Download
1 / 18
190 likes | 536 Views
Medtronic RDN Global Symplicity Registry (GSR). Key Takeaways. Six-month results confirm the procedural safety with the Symplicity TM system in the largest real-world population studied. The Symplicity TM system significantly reduced both office and ambulatory BP from baseline.
E N D
Key Takeaways • Six-month results confirm the procedural safety with the SymplicityTM system in the largest real-world population studied. • The SymplicityTM system significantly reduced both office and ambulatory BP from baseline. • It will be important to reconcile the results from this real-world registry with those of SYMPLICITY HTN-3, which included randomization, blinding, sham control, BP inclusion criteria, antihypertensive-drug treatment intensity, and an African American cohort.
Global Symplicity Registry (GSR) Consecutive patients treated in real-world population 5000 patients GREAT Registry N = 1000 Korea Registry* N = 102 South Africa Registry* N = 400 Rest of GSR N ≈ 3500 Canada and Mexico* 231 international sites in 37 countries Min. 10% randomly assigned to 100% monitoring 4Y 3M 6M 1Y 2Y 3Y 5Y Follow-up schedule * Limited to resistant hypertension only
Baseline Patient Characteristics * With ≥3 antihypertensive medication classes
Antihypertensive Medication Use *With ≥3 antihypertensive medication classes.
Safety in HTN-3 and GSR *With ≥3 antihypertensive medication classes.
Change in Office SBP at 6 Months for GSR and SYMPLICITY HTN-3 Patients
Change in Office SBP at 6 Months for GSR and Non–African American Patients in SYMPLICITY HTN-3
Change in Ambulatory SBP for GSR and SYMPLICITY HTN-3 Patients
Distribution of SBP in Patients With Office SBP≥160 mm Hg and Ambulatory SBP ≥135 mm Hg* at Baseline
S-22 Excellent procedural and clinical safety profile in the largest data set of real-world RDN patients to date. Significant reductions in both office and ambulatory BP from baseline. Differences from SYMPLICITY HTN-3 include randomization, blinding, sham control, BP inclusion criteria, antihypertensive-drug treatment intensity, and an African American cohort in HTN-3. Despite the limitations of comparing a registry with a randomized, blinded, controlled study, the reduction in blood pressure is numerically larger in the GSR at 6 months after treatment. Due to the nature of registry studies, it is difficult to account for the magnitude of a possible placebo effect in GSR. LBCT Conclusions
Medtronic Next Steps • Medtronic will continue to provide access to the Symplicity™ system in countries where it has regulatory approval and will continue to support a global hypertension clinical program. • Medtronic will continue to enroll in the Global SYMPLICITY Registry. • Our detailed analyses of SYMPLICITY HTN-3 suggest that further investigation is warranted; Medtronic is in discussions with the FDA to determine the path forward for the next US IDE trial. • In light of the results of the SYMPLICITY HTN-3 trial, Medtronic will discontinue the already suspended SYMPLICITY HTN-4 trial. • Medtronic will consult with local regulatory bodies to determine the future of the HTN-Japan and HTN-India clinical studies. • Medtronic will continue to pursue its studies in other disease states, including AF, CKD, HF, etc.
www.medtronic.com www.medtronicRDN.com United States Medtronic USA, Inc. 3576 Unocal Place Santa Rosa, CA 95403 USA Tel: 707.525.0111 LifeLine Customer Support Tel: 877.526.7890 Tel: 763.526.7890 Product Services Tel: 888.283.7868 Fax: 800.838.3103 Europe Medtronic Intl. Trading SARL Route du Molliau 31 Case Postale CH-1131 Tolochenaz Switzerland Tel: 41.21.802.7000 Fax: 41.21.802.7900 Canada Medtronic of Canada Ltd. 99 Hereford Street Brampton, Ontario L6Y0R3 Canada Tel: 905.460.3800 Fax: 905.460.3998 Toll-free: 800.268.5346 Asia Pacific Medtronic Intl. Ltd. 49 Changi South Avenue 2 Nasco Tech Center Singapore 486056 Singapore Tel: 65.6436.5000 Fax: 65.6776.6335 Latin America Medtronic USA, Inc. Doral Corporate Center II 3750 NW 87th Avenue, Suite 700 Miami, FL 33178 USA Tel: 305.500.9328 Fax: 786.709.4244
SYMPLICITY HTN-1: Significant, Sustained BP Reduction to 3 Years 6 Months (N = 144) 1 Year (N = 132) 2 Years (N = 105) 3 Years (N = 88) Change in Blood Pressure (mm Hg) Systolic Diastolic P < 0.01 for from baseline for all time points. Data is reported only on the patients available at each time point. Expanded results presented at the European Society of Cardiology Annual Meeting, 2013.
SYMPLICITY HTN-2: BP Reductions Sustained to 3 Years Sustained Reductions in the Pooled (RDN and Crossover) Group* 6 Months N = 84 12 Months N = 80 18 Months N = 74 24 Months N = 69 30 Months N = 69 36 Months N = 40 ∆ From Baseline to 36 Months (mm Hg) Systolic Diastolic P <0.01 at all time points *Crossover patients only had 30 months post-procedure data. Whitbourn, TCT 2013
Multiple Unblinded Trials Show RDN Lowers Blood Pressure N=313 N=102 N=346 N=153 N=63 N=146 N=15 N=109 N=46 N=15 Medtronic N=47 EnligHTN/St Jude Vessix/Boston Sci. Maya/Covidien Recor Published Sources: Lancet 2009 Lancet 2010 TCT 2013 Journal of Human Hypertension 2013 Circulation 2013 Clin Res Cardiol2013 J Am SocNephrol2012 Eur Heart J 2013 TCT 2013 Eurointervention 2013 EuroIntervention 2013 Mean Decrease in Office Systolic Blood Pressure at 6 Mo (mm Hg)
