Divisione di Medicina Generale II, Dipartimento di Scienze della Salute, ASST Santi Paolo e Carlo, Università degli Studi di Milano, Milan, Italy.
Divisione di Cardiologia, Dipartimento di Scienze della Salute, ASST Santi Paolo e Carlo, Università degli Studi di Milano, Milan, Italy.
Thromb Haemost. 2024 May;124(5):482-496. doi: 10.1055/a-2149-4344. Epub 2023 Aug 7.
The value of guided therapy (GT) with anti-P2Y12 drugs in percutaneous coronary intervention (PCI) is unclear. Meta-analyses lumped together randomized controlled trials (RCTs) with heterogeneous designs, comparing either genotype-GT or platelet function test (PFT)-GT with unguided therapy. Some meta-analysis also included RCTs that did not explore GT, but included the effects of switching patients with high on-treatment platelet reactivity (HTPR) to alternative therapies (HTPR-Therapy). We performed three distinct systematic reviews/meta-analyses, each exploring only RCTs with homogeneous design.
MEDLINE, Embase, and Central databases were searched for RCTs testing genotype-GT, PFT-GT, or HTPR-Therapy in PCI-treated patients, through October 1, 2022. Two reviewers extracted the data. Risk ratios (RRs) (95% confidence intervals) were calculated. Primary outcomes were major bleedings (MBs) and major adverse cardiovascular events (MACE).
In seven genotype-GT RCTs, RRs were: MB, 1.06 (0.73-1.54; = 0.76); MACE, 0.65 (0.47-0.91; = 0.01), but significant risk reduction was observed in RCTs performed in China (0.30, 0.16-0.54; < 0.0001) and not elsewhere (0.75, 0.48-1.18; = 0.21). In six PFT-GT RCTs, RRs were: MB, 0.91 (0.64-1.28, = 0.58); MACE, 0.82 (0.56-1.19; = 0.30): 0.62 (0.42-0.93; = 0.02) in China, 1.08 (0.82-1.41; = 0.53) elsewhere. In eight HTPR-Therapy RCTs, RRs were: MB, 0.71 (0.41-1.23; = 0.22); MACE, 0.57 (0.44-0.75; < 0.0001): 0.56 (0.43-0.74, < 0.0001) in China, 0.58 (0.27-1.23, = 0.16) elsewhere.
No GT strategy affected MB. Overall, genotype-GT but not PFT-GT reduced MACE. However, genotype-GT and PFT-GT reduced MACE in China, but not elsewhere. PFT-GT performed poorly compared to HTPR-Therapy, likely due to inaccurate identification of HTPR patients by PFT.
经皮冠状动脉介入治疗（PCI）中，指导治疗（GT）联合抗 P2Y12 药物的价值尚不清楚。荟萃分析将设计存在异质性的随机对照试验（RCT）混合在一起，比较基因分型-GT 或血小板功能试验（PFT）-GT 与非指导治疗。一些荟萃分析还包括未探索 GT 的 RCT，但纳入了对高治疗血小板反应性（HTPR）患者转换为替代治疗（HTPR-治疗）的影响。我们进行了三项不同的系统评价/荟萃分析，每项分析均仅探索设计同质的 RCT。
通过检索 MEDLINE、Embase 和中央数据库，我们搜索了截至 2022 年 10 月 1 日，在接受 PCI 治疗的患者中测试基因分型-GT、PFT-GT 或 HTPR-治疗的 RCT。两位评审员提取数据。计算风险比（RR）（95%置信区间）。主要结局为主要出血（MB）和主要不良心血管事件（MACE）。
在 7 项基因分型-GT RCT 中，RR 分别为：MB，1.06（0.73-1.54；=0.76）；MACE，0.65（0.47-0.91；=0.01），但在中国进行的 RCT 中观察到显著的风险降低（0.30，0.16-0.54；<0.0001），而在其他地方则未观察到（0.75，0.48-1.18；=0.21）。在 6 项 PFT-GT RCT 中，RR 分别为：MB，0.91（0.64-1.28，=0.58）；MACE，0.82（0.56-1.19；=0.30）：0.62（0.42-0.93；=0.02）在中国，1.08（0.82-1.41；=0.53）在其他地方。在 8 项 HTPR-治疗 RCT 中，RR 分别为：MB，0.71（0.41-1.23；=0.22）；MACE，0.57（0.44-0.75；<0.0001）：0.56（0.43-0.74，<0.0001）在中国，0.58（0.27-1.23；=0.16）在其他地方。
没有 GT 策略会影响 MB。总体而言，基因分型-GT 而非 PFT-GT 降低了 MACE。然而，基因分型-GT 和 PFT-GT 在降低中国的 MACE，但在其他地方没有。与 HTPR-治疗相比，PFT-GT 表现不佳，这可能是由于 PFT 不准确地识别 HTPR 患者。
