A Comparison of Contemporary Clinical Outcomes Following Femoro-Popliteal Plain Balloon Angioplasty and Bypass Surgery for Chronic Limb Threatening Ischemia

2021 ◽  
pp. 153857442110046
Author(s):  
Lewis Meecham ◽  
Mathew A. Popplewell ◽  
Gareth R. Bate ◽  
Smitaa Patel ◽  
Andrew W. Bradbury

Introduction: Despite the BASIL-1 trial concluding that bypass surgery (BS) was superior to plain balloon angioplasty (PBA) in terms of longer-term amputation free (AFS) and overall survival (OS), CLTI patients are increasingly offered an endovascular-first revascularization strategy. This study investigates whether the results of BASIL-1 are still relevant to current practice by comparing femoro-popliteal (FP) BS with PBA in a series of CLTI patients treated in our unit 10 years after BASIL-1 (1999-2004). Methods: We retrospectively analyzed prospectively gathered hospital data pertaining to 279 patients undergoing primary FP BS or PBA for CLTI in the period 2009 to 2014. We report baseline characteristics, 30-day morbidity and mortality, major adverse cardiovascular events (MACE) and long-term AFS, limb salvage (LS), OS, major adverse limb events (MALE), and freedom from re-intervention (FFR). Results: 234 (84%) and 45 (16%) patients underwent PBA and BS respectively. PBA patients were significantly older (77 vs 71 years, P = 0.001) and more likely to be female (45% vs 28%, P = 0.026). Bollinger and GLASS anatomic scores were significantly more severe in the BS group. Technical success was better for BS (100% vs 87%, P = 0.007). Index hospital stay was shorter for PBA (9.1 vs 15.6 days, P = 0.035) but there was no difference in hospital days or admissions over the next 12 months. AFS (HR 1.00), LS (HR 1.44), OS (HR 0.81), MALE (HR 1.25) and FFR (HR = 1.00) were not significantly different between PBA and BS. Conclusion: Important clinical outcomes following FP BS and PBA for CLTI have not changed significantly in our unit in the 10 years following the BASIL-1 trial. BASIL-1 therefore remains relevant to our current practice and should inform our approach to the management of CLTI going forward.

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C X Song ◽  
R Fu ◽  
J G Yang ◽  
K F Dou ◽  
Y J Yang

Abstract Background Controversy exists regarding the use of beta-blockers (BBs) among patients with acute myocardial infarction (AMI) in contemporary reperfusion era. Previous studies predominantly focused on beta-blockers prescribed at discharge, and the effect of long-term adherence to beta-blocker on major adverse cardiovascular events (MACE) remains unclear. Objective To explore the association between long-term beta-blocker use patterns and MACE among contemporary AMI patients. Methods We enrolled 7860 patients with AMI, who were discharged alive and prescribed with BBs based on CAMI registry from January 2013 to September 2014. Patients were divided into two groups according to BBs use pattern: Always users group (n=4476) were defined as patients reporting BBs use at both 6- and 12-month follow-up; Inconsistent users group were defined as patients reporting at least once not using BBs at 6- or 12-month follow-up. Primary outcome was defined as MACE at 24-month follow-up, including all-cause death, non-fatal MI and repeat-revascularization. Multivariable cox proportional hazards regression model was used to assess the association between BBs and MACE. Results Baseline characteristics are shown in table 1. At 2-year follow-up, 518 patients in inconsistent users group (15.6%) and 548 patients in always users group (12.3%) had MACE. After multivariable adjustment, inconsistent use of BBs was associated with higher risk of MACE (HR: 1.323, 95% CI: 1.171–1.493, p<0.001). Table 1 Baseline characteristics Variable Always user (N=4476) Inconsistent user (N=3384) P value Age (years) 60.6±12.0 61.2±12.2 <0.001 Male 3381 (75.7%) 2461 (74.3%) 0.084 Diabetes 892 (20.0%) 610 (18.4%) 0.003 Hypertension 2372 (53.2%) 1543 (46.6%) <0.001 Dyslipidemia 244 (5.5%) 126 (3.8%) <0.001 Prior myocardial infarction 351 (7.9%) 232 (7.0%) <0.001 Heart failure 88 (2.0%) 63 (1.9%) <0.001 Chronic obstructive pulmonary disease 66 (1.5%) 60 (1.8%) <0.001 Current smoker 2054 (46.1%) 1579 (47.8%) 0.179 Left ventricular ejection fraction (%) 53.7±11.48 54.0±10.9 <0.001 Major Adverse Cardiovascular Events 548 (12.3%) 518 (15.6%) <0.001 Conclusions Our results showed consistent BBs use was associated with reduced risk of MACE among patients with AMI managed by contemporary treatment. Acknowledgement/Funding CAMS Innovation Fund for Medical Sciences (CIFMS) (2016-I2M-1-009)


