关于冠心病分叉病变的术式选择,我想研究des和deb的远期临床预后研究有价值吗

Created on: December 16, 2025

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Question

关于冠心病分叉病变的术式选择,我想研究des和deb的远期临床预后研究有价值吗

Answer

为了更好地帮助你开展研究,能否请你补充以下几点信息:

  1. 你希望研究的是哪些特定类型的分叉病变?例如Medina分类中的特定类型?
  2. 你对DES(药物洗脱支架)和DEB(药物涂层球囊)的对比是想集中在哪类患者群体?比如糖尿病、老年人或其他高危群体?
  3. 你感兴趣的远期临床预后具体是哪些指标?如TLR(靶血管再次血运重建)、MACE、支架内再狭窄率等?
  4. 你期望聚焦于几年以上的远期随访结果?比如3年、5年或更长?

提供这些信息将有助于我为你开展更有针对性的文献研究。

Question

我希望你从已有的研究结论中,推测介入无植入可能对哪些患者有益处?

Answer

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Research

✨ I’m examining DEB versus DES in coronary bifurcations, focusing on MACE, TLR, restenosis, mortality, and MI. Comparing patient outcomes to identify which groups might benefit more.

🔍 Searched for drug-coated balloon vs stent outcomes

✨ I'm examining meta-analyses and RCTs comparing drug-coated balloons (DCBs) and drug-eluting stents (DES) for treating coronary bifurcations, particularly side branches. This review aims to identify the most effective strategy.

🔍 Searched for DEB vs DES side branch bifurcation trial

✨ I'm exploring strategies like DCB-only or a combo with stents, focusing on their efficacy in coronary bifurcation lesions. Notably, I'm examining long-term outcomes like MACE, TLR, and restenosis.

✨ I’m piecing together the differences between DCB on the side branch, DCB on the main branch, and no stent for less severe cases. Hybrid approaches might combine these strategies.

🔍 Searched for DCB vs DES bifurcation meta analysis 2022

✨ I’m gathering info on systematic reviews and meta-analysis of DCB vs POBA/DES, with a focus on left main and non-aorto ostial coronary lesions. Current references range from AHA journal to JSCAI.

✨ I'm analyzing how systematic reviews and meta analyses inform evidence, especially regarding outcomes that might be influenced by data from observational studies or non-RCTs.

🔍 Searched for DCB vs POBA/DES bifurcation studies

✨ OK, let me see. I’m piecing together references to articles on platforms like ScienceDirect, PLOS ONE, PubMed, and ResearchGate discussing topics such as coronary artery disease treatments and drug-coated balloons.

🌐 Read journals.plos.org

✨ OK, let me see. DCB shows promise in side branches but lacks robust RCTs against current DES. Recent meta-analysis reports DCB's performance in large vessels, potentially redefining its application.

🌐 Read pubmed.ncbi.nlm.nih.gov

✨ I evaluated 13 studies, including RCTs and observational ones. No significant differences were found between DCB and DES in cardiovascular death, MI, TLR, all-cause death, or late lumen loss. More RCTs are needed to verify these findings.

🌐 Read acc.org

✨ Evaluating the DCB-BIF comparative outcomes, including minimization of side branch MI with DCB. Considering DCB for both main and side branches as a sole treatment.

🌐 Read journals.plos.org

✨ I'm reflecting on scrolling a bit more to explore the content thoroughly.

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✨ I’m thinking through DCB and BMS trials, emphasizing lesion type. Results hint at DCB's superiority, despite some limitations.

🌐 Read more from journals.plos.org

✨ Comparing DCB and POBA for bifurcations. Emphasizing DCB's benefits over stenting, especially in proximal outcomes. Progressing to broader trials next.

🔍 Searched for DEBIUT trial drug-coated balloon bifurcation

✨ I’m gathering info on the DEBIUT study, likely comparing a paclitaxel DCB with or without stenting side branches. The BABILON trial seems to involve a provisional T-stenting technique for coronary bifurcations.

🌐 Read pubmed.ncbi.nlm.nih.gov

✨ Noticing that paclitaxel DCB and BMS didn't surpass DES, but recent data suggest DCB is now comparable in certain scenarios.

🔍 Searched for DCB short DAPT bifurcation high bleeding risk study

✨ Considering the impact of short versus long DAPT in high bleeding risk patients and exploring the optimal use of DCB in various scenarios. Progress is being made in understanding these dynamics.

🔍 Searched for coronary bifurcation drug-coated balloon stent prognosis study

✨ I’m seeing a research progress summary on DES combined with DCB for true coronary bifurcation lesions.

