Prognostic Significance of Right Ventricular Global Longitudinal Strain in Acute Myocardial Infarction and Angiographic Correlation

OBJECTIVESObjectives of this study were to evaluate right ventricular function using two dimensional speckle tracking echocardiography among patients who were admitted with acute myocardial infarction and treated with primary angioplasty, association between right ventricular strain global longitudinal strain and major adverse cardiovascular events and to analyse the angiographic results of all patients. METHODSThis was a prospective observational study conducted in 200 consecutive patients admitted with acute inferior wall myocardial infarction and treated with primary angioplasty. Right ventricular global longitudinal strain was measured by two dimensional speckle tracking echocardiography and angiographic results of all patients were recorded. All patients were followed up till discharge / death. Categorical data were compared using Chi-square test or Fisher’s exact test. Logistic regression was done to find out the major adverse cardiovascular outcomes predictive by RVGLS. P < 0.05 was considered statistically significant. RESULTS200 patients were enrolled for the study of which were 102 (51%) patients and 98 (49 %) patients were males and females respectively. Patients with low RVGLS had higher incidence of left ventricular dysfunction(P=0..006) ,low TAPSE and S’(P<0.001) ,angiographic triple vessel disease(p<0.001),arrhythmias(p=0.02) ,right heart failure(P<0.001),target lesion revascularisation(P=0.029) and prolonged hospital stay(P<0.001).In multivariate analysis , arrhythmias (P=0.046 ,OR - 2.05, CI 0.93-8.10) ad target lesion revascularisation were the two major adverse cardiovascular events predictive by RVGLS. CONCLUSIONRVGLS could be used a prognostic marker in patients admitted with acute inferior wall infarction, categorise the risk and might assist the interventionist in planning an earliest therapeutic strategy.

Provisional focal stenting of complex femoropopliteal lesions using the Multi-LOC multiple stent delivery system – 12-month results from the LOCOMOTIVE EXTENDED study

Summary: Background: This study aimed to evaluate a Multiple Stent Delivery System for provisional focal stenting of the femoropopliteal artery. Patient and methods: The LOCOMOTIVE EXTENDED study (Multi-LOC for flOw liMiting Outcomes after plain old balloon angioplasty and/or drug-coated balloon Treatment in the infrainguinal position with the objectIVE to implant multiple stent segments) is a prospective, single-arm, multicentre observational study. The Multi-LOC Multiple Stent Delivery System (B.Braun, Melsungen, Germany) was used for provisional focal stenting of the femoropopliteal artery. We enrolled 357 patients with 449 femoropopliteal lesions; all had flow-limiting dissections or recoil following angioplasty. Eligibility included Rutherford classification 2 to 5 with a de novo or non-stented restenotic femoropopliteal lesion undergoing plain balloon or drug-coated balloon angioplasty. The 6- and 12-month efficacy endpoints encompassed target lesion revascularisation and primary patency rates. Results: The mean patient age was 71 ± 10 years. The mean lesion length was 16.0 ± 9.7 cm; 44.5% were TASC II C/D lesions and 31.4% were chronic total occlusions. By operator choice, 45% of the patients underwent drug-coated balloon angioplasty. On average, 4.0 stents (each 13 mm long) were placed in each lesion, resulting in a scaffolding proportion of 56% of the total lesion length with a technical success rate of 98.3%. At 6 and 12 months, the freedom from clinically driven target lesion revascularisation was 95.5% and 88.7% and the primary patency rates were 88.7% and 82.3%, respectively. At 12 months, significant improvements were noted in Rutherford categories and ankle-brachial indices. In multiple regression analyses, both diabetes mellitus and no distal run-off vessel showed a trend toward worse TLR, while other factors such as DCB predilation or the lesion length were not predictive. Conclusions: The LOCOMOTIVE EXTENDED study demonstrated the safety and efficacy of the Multi-LOC stent system for focal provisional stenting of complex femoropopliteal lesions.

