Twenty years of coronary angioplasty

Transcription

1 08/12/2011 Twenty years of coronary angioplasty Michel E. BERTRAND, MD FESC,FRCP (London), FACC, FAHA Lille University Heart Hospital, Lille, France

2 Presenter disclosure information Within the last ten years, the presenter have had a financial interest/arrangement or affiliation with the organization listed below. Company American Medicine Company Bristol Myers Squibb Merck Sharp & Dohme Lilly Nycomed Sanofi-Aventis Servier Relationship Speaker bureau Speaker bureau Consultant/Speaker bureau Consultant Speaker bureau Consultant/Speaker bureau Consultant/Speaker bureau

3 20 ans d angioplastie coronaire Coronary angioplasty was borne in 1977 Currently: 34 years old In this talk we will consider only the last twenty years Except : Primary angioplasty in STEMI already addressed by P. G Steg

4 Era of balloon angioplasty First cor angioplasty: 1977 Andreas Gruentzig Steerable guide wire :1982 J. Simpson Monorail : 1986 T. Bonzel Era of new tools Era of stenting : 1986 J Puel U. Sigwart

5 What is the situation in 1991? With stenting, needs for surgical back up are declining: 0,3 % in 1991 vs. 8,8% in 1985 However the risk of stent thrombosis is still a major problem: 10,1% in bailout stenting and 4,5% in elective placement! In addition the risk of restenosis is ~35-40%! The first problem will be solved within a few years But it took 10 years to improve the second issue

6 Three randomized studies: stent thrombosis is no longer a serious problem with DAPT : ASA+Thienopyridine 6 ASA + Vit K antagonists ASA + ticlopidine 5 5,4 4 Percentage 3 2 3,5 2, ,8 0,4 0,5 ISAR FANTASTIC STARS ISAR N. Engl. J. Med 1996;334:1084 FANTASTIC Circulation 1998;98:1597 STARS N. Engl. J. Med 1998;339:1665

7 First generation of stents (ancesters) Wallstent: self-expanding Gianturco-Roubin Schatz-Palmaz: Tubular Wiktor stent: Coil

8 Benestent 1 & 2: November % 27.3% Restenosis is significantly reduced after stent implanation

9 Metanalysis of 9 randomized trials and 10 registries with baseline, post-procedural, 6-month FU QCA 9,120 treated lesions in 8,156 patients Restenosis (%) Balloon Stent Mercado & al JACC 2001;38:645-52

10 The mechanism of restenosis after balloon angioplasty is clarified Before balloon dilatation After balloon dilatation Shrinkage Negative remodeling + Hyperplasia

11 Remodeling vs. Hyperplasia 27% Remodeling Hyperplasia 73% Balloon angioplasty 2 98% Stent Adapted from G.Mintz

12 Patterns of ISR: Restenosis rate after treatment Incidence=42% 1: Focal TVR 19% 2: Diffuse Incidence= 21% 35% 3: Proliferation Incidence= 30% 50% R. MehranCirculation 1999;100:1872

13 Brachytherapy for In Stent Restenosis % Radiation Balloon Gamma source SCRIPPS WRIST GAMMA-1 WRIST Long 29 START Beta source INHIBIT N=56 n=130 n=252 n=120 n=476 n=332

14 The great breakthrough: RAVEL 238 patients 19 medical centers Prim EP: in stent luminal late loss Sec EP : Restenosis rate Cypher BMS p Lumin Late loss - 0,01 ± 0,33 0,80 ± 0,50 <0,001 Restenosis rate (%) 0% 26,6% <0,001

15 Surprise, comments and criticisms Sceptical : 0% does not exist in medicine Possibly late restenosis Possibly late stent thrombosis The firestorm in the blue sky: The Black Sunday of ESC Barcelona

16 The immediate period: Conflicting results Meta-analysis Nordmann: No significant difference but a trend of increased non cardiac mortality TCT meeting (Washington DC, October 2006) No significant difference for death, MI Small excess of DES thrombosis after 1 year Standardized definitions of ST (ARC) Bern-Rotterdam registry: Late ST : 0.6%/year Danish registry, SCAAR registry,basket trial But restenosis rate was markedly decreased Afterwards: Two major issues were solved Adjunctive pharmacotherapy Education and better selection of patients

17 Adjunctive pharmacotherapy Aspirin + Clopidogrel : 1 year then Aspirin alone ESC Guidelines More recently the debate restarted with the PRODIGY trial: 2 yrs 6 mths MACE (Death, MI, Stroke): 10,1% vs. 10% Bleedings: 7,4% vs. 3,6% p < 0,0001 Education of physicians and patients for strict adherence to this treatment

18 Development of the radial approach Initiated in 1993 by F. Kimenej Very popular in France and in Europe (but not in USA) France : Louvart, Hamon, Mc Fadden Significant decrease of bleeding and vascular complications New tools (Japanese tools) for Chronic total occlusion CTO is present in 20-30% of patients One of the remaining challenge

19 Period of first DES generation: Cypher TAXUS is over Second generation : Endeavor ZES, Xience everolimus 3rd generation: Metallic DES with durable polymers DES with biodegradable polymer Non polymeric DES Fully bioresorbable stent: Second generation : Revision I,I Absorbable metallic stent Balloon eluting

