DRUG-COATED BALL0ON TREATMENT FOR PATIENTS WITH INTERMITTENT CLAUDICATION: INSIGHTS FROM THE IN.PACT GLOBAL FULL CLINICAL COHORT MICHAEL R. JAFF, DO MASSACHUSETTS, UNITED STATES Medtronic Further. Together UC201704355IE 2016 Medtronic. All Rights Reserved. Medtronic, Medtronic logo and Further. Together are trademarks of Medtronic. Not for distribution in France, or Japan. 9/2016.
Drug-Coated Balloon Treatment for Patients with Intermittent Claudication: Insights from the IN.PACT Global Full Clinical Cohort Michael R. Jaff, DO Massachusetts General Hospital Boston, Massachusetts Dr. Jaff is a non-compensated advisor to Medtronic Vascular and has received no personal fees from the sponsor
Background Drug-coated balloons have emerged as a primary treatment for femoropopliteal peripheral artery disease Results from the IN.PACT SFA randomized trial show superiority of the IN.PACT Admiral DCB over uncoated PTA with sustained outcomes through 2 years 1 Real-world results have emerged, confirming safety and efficacy of IN.PACT Admiral DCB, helping clinicians identify role of this therapy and technology as part of their clinical algorithm 1. Laird JR, Schneider PA, Tepe G et al. Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA. J Am Coll Cardiol 2015;66:2329-38.
IN.PACT Global Study Overview Real-world, prospective, multicenter, single arm independently-adjudicated femoropopliteal study 1535 patients enrolled All-comers (RCC 2-4) Bilateral disease Multiple lesions SFA and Popliteal Artery TASC A, B, C, D de novo ISR Long Lesions CTOs 64 sites in EU, Mid-East, Latin America, Asia Independent adjudication by Clinical Events Committee 1 Prospective subset analysis with core lab 2,3 reported results (de novo ISR, long lesions 15 cm, CTOs 5 cm) Safety and effectiveness data on 150 mm DCB 3 1. Syntactx Clinical Events Committee, New York, NY, US 2. VasCore DUS Core Lab, Boston, MA, US 3. SynvaCor Angiographic Core Lab, Springfield, IL, US
IN.PACT Global Study Architecture Objective: Expand clinical evidence of the IN.PACT Admiral DCB in the treatment of a real-world patient population This presentation includes outcome data on the 1406 ITT subjects who compose the IN.PACT Global Clinical Cohort 4
IN.PACT Global Study Primary Endpoints Primary Efficacy Endpoint: Freedom from clinicallydriven Target Lesion Revascularization 1 within 12 months Primary Safety Endpoint: Freedom from device- and procedure-related death through 30 days, and freedom from target limb major amputation and clinically-driven Target Vessel Revascularization within 12 months 1. Any re-intervention within the target lesion(s) due to symptoms or drop of ABI of 20% or > 0.15 when compared to post-index procedure baseline ABI.
IN.PACT Global Study Key Eligibility Criteria Inclusion and exclusion criteria are intended to allow for evaluation of the IN.PACT Admiral DCB in a complex, real-world patient population Inclusion Criteria Rutherford Class 2, 3 and 4 Lesion(s) in SFA and/or popliteal artery Single or multiple stenosis or occlusions of any lesion length 2 cm De novo or restenotic (including ISR) At least one infrapopliteal runoff vessel Exclusion Criteria Rutherford Class 5 and 6 Acute or sub-acute thrombus in the target vessel Previous surgical bypass to the target lesion Failure to successfully cross the target lesion with a guidewire
IN.PACT Global Clinical Cohort Baseline Characteristics Characteristics N=1406 Subjects Age (Y, Mean ± SD) 68.6 ± 10.1 Male (%) 67.8% (953/1406) Diabetes (%) 39.9% (560/1402) Hypertension (%) 83.4% (1169/1401) Hyperlipidemia (%) 70.5% (960/1362) Current Smoker (%) 31.8% (447/1406) Obesity (BMI 30 kg/m 2, %) 20.5% (285/1391) Coronary Heart Disease (%) 40.5% (540/1332) Carotid Artery Disease (%) 20.2% (241/1196) Renal Insufficiency [1] (%) 11.2% (136/1217) Previous Peripheral Revasc (%) 52.4% (737/1406) Concomitant BTK Disease (%) 45.3% (594/1310) ABI [2] (Mean ± SD) 0.678 ± 0.218 1. Baseline serum creatinine 1.5 mg/dl 2. ABI for all target limbs treated during the 1st index procedure are included (can be bilateral) Rutherford Clinical Classification RCC 2 RCC 3 RCC 4 RCC 5 8% 58% * 3% 31% *Protocol Deviation
