Wire-based antegrade dissection re-entry technique for coronary chronic total occlusions percutaneous revascularization: Experience from the ERCTO Registry.

BACKGROUND: The recent development and widespread adoption of antegrade dissection re-entry (ADR) techniques have been underlined as one of the antegrade strategies in all worldwide CTO consensus documents. However, historical wire-based ADR experience has suffered from disappointing long-term outcomes. AIMS: Compare technical success, procedural success, and long-term outcome of patients who underwent wire-based ADR technique versus antegrade wiring (AW). METHODS: One thousand seven hundred and ten patients, from the prospective European Registry of Chronic Total Occlusions (ERCTO), underwent 1806 CTO procedures between January 2018 and December 2021, at 13 high-volume ADR centers. Among all 1806 lesions attempted by the antegrade approach, 72% were approached with AW techniques and 28% with wire-based ADR techniques. RESULTS: Technical and procedural success rates were lower in wire-based ADR than in AW (90.3% vs. 96.4%, p < 0.001; 87.7% vs. 95.4%, p < 0.001, respectively); however, wire-based ADR was used successfully more often in complex lesions as compared to AW (p = 0.017). Wire-based ADR was used in most cases (85%) after failure of AW or retrograde procedures. At a mean clinical follow-up of 21 ± 15 months, major adverse cardiac and cerebrovascular events (MACCEs) did not differ between AW and wire-based ADR (12% vs. 15.1%, p = 0.106); both AW and wire-based ADR procedures were associated with significant symptom improvements. CONCLUSIONS: As compared to AW, wire-based ADR is a reliable and effective strategy successfully used in more complex lesions and often after the failure of other techniques. At long-term follow-up, patient's MACCEs and symptoms improvement were similar in both antegrade techniques.

Single vs. multiple operators for chronic total occlusion percutaneous coronary interventions: From the PROGRESS-CTO Registry.

BACKGROUND: There is limited data on the impact of a second attending operator on chronic total occlusion (CTO) percutaneous coronary intervention (PCI) outcomes. METHODS: We analyzed the association between multiple operators (MOs) (>1 attending operator) and procedural outcomes of 9296 CTO PCIs performed between 2012 and 2021 at 37 centers. RESULTS: CTO PCI was performed by a single operator (SO) in 85% of the cases and by MOs in 15%. Mean patient age was 64.4 ± 10 years and 81% were men. SO cases were more complex with higher Japan-CTO (2.38 ± 1.29 vs. 2.28 ± 1.20, p = 0.005) and Prospective Global Registry for the Study of Chronic Total Occlusion Intervention scores (1.13 ± 1.01 vs. 0.97 ± 0.93, p < 0.001) compared with MO cases. Procedural time (131 [87, 181] vs. 112 [72, 167] min, p < 0.001), fluoroscopy time (49 [31, 76] vs. 42 [25, 68] min, p < 0.001), air kerma radiation dose (2.32 vs. 2.10, p < 0.001), and contrast volume (230 vs. 210, p < 0.001) were higher in MO cases. Cases performed by MOs and SO had similar technical (86% vs. 86%, p = 0.9) and procedural success rates (84% vs. 85%, p = 0.7), as well as major adverse complication event rates (MACE 2.17% vs. 2.42%, p = 0.6). On multivariable analyses, MOs were not associated with higher technical success or lower MACE rates. CONCLUSION: In a contemporary, multicenter registry, 15% of CTO PCI cases were performed by multiple operators. Despite being more complex, SO cases had lower procedural and fluoroscopy times, and similar technical and procedural success and risk of complications compared with MO cases.

Gender differences in percutaneous coronary intervention for chronic total occlusions from the ERCTO study.

BACKGROUND: Gender-specific data addressing percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) in female patients are scarce and based on small sample size studies. AIMS: We aimed to analyze gender-differences regarding in-hospital clinical outcomes after CTO-PCI. METHODS: Data from 35,449 patients enrolled in the prospective European Registry of CTOs were analyzed. The primary outcome was the comparison of procedural success rate in the two cohorts (women vs. men), defined as a final residual stenosis less than 20%, with Thrombolysis In Myocardial Infarction grade flow = 3. In-hospital major adverse cardiac and cerebrovascular events (MACCEs) and procedural complications were deemed secondary outcomes. RESULTS: Women represented 15.2% of the entire study population. They were older and more likely to have hypertension, diabetes, and renal failure, with an overall lower J-CTO score. Women showed a higher procedural success rate (adjusted OR [aOR] = 1.115, confidence interval [CI]: 1.011-1.230, p = 0.030). Apart from previous myocardial infarction and surgical revascularization, no other significant gender differences were found among predictors of procedural success. Antegrade approach with true-to-true lumen techniques was more commonly used than retrograde approach in females. No gender differences were found regarding in-hospital MACCEs (0.9% vs. 0.9%, p = 0.766), although a higher rate of procedural complications was observed in women, such as coronary perforation (3.7% vs. 2.9%, p < 0.001) and vascular complications (1.0% vs. 0.6%, p < 0.001). CONCLUSIONS: Women are understudied in contemporary CTO-PCI practice. Female sex is associated with higher procedural success after CTO-PCI, yet no sex differences were found in terms of in-hospital MACCEs. Female sex was associated with a higher rate of procedural complications.

Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease.

BACKGROUND: Long-term outcomes after percutaneous coronary intervention (PCI) with contemporary drug-eluting stents, as compared with coronary-artery bypass grafting (CABG), in patients with left main coronary artery disease are not clearly established. METHODS: We randomly assigned 1905 patients with left main coronary artery disease of low or intermediate anatomical complexity (according to assessment at the participating centers) to undergo either PCI with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). The primary outcome was a composite of death, stroke, or myocardial infarction. RESULTS: At 5 years, a primary outcome event had occurred in 22.0% of the patients in the PCI group and in 19.2% of the patients in the CABG group (difference, 2.8 percentage points; 95% confidence interval [CI], -0.9 to 6.5; P = 0.13). Death from any cause occurred more frequently in the PCI group than in the CABG group (in 13.0% vs. 9.9%; difference, 3.1 percentage points; 95% CI, 0.2 to 6.1). In the PCI and CABG groups, the incidences of definite cardiovascular death (5.0% and 4.5%, respectively; difference, 0.5 percentage points; 95% CI, -1.4 to 2.5) and myocardial infarction (10.6% and 9.1%; difference, 1.4 percentage points; 95% CI, -1.3 to 4.2) were not significantly different. All cerebrovascular events were less frequent after PCI than after CABG (3.3% vs. 5.2%; difference, -1.9 percentage points; 95% CI, -3.8 to 0), although the incidence of stroke was not significantly different between the two groups (2.9% and 3.7%; difference, -0.8 percentage points; 95% CI, -2.4 to 0.9). Ischemia-driven revascularization was more frequent after PCI than after CABG (16.9% vs. 10.0%; difference, 6.9 percentage points; 95% CI, 3.7 to 10.0). CONCLUSIONS: In patients with left main coronary artery disease of low or intermediate anatomical complexity, there was no significant difference between PCI and CABG with respect to the rate of the composite outcome of death, stroke, or myocardial infarction at 5 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776.).

Safety and efficacy of a sirolimus-eluting coronary stent with ultra-thin strut for treatment of atherosclerotic lesions (TALENT): a prospective multicentre randomised controlled trial.

BACKGROUND: Supraflex is a sirolimus-eluting stent with a biodegradable polymer coating and ultra-thin struts. We aimed to compare Supraflex with the standard of care, Xience, an everolimus-eluting stent with a durable polymer coating, regarding clinical outcomes with a randomised trial in an all-comer population. METHODS: We did a prospective, randomised, single-blind, multicentre study (TALENT) across 23 centres in Europe (the Netherlands, Poland, the UK, Spain, Bulgaria, Hungary, and Italy). Eligible participants were aged 18 years or older, had one or more coronary artery stenosis of 50% or greater in a native coronary artery, saphenous venous graft, or arterial bypass conduit, and had a reference vessel diameter of 2·25-4·50 mm. Patients underwent percutaneous coronary intervention in an all-comer manner. We randomly assigned patients (1:1) to implantation of either a sirolimus-eluting stent with a biodegradable polymer coating and ultra-thin struts (Supraflex) or an everolimus-eluting stent with a durable polymer coating (Xience). Randomisation was done by local investigators by use of a web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint-cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation-between groups at 12 months after the procedure, assessed in an intention-to-treat population. On assumption of 1-year composite endpoint prevalence of 8·3%, a margin of 4·0% was defined for non-inferiority of the Supraflex group compared with the Xience group. This trial is registered with ClinicalTrials.gov, number NCT02870140. FINDINGS: Between Oct 21, 2016, and July 3, 2017, 1435 patients with 1046 lesions were randomly assigned to Supraflex, of whom 720 received the index procedure, and 715 patients with 1030 lesions were assigned to Xience, all receiving the index procedure. At 12 months, the primary endpoint had occurred in 35 patients (4·9 %) in the Supraflex group and in 37 patients (5·3%) in the Xience group (absolute difference -0·3% [one-sided 95% upper confidence bound 1·6%], pnon-inferiority<0·0001). Definite or probable stent thrombosis prevalence, a safety indicator, was low in both groups and did not differ between them. INTERPRETATION: The Supraflex stent was non-inferior to the Xience stent for a device-oriented composite clinical endpoint at 12 months in an all-comer population. Supraflex seems a safe and effective alternative drug-eluting stent to other stents in clinical practice. FUNDING: European Cardiovascular Research Institute.

