent technologies whilst results may differ between the sexes. Females are known to have smaller, more tortuous coronary arteries and have generally more comorbidities. On the other hand, they may have smaller plaque burden. This subgroup-analysis sought to assess sex-specific outcomes after Absorb bioresorbable vascular scaffold (BVS) or XIENCE everolimus-eluting stent (EES) implantation. MethodsThe AIDA trial was an investigator-initiated, non-inferiority, all-comers trial, in which 1845 patients were randomly assigned to either Absorb BVS or XIENCE EES. Baseline clinical, angiography and procedural variables, as well as 2-year clinical outcomes were analyzed by sex and device modality. ResultsOf the 1845 randomized patients, 475 (25.7%) were females. The 2-year rates of target vessel failure (TVF) with Absorb BVS versus XIENCE EES in females were 6.4% versus 10.6% (HR 0.59; 95% CI: 0.31–1.11; p = 0.10) and in males 12.7% versus 9.7% (HR 1.34; 95% CI: 0.98–1.85; p = 0.07). Males treated with Absorb BVS were at higher risk for TVF compared to females treated with Absorb BVS (HR 2.06; 95% CI 1.21–3.53; p = 0.007). Definite/probable device thrombosis occurred in females with Absorb BVS versus XIENCE EES in 1.6% versus 1.4% (HR 1.15; 95% CI: 0.26–5.12; p = 0.86) and in males 3.9% versus 0.7% (HR 5.55; 95% CI: 2.11–14.35; p < 0.001). A statistical significant interaction between sex and device was present for TVF (p = 0.02), but was not seen for definite/probable device thrombosis (p = 0.08). ConclusionsIn this subgroup analysis, Absorb BVS used in routine practice tends to result in better clinical outcomes in females compared to males.

A comparison between statin with ACE inhibitor or ARB therapy in STEMI patients who underwent successful PCI with drug-eluting stents

Background and aimsStudies of the comparative clinical outcomes between statin with angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) in ST-segment elevation myocardial infarction (STEMI) patients are limited. We compared 2-year clinical outcomes between statin with ACEI or ARB therapy in STEMI patients after successful percutaneous coronary intervention (PCI) with drug-eluting stents (DES). MethodsA total of 11,706 STEMI patients were enrolled and separated into two groups: the ACEI group (statin + ACEI, n = 8705) and the ARB group (statin + ARB, n = 3001). The primary endpoint was major adverse cardiac events (MACE) defined as all-cause death, recurrent MI (re-MI), and any coronary revascularization. Secondary endpoints were the individual components of MACE and target vessel failure (TVF). ResultsAfter propensity score-matched (PSM) analysis, two PSM groups (2729 pairs, n = 5458, C-statistic = 0.675) were generated. The cumulative incidences of MACE, re-MI, and any coronary revascularization were similar between the two groups. However, the cumulative incidences of all-cause death (hazard ratio [HR], 1.548; 95% confidence interval [CI], 1.091–2.197; p = 0.014) and cardiac death (HR, 1.850; 95% CI, 1.218–2.811; p = 0.004) were significantly higher in the ARB group compared with the ACEI group after PSM analysis. ConclusionsThe combination of statin with ACEI may be the preferred treatment strategy to reduce mortality rates in STEMI patients after successful PCI with DES rather than statin with ARB in this study during a 2-year follow-up period.

Thin, Very Thin, or Ultrathin Strut Biodegradable or Durable Polymer-Coated Drug-Eluting Stents: 3-Year Outcomes of BIO-RESORT

ObjectivesThe aim of this study was to assess the 3-year safety and efficacy of treating all-comer patients with 3 contemporary drug-eluting stents (DES). BackgroundThe BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) (TWENTE III) randomized trial (NCT01674803) found similar 1-year safety and efficacy for the 2 biodegradable-polymer DES (i.e., ultrathin-strut cobalt-chromium Orsiro sirolimus-eluting stent [SES] and very-thin-strut platinum-chromium Synergy everolimus-eluting stent) compared with the durable-polymer thin-strut cobalt-chromium Resolute Integrity zotarolimus-eluting stent (ZES). Two-year follow-up suggested that the SES might reduce repeat revascularizations beyond 1 year compared with the ZES. MethodsA total of 3,514 all-comer patients were treated at 4 centers for coronary intervention. The main clinical endpoint, target vessel failure, was a composite of safety (cardiac death or target vessel–related myocardial infarction) and efficacy (target vessel revascularization). Secondary endpoints included the individual components of target vessel failure and stent thrombosis. ResultsThree-year follow-up data were available for 3,393 of 3,514 patients (96.6%). Target vessel failure occurred in 8.5% with SES and 10.0% with ZES (plog rank = 0.22) and in 8.8% with everolimus-eluting stents (vs. ZES, plog rank = 0.32). Rates of cardiac death, target vessel myocardial infarction, and target vessel revascularization were similar between stent groups. Landmark analyses found no statistically significant between-stent difference in repeat revascularization between 1 and 3 years. Definite or probable stent thrombosis rates were low (SES, 1.1%; everolimus-eluting stent, 1.1%; ZES, 0.9%) and similar with all 3 DES. ConclusionsDespite substantial differences in stent backbone and polymer coating, all 3 DES showed favorable 3-year safety and efficacy in all comers, without significant between-stent differences. Further follow-up is required to definitely answer the question of whether one stent might improve clinical outcomes at a later stage.

Influence of target vessel on prognostic relevance of fractional flow reserve after coronary stenting.

