Purpose
To determine the safety and efficacy of a new-generation nitinol stent with
enhanced flexibility in arterial lesions in the superficial femoral artery
(SFA) and proximal popliteal artery ...(PPA).
Methods
The Complete Self-Expanding (SE) Multicenter Trial (ClinicalTrials.gov identifier NCT00814970)
enrolled 196 patients (124 men; mean age 68.7±10.5 years) from 28
centers in the United States and Europe. The patients presented with
intermittent claudication (193/196) or ischemic rest pain (3/196) and were
treated with nitinol stents for obstructive lesions of the SFA or PPA. Over
a quarter of lesions (29.9%) were chronic total occlusions. The mean
lesion length was 60.7 mm. Moderate to severe calcification was present in
91.0% of lesions.
Results
A total of 225 stents were successfully implanted in 213 (99.5%) of
214 lesions. Acute lesion success (<30% residual stenosis) was
achieved in 90.0%. There were no in-hospital major adverse events.
Primary patency (defined as a peak systolic velocity ratio <2.0) at
12 months was 72.6%. Clinically-driven target lesion
revascularization (TLR) was required in 8.4% of patients at 12
months. The mean ankle-brachial index increased from 0.7 at baseline to 0.9,
and there was sustained improvement in the Rutherford category, with
83% of patients classified as Rutherford category 0 or 1 at 12-month
follow-up. No stent fractures were detected through 12 months.
Conclusion
In this multicenter trial, primary implantation of a new-generation
self-expanding nitinol stent in the SFA and PPA was associated with a low
rate of TLR and sustained clinical benefit at 12 months without stent
fracture.
This article is derived from an Atlantic Council report, “A Democratic Trade Partnership: Ally Shoring to Counter Coercion and Secure Supply Chains,” published June 1, ...2022.1https://www.atlanticcouncil.org/wp-content/uploads/2022/07/A-Democratic-Trade-Partnership-Ally-Shoring-to-Counter-Coercion-and-Secure-Supply-Chains.pdf.1
Objectives The RESOLUTE US (R-US) trial is a prospective, observational study designed to evaluate the clinical effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) in a U.S. population. ...Background The R-ZES releases zotarolimus over a 6-month period in order to achieve optimal clinical effectiveness and safety. Methods The R-US trial recruited patients with de novo native coronary lesions suitable for 1- or 2-vessel treatment with stents from 2.25 to 4.0 mm in diameter. In the main analysis cohort (2.5- to 3.5-mm stents and single-lesion treatment), the primary endpoint was 12-month target lesion failure (TLF) defined as the composite of cardiac death, myocardial infarction (MI), and clinically-driven target lesion revascularization (TLR), compared with data from Endeavor zotarolimus-eluting stent (E-ZES) trials, adjusting for baseline covariates through propensity scores. Results Overall, 1,402 patients were enrolled with a mean reference vessel diameter of 2.59 ± 0.47 mm and diabetes prevalence of 34.4%. In the main analysis cohort, TLF was 3.7% at 12 months compared with historical E-ZES results (TLF = 6.5%). The R-ZES met the 3.3% margin of noninferiority (rate difference = −2.8%, upper 1-sided 95% confidence interval: −1.3%, p < 0.001). The overall TLF rate was 4.7%, and rates of cardiac death, MI, and TLR were 0.7%, 1.4%, and 2.8%, respectively. The 12-month rate of stent thrombosis was 0.1%. Conclusions The R-ZES achieved a very low rate of clinical restenosis while maintaining low rates of important clinical safety events such as death, MI, and stent thrombosis at 1-year follow-up. (The Medtronic RESOLUTE US Clinical Trial R-US; NCT00726453 )
This study aimed to report the 5-year outcomes from the ILLUMENATE Pivotal randomized controlled trial of the lower dose (2 µg/mm2) Stellarex drug-coated balloon (DCB) (Philips, formerly ...Spectranetics Corp, Colorado Springs, Colorado) compared with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic peripheral arterial disease. Long-term safety and effectiveness data for DCBs remains limited. The ILLUMENATE Pivotal was a prospective, randomized, multi-center, single-blinded study. Patients (Rutherford Clinical Category 2 to 4) were randomized 2:1 to Stellarex DCB or PTA. Follow-up was through 60 months. In total, 300 patients were enrolled. The mean age was 68.8 ± 10.2 years. At 60 months, freedom from a primary safety event was 69.2% in the Stellarex DCB arm and 68.2% in the PTA arm (log-rank, p = 0.623). The cumulative rate of major adverse events was 41.0% compared with 44.6% (p = 0.597), respectively. Freedom from clinically-driven target lesion revascularization (CD-TLR) was 70.3% in the Stellarex DCB arm compared with 68.2% in the PTA arm (p = 0.505). Time to first CD-TLR was 768.3 ± 478.9 days compared with 613.5 ± 453.4 days, respectively (p = 0.161). Kaplan-Meier estimates of freedom from all-cause mortality were 80.1% in the Stellarex DCB arm and 80.2% in the PTA arm (log-rank, p = 0.980). In conclusion, the 5-year results of the ILLUMENATE Pivotal randomized controlled trial add to the consistent safety data from the broader ILLUMENATE clinical program. These are the first data to report the 5-year safety and efficacy of a lower dose (2 µg/mm2) DCB for the treatment of symptomatic peripheral arterial disease.
