Impact of wearable cardioverter-defibrillator compliance on outcomes in the VEST trial: As-treated and per-protocol analyses.
Impact of wearable cardioverter-defibrillator compliance on outcomes in the VEST trial: As-treated and per-protocol analyses.
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DOI：
10.1111/jce.14404
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发表时间：
2020-05
影响因子：
2.7
通讯作者：
Pletcher, Mark J.
中科院分区：
文献类型：
--
作者：
Olgin, Jeffrey E.;Lee, Byron K.;Vittinghoff, Eric;Morin, Daniel P.;Zweibel, Steven;Rashba, Eric;Chung, Eugene H.;Borggrefe, Martin;Hulley, Stephen;Lin, Feng;Hue, Trisha F.;Pletcher, Mark J.
关键词：
VEST did not demonstrate a significant reduction in arrhythmic death with the wearable cardioverter-defibrillator (WCD), but compliance with the device may have substantially affected the results. The influence of WCD compliance on outcomes has not yet been fully evaluated. Using linear and pooled logistic models, we performed as-treated analyses omitting person-time in the hospital and adjusted for correlates of WCD compliance. To assess the impact of early stopping of WCD, we performed a per-protocol Kaplan-Meier analysis, censoring after the last day the WCD was worn. Interactions of potential effect modifiers with treatment assignment and WCD compliance on outcomes were investigated. Lastly, we used linear models to identify predictors of WCD compliance. A per-protocol analysis demonstrated a significant reduction in total (p<0.001) and arrhythmic (p=0.001) mortality. Better WCD compliance was independently predicted by cardiac arrest during index MI, higher maximum Cr, diabetes, prior heart failure, EF≤25%, Polish enrolling center and number of WCD alarms, while worse compliance was predicted by being divorced, Asian race, higher BMI, prior PCI, or any WCD shock. Neither excluding time in hospital from the as-treated analysis nor adjustment for factors affecting WCD compliance materially changed the results. No variable demonstrated a significant interaction in either the intention-to-treat or as-treated analysis. Robust sensitivity analyses of as-treated and per-protocol analyses suggest that the WCD is protective in compliant patients with EF≤35% during the first 3 months post-MI.
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DOI：
10.1056/nejmoa1800781
发表时间：
2018-09-27
期刊：
The New England journal of medicine
影响因子：
--
作者：
Olgin JE;Pletcher MJ;Vittinghoff E;Wranicz J;Malik R;Morin DP;Zweibel S;Buxton AE;Elayi CS;Chung EH;Rashba E;Borggrefe M;Hue TF;Maguire C;Lin F;Simon JA;Hulley S;Lee BK;VEST Investigators
通讯作者：
VEST Investigators
影响因子：
37.8
作者：
Tseng, Zian H.;Olgin, Jeffrey E.;Moffatt, Ellen
通讯作者：
Moffatt, Ellen
影响因子：
24
作者：
Epstein, Andrew E.;Abraham, William T.;Szymkiewicz, Steven J.
通讯作者：
Szymkiewicz, Steven J.
影响因子：
37.8
作者：
Wäßnig NK;Günther M;Quick S;Pfluecke C;Rottstädt F;Szymkiewicz SJ;Ringquist S;Strasser RH;Speiser U
通讯作者：
Speiser U
影响因子：
158.5
作者：
Solomon, SD;Zelenkofske, S;Pfeffer, MA
通讯作者：
Pfeffer, MA