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Objectives

This study was designed to evaluate outcomes of adventitial dexamethasone delivery adjunctive to standard endovascular revascularization in femoropopliteal peripheral artery disease.

Background

Drug-coated balloons and drug-eluting stents improve patency of endovascular interventions with passive diffusion of antiproliferative drugs. Adventitial dexamethasone delivery targets the initial triggers of the inflammatory reaction to injury, thus potentially providing a potent antirestenotic strategy.

Methods

The single-arm DANCE (Dexamethasone to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization) trial enrolled 262 subjects (283 limbs) with symptomatic peripheral artery disease (Rutherford category 2 to 4) receiving percutaneous transluminal angioplasty (PTA) (n = 124) or atherectomy (ATX) (n = 159) in femoropopliteal lesions ≤15 cm in length. A mixture of dexamethasone/contrast medium (80%/20%) was delivered to the adventitia and perivascular tissues surrounding target lesions in all subjects. Thirty-day assessments included major adverse limb events (MALE) and post-operative death. Twelve-month assessments included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), Rutherford scoring, and walking impairment questionnaire.

Results

At 12 months, primary patency rates in DANCE-ATX and -PTA per-protocol populations were 78.4% (74.8% intent-to-treat [ITT]) and 75.5% (74.3% ITT), respectively. Rates of CD-TLR in DANCE-ATX and -PTA subjects were 10.0% (13.1% ITT) and 11.0% (13.7% ITT), respectively. There were no 30-day MALE + post-operative death events nor 12-month device- or drug-related deaths or MALE.

Conclusions

Direct adventitial delivery of dexamethasone appears to be an effective and safe therapy to prevent restenosis. Randomized studies are needed to further test this possibility. (Dexamethasone to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization [DANCE]; NCT01983449)  相似文献   

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A 38 year-old man was admitted because of half a year of recurrent bouts of eough and shortness of breath and 20 days of hemoptysis. He had been apparently healthy until the illness. In the recent 6 months, the dyspnea and fatigue gradually onset and became more severe, the hemoptysis being 100-200 mL per day. Spells of chest pain are associated with coughing. Despite accepting antibiotic and antispasmodic therapy in a hospital, there was no obvious improvement and he was transferred to our hospital. Physical examination on admission: He was in acute distress and anemic face With P 110/min., R 30/min., T36. 8oC and Bp 100/60 mmHg. There were Wheezes, medium and fine  相似文献   

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IntroductionEndovascular stenting of popliteal occlusion is a common procedure in vascular practice.Stent fractures normally cause restenosis or occlusion of the arterial segment treated.ReportWe present a case of a large aneurysm of the popliteal artery that was observed 14 months after popliteal stenting with self-expandable nitinol stent.We describe the endovascular approach that has been used to solve this severe complication.DiscussionStent fractures are often a hidden complication of femoro-popliteal stenting that can be associated with important disease; a careful follow-up and prompt management in expert hands in the majority of the cases lead to a favourable resolution.  相似文献   

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Between January 1995 and July 1998, percutaneous transluminal coronary angioplasty was performed on 27 lesions in 24 octogenarians. Half of the patients were African American. Women comprised 67% of the study group. Patients with unstable angina and myocardial infarction constituted 54% of the cohort. Two-thirds of the patients (83%) had single vessel disease with predominant class A and B lesion complexity of the angioplasty site. Acute success rate was 92%. Stents were successfully placed in 11 subjects (46%). None had acute myocardial infarction, emergency coronary artery bypass surgery, or stroke as a complication of the procedure. One patient presenting with acute myocardial infarction complicated by cardiogenic shock, died. Significant bleeding complications requiring blood transfusions occurred in 17% of patients. Of the patients, 23 (96%) were discharged in a clinically stable condition. Follow up during a two year period was completed in 21 patients (88%). One patient died of cancer. Four subjects (19%) underwent repeat percutaneous transluminal coronary angioplasty. One other patient had recurrent chest pain requiring multiple hospitalizations. The remaining 16 patients (76%) remained free of recurrence of angina. We concluded that percutaneous transluminal coronary angioplasty with stent placement can be performed in octogenarians with a high rate of clinical and angiographic success with an acceptable range of morbidity and mortality, and favorable long term (two year) outcome.  相似文献   

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The experimental and clinical results of the self-expanding nitinol coil stent have been reviewed. Animal data have shown that the stent is safe and provokes a mild proliferative response, similar to previously studied balloon-expandable stents. Data from femoral and popliteal arteries are supportive of long-term patency in these arteries, which are typically associated with unfavorable results from other stents. Data from coronary implantations in patients show that the stent can be safely used to treat coronary lesions of both simple and complex natures. Long-term results of these patients compare favorably with existing data in similar lesions using other stents. A larger clinical trial using the new flat wire design stent is required to test whether further stent expansion may contribute to low restenosis rates.  相似文献   