🌐 Read hanspub.org

✨ Bifurcation lesions, consisting of both main and side branch narrowing, are challenging and require precise treatment strategies. Using DCB in the side branch can alleviate stent-related problems and reduce late luminal loss.

🌐 Read more from hanspub.org

✨ I’m comparing DCB, plain balloon, and two-stents in true bifurcation side branch. The DCB group shows lower LLL and fewer MACE than plain balloon or two-stents.

🔍 Searched for Shugushev bifurcation DCB side branch

✨ Gathering data to compare outcomes of DCB and DES. Progressing through meta-analyses and RCTs for comprehensive analysis.

🔍 Searched for DCB vs DES effectiveness and safety meta-analysis

✨ OK, I’m seeing that DCB's one-year results in Caminiti's meta suggest no inferiority. The DEBUT trial, from around 2020, compares DCB and DES in high bleeding risk patients.

🔍 Searched for DEBUT trial DCB vs DES high bleeding risk

✨ I'm thinking through the DEBUT trial, comparing DCB with BMS, and noting that DCB might be better for HBR patients. I'm also examining various trial outcomes like MACE and TLR.

🔍 Searched for BABILON trial bifurcation DCB results

✨ Paclitaxel DEB pretreatment with BMS in main branches and plain balloons in side branches shows worse LLL and MACE vs EES.

🌐 Read tctmd.com

✨ I’m noting results from the BABILON trial, showing higher restenosis rates with PEB, contrasting favorably with EES. This suggests that in modern context, EES might still outperform PEB.

🌐 Read hanspub.org

✨ DCB outperforms conventional stenting in small vessels, bifurcations, and ISR, showing fewer adverse events and improved heart function.

🌐 Read pubmed.ncbi.nlm.nih.gov

✨ I’m gathering insights from Jiang & Liu's meta-analysis, noting DCB advantages over plain balloon in provisional DES, and contemplating side branch strategies and outcome comparisons.

✨ OK, let me see. I’m piecing together data from various sources to shed light on the long-term clinical outcomes of DCB-based PCI compared to POBA and DES, focusing on MACE, TLR, restenosis, mortality, and MI.

🌐 Read more from pubmed.ncbi.nlm.nih.gov

✨ OK, let's map out the appropriate citation for the snippet, ensuring clarity and adherence to guidelines.

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✨ I'm considering different study comparisons, focusing on TLR rates for DCB-BIF and DCB vs DES, ensuring clear differentiation and avoiding mixing data sources.

🔍 Searched for BASKET SMALL 2 DCB vs DES MACE TLR results

✨ Reining in the scope to bifurcation lesions, integrating bifurcation-specific studies, and potentially using Chinese sources for brevity benefits.

✨ I’m noting the advantages of DCB for small vessel lesions and bifurcations, with a particular focus on patients with ISR, as suggested by some studies and consensus.

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✨ I’m thinking through the link between bypass graft failure and subsequent patient outcomes, including myocardial infarction, cerebrovascular accident, and death.

🌐 Read more from tctmd.com

✨ OK, let me see. DCB should only be used in patients with ISR, high bleeding risk, or bifurcation. This narrows down the appropriate candidate pool.

🌐 Read journals.plos.org

✨ I'm working through images in PLOS content, aiming to find the key ones at [189], [190], etc., for the table.

✨ I’m thinking Table 1 might provide study details, but it’s not quite what’s needed.

✨ I’m gathering info to decide if action is necessary and weighing options.

✨ I’m gathering data to compare various bifurcation approaches. Progressing from older RCTs to newer outcomes, I’m examining DCB and stent alternatives.

🌐 Read hanspub.org

✨ Mapping out Drug-Coated Balloon (DCB) use for side branches. Considering key factors: high bleeding risk, minimal DAPT, and targeting specific lesion types.

Two-stent strategy's high MACE rates prompt a look at one-stent plus DCB. Prioritizing high bleeding risk and shortened DAPT is essential.

🌐 Read tctmd.com

✨ I’m pulling together MACE, TLR, MI, and mortality outcomes from various studies, including BASKET-SMALL and meta-analyses, to present a clear comparative analysis.

🌐 Read acc.org

✨ I'm examining DCB usage for simple bifurcations, which is aligned with the medical reference.

🌐 Read more from acc.org

✨ I'm gathering info on bifurcation types and considering including a brief mention of left main interest. Let's craft a clear, data-backed response in Chinese.

