Transcatheter aortic valve implantation (TAVI) has become the preferred treatment option for patients with severe aortic stenosis at increased risk for surgical aortic valve replacement (SAVR) and for older patients irrespective of risk. However, in younger, low-risk patients for whom both therapeutic options, TAVI and SAVR, are applicable, the optimal treatment strategy remains controversial, as data on long-term outcomes remain limited. The DEDICATE-DZHK6 Trial is an investigator-initiated, industry-independent, prospective, multicentre, randomised controlled trial investigating the efficacy and safety of TAVI compared to SAVR in low- to intermediate-risk patients aged 65 years or older. To evaluate both treatment strategies, approximately 1,404 patients determined eligible for both TAVI and SAVR by the interdisciplinary Heart Team were randomised to TAVI or SAVR. Broad inclusion and strict exclusion criteria targeted an all-comers patient population. Procedures were performed according to local best practice with contemporary routine medical devices. The primary endpoints are a composite of mortality or stroke at 1 year and 5 years in order to incorporate midterm efficacy results and complement early safety data. Primary outcomes will be tested sequentially for non-inferiority and superiority. The DEDICATE-DZHK6 Trial has been designed to mirror clinical reality for the treatment of severe aortic stenosis and provide unique information on overall outcomes after TAVI and SAVR that can be directly applied to clinical routines. Its results will help further define optimal treatment strategies for low- to intermediate-risk patients in whom both TAVI and SAVR are currently advisable.

中文翻译：

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低至中度手术风险患者的经导管主动脉瓣植入与手术主动脉瓣置换：随机 DEDICATE 试验的基本原理和设计。

经导管主动脉瓣植入术 (TAVI) 已成为主动脉瓣置换术 (SAVR) 风险增加的严重主动脉瓣狭窄患者以及无论风险如何的老年患者的首选治疗选择。然而，对于 TAVI 和 SAVR 两种治疗方案都适用的年轻、低风险患者，最佳治疗策略仍然存在争议，因为长期结果的数据仍然有限。DEDICATE-DZHK6 试验是一项由研究者发起、行业独立、前瞻性、多中心、随机对照试验，旨在研究 TAVI 与 SAVR 相比在 65 岁或以上低至中危患者中的疗效和安全性。为了评估这两种治疗策略，跨学科心脏团队确定约 1,404 名患者符合 TAVI 和 SAVR 的资格，被随机分配接受 TAVI 或 SAVR。广泛的纳入和严格的排除标准针对所有患者群体。手术是根据当地最佳实践使用当代常规医疗设备进行的。主要终点是 1 年和 5 年死亡率或卒中的综合终点，以便纳入中期疗效结果并补充早期安全性数据。主要结果将依次进行非劣效性和优效性测试。DEDICATE-DZHK6 试验旨在反映严重主动脉瓣狭窄治疗的临床现实，并提供有关 TAVI 和 SAVR 后总体结果的独特信息，可直接应用于临床常规。其结果将有助于进一步确定目前建议采用 TAVI 和 SAVR 的低至中风险患者的最佳治疗策略。