Chronic total occlusion (CTO) lesions of the femoropopliteal artery have been shown to benefit from drug-coated balloon (DCB) angioplasty. However, because bailout stenting is often performed, the outcome of DCB angioplasty alone remains unknown, particularly the differences in outcomes between low-dose DCB (LD-DCB) and high-dose DCB (HD-DCB). To address these issues, we conducted a single-center, retrospective cohort study and enrolled 66 consecutive patients undergoing initial endovascular therapy with DCBs for femoropopliteal CTO lesions from June 2018 to February 2023. Of the 66 patients, 25 underwent LD-DCB angioplasty and 41 underwent HD-DCB angioplasty. In all lesions, no bailout stenting was performed and intraplaque wiring was confirmed by intravascular ultrasound. The primary outcome measure was 1-year primary patency and the secondary outcome measures were 1-year freedom from clinically driven target lesion revascularization (CD-TLR) and reocclusion. There were no significant differences between LD-DCB and HD-DCB angioplasty in patient and lesion characteristics, 1-year primary patency (76.4% vs. 85.9%, log-rank p = 0.51), CD-TLR (95.2% vs. 94.3%, log-rank p = 0.97), and reocclusion (95.0% vs. 94.3%, log-rank p = 0.99). Patients with two of the three risk factors for restenosis, i.e., minimum lumen area < 12.6 mm2, dissection angle > 63°, and calcification angle > 270°, had a significantly lower patency rate (no factor: 100% vs. 1 factor: 90.3% vs. 2 factors: 62.6%; log-rank p = 0.04). In patients undergoing DCB angioplasty for femoropopliteal CTO lesions, 1-year primary patency and freedom from CD-TLR were favorable, with no significant difference between LD-DCB and HD-DCB angioplasty.
慢性全闭塞(CTO)病变的股腘动脉已显示受益于药物包被球囊(DCB)血管成形术。然而,由于经常进行救助支架置入,单独进行DCB血管成形术的结果仍然未知,特别是低剂量DCB (LD-DCB)和高剂量DCB (HD-DCB)之间的结果差异。为了解决这些问题,我们进行了一项单中心、回顾性队列研究,并在2018年6月至2023年2月期间连续招募了66名接受DCBs初始血管内治疗股腘动脉CTO病变的患者。66例患者中,25例行LD-DCB血管成形术,41例行HD-DCB血管成形术。在所有病变中,均未行支架置入术,并通过血管内超声确认斑块内连接。主要结局指标是1年的原发性通畅,次要结局指标是1年无临床驱动的靶病变血运重建术(CD-TLR)和再闭塞。LD-DCB和HD-DCB血管成形术在患者和病变特征、1年原发性通畅(76.4% vs. 85.9%, log-rank p = 0.51)、CD-TLR (95.2% vs. 94.3%, log-rank p = 0.97)和再闭塞(95.0% vs. 94.3%, log-rank p = 0.99)方面无显著差异。三种再狭窄危险因素中,最小管腔面积2、夹层角> 63°、钙化角> 270°的患者,其通畅率明显较低(无因素:100% vs. 1因素:90.3% vs. 2因素:62.6%;Log-rank p = 0.04)。在接受DCB血管成形术治疗股腘CTO病变的患者中,1年的初级通畅和CD-TLR的自由是有利的,LD-DCB和HD-DCB血管成形术之间没有显著差异。
{"title":"Clinical outcome of low-dose and high-dose drug-coated balloon angioplasty with intraplaque wiring for femoropopliteal chronic total occlusion lesions.","authors":"Yuki Shima, Narumi Taninobu, Akihiro Ikuta, Kazunori Mushiake, Hiroyuki Tanaka, Kazushige Kadota","doi":"10.1007/s12928-024-01067-5","DOIUrl":"https://doi.org/10.1007/s12928-024-01067-5","url":null,"abstract":"<p><p>Chronic total occlusion (CTO) lesions of the femoropopliteal artery have been shown to benefit from drug-coated balloon (DCB) angioplasty. However, because bailout stenting is often performed, the outcome of DCB angioplasty alone remains unknown, particularly the differences in outcomes between low-dose DCB (LD-DCB) and high-dose DCB (HD-DCB). To address these issues, we conducted a single-center, retrospective cohort study and enrolled 66 consecutive patients undergoing initial endovascular therapy with DCBs for femoropopliteal CTO lesions from June 2018 to February 2023. Of the 66 patients, 25 underwent