Five years of prospective clinical trials confirm that the paclitaxel drug-coated balloon (DCB) (IN.PACT Admiral, Medtronic, Dublin, Ireland) is safe and effective to treat femoropopliteal artery ...disease. A recent meta-analysis of heterogeneous trials of paclitaxel-based balloons and stents reported that they are associated with increased mortality and that higher doses are linked to higher mortality from 2 to 5 years.
The purpose of this study was to determine if there is a correlation between paclitaxel exposure and mortality by conducting an independent patient-level meta-analysis of 1,980 patients with up to 5-year follow-up.
Data from 2 single-arm and 2 randomized independently adjudicated prospective studies of a paclitaxel DCB (n = 1,837) and uncoated percutaneous transluminal angioplasty (PTA) (n = 143) were included. Analyses of baseline, procedure, and follow-up data of individual patients were performed to explore correlations of paclitaxel dose with long-term mortality. Survival time by paclitaxel dose tercile was analyzed with adjustment of inverse probability weighting to correct baseline imbalances and study as random effect. A standard cohort was defined to compare DCB- and PTA-treated patients with similar characteristics by applying criteria from pivotal studies (n = 712 DCB, n = 143 PTA).
A survival analysis stratified nominal paclitaxel dose by low, mid, and upper terciles; mean doses were 5,019.0, 10,007.5, and 19,978.2 μg, respectively. Rates of freedom from all-cause mortality between the 3 groups through 5 years were 85.8%, 84.2%, and 88.2%, respectively (p = 0.731). There was no significant difference in all-cause mortality between DCB and PTA through 5 years comparing all patients (unadjusted p = 0.092) or patients with similar characteristics (adjusted p = 0.188).
This independent patient-level meta-analysis demonstrates that this paclitaxel DCB is safe. Within DCB patients, there was no correlation between level of paclitaxel exposure and mortality. (Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease INPACT SFA I, NCT01175850; IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery SFA and Proximal Popliteal Artery PPA INPACT SFA II, NCT01566461; MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery MDT-2113 SFA, NCT01947478; The IN.PACT SFA Clinical Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery Using the IN.PACT Admiral™ Drug-Eluting Balloon in a Chinese Patient Population, NCT02118532; and IN.PACT Global Clinical Study, NCT01609296).
The Global SFA Registry sought to assess safety, clinical benefit, and outcomes of the Lutonix 035 drug-coated balloon (DCB) in a heterogeneous, real-world patient population at 12 and 24 months.
...Numerous clinical studies have evaluated the use of angioplasty for revascularization of femoropopliteal arteries in peripheral arterial disease with restenosis rates of 40% to 60% at 6 to 12 months. Data from recent studies document decreased restenosis rates and improvement in patency in patients receiving angioplasty of femoropopliteal arteries with DCBs.
The multicenter, prospective study enrolled 691 patients in 38 centers from 10 countries treated with the Lutonix 035 DCB in femoropopliteal lesions. The primary safety endpoint was freedom from a composite of target vessel restenosis, major index limb amputation, and device- or procedure-related death at 30 days. The primary effectiveness endpoint was freedom from target lesion restenosis at 12 months. Secondary endpoints were acute device and procedural success and clinically assessed primary patency.
Freedom at 30 days from the composite safety endpoint was 99.4%. Freedom from target lesion restenosis was 93.4%/89.3% for the overall population, 93.2%/88.2% for long lesions up to 500 mm, and 90.7%/84.6% for in-stent restenosis at 12/24 months. Clinically assessed primary patency by Kaplan-Meier estimates was 85.4%/75.6% at 12/24 months. More than 76% of patients showed improvement of at least 1 Rutherford category.
The Global SFA Registry 24-month outcomes confirm the Lutonix 035 DCB is a safe and effective long-term treatment option in real-world patients with peripheral arterial disease with superficial femoral artery lesions, also in long lesions and in-stent restenosis. (Lutonix Global SFA Registry; NCT01864278).
In this trial, patients with femoropopliteal artery disease were assigned to standard angioplasty or treatment with a paclitaxel-coated balloon. At 12 months, primary patency was seen more frequently ...with the drug-coated balloon than with standard angioplasty.
Atherosclerotic disease in the femoral and popliteal (femoropopliteal) arteries compromises perfusion to the legs and feet. Although treatment with percutaneous transluminal angioplasty is effective in initially restoring blood flow, restenosis from vessel recoil and neointimal hyperplasia occur in more than 60% of patients within 1 year after the procedure.
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Stents act as scaffolds to prevent recoil and reduce the incidence of restenosis,
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but the permanent presence of an intravascular prosthesis may limit subsequent therapeutic options. Stent fracture, although infrequent, can have negative consequences.
