Vest Prevention of Early Sudden Death Trial (VEST)
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1 ACC Late Breaking Clinical Trials 2018 Vest Prevention of Early Sudden Death Trial (VEST) Jeffrey Olgin, MD, FACC Division of Cardiology, UCSF On behalf of the VEST Investigators
2 Disclosures ClinicalTrials.gov registration: NCT Funding NHLBI (U01HL & U01HL089145) funded Coordinating Centers until 2012 funded study throughout and Coordinating Centers after 2012
3 Cumulative Incidence Rate of Sudden Cardiac Death or Cardiac Arrest (%/mo) Background: SCD is high after MI Olmsted County VALIANT Trial Death Sudden cardiac death Time to Event (year) Months after Myocardial Infarction (mo) Adabag, et al. JAMA 2008 VALIANT Solomon, et al. NEJM 2005
4 Cumulative Risk of Death from Arrhythmia Cumulative Risk of Sudden Cardiac Death Cumulative Risk of Death from Any Cause Cumulative Risk of Death from Any Cause Background: No benefit from early ICD Total Mortality DINAMIT IRIS ICD group Total Mortality ICD group Control group Control group SCD Mortality Control group SCD Mortality Control group ICD group ICD group DINAMIT: Hohnloser, et al. NEJM 2004 IRIS: Steinbeck, et al. NEJM 2009
5 Cumulative Risk of Death from Arrhythmia Cumulative Risk of Sudden Cardiac Death Cumulative Risk of Death from Any Cause Cumulative Risk of Death from Any Cause Background: No benefit from early ICD Total Mortality DINAMIT IRIS ICD group Total Mortality ICD group Control group Control group SCD Mortality Control group SCD Mortality Control group ICD group ICD group DINAMIT: Hohnloser, et al. NEJM 2004 IRIS: Steinbeck, et al. NEJM 2009
6 Cumulative Risk of Death from Arrhythmia Cumulative Risk of Sudden Cardiac Death Cumulative Risk of Death from Any Cause Cumulative Risk of Death from Any Cause Background: No benefit from early ICD Total Mortality DINAMIT IRIS ICD group ICD group 1 Outcome: Long-term Control group (>30 month) mortality Control group N = 674 Total Mortality N = 898 SCD Mortality Control group SCD Mortality Control group ICD group ICD group DINAMIT: Hohnloser, et al. NEJM 2004 IRIS: Steinbeck, et al. NEJM 2009
7 Background: Guideline recommendations Al-Khatib SM, et al VA/SCD Guidelines Primary Prevention of SCD in Patients with Ischemic Heart Disease Recommendations for Primary Prevention of SCD in Patients With Ischemic Heart Disease COR I LOE A Recommendations 1. In patients with LVEF of 35% or less that is due to ischemic heart disease who are at least 40 days post-mi and at least 90 days post revascularization, and with NYHA class II or III HF despite GDMT, an ICD is recommended if meaningful survival of greater than 1 year is expected (1,2) ACC/AHA/HRS Guideline for Management of Patients With Ventricular Arrhythmias. JACC 2017
8 Background: VEST rationale ICD not indicated in immediate post-mi period Some early mortality not due to arrhythmias immediately post-mi, thus not preventable by ICD LVEF may recover over 3 months post-mi Can a wearable cardioverter defibrillator (WCD) reduce SD mortality in the immediate post-mi period (<90 days) in patients with reduced LVEF, as a bridge to evaluation for ICD?
