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Objectives: We aimed to explore the impact of time to percutaneous coronary intervention (PCI) (T2P) on 1-year mortality in non-ST-elevation myocardial infarction (NSTEMI) patients., Background: The current guidelines recommend an early invasive strategy for NSTEMI patients. However, impact of an early invasive strategy on mortality is a matter of debate. For that reason, real world data are of great value to determine the optimal treatment window., Methods: This retrospective single center cohort study was performed in a high-volume PCI center in Amsterdam, The Netherlands. Intermediate- and high-risk NSTEMI patients undergoing PCI were included. The main discriminant was timing of PCI after admission (T2P), stratified according to different time windows (<24 h, 24-72 h, 72 h-7 days or >7 days). We analyzed 1-year mortality and the time distribution of overall survival., Results: In total, 848 patients treated between January 1, 2016 and January 1, 2018 were included in the analysis. T2P was <24 h in 145 patients, 24-72 h in 192 patients, 72 h-7 days in 275 patients, and >7 days in 236 patients. The mean GRACE-risk score was 127.1 (SD 28.7), 130.0 (33.1), 133.8 (32.1), and 148.7 (34.6) respectively, p = <0.001. After adjusting for confounders, 1-year mortality in patients with T2P <24 h did not significantly differ when compared with T2P 24-72 h (OR = 1.08; 95% CI = 0.33-3.51) and T2P 72 h-7 days (OR 1.72; 95% CI = 0.57-5.21) but was significantly higher in T2P >7 days (OR = 3.20; 95% CI = 1.06-9.68)., Conclusions: In an unselected cohort of patients with NSTEMI, treatment by PCI <24 h did not lead to improved survival as compared to aT2P <7 days strategy. Delay in PCI >7 days after admission resulted in worse outcome., (© 2021 Wiley Periodicals LLC.)

Background: In this prespecified AIDA-trial sub-study we investigate the clinical performance of absorb bioresorbable vascular scaffold (BVS) compared to Xience everolimus-eluting stent (EES) in routine percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) at complete 3-year follow-up., Methods and Results: All 1,845 randomized patients were subdivided by medical history with DM or without DM. Of the 924 Absorb BVS patients, 171 (18.5%) patients had DM, of which 65 (38.0%) were treated with insulin (iTDM). Of the 921 Xience EES patients, 153 (16.6%) patients had DM, of which 45 (29.4%) were insulin-treated diabetes mellitus (iTDM). Target vessel failure (TVF), composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization, occurred in 18.7% of diabetic patients treated with Absorb patients versus in 18.0% patients treated with Xience EES (p = .840). In nondiabetics the rates of TVF were 12.3% in Absorb BVS versus 11.0% in Xience EES (p = .391). Definite/probable device thrombosis occurred more frequently in Absorb BVS compared to Xience EES in both diabetic and nondiabetic patients (4.8% versus 0.7%; p = .028 and 3.2% vs. 0.5%; p < .001, respectively)., Conclusions: In routine PCI practice, both Absorb BVS and Xience EES have worse clinical outcomes in diabetic patients as compared to nondiabetic patients. Throughout all clinical presentations, Absorb BVS was associated with higher rates of device thrombosis at 3-year follow-up., (© 2020 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Objective: To evaluate predictors of procedural success of percutaneous coronary intervention (PCI) of chronic total coronary occlusions (CTOs) in a non-infarct-related artery following ST-segment elevation myocardial infarction (STEMI), and demonstrate the effect on left ventricular functionality (LVF), infarct size (IS), and pro-arrhythmic electrocardiogram (ECG) parameters., Background: Predictors of unsuccessful revascularization of a CTO are numerous, although following STEMI, these are lacking. Besides, effects of failed CTO PCI (FPCI) on the myocardium are unknown., Methods: This is a subanalysis of the EXPLORE trial, in which 302 STEMI patients with a concurrent CTO were randomized to CTO PCI (n = 147) or no-CTO PCI (NPCI, n = 154). For the purpose of this subanalysis, we divided patients into successful CTO PCI (SPCI, n = 106), FPCI (n = 41), and NPCI (n = 154) groups. Cardiac magnetic resonance imaging and angiographic data were derived from the EXPLORE database, combined with ECG parameters. To gain more insight, all outcomes were compared with patients that did not undergo CTO PCI., Results: In multivariate regression, only CTO lesion length >20 mm was an independent predictor of procedural failure (OR 3.31 [1.49-7.39]). No significant differences in median left ventricular ejection fraction, left ventricular end-diastolic volume, IS, and the pro-arrhythmic ECG parameters such as QT-dispersion, QTc-time, and TpTe-intervals were seen between the SPCI and FPCI groups at 4 months follow-up., Conclusion: This subanalysis of the EXPLORE trial has demonstrated that a CTO lesion length >20 mm is an independent predictor of CTO PCI failure, whereas procedural failure did not lead to any adverse effects on LVF nor pro-arrhythmic ECG parameters., (© 2020 Wiley Periodicals LLC.)

