Late Follow-up from REAL A Large Multicenter DES vs. BMS Registry in Italy

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Romina Bucci
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1 Late Follow-up from A Large Multicenter DES vs. BMS Registry in Italy Francesco Saia, MD, PhD Institute of Cardiology University of Bologna Policlinico S. Orsola Malpighi Bologna, IT

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 Abbott, Cordis, BSC, Corevalve, Edwards, Lilly Major Stock Shareholder/Equity - Royalty Income - Ownership/Founder - Intellectual Property Rights - Other Financial Benefit -

3 The Registry (REgistro AngiopLastiche dell Emilia-Romagna) PIACENZA PARMA REGGIO EMILIA MODENA FERRARA BOLOGNA RAVENNA COTIGNOLA FORLI -CESENA RIMINI Prospective registry of all PCI procedures performed in the Italian Region Emilia- Romagna (4 millions residents, 13 private and public cath labs) Started in July Aim: To evaluate the clinical and economic impact of DES utilization

4 Organization 13 Catheterization Laboratories Continuous prospective data collection Common internet database Clinical files Steering Committee Data Analyses REGIONAL HEALTH CARE AGENCY Feedback Hospital Discharge Records Mortality Registries Periodic reports to the Regional Commission for Cardiology and Cardiac Surgery

5 4-year follow-up

6 Study population Enrollment: July J 2002 December ,818 patients undergoing elective percutaneous coronary intervention with either DES (n= 5,198) or bare metal stents (BMS, n= 10,620)

7 Baseline (1) Age, yy ± SD Male Hypertension Diabetes Hypercholesterolemia BMS DES (n=10,620 pts) (n=5,198 pts) P value 69± % 65± % < % 72.5 % NS 21.7 % 33.6 % < % 65.0 % <.0001 Chronic renal disease 5.3% 4.6%.04 Peripheral vascular disease 4.7% 4.4% NS COPD <.0001 Cancer Poor (<35%) LVEF 7.9 % 7.5 % NS

8 Baseline (2) BMS (n=10,620 pts) DES (n=5,198 pts) P value Previous MI 28.4 % 27.4 % NS Previous PCI Previous CABG 10.2 % 6.4 % 13.0 % 8.2 % <.0001 <.0001 Chronic anticoagulant tx 6.4 % 4.7 % <.0001 Clinical presentation Stable Angina 46.7 % 47.5 % NS UA / NSTEMI 53.3 % 52.5 % NS

9 Angiographic and Procedural Characteristics (1) Vessel treated BMS n = 15,987 les DES n = 7,718 les P Value - Left main 1.3 % 2.9 % < ULMCA 0.9 % 2.1 % < LAD 36.6 % 53.6 % < LCX 28.7 % 23.3 % < RCA 33.4 % 20.3% < Bypass graft 2.4 % 1.4 %.0002 Multivessel PCI

10 Angiographic and Procedural Characteristics (2) Lesion type ACC/AHA BMS n = 15,987 les DES n = 7,718 les P Value - B2 / C 60.2 % 70.2 % <.0001 Bifurcation 14.7 % 22.3 % <.0001 Ostial lesion 6.3 % 11.5 % <.0001 Total occlusion 7.3 % 9.2 % <.0001 ISR 0.7 % 1.9 % <.0001

11 Angiographic and Procedural Characteristics (3) BMS n = 15,987 les DES n = 7,718 les P Value Average lesion length, mm 15.5 ± ± 9.0 <.0001 Average stent length, mm 16.8 ± ± 6.6 <.0001 RVD, mm 3.0 ± ± 0.4 <.0001 Total lesion length, mm 22.8 ± ± 16.9 <.0001 Total stent length, mm 25.3 ± ± 17.7 <.0001 Lesion >30mm, % <.0001 RVD <2.5 mm, % <.0001