9 Methods: Study design Multi-center, randomized, open-label trial Participants enrolled within 7 days of hospital d/c with acute MI and EF 35% Randomized 2:1 to receive: Wearable cardioverter defibrillator (WCD) + guidelinedirected therapy or Guideline-directed medical therapy alone MD s & sites blinded to detected arrhythmias Crossovers & ICDs prohibited (except for secondary prevention during follow-up)
10 Methods: Inclusion & exclusion Inclusion Criteria 7 days of hospital discharge for acute MI EF 35% assessed: 8 hrs after MI 8 hrs after PCI 48 hrs after CABG Exclusion Criteria Existing ICD Significant valve disease Unipolar pacing system Chronic hemodialysis Chest too small/large for WCD Discharge to SNF for >7 days Pregnancy
11 Methods: Screening & enrollment Screening & enrollment between enrolling sites 76 US sites 6 German sites 24 Polish sites 2 Hungarian sites Alaska Germany United States Poland Hungary
12 Methods: Intervention-WCD Washable- Interchangeable Garment Self-Gelling Defibrillation Electrodes Dry ECG Electrodes Rechargeable Monitor & Battery Pack Response Buttons Monitors Wear-time Noise Device warning Asystole VT/VF Treatment VT/VF Investigators blinded to data
13 Methods: Outcomes Follow-up at 1 month & 3 months Search NDI at end of study Primary Outcome: SCD & death due to ventricular arrhythmias Secondary outcomes Total mortality & Non-sudden death Cause-specific death Non-fatal outcomes CV Hospitalizations WCD compliance Adverse events
14 Methods: Analysis plan Primary Analysis: Intention-to-treat Participants with indeterminate causes of death or unknown vital status are treated as not having primary outcome Secondary Analyses Weighted sensitivity analyses excluding unknown vital status and indeterminate causes of death from denominator
15 Results: CONSORT diagram Died Prior to Consent (n=797) Refused (n=546) WCD + Guideline Rx (n=1,524) Received WCD (n=1,481) Never wore WCD (n=43) ICD implant during FU (n=67) Analyzed (n=1524) Vital status unknown (n=10) Assessed for Eligibility (n=13,774) Randomized (n=2,302) 2:1 Excluded (n=10,129) Existing ICD (n=2,158) Chronic Renal Failure (n=1,148) Discharge to SNF (n=740) Unipolar pacing system (n=160) Chest too large/small (n=76) Significant valve disease (n=102) Pregnancy (n=8) Inability to consent (n=1,327) Unsuitable/Other (n=4,364) Guideline Rx (n=778) Never given WCD (n=758) Given WCD-protocol viol (n=20) ICD implant during FU (n=44) Mean Follow-up = 84.3 ± 15.6 days Analyzed (n=778) Vital status unknown (n=12)
16 Results: Participant characteristics Characteristic WCD Group (N=1524) Control Group (N=778) Age, mean ± SD 60.9 ± ± 12.3 Men, n (%) 1107 (72.8%) 577 (74.7%) Body mass index, Mean ± SD 28.4 ± ± 6.6 Smoker, n(%) 561 (36.9%) 273 (35.5%) Race n (%) White 1278 (84.1%) 636 (82.6%) Black 143 (9.4%) 75 (9.7%) Asian 23 (1.5%) 14 (1.8%) Native American/Alaskan 25 (1.7%) 12 (1.6%) Pacific Islander/Hawaiian 1 (0.1%) 0 (0%) Mixed 20 (1.3%) 14 (1.8%) Hispanic, n (%) 85 (5.6%) 34 (4.4%)
17 Results: Prior history Characteristic WCD Group (N=1524) Control Group (N=778) Diabetes Mellitus, n (%) 496 (32.6%) 246 (31.7%) Hypertension, n(%) 993 (65.3%) 501 (64.6%) Prior MI, n (%) 380 (25.1%) 193 (24.9%) Prior CABG, n (%) 133 (8.8%) 70 (9.0%) Prior PCI, n (%) 374 (24.6%) 202 (26.0%) Prior CHF, n (%) 246 (16.2%) 146 (18.9%) NYHA Classification, n (%) I 691 (45.5%) 326 (42.1%) II 528 (34.8%) 286 (36.9%) III 211 (13.9%) 116 (15.0%) IV 46 (3.0%) 18 (2.3%)
