Case report: Chronic radial artery occlusion treated with paclitaxel-coated balloon via distal transradial access.

A 38-year-old male patient was diagnosed as acute non-ST-segment elevation myocardial infarction on Apr 21st 2021 and he received percutaneous transluminal coronary angioplasty for RCA via transradial artery access. He sought for second percutaneous coronary intervention in our center for frequently exertional angina on Sep 13th 2021. Proximal right radial artery pulsation can not be touched in physical examination, indicating right radial artery occlusion (RAO). Distal transradial access was applied and RAO was confirmed via angiography. With balloon pre-dilation, the guidewire and guiding catheter crossed the occlusion and coronary intervention was successfully completed. A Reewarm 2.5 × 220 mm paclitaxel drug-coated balloon (Endovastec, China) was released at 12 atm in radial arterial lesion with 90 s. Pulsation of radial artery can be well palpated 24 h after PCI. No oral anticoagulant was added. The right radial artery remained patent after 8-month and 14-month follow-up and there was no abnormal sensation or obstacle of right hand.

Association between inflammation, body mass index, and long-term outcomes in patients after percutaneous coronary intervention: A large cohort study.

Association between lipoprotein(a) and long-term outcomes after percutaneous coronary intervention for lesions with in-stent restenosis.

OBJECTIVES:This study aimed to evaluate the association between increased lipoprotein (a) [Lp(a)] and long-term outcomes in patients undergoing percutaneous coronary intervention (PCI) for in-stent restenosis (ISR).BACKGROUND:Elevated Lp(a) is demonstrated to be associated with recurrent ischemic events after PCI. However, the impact of Lp(a) in patients with ISR remains undetermined.METHODS:Between January 2017 and December 2018, a total of 2086 patients who underwent PCI for ISR were consecutively enrolled. Patients were categorized as elevated group (> 30 mg/dL, n=834) and non-elevated group (≤ 30 mg/dL, n=1252) according to baseline Lp(a) levels. The primary outcome was the rate of major adverse cardiac events (MACE), defined as a composite endpoint of all-cause death, spontaneous myocardial infarction (MI), or repeat revascularization.RESULTS:During a median follow-up of 36 months, the primary outcome occurred in 202 of 1252 patients (26.7%) in the elevated Lp(a) group and 237 of 834 patients (21.8%) in the non-elevated Lp(a) group (adjusted hazard ratio: 1.31; 95% confidence interval: 1.08-1.58; P = 0.007), driven by higher rate of all-cause death (4.1% vs. 2.5%, P = 0.002 by Log-rank test; aHR: 1.77; 95% CI: 1.07-2.94; P = 0.03) and repeat revascularization (22.3% vs. 19.5%, P = 0.04 by Log-rank test; aHR: 1.18; 95% CI: 0.94-1.49; P = 0.16). Adding continuous or categorical Lp(a) to the Cox model led to a significant improvement in C-statistic, net reclassification, and integrated discrimination. The results were consistent across subgroups.CONCLUSIONS:In the current cohort of patients who underwent PCI for ISR, elevated Lp(a) at baseline is associated with higher risk of long-term MACE.

[Clinical features and long-term prognosis of diabetic patients with low or intermediate complexity coronary artery disease post percutaneous coronary intervention].