A prospective multicentre randomized all-comers trial to assess the safety and effectiveness of the ultra-thin-strut sirolimus-eluting coronary stent Supraflex: 2-year results of the TALENT trial

Background and purpose Supraflex is a sirolimus-eluting stent with a biodegradable polymeric coating and 60um ultra-thin struts. In the TALENT study, we found the Supraflex stent was non-inferior to the Xience stent for a device-oriented composite endpoint (DOCE, defined as cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation) at 12 months in an all-comer population. Additionally, per-protocol analysis showed a significantly lower clinically indicated target lesion revascularisation (CI-TLR) in the Supraflex group than in the Xience group. We now present the 2-year follow-up results. Methods The TALENT study was a prospective, randomised, single-blind, multicentre study across 23 centres in Europe. Eligible participants underwent percutaneous coronary intervention in an all-comers fashion in vessels of 2.25–4.5 mm. Patients were randomized (1:1) to implantation of either Supraflex or Xience (NCT02870140). Results Between October 21, 2016 and July 3, 2017, 720 patients with 1046 lesions were randomly assigned to Supraflex, and 715 patients with 1030 lesions to Xience. At 24 months, DOCE had occurred in 49 patients (6.9%) in the Supraflex group and in 56 patients (7.9%) in the Xience group (absolute difference −1.0% [95% CI: −3.7 to 1.7], Plog-rank=0.491). Per-protocol analysis at 24 months showed CI-TLR occurred in 21 and 30 patients in the Supraflex and Xience, respectively (3.3% versus 4.5%, absolute difference −1.2%, [95% CI: −3.3 to 0.9], Plog-rank=0.267). Conclusion In an all-comer population, at 2-year follow-up, the use of Supraflex stent was at least as safe and efficacious as Xience stent. However, the significantly lower rate of CI-TLR shown in patients treated with Supraflex at 1-year was no longer retained in the 2-year results. Whether theoretical advantage of ultra-thin strut drug eluting stents Supraflex can translate into clinical benefit or not will be further elucidated through a total of 3 years of follow-up. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): SMT

Diabetic patients treated with novel thin composite-wire strut zotarolimus-eluting stents versus ultrathin strut sirolimus-eluting stents in the BIONYX trial: 2-year results of a prespecified analysis

Background/Introduction The novel thin composite-wire strut zotarolimus-eluting stent (ZES) is a drug-eluting stent that is frequently used for treating patients with obstructive coronary artery disease, but so far no clinical outcome data have been published in patients with diabetes. In all-comer patients, the BIONYX trial (NCT02508714) has established non-inferiority of the ZES versus the ultrathin strut biodegradable-polymer sirolimus-eluting stent (SES) regarding the primary composite endpoint of target vessel failure at 1 year follow-up. Purpose To assess in patients with diabetes, the 2-year safety and efficacy of the current generation thin composite-wire strut ZES, compared to the ultrathin strut SES. Methods In the international, multicentre BIONYX trial, randomisation was stratified for sex and the presence of diabetes mellitus. We performed a prespecified subgroup analysis of patients with diabetes. The main endpoint target vessel failure was a composite of safety and efficacy, consisting of cardiac death, target vessel-related myocardial infarction or clinically indicated target vessel revascularisation. Secondary endpoints, such as target lesion revascularisation and stent thrombosis were also assessed. Results A total of 510/2488 (20.5%) BIONYX trial participants had diabetes, and were therefore included in this analysis. Patients were on average 66.4±10.3 years old, and 28.6% were female. Most participants presented with acute coronary syndromes (65.1%), and 182/510 (35.7%) patients were insulin dependent. Two-year follow up was available in 500 of 510 (98.0%) patients. Target vessel failure occurred in 31/260 (12.2%) patients assigned to ZES versus 26/250 (10.7%) patients assigned to SES (HR 1.14, 95%-CI 0.68–1.92; P-logrank=0.63). Kaplan Meier curves of target vessel failure are displayed in Figure 1. There were no significant between-stent differences in the individual components of this endpoint. Target lesion revascularisation occurred in 15/260 (6.0%) patients treated with ZES versus 9/250 (3.7%) patients treated with SES (HR 1.61, 95%-CI 0.71–3.68; P-logrank=0.25). Definite stent thrombosis was an infrequent event and did not differ significantly between stent-arms (0.4% vs. 1.2%; HR 0.32, 95%-CI 0.03–3.06; P-logrank=0.30). Conclusion In patients with diabetes, the novel thin composite-wire strut durable polymer ZES was similarly safe and efficacious as compared to the ultrathin cobalt-chromium strut biodegradable-polymer SES at 2-year follow-up. Figure1. Target vessel failure at 2 years Funding Acknowledgement Type of funding source: Private company. Main funding source(s): The BIONYX trial was equally funded by Biotronik and Medtronic.