Outcomes with retrograde versus antegrade chronic total occlusion revascularization.

OBJECTIVES: The aim of the study was to evaluate the outcomes of retrograde versus antegrade approach in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). BACKGROUND: The retrograde approach has increased the success rate of CTO PCI but has been associated with a higher risk for complications. METHODS: We conducted a meta-analysis of studies published between 2000 and August 2019 comparing the in-hospital and long-term outcomes with retrograde versus antegrade CTO PCI. RESULTS: Twelve observational studies (10,240 patients) met our inclusion criteria (retrograde approach 2,789 patients, antegrade approach 7,451 patients). Lesions treated with the retrograde approach had higher J-CTO score (2.8 vs. 1.9, p < .001). Retrograde CTO PCI was associated with a lower success rate (80.9% vs. 87.4%, p < .001). Both approaches had similar in-hospital mortality, urgent revascularization, and cerebrovascular events. Retrograde CTO PCI was associated with higher risk of in-hospital myocardial infarction (MI; odds ratio [OR] 2.37, 95% confidence intervals [CI] 1.7, 3.32, p < .001), urgent pericardiocentesis (OR 2.53, 95% CI 1.41-4.51, p = .002), and contrast-induced nephropathy (OR 2.12, 95% CI 1.47-3.08; p < .001). During a mean follow-up of 48 ± 31 months retrograde crossing had similar mortality (OR 1.79, 95% CI 0.84-3.81, p = .13), but a higher incidence of MI (OR 2.07, 95% CI 1.1-3.88, p = .02), target vessel revascularization (OR 1.92, 95% CI 1.49-2.46, p < .001), and target lesion revascularization (OR 2.08, 95% CI 1.33-3.28, p = .001). CONCLUSIONS: Compared with antegrade CTO PCI, retrograde CTO PCI is performed in more complex lesions and is associated with a higher risk for acute and long-term adverse events.

Platelet reactivity and clinical outcomes in acute coronary syndrome patients treated with prasugrel and clopidogrel: a pre-specified exploratory analysis from the TROPICAL-ACS trial.

AIMS: The value of platelet function testing (PFT) in predicting clinical outcomes and guiding P2Y12-inhibitor treatment is uncertain. In a pre-specified sub-study of the TROPICAL-ACS trial, we assessed ischaemic and bleeding risks according to high platelet reactivity (HPR) and low platelet reactivity (LPR) to ADP in patients receiving uniform prasugrel vs. PFT-guided clopidogrel or prasugrel. METHODS AND RESULTS: Acute coronary syndrome patients with PFT done 14 days after hospital discharge were included with prior randomization to uniform prasugrel for 12 months (control group, no treatment modification) vs. early de-escalation from prasugrel to clopidogrel and PFT-guided maintenance treatment (HPR: switch-back to prasugrel, non-HPR: clopidogrel). The composite ischaemic endpoint included cardiovascular death, myocardial infarction, or stroke, while key safety outcome was Bleeding Academic Research Consortium (BARC) 2-5 bleeding, from PFT until 12 months. We identified 2527 patients with PFT results available: 1266 were randomized to the guided and 1261 to the control group. Before treatment adjustment, HPR was more prevalent in the guided group (40% vs. 15%), while LPR was more common in control patients (27% vs. 11%). Compared to control patients without HPR on prasugrel (n = 1073), similar outcomes were observed in guided patients kept on clopidogrel [n = 755, hazard ratio (HR): 1.06 (0.57-1.95), P = 0.86] and also in patients with HPR on clopidogrel switched to prasugrel [n = 511, HR: 0.96 (0.47-1.96), P = 0.91]. In contrast, HPR on prasugrel was associated with a higher risk for ischaemic events in control patients [n = 188, HR: 2.16 (1.01-4.65), P = 0.049]. Low platelet reactivity was an independent predictor of bleeding [HR: 1.74 (1.18-2.56), P = 0.005], without interaction (Pint = 0.76) between study groups. CONCLUSION: Based on this substudy of a randomized trial, selecting prasugrel or clopidogrel based on PFT resulted in similar ischaemic outcomes as uniform prasugrel therapy without HPR. Although infrequent, HPR on prasugrel was associated with increased risk of ischaemic events. Low platelet reactivity was a strong and independent predictor of bleeding both on prasugrel and clopidogrel.

Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease.

BACKGROUND: Patients with obstructive left main coronary artery disease are usually treated with coronary-artery bypass grafting (CABG). Randomized trials have suggested that drug-eluting stents may be an acceptable alternative to CABG in selected patients with left main coronary disease. METHODS: We randomly assigned 1905 eligible patients with left main coronary artery disease of low or intermediate anatomical complexity to undergo either percutaneous coronary intervention (PCI) with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). Anatomic complexity was assessed at the sites and defined by a Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score of 32 or lower (the SYNTAX score reflects a comprehensive angiographic assessment of the coronary vasculature, with 0 as the lowest score and higher scores [no upper limit] indicating more complex coronary anatomy). The primary end point was the rate of a composite of death from any cause, stroke, or myocardial infarction at 3 years, and the trial was powered for noninferiority testing of the primary end point (noninferiority margin, 4.2 percentage points). Major secondary end points included the rate of a composite of death from any cause, stroke, or myocardial infarction at 30 days and the rate of a composite of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years. Event rates were based on Kaplan-Meier estimates in time-to-first-event analyses. RESULTS: At 3 years, a primary end-point event had occurred in 15.4% of the patients in the PCI group and in 14.7% of the patients in the CABG group (difference, 0.7 percentage points; upper 97.5% confidence limit, 4.0 percentage points; P=0.02 for noninferiority; hazard ratio, 1.00; 95% confidence interval, 0.79 to 1.26; P=0.98 for superiority). The secondary end-point event of death, stroke, or myocardial infarction at 30 days occurred in 4.9% of the patients in the PCI group and in 7.9% in the CABG group (P<0.001 for noninferiority, P=0.008 for superiority). The secondary end-point event of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years occurred in 23.1% of the patients in the PCI group and in 19.1% in the CABG group (P=0.01 for noninferiority, P=0.10 for superiority). CONCLUSIONS: In patients with left main coronary artery disease and low or intermediate SYNTAX scores by site assessment, PCI with everolimus-eluting stents was noninferior to CABG with respect to the rate of the composite end point of death, stroke, or myocardial infarction at 3 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776 .).

Short- and long-term results with a percutaneous treatment in critical hand ischaemia.

BACKGROUND: The aim of this prospective registry was to determine the feasibility, safety, and outcomes of percutaneous transluminal angioplasty and thrombolysis in the treatment of critical hand ischemia (CHI). METHODS: One-hundred one patients (aged 60.6 ± 15.3 years) were treated for CHI between 2012 and 2016 in three cardiovascular centers. Anatomically, the upper arm was divided into three segments (I-subclavian, II-brachial, and III-forearm). We examined the rates of technical and clinical success, major adverse events (MAEs), and vascular complications at 1 year and at long-term follow-up. RESULTS: Nineteen patients (18.8%) were treated for acute CHI, and 82 (81.2%) for chronic CHI. Median follow-up was 36.9 (19.6-68.3) months. Clinical symptoms were isolated rest pain in 91 patients (90.1%) and digital ulcer or gangrene in 10 patients (9.9%). The technical and clinical success rate of intervention was 96.0% (97/101) and 84.2% (85/101) at 1 year. Angioplasty was performed in Segments I, II, and III in 28 (27.7%), in 29 (28.7%), and 44 (43.5%) patients. Stent implantation was necessary in 47 patients (46.8%). Vascular access site complications were found in 2.1% of the sample. After 1 year, MAEs occurred in 27 patients (26.9%), and the target lesion revascularization rate was 11.9%. In two patients (1.9%), thoracic sympatectomy was necessary, and two patients (1.9%) underwent minor finger amputations. CONCLUSIONS: Angioplasty of hand vessels for CHI is a feasible and safe procedure with acceptable rates of technical success and hand healing. MAEs are frequent because the rate of severe comorbidities is high.

Clinical outcomes in unselected patients treated with the PROMUS Element platinum-chromium, everolimus-eluting stent: Final five-year results from the PE PROVE Study.