LD-DCB angioplasty and 41 underwent HD-DCB angioplasty. In all lesions, no bailout stenting was performed and intraplaque wiring was confirmed by intravascular ultrasound. The primary outcome measure was 1-year primary patency and the secondary outcome measures were 1-year freedom from clinically driven target lesion revascularization (CD-TLR) and reocclusion. There were no significant differences between LD-DCB and HD-DCB angioplasty in patient and lesion characteristics, 1-year primary patency (76.4% vs. 85.9%, log-rank p = 0.51), CD-TLR (95.2% vs. 94.3%, log-rank p = 0.97), and reocclusion (95.0% vs. 94.3%, log-rank p = 0.99). Patients with two of the three risk factors for restenosis, i.e., minimum lumen area < 12.6 mm<sup>2</sup>, dissection angle > 63°, and calcification angle > 270°, had a significantly lower patency rate (no factor: 100% vs. 1 factor: 90.3% vs. 2 factors: 62.6%; log-rank p = 0.04). In patients undergoing DCB angioplasty for femoropopliteal CTO lesions, 1-year primary patency and freedom from CD-TLR were favorable, with no significant difference between LD-DCB and HD-DCB angioplasty.</p>","PeriodicalId":9439,"journal":{"name":"Cardiovascular Intervention and Therapeutics","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142766216","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-03DOI: 10.1007/s12928-024-01066-6
Luca Fazzini, Luca Pascalis, Hristo Kirov, Antonino Di Franco, Rhanderson Cardoso, Amr Osama Moustafa, Christian Schulze, Ricardo E Treml, Torsten Doenst, Tulio Caldonazo
The administration of crushed or chewed P2Y12 inhibitors (P2Y12i) allows faster platelet inhibition in patients presenting acute coronary syndrome (ACS). Whether this administration approach is safe needs further analysis. We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing chewed/crushed to integral P2Y12i administration in patients with ACS. Major bleeding, minor bleeding, and major adverse cardiovascular events (MACE) were analyzed as binary outcomes. Platelet reactivity unit (PRU) was assessed as a continuous outcome to estimate the impact on platelet physiology. A subgroup analysis of P2Y12i administered was performed. Nine studies comprising 1091 patients with ACS were included, 77% were males. Overall, 87% presented with ST-segment elevation acute myocardial infarction. Six studies administered Ticagrelor, while 3 studies used Prasugrel. The absolute risk of bleeding, assessed by TIMI, was low in both intervention and control arms (0.36% vs. 0.95% for major bleedings and 3.3% vs. 4.4% for minor bleedings), and crushed/chewed administration did not increase the relative risk of bleeding events for TIMI major or minor bleedings (RR 0.51, 95% CI 0.09-2.77, p = 0.293; RR 0.76, 95% CI 0.24-2.43, p = 0.542) or MACE (RR 0.94, 95% CI 0.28-3.19, p = 0.902). PRU was significantly reduced within 1 h after administration in the crushed/chewed P2Y12i group (MD: -70.0%, 95% CI, -89.0 to -51.1%, p<0.01) while we did not observe a significant difference after 4 h (MD: -15.1%, 95% CI -34.2 to 4.0%, p = 0.12). The type of drug did not influence the relative risk of crushed/chewed P2Y12i on major or minor bleeding (pinteraction = 0.62 and pinteraction = 0.23, respectively). The crushed/chewed administration of P2Y12i in the setting of ACS was not associated with an increased risk of bleeding, suggesting the safety of this strategy.