Background: Patients with acute coronary syndrome (ACS) might represent a specific subgroup, in which bioresorbable scaffold implantation in percutaneous coronary intervention (PCI), might lead to better outcomes when compared to conventional treatment with metallic drug eluting stents. In this prespecified subgroup analysis of the Amsterdam Investigator-Initiated Absorb Strategy All-Comers (AIDA) trial, we evaluated the clinical outcomes of Absorb bioresorbable vascular scaffold (BVS) versus Xience everolimus eluting stent (EES) treated patients presenting either with or without ACS., Methods and Results: We classified AIDA patients on the basis of clinical presentation of ACS or of no-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)., Conclusion: In the AIDA trial, the 2-year outcomes of PCI with Absorb BVS versus Xience EES were consistent in ACS and no-ACS patients: similar rates for TVF and consistently higher rates of definite or probable stent thrombosis under Absorb BVS versus Xience EES. There were no statistically significant interactions between clinical presentation and randomized device modality., (© 2019 Wiley Periodicals, Inc.)

Objectives: To assess the effect of chronic total occlusion percutaneous coronary intervention (CTO PCI) on ventricular ectopy (VE) and symptomatology during exercise testing., Background: During exercise, the hypoxic myocardium in the CTO-territory can act as a substrate for VE and could lead to anginal complaints., Methods: In the EXPLORE-trial, 302 ST-segment elevation myocardial infarction (STEMI)-patients were randomized to CTO PCI or no-CTO PCI. For this sub-study, we analyzed all available exercise electrocardiograms (X-ECGs) at 4 months follow-up on symptoms and electrocardiographic parameters., Results: A total of 155 X-ECGs were available, 80 in the CTO PCI group (51.6%) and 75 in the no-CTO PCI group (48.4%). There were no differences regarding exercised time, achieved endurance, ST-deviation nor maximum heart-rate. The percentage of patients experiencing chest-pain during exercise was lower in the CTO PCI group (0% vs. 8.5%, p = .03). Also, there was a trend towards a higher maximum systolic blood pressure (SBP, 185 mmHg vs. 175, p = .09). No difference in VE was found between randomization groups, but patients with successful CTO PCI had a higher frequency of VE, compared to failed and no-CTO PCI (26% vs. 8%, p = .02). This did not result in higher frequencies of sustained ventricular arrhythmias or mortality., Conclusion: In conclusion, in STEMI-patients, CTO PCI is associated with a small reduction of chest-pain during exercise and tended to be associated with an increase of maximum SBP. The observation that successful CTO PCI was associated with more VE during exercise, compared with failed/no-CTO PCI needs further exploration., (© 2019 Wiley Periodicals, Inc.)

Objectives: To investigate the relative performance of treatment with a paclitaxel-eluting balloon (PEB) compared with an everolimus-eluting stent (EES) for in-stent restenosis (ISR) in patients with diabetes mellitus (DM)., Background: ISR remains a challenge in contemporary clinical practice, particularly in patients with DM., Methods: In the multicenter randomized DARE trial, patients with BMS or DES ISR were randomized in a 1:1 fashion to treatment with a PEB or an EES. Patients underwent angiographic follow-up after 6 months. For the purpose of this analysis, the relative performance of PEB versus EES in diabetic patients was investigated., Results: Of 278 patients enrolled in DARE, 88 (32%) had DM, of whom 46 were randomized to EES and 42 to PEB treatment. Of patients with DM, 48 (55%) had DES-ISR. Angiographic follow-up was available in 30 patients (72%) in the PEB group and 36 patients (78%) in the DES group. There were no differences in terms of 6-months minimal lumen diameter in diabetic patients treated with EES (1.46 ± 0.66 mm) versus PEB (1.78 ± 0.58 mm, P = 0.15). Adverse events at one year follow-up were similar in both groups, with Major Adverse Events (MAE, death, target vessel MI, or TVR) occurring in 17.4% in the EES group versus 11.9% in the PEB group, P = 0.44., Conclusions: In patients with ISR and DM, use of a PEB resulted in similar 6-months in-segment minimal lumen diameter and comparable rates of MAE. In-segment late loss at 6 months was significantly lower in the PEB arm. Although larger trials in DM patients with ISR are necessary, PEB is a promising treatment option obviating the need for additional stent implantation., (© 2018 Wiley Periodicals, Inc.)