OBJECTIVES: The goal of this analysis was to evaluate the final 5-year safety and effectiveness of the PROMUS Element platinum-chromium everolimus-eluting stent in unselected patients treated in routine clinical practice. BACKGROUND: The prospective, open-label PROMUS Element™ European Post-Approval Surveillance Study (PE-PROVE) enrolled 1,010 "real-world" patients who received the PROMUS Element stent. Adverse event rates were low at 1-year, and the incidence of stent thrombosis was 0.6%. METHODS: The primary endpoint was target vessel failure (TVF; overall and PE stent-related), a composite of cardiac death, myocardial infarction (MI) related to the target vessel, or target vessel revascularization (TVR) at 1-year post-implantation. Five-year clinical outcomes were evaluated in overall as well as high-risk patient subgroups. RESULTS: The overall 5-year TVF rate was 14.9%, with 7.0% being related to the study stent. Cardiac death, MI and TVR related to the study stent occurred in 0.5%, 3.2%, and 5.7%, respectively. Stent thrombosis through 5-year follow-up was 1.0%. The rates of overall and study stent related TVF were numerically higher in patients with medically treated diabetes, long lesions (≥28 mm), and small diameter vessels (≤2.5 mm) compared to the overall study population. Additionally, favorable stent thrombosis rates through 5 years were reported for the PROMUS Element stent in these high-risk subgroups. CONCLUSIONS: The final 5-year data from the PE-PROVE study demonstrate favorable outcomes and low rates of adverse events with the PE stent when used in "real-world" patients with coronary artery disease.

Outcomes of the Tryton-dedicated bifurcation stent for the treatment of true coronary bifurcations: Individual-patient-data pooled analysis.

OBJECTIVES: We aimed to evaluate the safety and efficacy of the dedicated Tryton side branch (SB) stent for the treatment of true bifurcations involving large SBs. BACKGROUND: Bifurcation lesions are associated with lower procedural success and a higher risk of adverse cardiac events. Provisional stenting (PS) is currently the default approach for the treatment of bifurcation lesions. The Tryton stent is a dedicated bifurcation stent system for the treatment of true bifurcation lesions. METHODS: We performed an individual-patient-data pooled post-hoc analysis of the Tryton Pivotal randomized controlled trial and post-approval Confirmatory Study. Only patients with true bifurcations involving a SB ≥ 2.25 mm in diameter were included. The primary endpoint was non-inferiority of Tryton compared with PS for target vessel failure (TVF) at 1 year. RESULTS: Of the 411 patients meeting the criteria for enrolment, 287 patients were treated with the Tryton stent and 124 with PS. Procedural success was higher in the Tryton group (95.4 versus 82.3%, P < 0.0001). TVF at 1 year was 8.1% in the Tryton group and 9.7% in the PS group, meeting the pre-specified criteria for non-inferiority established for the randomized controlled trail (pnon-inferiority = 0.02). At 9-month angiographic follow-up, SB diameter stenosis was significantly lower in the Tryton group (29.3 ± 21.9 versus 41.1 ± 17.5, P = 0.0008) and in-segment binary restenosis (diameter stenosis ≥ 50%) was higher in the PS group (19.0 versus 34.2%, respectively, P = 0.052). CONCLUSIONS: In patients with true bifurcations involving a large SB, treatment with the Tryton SD Stent was clinically non-inferior to PS and showed favorable angiographic outcomes.

Prevalence, Presentation and Treatment of 'Balloon Undilatable' Chronic Total Occlusions: Insights from a Multicenter US Registry.

BACKGROUND: The prevalence, treatment and outcomes of balloon undilatable chronic total occlusions (CTOs) have received limited study. METHODS: We examined the prevalence, clinical and angiographic characteristics, and procedural outcomes of percutaneous coronary interventions (PCIs) for balloon undilatable CTOs in a contemporary multicenter US registry. RESULTS: Between 2012 and 2017 data on balloon undilatable lesions were available for 425 consecutive CTO PCIs in 415 patients in whom guidewire crossing was successful: 52 of 425 CTOs were balloon undilatable (12%). Mean patient age was 65 ± 10 years and most patients were men (84%). Patients with balloon undilatable CTOs were more likely to be diabetic (67 vs. 41%, P < 0.001) and have heart failure (44 vs. 28%, P = 0.027). Balloon undilatable CTOs were longer (40 mm [interquartile range, IQR 20-50] vs. 30 [IQR 15-40], P = 0.016), more likely to have moderate/severe calcification (87 vs. 54%, P < 0.001), and had higher J-CTO score (3.2 ± 1.1 vs. 2.5 ± 1.3, P < 0.001) and PROGRESS-CTO complications score (3.9 ± 1.7 vs. 3.1 ± 2.0, P < 0.005). They were associated with lower technical and procedural success (92 vs. 98%, P = 0.024; and 88 vs. 96%, P = 0.034, respectively) and higher risk for in-hospital major adverse events (8 vs. 2%, P = 0.008) due to higher perforation rates. The most frequent treatments for balloon undilatable CTOs were high pressure balloon inflations (64%), rotational atherectomy (31%), laser (21%), and cutting balloons (15%). CONCLUSIONS: Balloon undilatable CTOs are common and are associated with lower success and higher complication rates.

Chronic Total Occlusion Interventions: Update on Current Tips and Tricks.