Prognostic value of myeloperoxidase in patients with peripheral artery disease

Objectives The involvement of myeloperoxidase in the production of dysfunctional high-density lipoproteins and oxidised biomolecules leads to oxidative stress in the blood vessel endothelium. This prospective cohort study aimed to examine the prognostic value of myeloperoxidase in patients with peripheral artery disease in relation to major adverse cardiac events (MACEs), target lesion revascularisation, and major adverse limb events (MALEs) and its association with multi-bed vascular disease, which is defined as any combination of the following: peripheral artery disease and coronary artery disease. Methods Myeloperoxidase levels were measured in patients with peripheral artery disease and coronary artery disease during angiography. A total of 94 patients were analysed and followed up regarding their MACEs, target lesion revascularisation, and MALEs from August 2016 until February 2019. Results Among patients with peripheral artery disease, the rates of MACE and mortality were higher in patients with high myeloperoxidase levels than in those with low myeloperoxidase levels; the myeloperoxidase levels were 3.68 times higher in these patients ( p < 0.0001). Patients with peripheral artery disease and coronary artery disease (multi-bed vascular disease) had higher myeloperoxidase levels than those with only peripheral artery disease and only coronary artery disease (one-bed vascular disease). Peripheral artery disease patients with higher myeloperoxidase levels had significantly higher rates of limb ischaemia, requiring further revascularisation than those with low myeloperoxidase levels. Conclusions High myeloperoxidase levels suggest poor outcomes and are associated with MACE and limb ischaemia. Our findings indicated that myeloperoxidase levels could become a prognostic marker and may be used in conjunction with other methods for risk stratification in patients with peripheral artery disease and multi-bed vascular disease.

First-in-man experience of self-expanding nitinol stents combined with drug-coated balloon in the treatment of femoropopliteal occlusive disease

Purpose The present study aimed to determine the safety and efficacy of a drug-coated balloon inflated within a thin-strut self-expanding bare-metal stent in patients with severe and complex femoropopliteal occlusive disease. Methods This prospective study used the Pulsar-self-expanding stent and Passeo-18 Lux drug-coated balloon in patients with severe and complex femoropopliteal occlusive disease. The primary endpoint was the 12-month primary patency, and the secondary endpoints included 24-month primary patency, assisted primary patency, secondary patency, and clinically associated target lesion revascularisation. Results The study included 44 patients (51 limbs). The mean age of the patients was 67.6 ± 10.2 years, with 73% men. Chronic limb severity was classified as Rutherford Category III in 41% of the patients, stage IV in 31%, and stage V in 27%. Lesions were predominantly Trans-Atlantic Inter-Society Consensus (TASC 2007) D (51%) and C (45%), with 32 (63%) chronic total occlusions. Procedural success was obtained in all cases. The mean lesion length was 200 ± 74.55 mm (95% CI = 167.09–208.01) with a mean number of stents per limb used of 1.57 ± 0.70 (95% CI = 1.37–1.76). Distal embolisation occurred in two patients. The primary patency rates at the 12- and 24-month follow-up were 94% (95% CI = 82.9–98.1) and 88% (95% CI = 75.7–94.5), respectively. The assisted primary was 94% (95% CI = 82.9–98.1) and secondary patency was 96% (95% CI = 85.2–99.0) at 24-month follow-up. The cumulative stent fracture rate at the 24-month follow-up was 10%. Freedom from clinically driven target lesion revascularisation was 94% (95% CI = 83–98%) at 12-month follow-up and 88% (95% CI = 76–94%) at 24-month follow-up, with two patients requiring a bypass graft. Conclusion Our novel approach involving the combination of a thin-strut bare-metal stent and a drug-coated balloon may be safe and effective, with sustainable and promising clinical outcomes up to 24 months after treatment.