Abstract：
OBJECTIVE: Cardiovascular complications after revascularization to treat chronic limb-threatening ischemia (CLTI) are a major concern that guides treatment. Our goal was to assess periprocedural cardiac and vascular serious adverse events (SAEs) in the Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial.
METHODS: BEST-CLI was a prospective randomized trial comparing surgical (OPEN) and endovascular (ENDO) revascularization for patients with CLTI. Thirty-day SAEs, classified as cardiac or vascular, were analyzed. Adverse events are defined as serious when they affect safety in the trial, require prolonged hospitalization, result in significant disability or incapacitation, are life-threatening, or result in death. Interventions were analyzed in a per protocol fashion.
RESULTS: In the BEST-CLI trial, 850 OPEN and 896 ENDO interventions were evaluated. Forty (4.7%) and 34 (3.8%) patients experienced at least one cardiac SAE after OPEN and ENDO intervention, respectively (P = .35). Overall, there were 53 cardiac SAEs (0.06 per patient) after OPEN and 40 (0.045 per patient) after ENDO interventions. Cardiac SAEs in the OPEN arm were classified as related to ischemia (50.9%), arrhythmias (17%), heart failure (15.1%), arrest (13.2%), and heart block (3.8%); in the ENDO arm, they were classified as ischemia (47.5%), heart failure (17.5%), arrhythmias (15%), arrest (15%), and heart block (5%). Approximately half of SAEs were classified as severe for both OPEN and ENDO. SAEs were definitely or probably related to the procedure in 30.2% and 25% in the OPEN and ENDO arms, respectively (P = .2). Vascular SAEs occurred in 58 (6.8%) and 86 (9.6%) of patients after OPEN and ENDO revascularization, respectively (P = .19). In total, there were 59 (0.07 per patient) and 87 (0.097 per patient) vascular SAEs after OPEN and ENDO procedures. Vascular SAEs in the OPEN arm were classified as distal ischemia/infection (44.1%), bleeding (16.9%), occlusive (15.3%), thromboembolic (15.3%), cerebrovascular (5.1%), and other (3.4%); in the ENDO arm, they were distal ischemia/infection (40.2%), occlusive (31%), bleeding (12.6%), thromboembolic (8%), cerebrovascular (1.1%), and other (4.6%). SAEs were classified as severe for OPEN in 45.8% and ENDO in 46%. SAEs were definitely or probably related to the procedure in 23.7% and 35.6% in the OPEN and ENDO arms (P = .35), respectively.
CONCLUSIONS: Patients undergoing OPEN and ENDO revascularization experienced similar degrees of cardiac and vascular SAEs. The majority were not related to the index intervention, but approximately half were severe.
METHODS: BEST-CLI was a prospective randomized trial comparing surgical (OPEN) and endovascular (ENDO) revascularization for patients with CLTI. Thirty-day SAEs, classified as cardiac or vascular, were analyzed. Adverse events are defined as serious when they affect safety in the trial, require prolonged hospitalization, result in significant disability or incapacitation, are life-threatening, or result in death. Interventions were analyzed in a per protocol fashion.
RESULTS: In the BEST-CLI trial, 850 OPEN and 896 ENDO interventions were evaluated. Forty (4.7%) and 34 (3.8%) patients experienced at least one cardiac SAE after OPEN and ENDO intervention, respectively (P = .35). Overall, there were 53 cardiac SAEs (0.06 per patient) after OPEN and 40 (0.045 per patient) after ENDO interventions. Cardiac SAEs in the OPEN arm were classified as related to ischemia (50.9%), arrhythmias (17%), heart failure (15.1%), arrest (13.2%), and heart block (3.8%); in the ENDO arm, they were classified as ischemia (47.5%), heart failure (17.5%), arrhythmias (15%), arrest (15%), and heart block (5%). Approximately half of SAEs were classified as severe for both OPEN and ENDO. SAEs were definitely or probably related to the procedure in 30.2% and 25% in the OPEN and ENDO arms, respectively (P = .2). Vascular SAEs occurred in 58 (6.8%) and 86 (9.6%) of patients after OPEN and ENDO revascularization, respectively (P = .19). In total, there were 59 (0.07 per patient) and 87 (0.097 per patient) vascular SAEs after OPEN and ENDO procedures. Vascular SAEs in the OPEN arm were classified as distal ischemia/infection (44.1%), bleeding (16.9%), occlusive (15.3%), thromboembolic (15.3%), cerebrovascular (5.1%), and other (3.4%); in the ENDO arm, they were distal ischemia/infection (40.2%), occlusive (31%), bleeding (12.6%), thromboembolic (8%), cerebrovascular (1.1%), and other (4.6%). SAEs were classified as severe for OPEN in 45.8% and ENDO in 46%. SAEs were definitely or probably related to the procedure in 23.7% and 35.6% in the OPEN and ENDO arms (P = .35), respectively.