Objective: To investigate the clinical features and long-term prognostic factors of diabetic patients with low or intermediate complexity coronary artery disease (CAD) post percutaneous coronary intervention (PCI). Methods: This was a prospective, single-centre observational study. Consecutive diabetic patients with SYNTAX score (SS)≤32 undergoing PCI between January and December 2013 in Fuwai hospital were included in this analysis. The patients were divided into two groups based on SS, namely SS≤22 group and SS 23-32 group. Multivariate Cox regression analysis was performed to identify independent factors related to poor 5-year prognosis. The primary outcomes were cardiac death and recurrent myocardial infarction, the secondary outcomes were all cause death and revascularization. Results: Of the 3 899 patients included in the study, 2 888 were men (74.1%); mean age was 59.4±9.8 years. There were 3 450 patients in the SS≤22 group and 449 patients in the SS 23-32 group. Compared with SS≤22 group, the incidence of revascularization was higher in SS 23-32 group (18.9% (85/449) vs. 15.2% (524/3450), log-rank P=0.019). There was no significant difference in all-cause death, cardiac death and recurrent myocardial infarction between the two groups (log-rank P>0.05). Multivariate Cox regression analysis showed that age (HR=1.05, 95%CI 1.02-1.08, P<0.001), chronic obstructive pulmonary disease (HR=3.12, 95%CI 1.37-7.07, P=0.007) and creatinine clearance rate (CCr)<60 ml/min (HR=3.67, 95%CI 2.05-6.58, P<0.001) were independent risk factors for 5-year cardiac death, while left ventricular ejection fraction (HR=0.94, 95%CI 0.91-0.96, P<0.001) was a protective factor. Previous PCI (HR=2.04, 95%CI 1.38-3.00, P<0.001), blood glucose level≥11.1 mmol/L on admission (HR=2.49, 95%CI 1.32-4.70, P=0.005) and CCr<60 ml/min (HR=1.85, 95%CI 1.14-2.99, P=0.012) were independent risk factors for 5-year recurrent myocardial infarction. The SS of 23-32 was independently associated with risk of revascularization (HR=1.54, 95%CI 1.09-2.16, P=0.014), after adjusting for residual SS. Residual SS was not a risk factor for 5-year prognosis. Conclusions: In diabetic patients with low-or intermediate complexity CAD, SS 23-32 is associated with increased risk of 5-year revascularization; the clinical characteristics of the patients are associated with the long-term mortality and recurrent myocardial infarction, but not related to revascularization.

Comparison of Recurrent With First-Time In-Stent Restenosis.

Recurrent in-stent restenosis (Re-ISR) remains a therapeutic challenge. We aimed to investigate the clinical characteristics, treatment, and long-term outcomes in patients with Re-ISR compared with those with first-time ISR (First-ISR). This retrospective study consecutively enrolled patients who underwent percutaneous coronary intervention (PCI) for ISR in Fuwai Hospital between January 2017 and December 2018. Re-ISR was defined as a second event of ISR after a previous successful treatment of the ISR lesion. The primary outcome was defined as a composite of all-cause death, spontaneous myocardial infarction, and repeat revascularization. A total of 2,006 patients (2,154 lesions) with ISR underwent successful PCI were enrolled and categorized into 2 groups: the Re-ISR group (246 patients/259 lesions) and the First-ISR group (1,760 patients/1,895 lesions). During a mean follow-up of 36 months, the primary outcomes occurred in 80 patients (32.5%) in the Re-ISR group and 349 patients (19.3%) in the First-ISR group (p <0.001 by log-rank test), major driven by spontaneous myocardial infarction (4.9% vs 2.7%, p = 0.049) and repeat revascularization (30.1% vs 16.5%, p <0.001). The multivariable Cox regression analysis revealed that Re-ISR was independently associated with a higher rate of major adverse cardiovascular events (adjusted hazard ratio 1.88, 95% confidence interval 1.39 to 2.53, p <0.001) and repeated revascularization (adjusted hazard ratio 2.09, 95% confidence interval 1.53 to 2.84, p <0.001). The relation remained consistent after the propensity score analysis. In conclusion, in the present cohort of patients who underwent PCI for ISR, Re-ISR was significantly associated with a higher risk of long-term outcomes than First-ISR.

Prognostic impact of lipoprotein(a) in patients undergoing percutaneous coronary intervention modified by low density lipoprotein cholesterol.

