Drug-Coated Balloon for de-novo Coronary Artery Lesions Exceeding 2.5 mm in Diameter: Optical Coherence Tomography Analysis and Clinical Follow-Up.

Objective: To investigate the precise changes in the lumen and lesions, and clinical outcomes after DCB treatment for de-novo coronary lesions exceeding 2.5 mm in diameter through a detailed analysis of OCT. Methods: This is a prospective study including 53 consecutive patients with 55 de-novo coronary lesions, who underwent DCB angioplasty-only between January 2021 and April 2022. Quantitative coronary angiography (QCA) and OCT were performed before percutaneous coronary interventions (PCI), immediately after PCI, and at 6-9 months follow-up after PCI. Target lesion failure (TLF) was the primary endpoint of the present study. Multivariate logistic regression analysis was performed to identify the predictors or risks for late lumen enlargement (LLE). Results: A total of 52 patients were successfully treated with DCB. The median follow-up was 7 months, and the incidence of TLF was 7.5%. After the DCB procedure, 43 patients had their scheduled angiographic and OCT examination. QCA demonstrated that the late lumen loss was -0.79 ± 0.28 mm. OCT demonstrated LLE in 79.1% and dissection healing in 65.1% of lesions. After multivariable logistic analysis, type B dissection (odds ratio [OR] 2.92, 95% confidence interval [CI] 1.34-7.41, p = 0.037) was found to be a predictor of LLE, but lipid plaque (OR 0.09, 95% CI 0.01-0.63, p = 0.015) was a risk of LLE. Conclusion: This is the first and largest prospective study to assess the outcomes of DCB treatment for de-novo coronary lesions exceeding 2.5 mm in diameter and the detection of significant vessel enlargement and dissection healing guide by OCT. DCB could be a novel, safe and effective treatment for de-novo coronary lesions exceeding 2.5 mm in diameter through a detailed analysis of OCT.

Prognostic Value of Fibrinogen-to-Albumin Ratio in Coronary Three-Vessel Disease.

Objective: To investigate the prognostic value of fibrinogen-to-albumin ratio (FAR) in the adverse outcomes of patients with coronary three-vessel disease (TVD). Methods: A total of 4061 patients with TVD between 2013 and 2018 were analyzed in this retrospective cohort study. The best cut­off value of the FAR determined by receiver operating characteristic (ROC) curve analysis was 0.084. 2782 (68.5%) patients were in the low FAR group (FAR < 0.084) and 1279 (31.5%) patients were in the high FAR group (FAR ≥ 0.084), respectively. Three multivariate Cox proportional hazards models were applied to determine the associations of FAR with clinical outcomes. The concordance index (C-index), net reclassification index (NRI), and integrated discrimination improvement (IDI) were used to assess the incremental predictive value of the FAR and baseline models with respect to the additive effects of the established traditional risk factors on the discrimination of clinical outcomes. The primary endpoint was all-cause mortality. The secondary endpoint was major adverse cardiac and cerebrovascular events (MACCEs). Results: The median follow-up duration was 2.4 years (range 1.1-4.1 years). Multivariate Cox regression analyses showed that the incidence of all-cause mortality (4.7% vs 2.2%, adjusted hazard ratio [HR] 1.68, 95% confidence interval [CI] 1.12-2.52, p=0.011) and MACCE (34.6% vs 27.3%, HR 1.28, 95% CI 1.13-1.46, p<0.001) were significantly higher in the high FAR group compared to the low FAR group. The C-index was 0.72 (p < 0.001), the value of NRI was 0.3778 (p < 0.001), and the value of IDI was 0.0098 (p < 0.001) for those with FAR. After FAR was added to the traditional model, the discrimination and risk reclassification ability can be significantly improved for all-cause mortality. The similar results were found for MACCE. Conclusion: Higher level of FAR was associated with all-cause mortality and MACCE among patients with TVD. FAR could help to improve the prognostic performance of the traditional risk factors for TVD patients.

Effect of complete percutaneous revascularization on improving long-term outcomes of patients with chronic total occlusion and multi-vessel disease.

BACKGROUND: Limited data are available on the comparison of clinical outcomes of complete vs. incomplete percutaneous coronary intervention (PCI) for patients with chronic total occlusion (CTO) and multi-vessel disease (MVD). The study aimed to compare their clinical outcomes. METHODS: A total of 558 patients with CTO and MVD were divided into the optimal medical treatment (OMT) group ( n = 86), incomplete PCI group ( n = 327), and complete PCI group ( n = 145). Propensity score matching (PSM) was performed between the complete and incomplete PCI groups as sensitivity analysis. The primary outcome was defined as the occurrence of major adverse cardiovascular events (MACEs), and unstable angina was defined as the secondary outcome. RESULTS: At a median follow-up of 21 months, there were statistical differences among the OMT, incomplete PCI, and complete PCI groups in the rates of MACEs (43.0% [37/86] vs. 30.6% [100/327] vs. 20.0% [29/145], respectively, P = 0.016) and unstable angina (24.4% [21/86] vs. 19.3% [63/327] vs. 10.3% [15/145], respectively, P = 0.010). Complete PCI was associated with lower MACE compared with OMT (adjusted hazard ratio [HR] = 2.00; 95% confidence interval [CI] = 1.23-3.27; P = 0.005) or incomplete PCI (adjusted HR = 1.58; 95% CI = 1.04-2.39; P = 0.031). Sensitivity analysis of PSM showed similar results to the above on the rates of MACEs between complete PCI and incomplete PCI groups (20.5% [25/122] vs. 32.6% [62/190], respectively; adjusted HR = 0.55; 95% CI = 0.32-0.96; P = 0.035) and unstable angina (10.7% [13/122] vs. 20.5% [39/190], respectively; adjusted HR = 0.48; 95% CI = 0.24-0.99; P = 0.046). CONCLUSIONS: For treatment of CTO and MVD, complete PCI reduced the long-term risk of MACEs and unstable angina, as compared with incomplete PCI and OMT. Complete PCI in both CTO and non-CTO lesions can potentially improve the prognosis of patients with CTO and MVD.

