Preoperative β-blockers before major elective vascular surgery does not improve cardiac outcomes and may be harmful

Transcription

1 Preoperative β-blockers before major elective vascular surgery does not improve cardiac outcomes and may be harmful Salvatore Scali 1*, Virendra Patel 2*, Daniel Neal 1, Daniel Bertges 3, Karen Ho 4, Jens-Eldrup Jorgensen 5, Jack Cronenwett 6 and Adam Beck 1 1 University of Florida, Gainesville, FL, 2 Mass. General Hosp., Harvard Medical School, Boston, MA, 3 University of Vermont, Burlington, VT, 4 Northwestern University, Chicago, IL, 5 Maine Medical Center, Portland, ME, 6 Dartmouth-Hitchcock Medical Center, Lebanon, NH

2 Disclosures Nothing to disclose

3 Introduction >1.5 million vascular operations/year in the U.S. Postoperative MI is a major cause of morbidity and mortality in non-cardiac surgery patients - 30-day mortality d 2-3 fold Autopsy studies of perioperative MI % associated with plaque rupture - Remaining causes associated with D0 2 /VO 2 mismatch Lindenauer et. al. NEJM. 353(4): Auerbach. AHRQ.

4 Introduction Increased preoperative β-blocker use after 2000 based on limited evidence in 1990s Disproportionate impact of the DECREASE family of trials Poldermans D, et. al. NEJM 1999;341: ; NEJM 2005:353:412-4; JACC 2006;48(5):964-9; JACC 2007:49:1763-9; JACC 2010:56: Safe practice quality measure:

5 Controversial role of preop β-blockers Multiple trials since 2005 have failed to demonstrate benefit of initiating preoperative β-blockers -e.g. POBBLE, DIPOM, POISE Non-secure data identified from DECREASE trials stimated difference of effect size between secure and non-secure studies. Bouri S et al. Heart 2014;100:

6 Controversial role of preop β-blockers Multiple trials since 2005 have failed to demonstrate benefit of initiating preoperative β-blockers Impact -e.g. POBBLE, of preoperative DIPOM, β-blockers POISE on postoperative major adverse cardiac events Non-secure data identified from DECREASE trials Secure trials RR 1.27 [95% C.I ] stimated difference of effect size between secure and non-secure studies. Favors no routine initiation of preoperative β-blockers Bouri S et al. Heart 2014;100:

7 β-blocker use trends in the VQI N=13,291 Elective Infrainguinal, Aortoiliac/femoral bypass and Open AAA 100% 80% DIPOM 2006 AHA Guidelines POISE β-blocker 0-30 days β-blocker > 30 days Goodney VSGNE 60% 40% 20% Year

8 Purpose Determine whether initiation of preoperative β-blockers before major elective vascular surgery decreased postoperative cardiac events or 30-day mortality within the VQI

9 Methods Study population VQI dataset: 2003 to June Elective infrainguinal bypass - Elective aortoiliac/femoral bypass - Elective open AAA repair Excluded patients chronically (>30 days preop) on β-blocker Compared outcomes between patients placed on preoperative vs. no β-blocker before surgery

10 Methods Definitions - Preoperative β-blocker: 0-30 days - MACE: any postoperative in-hospital MI, CHF, or arrhythmia severe enough to require treatment End-points - Any in-hospital MACE - 30-day mortality

11 Methods Derived procedure-specific MACE risk models Analysis #1: -1:1 propensity-score matched pairs analysis -Outcome = β-blocker exposure (ACC guidelines 1 ) Analysis #2: -Procedure-specific MACE risk models applied to risk stratify all patients -Tertiles of risk: low, intermediate, high * ACC guidelines, JACC 2009 Nov 24;54(22):e13-e118.

12 Analysis #1: Matched patient characteristics No differences in matched No Preop and Preop β-blocker groups Procedure No β-blocker % (No.) Infrainguinal bypass 62 (907) 62 (911) Aortoiliac/femoral bypass 14 (203) 14 (201) Preop β-blocker % (No.) P-value Open AAA 24 (349) 24 (347).9

13 Analysis #1: Matched patient characteristics No differences in matched No β-blocker No Preop β-blocker and Preop Variable β-blocker groups % (N=1459) % (N=1459) P-value Any Smoking 90% 89%.5 Hypertension 79% 78%.8 No β-blocker Preop β-blocker Statin 65% 67%.4 Procedure % (No.) % (No.) P-value Any prior Vasc. Op. 37% 39%.4 Infrainguinal bypass 62 (907) 62 (911) Diabetes mellitus 32% 31%.5 Aortoiliac/femoral 14 (203) 14 (201) CAD bypass 20% 21%.9 Prior Open PCI/CABG AAA 2417% (349) 2418% (347).9.7

14 Analysis#1: Overall major adverse cardiac events and 30-day mortality * End-point Preop β-blocker No β-blocker

15 Analysis #1: Major adverse cardiac events by cardiac risk group Cardiac risk Preop β-blocker No β-blocker Low Medium High

16 Analysis #1: 30-day Mortality by cardiac risk group Cardiac risk Preop β-blocker No β-blocker Low Medium High

17 Analysis #1: Survival of all matched pbb and No BB patients Months

18 Analysis #1: Survival of all matched pbb and No BB patients 1-yr survival within matched low, intermediate, and high risk patient groups did not differ Low-risk P = NS Medium-risk P = NS High-risk P = NS Months

19 Analysis #2: Infrainguinal Bypass

20 Analysis #2: Aortoiliac/femoral Bypass

21 Analysis #2: Open AAA

22 Limitations No RCT Relatively low event numbers within each risk group No dose information or postoperative data regarding reason for continuation/titration or medication stoppage Non-validated MACE risk tool

23 Summary Initiation of preoperative β-blockade did not significantly decrease MACE or 30-day mortality in most patients MACE were increased in multiple subgroups who received preoperative beta blockers

24 Conclusions Routine initiation of β-blockers before major vascular surgery in most VQI patients is not beneficial Initiation of preoperative β-blockers in high risk open AAA may be protective

25 Thank you