Browsing by Subject "ANGIOPLASTY"

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  • Sen, Sayan; Ahmad, Yousif; Dehbi, Hakim-Moulay; Howard, James P.; Iglesias, Juan F.; Al-Lamee, Rasha; Petraco, Ricardo; Nijjer, Sukhjinder; Bhindi, Ravinay; Lehman, Sam; Walters, Darren; Sapontis, James; Janssens, Luc; Vrints, Christiaan J.; Khashaba, Ahmed; Laine, Mika; Van Belle, Eric; Krackhardt, Florian; Bojara, Waldemar; Going, Olaf; Haerle, Tobias; Indolfi, Ciro; Niccoli, Giampaolo; Ribichini, Flavio; Tanaka, Nobuhiro; Yokoi, Hiroyoshi; Takashima, Hiroaki; Kikuta, Yuetsu; Erglis, Andrejs; Vinhas, Hugo; Silva, Pedro Canas; Baptista, Sergio B.; Alghamdi, Ali; Hellig, Farrel; Koo, Bon-Kwon; Nam, Chang-Wook; Shin, Eun-Seok; Doh, Joon-Hyung; Brugaletta, Salvatore; Alegria-Barrero, Eduardo; Meuwissen, Martijin; Piek, Jan J.; van Royen, Niels; Sezer, Murat; Di Mario, Carlo; Gerber, Robert T.; Malik, Iqbal S.; Sharp, Andrew S. P.; Talwar, Suneel; Tang, Kare; Samady, Habib; Altman, John; Seto, Arnold H.; Singh, Jasvindar; Jeremias, Allen; Matsuo, Hitoshi; Kharbanda, Rajesh K.; Patel, Manesh R.; Serruys, Patrick; Escaned, Javier; Davies, Justin E. (2019)
    BACKGROUND Physicians are not always comfortable deferring treatment of a stenosis in the left anterior descending (LAD) artery because of the perception that there is a high risk of major adverse cardiac events (MACE). The authors describe, using the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) trial, MACE rates when LAD lesions are deferred, guided by physiological assessment using fractional flow reserve (FFR) or the instantaneous wave-free ratio (iFR). OBJECTIVES The purpose of this study was to establish the safety of deferring treatment in the LAD using FFR or iFR within the DEFINE-FLAIR trial. METHODS MACE rates at 1 year were compared between groups (iFR and FFR) in patients whose physiological assessment led to LAD lesions being deferred. MACE was defined as a composite of cardiovascular death, myocardial infarction (MI), and unplanned revascularization at 1 year. Patients, and staff performing follow-up, were blinded to whether the decision was made with FFR or iFR. Outcomes were adjusted for age and sex. RESULTS A total of 872 patients had lesions deferred in the LAD (421 guided by FFR, 451 guided by iFR). The event rate with iFR was significantly lower than with FFR (2.44% vs. 5.26%; adjusted HR: 0.46; 95% confidence interval [CI]: 0.22 to 0.95; p = 0.04). This was driven by significantly lower unplanned revascularization with iFR and numerically lower MI (unplanned revascularization: 2.22% iFR vs. 4.99% FFR; adjusted HR: 0.44; 95% CI: 0.21 to 0.93; p = 0.03; MI: 0.44% iFR vs. 2.14% FFR; adjusted HR: 0.23; 95% CI: 0.05 to 1.07; p = 0.06). CONCLUSIONS iFR-guided deferral appears to be safe for patients with LAD lesions. Patients in whom iFR-guided deferral was performed had statistically significantly lower event rates than those with FFR-guided deferral. (c) 2019 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY license (
  • Settembre, Nicla; Biancari, Fausto; Spillerova, Kristyna; Albäck, Anders; Söderström, Maria; Venermo, Maarit (2020)
    Introduction In the context of chronic limb threatening ischemia (CLTI), the prognostic impact of angiosome-targeted revascularization and of the status of the pedal arch are debated. Materials and method This series includes 580 patients who underwent endovascular (n=407) and surgical revascularization (n=173) of the infrapopliteal arteries for CLTI associated with foot ulcer or gangrene. The risk of major amputation after infrapopliteal revascularization was assessed by a competing risk approach. A subanalysis was made separately for patients who underwent endovascular or open surgical revascualrization. Results At 2 years, survival was 65.1% and leg salvage was 76.1%. Multivariable competing risk analysis showed that C-reactive protein≥ 10 mg/dL, diabetes, rheumatoid arthritis, increased number of affected angiosomes and the incomplete or total absence of pedal arch compared to complete pedal arch were independent predictors of major amputation after infrapopliteal revascularization. Multivariable analysis showed increasing risk estimates of major amputation in patients with incomplete (SHR 2.131, 95%CI 1.282-3.543) and no visualized pedal arch (SHR 3.022, 95%CI 1.553-5.883) compared to complete pedal arch. Pedal arch was important even if angiosome-targeted