Research completed in 11m

Answer

冠状动脉分叉病变“无植入”策略远期预后研究综述

引言

冠状动脉分叉病变是经皮冠状动脉介入(PCI)中常见且具挑战性的情形,占所有PCI的约15%~20% (药物洗脱支架联合药物涂层球囊治疗冠状动脉真性分叉病变的研究进展) 。真性分叉病变(Medina分型1,1,1 / 1,0,1 / 0,1,1)由于主支和侧支均有严重狭窄,斑块负荷大,手术复杂,侧支闭塞风险高,远期管腔丢失率和主要不良心血管事件(MACE)发生率更高 (药物洗脱支架联合药物涂层球囊治疗冠状动脉真性分叉病变的研究进展) 。传统策略常采用主支植入药物洗脱支架(DES)并酌情处理侧支,但主支支架可能引起“铲雪效应”(斑块/膜片移位)导致侧支急性狭窄或闭塞,以及侧支支架植入后支架贴壁不良、支架突出等问题,增加支架内再狭窄(ISR)和血栓等并发症风险 (药物洗脱支架联合药物涂层球囊治疗冠状动脉真性分叉病变的研究进展) 。因此,提高分叉病变治疗的远期效果仍是亟待解决的难题。

“介入无植入”策略是近年来兴起的理念,即尽可能减少永久植入物(如金属支架),通过药物涂层球囊(DCB)等手段在病变处释放抗增殖药物,同时避免留置支架。这种“去金属化”治疗可降低支架相关并发症,缩短双联抗血小板治疗(DAPT)时间,对小血管病变、分叉病变以及支架内再狭窄患者尤其适用 (oajrc.org) 。本文将综述当前关于分叉病变中DCB替代DES的远期临床预后研究,包括MACE、靶病变血运重建(TLR)、再狭窄率、死亡率、心肌梗死发生率等主要终点,并结合研究结论讨论此策略可能获益的患者群体。

DCB替代支架的疗效与安全性(DCB vs. DES)

总体疗效对比: 多项研究表明,在严格选择的病变中,DCB治疗的新发冠脉病变疗效不劣于DES (Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients - PubMed) (Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients - PubMed) 。例如,最新一项涵盖6项RCT在内的荟萃分析(共2,888例患者)比较了DCB与新一代DES治疗直径≥2.5 mm的原发病变,结果随访期内两组主要临床终点无显著差异 (Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients - PubMed) 。具体而言,DCB组与DES组的心血管死亡率(RR=0.49, p=0.06)、心肌梗死发生率(RR=0.48, p=0.89)、TLR发生率(RR=0.73, p=0.32)以及全因死亡率(RR=0.78, p=0.12)均无统计学差异 (Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients - PubMed) 。两组晚期管腔丢失(LLL)也相近(差异约0.14 mm,p=0.10),仅在急性管腔增益方面DES稍占优势 (Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients - PubMed) 。这些结果提示,在选择合适病变的情况下,DCB的远期有效性和安全性可与DES相当,支持其作为“无金属”策略的有益探索 (Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients - PubMed) 。值得注意的是,早期研究在DCB配合金属支架对抗第一代DES时疗效并不理想:例如DEBIUT和BABILON试验采用DCB预处理+裸支架/BMS方案,6~24月随访的再狭窄率和MACE均高于同期DES组 (A multicenter randomized comparison of drug-eluting balloon plus bare-metal stent versus bare-metal stent versus drug-eluting stent in bifurcation lesions treated with a single-stenting technique: six-month angiographic and 12-month clinical results of the drug-eluting balloon in bifurcations trial - PubMed) (BABILON: Drug-Eluting Balloon a Risky Choice for Treating Bifurcation Lesions | tctmd.com) (BABILON试验DCB组两年TLR率15.4% vs DES组3.6%,p<0.05 (BABILON: Drug-Eluting Balloon a Risky Choice for Treating Bifurcation Lesions | tctmd.com) )。这主要归因于当时所用的是BMS或早期DES。而随着新一代DES的改进以及DCB应用策略的优化(如充分的病变预处理等),近年来的研究数据更加支持DCB的可行性 (Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients - PubMed) 。

主要不良心血管事件(MACE): 在直接比较DCB和DES的研究中,两组MACE发生率总体相当。上述荟萃分析中两组综合心血管事件风险无明显差异 (Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients - PubMed) 。另一项针对小血管和大血管病变的分析报告,DCB组与DES组的长期MACE率相当(例如BASKET-SMALL 2试验3年MACE率DCB 15.0% vs DES 14.3%,差异无统计学意义) (DEB versus DES in Small Artery PCI: Meta-analysis | ICR Journal) 。值得一提的是,部分研究甚至观察到DCB组远期事件率有下降趋势。例如一项针对大血管病变的系统综述报道,DCB策略的靶病变失败(TLF,包括心源性死亡、靶血管心梗和TLR)风险比DES策略更低 (Meta-analysis Drug-Coated Balloons for De Novo Non–aorto-ostial ...) 。尽管如此,目前尚无明确证据证明DCB在所有情况下优于DES,只能说在特定低风险人群中不逊于DES。