2020 ◽  
Vol 55 (1) ◽  
pp. 26-32
Author(s):  
Matthew A. Popplewell ◽  
Huw O. B. Davies ◽  
Lewis Meecham ◽  
Gareth Bate ◽  
Andrew W. Bradbury

Introduction: A published subgroup analysis of the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-1 trial suggests that, in patients with chronic limb threatening ischemia (CLTI) due to infra-popliteal (IP) disease, clinical outcomes are better following vein bypass surgery (BS) than after plain balloon angioplasty (PBA). The aim of the present study is to determine if clinical outcomes following IP revascularization in our unit are concordant with those found in BASIL-1. Methods: We analyzed prospectively gathered data pertaining to 137 consecutive CLTI patients undergoing IP PBA or BS between 2009 and 2013. We compared 30-day morbidity and mortality, days in hospital (index admission and out to 12-months), amputation free survival (AFS), overall survival (OS), limb salvage (LS), and freedom from arterial re-intervention (FFR). Patient outcomes were censored on 1 February 2017, providing a minimum 3 years follow-up. Results: Patients undergoing BS (73/137, 47%) tended to be younger, have less comorbidity, and were more likely to be on best medical therapy (BMT). BS patients spent more days in hospital during the index admission (median 9 vs 5, p = .003), but not out to 12 months (median 15 vs 13, NS). BS patients suffered more 30-day morbidity (36% vs 10%, p < .001), mainly due to infective complications, but not mortality (3.1% vs 6.8%, NS). AFS (p = .001) and OS (p < .001), but not LS or FFR, were better after BS. Conclusions: CLTI patients selected for revascularization by means of IP BS had better long-term outcomes in terms of AFS and OS, but not FFR or LS. Although we await the results of the BASIL-2 trial, current data support the BASIL-1 sub-group analysis which suggests that patients requiring revascularization for IP disease should have BS where possible and that PBA should usually be reserved for patients who are not suitable for BS.


2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Walter P. Maksymowych ◽  
Thomas Kumke ◽  
Simone E. Auteri ◽  
Bengt Hoepken ◽  
Lars Bauer ◽  
...  