PURPOSE OF REVIEW: To summarize novel techniques and developments in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). RECENT FINDINGS: Using an algorithmic, step-by-step approach can help overcome several complex CTO lesions subsets, such as proximal cap ambiguity, ostial location, in-stent occlusion, bifurcations, balloon uncrossable and undilatable lesions. Similarly, an algorithmic approach can help prevent and optimally treat CTO PCI-related complication, such as perforation, radiation, and contrast-induced nephropathy. Continual update and reassessment of each operator's algorithm for performing CTO PCI can lead to improved outcomes.

[Prognostic significance of the total ischemic time in patients with ST-elevation myocardial infarction]. / A teljes ischaemiás ido prognosztikus jelentosége az ST-elevációval járó szívinfarktus miatt kezelt betegekben.

INTRODUCTION: The significance of the total ischemic time (from the beginning of the complaint to the opening of the vessel) is an important factor for myocardial salvage. AIM: The aim of the study was to determine the prognostic significance of the TIT in patients with ST elevation myocardial infarction in Hungary. METHOD: From 1 January 2014 all patients with myocardial infarction were recorded by law in an on-line database of the Hungarian Myocardial Infarction Registry. Between 1 January 2014 and 31 March 2016, 27 157 patients with 28 408 myocardial infarction events were recorded. To investigate TIT, 7146 STEMI patients were selected who were treated with percutaneous coronary intervention (PCI) within 24 hours of the beginning of the complaint and all of its components were known. RESULTS: Average follow-up was 740 ± 346 days. The median time of the TIT is 260 minutes, within which the earliest prehospital time was found (median 205 minutes). The TIT influenced survival: if this time was less than 400 minutes, the 30-day and the 1-year deaths were 7.5% and 12.2%, respectively. In longer TIT, higher mortality rate was found (9.2% versus 19.7%, respectively). Multivariate analysis was performed for short (<30 days), medium (30-364 days) and long-term (≥365 days) survival. Diabetes mellitus is a short-term prognostic factor, abnormal creatinine, and severe coronary status have affected short and medium survival. PCI was significant in terms of medium and long-term survival. Previous myocardial infarction and TIT influenced the long-term survival significantly. CONCLUSIONS: In Hungary, TIT is too long, and its dominant part falls within the prehospital period. The TIT is an independent prognostic factor, so reducing this time can improve the long-term prognosis of patients with ST-elevation myocardial infarction. Orv Hetil. 2018; 159(27): 1113-1120.

Outcomes of a dedicated stent in coronary bifurcations with large side branches: A subanalysis of the randomized TRYTON bifurcation study.

OBJECTIVES: To examine the benefit of the Tryton dedicated side branch (SB) stent compared with provisional stenting in the treatment of complex bifurcation lesions involving large SBs. BACKGROUND: The TRYTON Trial was designed to evaluate the utility of a dedicated SB stent to treat true bifurcation lesions involving large (≥2.5 mm by visual estimation) SBs. Patient enrolled in the trial had smaller SB diameters than intended (59% SB ≤2.25 mm by Core Lab QCA). The TRYTON Trial did not meet its primary endpoint due to an increased rate of peri-procedural myocardial infarctions (MIs). METHODS: The TRYTON Trial randomized 704 patients to the Tryton SB stent with main vessel DES versus provisional SB treatment with main vessel DES. The rates of the primary end point of target vessel failure and the secondary powered end point of angiographic percent diameter stenosis in the SB at 9 months were assessed and compared between the two treatment strategies among patients with a SB ≥2.25 mm diameter at baseline determined by Core Lab QCA. RESULTS: Among the 704 patients enrolled in the TRYTON Trial, 289 patients (143 provisional and 146 Tryton stent; 41% of entire cohort) had a SB ≥2.25 mm. The primary end point of TVF was numerically lower in the Tryton group compared with the provisional group (11.3% vs. 15.6%, P = 0.38), and was within the non-inferiority margin. No difference among the rates of clinically driven target vessel revascularization (3.5% vs. 4.3% P = 0.77) or cardiac death (0% both groups) were seen. In-segment percent diameter stenosis of the SB was significantly lower in the Tryton group compared with the provisional group (30.4% vs. 40.6%, P = 0.004). CONCLUSIONS: Analysis of the TRYTON Trial cohort of SB ≥2.25 mm supports the safety and efficacy of the Tryton SB stent compared with a provisional stenting strategy in the treatment of bifurcation lesions involving large SBs. © 2015 Wiley Periodicals, Inc.

Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated Patients: The GLAGOV Randomized Clinical Trial.