Clinicaltrials.gov Registration:NCT01858428
Objectives The ENDEAVOR IV (Randomized Comparison of Zotarolimus-Eluting and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease) trial evaluated the safety and efficacy of the ...zotarolimus-eluting stent (ZES) compared with the paclitaxel-eluting stent (PES). Background First-generation drug-eluting stents have reduced angiographic and clinical restenosis, but long-term safety remains controversial. A second-generation drug-eluting stent, which delivers zotarolimus, a potent antiproliferative agent, via a biocompatible phosphorylcholine polymer on a cobalt alloy thin-strut stent has shown promising experimental and early clinical results. Methods This is a prospective, randomized (1:1), single-blind, controlled trial comparing outcomes of patients with single de novo coronary lesions treated with ZES or PES. The primary end point was noninferiority of 9-month target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization. Results Among a total of 1,548 patients assigned to ZES (n = 773) or PES (n = 775), at 9 months, ZES was noninferior to PES with rates of target vessel failure 6.6% versus 7.1%, respectively (pnoninferiority ≤ 0.001). There were fewer periprocedural myocardial infarctions with ZES (0.5% vs. 2.2%; p = 0.007), whereas at 12 months, there were no significant differences between groups in rates of cardiac death, myocardial infarction, target vessel revascularization, or stent thrombosis. Although incidence of 8-month binary angiographic in-segment restenosis was higher in patients treated with ZES versus PES (15.3% vs. 10.4%; p = 0.284), rates of 12-month target lesion revascularization were similar (4.5% vs. 3.2%; p = 0.228), especially in patients without planned angiographic follow-up (3.6% vs. 3.2%; p = 0.756). Conclusions These findings demonstrate that ZES has similar clinical safety and efficacy compared with PES in simple and medium complexity single de novo coronary lesions. (ENDEAVOR IV Clinical Trial; NCT00217269 )
BACKGROUND:Drug-coated balloons (DCBs) are a predominant revascularization therapy for symptomatic femoropopliteal artery disease. Because of the differences in excipients, paclitaxel dose, and ...coating morphologies, varying clinical outcomes have been observed with different DCBs. We report the results of 2 studies investigating the pharmacokinetic and clinical outcomes of a new DCB to treat femoropopliteal disease.
METHODS:In the ILLUMENATE Pivotal Study (Prospective, Randomized, Single-Blind, U.S. Multi-Center Study to Evaluate Treatment of Obstructive Superficial Femoral Artery or Popliteal Lesions With A Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon), 300 symptomatic patients (Rutherford class 2–4) were randomly assigned to DCB (n=200) or standard angioplasty (percutaneous transluminal angioplasty PTA) (n=100). The primary safety end point was freedom from device- and procedure-related death through 30 days, and freedom from target limb major amputation and clinically driven target lesion revascularization through 12 months. The primary effectiveness end point was primary patency through 12 months. In the ILLUMENATE PK study (Pharmacokinetic Study of the Stellarex Drug-Coated Angioplasty Balloon), paclitaxel plasma concentrations were measured after last DCB deployment and at prespecified times (at 1, 4, 24 hours and at 7 and 14 days postprocedure) until no longer detectable.