revascularization was achieved: Angiosome-directed revascularization in presence of complete pedal arch had a lower risk of major amputation (adjusted SHR 0.463, 95%CI 0.240-0.894) compared to angiosome-directed revascularization without complete pedal arch. In the subanalysis, among patients who underwent endovascular revascularization, complete pedal arch (SHR 0.509, 95%CI 0.286-0.905) and angiosome-targeted revascularization (SHR 0.613, 95%CI 0.394-0.956) were associated with a lower risk of major amputation. Conclusions Competing risk analysis showed that a patent pedal arch had significant impact on leg salvage and that the subset of patients undergoing endovascular procedure may most benefit of an angiosome-targeted revascularization.
  • IN.PACT Global Study Investigators; Venermo, Maarit (2018)
    OBJECTIVES The IN. PACT Global Study is the largest prospective, multicenter, independently adjudicated trial to evaluate a paclitaxel drug-coated balloon in patients with lifestyle-limiting claudication and/or ischemic rest pain due to atherosclerotic disease of the femoropopliteal artery and includes complex lesions beyond what are typically included in randomized controlled trials. BACKGROUND Randomized controlled trials have demonstrated the safety and efficacy of drug-coated balloons for the treatment of Trans-Atlantic Inter-Society Consensus Document II A and B lesions, but there is a need for large-scale prospective studies to evaluate a broader range of lesions. METHODS The IN. PACT Global Study enrolled 1,535 subjects, and 1,406 (1,773 lesions) were included in the pre-defined clinical cohort analysis. Freedom from clinically driven target lesion revascularization was evaluated at 24 months. The safety composite endpoint was freedom from device-and procedure-related death through 30 days and freedom from target limb major amputation and clinically driven target vessel revascularization within 24 months. RESULTS Mean lesion length was 12.1 cm, 35.5% were total occlusions, and 18.0% had in-stent restenosis. Freedom from clinically driven target lesion revascularization at 24 months was 83.3%, the composite safety endpoint was met in 81.7%, the 2-year all-cause mortality rate was 7.0%, and the major target limb amputation rate was 0.7%. Increased lesion length and the presence of de novo in-stent restenosis or coronary artery disease were associated with increased risk for clinically driven target lesion revascularization by 24 months. CONCLUSIONS This real-world study of femoropopliteal artery disease treatment with drug-coated balloons confirmed positive findings reported from more strictly designed randomized controlled trials and showed that outcomes are durable in this population up to 2 years after treatment. (c) 2018 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (
  • Björkman, Patrick; Auvinen, Tommi; Hakovirta, Harri; Romsi, Pekka; Turtiainen, Johanna; Manninen, Hannu; Venermo, Maarit (2018)
    Background: Claudication and critical limb threatening ischemia are significant causes of mortality in the elderly. The gold standard of superficial femoral artery (SFA) revascularization is thus far considered to be the femoropopliteal bypass. The aim of this study was to compare mid-term patency between drug-eluting stents (DESs) and prosthetic bypass grafts (BSX). Studies have reported comparable results for both the methods. Methods: Forty-six patients with claudication or rest pain due to a 5-25 cm SFA occlusion were randomized between DES and BSX groups. The follow-up period was 24 months, and the primary outcome measure was overall patency. Secondary outcome measures were primary and primary assisted patency, change in ankle-brachial index (ABI), and amputation-free survival. Results: Forty-one patients were eventually analyzed. Six-month secondary patency was 91% (DES) versus 83% (BSX) (P = 0.450). The corresponding numbers at 12 months in the DES and BSX groups were 74% and 80% (P = 0.750), respectively. At 24 months, the respective numbers were 56% and 71% (P = 0.830). There were no statistically significant differences in primary or assisted primary patency at 1, 6, or 12 months. Conclusion: There were no demonstrable differences in patency rates or clinical outcomes such as ABI or major amputations between DES and BSX. Although underpowered, the results suggest noninferiority of the DES compared with prosthetic bypass surgery.
