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PCI in Patients Undergoing Transcatheter Aortic-Valve Implantation.
The New England Journal of Medicine ( IF 96.2 ) Pub Date : 2024-08-31 , DOI: 10.1056/nejmoa2401513 Jacob Lønborg 1 , Reza Jabbari 1 , Muhammad Sabbah 1 , Karsten T Veien 1 , Matti Niemelä 1 , Phillip Freeman 1 , Rickard Linder 1 , Dan Ioanes 1 , Christian J Terkelsen 1 , Olli A Kajander 1 , Sasha Koul 1 , Mikko Savontaus 1 , Pasi Karjalainen 1 , Andrejs Erglis 1 , Mikko Minkkinen 1 , Rikke Sørensen 1 , Hans-Henrik Tilsted 1 , Lene Holmvang 1 , Gintautas Bieliauskas 1 , Julia Ellert 1 , Jarkko Piuhola 1 , Ashkan Eftekhari 1 , Oskar Angerås 1 , Andreas Rück 1 , Evald H Christiansen 1 , Troels Jørgensen 1 , Burcu T Özbek 1 , Charlotte Glinge 1 , Lars Søndergaard 1 , Ole De Backer 1 , Thomas Engstrøm 1 ,
The New England Journal of Medicine ( IF 96.2 ) Pub Date : 2024-08-31 , DOI: 10.1056/nejmoa2401513 Jacob Lønborg 1 , Reza Jabbari 1 , Muhammad Sabbah 1 , Karsten T Veien 1 , Matti Niemelä 1 , Phillip Freeman 1 , Rickard Linder 1 , Dan Ioanes 1 , Christian J Terkelsen 1 , Olli A Kajander 1 , Sasha Koul 1 , Mikko Savontaus 1 , Pasi Karjalainen 1 , Andrejs Erglis 1 , Mikko Minkkinen 1 , Rikke Sørensen 1 , Hans-Henrik Tilsted 1 , Lene Holmvang 1 , Gintautas Bieliauskas 1 , Julia Ellert 1 , Jarkko Piuhola 1 , Ashkan Eftekhari 1 , Oskar Angerås 1 , Andreas Rück 1 , Evald H Christiansen 1 , Troels Jørgensen 1 , Burcu T Özbek 1 , Charlotte Glinge 1 , Lars Søndergaard 1 , Ole De Backer 1 , Thomas Engstrøm 1 ,
Affiliation
BACKGROUND
The benefit of percutaneous coronary intervention (PCI) in patients with stable coronary artery disease and severe aortic stenosis who are undergoing transcatheter aortic-valve implantation (TAVI) remains unclear.
METHODS
In an international trial, we randomly assigned, in a 1:1 ratio, patients with severe symptomatic aortic stenosis and at least one coronary-artery stenosis with a fractional flow reserve of 0.80 or less or a diameter stenosis of at least 90% either to undergo PCI or to receive conservative treatment, with all patients also undergoing TAVI. The primary end point was a major adverse cardiac event, defined as a composite of death from any cause, myocardial infarction, or urgent revascularization. Safety, including bleeding events and procedural complications, was assessed.
RESULTS
A total of 455 patients underwent randomization: 227 to the PCI group and 228 to the conservative-treatment group. The median age of the patients was 82 years (interquartile range, 78 to 85), and the median Society of Thoracic Surgeons-Predicted Risk of Mortality score (on a scale from 0 to 100%, with higher scores indicating a greater risk of death within 30 days after the procedure) was 3% (interquartile range, 2 to 4). At a median follow-up of 2 years (interquartile range, 1 to 4), a major adverse cardiac event (primary end point) had occurred in 60 patients (26%) in the PCI group and in 81 (36%) in the conservative-treatment group (hazard ratio, 0.71; 95% confidence interval [CI], 0.51 to 0.99; P = 0.04). A bleeding event occurred in 64 patients (28%) in the PCI group and in 45 (20%) in the conservative-treatment group (hazard ratio, 1.51; 95% CI, 1.03 to 2.22). In the PCI group, 7 patients (3%) had PCI procedure-related complications.