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BackgroundThe PAST-PERF registry was initiated to collect data on the PK Papyrus covered stent, a second-generation device for the treatment of coronary artery perforations with enhanced mechanical properties, but with limited available data.MethodsPatients treated for coronary artery perforations with the PK Papyrus stent at 14 international centers were retrospectively identified. The primary effectiveness outcome was successful sealing of the perforation. The primary safety outcome was a composite of all-cause mortality, definite or probable stent thrombosis, myocardial infarction and target lesion revascularization.ResultsAmong the 94 included patients, 72.3% (68/94) had Ellis type III and cavity spilling perforations. Complete sealing was achieved in 93.6% (n = 88), and no sealing could be achieved in 3.2% (n = 3, including one patient with a geographical miss and one patient in whom the device could not be implanted). Pericardiocentesis was required in 25.0% (n = 23), emergency cardiac surgery was needed in 7.6% (n = 7), acute stent thrombosis was observed in 1.1% (n = 1), and in-hospital mortality occurred in 11.7% (n = 11). The median follow-up duration was 283 (IQR:40;670) days. At 6 and 12 months, the incidence of the primary safety endpoint was 26.6% [95%CI:18.6;37.1] and 32.0% [95%CI:22.8;43.4], mortality 15.0% [95%CI:9.0;24.6] and 19.0% [95%CI:11.3;30.0], and target lesion revascularization 5.5% [95%CI:2.0;14.6] and 7.7% [95%CI:3.1;18.2]. Two definite stent thrombosis occurred, one during the procedure and one on post-procedure day 233.ConclusionsThe registry demonstrates favorably high rates of successful stent delivery and sealing of coronary perforations using a second-generation covered stent with low target lesion revascularization and stent thrombosis rates.Annotated table of contentThe PAST-PERF registry demonstrates favorably high rates of successful stent delivery and sealing of coronary perforations using a second-generation covered stent with low target lesion revascularization and stent thrombosis rates. Specifically, complete sealing was achieved in 93.6% of patients (n = 88/94), and no sealing could be achieved in 3.2% (n = 3, including one patient with a geographical miss and one patient in whom the device could not be implanted). The 12-month mortality was 19.0% [95%CI:11.3;30.0], the rate of target lesion revascularization was 7.7% [95%CI:3.1;18.2], and two definite stent thromboses occurred (one during procedure and one on post-procedure day 233).  相似文献   

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BackgroundIntravascular lithotripsy (IVL) is a novel endovascular treatment for calcified common femoral artery disease (CFA). Data on midterm effectiveness for clinically driven target lesions revascularization (CD-TLR) is lacking. This study investigated CD-TLR during 18-month follow-up in patients requiring IVL for CFA disease treatment.MethodsIn a single-center retrospective cohort study, electronic medical record of patients undergoing IVL for CFA disease from January 2018 to March 2020 were reviewed. Primary outcome was CD-TLR estimated by Kaplan-Meier method during 18-month follow-up. Univariate logistic regression was used to compare differences in CD-TLR by the type of adjunct therapy used.ResultsAmong 54 CFA lesions in 50 patients, mean age (SD) was 75(8) years, gender and race were predominantly male (74%, n = 37) and white (94%, n = 47), respectively. Rutherford class III claudication was most common (70%, n = 35) with mean ABI of 0.66 (0.26) and mean angiographic stenosis of 77% (13%). Adjunct use of drug-coated balloon (DCB) angioplasty was 83% (n = 45) and atherectomy was 39% (n = 21). Residual angiographic stenosis was <30% in all cases. Complications included dissection requiring stent placement (2%, n = 1). After 18-months, 18% (n = 9) died unrelated to procedural complications and 6% (n = 3) were lost to follow-up. 18-month cumulative freedom from CD-TLR was 80.6% (95% CI: 69.1%, 92%). Univariate logistic regression did not reveal a statistically significant difference in CD-TLR with type of adjunct therapy used (p > 0.05).ConclusionIVL with adjunct use of DCB and/or atherectomy is safe and effective in treatment of calcified CFA disease. Randomized studies are required to confirm these findings.  相似文献   

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This is the first reported use of the JOSTENT stent graft for aneurysm disease in native coronaries. Consideration can be given to using this polytetrafluoroethylene (PTFE)-covered stent in situations such as dissections and restenosis in saphenous vein grafts or in long native coronary arteries without side branches, though further investigation is warranted. Cathet. Cardiovasc. Intervent. 46:113–116, 1999. © 1999 Wiley-Liss, Inc.  相似文献   

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ObjectivesThe aim of this study was to determine the incidence, predictors, and outcomes of recurrent stent thrombosis (rST).BackgroundPatients who had an initial stent thrombosis (ST) develop may be at high risk of rST.MethodsWe analyzed a multicenter California registry of angiographic definite ST at 5 academic hospitals from 2005 to 2013. A detailed review of the angiogram and procedure was performed of patients with and without rST.ResultsAmong 221 patients with a median follow-up of 3.3 years, definite or probable rST developed in 29, including 19 with angiographic definite rST. The cumulative hazard ratio (HR) of definite or probable rST was 16% at 1 year and 24% at 5 years, whereas the cumulative HR of angiographic definite rST was 11% at 1 year and 20% at 5 years. Despite similar angiographic results, patients who had rST develop had significantly greater peak creatine kinase at the time of initial ST (mean, 2,655 mg/dl vs. 1,654 mg/dl; p = 0.05) than those without rST. The 3-year rate of major adverse cardiovascular events was 50% for patients with rST compared with 22% for patients with a single ST (p = 0.01). After multivariable adjustment, independent predictors of definite/probable rST were age (HR: 1.4; 95 confidence interval [CI]: 1.1 to 1.8 per 10 years), bifurcation ST (HR: 4.4; 95% CI: 1.8 to 10.9), and proximal vessel diameter (HR: 1.8; 95% CI: 1.1 to 3.2 per millimeter).ConclusionsrST represents an important cause of long-term morbidity and mortality after an initial ST. Bifurcation ST and a larger proximal reference vessel diameter are independently associated with an increased risk of rST.  相似文献   

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