Background and purpose: Matching the anti-proliferative drug effect with endothelial healing after drug-eluting stent (DES) implantation may help reduce cardiac events, especially stent thrombosis. A previous PIONEER II optical coherence tomography (OCT) sub-study demonstrated significantly better 1-month strut coverage with the novel healing-targeted BuMA Supreme DES, which was designed with a drug elution period of 4 to 6 weeks after implantation, compared with the XIENCE everolimus eluting stent (EES). This clinical trial aimed to evaluate whether the early endothelial healing observed in previous OCT sub-study would translate into improved intermediate-term angiographic and short-term clinical outcomes. Methods: PIONEER II was a multicenter, prospective, tandem clinical trial conducted in China. It was part of a series of clinical investigations of the BuMA Supreme DES, together with PIONEER I in Europe and PIONEER III in the United States, Canada, Europe, and Japan. The efficacy and safety of the BuMA Supreme DES were evaluated in patients with de novo coronary artery lesions. Results: From December 2015 to March 2018, 459 patients were randomly assigned to the randomized controlled trial (RCT) arm and received either the BuMA Supreme DES (n = 226) or the BuMA biodegradable polymer sirolimus-eluting stent (BP-SES; n = 233). In addition, 819 patients were enrolled in the objective performance criteria (OPC) arm. In the RCT arm, the BuMA Supreme DES was non-inferior to the BuMA BP-SES with respect to 9-month in-stent late lumen loss (LLL), with values of 0.23 ± 0.37 mm and 0.27 ± 0.36 mm, respectively (difference: −0.046 mm, 95% confidence interval: −0.107 to 0.015; P < 0.001 for non-inferiority). Furthermore, the BuMA Supreme DES demonstrated significantly lower values for secondary angiographic endpoints, including in-segment LLL and in-stent/in-segment diameter stenosis, compared with the BuMA BP-SES. In the OPC arm analysis, which combined patients from the BuMA Supreme group of the RCT arm with patients enrolled in the single-arm cohort, the 1-year target lesion failure rate was 4.17%. Both primary endpoints met the pre-specified non-inferiority criteria. Conclusion: The BuMA Supreme DES was non-inferior to the BuMA BP-SES with respect to 9-month in-stent LLL and was associated with the expected target lesion failure rate and a low incidence of stent thrombosis at 1-year follow-up.
Background and purpose: Percutaneous coronary intervention (PCI) in complex high-risk and indicated patients (CHIP-PCI) remains a challenging procedure. The objective of this study was to evaluate the safety and efficacy of the novel microaxial flow pump, SynFlow 3.0, in patients undergoing CHIP-PCI. Methods: Between August and November 2022, a prospective, single-center, single-arm feasibility study was conducted at Zhongshan Hospital, Fudan University in Shanghai, China, to evaluate the SynFlow 3.0, a novel microaxial flow pump. A total of 10 nonemergency CHIP-PCI patients were recruited for this study. The complex high-risk condition was determined based on both clinical characteristics and anatomic lesions. Specifically, eligibility was defined by a left ventricular ejection fraction (LVEF) of less than 40%, accompanied by significant clinical symptoms. To evaluate hemodynamic stability, continuous invasive arterial pressure monitoring (IAPM) of mean arterial pressure (MAP) was conducted intraoperatively, with freedom from compromise serving as the primary efficacy endpoint in CHIP-PCI. The primary safety endpoint was the occurrence of major adverse cardiovascular and cerebrovascular events (MACCEs), including death, myocardial infarction, emergency coronary artery bypass surgery, or stroke at 30 days. Results: Preoperative stenosis was 90.00% (range: 70.00%-100.00%), with postoperative residual stenosis reduced to 0.00% (range: 0.00%-30.00%). The Syntax Score II decreased from 39.66 +/- 9.69 to 35.51 +/- 11.20, and thrombolysis in myocardial infarction (TIMI) flow grading improved to 2.94 +/- 0.25 postoperatively. Hemodynamic stability during PCI was achieved in 90% of patients, with intraoperative MAP significantly higher than preoperative levels (94.50 +/- 12.32 mmHg vs. 90.96 +/- 9.92 mmHg; P < 0.05). The SynFlow 3.0 system achieved 100% technical success and a 90% PCI angiographic success rate. LVEF improved from 35.40 +/- 3.95% to 38.40 +/- 5.85% at 30 days. No MACCEs or serious adverse events occurred during the 30-day follow-up. The mean delivery time of the SynFlow 3.0 was 1.40 +/- 0.97 minutes, with mechanical support lasting 87.30 +/- 42.76 minutes. Minor complications included transiently elevated plasma-free hemoglobin levels in two patients (which normalized post-procedure) and three cases of puncture-site hematoma, with no major complications reported. Conclusions: The SynFlow 3.0 system is user-friendly, and its preliminary safety and efficacy have been verified in CHIP-PCI patients.