  • Venermo, Maarit; Sprynger, Muriel; Desormais, Ileana; Björck, Martin; Brodmann, Marianne; Cohnert, Tina; De Carlo, Marco; Espinola-Klein, Christine; Kownator, Serge; Mazzolai, Lucia; Naylor, Ross; Vlachopoulos, Charalambos; Ricco, Jean-Baptiste; Aboyans, Victor (2019)
    Peripheral arterial diseases comprise different clinical presentations, from cerebrovascular disease down to lower extremity artery disease, from subclinical to disabling symptoms and events. According to clinical presentation, the patient's general condition, anatomical location and extension of lesions, revascularisation may be needed in addition to best medical treatment. The 2017 European Society of Cardiology guidelines in collaboration with the European Society for Vascular Surgery have addressed the indications for revascularisation. While most cases are amenable to either endovascular or surgical revascularisation, maintaining long-term patency is often challenging. Early and late procedural complications, but also local and remote recurrences frequently lead to revascularisation failure. The rationale for surveillance is to propose the accurate implementation of preventive strategies to avoid other cardiovascular events and disease progression and avoid recurrence of symptoms and the need for redo revascularisation. Combined with vascular history and physical examination, duplex ultrasound scanning is the pivotal imaging technique for identifying revascularisation failures. Other non-invasive examinations (ankle and toe brachial index, computed tomography scan, magnetic resonance imaging) at regular intervals can optimise surveillance in specific settings. Currently, optimal revascularisation surveillance programmes are not well defined and systematic reviews addressing long-term results after revascularisation are lacking. We have systematically reviewed the literature addressing follow-up after revascularisation and we propose this consensus document as a complement to the recent guidelines for optimal surveillance of revascularised patients beyond the perioperative period.
  • Hytonen, Jarkko P.; Taavitsainen, Jouni; Laitinen, Johannes T. T.; Partanen, Anna; Alitalo, Kari; Leppänen, Olli; Ylä-Herttuala, Seppo (2018)
    Background: Antiproliferative drugs in drug eluting stents (DES) are associated with complications due to impaired re-endothelialization. Additionally, adventitial neovascularization has been suggested to contribute to in-stent restenosis (ISR). Since Vascular Endothelial Growth Factors (VEGFs) are the key mediators of angiogenesis, we investigated feasibility and efficacy of local gene therapy for ISR utilizing soluble decoy VEGF receptors to reduce biological activity of adventitial VEGFs. Method Sixty-nine adult WHHL rabbit aortas were subjected to endothelial denudation. Six weeks later catheter-mediated local intramural infusion of 1.5x10e10 pfu adenoviruses encoding soluble VEGF Receptor-1 (sVEGFR1), sVEGFR2, sVEGFR3 or control LacZ and bare metal stent implantation were performed in the same aortic segment. Marker protein expression was assessed at 6d in LacZ cohort. Immunohistochemistry, morphometrical analyses and angiography were performed at d14, d42 and d90. Results: Transgene expression was localized to adventitia. All decoy receptors reduced the size of vasa-vasorum at 14d, AdsVEGFR2 animals also had reduced density of adventitial vasa-vasorum, whereas AdsVEGFR3 increased the density of vasa-vasorum. At d42, AdsVEGFR1 and AdsVEGFR2 reduced ISR (15.7 +/- 6.9% stenosis, P <0.01 and 16.5 +/- 2.7%, P <0.05, respectively) vs. controls (28.3 +/- 7.6%). Moreover, AdsVEGFR-3 treatment led to a non-significant trend in the reduction of adventitial lymphatics at all time points and these animals had significantly more advanced neointimal atherosclerosis at 14d and 42d vs. control animals. Conclusions: Targeting adventitial neovascularization using sVEGFR1 and sVEGFR2 is a novel strategy to reduce ISR. The therapeutic effects dissipate at late follow up following short expression profile of adenoviral vectors. However, inhibition of VEGFR3 signaling accelerates neoatherosclerosis.