CONCLUSIONS: Patients undergoing OPEN and ENDO revascularization experienced similar degrees of cardiac and vascular SAEs. The majority were not related to the index intervention, but approximately half were severe.
摘要：
目的：血运重建治疗慢性威胁肢体缺血（CLTI）后的心血管并发症是指导治疗的主要关注点。我们的目标是在CLTI患者的最佳血管内治疗与最佳外科治疗（BEST-CLI）试验中评估围手术期心脏和血管严重不良事件（SAE）。
方法：BEST-CLI是一项前瞻性随机试验，比较了CLTI患者的手术（OPEN）和血管内（ENDO）血运重建。30天SAE，分类为心脏或血管，进行了分析。不良事件在试验中影响安全性时被定义为严重事件，需要长期住院，导致严重的残疾或失能，危及生命,或导致死亡。以每个方案的方式分析干预。
结果：在BEST-CLI试验中，评估了850个OPEN和896个ENDO干预措施。40例（4.7％）和34例（3.8％）患者在OPEN和ENDO干预后至少经历了一次心脏SAE，分别(P=.35)。总体而言，OPEN后有53例心脏SAE（每位患者.06例），ENDO干预后有40例（每位患者.045例）。OPEN组的心脏SAE被分类为与缺血相关（50.9%），心律失常（17%），心力衰竭（15.1%），逮捕(13.2%)，和心脏传导阻滞（3.8％）；在ENDO组中，它们被分类为缺血（47.5％），心力衰竭（17.5%），心律失常（15%），逮捕（15%）和心脏传导阻滞（5%）。大约一半的SAE被归类为严重的OPEN和ENDO。SAE肯定或可能与OPEN和ENDO臂中的30.2%和25%的手术有关，分别为(P=2)。OPEN和ENDO血运重建后58例（6.8%）和86例（9.6%）患者发生血管SAE，分别(P=.19)。总的来说,OPEN和ENDO手术后有59例(每位患者.07例)和87例(每位患者.097例)血管SAE.OPEN组的血管SAE分为远端缺血/感染（44.1%），出血（16.9%），闭塞（15.3%），血栓栓塞（15.3%），脑血管(5.1%)，和其他（3.4％）；在ENDO臂中，他们是远端缺血/感染（40.2％），闭塞（31%），出血（12.6%），血栓栓塞（8%），脑血管(1.1%)，和其他（4.6%）。SAE被分类为严重的OPEN占45.8%，ENDO占46%。SAE肯定或可能与OPEN和ENDO臂中的23.7%和35.6%的手术相关(P=.35),分别。
结论：接受OPEN和ENDO血运重建的患者经历了相似程度的心脏和血管SAE。大多数与指数干预无关，但大约一半是严重的。
方法：BEST-CLI是一项前瞻性随机试验，比较了CLTI患者的手术（OPEN）和血管内（ENDO）血运重建。30天SAE，分类为心脏或血管，进行了分析。不良事件在试验中影响安全性时被定义为严重事件，需要长期住院，导致严重的残疾或失能，危及生命,或导致死亡。以每个方案的方式分析干预。
结果：在BEST-CLI试验中，评估了850个OPEN和896个ENDO干预措施。40例（4.7％）和34例（3.8％）患者在OPEN和ENDO干预后至少经历了一次心脏SAE，分别(P=.35)。总体而言，OPEN后有53例心脏SAE（每位患者.06例），ENDO干预后有40例（每位患者.045例）。OPEN组的心脏SAE被分类为与缺血相关（50.9%），心律失常（17%），心力衰竭（15.1%），逮捕(13.2%)，和心脏传导阻滞（3.8％）；在ENDO组中，它们被分类为缺血（47.5％），心力衰竭（17.5%），心律失常（15%），逮捕（15%）和心脏传导阻滞（5%）。大约一半的SAE被归类为严重的OPEN和ENDO。SAE肯定或可能与OPEN和ENDO臂中的30.2%和25%的手术有关，分别为(P=2)。OPEN和ENDO血运重建后58例（6.8%）和86例（9.6%）患者发生血管SAE，分别(P=.19)。总的来说,OPEN和ENDO手术后有59例(每位患者.07例)和87例(每位患者.097例)血管SAE.OPEN组的血管SAE分为远端缺血/感染（44.1%），出血（16.9%），闭塞（15.3%），血栓栓塞（15.3%），脑血管(5.1%)，和其他（3.4％）；在ENDO臂中，他们是远端缺血/感染（40.2％），闭塞（31%），出血（12.6%），血栓栓塞（8%），脑血管(1.1%)，和其他（4.6%）。SAE被分类为严重的OPEN占45.8%，ENDO占46%。SAE肯定或可能与OPEN和ENDO臂中的23.7%和35.6%的手术相关(P=.35),分别。
结论：接受OPEN和ENDO血运重建的患者经历了相似程度的心脏和血管SAE。大多数与指数干预无关，但大约一半是严重的。