CONCLUSIONS
Among patients with coronary artery disease who were undergoing TAVI, PCI was associated with a lower risk of a composite of death from any cause, myocardial infarction, or urgent revascularization at a median follow-up of 2 years than conservative treatment. (Funded by Boston Scientific and the Danish Heart Foundation; NOTION-3 ClinicalTrials.gov number, NCT03058627.).
中文翻译:
经导管主动脉瓣植入术患者的 PCI。
背景经皮冠状动脉介入治疗 (PCI) 对接受经导管主动脉瓣植入术 (TAVI) 的稳定冠状动脉疾病和严重主动脉瓣狭窄患者的益处仍不清楚。方法 在一项国际试验中,我们以 1:1 的比例随机分配患有严重症状性主动脉瓣狭窄和至少一例血流储备分数为 0.80 或更小或直径狭窄至少 90% 的冠状动脉狭窄患者接受 PCI 或接受保守治疗,所有患者也接受 TAVI。主要终点是主要不良心脏事件,定义为全因死亡、心肌梗死或紧急血运重建的复合。评估了安全性,包括出血事件和手术并发症。结果 共有 455 例患者接受了随机分组: PCI 组 227 例,保守治疗组 228 例。患者的中位年龄为 82 岁(四分位距,78 至 85 岁),胸外科医师协会预测死亡风险评分的中位数(从 0 到 100% 的范围内,分数越高表示手术后 30 天内死亡的风险越高)为 3%(四分位距,2 至 4)。中位随访 2 年 (四分位距,1 至 4),PCI 组 60 例 (26%) 患者和保守治疗组 81 例 (36%) 发生了主要不良心脏事件(主要终点)(风险比,0.71;95% 置信区间 [CI],0.51 至 0.99;P = 0.04)。PCI 组 64 例 (28%) 患者发生出血事件,保守治疗组 45 例 (20%) 发生出血事件 (风险比,1.51;95% CI,1.03 至 2.22)。在 PCI 组中,7 例患者 (3%) 出现 PCI 手术相关并发症。 结论 在接受 TAVI 的冠状动脉疾病患者中,与保守治疗相比,PCI 与中位随访 2 年时全因死亡、心肌梗死或紧急血运重建的复合风险较低相关。(由波士顿科学公司和丹麦心脏基金会资助;NOTION-3 ClinicalTrials.gov number, NCT03058627.)。
更新日期:2024-08-31
中文翻译:
经导管主动脉瓣植入术患者的 PCI。
背景经皮冠状动脉介入治疗 (PCI) 对接受经导管主动脉瓣植入术 (TAVI) 的稳定冠状动脉疾病和严重主动脉瓣狭窄患者的益处仍不清楚。方法 在一项国际试验中,我们以 1:1 的比例随机分配患有严重症状性主动脉瓣狭窄和至少一例血流储备分数为 0.80 或更小或直径狭窄至少 90% 的冠状动脉狭窄患者接受 PCI 或接受保守治疗,所有患者也接受 TAVI。主要终点是主要不良心脏事件,定义为全因死亡、心肌梗死或紧急血运重建的复合。评估了安全性,包括出血事件和手术并发症。结果 共有 455 例患者接受了随机分组: PCI 组 227 例,保守治疗组 228 例。患者的中位年龄为 82 岁(四分位距,78 至 85 岁),胸外科医师协会预测死亡风险评分的中位数(从 0 到 100% 的范围内,分数越高表示手术后 30 天内死亡的风险越高)为 3%(四分位距,2 至 4)。中位随访 2 年 (四分位距,1 至 4),PCI 组 60 例 (26%) 患者和保守治疗组 81 例 (36%) 发生了主要不良心脏事件(主要终点)(风险比,0.71;95% 置信区间 [CI],0.51 至 0.99;P = 0.04)。PCI 组 64 例 (28%) 患者发生出血事件,保守治疗组 45 例 (20%) 发生出血事件 (风险比,1.51;95% CI,1.03 至 2.22)。在 PCI 组中,7 例患者 (3%) 出现 PCI 手术相关并发症。 结论 在接受 TAVI 的冠状动脉疾病患者中,与保守治疗相比,PCI 与中位随访 2 年时全因死亡、心肌梗死或紧急血运重建的复合风险较低相关。(由波士顿科学公司和丹麦心脏基金会资助;NOTION-3 ClinicalTrials.gov number, NCT03058627.)。