粉碎或咀嚼P2Y12抑制剂(P2Y12i)的给药可以更快地抑制急性冠脉综合征(ACS)患者的血小板。这种给药方式是否安全还需要进一步分析。我们对随机对照试验(rct)进行了系统回顾和荟萃分析,比较咀嚼/碾碎P2Y12i与整体P2Y12i在ACS患者中的应用。大出血、轻微出血和主要不良心血管事件(MACE)作为二元结局进行分析。血小板反应单位(PRU)作为评估血小板生理影响的连续指标进行评估。对给药P2Y12i进行亚组分析。9项研究纳入1091例ACS患者,77%为男性。总的来说,87%的患者表现为st段抬高急性心肌梗死。6项研究使用替格瑞洛,3项研究使用普拉格雷。TIMI评估的绝对出血风险在干预组和对照组均较低(大出血0.36% vs 0.95%,小出血3.3% vs 4.4%),碾碎/咀嚼给药不会增加TIMI大出血或小出血的相对出血事件风险(RR 0.51, 95% CI 0.09-2.77, p = 0.293;RR 0.76, 95% CI 0.24-2.43, p = 0.542)或MACE (RR 0.94, 95% CI 0.28-3.19, p = 0.902)。粉碎/咀嚼P2Y12i组PRU在给药后1 h内显著降低(MD: -70.0%, 95% CI, -89.0 ~ -51.1%, p - interaction = 0.62, p - interaction = 0.23)。在ACS情况下,粉碎/咀嚼P2Y12i与出血风险增加无关,表明该策略的安全性。
{"title":"Safety of crushed/chewed P2Y12 inhibitors in acute coronary syndromes - a meta-analysis of randomized controlled trials.","authors":"Luca Fazzini, Luca Pascalis, Hristo Kirov, Antonino Di Franco, Rhanderson Cardoso, Amr Osama Moustafa, Christian Schulze, Ricardo E Treml, Torsten Doenst, Tulio Caldonazo","doi":"10.1007/s12928-024-01066-6","DOIUrl":"https://doi.org/10.1007/s12928-024-01066-6","url":null,"abstract":"<p><p>The administration of crushed or chewed P2Y12 inhibitors (P2Y12i) allows faster platelet inhibition in patients presenting acute coronary syndrome (ACS). Whether this administration approach is safe needs further analysis. We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing chewed/crushed to integral P2Y12i administration in patients with ACS. Major bleeding, minor bleeding, and major adverse cardiovascular events (MACE) were analyzed as binary outcomes. Platelet reactivity unit (PRU) was assessed as a continuous outcome to estimate the impact on platelet physiology. A subgroup analysis of P2Y12i administered was performed. Nine studies comprising 1091 patients with ACS were included, 77% were males. Overall, 87% presented with ST-segment elevation acute myocardial infarction. Six studies administered Ticagrelor, while 3 studies used Prasugrel. The absolute risk of bleeding, assessed by TIMI, was low in both intervention and control arms (0.36% vs. 0.95% for major bleedings and 3.3% vs. 4.4% for minor bleedings), and crushed/chewed administration did not increase the relative risk of bleeding events for TIMI major or minor bleedings (RR 0.51, 95% CI 0.09-2.77, p = 0.293; RR 0.76, 95% CI 0.24-2.43, p = 0.542) or MACE (RR 0.94, 95% CI 0.28-3.19, p = 0.902). PRU was significantly reduced within 1 h after administration in the crushed/chewed P2Y12i group (MD: -70.0%, 95% CI, -89.0 to -51.1%, p<0.01) while we did not observe a significant difference after 4 h (MD: -15.1%, 95% CI -34.2 to 4.0%, p = 0.12). The type of drug did not influence the relative risk of crushed/chewed P2Y12i on major or minor bleeding (p<sub>interaction</sub> = 0.62 and p<sub>interaction</sub> = 0.23<sub>,</sub> respectively). The crushed/chewed administration of P2Y12i in the setting of ACS was not associated with an increased risk of bleeding, suggesting the safety of this strategy.</p>","PeriodicalId":9439,"journal":{"name":"Cardiovascular Intervention and Therapeutics","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142766233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Patients with atrial fibrillation (AF) often present with concomitant significant mitral regurgitation (MR). Percutaneous left atrial appendage closure (LAAC) is indicated for patients with AF to prevent thromboembolism and reduce the need for long-term anticoagulation. Transcatheter edge-to-edge repair (TEER) is recommended for patients with significant MR. However, the feasibility and efficacy of combining these therapeutic interventions remain uncertain. This study included consecutive patients who underwent LAAC. Feasibility was assessed by comparing outcomes between those undergoing combined LAAC + TEER and those receiving LAAC alone. Among 192 patients, 11 underwent the combined LAAC + TEER procedure, while 181 underwent LAAC alone. Procedural success was high in both groups (100% vs. 99%). At the 1-year follow-up, the incidence of significant device leak and device-related thrombus did not differ significantly between the groups (0% vs. 1.1% and 0% vs. 6.7%, respectively; p > 0.05 for both). Additionally, the cumulative incidence of thromboembolic and bleeding events was comparable between the two groups (thromboembolic p = 0.57 and bleeding p = 0.42). The combination of LAAC + TEER may be a feasible and effective therapeutic strategy when performed in carefully selected patients at high-volume, experienced centers.