We sought to investigate the influence of the target vessel on the prognostic relevance of fractional flow reserve (FFR) after percutaneous coronary intervention (PCI). A total of 835 patients with available FFR after second-generation drug-eluting stent (DES) implantation were included in this study. The primary outcome was target-vessel failure (TVF), including cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularisation. The target vessel was the left anterior descending artery (LAD) in 603 patients (72.2%) and non-LAD in 232 patients (27.8%). The distribution pattern of post-PCI FFR values was different between the LAD and non-LAD (p<0.001). The optimal cut-off values of post-PCI FFR for predicting TVF were 0.82 and 0.88 in the LAD and non-LAD, respectively. The cumulative incidence of TVF was significantly higher in patients with lower post-PCI FFR than each cut-off value (10.9% vs. 2.5%, hazard ratio [HR] 4.08, 95% confidence interval [CI]: 2.63-6.34, p<0.001 in LAD; 8.0% vs. 1.9%, HR 6.00, 95% CI: 1.78-20.26, p=0.004 in non-LAD). Higher post-PCI FFR after second-generation DES implantation was associated with better clinical outcomes. Different cut-off values of post-PCI FFR need to be applied according to the target vessel. ClinicalTrials Identifier: NCT01873560.

Retrograde approach for the percutaneous recanalisation of coronary chronic total occlusions: contribution to clinical practice and long-term outcomes.

We aimed to evaluate the contribution of the retrograde approach to real-world practice over time and its long-term outcomes in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We evaluated 1,635 CTO procedures conducted at our high-volume centre between 2003 and 2015. The retrograde approach has been actively adopted in practice since January 2007. The primary endpoint was target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularisation/reocclusion. The technical success rate of CTO-PCI has increased from 79.5% to 87.1% since 2007, although the complexity of the CTOs has also significantly increased in that time (J-CTO scores: from 1.8±1.2 to 2.0±1.1, p=0.03). The incidence of in-hospital MACCE using the retrograde approach was 4.5%, which was comparable to the antegrade-only approach rate of 4.1% (p=0.58). The retrograde approach showed a higher four-year TVF rate after successful stenting compared with the antegrade-only approach (17.1% vs 9.4%, p=0.01), but this difference was mainly driven by a higher target vessel revascularisation/reocclusion rate. Multivariable analysis revealed that renal dysfunction (hazard ratio [HR] 3.33, 95% confidence interval [CI]: 1.42-7.83), acute coronary syndrome (HR 1.99, 95% CI: 1.26-3.14), the J-CTO score (per 1, HR 1.23, 95% CI: 1.00-1.51), and the smallest stent diameter (per 1 mm, HR 0.39, 95% CI: 0.21-0.74) (all p<0.05) were independently associated with TVF. A retrograde approach contributes to the increased success of more complex CTO-PCI over time with an acceptable frequency of in-hospital complications and four-year TVF rate.

A prospective multicentre randomised all-comers trial to assess the safety and effectiveness of the thin-strut sirolimus-eluting coronary stent SUPRAFLEX: rationale and design of the Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent (TALENT) trial.

The aim of this study is to compare the SUPRAFLEX sirolimus-eluting stent (SES) with the XIENCE everolimus-eluting stent (EES) with respect to target lesion failure (TLF) at 12 months in a non-inferiority trial in a "real-world" patient population. This is a prospective, randomised, 1:1 balanced, controlled, single-blind, multicentre study comparing clinical outcomes at 12 months between SUPRAFLEX and XIENCE in an "all-comers" patient population, comprising a total of 1,430 enrolled subjects with symptomatic coronary artery disease who qualify for percutaneous coronary interventions at 23 centres in Europe. The primary endpoint is a non-inferiority comparison of the device-oriented composite endpoint target lesion failure (cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation) of the SUPRAFLEX group to the XIENCE group at 12 months post procedure. Secondary endpoints include the patient-oriented composite endpoint, target vessel failure, mortality, myocardial infarction, revascularisation and stent thrombosis rates (ARC classification). The TALENT trial aims to assess the safety and effectiveness of the thin-strut SUPRAFLEX compared to the current standard of care (XIENCE EES) in patients with atherosclerotic lesions. This will provide valuable information on the impact of this thin-strut device in an all-comers population.

Hybrid Coronary Percutaneous Treatment with Metallic Stents and Everolimus-Eluting Bioresorbable Vascular Scaffolds: 2-years Results from the GABI-R Registry.

The limitations of the first-generation everolimus-eluting coronary bioresorbable vascular scaffolds (BVS) have been demonstrated in several randomized controlled trials. Little data are available regarding the outcomes of patients receiving hybrid stenting with both BVS and drug-eluting stents (DES). Of 3144 patients prospectively enrolled in the GABI-Registry, 435 (age 62 ± 10, 19% females, 970 lesions) received at least one BVS and one metal stent (hybrid group). These patients were compared with the remaining 2709 (3308 lesions) who received BVS-only. Patients who had received hybrid stenting had more frequently a history of cardiovascular disease and revascularization (p < 0.05), had less frequently single-vessel disease (p < 0.0001), and the lesions treated in these patients were longer (p < 0.0001) and more frequently complex. Accordingly, the incidence of periprocedural myocardial infarction (p < 0.05) and that of cardiovascular death, target vessel and lesion failure and any PCI at 24 months was lower in the BVS-only group (all p < 0.05). The 24-months rate of definite and probable scaffold thrombosis was 2.7% in the hybrid group and 2.8% in the BVS-only group, that of stent thrombosis in the hybrid group was 1.86%. In multivariable analysis, only implantation in bifurcation lesions emerged as a predictor of device thrombosis, while the device type was not associated with this outcome (p = 0.21). The higher incidence of events in patients receiving hybrid stenting reflects the higher complexity of the lesions in these patients; in patients treated with a hybrid strategy, the type of device implanted did not influence patients´ outcomes.