Single Center Consecutive Registry Of The New Atrium Flyer Coronary Stent System

Transcription

1 Single Center Consecutive Registry Of The New Atrium Flyer Coronary Stent System TO Kjellevand, AJ Tofte Department of Cardiology, Rikshospitalet, NO-0027 Oslo Norway 19th Annual Interventional Cardiology 2004 Snowmass Village, CO March 22-26, 2004

2 Purpose In the era of drug eluting stents, the need for a highly optimized, easily deployable bare metal stent still exists for economic reasons. The study was performed to evaluate the performance of the Atrium Flyer Coronary Stent System in the treatment of patients with de novo, lesions in native coronary arteries between 2.5mm and 4.0mm diameter.

3 Methods We reviewed the records and contacted the first 200 patients to receive the Atrium Flyer Coronary Stent at Rikshospitalet (Oslo, Norway) between October 2001 and March Demographics, lesion classification, and clinical outcomes were compiled at 6-months post-implantation through telephone contact, coincidental office visits, and chart review.

4 Patient Demographics FLYER (n = 200) Age (yrs) (mean) Male Smoker (Current) Smoker (Previous) Diabetes Hyperlipidemia Hypertension Stable Angina Unstable Angina Prior MI Emergent Presentation % 43.7% 26.3% 11.0% 14.0% 22.5% 38.2% 37.0% 55.5% 56.0%

5 Lesion Characteristics FLYER (n = 200 pts) # of Lesions # of Stents Stents/patient Lesion Length (mm) RVD (mm) Preprocedure % Diameter Stenosis %

6 Lesion Characteristics ACC/AHA Lesion Class A B1 B2 C 26.1% 36.2% 23.3% 14.4% 23.3% 14.4% 36.2% 26.1% # of Lesions % 21.5% 3.5% 21.5% 3.5% 75.0% # of Stents per Patient % 28.5% 9.5% 1.5% 28.5% 9.5% 1.5% 60.5%

7 Results At 180 Days Device Success by QCA Procedure Success by QCA Subacute Thrombosis MACE (Cardiac death, MI, TLR) Cardiac Death MI TLR MACE w/ TVF (Cardiac death, MI, TVF) TVR (non-tlr) TVF w/o intervention 99.7% 99.5% 0.5% 7.0% 1.0% 1.0% 5.0% 9.0% 1.0% 1.0% (304/305) (199/200) (1/200) (14/200) (2/200) (2/200) (10/200) (18/200) (2/200) (2/200)

8 MACE Rates 10% 1% Death 1% MI 1% Death 1% MI 1% TVF 1% TVR 5% TLR 5% TLR 0% MACE MACE w/tvf

9 Notable Findings 10 target lesion revascularization procedures 90% had prior MI within 6 months of procedure Only 10% had prior revascularization procedure(pci or CABG) 100% had angina (50% - stable, 50% - unstable) 30% had concomitant inflammatory diseases (rheumatoid arthritis, psoriasis, fibromyalgia)

10 Economic Analysis Assumptions: TVR reduction of 64% through DES use* Flyer BMS (bare metal stent): TVR 7.0% Cost US$500 DES (drug eluting stent): TVR 2.5% Cost US$2000 Primary procedure 1 stent cost COST DIFFERENTIAL FLYER BMS 305 stents x $500 $152,500 $457,500 DES 305 stents x $2000 $610,000 *Patrick W. Serruys. M.D., PhD 2004 ACC ACCIS Session

11 1 Rikshospitaletestimates 2 Catholic Medical Center, Manchester, NH estimates 3 USA Today, March 4, 2004 Economic Analysis Assumptions: For 200 patient analysis 14 (7.0%) revascularization procedures with BMS & 5 (2.5%) with DES ISR treatment costs: $ (low) $ (medium) $ (high) Revascularization procedure Low revascularization costs Medium revascularization costs High revascularization costs FLYER BMS 14 pts x $2500 $35, pts x $5000 $70, pts x $10,000 $140,000 DES 5 pts x $2500 $12,500 5 pts x $5000 $25,000 5 pts x $10,000 $50,000

12 1 Rikshospitaletestimates 2 Catholic Medical Center, Manchester, NH estimates 3 USA Today, March 4, 2004 Economic Analysis ISR cost estimates Low Medium High BMS DES BMS DES BMS DES 1 proc costs $152,500 $610,500 $152,500 $610,500 $152,500 $610,500 ISR costs $35,000 $12,500 $70,000 $25,000 $140,000 $50,000 Total costs $187,500 $623,000 $222,500 $635,500 $292,500 $660,500 DIFFERENTIAL - BMS Savings - $435,500 $413,000 $368,000 Commentary: Low revascularization costs of $ would yield highest savings. Higher revascularization costs of $ would provide reduced savings but still significant.

13 Conclusions The low MACE rate demonstrates excellent performance of the Flyer Coronary Stent System in a difficult patient population providing a low cost option with excellent outcomes. For the 200 patient study, between $368,000 and $435,500 could be saved by using a bare metal Flyer stent with excellent clinical results over complete DES conversion in the cath lab.

14 Acknowledgements Eva Goldwater, University of Massachusetts, School of Public Health Statistical analysis Disclosure This studied was funded by a grant from Atrium Medical International LLC, Mijdrecht, The Netherlands