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Results with drug-eluting stents in peripheral vessels have varied,
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although a recent study showed . . .
Purpose: To investigate the angiographic dissection patterns after balloon angioplasty for superficial femoral artery (SFA) lesions, the clinical outcome associated with each dissection pattern, and ...the predictive factors for severe dissection. Methods: A retrospective, multicenter analysis examined 621 patients (mean age 72.8±9.5 years; 414 men) with 748 symptomatic de novo SFA lesions treated with endovascular therapy. Vessel dissection after the initial balloon angioplasty procedure was graded into 7 types according to a modified version of the coronary artery classification types A to F. Severe vessel dissection patterns were defined as type C or higher. Nitinol stent implantation was performed in 555 (74.2%) lesions for residual stenosis >30% or flow-limiting dissection; 193 lesions (25.8%) were treated with balloon angioplasty only. To determine the clinical outcomes associated with each dissection pattern and identify predictive factors for severe dissection, 2-year follow-up data for the 193 lesions treated with balloon angioplasty only were analyzed for primary patency and clinically driven target lesion revascularization (TLR). Results: No dissection was found in 16% (120/748) of lesions, and types A and B dissections were seen in 19% (142/748) and 23% (172/748), respectively. Dissection grades above type C were observed in 42% of cases, most frequently type D (180/748, 24%) and less often type C (37/748, 5%), type E (67/748, 9%), and type F (30/748, 4%). The bailout stent implantation rate increased according to dissection severity. At up to 2 years, the severe dissection group (types C–F) showed a significantly lower patency rate (p<0.001) and higher clinically driven TLR (p<0.001) compared to the nonsevere group (no dissection and types A and B dissections). Severe dissection was a significant risk factor for restenosis, which rose progressively from types C to F. Multivariate analysis identified a small reference vessel diameter <5 mm (p=0.001), lesion length >15 cm (p=0.001), and chronic total occlusion (p<0.001) as independent predictors of severe dissection. In subgroup analysis, vessels with a small reference diameter and TASC II C and D lesions had a higher prevalence of severe dissection. Conclusion: Severe dissection was found in 42% of cases after PTA. A small vessel diameter and/or TASC II C/D lesions were related to a high incidence of dissection. Severe dissection during procedures employing balloon angioplasty only could affect long-term patency.
Our purpose was to determine if "Japanese style" technical strategies can be successfully applied in the U.S. practice environment and to better understand the learning curve for chronic total ...occlusion (CTO) percutaneous coronary intervention (PCI).
Procedural technical success remains the major limiting factor for CTO PCI, and has been unchanged over time.
Demographic, procedural, and outcome data were collected on 636 consecutive patients between January 2005 and March 2008 having CTO PCI (514 antegrade, 122 retrograde attempts) at 2 U.S. medical centers. Operators were divided into 2 groups: higher CTO volume, retrograde operators (ROs) (>75 total CTO PCI cases and >20 retrograde attempts during the study period) and lower CTO volume, nonretrograde operators (NROs) to evaluate the impact of CTO-specific operator case volume and retrograde techniques on procedural outcomes.
Two operators met the criteria for RO category and 10 were NRO. ROs performed 395 CTO PCI cases (mean total CTO case experience = 197.5, 60 retrograde) and NROs performed 241 CTO PCI cases (mean total CTO case experience = 24.1, <1 retrograde) during the observed timeframe. The overall technical success was 58.9% for NROs and 75.2% for ROs (p < 0.0001). The technical success rate of NROs did not change, but the technical success for the ROs increased to 90% over time (p < 0.0001 for trend, 94.4% for retrograde and 85.7% for antegrade approaches). Observed major adverse events were similar between ROs and NROs.
Complex antegrade and retrograde "Japanese style" PCI approaches can be applied in the U.S. practice environment with high technical success and low adverse event rates. Higher CTO-specific operator case volume is associated with improved technical success rates.
The COVID-19 outbreak has had an unclear impact on the treatment and outcomes of patients with ST-segment elevation myocardial infarction (STEMI). The aim of this study was to assess changes in STEMI ...management during the COVID-19 outbreak.
Using a multicenter, nationwide, retrospective, observational registry of consecutive patients who were managed in 75 specific STEMI care centers in Spain, we compared patient and procedural characteristics and in-hospital outcomes in 2 different cohorts with 30-day follow-up according to whether the patients had been treated before or after COVID-19.