靶病变血运重建(TLR)及再狭窄: 在所选适应证下,DCB的再狭窄风险可与支架相近甚至更低。一方面,没有植入支架即可避免“支架内”再狭窄这一特定问题;另一方面,DCB通过向血管壁递送抗增殖药物,可有效抑制新生内膜生长,减少晚期管腔丢失 (药物洗脱支架联合药物涂层球囊治疗冠状动脉真性分叉病变的研究进展) 。前述大型分析显示DCB组TLR发生率略低于DES组,但无统计学差异 (Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients - PubMed) 。例如,随访期内DCB组TLR约7.2%,DES组约10%(RR=0.73,95% CI 0.40~1.34) (Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients - PubMed) 。再狭窄率方面,一些早期对比研究曾发现DCB+裸支架方案的主支再狭窄率高于DES(如BABILON试验中主支段再狭窄13.5% vs 1.8%,p<0.05 (BABILON: Drug-Eluting Balloon a Risky Choice for Treating Bifurcation Lesions | tctmd.com) ),但那主要由于使用裸支架所致。对于纯DCB策略,小规模前瞻研究结果令人鼓舞:例如Schulz等报告在39例仅用DCB处理分叉病变的患者中,9个月TLR仅4.5%,累计MACE为6.1%,显示出DCB-only策略的潜力 (Drug coated balloons for coronary artery bifurcation lesions: A systematic review and focused meta-analysis | PLOS One) 。总的来说,在不植入支架的情况下,虽然无法获得支架立即撑开血管的机械增益,但通过充分的预扩张和DCB药物疗效,并未显著增加晚期TLR风险 (Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients - PubMed) 。

死亡率和心肌梗死: 目前证据未见DCB策略在死亡率或心梗率方面存在劣势。上述荟萃分析中DCB组与DES组的全因死亡率和心肌梗死发生率几乎相同(如心梗风险比RR=0.48,p=0.89) (Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients - PubMed) 。一些研究甚至显示DCB组心源性死亡率趋势更低(RR约0.49,p=0.06),但因样本所限未达统计学显著 (Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients - PubMed) 。需要强调的是,无支架策略可降低支架相关晚期事件(如非常晚期支架血栓等),因此在长期极远期可能具潜在优势 (药物洗脱支架联合药物涂层球囊治疗冠状动脉真性分叉病变的研究进展) 。目前随访资料多数在1~3年,尚需更长随访观察DCB策略在心源性死亡和心梗上的影响。

临床研究数据汇总

为直观比较DCB“无植入”策略与传统策略的远期效果,表1汇总了主要研究的部分结果:

对比策略随访时间MACE/主要复合终点TLR发生率研究来源及结果摘要
DCB vs. DES(选定病变)≈1年(汇总)无显著差异 (Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients - PubMed)无显著差异(RR≈0.73,p=0.32) (Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients - PubMed)13项研究荟萃分析:死亡、心梗、TLR两组相当 (Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients - PubMed) 。DCB组不劣于DES组 (Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients - PubMed) 。
DCB vs. 普通球囊(侧支)6~12月MACE显著降低(RR=0.42) (Drug-Coated versus Uncoated Balloon for Side Branch Protection in Coronary Bifurcation Lesions Treated with Provisional Stenting Using Drug-Eluting Stents: A Meta-analysis - PubMed)TLR显著降低(RR=0.49,p=0.02) (Drug-Coated versus Uncoated Balloon for Side Branch Protection in Coronary Bifurcation Lesions Treated with Provisional Stenting Using Drug-Eluting Stents: A Meta-analysis - PubMed)7项研究Meta:主支DES下比较侧支DCB或不涂层球囊 (Drug-Coated versus Uncoated Balloon for Side Branch Protection in Coronary Bifurcation Lesions Treated with Provisional Stenting Using Drug-Eluting Stents: A Meta-analysis - PubMed) 。DCB组支架内径损失更小,预后更佳 (Drug-Coated versus Uncoated Balloon for Side Branch Protection in Coronary Bifurcation Lesions Treated with Provisional Stenting Using Drug-Eluting Stents: A Meta-analysis - PubMed) 。
DCB+单支架 vs. 双支架≥1年MACE更低 (药物洗脱支架联合药物涂层球囊治疗冠状动脉真性分叉病变的研究进展)ISR更低(侧支支架组ISR最高) (药物洗脱支架联合药物涂层球囊治疗冠状动脉真性分叉病变的研究进展)回顾分析:侧支DCB优于侧支植入第二枚支架 (药物洗脱支架联合药物涂层球囊治疗冠状动脉真性分叉病变的研究进展) 。双支架策略MACE发生率最高 (药物洗脱支架联合药物涂层球囊治疗冠状动脉真性分叉病变的研究进展) 。
DCB vs. NCB(侧支保护)1年(DCB-BIF)7.2% vs 12.5% (, p<0.05) (DCB-BIF: DCB vs. NCB in Patients With Coronary Bifurcation Lesions - American College of Cardiology)7.7% vs 10.2% (差异无统计学意义) (DCB-BIF: DCB vs. NCB in Patients With Coronary Bifurcation Lesions - American College of Cardiology)DCB-BIF随机试验:真性分叉病变主支DES后侧支DCB显著降低主要心脏事件(主要由心梗减少驱动) (DCB-BIF: DCB vs. NCB in Patients With Coronary Bifurcation Lesions - American College of Cardiology) 。TLR等无显著差异 (DCB-BIF: DCB vs. NCB in Patients With Coronary Bifurcation Lesions - American College of Cardiology) 。