20 CYP 2C19*2 genetic variant is a major determinant of prognosis in Patients receiving clopidogrel JP Collet, T. Simon: genetic predisposition of stent thrombosis Evidence based on 9 studies with 9685 pts suggest an association of CYP2C29 loss-offunction alleles to MACE and stent thrombosis RAPID-GENE study: Is a strategy of rapid genotyping followed by selective administration of Prasugrel to CYP2C19* carriers decrease high on treatment platelet reactivity? Mega et al. JAMA 2010;304:

21 Point of care genetic testing

22 ADAPT-DES A Large-Scale, Prospective, Multicenter Registry Examining the Relationship Between Platelet Responsiveness and Stent Thrombosis After DES Implantation 11,000 patients with 1 DES: Accumetrics VerifyNow Aspirin, VerifyNow P2Y12, and VerifyNow IIb/IIIa assays (results blinded) The Base level of platelet P2Y12 response, as well as aspirin and overall platelet responsiveness after DAPT loading as assessed by VerifyNow were not shown to be related to the 30-day rate of stent thrombosis The modest sensitivity and specificity of platelet function testing, coupled with the low prevalence of events, implies that testing of platelet ADP antagonist responsiveness is unlikely to provide useful information to guide clinical decision-making in most individual patients for the prevention of stent thrombosis at 30 days The degree of platelet responsiveness to ADP antagonist loading is useful to predict 30-day stent thrombosis in diabetic and non-diabetic patients, as well as those with ACS, but may have less clinical utility in patients with stable CAD. TCT 2011

23 : Strategy of PCI Strategy in stable CAD patients: COURAGE 2,287 pts from 35,539 pts EP: All cause mortality, non fatal MI Boden WE et al. N Engl J Med. 2007;356. Strategy: PCI +DES vs, CABG in 3 VD & LM: 1800 patients Endpoint: MACCE: (Death, MI, Stroke, Revascularization Serruys PW: N Engl J Med 2009;360: Strategy in diabetics: CarDia 510 patients EP:Death, MI, Stroke K. Beatt : J. Am. Coll. Cardiol. 2010;55; Unpowered study No conclusion

24 PCI + Optimal Med Rx vs Optimal Med RX : COURAGE All-cause death, MI Primary outcome Survival free of primary outcome HR 1.05* ( ) P = No. at risk Medical therapy PCI Medical therapy Years PCI + medical therapy *Unadjusted Boden WE et al. N Engl J Med. 2007;356.

25 COURAGE: Cumulative event rates* Outcome PCI (%) Medical Tt(%) Hazard ratio 95% CI p Death, MI Death, MI, stroke Death Nonfatal MI Stroke Hospitalization for ACS Revascularization <0.001 This is a failure of PCI This is a failure of Med Rx! *At a median of 4.6 years Boden WE et al. N Engl J Med 2007;

26 Nowadays the primary endpoint in most of the studies is a combination of Death, MI, Stroke and revascularization Death, MI, Stroke and revascularization OR: 0.66 (95% CI: ) P < ,5 0,75 1 1,25 1,5 PCI + OMT better OMT better This is why, I have the COURAGE to recommend PCI You can t say that: This is a trial of strategy and not a treatment comparison The patients don t care of this subtile distinction

27 Year 2009: SYNTAX trial 1800 patients with 3-VD or LM: randomized to PCI or CABG: A non-inferiority trial Results: Rates of major adverse cardiac or cerebrovascular events at 12 months were significantly higher in the PCI group (17.8%, vs. 12.4% for CABG; P = 0.002), in large part because of an increased rate of repeat revascularization (13.5% vs. 5.9%, P<0.001); as a result, the criterion for noninferiority was not met. At 12 months, the rates of death and myocardial infarction were similar in the two groups; Stroke was significantly more likely to occur with CABG (2.2%, vs. 0.6% with PCI; P = 0.003).

28 SYNTAX: Personal comments Fantastic study A landmark trial Exemplary logistic Clear-cut results Providing new information The need for heart team SYNTAX score Demonstrating that PCI/ Des in LM is an alternative to CABG But Criticism (personal) Definition of the enpoint: MACE does not include Death MI Stroke TVR

29 SYNTAX : 4 year cumulative results Outcome CABG (n=819) PCI (n=879) p MACCE 23,6 33,5 <0,001 Death/MI/Stroke 14,6 18 0,07 Total mortality 8,8 11,7 0,048 CV mortality 4,3 7,6 0,004 Stroke 3,7 2,3 0,06 MI 3,8 8,3 <0,001 Repeat revasc 11,9 23 <0,001 SYNTAX score CABG PCI p ,1 28,6 0, ,5 32 0,006 >33 mortality 8,4 16,1 0,04 TCT 2011

30 Beyond 2011: What else? New stents: Bioabsorbable Impact of new anticoagulants on the post PCI management of ACS FREEDOM: 1900 diabetics: Results AHA 2012 A trend to disaffection of interventional cardiologists attracted by TAVI Decline in coronary artery disease? Optimal medical treatment PCI CABG