BACKGROUND:It is well established that lipoprotein(a)[Lp(a)] and low-density lipoprotein cholesterol (LDL-C) play a vital role in atherosclerosis. We investigated the prevalence and prognostic implications of increased Lp(a) in patients undergoing percutaneous coronary intervention (PCI) according to different LDL-C concentrations.METHODS:A total of 9,190 patients with CAD after PCI were consecutively enrolled in the study and subsequently divided into three groups according to baseline LDL-C at cut-off of 70 and 100 mg/dl. Increased Lp(a) was defined as > 30 mg/dl. The primary endpoint was all-cause death. Second endpoint was cardiac death. Cox regression, Kaplan-Meier and Sensitivity analysis were performed.RESULTS:During an average of 5.0 y of follow-up, 354 (3.9 %) patients experienced all-cause death with 213(2.3 %) of whom from cardiac death. Increased Lp(a) was present in 25.7 %, 34.2 %, and 40.6 % across the LDL-C < 70, 70-100 and≧100 mg/dl groups, respectively. After multivariate adjustment, Lp(a) elevation remained significantly associated with 5-y all-cause death (adjusted HR, 1.243; 95 % CI 1.001-1.544; p = 0.048) in the total cohort and only in those with LDL-C ≥ 100 mg/dl (adjusted HR, 1.642; 95 % CI 1.139-2.367; p = 0.008) when analyzed within each LDL-C category. Consistently with the results of associations between Lp(a) and cardiac death (adjusted HR, 1.534; 95 % CI 1.164-2.021; p = 0.002 for total cohort and adjusted HR, 2.404; 95 % CI 1.439-3.872; p < 0.001 for LDL-C ≥ 100 mg/dl). And this relationship holds after adjusting for LDL-Ccorr additionally. These findings are confirmed again in sensitivity analyses that excluded patients with Lp(a) concentrations in the top or the bottom 5 %.CONCLUSIONS:We confirmed that increased Lp(a) was associated with increased risk of long-term outcomes, and such an association was modified by the baseline LDL-C concentrations. Screening of high Lp(a) in individuals with elevations of LDL-C may enables risk stratification for poor prognosis.

First-in-human evaluation of a novel ultrathin sirolimus-eluting iron bioresorbable scaffold: 3-year outcomes of the IBS-FIM trial.

BACKGROUND:The first-generation polymeric bioresorbable scaffolds resulted in higher than acceptable 3-year rates of device-related adverse outcomes.AIMS:We aimed to assess the intermediate-term safety and performance of a novel ultrathin-strut sirolimus-eluting iron bioresorbable scaffold (IBS) in non-complex coronary lesions.METHODS:The prospective, single-arm, open-label IBS first-in-human study enrolled 45 patients, each with a single de novo lesion. Enrolled patients were randomly assigned to 2 follow-up cohorts. Angiographic and imaging follow-up with intravascular ultrasound and optical coherence tomography (OCT) were conducted at 6 and 24 months in cohort 1 (n=30) and at 12 and 36 months in cohort 2 (n=15). Clinical follow-up was conducted at 1, 6 and 12 months, and annually thereafter up to 5 years. The coprimary outcomes were target lesion failure (TLF) and angiographic late lumen loss (LLL) at 6 months.RESULTS:A total of 45 patients were enrolled between April 2018 and January 2019. The mean age was 53.2 years, 77.8% were male, and 26.7% had diabetes. The TLF rates were 2.2% at 6 months and 6.7% at 3 years, which in all cases were due to clinically indicated target lesion revascularisation. No deaths, myocardial infarctions or stent thromboses occurred during 3-year follow-up. In-scaffold LLL was 0.33±0.27 mm at 6 months and 0.37±0.57 mm at 3 years. By OCT, the proportion of covered struts was 99.8% at 6 months and 100% after 1 year. The 3-year strut absorption rate was 95.4%.CONCLUSIONS:In this first-in-human experience, an ultrathin IBS was safe and effective for the treatment of de novo non-complex coronary lesions up to 3-year follow-up.

Protective ballooning technique for prevention of side branch occlusion in coronary nonleft main true bifurcation lesions: A single-center study.

OBJECTIVES:We aimed to evaluate the efficacy of a protective ballooning technique in preventing side branch (SB) occlusion and to assess the long-term clinical outcomes for coronary nonleft main true bifurcation lesions.BACKGROUND:SB occlusion is a major complication associated with percutaneous coronary intervention (PCI) for coronary bifurcation lesions.METHODS:Patients were consecutively enrolled and randomly assigned to protective ballooning technique or jailed wire technique group. Periprocedural and long-term clinical outcomes were compared.RESULTS:Patients in the protective ballooning technique (n = 173) and jailed wire technique (n = 167) groups were followed up for 12 months. SB occlusion occurred in one patient (0.6%) and nine patients (5.4%) in each group, respectively. The proportion of thrombolysis in myocardial infarction (TIMI) flow grade 3 of the SB was higher in the protective ballooning technique group (98.8% vs. 95.2%, p < 0.05). SB rewiring was necessary in one patient in the protective ballooning technique group (0.6%) with provisional stenting, significantly lower than that in the jailed wire technique group (seven patients, 4.2%; p = 0.03). Periprocedural myocardial infarction occurred in three (1.73%) and six (3.59%) patients in the protective ballooning technique and jailed wire technique groups without significant difference, respectively. Major adverse cardiovascular events at 12 months were similar in both groups.CONCLUSIONS:Protective ballooning technique is effective for the prevention of SB occlusion in nonleft main true bifurcation lesions and had favorable long-term outcomes at the 12-month follow-up.