12 All cause death PS-adjusted 12.7% 11.2%

13 Cardiac death PS-adjusted 6.8% 6.2%

14 Myocardial Infarction PS-adjusted 9.3% 9.2%

15 Death and MI PS-adjusted 19.5% 18.1%

16 Cardiac death and MI PS-adjusted 14.3% 13.7%

17 TVR PS-adjusted 17.2% 12.6%

18 Cardiac death, MI, TVR PS-adjusted 25.9% 20.8%

19 Stent thrombosis Angiographic 1.5% 0.8%

20 On/Off-label indications

21 Cardiac death and MI PS-adjusted On-label Off-label 12.6% 12.4% 15.6% 14.7% = No safety issues with both strategies

22 TVR PS-adjusted On-label Off-label 13.8% 12.6% 12.4% 12.4% 20.0% 12.9% = DESs significantly reduce TVR in both groups

23 Diabetes mellitus

24 Cardiac death and MI PS-adjusted Diabetics Non-diabetics 20.4% 19.6% 12.3% 11.9% = No safety issues in diabetic patients

25 TVR PS-adjusted Diabetics Non-diabetics 21.6% 18.7% 15.9% 11.0% = DESs significantly reduce TVR in both groups

26 Quintiles of baseline risk of 1-year TVR, estimate of DES effect, and assessment of number needed to treat to prevent a TVR HR 1,20 1,10 DES vs BMS Quintiles Baseline 1-year TVR risk HR 95% CI Likelihood of TVR with DES NNT 1,00 0,80 0,60 0,84 0,66 0,59 0, % 7.9% % 6.6% , % % 28 0,20 0,00 1st 2nd 3rd 4th 5th % 21.0% % 10.5% Quintiles of baseline risk for 1-year TVR DESs are more effective in patients at higher risk of TVR

27 Conclusions The registry confirms, in a real-world setting, that DESs reduce the incidence of repeat revascularization compared with BMS up to 4 years of follow-up Similar rates of cardiac death and MI demonstrate that the higher risk of (late) definite stent thrombosis is counterbalanced by the reduction of risks related to restenosis New strategies of utilization of DES and / or introduction in clinical practice of new DES systems might further improve the net positive effect of DES

28 The Investigators Agenzia Sanitaria Regionale dell Emilia Romagna: R. Grilli, P. Guastaroba Istituto di Cardiologia, Università di Bologna, Policlinico S. Orsola-Malpighi: A. Marzocchi, F. Saia, C. Marrozzini, P. Ortolani, T. Palmerini, N. Taglieri, F. Baldazzi. U. O. di Cardiologia, Ospedale degli Infermi, Rimini: G. Piovaccari, A. Santarelli, D. Santoro, N. Franco. U. O. di Cardiologia Interventistica, Ospedale S. Maria Nuova, Reggio Emilia: A. Manari, P. Giacometti, S. Fioroni, V. Guiducci, G. Pignatelli. U. O. di Cardiologia, Ospedale Maggiore, Parma: L. Vignali, A. Menozzi, M. A. Cattabiani, E. Solinas. Laboratorio di Emodinamica, Hesperia Hospital, Modena: A. Benassi, G. D Anniballe, L. Steffanon. U. O. di Cardiologia, Ospedale Maggiore, Bologna: P. Sangiorgio, G. Casella, A. Rubboli, G. Nobile. U. O. di Cardiologia - Centro Interventistico, Sezione di Emodinamica - Aritmologia "B. Venturi", Ospedale S. Maria delle Croci, Ravenna: A. Maresta, E. Varani, M. Balducelli, G. Vecchi, M. Aquilina. U. O. di Cardiologia, Ospedale di Piacenza: A. Capucci, F. Passerini, G. Giovannini, C. Tumscitz. Laboratorio di Emodinamica, Ospedale Morgagni di Forlì: F. Tarantino, O. Catapano, F. Ottani, M. Galvani. Laboratorio di Emodinamica, Policlinico di Modena: R. Rossi, F. Sgura. Laboratorio di Emodinamica, Ospedale di Ferrara: M. Valgimigli, F. Ferrari, D. Barbieri, G. Campo. Unità di Cardio-Angiologia Interventistica, Casa di Cura Villa Maria Cecilia Hospital, Cotignola (RA): A. Cremonesi, F. Castriota, E. Ricci, R. Manetti, A. Liso, K. Oshoala. Laboratorio di Emodinamica, Nuovo Ospedale S. Agostino, Modena: S. Tondi, P. Magnavacchi, D. Tosoni, C. Cappelli.

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