Objectives: Available data indicate mixed outcomes after using retrograde techniques for chronic total occlusion(CTO) recanalization, with generally higher need for repeat revascularization. Aim of this study is to analyze the angiographic and clinical outcome of patients treated with retrograde techniques in the PRISON-IV trial., Methods and Results: This is a post-hoc sub-analysis from the randomized PRISON-IV trial. Briefly, 330 patients with a successfully recanalized CTO lesion were randomized 1:1 to receive either hybrid-SES or EES. The hybrid-SES failed to reach the non-inferiority primary endpoint of in-segment late lumen loss at 9-month angiography follow-up. In the present analysis, we divided the population according to the first technical approach, namely antegrade (n = 285) or retrograde approach (n = 45). Demographic characteristics were similar between the two groups, while angiographic features disclosed higher CTO lesion complexity in the group treated with retrograde techniques (J-CTO score: 1.8 ± 1.1 vs 2.6 ± 1.1, respectively, P < 0.001), with longer occlusions (17.6 ± 10 mm vs 28.8 ± 18.7 mm, P < 0.001) and longer stented segment (48.9 ± 24.4 mm vs 73.1 ± 33.2 mm, P < 0.001). Quantitative coronary analysis disclosed similar results at follow-up angiography, with a non-significantly higher in-stent late-lumen loss in the retrograde group (0.08 ± 0.52 mm vs 0.18 ± 0.56 mm, P = 0.32). Clinical follow-up at 12-months showed similar outcome, with a non-significantly higher target-lesions revascularization rate in the retrograde group (6% vs 11.1% respectively, P = 0.2). Significant improvements in angina functional class were observed in both groups., Conclusions: The present analysis supports the benefits of retrograde techniques in CTO revascularization, with non-significant differences in angiographic and clinical outcomes at late follow-up., (© 2018 Wiley Periodicals, Inc.)

Objectives: To identify potential underlying mechanisms of early and (very) late scaffold thrombosis (ScT) by optical coherence tomography (OCT), in a frame-by-frame analysis., Background: The absorb scaffold is associated with an increased risk of ScT compared with metallic stents. Several potential causes of bioresorbable ScT have been identified, however the precise etiology still remains unclear., Methods: Between February 2013 and February 2016, 13 patients presenting with definite ScT underwent OCT imaging. After guidewire passage or balloon inflations, OCT images were acquired. Pullbacks were assessed offline at each 1 mm longitudinal interval within the treated segment and the 5 mm segments adjacent to both edges. Primary cause of ScT was assessed by reviewing medical records, baseline angiographic films, and OCT pullback and angiographic films at time of ScT., Results: 13 patients, with 14 thrombotic lesions presented either with early ScT (i.e., ≤30 days) or very (late) (i.e., >30 days). Analysis demonstrated a significantly smaller in-scaffold maximal lumen diameter in the early cases (2.75 ± 0.85 mm vs. 3.00 ± 0.46 mm; P = 0.033) and a nonsignificant smaller minimal scaffold diameter (2.44 ± 0.62 mm vs. 2.58 ± 0.37 mm P = 0.097). Per-strut analysis demonstrated significantly more malapposed scaffold struts in (very) late cases (6% versus 0.6%, P < 0.001). Assessment of the predominate cause showed underexpansion as the dominant factor in the early cases, while malapposition was predominantly seen in the (very)late cases., Conclusions: OCT performed in patients presenting with Absorb ScT demonstrated that malapposition of scaffold struts was more prominent in patients presenting with (very) late ScT, while underexpansion was more frequent in the early cases., (© 2018 Wiley Periodicals, Inc.)