The PRECISE-DAPT score and 5-year outcomes after percutaneous coronary intervention: a large-scale, real-world study from China.

AIMS:The PRECISE-DAPT (predicting bleeding complications in patients undergoing stent implantation and subsequent dual-antiplatelet therapy) score is recommended by guidelines for predicting out-of-hospital bleeding in patients after percutaneous coronary intervention (PCI). However, the long-term prognostic value of the PRECISE-DAPT score in patients after PCI remains unclear.METHODS AND RESULTS:We performed a prospective study of 10 724 patients who underwent PCI throughout 2013 in Fuwai Hospital. The bleeding endpoint was Bleeding Academic Research Consortium 2, 3, or 5 bleeding. The ischaemic endpoints were all-cause death and major adverse cardiovascular and cerebrovascular events (MACCE). After a 5-year follow-up, 10 109 patients were finally analysed. A total of 415 (4.11%) patients experienced bleeding, 364 (3.60%) experienced all-cause death, and 2049 (20.27%) had MACCE. Using Cox regression, the risks of bleeding [hazard ratio (HR): 1.721, 95% confidence interval (CI): 1.180-2.511, P = 0.005], MACCE (HR: 1.607, 95% CI: 1.347-1.917, P < 0.001), and all-cause-death (HR: 3.902, 95% CI: 2.916-5.221, P < 0.001) in patients with a high score were significantly higher than those in patients with a low score. The PRECISE-DAPT score showed prognostic value for 5-year events of bleeding (C-statistic: 0.566, 95% CI: 0.537-0.594), MACCE (C-statistic: 0.540, 95% CI: 0.527-0.553), and all-cause death (C-statistic: 0.673, 95% CI: 0.644-0.702).CONCLUSION:After 5 years of follow-up, the PRECISE-DAPT score has a statistically significant predictive value for long-term bleeding events in the Chinese PCI population, and also some prognostic value for death and MACCE.ONE-SENTENCE SUMMARY:In this real-world, large-sample study, the PRECISE-DAPT (predicting bleeding complications in patients undergoing stent implantation and subsequent dual-antiplatelet therapy) score shows a statistically significant 5-year predictive value for bleeding in Chinese patients with percutaneous coronary intervention and dual-antiplatelet therapy. The study also shows that the PRECISE-DAPT score has moderate predictive value for all-cause death.

Long-Term Clinical Outcomes of Unprotected Left Main Percutaneous Coronary Intervention: A Large Single-Centre Experience.

AIMS:This study sought to report the 10-year clinical outcomes of patients who underwent unprotected left main (LM) percutaneous coronary intervention (PCI) in a large centre.METHODS AND RESULTS:A total of 913 consecutive patients who underwent unprotected LM PCI from January 2004 to December 2008 at Fu Wai Hospital were retrospectively analysed; the mean age was 60.0 ± 10.9 years, females accounted for 22% of patients, diabetes was present in 27.7% of patients, and an LM bifurcation lesion occurred in 82.9% of patients. During the median follow-up of 9.7 years, major adverse cardiac or cerebrovascular events (MACCEs) occurred in 25.6% (234) of patients, and the rates of all-cause death, myocardial infarction, and stroke were 14.9%, 11.0%, and 7.1%, respectively. Cardiac death occurred in only 7.9% of patients. The estimated event rate was 41.9% for death/myocardial infarction/any revascularization and 45.9% for death/MI/stroke/any revascularization. Definite/probable stent thrombosis occurred in 4.3% (39) of patients. According to the subgroup analysis, IVUS-guided PCI was associated with less long-term MACCEs. Further multivariate analysis identified that age and LVEF<40% were the only independent predictors for 10-year death. Age, LVEF<40%, creatinine clearance, and incomplete revascularization were independent predictors for death/MI, while a two-stent strategy, diabetes, a transradial approach, and the use of bare metal stents (BMSs) or first-generation drug-eluting stents (DESs) were not.CONCLUSIONS:Unprotected LM PCI in a large cohort of consecutive patients in a single large centre demonstrated favourable long-term outcomes up to 10 years even with the use of BMSs and first-generation of DESs.