18 Results: Characteristics of index MI Characteristic WCD Group (N=1524) Control Group (N=778) LVEF 28.2 ± 6.1% 28.2 ± 5.9% PCI during MI hospitalization 1272 (84.2%) 650 (84.1%) Thrombolytics during MI hospitalization 118 (7.8%) 71 (9.2%) CABG during index hospitalization 14 (0.9%) 12 (1.5%) Cardiac Arrest/VF 169 (11.2%) 70 (9.1%) Pulmonary Edema requiring Intubation 162 (10. 7%) 88 (11.4%) Intra-aortic Balloon Pump 173 (11.5%) 93 (12.0%) Cardiogenic Shock 136 (9.0%) 79 (10.2%)
19 Results: Medical treatment Characteristic WCD Group (N=1524) Control Group (N=778) ASA 1328 (87.1%) 677 (87.0%) Other antiplatelet 1378 (90.4%) 679 (87.3%) Statin 1384 (90.8%) 695 (89.3%) Beta blocker (including carvedilol) 1407 (92.3%) 716 (92.0%) ACEI/ARB 1330 (87.3%) 665 (85.5%) Eplerenone/spironolactone 661 (43.4%) 342 (44.0%) Other diuretic 736 (48.3%) 384 (49.4%) Amiodarone 106 (7.0%) 55 (7.1%)
20 Results: Crossover treatment Characteristic WCD Group (N=1524) Control Group (N=778) WCD received, n (%) 1455 (95.5%) 20 (2.6%)* Average hours/day WCD worn 14.1 ± ± 3.9* ICD during follow up (<90 days), n (%) 67 (4.4%) 44 (5.7%) ICD Implant timing (days since randomization), median (IQR) 62 (24-81) 58 (25-77) *P <0.001
21 Mean Hrs worn Mean Hrs worn when used Percent (%) Results: WCD wear-time 0 Hours worn/day (incl non-users) Percent using WCD, by day Days since randomization Hours worn on days used Observed Smoothed 95% Confidence Interval Days since randomization
22 Results: Outcomes, intention-to-treat A Sudden + Ventricular Tachyarrhythmia Death Nominal P=0.18 Control WCD
23 Nominal P=0.18 Results: Outcomes, intention-to-treat B Non-sudden Death Nominal P=0.14 Control WCD
24 Nominal P=0.18 Results: Outcomes, intention-to-treat C Death from Any Cause Nominal P=0.04 Control WCD Nominal P=0.14
25 Results: Cause-specific death Clinical event type WCD (N=1524) Control (N=778) P value* FATAL EVENTS, n (%) Sudden Death (1 outcome) 25 (1.6%) 19 (2.4%) 0.18 Non-sudden death 21 (1.4%) 17 (2.2%) 0.15 Congestive heart failure death 10 (0.7%) 5 (0.6%) 1.0 Recurrent MI death 1 (0.1%) 1 (0.1%) 1.0 Stroke death 0 (0.0%) 4 (0.5%) 0.01 Other cardiovascular death 5 (0.3%) 3 (0.4%) 1.0 Other death 5 (0.3%) 4 (0.5%) 0.72 Indeterminate death 2 (0.1%) 2 (0.3%) 0.83 Death, any cause 48 (3.1%) 38 (4.9%) 0.04 NON-FATAL EVENTS, n (%) Rehospitalization, cardiovascular 334 (22%) 174 (22%) 0.81 Rehospitalization, any cause 475 (31%) 253 (33%) 0.51
26 Results: WCD therapies & events Therapies Appropriate shocks (p=0.002) WCD Group (N=1524) Control Group (N=778) 1 appropriate shock 13 (0.9%) 0 (0%) 2 appropriate shocks 7 (0.5%) 1 (0.1%) Inappropriate shocks (p=0.05) 1 inappropriate shock 8 (0.5%) 0 (0%) 2 inappropriate shocks 2 (0.1%) 0 (0%) Aborted shocks (p<0.001) 1 aborted shock 43 (2.8%) 0 (0%) 2 aborted shocks 12 (0.8%) 0 (0%) >5 aborted shocks 15 (1.0%) 0 (0%)