Suspected STEMI patients treated in STEMI networks decreased by 27.6% and patients with confirmed STEMI fell from 1305 to 1009 (22.7%). There were no differences in reperfusion strategy (> 94% treated with primary percutaneous coronary intervention in both cohorts). Patients treated with primary percutaneous coronary intervention during the COVID-19 outbreak had a longer ischemic time (233 150-375 vs 200 140-332 minutes,
< .001) but showed no differences in the time from first medical contact to reperfusion. In-hospital mortality was higher during COVID-19 (7.5% vs 5.1%; unadjusted OR, 1.50; 95%CI, 1.07-2.11;
< .001); this association remained after adjustment for confounders (risk-adjusted OR, 1.88; 95%CI, 1.12-3.14;
= .017). In the 2020 cohort, there was a 6.3% incidence of confirmed SARS-CoV-2 infection during hospitalization.
The number of STEMI patients treated during the current COVID-19 outbreak fell vs the previous year and there was an increase in the median time from symptom onset to reperfusion and a significant 2-fold increase in the rate of in-hospital mortality. No changes in reperfusion strategy were detected, with primary percutaneous coronary intervention performed for the vast majority of patients. The co-existence of STEMI and SARS-CoV-2 infection was relatively infrequent.
Multivariable regression models were used to estimate clinical outcomes by operator case number. Adjusted regression models based on CTO case number showed linear improvements in procedural outcomes ...at the expense of increased contrast use, fluoroscopy use, and bleeding (Figure 1).
Methods Nationwide Inpatient Sample data files from 2003 to 2014 were used to extract adult patients (age > 18 years) who underwent elective PCI. Patients who developed major complications (acute ...stroke, gastrointestinal bleeding, acute kidney injury, cardiac arrest, cardiogenic shock, vascular complications, and in-hospital mortality) after PCI were excluded to identify those with uncomplicated hospital stay.
Introduction
The current FDA approved intracranial stent delivery system requires a multi‐step deployment involving the use of exchange length microwire (ELW), typically 0.014‐inch 300 cm wire, to ...navigate the balloon catheter, which is then exchanged, after performing the angioplasty, over the ELW to a 0.017’ microcatheter that is used to deploy the intracranial stent. Herein, we describe a single‐step approach to deploy Neuroform Atlas stent (Stryker Neurovascular, Fremont, CA) which is a hybrid laser‐cut, nitinol self‐expanding stent without the need for ELW or lesion re‐access using MINI TREK RX (Abbott Vascular, Inc., Santa Clara, CA, USA) semi compliant balloon adapted from cardiovascular literature which showed a pre‐dilation angioplasty capability in coronary stenotic lesions.
Methods
We performed a retrospective review of prospectively maintained mechanical thrombectomy (MT) databases of 2 comprehensive stroke centers between November 2020, and May 2023. The inclusion criteria were consecutive large vessel occlusion stroke patients in whom single step MINI TREK RX balloon angioplasty followed by Neuroform Atlas intracranial stent deployment was performed without using ELW (Figure‐1). There was no restriction on time from last known well (TLKW) to MT. During the standard mechanical thrombectomy procedure, intracranial atherosclerotic disease/ significant stenotic lesion was suspected by immediate re‐occlusion/ persistent occlusion following at least 1 thrombectomy pass. This is followed by pursuing intracranial angioplasty and stent placement as a rescue recanalization measure. The primary outcome was successful reperfusion defined as a Modified Treatment in Cerebral Ischemia (mTICI) score of 2b or greater at the end of the procedure. Secondary outcomes included NIH Stroke Scale (NIHSS) at 24 hours, NIHSS at discharge, median modified Rankin Scale (mRS) score at discharge and at 90‐day follow‐up. Safety measures included rates of symptomatic intracranial hemorrhage (sICH) and mortality at 90 days.
Results
Among 9 patients who met our criteria, the median age was 63 (51‐69.5) years and 55.6% were females. Most patients had left middle cerebral artery‐ M1 occlusion (66.7%) and one third received thrombolytics (33.3%). All patients underwent the single‐step approach and achieved successful reperfusion (m TICI 2b‐3) with 2 median number of passes. The median NIHSS was reduced from 13.5 (8.5‐17.5) at baseline to 4 (1‐16.5) at discharge. In addition, median mRS was 1 (1‐3.5) at discharge and 3 (3‐4) at 90 days. None of the patients included in this series had sICH while only one patient with basilar artery occlusion underwent ventriculostomy during hospital stay and was sedated/intubated and died.
Conclusion
This preliminary experience showed technical feasibility and success of using single‐ step to deploy Neuroform Atlas stent after performing angioplasty using MINI TREK RX without the need for ELW or lesion re‐access. Prospective studies with larger sample size and long‐term clinical follow‐up are warranted to confirm these results.
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