User:Radhippo/Interventional Radiology Clinical Trials

Interventional Radiology Trials Quick Review is a collection of short summaries on some of the important landmark interventional radiology trials. It is kept short and organized based on topics, in order to simplify the daunting task of learning appropriate evidence-based medicine in interventional radiology, especially since time is limited for many health care professionals.

Abdominal Aortic Aneurysm

UKSAT - (United Kingdom Aneurysm Trial). Initial results showing that open repair was no better than observation until the AAA was >5.5cm. Smoking had 20% faster growth. Telling patient to stop smoking had 50% better chance of quitting; 1998

ADAM - (Aneurysm Detection And Management). Again showed that open repair provides no benefit for AAAs <5.5cm; 2002

CAESAR - (Comparison of surveillance vs Aortic Endografting for Small Aneurysm Repair). Comparing early endograft (AAA 4.1-5.4cm) vs surveillance (small aneurysms). Cook Trial. At 3 years, 16% no longer EVAR candidates; 2005

PIVOTAL - (Positive Impact of endoVascular Options for Treating Aneurysm earLy). Comparing early endograft (AAA 4-5cm) vs surveillance (small aneurysms). Medtronic Trial; 2009

OVER - (Standard Open surgery Versus Endovascular Repair of AAA). Open vs EVAR; as per DREAM/EVAR-1. 30 day mortality smaller in EVAR (<1%) vs. Open (3-6%). No difference at 2 years; 2009

DREAM - (Dutch Randomized Endovascular Aneurysm Repair). Open vs EVAR; similar long term survival, higher reintervention rate with EVAR; 2010

EVAR 1 - (United Kingdom EndoVascular Aneurysm Repair 1). Open vs EVAR; as per DREAM

EVAR 2 - (United Kingdom EndoVascular Aneurysm Repair 2). EVAR in patients ineligible for open repair helps AAA mortality but not all-cause mortality; 2010

Hepatocellular Carcinoma

Randomized controlled trial of transarterial lipiodol chemoembolization for unresectable hepatocellular carcinoma. - 80 newly diagnosed unresectable HCC patients were randomized to TACE vs. symptomatic treatment. Chemoembolization resulted in a marked tumor response abd survival benefit. Chemoembolization group: 1 year, 57%; 2 years, 31%; 3 years, 26%. Control group: 1 year, 32%; 2 years, 11%; 3 years, 3%. P =0.002); 2002

Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. - 112 Child Pugh A or B unresectable HCC patients were randomized to TAE/TACE vs. symptomatic treatment. TAE/TACE resulted in a survival benefit.; 2002

A prospective randomized trial comparing percutaneous local ablative therapy and partial hepatectomy for small hepatocellular carcinoma. - 180 patients with solitary HCC less than 5 cm were randomized. The 1-, 2-, 3-, and 4-year overall survival rates after ablation and surgery were 95.8%, 82.1%, 71.4%, 67.9% and 93.3%, 82.3%, 73.4%, 64.0%, respectively. There was no statistical significance.; 2006

SHARP - (Sorafenib HCC Assessment Randomized Protocol). Author of the Milan criteria, Mazzaferro, assesses the utility of Sorafenib (VEGF inhibitor) vs. placebo, in patients with advanced HCC; 2008

A Randomized Trial Comparing Radiofrequency Ablation and Surgical Resection for HCC Conforming to the Milan criteria. - 230 HCC patients were randomized. Surgical resection provides better survival and lower recurrence rates than RFA for patients with HCC within the Milan criteria. The 1-, 2-, 3-, 4- and 5-year overall survival rates for the RFA group and the resection group were 86.96%, 76.52%, 69.57%, 66.09%, 54.78% and 98.26%, 96.52%, 92.17%, 82.60%, 75.65%, respectively. The corresponding recurrence-free survival rates for the 2 groups were 81.74%, 59.13%, 46.08%, 33.91%, 28.69% and 85.22%, 73.92%, 60.87%, 54.78%, 51.30%, respectively; 2010

A Randomized Controlled Trial of Radiofrequency Ablation and Surgical Resection in the Treatment of Small Hepatocellular Carcinoma. - 168patients with HCC diameters of less than 4 cm and up to 2 nodules were randomized. The 1, 2, and 3year survival rates for the RES and the RFA groups were 96.0%, 87.6%, 74.8% and 93.1%, 83.1%, 67.2%, respectively. There was no statistically significant difference between the two groups in overall survival rate (P = 0.342) or recurrence-free survival rate (P = 0.122); 2012