27 Results: Pre-specified symptoms Characteristics WCD Control P value Fatigue 36.0% 38.8% 0.21 Back pain 20.0% 19.4% 0.73 Trouble sleeping 39.0% 37.3% 0.47 Dizziness 24.3% 23.5% 0.66 Fainting 4.2% 5.1% 0.34 Nausea 9.4% 12.0% 0.06 Headache 18.3% 19.1% 0.66 Palpitations 23.1% 25.7% 0.18 Chest pain 18.7% 21.4% 0.14 Shortness of breath 38.7% 45.4% Rash in any location 15.2% 7.1% <0.001 Rash on torso 12.9% 3.8% <0.001 Itch in any location 17.2% 6.4% <0.001 Itch on torso 14.5% 3.1% <0.001
28 Discussion: Sudden vs total mortality Possible misclassification of sudden deaths Reducing power for SD outcome but not total mortality 14 of 20 participants who received an appropriate shock survived to 90 days WCD may confer additional protection beyond SD Earlier care for bradycardia, NSVT or aborted shocks Reduced anxiety or increased medication compliance More shortness of breath in controls
29 Discussion: Limitations Participants and investigators not blinded Differences in shortness of breath between groups No differences in prescribing guideline-directed Rx Crossovers 20 participants in Control group received the WCD 19% in WCD group did not use the WCD Should bias results toward the null, but still found a difference in total mortality
30 Conclusions VEST represents the first randomized controlled trial of the WCD The WCD did not statistically significantly reduce sudden death mortality, our primary outcome The WCD was associated with lower total mortality in the first 90 days post-mi in patients with LVEF 35% Prescribing the WCD is reasonable to protect high-risk patients with a low LVEF post-mi until evaluation for an ICD at days
31 Thank you: VEST Investigators Jeffrey Olgin UCSF Mark Pletcher UCSF Eric Vittinghoff UCSF Jerzy Wranicz Medical Univ Lodz Rajesh Malik McLeod Regional Daniel Morin Ochsner Steven Zweibel Univ of CT Alred Buxton Beth Israel Claude S Elayi Univ of KY Eugene Chung Univ of MI Eric Rashba Stoney Brook Martin Borggrefe Univ Mannheim Stephen Hulley UCSF Byron Lee UCSF On Behalf of the VEST Investigators
32 Thank you
33 Discussion: Sudden death etiology Autopsy-proven cause of death 525 consecutive sudden deaths in SF County 98% autopsy rate. Cardiac, Non Arrhythmic N = 10 (8%) Non-Cardiac N = 32 (27%) Witnessed N = 120 Cardiac, Arrhythmic (SAD) N = 78 (65%) Non-Cardiac N = 178 (44%) Unwitnessed N = 405 Cardiac, Arrhythmic (SAD) N = 215 (53%) Tseng, Z. et al Circulation, in press Cardiac, Non Arrhythmic N = 12 (3%)
34 Results: ICD implants TIMING OF ICD IMPLANT: WCD (n=67) Control (n=44) Days since randomization, med (IQR) 62 (24-81) 58 (25-77) REASON FOR EARLY ICD IMPLANT: Cardiac arrest/wcd shock 15 6 Sustained VT 4 1 Bradycardia 0 1 HF treatment (required CRT) 5 1 Syncope and inducible VT 0 1 Protocol violation Unknown reason 19 16
35 Results: Outcomes, as-treated
36 Background: EF improves over time Time of VEST Enrollment 3 Months post-mi 100% EF 35% 3 months 26% EF 50% 31% 43% EF 35% EF 36-49% PREDICTS: Brooks, et al. JACC 2016
37 Unblided Data Reports Methods: Study governance & oversight DSMB Data Firewall STEERING COMMITTEE Executive Committee General Oversight Quality Control Statistician (Vittinghoff) Scientific Oversight Publications Committee Mark Pletcher (PI) Eric Vittinghoff Jeffrey Olgin (PI) Byron Lee Data Coordinating Center Clinical Coordinating Center UCSF IRB Data Firewall Study Sites Site IRBs
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