Case report: Chronic radial artery occlusion treated with paclitaxel-coated balloon via distal transradial access.

A 38-year-old male patient was diagnosed as acute non-ST-segment elevation myocardial infarction on Apr 21st 2021 and he received percutaneous transluminal coronary angioplasty for RCA via transradial artery access. He sought for second percutaneous coronary intervention in our center for frequently exertional angina on Sep 13th 2021. Proximal right radial artery pulsation can not be touched in physical examination, indicating right radial artery occlusion (RAO). Distal transradial access was applied and RAO was confirmed via angiography. With balloon pre-dilation, the guidewire and guiding catheter crossed the occlusion and coronary intervention was successfully completed. A Reewarm 2.5 × 220 mm paclitaxel drug-coated balloon (Endovastec, China) was released at 12 atm in radial arterial lesion with 90 s. Pulsation of radial artery can be well palpated 24 h after PCI. No oral anticoagulant was added. The right radial artery remained patent after 8-month and 14-month follow-up and there was no abnormal sensation or obstacle of right hand.

Association between inflammation, body mass index, and long-term outcomes in patients after percutaneous coronary intervention: A large cohort study.

Association between lipoprotein(a) and long-term outcomes after percutaneous coronary intervention for lesions with in-stent restenosis.

OBJECTIVES:This study aimed to evaluate the association between increased lipoprotein (a) [Lp(a)] and long-term outcomes in patients undergoing percutaneous coronary intervention (PCI) for in-stent restenosis (ISR).BACKGROUND:Elevated Lp(a) is demonstrated to be associated with recurrent ischemic events after PCI. However, the impact of Lp(a) in patients with ISR remains undetermined.METHODS:Between January 2017 and December 2018, a total of 2086 patients who underwent PCI for ISR were consecutively enrolled. Patients were categorized as elevated group (> 30 mg/dL, n=834) and non-elevated group (≤ 30 mg/dL, n=1252) according to baseline Lp(a) levels. The primary outcome was the rate of major adverse cardiac events (MACE), defined as a composite endpoint of all-cause death, spontaneous myocardial infarction (MI), or repeat revascularization.RESULTS:During a median follow-up of 36 months, the primary outcome occurred in 202 of 1252 patients (26.7%) in the elevated Lp(a) group and 237 of 834 patients (21.8%) in the non-elevated Lp(a) group (adjusted hazard ratio: 1.31; 95% confidence interval: 1.08-1.58; P = 0.007), driven by higher rate of all-cause death (4.1% vs. 2.5%, P = 0.002 by Log-rank test; aHR: 1.77; 95% CI: 1.07-2.94; P = 0.03) and repeat revascularization (22.3% vs. 19.5%, P = 0.04 by Log-rank test; aHR: 1.18; 95% CI: 0.94-1.49; P = 0.16). Adding continuous or categorical Lp(a) to the Cox model led to a significant improvement in C-statistic, net reclassification, and integrated discrimination. The results were consistent across subgroups.CONCLUSIONS:In the current cohort of patients who underwent PCI for ISR, elevated Lp(a) at baseline is associated with higher risk of long-term MACE.

[Clinical features and long-term prognosis of diabetic patients with low or intermediate complexity coronary artery disease post percutaneous coronary intervention].