Antegrade wiring (AW) is the prevailing chronic total occlusion (CTO) crossing technique. For proximal cap ambiguity, the Global CTO consensus group uses the "anatomy dictates strategy" method: 1) intravascular ultrasound; 2) move the cap; or 3) retrograde. For CTO body crossing, anatomy dictates 4 strategies: 1) CTOs with tapered stump-loose tissue tracking; 2) CTOs with clear intimal path-intentional intimal tracking with 3-dimensional (3D) wiring; 3) CTOs without a clear intimal path-intentional intimal tracking with intermediate penetration wire; and 4) the "long plus CTOs"-intentional subintimal wiring. The new angiographic 3D antegrade puncture technique from the APCTO (Asia Pacific Chronic Total Occlusion) Club is presented for distal cap puncture. angiographic 3D antegrade puncture technique can be used as a 3D wiring technique as well as an antegrade dissection and re-entry technique. Based on these new frontiers, we have updated our APCTO algorithm in this paper. This update can form a basis for research and training. (JACC Asia. 2025;5:219-230) (c) 2025 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Background:It remains unclear how rapidly the collateral circulation regresses after percutaneous coronary intervention (PCI) of chronic total occlusion (CTO). This study aimed to investigate the short-term changes of myocardial perfusion in the predominant donor vessel after successful CTO PCI. Methods:A total of 68 patients who underwent single-photon emission computerized tomography (SPECT) assessment before and within 24-72 hours after successful CTO PCI were retrospectively included into this study. The coronary flow reserve (CFR) in the CTO territory and the predominant donor vessel territory were analyzed. Results:The average age of the included patients was 57.1±12.5 years old, and 88.2% were male. In the CTO territory, the CFR increased from 1.80±0.99 at baseline to 2.13±1.02 after PCI (P=0.018). In the predominant donor territory, the CFR at baseline did not significantly differ from that of after PCI (baseline: 2.12±1.09; after-PCI: 2.27±0.78; P=0.214). However, the change in CFR (ΔCFR) of the predominant donor territory was correlated with that in the CTO territory (P<0.001). The target vessel of CTO [left anterior descending artery (LAD) vs. left circumflex artery (LCX); P=0.022] and diabetes mellitus (P=0.011) were other independent factors associated with ΔCFR in the predominant donor territory. In the those treated with CTO of the LAD, CFR in the predominant donor territory increased from 1.65±0.61 at baseline to 2.30±0.75 after PCI (P=0.003). In contrast, no significant ΔCFR was not observed in those treated with CTO of the LCX or right coronary artery (RCA). Conclusions:The myocardial perfusion in the predominant donor territory was positively associated with that in the CTO territory. The myocardial perfusion in the predominant donor territory increased within a short-term period after CTO PCI, specifically in those patients with CTO of the LAD.
BACKGROUND:Device-based antegrade dissection re-entry (ADR) and parallel wire technique (PWT) are two important techniques in the antegrade approach in percutaneous coronary intervention (PCI) of chronic total occlusion (CTO). The study is aimed to compare the procedural and mid-term outcomes between device-based ADR using the CrossBoss/Stingray system and PWT in CTO PCI.METHODS:Data was retrospectively collected from consecutive patients who underwent CTO PCI using device-based ADR or PWT. CTO due to in-stent restenosis were excluded.RESULTS:A total of 273 patients were included in the study (n = 55 in device-based ADR group, n = 218 in PWT group). Baseline characteristics were similar across groups except for higher prevalence of prior PCI and lower level of lipid profile in the ADR group. Moreover, although patients in the ADR group showed higher contrast volume (441.6 ± 162.4 mL vs. 361.5 ± 142.1 mL, p < 0.001), more intravascular ultrasound guidance (50.9% vs. 22.9%, p < 0.001), more guidewires used (4.6 ± 1.4 vs. 3.4 ± 1.2, p < 0.001) and higher troponin T level after PCI (0.167 vs. 0.087, p = 0.004), the technical success, procedural success and in-hospital complications were similar between the two groups. During a median follow-up of 1 year, the ADR group showed no difference in major adverse cardiac events (MACE, including all cause death, nonfatal myocardial infarction, and ischemia driven target vessel revascularization) (7.3% vs. 14.7%, p = 0.150) as compared with the PWT group.CONCLUSIONS:In the documented center, the use of device-based ADR for CTO PCI showed no difference in in-hospital complications and mid-term MACE as compared with PWT, despite higher procedure complexity in ADR group.