Importance: Reducing levels of low-density lipoprotein cholesterol (LDL-C) with intensive statin therapy reduces progression of coronary atherosclerosis in proportion to achieved LDL-C levels. Proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors produce incremental LDL-C lowering in statin-treated patients; however, the effects of these drugs on coronary atherosclerosis have not been evaluated. Objective: To determine the effects of PCSK9 inhibition with evolocumab on progression of coronary atherosclerosis in statin-treated patients. Design, Setting, and Participants: The GLAGOV multicenter, double-blind, placebo-controlled, randomized clinical trial (enrollment May 3, 2013, to January 12, 2015) conducted at 197 academic and community hospitals in North America, Europe, South America, Asia, Australia, and South Africa and enrolling 968 patients presenting for coronary angiography. Interventions: Participants with angiographic coronary disease were randomized to receive monthly evolocumab (420 mg) (n = 484) or placebo (n = 484) via subcutaneous injection for 76 weeks, in addition to statins. Main Outcomes and Measures: The primary efficacy measure was the nominal change in percent atheroma volume (PAV) from baseline to week 78, measured by serial intravascular ultrasonography (IVUS) imaging. Secondary efficacy measures were nominal change in normalized total atheroma volume (TAV) and percentage of patients demonstrating plaque regression. Safety and tolerability were also evaluated. Results: Among the 968 treated patients (mean age, 59.8 years [SD, 9.2]; 269 [27.8%] women; mean LDL-C level, 92.5 mg/dL [SD, 27.2]), 846 had evaluable imaging at follow-up. Compared with placebo, the evolocumab group achieved lower mean, time-weighted LDL-C levels (93.0 vs 36.6 mg/dL; difference, -56.5 mg/dL [95% CI, -59.7 to -53.4]; P < .001). The primary efficacy parameter, PAV, increased 0.05% with placebo and decreased 0.95% with evolocumab (difference, -1.0% [95% CI, -1.8% to -0.64%]; P < .001). The secondary efficacy parameter, normalized TAV, decreased 0.9 mm3 with placebo and 5.8 mm3 with evolocumab (difference, -4.9 mm3 [95% CI, -7.3 to -2.5]; P < .001). Evolocumab induced plaque regression in a greater percentage of patients than placebo (64.3% vs 47.3%; difference, 17.0% [95% CI, 10.4% to 23.6%]; P < .001 for PAV and 61.5% vs 48.9%; difference, 12.5% [95% CI, 5.9% to 19.2%]; P < .001 for TAV). Conclusions and Relevance: Among patients with angiographic coronary disease treated with statins, addition of evolocumab, compared with placebo, resulted in a greater decrease in PAV after 76 weeks of treatment. Further studies are needed to assess the effects of PCSK9 inhibition on clinical outcomes. Trial Registration: clinicaltrials.gov Identifier: NCT01813422.

Serum lipids and cardiac function correlate with nitrotyrosine and MMP activity in coronary artery disease patients.

AIMS: Peroxynitrite-matrix metalloproteinase (MMP) signalling has been shown to contribute to myocardial ischaemia/reperfusion injury and heart failure and to be influenced by hyperlipidaemia in preclinical models. Therefore, here we investigated the correlation between the markers of peroxynitrite-MMP signalling and hyperlipidaemia in patients with significant coronary stenosis. METHODS: Five minutes before percutaneous coronary intervention (PCI), arterial blood samples were collected from 36 consecutive patients with coronary artery disease (CAD) selected for elective PCI. RESULTS: Serum nitrotyrosine positively correlated with MMP-9 activity (r = 0·54, P = 0·01), but not with MMP-2 activity. Nitrotyrosine positively correlated with total (r = 0·58; P < 0·01) and LDL cholesterol (r = 0·55; P < 0·01), serum triglyceride (r = 0·47; P < 0·05), and creatinine (r = 0·42; P < 0·05) and negatively correlated with HDL cholesterol (r = -0·46; P < 0·05) and with left ventricular ejection fraction (LVEF; r = -0·55; P < 0·05), respectively. MMP-2 activity correlated positively with total (r = 0·55; P < 0·05) and LDL cholesterol (r = 0·45; P < 0·05). In statin-treated patients, a significantly reduced serum nitrotyrosine was found as compared to statin naives; however, MMP activities and serum cholesterol levels were not different. MMP-9 activity correlated with urea nitrogen (r = 0·42; P < 0·05) and LVEF (r = -0·73; P < 0·01). Serum creatinine correlated negatively with LVEF (r = -0·50, P < 0·01). CONCLUSIONS: This is the first demonstration that (i) serum nitrotyrosine correlates with MMP-9 activity, (ii) lipid parameters correlate with nitrotyrosine and MMP-2 activity, (iii) myocardial function correlates with creatinine, nitrotyrosine and MMP-9 activity, and (iv) creatinine correlates with nitrotyrosine and urea nitrogen with MMP-9 activity in patients with CAD. Studying the biomarkers of peroxynitrite-MMP pathway in large prospective trials may reveal their diagnostic avails.