Objective: To investigate the clinical features and long-term prognostic factors of diabetic patients with low or intermediate complexity coronary artery disease (CAD) post percutaneous coronary intervention (PCI). Methods: This was a prospective, single-centre observational study. Consecutive diabetic patients with SYNTAX score (SS)≤32 undergoing PCI between January and December 2013 in Fuwai hospital were included in this analysis. The patients were divided into two groups based on SS, namely SS≤22 group and SS 23-32 group. Multivariate Cox regression analysis was performed to identify independent factors related to poor 5-year prognosis. The primary outcomes were cardiac death and recurrent myocardial infarction, the secondary outcomes were all cause death and revascularization. Results: Of the 3 899 patients included in the study, 2 888 were men (74.1%); mean age was 59.4±9.8 years. There were 3 450 patients in the SS≤22 group and 449 patients in the SS 23-32 group. Compared with SS≤22 group, the incidence of revascularization was higher in SS 23-32 group (18.9% (85/449) vs. 15.2% (524/3450), log-rank P=0.019). There was no significant difference in all-cause death, cardiac death and recurrent myocardial infarction between the two groups (log-rank P>0.05). Multivariate Cox regression analysis showed that age (HR=1.05, 95%CI 1.02-1.08, P<0.001), chronic obstructive pulmonary disease (HR=3.12, 95%CI 1.37-7.07, P=0.007) and creatinine clearance rate (CCr)<60 ml/min (HR=3.67, 95%CI 2.05-6.58, P<0.001) were independent risk factors for 5-year cardiac death, while left ventricular ejection fraction (HR=0.94, 95%CI 0.91-0.96, P<0.001) was a protective factor. Previous PCI (HR=2.04, 95%CI 1.38-3.00, P<0.001), blood glucose level≥11.1 mmol/L on admission (HR=2.49, 95%CI 1.32-4.70, P=0.005) and CCr<60 ml/min (HR=1.85, 95%CI 1.14-2.99, P=0.012) were independent risk factors for 5-year recurrent myocardial infarction. The SS of 23-32 was independently associated with risk of revascularization (HR=1.54, 95%CI 1.09-2.16, P=0.014), after adjusting for residual SS. Residual SS was not a risk factor for 5-year prognosis. Conclusions: In diabetic patients with low-or intermediate complexity CAD, SS 23-32 is associated with increased risk of 5-year revascularization; the clinical characteristics of the patients are associated with the long-term mortality and recurrent myocardial infarction, but not related to revascularization.

Comparison of Recurrent With First-Time In-Stent Restenosis.

Recurrent in-stent restenosis (Re-ISR) remains a therapeutic challenge. We aimed to investigate the clinical characteristics, treatment, and long-term outcomes in patients with Re-ISR compared with those with first-time ISR (First-ISR). This retrospective study consecutively enrolled patients who underwent percutaneous coronary intervention (PCI) for ISR in Fuwai Hospital between January 2017 and December 2018. Re-ISR was defined as a second event of ISR after a previous successful treatment of the ISR lesion. The primary outcome was defined as a composite of all-cause death, spontaneous myocardial infarction, and repeat revascularization. A total of 2,006 patients (2,154 lesions) with ISR underwent successful PCI were enrolled and categorized into 2 groups: the Re-ISR group (246 patients/259 lesions) and the First-ISR group (1,760 patients/1,895 lesions). During a mean follow-up of 36 months, the primary outcomes occurred in 80 patients (32.5%) in the Re-ISR group and 349 patients (19.3%) in the First-ISR group (p <0.001 by log-rank test), major driven by spontaneous myocardial infarction (4.9% vs 2.7%, p = 0.049) and repeat revascularization (30.1% vs 16.5%, p <0.001). The multivariable Cox regression analysis revealed that Re-ISR was independently associated with a higher rate of major adverse cardiovascular events (adjusted hazard ratio 1.88, 95% confidence interval 1.39 to 2.53, p <0.001) and repeated revascularization (adjusted hazard ratio 2.09, 95% confidence interval 1.53 to 2.84, p <0.001). The relation remained consistent after the propensity score analysis. In conclusion, in the present cohort of patients who underwent PCI for ISR, Re-ISR was significantly associated with a higher risk of long-term outcomes than First-ISR.

Prognostic impact of lipoprotein(a) in patients undergoing percutaneous coronary intervention modified by low density lipoprotein cholesterol.