随着技术、理念的精进及新型器械的出现,冠状动脉慢性完全闭塞(CTO)病变接受经皮冠状动脉介入治疗(PCI)的成功率较前有了很大的提高.全球多个国家、地区陆续形成了各自的手术推荐路径,即流程图.各流程图特点鲜明,有着明显的时代及地区印记,体现出了流程图制定者对CTO-PCI的深刻理解,对全球CTO-PCI的普及与规范起到了积极的推动作用.随着未来学术交流环境更加全球化、规范化,CTO-PCI的技术、理念也必将得以进一步提高.
目的 探讨药物洗脱支架(drug-eluting stent,DES)联用药物涂层球囊(drug-coated balloon,DCB)的杂交策略治疗冠状动脉慢性完全闭塞(chronic total occlusion,CTO)病变的有效性和安全性.方法 连续纳入2021年9月至2022年9月在复旦大学附属中山医院确诊为CTO并采用单纯DES植入或杂交策略治疗的369例患者,分为DES组(n=220)和杂交策略组(n=149).比较两组患者的临床基线信息、介入手术特征、术后定量冠状动脉造影(quantitative coronary angiography,QCA)参数和定量血流分数(quantitative flow ratio,QFR).随访术后1个月内主要不良心血管事件(major adverse cardiovascular events,MACE)发生率.结果 369例患者的369个病变以前降支病变(44.7%)和右冠状动脉病变(43.1%)为主.与DES组相比,杂交策略组植入支架数[1.67±0.66vs2.00±0.81,P<0.001]和植入支架总长度[(51.53±21.52)mmvs(58.63±26.95)mm,P=0.005]均减少,术后即刻靶血管 QFR 显著增高[0.94(0.91,0.97)vs 0.96(0.93,0.98),P=0.045].两组患者术后1月内均无MACE发生.结论 在CTO病变介入治疗中,DES联合DCB的杂交治疗较单纯DES植入治疗可显著减少支架植入,明显改善靶血管功能性血流供应,且不增加短期MACE发生.
Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is the standard of care after coronary stenting, including coronary stenting involving bioresorbable scaffolds (BRSs). Current clinical guidelines recommend at least 12 months of DAPT after BRS implantation. However, the correlation between prolonged DAPT and net clinical benefits remains unknown. The SPARTA trial is designed to be a prospective, randomized, parallel-group, clinical trial. It aims to compare the benefits and risks of DAPT applied for either 12 or 36 months after XINSORB BRS implantation. The primary endpoints are the incidence of the composite endpoint of major adverse cardiac events (MACEs), including all-cause death, any myocardial infarction (MI), and all revascularizations, as well as Bleeding Academic Research Consortium Definition (BARC) type 3 or 5 bleeding events. The secondary endpoints of the study include the device-oriented composite endpoint of target lesion failure (defined as cardiac death, target vessel-related MI, or ischemia-driven target lesion revascularization), target vessel failure (defined as cardiac death, MI, or ischemia-driven target vessel revascularization), scaffold thrombosis, and minor bleeding events. This trial will enroll 2106 subjects treated with the XINSORB BRS only. All subjects will receive DAPT after the index procedure for 12 (± 1) months. Subjects without MACEs or major bleeding will be randomized to receive either 24 additional months of DAPT or aspirin alone. This trial is designed to investigate the impact of extending the duration of DAPT up to 3 years after XINSORB BRS implantation by investigating the balance of risks and benefits in a broad population of treated patients. ClinicalTrials.gov NCT04501900 . Registered on 6 August 2020.