RESULTS:In the ILLUMENATE Pivotal Study, baseline characteristics were similar between groups50% had diabetes mellitus, 41% were women, mean lesion length was 8.3 cm, and 44% were severely calcified. The primary safety end point was met (92.1% for DCB versus 83.2% for PTA, P=0.025 for superiority) and the primary patency rate was significantly higher with DCB (76.3% for DCB versus 57.6% for PTA, P=0.003). Primary patency per Kaplan-Meier estimates at day 365 was 82.3% for DCB versus 70.9% for PTA (P=0.002). The rate of clinically driven target lesion revascularization was significantly lower in the DCB cohort (7.9% versus 16.8%, P=0.023). Improvements in ankle-brachial index, Rutherford class, and quality of life were comparable, but the PTA cohort required twice as many revascularizations. Pharmacokinetic outcomes showed that all patients had detectable paclitaxel levels after DCB deployment that declined within the first hour (54.4±116.9 ng/mL to 1.4±1.0 ng/mL).
CONCLUSIONS:The data demonstrate superior safety and effectiveness of the Stellarex DCB in comparison with PTA, and plasma levels of paclitaxel fall to low levels within 1 hour.
CLINICAL TRIAL REGISTRATION:URLhttp://clinicaltrials.gov. Unique identifiersNCT01858428 and NCT01912937.
Abstract only Background: CHADS2 and CHA2DS2-VASC are predictors of thromboembolic events for atrial fibrillation (AF). There is limited data on using CHA2DS2-VASC to evaluate stroke recurrence in ...community hospitals. This study compared the utility of CHADS2 and CHA2DS2-VASC to predict recurrent stroke risk in a community hospital setting. Methods: • The study population included all ischemic stroke cases from July 2006 to July 2014. • Demographics including age, gender, ethnicity; co-morbidities including hypertension, dyslipidemia and diabetes and neurological-impairment-on-arrival were considered as confounders. The outcome was number of recurrent strokes over the eight year period. • CHADS2 and CHA2DS2-VASC were analyzed as continuous variables. Results: • Of 1,986 ischemic stroke patients, 468 had AF either prior to hospitalization, at admission or at discharge. • In our patient population, CHADS2 was a more sensitive predictor recurrent stroke predictor compared to CHA2DS2-VASC (c-statistic: 0.85 and 0.78 respectively). • Average CHADS2 score of patients with recurrent stroke was 2.9 vs. 1.4 in patients with no recurrent stroke. • Average CHA2DS2-VASC score of patients with recurrent stroke was 4.2 vs. 2.7 in patients with no recurrent stroke. • With every one point increase in CHADS2 patients were six times as likely to have a recurrent stroke, while with every one point increase in CHA2DS2-VASC, patients were 2.5 times as likely to have a recurrent stroke. o Vascular disease (p=0.62) and gender (p=0.87) did not affect recurrent stroke. Hypertension (p<0.0001) and congestive heart failure (p<0.0001) were most significant predictors of recurrent stroke. Conclusion: • At our community hospital, CHADS2 was the better predictor of recurrent strokes. • While composite scores are clinically useful, vascular disease and gender were not strong predictors of recurrent stroke in our population.