BACKGROUND:It is well established that lipoprotein(a)[Lp(a)] and low-density lipoprotein cholesterol (LDL-C) play a vital role in atherosclerosis. We investigated the prevalence and prognostic implications of increased Lp(a) in patients undergoing percutaneous coronary intervention (PCI) according to different LDL-C concentrations.METHODS:A total of 9,190 patients with CAD after PCI were consecutively enrolled in the study and subsequently divided into three groups according to baseline LDL-C at cut-off of 70 and 100 mg/dl. Increased Lp(a) was defined as > 30 mg/dl. The primary endpoint was all-cause death. Second endpoint was cardiac death. Cox regression, Kaplan-Meier and Sensitivity analysis were performed.RESULTS:During an average of 5.0 y of follow-up, 354 (3.9 %) patients experienced all-cause death with 213(2.3 %) of whom from cardiac death. Increased Lp(a) was present in 25.7 %, 34.2 %, and 40.6 % across the LDL-C < 70, 70-100 and≧100 mg/dl groups, respectively. After multivariate adjustment, Lp(a) elevation remained significantly associated with 5-y all-cause death (adjusted HR, 1.243; 95 % CI 1.001-1.544; p = 0.048) in the total cohort and only in those with LDL-C ≥ 100 mg/dl (adjusted HR, 1.642; 95 % CI 1.139-2.367; p = 0.008) when analyzed within each LDL-C category. Consistently with the results of associations between Lp(a) and cardiac death (adjusted HR, 1.534; 95 % CI 1.164-2.021; p = 0.002 for total cohort and adjusted HR, 2.404; 95 % CI 1.439-3.872; p < 0.001 for LDL-C ≥ 100 mg/dl). And this relationship holds after adjusting for LDL-Ccorr additionally. These findings are confirmed again in sensitivity analyses that excluded patients with Lp(a) concentrations in the top or the bottom 5 %.CONCLUSIONS:We confirmed that increased Lp(a) was associated with increased risk of long-term outcomes, and such an association was modified by the baseline LDL-C concentrations. Screening of high Lp(a) in individuals with elevations of LDL-C may enables risk stratification for poor prognosis.

First-in-human evaluation of a novel ultrathin sirolimus-eluting iron bioresorbable scaffold: 3-year outcomes of the IBS-FIM trial.

BACKGROUND:The first-generation polymeric bioresorbable scaffolds resulted in higher than acceptable 3-year rates of device-related adverse outcomes.AIMS:We aimed to assess the intermediate-term safety and performance of a novel ultrathin-strut sirolimus-eluting iron bioresorbable scaffold (IBS) in non-complex coronary lesions.METHODS:The prospective, single-arm, open-label IBS first-in-human study enrolled 45 patients, each with a single de novo lesion. Enrolled patients were randomly assigned to 2 follow-up cohorts. Angiographic and imaging follow-up with intravascular ultrasound and optical coherence tomography (OCT) were conducted at 6 and 24 months in cohort 1 (n=30) and at 12 and 36 months in cohort 2 (n=15). Clinical follow-up was conducted at 1, 6 and 12 months, and annually thereafter up to 5 years. The coprimary outcomes were target lesion failure (TLF) and angiographic late lumen loss (LLL) at 6 months.RESULTS:A total of 45 patients were enrolled between April 2018 and January 2019. The mean age was 53.2 years, 77.8% were male, and 26.7% had diabetes. The TLF rates were 2.2% at 6 months and 6.7% at 3 years, which in all cases were due to clinically indicated target lesion revascularisation. No deaths, myocardial infarctions or stent thromboses occurred during 3-year follow-up. In-scaffold LLL was 0.33±0.27 mm at 6 months and 0.37±0.57 mm at 3 years. By OCT, the proportion of covered struts was 99.8% at 6 months and 100% after 1 year. The 3-year strut absorption rate was 95.4%.CONCLUSIONS:In this first-in-human experience, an ultrathin IBS was safe and effective for the treatment of de novo non-complex coronary lesions up to 3-year follow-up.

Protective ballooning technique for prevention of side branch occlusion in coronary nonleft main true bifurcation lesions: A single-center study.

OBJECTIVES:We aimed to evaluate the efficacy of a protective ballooning technique in preventing side branch (SB) occlusion and to assess the long-term clinical outcomes for coronary nonleft main true bifurcation lesions.BACKGROUND:SB occlusion is a major complication associated with percutaneous coronary intervention (PCI) for coronary bifurcation lesions.METHODS:Patients were consecutively enrolled and randomly assigned to protective ballooning technique or jailed wire technique group. Periprocedural and long-term clinical outcomes were compared.RESULTS:Patients in the protective ballooning technique (n = 173) and jailed wire technique (n = 167) groups were followed up for 12 months. SB occlusion occurred in one patient (0.6%) and nine patients (5.4%) in each group, respectively. The proportion of thrombolysis in myocardial infarction (TIMI) flow grade 3 of the SB was higher in the protective ballooning technique group (98.8% vs. 95.2%, p < 0.05). SB rewiring was necessary in one patient in the protective ballooning technique group (0.6%) with provisional stenting, significantly lower than that in the jailed wire technique group (seven patients, 4.2%; p = 0.03). Periprocedural myocardial infarction occurred in three (1.73%) and six (3.59%) patients in the protective ballooning technique and jailed wire technique groups without significant difference, respectively. Major adverse cardiovascular events at 12 months were similar in both groups.CONCLUSIONS:Protective ballooning technique is effective for the prevention of SB occlusion in nonleft main true bifurcation lesions and had favorable long-term outcomes at the 12-month follow-up.

