Directional Atherectomy and Gender Outcomes in DEFINTIVE LE

Transcription

1 Directional Atherectomy and Gender Outcomes in DEFINTIVE LE Lawrence A. Garcia MD, on behalf of the DEFINITIVE LE Investigators Chief, Section Interventional Cardiology St. Elizabeth s Medical Center, Boston, MA

2 Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company Grant/Research Support Consulting Fees/Honoraria Major Stock Shareholder/Equity Royalty Income Ownership/Founder Intellectual Property Rights Other Financial Benefit idev (Abbott), Covidien (Medtronic) Covidien, Boston Scientific, Angiosculpt (Spectranetics) Arsenal, Primacea, TissueGen, CV Ingenuity, Spirox, Essential Medical, Scion Cardiovascular, Syntervention None None None None

3 Key Study Design Elements Study Design and Oversight Prospective, non-randomized, global study 800 subjects enrolled at 47 centers CEC and Steering Committee oversight and CEC adjudication Angiographic and Duplex core laboratory analyses Gender Subset Analysis Objective To assess the baseline lesion characteristics and outcomes of the DEFINITIVE LE Study stratified by gender Inclusion Criteria RCC % stenosis Lesion lengths up to 20 cm Reference Vessel 1.5 mm and 7.0 mm Exclusion Criteria Severe calcification In-stent restenosis Aneurysmal target vessel

4 Study Design & Primary Endpoints 800 patients 47 centers Claudicants (RCC 1-3) 598 patients* Primary patency by Duplex US at 12 mos CLI (RCC 4-6) 201 patients Freedom from major unplanned amputation at 12 mos

5 DEFINITIVE LE AND GENDER Results Eight hundred (800) subjects with 1022 lesions were enrolled 476 (46.6%) treated lesions were female; 546 (53.4%) were male Lesion Characteristics Female Male P-Value Age (yrs) 71.8 ± 10.8 (363) 68.7 ± 10.5 (436) <0.001 Diabetes 48.8% (177/363) 55.3% (241/436) Current Smoker, at least 1 pack per day 10.2% (37/363) 16.5% (72/436) Lesion Length (cm) 7.2 ± ± Reference Vessel Diameter (mm) 3.9 ± ± 1.3 <0.001 Minimum Lumen Diameter (mm) 1.1 ± ± Baseline stenosis (%) 71.3 ± ± 18.2 <0.001 Occlusions 18.2%

6 DEFINITIVE LE AND GENDER Results Females demonstrated less calcification than male Lesion Characteristics Female Male P-value Lesion Location SFA 67.6% 63.9% Popliteal 16.2% 15.6% Infrapopliteal 16.2% 20.5% Calcification None 70.7% 56.2% <0.001 Present 27.0% 39.0% <0.001 Severe 2.3% 4.8% 0.043

7 12 Month Primary Patency Results No significant difference in outcomes by gender 100% P=0.483 P= % 76.1% 78.6% 71.8% 70.4% 50% Female Male 25% 0% CLD CLI

8 Diabetic Status and 12 Month Patency Results Diabetic status did not significantly impact outcomes in either cohort 100% P=0.914 P=0.450 P=0.486 P= % 76.9% 76.8% 80.3% 75.2% 69.2% 66.1% 80.7% 74.3% 50% Female Male 25% 0% Diabetic CLD Non-Diabetic CLD Diabetic CLI Non-Diabetic CLI

9 Wound Healing Changes from baseline (CLI) % with improvement of 1 or more categories on the Wagner Score* 100% 86.2% 82.1% 83.3% 75% 67.3% 65.3% 50% 25% 54.9% P=0.228 P=0.012 P=1.00 Female Male 0% 3 Mos 6 Mos 12 Mos * Wagner Score consists of 5 categories ranging from no wound/ulcer to extensive gangrene

10 12 Month Limb Salvage Results Limb salvage outcomes were comparable by gender (CLI) 100% % Limb Salvage 94.9% 95.3% P= % 50% Female Male 25% 0% Female Male

11 Improvements in ABI Results Mean Change at 12 months The CHD cohort shows a trend for more improvement in the males No significant difference was seen between the genders in the CLI cohort Cohort Female Mean Change from Baseline in ABI - 12 Months Male Mean Change from Baseline in ABI - 12 Months Male vs Female p- value* Claudicant 0.1 ± 0.2 (156) 0.2 ± 0.2 (187) CLI 0.2 ± 0.3 (48) 0.2 ± 0.3 (38) *p-value by Wilcoxon Rank Sum Test

12 Rutherford Clinical Categories Results % Improvement of 1 or More Categories at 12 Months* 100% 89.2% 88.2% 75% 75.2% 69.2% 50% P<0.001 P=0.010 Female Male 25% 0% CLD CLI *p-value by Fisher's Exact Test

13 CONCLUSIONS This study was in agreement with previous studies in that females typically have smaller vessels and are older at time of treatment/presentation While males and females differ in clinical presentation, general anatomic pathology, 12 month outcomes following directional atherectomy are similar between the genders The understanding of potential similarities and/or differences between genders may have an inpact on the response to disease and/or treatments we choose