Abstract only Background: Paroxysmal atrial fibrillation (PAF) is more prevalent than chronic AF in the general population. It may also be more prevalent in ischemic/TIA patients. It is difficult to ...diagnose PAF prior to event and most studies focus on chronic AF (CAF). In this study we evaluate the effect of PAF on stroke outcomes and highlight the need to focus on this treatable condition to ensure appropriate care. Methods: • The study population included ischemic/TIA cases with AF status known from July, 2006-July, 2014 (n=2951). AF status (n=573) was classified as paroxysmal (31.4%) or chronic (68.6%). o PAF was diagnosed with telemetry during hospitalization. • Outcomes included discharge disposition (alive/expired) and neurological impairment at discharge, quantified using the National Institutes of Health Stroke Scale (NIHSS). CHADS2 score was evaluated as a continuous variable. • Patient demographics and co-morbidities including diabetes, hypertension, smoking and dyslipidemia were considered as confounders in logistic regression. • Analysis was done using R-based statistical tools. Bi-variate analysis included t-tests for continuous variables and chi-square tests for categorical variables. Multivariable analysis was done using logistic regression. Results were determined to be statistically significant within a 95% confidence interval. Results: • PAF patients were more likely to be female (61.3%) than CAF (56.7%), although not significantly more likely, p=0.38. PAF patients were mean age of 76 (± 12.4) years. • PAF patients were two times as likely as non-AF patients and three times as likely CAF patients to expire (R.R. 2.2, 95% C.I. 1.17-10.9; R.R. 3.1, 95% C.I. 0.55-17.97). • There were no significant differences in recurrent stroke rate between PAF and CAF patients or PAF patients and non-AF patients. • Admission NIHSS and CHADS2 for PAF patients were higher than for non-AF patients (p<0.0001 for both). There were no significant differences between PAF and CAF patients. Conclusion: • PAF patients had a significantly higher mortality rates compared to CAF patients, despite no significant differences in CHADS2 or admissions NIHSS. • Careful evaluation is important for PAF patients since they are higher risk of poor outcomes.
Background:
Paclitaxel-coated balloons have shown safety and efficacy in the short- to intermediate-term; however, long-term data remain limited.
Objectives:
To report late safety and efficacy ...outcomes for a low-dose paclitaxel drug-coated balloon (DCB) compared with percutaneous transluminal angioplasty (PTA) in femoropopliteal lesions from a large randomized controlled trial (RCT).
Methods:
ILLUMENATE Pivotal is a multicenter, single-blind RCT conducted across 43 US and EU centers to examine the safety and efficacy of the Stellarex DCB for the treatment of femoropopliteal disease. Assessments were recorded for all active patients at 36 and 48 months. Vital status of patients formally exited from the study was also collected.
Results:
Primary patency through 36 months for patients treated with DCB was significantly higher compared with PTA (p=0.016). The primary safety endpoint through 36 months was 77.4% and 72.4%, respectively (p=0.377). Kaplan-Meier analysis indicated that a higher proportion of DCB subjects were event-free compared with PTA at all study visits. The rate of major adverse event (MAE) through 48 months was 32.9% in the DCB group and 37.9% in the PTA group (p=0.428). No differences in the rate of mortality were evident through 48 months of follow-up with 15.6% in the DCB group and 15.2% in the PTA group (p=0.929).
Conclusions:
Stellarex DCB was associated with significantly higher patency compared with PTA through 3 years with no mortality difference detected through 4 years. The data from the ILLUMENATE Pivotal RCT support the long-term safety and efficacy of the low-dose Stellarex DCB.
The RESOLUTE US (R-US) trial is a prospective, observational study designed to evaluate the clinical effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) in a U.S. population.
The R-ZES ...releases zotarolimus over a 6-month period in order to achieve optimal clinical effectiveness and safety.
The R-US trial recruited patients with de novo native coronary lesions suitable for 1- or 2-vessel treatment with stents from 2.25 to 4.0 mm in diameter. In the main analysis cohort (2.5- to 3.5-mm stents and single-lesion treatment), the primary endpoint was 12-month target lesion failure (TLF) defined as the composite of cardiac death, myocardial infarction (MI), and clinically-driven target lesion revascularization (TLR), compared with data from Endeavor zotarolimus-eluting stent (E-ZES) trials, adjusting for baseline covariates through propensity scores.
Overall, 1,402 patients were enrolled with a mean reference vessel diameter of 2.59 ± 0.47 mm and diabetes prevalence of 34.4%. In the main analysis cohort, TLF was 3.7% at 12 months compared with historical E-ZES results (TLF = 6.5%). The R-ZES met the 3.3% margin of noninferiority (rate difference = -2.8%, upper 1-sided 95% confidence interval: -1.3%, p < 0.001). The overall TLF rate was 4.7%, and rates of cardiac death, MI, and TLR were 0.7%, 1.4%, and 2.8%, respectively. The 12-month rate of stent thrombosis was 0.1%.
The R-ZES achieved a very low rate of clinical restenosis while maintaining low rates of important clinical safety events such as death, MI, and stent thrombosis at 1-year follow-up. (The Medtronic RESOLUTE US Clinical Trial R-US; NCT00726453).
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