ANGIOPLASY SUMMIT 2007 TCT ASIA PACIFIC. Seoul, Korea: April The problem is exaggerated: Data from Real World Registries

Transcription

1 ANGIOPLASY SUMMIT 007 TCT ASIA PACIFIC Seoul, Korea: April min Plenary Session: State-of of-the-art Lectures The problem is exaggerated: Data from Real World Registries Antonio Colombo Centro Cuore Columbus Milan, Italy S. Raffaele Hospital Milan, Italy

2 Year cases ( SES and PES) of thrombosis after 300 days

3 Iakovou et al. JAMA 005: 9 months FU- SAT 1 months 9 patients after successful DES implantation 6 month FU available for all patients Cypher 106 patients TAXUS 1167 patients SAT 4 (0.4%) P=0.5 SAT 9 (0.8%) LST 5 (0.5%) P=0.3 LST 9 (0.8%) 10. ± 4.4 m 9.3 ± 5.6 months 7.9 ± 3.6 m Total DES 7/9 (1.%) Cypher Total : 9 (0.9%) Total: 18 (1.5%) P=0. TAXUS

4 Premature APLT discontinuation No No 18 No 16 No 13 No d 10 d 8 0 d 15 d d Time to discontinuation Duration of disc Time of assigned therapy

5 35 30 % 9 Thrombosis rates according to selected patient characteristics *Antiplatelet Therapy disc 8,7 Prior Brachy * Premature discontinuation 5,5 Renal failure 3,5 3,,6 1,3 Bifurcations ULM Diabetes UA

6 From 7 till 18 months MI % Death% DES BMS P Incidence (%) Month Death/MI Outcomes no longer significant Bare Metal Stent n=81,8 Drug-Eluting Stent n=545 p=0.83,5 6,1 p=0.66 5,3 7,5 p=0.6 11,6 p= ,8 18,9 Cardiac Death AMI TVR non MI-related BASKET-Late presented by Dr. Kaiser at ESC 06. MACE

7 Cumulative Incidence of Stent Thrombosis 4 P Wenaweser and PW Serruys ESC 006 % PES.5 SES Log rank p-value: Days after stenting Days after PCI Incidence-SES (%) Incidence-PES (%) Pts at risk

8 Bo Lagerqvist, M.D., PhD, NEJM 007

9 Stent diameter BMS DES

10 Adverse clinical baseline characteristics BMS DES 9.6% 39.9%

11 Unadjusted death rates

12 Individual 58 patients (each line bar is a patient) CENTRO Relationship between thrombosis and antiplatelet therapy discontinuation Thienopyridine therapy continuation Thienopyridine therapy discontinuation Thrombotic event thrombotic events 1.9% at 18 months FU Antiplatelets Resistance or poor technique Before 6 mo 4 16 After 6 mo 9 with clopidogrel 7 without clopidogrel Time (days)

13 Individual 58 patients (each line bar is a patient) CENTRO Occurrence of Stent Thrombosis Stent thrombosis is quite frequent In the first 6 months after stenting Most of the effort should concentrate there Time (days)

14 ARTS II Stent thrombosis up to 3 years * * Re-adjudication according to Dublin definitions % of Patients Definite (angiography pathological confirmation) - Definite & Probable (MI in stent area) - Definite, probable and possible (any unexplained death) ARTS II was performed with SES 6.4% 5.3% 3.3%

15 A problem There is an intrinsic risk for overestimation when we assign the label of stent thrombosis to all events which occur in a stented and diseased coronary segment. The concept that stents passivate the treated segment has never been proven. Treatment of multiple vessels will label any future myocardial infarction as stent related.

16 CEN TRO CENTRO ARTS II Stent thrombosis up to 3 years * ARTS II - Death/CVA/MIs up to 3 years * Re-adjudication according to Dublin definitions Survival (%) % of Patients ARTS II -ARTS I CABG - ARTS I PCI - Definite (angiography pathological 87.% confirmation) P (log rank) =0.07 between ARTS - Definite II and & ARTS Probable I-CABG (MI in stent area) - Definite, P (log probable rank) =0.004 between and possible (any unexplained death) ARTS II and ARTS I-PCI Time (Months) 9.0% 89.1% ARTS II was performed with SES 6.4% 5.3% 3.3%

17 Survival (%) ARTS II - Deaths up to 3 years - ARTS II - ARTS I CABG - ARTS I PCI P (log rank) =0.0 between ARTS II and ARTS I-CABG P (log rank) =0.33 between ARTS II and ARTS I-PCI Time (Months) 3 to 5% of pts will die at 3 yrs: In which cohort do you want to die? 97.0% 96.0% 95.6%

18 Patients with on label and off label indications: : Milan experience Indication On label Off label Off label Indication Bifurcation Ostial CTO Restenosis Left Main Vein Graft EF< 30% Patients Percentage of total 34.9% 65.1% 49.9% 36.% 8.8%.4% 6.5% 5.3% 1.9%

19 Baseline Clinical and Procedural Characteristics: : Milan Experience Variable On Label Off Label P Value Pts Male 35(89.3%) 603(88.7%) 0.84 Age (yrs) 63.8± ± EF (%) 54.± ± Diabetes Mellitus 64(17.6%) 137(0.1%) 0.3 Nr Stents per Pt median (range) (1-8) 3 (1-10) 10) Total stent length (mm) Median (IQR) 33 (6-66) 66) 60(36-99) Pts with >1 stent per les 79(1.7%) 19(8.%) 0.0

20 In-Hospital And FU clinical Events: : Milan Experience Variable On Label Off Label P Value Pts Acute Stent Throm 0 0.3%() 0.55 Sub-Acute ST 0 0.6%(4) 0.30 Late ST 1.4%(5) 1.%(8) 0.78 MI 1.9%(7).4%(16) 0.83 Total death 4.9%(18) 4.1%(8) 0.53 Cardiac death.7%(10).5%(17) 1.00 MACE 17.6%(64) 8.%(19)

21 DES represent an unique step forward We did not pay sufficient attention to possible complications: only placebo has almost no complications! Efforts should concentrate to prevent: early thrombosis- technique and antiplatelets late thrombosis- innovative solutions and further understanding DES allow treatment of more complex lesions with less immediate and late complications (personal opinion!)