心房颤动(房颤)患者通常伴有严重的二尖瓣反流(MR)。经皮左心房阑尾关闭术(LAAC)适用于心房颤动患者,可预防血栓栓塞并减少长期抗凝的需要。对于有明显 MR 的患者,建议采用经导管边缘到边缘修补术(TEER)。然而,结合这些治疗干预措施的可行性和疗效仍不确定。本研究纳入了接受 LAAC 的连续患者。通过比较联合 LAAC + TEER 与单独接受 LAAC 的患者的疗效来评估可行性。在192名患者中,11人接受了LAAC+TEER联合手术,181人接受了单纯LAAC手术。两组患者的手术成功率都很高(100% 对 99%)。在 1 年的随访中,两组患者明显的器械泄漏和器械相关血栓发生率没有显著差异(分别为 0% vs. 1.1% 和 0% vs. 6.7%;P 均大于 0.05)。此外,两组血栓栓塞和出血事件的累积发生率相当(血栓栓塞 p = 0.57,出血 p = 0.42)。LAAC+TEER联合疗法可能是一种可行且有效的治疗策略,但必须在高容量、经验丰富的中心对经过仔细筛选的患者进行治疗。
{"title":"Feasibility of combined therapy: percutaneous left atrial appendage closure and transcatheter edge-to-edge repair.","authors":"Nobuyuki Fukuda, Teruhiko Imamura, Shuhei Tanaka, Naoya Kataoka, Ryuichi Ushijima, Hiroshi Ueno, Koichiro Kinugawa","doi":"10.1007/s12928-024-01065-7","DOIUrl":"https://doi.org/10.1007/s12928-024-01065-7","url":null,"abstract":"<p><p>Patients with atrial fibrillation (AF) often present with concomitant significant mitral regurgitation (MR). Percutaneous left atrial appendage closure (LAAC) is indicated for patients with AF to prevent thromboembolism and reduce the need for long-term anticoagulation. Transcatheter edge-to-edge repair (TEER) is recommended for patients with significant MR. However, the feasibility and efficacy of combining these therapeutic interventions remain uncertain. This study included consecutive patients who underwent LAAC. Feasibility was assessed by comparing outcomes between those undergoing combined LAAC + TEER and those receiving LAAC alone. Among 192 patients, 11 underwent the combined LAAC + TEER procedure, while 181 underwent LAAC alone. Procedural success was high in both groups (100% vs. 99%). At the 1-year follow-up, the incidence of significant device leak and device-related thrombus did not differ significantly between the groups (0% vs. 1.1% and 0% vs. 6.7%, respectively; p > 0.05 for both). Additionally, the cumulative incidence of thromboembolic and bleeding events was comparable between the two groups (thromboembolic p = 0.57 and bleeding p = 0.42). The combination of LAAC + TEER may be a feasible and effective therapeutic strategy when performed in carefully selected patients at high-volume, experienced centers.</p>","PeriodicalId":9439,"journal":{"name":"Cardiovascular Intervention and Therapeutics","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142738519","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}