The RAdial SAme Day DischArge after PCI The RASADDA-PCI trial William Rollefson1, Mehmet Cilingiroglu1, David Mego1, Abdul Hakeem2, Ian Cawich1, Vasili Lendel1, Andre Paixao1, Konstantinos Marmagkiolis3, Daniel Sherbet1, Patrick Flaherty1, Gerardo Rodriguez-Araujo1 1Arkansas Heart Hospital, Little Rock, AR; 2University of Arkansas for Medical Sciences, Little Rock, AR 3Florida Hospital Pepin Hospital Institute, Tampa, FL

Disclosures Funding This study was performed with the support of Terumo, Inc. Consultant: Terumo Medical Medtronic Endologix.

Background Transradial (TR) PCI rates have been progressively increasing over the last decade (up to 15x increase). Same-day discharge after elective PCI is associated with similar safety compared to overnight observation This study sought to assess the clinical and financial impact of early discharge in patients undergoing TR-PCI.

Mention that the prior 4/5 RCTs were exclusively transfemoral, mostly performed > 10 years ago and did not assess cost in the US healthcare market

ACC NCDR registry N = 107 018 Same-day discharge 1.25% (1.19%-1.32%) Significant variation across facilities.

Arkansas Heart Hospital 10000+ Diagnostic Cath 3000 PCI 80-90% Radial Access SDD increased from <5% to 75% since 2013

Study Design Prospective- Retrospective Comparative Two- Arm Consecutive transradial PCIs Same Day vs One Night Stay 852 Elective PCI patients 429 423

Inclusion Criteria Age ≥18 years and ≤80 years . Single or multi-vessel coronary artery disease. Indication of TR-PCI Life expectancy greater than 30 days.

Exclusion Criteria Patients without health insurance. Complicated type 2 diabetes mellitus. History of cancer within the past 5 years. Presence of any other clinically-significant medical condition, psychiatric condition, or laboratory abnormality, that in the judgment of the Investigator or Sponsor for which participation in the study would pose a safety risk to the subject Participation in another study with an investigational drug or device within 1 month prior to treatment Allergy to sodium citrate or any “-caine” type of local anesthetic.

Baseline Demographic And Characteristics Variable SD* ON* p-value N 245 Age 66.40 ± 9.10 66.27 ± 10.81 0.8886 Gender (Masc) 61.2% (150) 1.0000 Hispanic/Latino 0.8% (2) Not hispanic/latino 99.2% (243) Asian 0% (0) 0.4% (1) 0.3178 Black/ African American 4.9% (12) 6.1% (15) 0.5535 White 94.3% (231) 92.7% (227) 0.4656 Other BMI 31.05 +/-30.30 31.10 +/-6.594 0.9341 Type 2 Diabetes Mellitus 40.0% (98) 40.8% (100) 0.8543 Tobacco Use 52.7% (129) 51.8% (127) 0.8568 Hypertension 76.3% (187) 74.7% (183) 0.6751 Prior PCI 54.2% (133) 53.1% (130) 0.7863 Recent Hospitalization for CV Cause 2.0% (5) 0.0246 Prior Myocardial Infarction Prior Stroke . Medications: GP IIb/IIIa inhibitor Aspirin 70.2% (172) 70.0% (171) 0.7689 Insulin/Other antidiabetic 32.2% (79) 34.3% (84) 0.6325 Statin 64.5% (158) 0.4555 ACE inhibitor 40.4% (99) 38.4% (94) 0.6447 Beta Blocker 63.3% (155) 62.4% (153) 0.8520 ARB 16.7% (41) 18.0% (44) 0.7211 Nitrate 30.2% (74) 27.8% (68) 0.5511 Warfarin Low molecular weight heparin Unfractionated heparin * Values Represent Means ± SD or Percentage (n value) . This table includes only the propensity matched patients. The main point to be made here is the groups were well matched and no significant differences were detected in the measured variables after matching.

Max % stenosis prior PCI Number of balloons used Procedural Outcomes Variable SD (n ± SD) ON (n ± SD) p-value n 245   Number of stenosis 1.26 ± 0.465 1.21 ± 0.481 0.2431 Max % stenosis prior PCI 83.57 ± 8.99 84.44 ± 9.24 0.2943 Stenting 97.6% (239) 96.3% (236) 0.4325 Number of stents used 1.245 ± 0.584 1.245 ± 0.632 1.0000 DES 87.3% (214) 82.4% (202) 0.1306 BMS 11.8% (29) 14.7% (36) 0.3522 PTCA 56.7% (139) 61.2% (150) 0.3174 Number of balloons used 0.840 ± 0.957 0.943 ± 0.986 0.2432 Total Contrast Volume 110.64 ± 62.63 109.41 ± 57.70 0.8220

30- Day Outcomes *P value non significant for all comparisons

30 Day- Cumulative Cost(USD) of TR-PCI Procedure Variable SD (n ± SD) ON (n ± SD) p-value n 245   Total Cost for Procedure/Hospitalization 3346 ± 1280 4682 ± 28450 <0.0001 Total Cost at 30 Day Follow Up 4493 ± 1887 7112 ± 4226 Total Cost for Concomitant Medications 25 ± 71 32 ± 98 0.3688 $1336- $2619

Costs P<0.0001

Limitations Non randomized study Propensity matching to control for baseline differences in the two groups Experienced center with most operators routinely using TR access Generalizability to other settings warrants further study

Conclusions In patients undergoing TR PCI, same-day discharge is as safe and effective as overnight observation. SD discharge is associated with robust cost reduction compared to overnight observation. Significant implications for health care economics.

Retrospective vs Prospective Variable ON SD n 245 Retrospective (%) 78.4 57.6 Prospective (%) 21.6 42.4