Background:The septal collateral channel (CC) is the preferred channel in retrograde percutaneous coronary intervention (PCI) for chronic total occlusion (CTO). However, reports on the utilization of the ipsilateral septal CC are limited.Objective:To evaluate the feasibility and safety of the ipsilateral septal CC in retrograde CTO PCI.Methods:Twenty-five patients with successful wire CC tracking via the ipsilateral septal CC in retrograde CTO PCI were retrospectively analyzed. All procedures were performed by experienced CTO operators. Procedures were divided into the left descending coronary artery (LAD)-septal-LAD group and the LAD-septal-left circumflex coronary artery (LCX) group. Procedural complications and in-hospital outcomes were ascertained.Results:Both groups were similar with respect to risk factors and angiographic characteristics of the CTO, except for the collateral tortuosity (86.7% vs 20%, p=0.002). The success rate of microcatheter CC tracking was 96%. Both technical success and procedural success rates were 92%. Procedural complications were found in one case (septal perforation, 4%), which happened in the LAD-septal-LAD group (p=0.250). One postoperative adverse event (Q-wave myocardial infarction, 4%) was observed before discharge.Conclusion:The retrograde approach via the ipsilateral septal CC was feasible, with high success rates and acceptable complications, in the hands of experienced operators.
BACKGROUND:The predictors of success of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) through antegrade dissection and re-entry (ADR) using the Stingray system (Stingray ADR) remain elusive, mainly owing to the lack of consecutive angiographic and procedural records of patients.OBJECTIVES:This study aimed to identify indicators that can determine the success of CTO PCI performed using the Stingray ADR technique.METHODS:The clinical data of 115 patients who underwent CTO PCI through Stingray ADR at the same cardiac center were retrospectively and consecutively collected. Multivariate logistic regression analysis was performed to investigate the indicators of the success of ADR attempts.RESULTS:The technical success rate of Stingray ADR in CTO PCI was 72.2%. The overall technical success rate of CTO recanalization was 78.3% in all CTO PCIs having used Stingray Low Profile balloon. Vessel calcification (odds ratio [OR]: 4.03; 95% confidence interval [CI]: 1.49-11.88; p = 0.008), and retrograde puncture indicator (OR: 4.89; 95% CI: 1.51-17.11; p = 0.009) were identified as independent positive predictors. Blunt/no stump proximal to the occlusion segment (OR: 0.22; 95% CI: 0.06-0.64; p = 0.009), decision time before Stingray ADR (per 1 h increase) (OR: 0.54; 95% CI: 0.31-0.92; p = 0.026), operation duration of Stingray ADR (per 10 min increase) (OR: 0.62; 95% CI: 0.40-0.94; p = 0.028), and puncture site at the intraplaque region (OR: 0.24; 95% CI: 0.06-0.84; p = 0.026) were identified as the four negative independent predictors.CONCLUSIONS:This study revealed independent predictors of the success of CTO PCI performed using the Stingray ADR technique. As for CTO characteristics, the presence of calcification in the CTO segment and a tapered stump proximal to the lesion site can facilitate successful Stingray ADR. As for the procedures, the success rate of Stingray ADR can be improved by initiating the technique decisively and promptly, operating the system quickly and accurately and creating a puncture in the distal cap region of CTO under retrograde guidance.
Background Rapid development in coronary chronic total occlusion (CTO) interventional techniques and devices have achieved a greater success rate with favorable outcomes. Antegrade dissection re-entry (ADR) technique is an important CTO crossing strategy and a desirable approach for long CTOs with good distal landing zone. However, unsuccessful procedures in contemporary CTO-percutaneous coronary intervention (PCI) remain, especially in lesions with non-interventional collaterals. Method Based on a single center experience, a hybrid interventional algorithm, parallel wire-based ADR (PW-ADR) combines the advantages of parallel wire technique (PWT) and device-based ADR to target CTO lesions with failed retrograde approach. A retrospective analysis of patients who underwent PW-ADR was performed. A risk nomogram was created to identify patients at high risk for technical failure. Results A total of 57 patients treated with PW-ADR were ultimately included in the present study. A total of 46 (80.7%) cases achieved technical success and procedural success, with low incidence of in-hospital complications or 1-year major adverse cardiac events (MACE). The risk nomogram identified 3 predictor variables associated with technical failure of PW-ADR, including tortuous vessel, J-CTO score, and times of antegrade coronary angiography (CAG) during ADR, with promising accuracy (AUROC 0.947). Conclusion The novel hybrid CTO-PCI algorithm, PW-ADR, provided an alternative interventional approach for complex CTO lesions with a promising success rate. The risk nomogram served as a prompter for high-risk cases, which may warrant a change in treatment strategy.