Transarterial Chemoembolization Plus Sorafenib: a Sequential Therapeutic Scheme for HCV-related Intermediate-stage Hepatocellular Carcinoma: a Randomized Clinical Trial. - 80 HCV-infected patients, Barcelona Clinic Liver Cancer stage B HCC, Child-Pugh class A. Randomized 1:1 to receive sorafenib 400 mg twice daily or placebo following TACE. Endpoints were the TTP and the rates of adverse events and toxicity. A conventional TACE procedure followed by sorafenib treatment resulted in a significantly longer TTP in patients with intermediate-stage HCV-related HCC, with no unexpected side effects; 2012

A prospective randomized controlled trial of preoperative whole-liver chemolipiodolization for hepatocellular carcinoma. - Selective TACE targeting the tumor (selective group n=42), TACE targeting the tumor plus chemolipiodolization of the whole liver (whole-liver group n=39), and no preoperative TACE or chemolipiodolization (control group n=43). Preoperative selective TACE and whole-liver chemolipiodolization plus TACE do not reduce the incidence of postoperative recurrence or prolong survival in patients with resectable HCC; 2012

Recurrent hepatocellular carcinoma treated with sequential transcatheter arterial chemoembolization and RF ablation versus RF ablation alone: a prospective randomized trial. - The 1-, 3-, and 5-year overall survival rates were 94%, 69%, and 46%, respectively, for the sequential treatment group and 82%, 47%, and 36% for the RF ablation group (P=.037). The efficacy of sequential TACE-RF ablation is better than that of RF ablation alone for recurrent HCC; 2012

Carotid

NASCENT - (North American Symptomatic Carotid ENdarterectomy Trial). In symptomatic patients with > 70% stenosis, CEA is recommended, at 5 years NNT to prevent stroke is 6. In symptomatic patients with 50-69% stenosis, CEA is recommended in men, at 5 years NNT to prevent stroke is 22; 1994

ACAS - (Asymptomatic Carotid Atherosclerosis Study). Looked at ipsilateral stroke. 60-99% asymptomatic stenosis; 11% 5 year ipsilateral risk of stroke with Best Medical Therapy vs 5.1% CEA; 1995

ACST - (Asymptomatic Carotid Surgery Trial). In asymptomatic patients with >70% stenosis, CEA is recommended, at 3 years NNT to prevent stroke is 33. CEA more beneficial in symptomatic patients > asymptomatic. Also, see risk benefit more quickly in symptomatic patients (months vs. 2 years). CEA is recommended only for asymptomatic and symptomatic who have a 5 year life expectency; 2004

SAPPHIRE^2 - (Stenting and Angioplasty with Protection in Patients at HIgh Risk for Endarterectomy). carotid stenting is equivalent to CEA in patients with severe stenosis (50% for symptomatic and 80% for asymptomatic) and comorbiditie, 2004.

CREST - (Carotid Revascularization Endarterectomy versus Stenting Trial). No difference in CVA/MI/death. More periprocedure stroke with stent; more periprocedure MI with CEA; 2010

IST - (International Stroke Trial). ASA vs. heparin vs. placebo. ASA reduced stroke recurrence and mortality after acute ischemic stroke. Heparin provided no benefit; 1997

CAST - (Chinese Acute Stroke Trial). ASA vs. placebo. similar to IST, ASA reduced stroke recurrence and mortality after acute ischemic stroke.

CAPRIE - (Clopidogrel versus Aspirin in Patients at Risk of Ischaemic Events). ASA vs. clopidogrel. clopidogrel had a small but measurable benefit over ASA in reducing the risk of stroke, MI, and mortality, 1996

MATCH - (Management of ATherothrombosis with Clopidogrel in High-risk patients). ASA + clopidogrel vs. clopidogrel alone. both groups were equally effective in reducing risk of stroke, but the combined group had a higher incidence of life threatening bleeding, 2004

PRoFESS - (Prevention Regimen For Effectively rEducing Second Strokes). Aggrenox vs. clopidogrel. both groups were equally effective in reducing stroke recurrence and mortality after acute ischemic stroke; 2008

NINDS - (National Institute of Neurological Disorders and Stroke rt-PA Stroke Study). t-PA vs. placebo. when administered between 0 and 3 hours after the onset of symptoms, t-PA improved clinical outcome, no affect on mortality; 1995

ECASSIII - (European Cooperative Acute Stroke Study III). IV Alteplase vs. placebo. alteplase administered between 3 and 4.5 hours after the onset of symptoms significantly improved clinical outcome in patients with acute ischemic stroke, no affect on mortality.

