我认为,越来越多的证据支持这种做法。已经有多项随机试验及注册对比研究表明,短期双联抗血小板治疗的疗效至少与相对更长期治疗相当,而后者具有增加出血风险的劣势。我认为在广泛缩短双联抗血小板持续时间前,必须首先认识到自行停药与因其他原因如出血或需手术的停药是不同的。所有人群的支架放置情况可能更复杂,尚不确定我们已拥有充足的证据来普遍采用短期双联抗血小板治疗。
Duane Pinto博士 哈佛医学院波士顿贝斯以色列女执事医疗中心
<International Circulation>: Regarding dual antiplatelet therapy, when talking about patients using second-generation drug-eluding stents, is there sufficient evidence to promote the application of short-term dual antiplatelet therapy versus long-term antiplatelet therapy?
Dr. Pinto: I think there is accumulating evidence to support this practice. We’ve had numerous randomized trials as well as registry comparisons that have shown at least equivalent outcomes compared with longer duration therapy, and (this) longer duration therapy may be associated with increased risk of bleeding. Now I think before we have an unrestrained approach to short duration of dual antiplatelet therapy, I think we have to recognize that protocol-mandated discontinuation is different from discontinuation for cause. For example, a patient has bleeding or needs surgery.
In an all-comers population, where there may be more complex stenting, I’m not sure that we have sufficient evidence to apply this uniformly. I would be cautiously optimistic. The trials, by virtue of the infrequent nature of stent thrombosis, are somewhat underpowered to detect small differences. So I think we have enough information in selected cases where we have to do it, but remember, that was the FDA guideline from the beginning. 12 months of therapy if the person is at acceptable bleeding risk so for a person who is thought to be at high bleeding risk or is having a bleeding complication, I think we can feel more comfortable that our stent is not going to thrombus with the newer generation stents. Certainly the newer generation stents are better than the first generation.
《国际循环》:就双联抗血小板治疗而言,与长期治疗相比,是否有充足证据支持应用第二代药物洗脱支架的患者采用短期双联抗血小板治疗?
Pinto博士:我认为,越来越多的证据支持这种做法。已经有多项随机试验及注册对比研究表明,短期双联抗血小板治疗的疗效至少与相对更长期治疗相当,而后者具有增加出血风险的劣势。我认为在广泛缩短双联抗血小板持续时间前,必须首先认识到自行停药与因其他原因如出血或需手术的停药是不同的。所有人群的支架放置情况可能更复杂,尚不确定我们已拥有充足的证据来普遍采用短期双联抗血小板治疗。我持谨慎乐观的态度。鉴于支架内血栓形成并不经常发生,临床试验有时无法发现较小的差异。因此,我认为已经有充分信息支持在特定患者中采用这一策略,但仍要牢记FDA指南的一贯推荐。在可接受的出血风险前提下,可实施为期12个月的双联抗血小板治疗;如果患者存在较高的出血风险或出血并发症,可能应用新一代支架的血栓形成风险更低,更安全。当然,新一代支架肯定优于第一代支架。
<International Circulation>:So what about patient selection, those candidates for this therapy, who would be ideal for short-term therapy?
Dr. Pinto: Next generation stents, short–focal lesions in a person who’s at high bleeding risk. For example, patients on anti-coagulation for atrial fibrillation, where we may not want triple therapy and such, we can consider those patients. I think you want to have a very effective outcome in a patient where you are “on balance” worried about dual anti-platelet therapy and the risk of complications.
《国际循环》:就患者选择而言,哪些患者更适合行短期双联抗血小板治疗?
Pinto博士:我认为存在较高出血风险的短期局部病变患者采用新一代支架治疗时最适合行双联抗血小板治疗,如不愿采用三联抗血小板治疗的心房颤动抗凝患者。要平衡双联抗血小板治疗的获益与并发症风险,有效改善患者结局。
<International Circulation>:Same-day discharge post-PCI can reduce health care costs. How can we apply this in clinical practice and make it a viable option?
Dr. Pinto: You’re right to point out that you use fewer resources with same-day discharge. Those are primarily hospital resources (nurses time, overhead and such). As for reimbursement for outpatient procedures, it is much lower compared to inpatient and most PCIs are outpatient. We have to be able to use our margin most effectively. That means having the resources committed to a same day program so the patients are safe and supported. This involves being able to teach them about their procedure prior to their discharge, having the ability to come back rapidly if necessary, and to observe the patient for 4-6 hours (majority of complications occur during this window of time). Similarly, it’s not enough to just discharge patients same day, because the opportunity is created now to do something else with those hospital beds. If you don’t do something else with those hospital beds, you’re not realizing any benefit. The only thing you’ve saved is an extra meal tray that night. Repurposing those beds, either by closing them or other inpatient stays to realize a financial benefit. Otherwise, it’s an additional cost.
《国际循环》:PCI术后当天出院能降低医疗成本,我们应如何推进其在临床实践中的实施进程?
Pinto博士:你提到当天出院能减少医疗资源应用是正确的,主要是医院资源(护理及院内开销等)。门诊报销费用比住院费用低得多,大多数PCI在门诊实施。我们需要更有效地利用资源。这意味着要将更多资源投入到当天出院策略中,使患者得到支持,确保其安全。我们需要能在患者出院前就其所接受的治疗进行教育和告知,使其在必要时能迅速赶回医院;还需对患者进行4~6小时的观察(因为大多数并发症发生在这个时间窗内)。同时,仅让患者当天出院远远不够,还需充分利用节省出的病床,否则无法实现从中获益。通过关闭或让其他患者住院再利用这些病床才能带来经济获益。