The PRECISE-DAPT score and 5-year outcomes after percutaneous coronary intervention: a large-scale, real-world study from China.

AIMS:The PRECISE-DAPT (predicting bleeding complications in patients undergoing stent implantation and subsequent dual-antiplatelet therapy) score is recommended by guidelines for predicting out-of-hospital bleeding in patients after percutaneous coronary intervention (PCI). However, the long-term prognostic value of the PRECISE-DAPT score in patients after PCI remains unclear.METHODS AND RESULTS:We performed a prospective study of 10 724 patients who underwent PCI throughout 2013 in Fuwai Hospital. The bleeding endpoint was Bleeding Academic Research Consortium 2, 3, or 5 bleeding. The ischaemic endpoints were all-cause death and major adverse cardiovascular and cerebrovascular events (MACCE). After a 5-year follow-up, 10 109 patients were finally analysed. A total of 415 (4.11%) patients experienced bleeding, 364 (3.60%) experienced all-cause death, and 2049 (20.27%) had MACCE. Using Cox regression, the risks of bleeding [hazard ratio (HR): 1.721, 95% confidence interval (CI): 1.180-2.511, P = 0.005], MACCE (HR: 1.607, 95% CI: 1.347-1.917, P < 0.001), and all-cause-death (HR: 3.902, 95% CI: 2.916-5.221, P < 0.001) in patients with a high score were significantly higher than those in patients with a low score. The PRECISE-DAPT score showed prognostic value for 5-year events of bleeding (C-statistic: 0.566, 95% CI: 0.537-0.594), MACCE (C-statistic: 0.540, 95% CI: 0.527-0.553), and all-cause death (C-statistic: 0.673, 95% CI: 0.644-0.702).CONCLUSION:After 5 years of follow-up, the PRECISE-DAPT score has a statistically significant predictive value for long-term bleeding events in the Chinese PCI population, and also some prognostic value for death and MACCE.ONE-SENTENCE SUMMARY:In this real-world, large-sample study, the PRECISE-DAPT (predicting bleeding complications in patients undergoing stent implantation and subsequent dual-antiplatelet therapy) score shows a statistically significant 5-year predictive value for bleeding in Chinese patients with percutaneous coronary intervention and dual-antiplatelet therapy. The study also shows that the PRECISE-DAPT score has moderate predictive value for all-cause death.

Long-Term Clinical Outcomes of Unprotected Left Main Percutaneous Coronary Intervention: A Large Single-Centre Experience.

AIMS:This study sought to report the 10-year clinical outcomes of patients who underwent unprotected left main (LM) percutaneous coronary intervention (PCI) in a large centre.METHODS AND RESULTS:A total of 913 consecutive patients who underwent unprotected LM PCI from January 2004 to December 2008 at Fu Wai Hospital were retrospectively analysed; the mean age was 60.0 ± 10.9 years, females accounted for 22% of patients, diabetes was present in 27.7% of patients, and an LM bifurcation lesion occurred in 82.9% of patients. During the median follow-up of 9.7 years, major adverse cardiac or cerebrovascular events (MACCEs) occurred in 25.6% (234) of patients, and the rates of all-cause death, myocardial infarction, and stroke were 14.9%, 11.0%, and 7.1%, respectively. Cardiac death occurred in only 7.9% of patients. The estimated event rate was 41.9% for death/myocardial infarction/any revascularization and 45.9% for death/MI/stroke/any revascularization. Definite/probable stent thrombosis occurred in 4.3% (39) of patients. According to the subgroup analysis, IVUS-guided PCI was associated with less long-term MACCEs. Further multivariate analysis identified that age and LVEF<40% were the only independent predictors for 10-year death. Age, LVEF<40%, creatinine clearance, and incomplete revascularization were independent predictors for death/MI, while a two-stent strategy, diabetes, a transradial approach, and the use of bare metal stents (BMSs) or first-generation drug-eluting stents (DESs) were not.CONCLUSIONS:Unprotected LM PCI in a large cohort of consecutive patients in a single large centre demonstrated favourable long-term outcomes up to 10 years even with the use of BMSs and first-generation of DESs.