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Percutaneous Coronary Intervention Outcomes Based on Decision-Making Capacity.

ABSTRACT: Background Long-term outcomes of percutaneous coronary intervention (PCI) based on patients' decision-making ability have not been studied. Our objective was to assess long-term outcomes after PCI in patients who provided individual versus surrogate consent. Methods and Results Data were collected retrospectively for patients who underwent PCI at Cleveland Clinic between January 1, 2015 and December 31, 2016. Inclusion criteria consisted of hospitalized patients aged ≥20 years who had PCI. Patients with outpatient PCI, or major surgery 30 days before or 90 days after PCI, were excluded. Patients who underwent PCI with surrogate consent versus individual consent were matched using the propensity analysis. Kaplan-Meier, log rank, t-statistic, and χ² tests were used for statistical analysis. The study was approved by the Institutional Review Board at Cleveland Clinic, Ohio. Of 3136 patients who underwent PCI during the study period, 183 had surrogate consent. Propensity matching yielded 149 patients from each group. Two-year all-cause mortality was significantly higher in the surrogate consent group (38 [25.5%] versus 16 [10.7%] deaths, log-rank χ²=10.16, P<0.001). The 2-year major adverse cardiac events rate was also significantly higher in the surrogate consent group (60 versus 36 events, log-rank χ²=8.36, P=0.003). Conclusions Patients with surrogate consent had significantly higher all-cause mortality and higher major adverse cardiac events when compared with patients with individual consent. This study emphasizes the fact that patients with an inability to give consent are at high risk and may need special attention in postprocedural and postdischarge care.

SUBMITTER: Singh J

PROVIDER: S-EPMC8649233 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background Drug-eluting stents reduce the risk of restenosis in patients undergoing percutaneous coronary intervention, but their use necessitates prolonged dual antiplatelet therapy, which increases costs and bleeding risk, and which may delay elective surgeries. While >80% of patients in the United States receive drug-eluting stents, less than a third report that their physicians discussed options with them. Methods and Results An individualized shared decision-making (SDM) tool for stent selection was designed and implemented at 2 US hospitals. In the postimplementation phase, all patients received the SDM tool before their procedure, with or without decision coaching from a trained nurse. All patients were interviewed with respect to their knowledge of stents, their participation in SDM, and their stent preference. Between May 2014 and December 2016, 332 patients not receiving the SDM tool, 113 receiving the SDM tool with coaching, and 136 receiving the tool without coaching were interviewed. Patients receiving the SDM tool + coaching, as compared with usual care, demonstrated higher knowledge scores (mean difference +1.8; P<0.001), reported more frequent participation in SDM (odds ratio=2.96; P<0.001), and were more likely to state a stent preference (odds ratio=2.00; P<0.001). No significant differences were observed between the use of the SDM tool without coaching and usual care. For patients who voiced a stent preference, concordance between stent desired and stent received was 98% for patients who preferred a drug-eluting stent and 50% for patients who preferred a bare metal stent. The SDM tool (with or without coaching) had no impact on stent selection or concordance. Conclusions An SDM tool for stent selection was associated with improvements in patient knowledge and SDM only when accompanied by decision coaching. However, the SDM tool (with or without coaching) had no impact on stent selection or concordance between patients' stent preference and stent received, suggesting that physician-level barriers to SDM may exist. Clinical Trial Information URL: https://www.clinicaltrials.gov . Unique Identifier: NCT02046902.

Project description:BackgroundThe interval between inpatient hospitalization for symptomatic coronary artery disease (CAD) and post-discharge office consultation is a vulnerable period for adverse events.MethodsContent was customized on a smartphone app-based platform for hospitalized patients receiving percutaneous coronary intervention (PCI) which included education, tracking, reminders and live health coaches. We conducted a single-arm open-label pilot study of the app at two academic medical centers in a single health system, with subjects enrolled 02/2018-05/2019 and 1:3 propensity-matched historical controls from 01/2015-12/2017. To evaluate feasibility and efficacy, we assessed 30-day hospital readmission (primary), outpatient cardiovascular follow-up, and cardiac rehabilitation (CR) enrollment as recorded in the health system. Outcomes were assessed by Cox Proportional Hazards model.Findings118 of 324 eligible (36·4%) 21-85 year-old patients who underwent PCI for symptomatic CAD who owned a smartphone or tablet enrolled. Mean age was 62.5 (9·7) years, 87 (73·7%) were male, 40 of 118 (33·9%) had type 2 diabetes mellitus, 68 (57·6%) enrolled underwent PCI for MI and 59 (50·0%) had previously known CAD; demographics were similar among matched historical controls. No significant difference existed in all-cause readmission within 30 days (8·5% app vs 9·6% control, ARR -1.1% absolute difference, 95% CI -7·1-4·8, p = 0·699) or 90 days (16·1% app vs 19·5% control, p = 0.394). Rates of both 90-day CR enrollment (HR 1·99, 95% CI 1·30-3·06) and 1-month cardiovascular follow up (HR 1·83, 95% CI 1·43-2·34) were greater with the app. Weekly engagement at 30- and 90-days, as measured by percentage of weeks with at least one day of completion of tasks, was mean (SD) 73·5% (33·9%) and 63·5% (40·3%). Spearman correlation analyses indicated similar engagement across age, sex, and cardiovascular risk factors.InterpretationsA post-PCI smartphone app with live health coaches yielded similarly high engagement across demographics and safely increased attendance in cardiac rehabilitation. Larger prospective randomized controlled trials are necessary to test whether this app improves cardiovascular outcomes following PCI.FundingNational Institutes of Health, Boston Scientific.Clinical trial registrationNCT03416920 (https://clinicaltrials.gov/ct2/show/NCT03416920).

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Percutaneous Coronary Intervention Outcomes Based on Decision-Making Capacity.

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