Aim: In primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI), stenting has proved to reduce the need for repeat revascularization compared with balloon angioplasty alone. The incidence of cardiac death or recurrent myocardial infarction, though, is not reduced by stenting. This is in part attributable to stent-related complications like stent thrombosis which may occur even years after implantation. A strategy of drug coated balloon (DCB) angioplasty without stenting would abolish the potential disadvantages of stent implantation while reducing the probability of restenosis observed in plain old balloon angioplasty. Our aim is to evaluate the efficacy and safety of a DCB only strategy versus drug-eluting stents (DES) in PPCI for STEMI., Study Design: The REVELATION trial is a prospective, single center, randomized study, in which 120 patients presenting with STEMI will be allocated to treatment with a DCB versus DES. Appertaining to the established prognostic value of fractional flow reserve (FFR) rather than angiographic lesion severity, the functional assessment of the infarct-related lesion by FFR at 9 months after initial treatment is the primary end point. Assuming an FFR value of 0.90 after stenting and an increased risk of adverse events if post-PCI FFR <0.85, we decided to accept an FFR value of ≥0.85 after DCB only at follow-up as noninferiority margin. Secondary end points include major adverse cardiac events up to 5-year follow-up., Conclusion: Our trial will address the efficacy and safety of DCB angioplasty versus DES in the setting of PPCI for STEMI. The REVELATION trial will introduce the recognized prognostic significance of physiologic assessment of the infarct-related lesion by FFR at 9 months follow-up as primary end point. © 2015 Wiley Periodicals, Inc., (© 2015 Wiley Periodicals, Inc.)

Aims: We sought to evaluate the procedural and clinical performances of the MGuard Prime Embolic Protection Stent (EPS) in a "real-world" population with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI)., Methods and Results: Consecutive STEMI patients meeting the inclusion criteria and undergoing PPCI were enrolled. The primary endpoint was major adverse cardiac events (MACE) at 30 days, defined as the composite of cardiac death, myocardial infarction (Q wave and non-Q wave) or target lesion revascularization (PCI or coronary artery bypass graft). Secondary endpoints included device success, lesion success, and postprocedural reperfusion outcomes: thrombolysis in myocardial infarction (TIMI) flow and ST-segment elevation resolution (STR). A total of 97 patients (62 years, 77% men) were included. Symptom to cathlab time was 238 min. Device and lesion success were 100%. Final TIMI-3 flow was achieved in 91.8%, and STR > 50% in 87% of the patients. MACE at 30 days was 2.2%, which consisted of one case each of target vessel (TV)-myocardial infarction (MI), and non-TV-MI., Conclusions: The use of the MGuard Prime EPS stent is feasible and safe and could be also effective in achieving myocardial reperfusion in STEMI patients undergoing PPCI., (© 2015 Wiley Periodicals, Inc.)

Objectives: We studied the effects of LV unloading by the Impella on coronary hemodynamics by simultaneously measuring intracoronary pressure and flow and the derived parameters fractional flow reserve (FFR), coronary flow velocity reserve (CFVR), and coronary microvascular resistance (MR)., Background: Patients with compromised left ventricular (LV) function undergoing high-risk percutaneous coronary intervention (PCI) may benefit from LV unloading. Limited information is available on the effects of LV unloading on coronary hemodynamics., Methods: Eleven patients (mean LV ejection fraction of 35 +/- 11%) underwent PCI during LV support by the LV unloading device (Impella Recover LP2.5). Intracoronary measurements were performed in a nonstenotic coronary artery after the PCI, before and after adenosine-induced hyperemia at four different support levels (0-2.5 L/min)., Results: Aortic and coronary pressure increased with increasing support levels, whereas FFR remained unchanged. Baseline flow velocity remained unchanged, while hyperemic flow velocity and CFVR increased significantly with increasing support levels (61 +/- 24 to 72 +/- 27 cm/sec, P = 0.001 and 1.88 +/- 0.52 to 2.34 +/- 0.63, P < 0.001 respectively). The difference between baseline MR and hyperemic MR significantly increased with increasing support levels (1.28 +/- 1.32 to 1.89 +/- 1.43 mm Hg cm(-1) sec, P = 0.005)., Conclusions: Unloading of the LV by the Impella increased aortic and intracoronary pressure, hyperemic flow velocity and CFVR, and decreased MR. The Impella-induced increase in coronary flow, probably results from both an increased perfusion pressure and a decreased LV volume-related intramyocardial resistance., ((c) 2007 Wiley-Liss, Inc.)