Puck J. A. van Nuland, Dirk Jan van Ginkel MD, Daniel C. Overduin MD, Willem L. Bor MD, Jorn Brouwer MD, PhD, Vincent J. Nijenhuis MD, PhD, Joyce Peper PhD, Arnoud W. J. van't Hof MD, PhD, Pieter A. Vriesendorp MD, PhD, Jurriën M. ten Berg MD, PhD
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The mortality risk associated with these events has been reported before, but data regarding their impact on health-related quality of life (QoL) is limited.</p>\n </section>\n \n <section>\n \n <h3> Aim</h3>\n \n <p>To evaluate the impact of bleeding and stroke occurring within 30 days after TAVI, on mortality and QoL during the first year after TAVI.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>POPular TAVI was a randomized clinical trial that evaluated the addition of clopidogrel to aspirin or oral anticoagulation in patients undergoing TAVI. Besides clinical outcomes, QoL was assessed using the Short Form-12 and EuroQoL Five Dimensions questionnaires before, and at 3, 6, and 12 months after TAVI.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Major or life-threatening bleeding occurred in 81 patients (8.3%) and was associated with an increased risk of death (hazard ratio [HR] 1.95 [95% confidence interval (CI) 1.00–3.79]); minor bleeding occurred in 104 patients (10.6%) and was not associated with mortality (HR 0.75 [95% CI 0.30–1.89]). Stroke occurred in 35 patients (3.6%) and was associated with an increased risk of death (HR 2.90 [95% CI 1.23–6.83]). Mean mental component summary (MCS-12) scores over time were lower in patients with major or life-threatening bleeding (<i>p</i> = 0.01), and similar in patients with minor bleeding, compared to patients without bleeding; mean physical component summary (PCS-12) scores, EQ-5D index, and visual analog scale (VAS) were similar between those patients. Mean MCS-12 scores were lower in patients with stroke (<i>p</i> = 0.01), mean PCS-12, EQ-5D index, and VAS were similar compared to patients without stroke.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>Major or life-threatening bleeding and stroke were associated with an increased risk of death and decreased mental QoL in the first year after TAVI.</p>\n </section>\n </div>","PeriodicalId":9650,"journal":{"name":"Catheterization and Cardiovascular Interventions","volume":"104 5","pages":"1107-1118"},"PeriodicalIF":2.1000,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The impact of stroke and bleeding on mortality and quality of life during the first year after TAVI: A POPular TAVI subanalysis\",\"authors\":\"Puck J. A. van Nuland, Dirk Jan van Ginkel MD, Daniel C. Overduin MD, Willem L. Bor MD, Jorn Brouwer MD, PhD, Vincent J. 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引用次数: 0
摘要
背景出血和中风是经导管主动脉瓣植入术（TAVI）后的常见并发症。方法POPular TAVI是一项随机临床试验，评估了在阿司匹林或口服抗凝药的基础上加用氯吡格雷对接受TAVI的患者的影响。除临床结果外，还在 TAVI 术前、术后 3、6 和 12 个月使用 Short Form-12 和 EuroQoL Five Dimensions 问卷对患者的 QoL 进行了评估。结果81例患者（8.3%）发生大出血或危及生命的出血，与死亡风险增加有关（危险比 [HR] 1.95 [95% 置信区间 (CI) 1.00-3.79]）；104例患者（10.6%）发生轻微出血，与死亡率无关（HR 0.75 [95% CI 0.30-1.89]）。35名患者（3.6%）发生了中风，与死亡风险增加有关（HR 2.90 [95% CI 1.23-6.83]）。与没有出血的患者相比，大出血或危及生命的患者在一段时间内的平均精神成分汇总（MCS-12）得分较低（P = 0.01），而轻微出血患者的平均精神成分汇总（PCS-12）得分类似；这些患者的平均身体成分汇总（PCS-12）得分、EQ-5D指数和视觉模拟量表（VAS）相似。结论：大出血或危及生命的出血和中风与TAVI术后第一年死亡风险增加和心理QoL下降有关。
The impact of stroke and bleeding on mortality and quality of life during the first year after TAVI: A POPular TAVI subanalysis
Background
Bleeding and stroke are frequent complications after transcatheter aortic valve implantation (TAVI). The mortality risk associated with these events has been reported before, but data regarding their impact on health-related quality of life (QoL) is limited.
Aim
To evaluate the impact of bleeding and stroke occurring within 30 days after TAVI, on mortality and QoL during the first year after TAVI.
Methods
POPular TAVI was a randomized clinical trial that evaluated the addition of clopidogrel to aspirin or oral anticoagulation in patients undergoing TAVI. Besides clinical outcomes, QoL was assessed using the Short Form-12 and EuroQoL Five Dimensions questionnaires before, and at 3, 6, and 12 months after TAVI.
Results
Major or life-threatening bleeding occurred in 81 patients (8.3%) and was associated with an increased risk of death (hazard ratio [HR] 1.95 [95% confidence interval (CI) 1.00–3.79]); minor bleeding occurred in 104 patients (10.6%) and was not associated with mortality (HR 0.75 [95% CI 0.30–1.89]). Stroke occurred in 35 patients (3.6%) and was associated with an increased risk of death (HR 2.90 [95% CI 1.23–6.83]). Mean mental component summary (MCS-12) scores over time were lower in patients with major or life-threatening bleeding (p = 0.01), and similar in patients with minor bleeding, compared to patients without bleeding; mean physical component summary (PCS-12) scores, EQ-5D index, and visual analog scale (VAS) were similar between those patients. Mean MCS-12 scores were lower in patients with stroke (p = 0.01), mean PCS-12, EQ-5D index, and VAS were similar compared to patients without stroke.
Conclusion
Major or life-threatening bleeding and stroke were associated with an increased risk of death and decreased mental QoL in the first year after TAVI.
期刊介绍：
Catheterization and Cardiovascular Interventions is an international journal covering the broad field of cardiovascular diseases. Subject material includes basic and clinical information that is derived from or related to invasive and interventional coronary or peripheral vascular techniques. The journal focuses on material that will be of immediate practical value to physicians providing patient care in the clinical laboratory setting. To accomplish this, the journal publishes Preliminary Reports and Work In Progress articles that complement the traditional Original Studies, Case Reports, and Comprehensive Reviews. Perspective and insight concerning controversial subjects and evolving technologies are provided regularly through Editorial Commentaries furnished by members of the Editorial Board and other experts. Articles are subject to double-blind peer review and complete editorial evaluation prior to any decision regarding acceptability.
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