Abstract Background Identification of predictive clinical factors of long-term treatment response may contribute to improved management of non-radiographic axSpA (nr-axSpA) patients. This analysis aims to identify whether any baseline characteristics or Week 12 clinical outcomes in nr-axSpA patients with elevated C-reactive protein (CRP) and/or sacroiliitis on magnetic resonance imaging (MRI) enrolled in the C-axSpAnd study are predictive of achieving clinical response after 1 year of certolizumab pegol (CZP). Methods C-axSpAnd (NCT02552212) was a phase 3, multicentre study, including a 52-Week double-blind, placebo-controlled period. Enrolled patients were randomised to CZP 200 mg Q2W or placebo. Predictors of Week 12 (CZP group only) and Week 52 clinical response were identified using a multivariate stepwise logistic regression analysis. Response variables included Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI), Assessment of SpondyloArthritis International Society 40% response (ASAS40), Bath Ankylosing Spondylitis Disease Activity Index 50% response (BASDAI50) and ASDAS inactive disease (ASDAS-ID). Predictive factors assessed included demographic and baseline characteristics and clinical outcomes at Week 12. A p-value <0.05 was required for forward selection into the model and p ≥0.1 for backward elimination. Missing data or values collected after switching to open-label treatment were accounted for using non-responder imputation. Sensitivity analyses accounted for patients with changes in non-biologic background medication. Results Of 317 enrolled patients, 159 and 158 were randomised to CZP and placebo, respectively. Younger age and male sex were identified as predictors of Week 12 response across all assessed efficacy outcomes in CZP-treated patients. Consistent predictors of Week 52 response, measured by ASDAS-MI, ASAS40 and BASDAI50, included human leukocyte antigen (HLA)-B27 positivity and sacroiliitis on MRI at baseline. MRI positivity was also predictive of achieving ASDAS-ID at Week 52. Sensitivity analyses were generally consistent with the primary analysis. In placebo-treated patients, no meaningful predictors of Week 52 response were identified. Conclusions In this 52-Week, placebo-controlled study in nr-axSpA patients with elevated CRP and/or active sacroiliitis on MRI at baseline, MRI sacroiliitis and HLA-B27 positivity, but not elevated CRP or responses at Week 12, were predictive of long-term clinical response to CZP. Findings may support rheumatologists to identify patients suitable for TNFi treatment. Trial registration ClinicalTrials.gov, NCT02552212. Registered on 15 September 2015


2018 ◽  
Vol 11 (4) ◽  
pp. S24
Author(s):  
Sameer Dani ◽  
Keyur Parikh ◽  
Prathap Kumar N. Pillai ◽  
Ranjan Shetty ◽  
Jagdish Hiremath ◽  
...  

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
C Otte Alba ◽  
M J Romero Reyes ◽  
A Padilla Escamez ◽  
S Rufian Andujar ◽  
F J Molano Casimiro

Abstract Background Incomplete revascularization versus complete revascularization in patients undergoing percutaneous coronary intervention (PCI) is associated with higher risk of mortality and major adverse cardiac events. Cardiac rehabilitation (CR) is one of the most important evidence-based interventions for secondary prevention after ischemic heart disease. However, it has been less studied in patients with incomplete PCI. Purpose The aim of our study was to evaluate the effects of CR on long-term clinical outcomes after incomplete PCI. Methods Unicentric, descriptive and analitical study. We included 285 patients who underwent incomplete PCI at our hospital from 2004 to 2011. We compared those who participated in a CR program with those who refused to. We analyzed events occurring during a median follow-up of 11 years. Results This study included 285 patients, 121 (42.5%) participated in the CR program. Attending to baseline characteristics, there were significant differences in prevalence of male gender (88.4% vs 67.7%, p=0.000) and DM (69.4% vs 51.8%, p=0.003), which were more prevalent in CR group; they were also significantly younger (58.81 vs 66.34 years, p=0.000). Acute myocardial infarction (AMI) was the most common indication for PCI in those who attended CR, whereas in the other group it was unstable angina. Using univariate logistic analysis, CR participation was found to be associated with significantly reduced heart failure readmissions (14.2% vs 31.7%; OR 0.356; IC95% 0.193- 0.656; p=0.001), all-cause mortality (21.5% vs 56.7%; OR 0.209; IC95% 0.123- 0.356; p=0.000) and cardiovascular mortality (5.8% vs 26.8%; OR 0.167; IC95% 0.072- 0.387; p 0.000). No significant differences were observed in re-AMI (20.8% vs 26.4%, p=0.280) nor incidence of stroke (5.8% vs 9.8%, p=0.226) during the follow-up. The multivariate regression showed as well that CR was associated with a lower rate of all-cause and cardiovascular mortality and heart failure readmissions. Other predictors of clinical outcomes were NYHA stage, age &gt;65 years and LVEF &lt;40%. Conclusion CR is an excellent strategy for reducing hospital readmissions and mortality during long-term follow-up in patients with incomplete PCI. FUNDunding Acknowledgement Type of funding sources: Public hospital(s). Main funding source(s): Hospital Universitario de Valme, Sevilla, Spain Baseline characteristics


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Ryo Naito ◽  
Katsumi Miyauchi ◽  
Hirokazu Konishi ◽  
Shuta Tsuboi ◽  
Manabu Ogita ◽  
...  

