Transradial vs. Transfemoral Access in STEMI: Should We Randomize?

Transcription

1 Transradial vs. Transfemoral Access in STEMI: Should We Randomize? Ajay J. Kirtane, MD, SM Center for Interventional Vascular Therapy Columbia University Medical Center / New York Presbyterian Hospital

2 Conflict of Interest Disclosure Ajay J. Kirtane None Off-label use will be discussed

3 Some Commonly Held Beliefs Regarding Transradial PCI in STEMI Patients TRI for STEMI is cutting-edge therapy Clearly bleeding with TRI in STEMI Mortality with TRI in STEMI Non-significant differences in D2B time with TRI in STEMI No way I d ever do a STEMI transradially! Not with bivalirudin/vcd s; definitional Unproven claim, alpha error D2B times will be longer with STEMI TRI done by US operators with less experience

4 Complications of PCI: Relative Frequency of Bleeding Emergent CABG <0.3% Abrupt Closure/Acute ST <0.2% Arrhythmia <0.01% LST = 0.1% per year Bleeding Complications ~5% from Baim and Grossman

5 Access and Non-Access Site Bleeding after PCI 17,393 pts underwent PCI in REPLACE-2, ACUITY and HORIZONS 925 pts (5.3%) had TIMI major or minor bleeding within 30 days 145 (15.7%) Source of bleeding (absolute rate) 568 (61.4%) non access site related 142 (15.4%) 357 (38.6%) Access site only (2.1%) Indeterminate (1.6%) Non access site (0.8%) Access + non access site (0.8%) 281 (30.4%) Indeterminate most likely intraprocedural (catheter exchanges) or baseline anemia with lower transfusion threshold Verheugt FWA et al. JACC Int 2011;4;

6 Prognostic Value of Access and Non-Access Site Bleeding After PCI Study retrospectively categorized bleeding events from 7 randomized trials (n = 14,180 patients) between June 2000 and May Year Mortality Adjusted HR 95% CI No Bleeding 2.5% Access Site 4.5% Non-Access Site 10.0% Non-access site bleeding tended to be more severe, with 74.4% of events ranked BARC class 2 vs. 47.3% of access site bleeds (P < 0.001). Conclusion: Both access site and non-access site bleeding within 30 days of PCI heighten mortality at 1 year, but non-access events have greater prognostic impact. Ndrepepa G, et al. Circ Cardiovasc Interv. 2013;Epub ahead of print.

7 RIVAL MAJOR BLEEDING % pts Radial Femoral P< Non-CABG RIVAL definition Non-CABG TIMI definition Non-CABG ACUITY definition Blood Transfusions

8 RIFLE STEACS results 30-day bleeding rate femoral arm radial arm p = p = p = % 7.8% 6.8% 2.6% 5.4% 5.2% Bleedings Access site related Non access site related

9 RIFLE STEACS results 30-day MACCE rate p = % femoral arm radial arm 5.2% p = p = p = % 1.2% 1.8% 1.2% 0.6% 0.8% Cardiac death Myocardial Infarction Target Lesion Revascularization Cerebrovascular Accident

10 RIVAL: Operator Volumes and Procedure Characteristics Radial (n=3507) Femoral (n=3514) HR (95% CI) P value Operator Annual Volume PCI/year (median, IQR) 300 (190, 400) 300 (190, 400) Percent Radial PCI (median, IQR) 40 (25,70) 40 (25, 70) PCI Success ( ) 0.83 Vascular closure devices used in 26% of femoral group Jolly et al, Lancet 2011

11 Learning Curve in Transradial PCI Individual Operator Learning Curve Case numbers Procedural Success % Procedural Success Procedure duration (min) Fluoroscopy time (min) /20 90% 48 ± ± / % 48 ± ± 4.8 > / % 38 ± ± 5.0 Hildick-Smith. CCI 2004; 61:60-68.

12 Non CABG major bleeding by actual access site used to complete procedure (not intent to treat)* *Post Hoc analysis

13 Can we Rival our OUS Colleagues here in the United States?

14 % TR PCI TRA for PCI in France/Europe/USA France Series1 Europe Series4 USA Series c/o T. LeFevre

15 US Transradial Access Update: NCDR Only 10.1% of sites used radial access in >19.2% (90 th percentile) of total PCIs performed Feldman et al, Circulation 2013:127:

16 Radial STEMI-PCI Update - NCDR r-pci increased from 0.9% in Q1, 2077 to 6.4% in Q3, 2011 (P < ) JACC 2013;61:420-6

17 SCAI Survey: Preferred Approach for STEMI PCI 17% Femoral 83% Radial n = 359 Chiang and Kirtane, submitted

18 Other Unresolved questions in STEMI Radial (Heparin or Bivalirudin) vs. Bivalirudin Femoral + closure device

19 Bleeding Reductions with Bivalirudin: REPLACE-2, ACUITY, and HORIZONS Heparin + GP2b3a Bivalirudin alone REPLACE Heparin + GP2b3a Bivalirudin alone % % % P<0.001 P< ACUITY Heparin + GP2b3a Bivalirudin alone P< HORIZONS-AMI

20 Impact of Bleeding Avoidance Strategies NCDR CathPCI Registry : PCI in 1,522,935 pts Manual compression alone, closure devices, bivalirudin, or both were used in 35%, 24%, 23%, and 18% of pts, respectively. Propensity-adjusted bleeding Major bleeding (%) Manual compression (n=508,455) Bivalirudin (n=172,471) All pts Vascular closure devices (n=205,606) Bivalirudin + VCD (n=130,378) Adj OR (95%CI) = 0.77 ( ) NNT = 148 Adj OR (95%CI) = 0.67 ( ) NNT = 118 Adj OR (95%CI) = 0.38 ( ) NNT = 70 23% % % Marso SP et al. JAMA. 2010;303:

21 RIVAL Pharmacotherapy Radial (n=3507) % Femoral (n=3514) % ASA Clopidogrel LMWH UFH Fondaparinux Bivalirudin GP IIb IIIa inhibitors PCI CABG

22 Access Site and Closure device: HORIZONS-AMI Access and closure % Radial 5.9% Femoral without VCD 66% Femoral with VCD 27% AngioSeal 58.3% StarClose 32.4% PerClose 8.7% Other 0.6%

23 Highest Priority Short-Term Getting US operators trained in transradial PCI Getting trained operators comfortable doing TRI in STEMI cases Comfort issues Staffing issues Fear of the unknown vis-à-vis pay for performance Expanding the clinical evidence base

24 Highest Priority Longer Term Expanding the clinical evidence base Ensuring high-quality PCI is performed in all cases as TRI for STEMI continues to develop Movement beyond D2B as the predominant STEMI process metric

25 SCAI Survey: Variation in Mechanics of STEMI PCI 23% 58% 19% Start with a guiding catheter for the presumed culprit artery and perform PCI (generally prior to angiography of the non-culprit artery) Start with a diagnostic catheter for the presumed NON-culprit artery, followed by guide catheter for angiography/pci of the culprit artery Start with full diagnostic catheterization (using diagnostic catheters) and then follow with a guide catheter used to treat the culprit artery n = 361 Chiang and Kirtane, submitted

26 Summary The role of TRI in STEMI patients (in the US particularly) is emerging, but is still in fact somewhat controversial currently Trials have involved operators with more experience than most US operators Mortality reductions have been out of proportion to the bleeding benefits Thus, it makes good clinical sense to pursue study of TRI for STEMI Randomization is ESSENTIAL for an unbiased assessment of this treatment!!