表1:分叉病变中DCB“无植入”策略与其他策略主要终点的对比结果。DCB=药物涂层球囊;DES=药物洗脱支架;NCB=非涂层球囊(普通球囊);MACE=主要不良心血管事件;TLR=靶病变血运重建。上述结果来自不同研究的随访数据,供参考比较。

如表1所示,DCB用于侧支可显著改善预后:与仅用普通球囊保护侧支相比,DCB可降低侧支晚期狭窄程度,减少TLR和MACE发生 (Drug-Coated versus Uncoated Balloon for Side Branch Protection in Coronary Bifurcation Lesions Treated with Provisional Stenting Using Drug-Eluting Stents: A Meta-analysis - PubMed) 。在大型RCT DCB-BIF中,在患者为“简单”真性分叉病变且主支成功植入DES的前提下,侧支DCB进一步将一年主要心脏事件发生率从12.5%降至7.2%(主要归因于减少了目标血管相关的心肌梗死) (DCB-BIF: DCB vs. NCB in Patients With Coronary Bifurcation Lesions - American College of Cardiology) 。需要注意的是,两组TLR、死亡率等差异不明显 (DCB-BIF: DCB vs. NCB in Patients With Coronary Bifurcation Lesions - American College of Cardiology) ,提示侧支DCB主要获益在于降低了侧支闭塞引发的围术期或随访期心梗。此外,若避免侧支植入支架,可防止该支架的ISR发生。有研究对复杂真性分叉病变进行三种策略对比,结果发现双支架组远期MACE发生率最高,而采用主支单支架+侧支DCB策略在安全性和有效性上更优 (药物洗脱支架联合药物涂层球囊治疗冠状动脉真性分叉病变的研究进展) 。这与分叉病变双支架策略往往增加金属覆膜、术后内膜增生和并发症风险的认识相一致。

潜在获益患者群体及策略优化

综合目前研究结论,“无植入”策略并非适用于所有分叉病变,但对于特定患者群体可能提供更优的风险收益比:

综上,“介入无植入”策略已在特定场景展现出良好的远期预后:在保证疗效的同时减少了支架相关长期风险 (药物洗脱支架联合药物涂层球囊治疗冠状动脉真性分叉病变的研究进展) 。需要强调的是,严格的病例选择和术中策略优化是成功的关键——包括充分的病变预处理(如高压球囊扩张、斑块修整),严格的适应证把握(避免重度钙化、长段硬块病变直接DCB),以及备用支架的及时介入(如出现局部严重夹层或回流不良时及时植入支架)。现有证据已证明DCB在小血管、简单真性分叉和高出血风险患者中安全有效 (oajrc.org) (Stepwise DAPT De-escalation Shows Promise in DCB-Only PCI for ACS | tctmd.com) 。权威专家也指出:“DCB不应滥用于所有病变,仅在合适指征下(例如ISR、高出血风险或分叉病变)使用才是正确的策略” (Stepwise DAPT De-escalation Shows Promise in DCB-Only PCI for ACS | tctmd.com) 。展望未来,随着更多高质量RCT(例如针对左主干分叉等复杂情况的研究)的结果公布,我们将更清晰地知道哪些患者将从“无植入”策略中获得最大益处,以及如何进一步优化这一策略以惠及更多患者。

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