OBJECTIVES:This study aims to compare the clinical outcomes of patients with de novo chronic total occlusion (CTO) lesions treated by hybrid strategy and drug-coated balloons (DCB)-only strategy.BACKGROUNDS:DCBs have been used as an alternative to or in combination with drug-eluting stents in CTO lesions. However, the clinical impact of DCB treatment on CTO lesion remains uncertain.METHODS:We retrospectively enrolled 154 patients with de novo CTO lesions treated by DCB, including 57 cases in hybrid group and 97 cases in DCB-only group.RESULTS:The lesions in hybrid group were more complicated than those in DCB-only group as shown by higher J-CTO score, and therefore higher percentage of retrograde approach, more IVUS guidance, more CTO guidewires, and longer procedural time were demonstrated. Although the percentage of non-flow-limiting dissection and residual stenosis of more than 30% were lower in hybrid group, TIMI flow grade, satisfactory and acceptable recanalization rate were not significantly different between two groups. During a median follow-up was 470 days, the incidence of target lesion revascularization (TLR), myocardial infarction and cardiac death was 11.0%, 1.3% and 1.9%, respectively. The long-term TLR-free survival was comparable between hybrid and DCB-only groups. By multivariate analysis, DCB length and age were predictors of TLR.CONCLUSION:DCB treatment appears effective and safe in selected de novo CTO lesions during long-term follow up. The recanalization results and long-term outcomes are comparable between hybrid and DCB-only group despite more complicated lesions in hybrid group.
冠状动脉慢性完全闭塞病变(chronic total occlusion,CTO)是冠状动脉介入治疗领域最具挑战性的病变,近20年来针对CTO经皮冠状动脉介入治疗(percutaneous coronary intervention, PCI)的理念、技术及相关器械均出现了长足的发展,CTO-PCI的成功率较前有了大幅度的提升,但CTO-PCI的发展也伴随着争议与讨论,一方面CTO-PCI成功率的提升,并没有带来明确改善患者预后的循证医学证据;另一方面,冠状动脉造影发现CTO的比例超过30%,但CTO-PCI仅占择期PCI量的5%~15% [1],CTO-PCI技术推广和认识理念的不足导致了CTO-PCI的比例相对较低。为了更好地规范CTO-PCI,改善患者的预后,我们应正视目前CTO-PCI的不足,了解目前CTO介入治疗的循证医学证据,进而能够依此制定合适的CTO-PCI治疗策略。
冠状动脉慢性完全闭塞病变(chronic total occlusion, CTO)的经皮冠状动脉介入治疗(percutanous coronary intervention, PCI)是对术者PCI策略、技巧、技术等诸多方面最全面、苛刻的考验,相对于非CTO病变,CTO PCI的成功率低,并发症发生率高,因此CTO常常被称为"待攻克的堡垒"。近年来,随着器械的进步和术者技术水平的提高,尤其是各种CTO PCI专题活动的开展,激起了很多术者挑战复杂病变的热情。除了参加传统的学术会议外,初学者常常通过各种新媒体手段,向不同术者学习和交流,短时间内获得了大量信息,其手术成功率虽有一定程度的提高,但如果不能对这些碎片化的信息进行认真分析和甄别,有可能会误导初学者,使其陷入误区。中国冠状动脉慢性完全闭塞病变介入治疗俱乐部(Chronic Total Occlusion Club,China, CTOCC)自2005年成立之初,就非常重视CTO PCI的规范化操作,俱乐部根据我国术者CTO PCI理念和操作特点的变化先后撰写了CTOCC CTO PCI推荐路径及更新版 [1,2,3]。该推荐路径在很大程度上规范了我国CTO PCI的教学及临床实践。然而,随着CTO PCI在全国范围内的普及,尤其是在基层医院的开展,一些不规范的操作仍时有发生,进一步规范CTO PCI常用技术操作仍是当前亟须解决的一个问题。
Exome sequencing identifies rare mutations of LDLR and QTRT1 conferring risk for early-onset coronary artery disease in Chinese Kang Yao1,2,†, Yuxiang Dai1,2,†, Juan Shen3,†, Yi Wang4,†, Huanjie Yang5, Runda Wu1,2, Qijun Liao3, Hongyi Wu1,2, Xiaodong Fang3, Shalaimaiti Shali1,2, Lili Xu1,2, Meng Hao4, Chenhao Lin4, Zhonghan Sun4, Yilian Liu4, Mengxin Li4, Zhen Wang1,2, Qiang Gao5, Shuning Zhang1,2, Chenguang Li1,2, Wei Gao1,2, Lei Ge1,2, Yunzeng Zou1,2, Aijun Sun1,2, Juying Qian1,2, Li Jin4, Shangyu Hong4,∗, Yan Zheng1,4,∗ and Junbo Ge1,2,∗