PROACTII - (PROlyse in Acute Cerebral Thromboembolism). IA prourokinase + heparin vs. heparin alone vs. placebo. prourokinase group had a significantly higher rate of recanaization and better clinical outcome when given within 6 hours of symptom onset. no affect on mortality; 1999

MERCI - (Mechanical Embolus Removal in Cerebral Ischemia). Merci device vs. no intervention. Patients were selected based on presentation outside the 3 hour IV thrombolysis window, outside the 6 hour IA thrombolysis window. They received mechanical thrombectomy within 8 hours of symptom onset. Higher recanalization rates were reached, but clinical outcome was not improved, mortality was higher, and intracranial hemorrhage incidence was higher. Results were thought to be confounded by the study population (higher NIHSS, older patients, late presentation); 2005

Multi MERCI - (followup to MERCI with newer Retriever device). Prospective, Multicenter, singlearm (no controls): Newer Generation L5 Retriever showed higher rate of recanulization, with fav clinical outcomes Rankin < 2 occurred in 36% and mortality was 34$, both sig related to vasc recan.

Peripheral Vascular Disease

ATTRACT - (Acute venous Thrombosis: Thrombus Removal with Adjunctive Catheter-directed Thrombolysis). Ongoing study regarding management of acute deep vein thrombosis (DVT) by medical therapy with anticoagulation vs. catheter directed thrombolysis; 2010

BASIL - (Bypass versus Angioplasty in Severe Ischaemia of the Leg) In patients presenting with severe limb ischaemia caused by infra-inguinal vascular disease, bypass-surgery-first and a balloon-angioplasty-first strategy have no significant difference in amputation-free survival. Post hoc analysis showed that of the patients who survived to 2 years, the surgery first cohort had significantly higher overall survival.

Uterine Fibroids

EMMY - (dutch EMbolisation versus hysterectoMY) A total of 177 patients were included in the trial (89 hysterectomies; 88 UAEs). After 24 hours UAE patients experienced significantly more pain after treatment, although less pain at 10 days and 6 weeks. The overall costs revealed that UAE was 37% lower than the surgical option; 2006.

REST - (Uterine-artery embolization versus surgery for symptomatic uterine fibroids) 157 patients randomized to UFE (n=106) and surgery (hysterectomy n=42, myomectomy n=9). Symptom score reduction, patient satisfaction, cost and rates of adverse events were similar at 5 years. The 5-year reintervention rate for treatment failure or complications was higher for uterine fibroid embolization, 32% vs. 4%.; 2007.

Randomized controlled trial comparing uterine fibroid embolization and myomectomy - 121 patients with reproductive plans and fibroids greater than 4 cm were randomized to UFE (n=58) and myomectomy n=63. 40women after myomectomy and 26 after UFE attempted to conceive. There were more pregnancies (n=33) and labors (n=19) and fewer abortions (n=6) after surgery than after embolization (n=17 pregnancies, 5 labors, 9 abortions) (p < 0.05).; 2007.

FUME -(Fibroids of the Uterus: Myomectomy versus Embolization) 163 patients randomized to UFE (n=82) and myomectomy n=81.; 2011.

Deep Femoral Vein (DVT) Thrombolysis

CAVENT - (CAtheter-directed VENous Thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis); 2012.

Seldinger Technique

Original publication - Dr. Seldinger, a swedish radiologist, introduced the procedure in Acta Radiologica. It is the common technique to obtain safe access to blood vessels; 1953.

Charles Theodore Dotter

Dottering Technique - Dr. Dotter, the "Father of IR," describes in his original article the percutaneous treatment of an atherosclerotic obstruction (angioplasty), which became known as "Dottering;" 1964.

Transvenous Liver Biopsy - Dr. Dotter describes his new technique of transvenous liver biopsy; 1964.

References

See appropriate links for trials. Note - Direct Links to the original article/pubmed references will be added overtime. If link is not available, please use pubmed to obtain the article.

External Links

• Interventional Radiology
• PubMed
• Trial Results Center
• Journal of Vascular and Interventional Radiology