IN.PACT Global Clinical Cohort Lesion and Procedural Characteristics Lesion Characteristics Lesion Type: % (n) De novo Restenotic (non-stented) In-stent Restenosis N=1406 Subjects N=1773 Lesions 74.4% (1326/1773) 7.7% (136/1773) 18.0% (320/1773) Lesion Length (cm ± SD) 12.09 ± 9.54 Procedural Characteristics N=1406 Subjects N=1773 Lesions Device Success [1] % (n) 99.4% (2984/3002) Procedure Success [2] % (n) 99.3% (1386/1396) Clinical Success [3] % (n) 98.8% (1379/1396) Total Occlusions % (n) 35.5% (629/1773) Calcification % (n) Severe % (n) 68.7% (1217/1773) 10.2% (181/1771) RVD (mm ± SD) 5.186 ± 0.681 Diameter Stenosis (% ± SD) 88.8% ± 12.3 Dissections: 0 A-C D-F 56.8% (1006/1772) 35.4% (627/1772) 7.8% (139/1772) Pre-dilatation % (n) Post-dilatation % (n) 78.0% (1097/1406) 35.1% (491/1397) Provisional Stent % (n) 25.3% (353/1397) 1. Device success defined as successful delivery, inflation, deflation and retrieval of the intact study balloon device without burst below the RBP. 2. Procedure success defined as residual stenosis of 50% (nonstented subjects) or 30% (stented subjects) 3. Clinical success defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge.
IN.PACT Global Clinical Cohort Primary Endpoint: Freedom from CD-TLR through 1 Year 1 1. Number at risk represents the number of evaluable subjects at the beginning of each 30-day window
IN.PACT Global Clinical Cohort Additional Effectiveness Outcomes N=1406 Subjects Clinically-Driven TLR [1] 7.5% (98/1311) Any TLR [2] 7.8% (102/1311) Primary Sustained Clinical Improvement [3] 80.6% (953/1183) 1. Clinically-driven TLR adjudicated by an independent Clinical Event Committee, blinded to the assigned treatment based on any reintervention at the target lesion due to symptoms or drop of ABI of 20% or >0.15 when compared to post-procedure baseline ABI 2. Any TLR includes clinically-driven and incidental or duplex driven TLR 3. Primary sustained clinical improvement defined as freedom from target limb amputation, freedom from target vessel revascularization, and increase in Rutherford class at 12 months
IN.PACT Global Clinical Cohort 1-Year Safety Outcomes N=1406 Subjects Primary Safety Composite [1] 92.1% (1207/1311) Major Adverse Events [2] 12.0% (157/1311) All-cause Death 3.5% (46/1311) Device- or Procedure-related Death (@ 30 days) 0.2% (3/1394) CD-TVR 8.1% (106/1311) Major Target Limb Amputation 0.2% (3/1311) Thrombosis 2.9% (38/1311) 1. Safety composite endpoint consists of: Freedom from device- and procedure-related to 30 days, freedom from target limb amputation within 12 months; and freedom from clinically-driven TVR within 12 months. 2. Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 360 days.
IN.PACT Admiral DCB Studies Comparison of 12-month Outcomes IN.PACT SFA (DCB ARM) (N=220) IN.PACT Global Long Lesion Imaging Cohort (N=157) IN.PACT Global ISR Imaging Cohort (N=131) IN.PACT Global CTO Imaging Cohort (N=126) IN.PACT Global Clinical Cohort (N=1406) Lesion Length (Mean ± SD, cm) Primary Patency (KM @ 360 days) 8.94 ± 4.89 26.40 ± 8.61 17.17 ± 10.47 22.83 ± 9.76 12.09 ± 9.54 86.6%* 91.1% 88.7% 85.3% N/A CD-TLR 2.4% 6.0% 7.3% 11.3% 7.5% Thrombosis 1.4% 3.7% 0.8% 4.3% 2.9% Major Amputation Target Limb 0.0% 0.0% 0.0% 0.0% 0.2% *KM Day 360 rate of 87.5% using 2-year data
IN.PACT Global Clinical Cohort Summary Largest independently-adjudicated drug-coated balloon study of real-world patients with femoropopliteal PAD Results demonstrate consistent efficacy of the IN.PACT Admiral DCB in the clinical cohort and across pre-specified imaging subgroups, confirming positive outcomes seen in other IN.PACT SFA studies Real-world experience confirms safety of the IN.PACT Admiral DCB 1-Year IN.PACT Global results and durable long-term results from the IN.PACT SFA randomized trial provides reassurance to the vascular community that IN.PACT Admiral DCB is first-line therapy for SFA/popliteal PAD, and can be used in complex lesions and patient populations.
