PACEmaker & Beta-Blocker Therapy Post-Myocardial Infarct

PACEmaker和B受体阻滞剂治疗后心肌梗死（PACE-MI）试验将调查是否 起搏器辅助β受体阻滞剂治疗降低了总死亡率+非致死性的联合终点 患有心肌梗死并有心动过缓禁忌症的患者再次梗死 β受体阻滞剂目前，这些患者没有接受β受体阻滞剂治疗，因为他们可能会发展成 可能有危险的缓慢性心律失常因为β受体阻滞剂是非常有效的药物 在降低心肌梗死后死亡率和再梗死方面，特别是在高危亚组中， 越来越重视其使用。排除β受体阻滞剂治疗的心动过缓患者 理论上，如果先植入起搏器以提供备用频率， 支持.由于这些患者通常被排除在临床试验之外，因此没有直接数据表明 支持这样的建议。PACE-MI试验的具体目的是测试起搏器是否 心肌梗死后易化β受体阻滞剂治疗在这一亚组中具有临床优势， 患者这一目标将在这项多中心临床试验中实现，在该试验中， 有心动过缓或心脏传导阻滞禁忌症的心肌梗死患者， 随机接受标准治疗（不包括β受体阻滞剂，因为这些患者 有禁忌症）或标准治疗加起搏器和β受体阻滞剂。这一具体目标 重要的意义在于：1）提供数据来支持（如果假设得到验证） 医疗保险覆盖政策; 2）为起搏器易化β- 阻滞剂治疗; 3）即使在现代管理时代，也要强调β阻滞剂治疗的重要性 心肌梗死，特别是在目前治疗不足的老年人群中。试验主要 复合终点是总死亡率加上非致命性再梗死。入组试验的患者将接受两次随访 年样本量为1124例患者，将入组60家临床试验机构。

The PACEmaker & B-Blocker Therapy Post-Myocardial Infarction (PACE-MI) Trial will investigate whether pacemaker facilitated beta blocker therapy decreases the combined endpoint of total mortality plus nonfatal reinfarction in patients who have suffered a myocardial infarction and have bradycardia contraindications to beta blockers. Currently, these patients are not treated with beta blockers due to the likelihood of developing potentially dangerous bradyarrhythmias from treatment. Because beta blockers are highly effective agents in reducing mortality and reinfarction post-myocardial infarction, particularly in high risk subgroups, there has been increasing emphasis on their use. The patients with bradycardia precluding beta blocker therapy could, in theory, be treated with beta blockers if a pacemaker is implanted first to provide backup rate support. As these patients have been routinely excluded from clinical trials, there is no direct data to support such a recommendation. The specific aim of the PACE-MI Trial is to test whether pacemaker facilitated beta blocker therapy after myocardial infarction confers a clinical advantage in this subgroup of patients. This aim will be accomplished in this multicenter clinical trial in which patients within one month of a myocardial infarction who have either bradycardia or heart block contraindications to beta blockers will be randomized to receive either standard therapy (which would not include a beta-blocker as these patients have contraindications) or standard therapy plus a pacemaker and beta-blocker. This specific aim has important implications in that it will: 1) Provide data to support (if the hypothesis is verified) a change in Medicare coverage policy; 2) Provide support for the treatment paradigm of pacemaker facilitated beta- blocker therapy; 3) Highlight the importance of beta blocker therapy even in the modern era of management of myocardial infarction, particularly in the currently undertreated elderly population. The trial primary composite is total mortality plus nonfatal reinfarction. Patients enrolled in the trial will be followed for two years. The sample size will be 1124 patients who will be enrolled in 60 sites.