Randomized comparison of Zotarolimus-Eluting Endeavor Sprint versus bare-metal stent implantation in uncertain drug-eluting stent candidates: rationale, design, and characterization of the patient population for the Zotarolimus-eluting Endeavor Sprint stent in uncertain DES candidates study.

BACKGROUND: The use of drug-eluting stent (DES) instead of bare-metal stent (BMS) in patients at high stent thrombosis or bleeding risk as well as in those at low restenosis risk (ie, uncertain DES candidates) remains a matter of debate. Zotarolimus-Eluting Endeavor Sprint stent (E-ZES) (Santa Rosa, CA) is a hydrophilic polymer-based second-generation device with unique drug fast-release profile, which may allow for a shorter dual antiplatelet therapy (DAPT) duration without safety concerns. HYPOTHESIS: The primary objective is to assess whether E-ZES implantation followed by a shorter than currently recommended course of DAPT will decrease the incidence of 12-month major adverse cardiovascular events as compared with BMS in undefined DES recipients. Actual duration of DAPT regimen will be dictated by patients' characteristics and not by stent type and, as such, can be as short as 30 days after intervention in both stent groups. STUDY DESIGN: The ZEUS study is an open-label randomized clinical trial conducted at 20 clinical sites in Italy, Switzerland, Portugal, and Hungary. With 1,600 individuals, this study will have 85% power to detect a 33% difference in the primary end point consisting of the composite of death, nonfatal myocardial infarction, or target vessel revascularization. SUMMARY: The ZEUS trial aims to assess whether the use of E-ZES, followed by a DAPT duration regimen based on patients' characteristics and not by stent type, is superior to conventional BMS implantation in undefined DES recipients who qualify for the presence of high thrombosis, bleeding, or low restenosis risk criteria.

Combination of Laser Atherectomy and Super High-pressure Non-compliant Balloon to Treat Stent Under-expansion in Cases of Failed Interventional Options.

Patients with calcified, fibrotic native coronary vessels with prior suboptimal stenting outcomes are at major risk of stent thrombosis and could face serious consequences if untreated. In cases of multiple layers of under-expanded stents, the risk is multiplied. If conventional balloon post-dilatation is unsuccessful after stent implantation without proper lesion preparation, few interventional options remain. The authors report on a patient with prior numerous right coronary unsuccessful coronary interventions resulting in partially crushed multiple layers of stent material with critical lumen narrowing caused by stent under-expansion. Balloon angioplasty and stent rotational atherectomy (ROTA) had been attempted to overcome stent under-expansion but were unsuccessful. The authors investigated a new combination therapy of laser atherectomy (ELCA) and super high-pressure balloon (OPN non-compliant balloon) to treat single or multiple layers of stent with severe under-expansion due to fibrotic, calcified tissue surrounding the under-expanded stent structure.

Development of a Novel Score to Predict Urgent Mechanical Circulatory Support in Chronic Total Occlusion Percutaneous Coronary Intervention.

Estimating the likelihood of urgent mechanical circulatory support (MCS) can facilitate procedural planning and clinical decision-making in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We analyzed 2,784 CTO PCIs performed between 2012 and 2021 at 12 centers. The variable importance was estimated by a bootstrap applying a random forest algorithm to a propensity-matched sample (a ratio of 1:5 matching cases with controls on center). The identified variables were used to predict the risk of urgent MCS. The performance of the risk model was assessed in-sample and on 2,411 out-of-sample procedures that did not require urgent MCS. Urgent MCS was used in 62 (2.2%) of cases. Patients who required urgent MCS were older (70 [63 to 77] vs 66 [58 to 73] years, p = 0.003) compared with those who did not require urgent MCS. Technical (68% vs 87%, p <0.001) and procedural success (40% vs 85%, p <0.001) was lower in the urgent MCS group compared with cases that did not require urgent MCS. The risk model for urgent MCS use included retrograde crossing strategy, left ventricular ejection fraction, and lesion length. The resulting model demonstrated good calibration and discriminatory capacity with the area under the curve (95% confidence interval) of 0.79 (0.73 to 0.86) and specificity and sensitivity of 86% and 52%, respectively. In the out-of-sample set, the specificity of the model was 87%. The Prospective Global Registry for the Study of Chronic Total Occlusion Intervention CTO MCS score can help estimate the risk of urgent MCS use during CTO PCI.