IN.PACT Admiral Drug-Coated PTA Balloon Catheter Brief Statement Indications for Use: The IN.PACT Admiral Paclitaxel-Coated PTA Balloon catheter is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions with lengths up to 180 mm in superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm. Contraindications The IN.PACT Admiral DCB is contraindicated for use in: Coronary arteries, renal arteries, and supra-aortic/cerebrovascular arteries Patients who cannot receive recommended antiplatelet and/or anticoagulant therapy Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system Patients with known allergies or sensitivities to paclitaxel Women who are breastfeeding, pregnant or are intending to become pregnant or men intending to father children. It is unknown whether paclitaxel will be excreted in human milk and whether there is a potential for adverse reaction in nursing infants from paclitaxel exposure. Warnings Use the product prior to the Use-by Date specified on the package. Contents are supplied sterile. Do not use the product if the inner packaging is damaged or opened. Do not use air or any gaseous medium to inflate the balloon. Use only the recommended inflation medium (equal parts contrast medium and saline solution). Do not move the guidewire during inflation of the IN.PACT Admiral DCB. Do not exceed the rated burst pressure (RBP). The RBP (14 atm [1419 kpa]) is based on the results of in vitro testing. Use of pressures higher than RBP may result in a ruptured balloon with possible intimal damage and dissection. The safety and effectiveness of using multiple IN.PACT Admiral DCBs with a total drug dosage exceeding 20,691 µg of paclitaxel in a patient has not been clinically evaluated in the IN.PACT SFA Trial.. UC201704355IE 2016 Medtronic. All Rights Reserved. Medtronic, Medtronic logo and Further. Together are trademarks of Medtronic. Not for distribution in France, or Japan. 9/2016.
IN.PACT Admiral Drug-Coated PTA Balloon Catheter Brief Statement Precautions This product should only be used by physicians trained in percutaneous transluminal angioplasty (PTA). This product is designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death. Assess risks and benefits before treating patients with a history of severe reaction to contrast agents. The safety and effectiveness of the IN.PACT Admiral DCB used in conjunction with other drug-eluting stents or drug-coated balloons in the same procedure or following treatment failure has not been evaluated. The extent of the patient s exposure to the drug coating is directly related to the number of balloons used. Refer to the Instructions for Use (IFU) for details regarding the use of multiple balloons and paclitaxel content. The use of this product carries the risks associated with percutaneous transluminal angioplasty, including thrombosis, vascular complications, and/or bleeding events Vessel preparation using only pre-dilatation was studied in the clinical study. Other methods of vessel preparation, such as atherectomy, have not been studied clinically with IN.PACT Admiral DCB. This product is not intended for the expansion or delivery of a stent Potential Adverse Effects The potential adverse effects (e.g. complications) associated with the use of the device are: abrupt vessel closure; access site pain; allergic reaction to contrast medium, antiplatelet therapy, or catheter system components (materials, drugs, and excipients); amputation/loss of limb; arrhythmias; arterial aneurysm; arterial thrombosis; arteriovenous (AV) fistula; death; dissection; embolization; fever; hematoma; hemorrhage; hypotension/hypertension; inflammation; ischemia or infarction of tissue/organ; local infection at access site; local or distal embolic events; perforation or rupture of the artery; pseudoaneurysm; renal insufficiency or failure; restenosis of the dilated artery; sepsis or systemic infection; shock; stroke; systemic embolization; vessel spasms or recoil; vessel trauma which requires surgical repair. Potential complications of peripheral balloon catheterization include, but are not limited to the following: balloon rupture; detachment of a component of the balloon and/or catheter system; failure of the balloon to perform as intended; failure to cross the lesion. Although systemic effects are not anticipated, potential adverse events that may be unique to the paclitaxel drug coating include, but are not limited to: allergic/immunologic reaction; alopecia; anemia; gastrointestinal symptoms; hematologic dyscrasia (including leucopenia, neutropenia, thrombocytopenia); hepatic enzyme changes; histologic changes in vessel wall, including inflammation, cellular damage, or necrosis; myalgia/arthralgia; myelosuppression; peripheral neuropathy. Refer to the Physician s Desk Reference for more information on the potential adverse effects observed with paclitaxel. There may be other potential adverse effects that are unforeseen at this time. Please reference appropriate product Instructions for Use for a detailed list of indications, warnings, precautions and potential adverse effects. This content is available electronically at www.manuals.medtronic.com. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. UC201704355IE 2016 Medtronic. All Rights Reserved. Medtronic, Medtronic logo and Further. Together are trademarks of Medtronic. Not for distribution in France, or Japan. 9/2016.
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