Introduction: PCI has evolved with technological advance, improvement of operators’ techniques and medical therapy for secondary prevention. Despite these improvements, diabetes remains a negative predictor. To date, little is known regarding improvement of clinical outcomes in diabetic patients with PCI. We examined a temporal trend of long-term clinical outcomes in diabetic cohort across the different generations. Hypothesis: We hypothesized that clinical outcomes would improve with advances of PCI. Methods: We analyzed data of diabetic patients with PCI in Juntendo University from 1984 to 2010. The patients were divided into three groups according to the procedure data (POBA-era; January 1984 - December 1997, BMS-era; January 1998 - July 2004 and DES-era; August 2004 - February 2010). Primary endpoint was a composite of major adverse cardiovascular events including all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and revascularization. Results: A total of 1544 patients were examined (POBA-era; 374, BMS-era; 494 and DES-era; 676). The mean age was higher in DES-era. A higher prevalence of hypertension and dyslipidemia was observed in DES-era. The success rate of PCI was lower among the patients in POBA-era. Kaplan-Meier estimation for 3-year MACE was significantly different among the eras (Figure 1). Multivariable Cox regression analysis showed that DES-era was a predictor for long-term MACE (DES- vs BMS era; HR 0.50, 95%, CI 0.38 - 0.66, P < 0.001, DES- vs POBA-era; HR 1.60, 95% CI 0.34-27.9, P = 0.6). Conclusions: Long-term clinical outcomes in diabetic patients who underwent PCI were more favorable in DES-era, despite the higher risk profiles.


2011 ◽  
Vol 142 (4) ◽  
pp. 829-835 ◽  
Author(s):  
Mark A. Hlatky ◽  
David Shilane ◽  
Derek B. Boothroyd ◽  
Eric Boersma ◽  
Maria M. Brooks ◽  
...  

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
J Yonekawa ◽  
Y Mizutani ◽  
D Yamashita ◽  
Y Makino ◽  
T Hiramatsu ◽  
...  

Abstract Background With regards to short-term outcome in atrial fibrillation (AF), the benefit of cryoballoon ablation (CBA) by pressing a balloon against the earliest pulmonary vein (PV) potential site during pulmonary vein isolation, (earliest potential [EP]-guided CBA) has been previously demonstrated. Objective The present study aimed to evaluate the long-term outcome of the EP-guided CBA. Methods This study included 136 patients from two randomized studies, who underwent CBA for paroxysmal AF for the first time. Patients were randomly assigned to the EP-guided and conventional CBA groups in each study. In the EP-guided CBA group, we pressed a balloon against the EP site when the time to isolation (TTI) after cryoapplication exceeded 60 s and 45 s in the first and second studies, respectively. The patients were followed up for 1 year after procedure. We compared the clinical outcomes between the EP-guided CBA group (68 patients) and the conventional CBA group (68 patients). Results No significant differences in baseline characteristics were observed between the two groups. Compared with the conventional CBA group, the EP-guided CBA group had a significantly higher success rate at TTI ≤90 s (98.5% vs. 90.0%, P&lt;0.001); lower touch-up rate and total cryoapplication; and shorter procedure time, and fluoroscopy time. The recurrence at 1-year after ablation was significantly lower in the EP-guided CBA group than in the conventional CBA group (6.0% vs. 19.4%; P=0.019). Conclusions The EP-guided CBA approach can facilitate the ablation procedure and achieve low recurrence at 1-year after ablation. FUNDunding Acknowledgement Type of funding sources: None. Earliest potential [EP]-guided CBA The recurrence at 1-year after ablation


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