Ahmed A. Khattab, MD For the German Cypher Registry Investigators Sirolimus-Eluting Stent Treatment at High-Volume Centers Confers Lower Mortality at 6-Month Follow-Up Results from the German Cypher Registry Ahmed A. Khattab, MD For the German Cypher Registry Investigators University Hospital Bern - Switzerland

No conflict of interests for any of the authors Disclosure No conflict of interests for any of the authors

PCI volume is inversely related to adverse outcome Background (I) PCI volume is inversely related to adverse outcome Both for hospital and operator volumes Threshold activity level of > 400 PCI annually for hospitals and > 75 for operators Outcome measures include death and emergent CABG within 30 days

DES volume-outcome relation is not known Background (II) DES volume-outcome relation is not known Volume-outcome relation beyond one month is not known

To investigate the institutional SES procedural volume-6-month-outcome Study aim To investigate the institutional SES procedural volume-6-month-outcome relation from the German Cypher Registry

The Prospective Multicenter German Cypher Registry From April 2002 - Dec. 2005 Inclusion of 12.085 patients with at least one SES Central prospective data collection in 122 german centers via Internet by IKKF Monitoring in 15 centers 91% follow-up (median 6.6 months) This analysis includes 8201 patients: 1140 (13.9%) in low-volume centers 2360 (28.8%) in intermediate-volume 4701 (57.3%) in high-volume centers

< 150 SES patients = low volume Tertiles definition < 150 SES patients = low volume 150 – 400 SES patients = intermediate > 400 SES patients = high-volume

Baseline criteria (I) Variable Low-volume Intermediate High-volume Men,% 73.6 75.2 75.5 Age (y), mean 63.3 64.5 65.5 Diabetes,% 28.3 36.9 25.7 Hypertension,% 78.4 84.2 85.7 Dyslipidemia,% 85.2 86.7 89.9 Smoker,% 29.5 33.2 31.1 LV EF <40,% 12.9 16.9 12.4 Multivessel CAD,% 68.1 69.2 71.5 ACS,% 50 44.3 37.8

Baseline criteria (II) Variable Low-volume Intermediate High-volume Ostial lesion,% 11 12.7 7.9 Bifurcated lesion,% 14.6 17 12.9 CTO,% 5.6 In-stent restenosis,% 22.8 23.9 16.6 Treated vessel: Left main,% 1.7 2.7 3.0 LAD,% 57.7 54.3 60.6 LCX,% 14.8 14 14.2 RCA,% 25.7 29 22.2 SVG,% 5.4 5.2

Procedural characteristics Variable Low-volume Intermediate High-volume P-value Direct stenting,% 37.3 32.8 33 <0.01 Inflation pressure 13 14 <0.0001 Inflation >16 atm,% 26.2 33.8 35.5 Stent diameter, mm 2.89 2.94 2.95 <0.001 Stented length, mm 17.9 18 20.4 Residual dissection,% 2.7 2.8 1.9 <0.05 Residual stenosis >30% 1.4 1.3 0.6 Final TIMI flow < 3 3.1 2.2 2.3 0.17

Early outcome (in-hospital) Variable Low-volume Intermediate High-volume P-value All deaths,% 0.7 0.6 0.3 0.08 Cardiac,% 0.5 Non-cardiac,% 1 patient Unknown,% New MI,% 1.7 1.2 <0.0001 Urgent TVR,% 2.8 1.4 1.1 Death/MI/TVR,% 4.4 1.6

Clinical events at 6-month Follow-up Variable Low-volume Intermediate High-volume P-value All deaths,% 1.9 2.0 1.3 <0.05 Cardiac,% 0.7 1.2 0.5 Non-cardiac,% 0.3 0.92 Unknown,% 0.9 0.23 New MI,% 1.1 1.8 0.8 <0.001 TVR,% 7.2 7.8 6.9 0.38 CVA,% 0.54 Death/MI/TVR,% 11.3 12.1 9 0.0001

Adverse clinical events at 6-month follow-up

Adverse clinical events at 6-month follow-up

Medication at 6-month Follow-up Low-volume Intermediate High-volume P-value Aspirin,% 91.5 90.5 91.9 0.19 Clopidogrel,% 57.9 61.3 40.3 <0.0001 weeks 12 24 26 < 8 weeks,% 27.6 11.2 11.8 Beta blocker,% 80.5 84.9 87.2 ACE-I/ARB,% 71.3 78.7 76.4 Ca-antag.,% 15.2 15.6 15.4 0.97 Statins,% 81.6 87 90

This association cannot be explained Conclusion Patients receiving SES at high-volume centers have lower mortality and MI at 6 months No difference in TVR This association cannot be explained Significant differences in procedural conduct were documented The underlying etiology of death/MI cannot be defined