  • Björkman, Patrick; Hietala, Eeva-Maija; Venermo, Maarit (2021)
    Background: Concern has been raised over potential paclitaxel-related increase in mortality following treatment with drug-coated balloons. We report mid-term and long-term patient-level mortality in three trials from our institution. Methods: Patient data from the DRECOREST I and II trials, as well as the FINNPTX-trial, were included for analysis. The DRECOREST I involved patients with stenosis in a bypass vein graft, and the DRECOREST II included patients with stenosis in a dialysis fistula. The FINNPTX-trial randomized patients to either a prosthetic bypass or drug-eluting stent for long femoropopliteal lesions. Since the present retrospective study addressed mortality related to intravascular paclitaxel exposure and population data in Finland are comprehensive, we were able to include all patients exposed to paclitaxel in the three trials. Mortality data were extracted from the population registry, as well as patient records. Survival rates were analyzed for all trials pooled and separately. Late mortality was retrospectively analyzed and cross-referenced with national registry data. Results: A total of 142 patients were included, 76 treated with paclitaxel-eluting device, and 66 without. The mean follow-up time for survivors was 3.9 years. Overall all-cause mortality was 31.7% during follow-up. In the DRECOREST I-trial, 35.5% of patients died in the pacli-taxel group and 37.9% in the control group (P = 0.84). In the DRECOREST II, overall mor-tality was 55.6% in the paclitaxel group and 44.4% in the control group (P = 0.51). In the FINNPTX-trial 22.2% died in the paclitaxel group and 10.5% in the control group during follow-up (P = 0.30). No single cause of death was overrepresented. The most common causes of death in both groups were cardiovascular death, 59.3% in the paclitaxel group and 52.4% in the control group (P = 0.733), followed by malignancy (14.8% vs. 14.3% in the groups respectively). Conclusions: No significant difference was seen in the overall analysis between the pacli-taxel and the control group. A statistically nonsignificant elevated late mortality in the FINNPTX-trial after paclitaxel exposure was observed. However, the numbers in the individ-ual trials are small and should be interpreted in the context of future patient-level meta -analysis.
  • Koivula, Kimmo; Eskola, Markku; Viikilä, Juho; Lilleberg, Jyrki; Huhtala, Heini; Birnbaum, Yochai; Nikus, Kjell (2018)
    Background: Grade 3 ischemia (G3I) in the 12 lead electrocardiogram (ECG) predicts poor outcome in patients with ST-elevation myocardial infarction (STEMI). The outcome of G3I in "real-life" patient cohorts is unclear. Methods: The aim of the study was to establish the prognostic significance of grade 2 ischemia (G2I), G3I and the STEMI patients excluded from ischemia grading (No grade of ischemia, NG) in a real-life patient population. We assessed in-hospital, 30-day and 1-year mortality as well as other endpoints. Results: The NG patients had more comorbidities and longer treatment delays than the two other groups. Shortterm and 1-year mortality were highest in patients with NG and lowest in patients with G2I. Maximum troponin level was highest in G3I, followed by NG and G2I. In logistic regression multivariable analysis, NG was independently associated with 1-year mortality. Conclusions: NG predicted poor outcome in STEMI patients. G2I predicted relatively favorable outcome. (C) 2018 Elsevier Inc. All rights reserved.
  • Allonen, Jaakko; Nieminen, Markku S.; Hiippala, Seppo; Sinisalo, Juha (2018)
    Registry studies have associated red blood cell (RBC) transfusion with increased in hospital mortality in patients with acute coronary syndrome (ACS). The impact on long-term mortality after 1-year follow-up remains unknown. Consecutive patients with ACS (n = 2,009) of a prospective Genetic Predisposition of Coronary Artery Disease cohort were followed for a median of 8.6 years (95% confidence interval [CI] 8.59 to 8.69). After discharge, 1,937 (96%) patients survived for over 30 days. Of those survivors, a subgroup of previously transfusion-nave patients 85/1,937 (4.4%) who had received at least 1 RBC transfusion during hospitalization were compared with 1,278/1,937 patients (66.0%) who had not received any transfusion either during the hospitalization or the entire follow-up. Unadjusted long-term mortality was significantly higher in the patients transfused with RBC compared with their counterparts not transfused with RBC (58.8% vs 20.3%, p
  • Böhm, Felix; Mogensen, Brynjölfur; Östlund, Ollie; Engstrøm, Thomas; Fossum, Eigil; Stankovic, Goran; Angerås, Oskar; Ērglis, Andrejs; Menon, Madhav; Schultz, Carl; Berry, Colin; Liebetrau, Christoph; Laine, Mika; Held, Claes; Rück, Andreas; James, Stefan K. (2021)
    Background: Complete revascularization in ST elevation myocardial infarction (STEMI) patients with multivessel disease has resulted in reduction in composite clinical endpoints in medium sized trials. Only one trial showed an effect on hard clinical endpoints, but the revascularization procedure was guided by angiographic evaluation of stenosis severity. Consequently, it is not clear how Fractional Flow Reserve (FFR)-guided percutaneous coronary intervention (PCI) affects hard clinical endpoints in STEMI. Methods and Results: The Ffr-gUidance for compLete non-cuLprit REVASCularization (FULL REVASC) – is a pragmatic, multicenter, international, registry-based randomized clinical trial designed to evaluate whether a strategy of FFR-guided complete revascularization of non-culprit lesions, reduces the combined primary endpoint of total mortality, non-fatal MI and unplanned revascularization. 1,545 patients were randomized to receive FFR-guided PCI during the index hospitalization or initial conservative management of non-culprit lesions. We found that in angiographically severe non-culprit lesions of 90-99% severity, 1 in 5 of these lesions were re-classified as non-flow limiting by FFR. Considering lesions of intermediate severity (70%-89%), half were re-classified as non-flow limiting by FFR. The study is event driven for an estimated follow-up of at least 2.75 years to detect a 9.9%/year>7.425%/year difference (HR = 0.74 at 80% power (α = .05)) for the combined primary endpoint. Conclusion: This large randomized clinical trial is designed and powered to evaluate the effect of complete revascularization with FFR-guided PCI during index hospitalization on total mortality, non-fatal MI and unplanned revascularization following primary PCI in STEMI patients with multivessel disease. Enrollment completed in September 2019 and follow-up is ongoing.
  • Spillerova, Kristyna; Biancari, Fausto; Settembre, Nicla; Albäck, Anders; Venermo, Maarit (2017)
    Background: The definition of angiosome-targeted revascularization is confusing, especially when a tissue lesion affects several angiosomes. Two different definitions of direct revascularization exist in the literature. The study aim was (1) to compare the 2 definitions of direct revascularization in patients with foot lesions involving more than one angiosome and (2) to evaluate which definition better predicts clinical outcome. Methods: This study cohort comprises 658 patients with Rutherford 5-6 foot lesions who underwent infrapopliteal endovascular or surgical revascularization between January 2010 and July 2013. We compared the 2 angiosome-targeted definitions using multivariate analysis; the impact of each angiosome-targeted definition was adjusted for a propensity score obtained by means of nonparsimonious logistic regression. Results: Direct revascularization according to definition A was performed in 367 cases (55.8%) versus 198 cases (30.1%) with definition B. The propensity-score-adjusted analysis showed that definition A of direct revascularization was associated with significantly better wound healing (P <0.044, hazard ratio [HR] 1.291) and lower amputation rates (P <0.047, HR 0.706), whereas definition B was associated only with significantly better wound healing (P <0.029, HR 1.321). The prognostic ability of direct revascularization according to definition A was confirmed in a Cox proportional hazard analysis. Conclusions: Definition A of direct revascularization was associated with a significantly higher wound healing and leg salvage rate than indirect revascularization in both series. Therefore, it seems that, if the wound spreads over several angiosomes in the forefoot or heel, any angiosome involved in the wound can be targeted.