Predictive value of high sensitivity C-reactive protein in three-vessel disease patients with and without type 2 diabetes.

BACKGROUND: Diabetes mellitus (DM) and atherosclerosis are multifactorial conditions and share a common inflammatory basis. Three-vessel disease (TVD) represents a major challenge for coronary intervention. Nonetheless, the predictive value of high-sensitivity C-reactive protein (hs-CRP) for TVD patients with or without type 2 DM remains unknown. Herein, we aimed to ascertain the long-term predictive value of hs-CRP in TVD patients according to type 2 DM status from a large cohort. METHODS: A total of 2734 TVD patients with (n = 1040, 38%) and without (n = 1694, 62%) type 2 diabetes were stratified based on the hs-CRP (< 2 mg/L vs. ≥ 2 mg/L). Three multivariable analysis models were performed to evaluate the effect of potential confounders on the relationship between hs-CRP level and clinical outcomes. The Concordance index, net reclassification improvement (NRI), and integrated discrimination improvement (IDI) were calculated to assess the added effect of hs-CRP and the baseline model with established risk factors on the discrimination of clinical outcomes. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE). RESULTS: The median follow-up duration was 2.4 years. Multivariate Cox regression analyses showed that the incidence of MACCE (adjusted hazard ratio [HR] 1.17, 95% confidence interval [CI] 1.01-1.35, p = 0.031) and all-cause death (HR 1.82, 95% CI 1.07-3.11, p = 0.026) were significantly higher in the diabetic group compared to the non-diabetic group. In the diabetic group, the incidence of MACCE (adjusted HR 1.51, 95% CI 1.09-2.10, p = 0.013) was significantly higher in the high hs-CRP group than in the low hs-CRP group; no significant difference was found for all-cause death (HR 1.63; 95% CI 0.58-4.58, p = 0.349). In the non-diabetic group, the prevalence of MACCE (adjusted HR 0.93, 95% CI 0.71-1.22, p = 0.613) was comparable between the two groups. Finally, the NRI (0.2074, p = 0.001) and IDI (0.0086, p = 0.003) for MACCE were also significantly increased after hs-CRP was added to the baseline model in the diabetic group. CONCLUSIONS: Elevated hs-CRP is an independent prognostic factor for long-term outcomes of MACCE in TVD patients with type 2 diabetes but not in those without type 2 diabetes. Compared to traditional risk factors, hs-CRP improved the risk prediction of adverse cardiovascular events in TVD patients with type 2 diabetes.

Good coronary collateral circulation is not associated with better prognosis in patients with chronic total occlusion, regardless of treatment strategy.

OBJECTIVE: This study aimed to assess the effects of coronary collateral circulation (CCC) on the prognosis of patients with chronic total occlusion (CTO) under different treatment strategies. METHODS: We analyzed a total of 1124 patients who were diagnosed with CTO and divided them into groups with good CCC (grade 2 to 3, n = 539) or poor CCC (grade 0 to 1, n = 531). The primary outcome was cardiac death during follow-up; the secondary outcome was major adverse cardiovascular events (MACEs). We also performed subgroup analyses in groups with and without CTO revascularization (CTO-R and CTO-NR, respectively), and sensitivity analyses excluding patients who received failed CTO-PCI to further investigate the effect of CCC. RESULTS: During a median follow-up duration of 23 months, we did not detect any significant differences between the good CCC group and the poor CCC group in terms of cardiac death (4.2% vs 4.1%; adjusted hazard ratio [HR], 1.01; 95% confidence interval [CI], 0.56-1.83; p = 0.970) and MACEs (23.6% vs 23.2%; adjusted HR, 1.07; 95% CI, 0.84-1.37; p = 0.590). Subgroup analyses according to CTO revascularization showed similar results. In addition, we observed no differences in sensitivity analyses when patients who received failed CTO-PCI were excluded. CONCLUSION: Good CCC was not associated with a lower risk of cardiac death or MACEs among patients with CTO, regardless of whether the patients received CTO revascularization treatment.

Systemic Immune-Inflammation Index Predicts Long-Term Outcomes in Patients with Three-Vessel Coronary Disease After Revascularization: Results from a Large Cohort of 3561 Patients.

Objective: This study aimed to investigate the prognostic value of systemic immune inflammation index (SII) concerning long-term outcomes in patients with the three-vessel disease (TVD) after revascularization in a large cohort. Methods: In total, 3561 TVD patients who had undergone revascularization between 2013 and 2018 were included in the study. Patients were divided into the low SII (<694.3 × 109/L) (n = 2556, 71.8%) and the high SII (≥694.3 × 109/L) group (n = 1005, 28.2%). The C-index, net reclassification improvement (NRI), and integrated discrimination improvement (IDI) were calculated to assess whether the addition of SII to a baseline model with traditional risk factors improved the accuracy of cardiac event prediction. The primary outcome was the frequency of major adverse and cerebrovascular events (MACCE). The secondary outcome was the incidence of all-cause death. Results: After 2.4 years of follow-up, the Cox proportional hazard regression model analysis displayed that high SII was independently associated with an increased risk of developing future MACCE (hazard ratio [HR] 1.65, 95% confidence interval [CI] 1.23-2.21, p = 0.001) and all-cause death (HR: 2.96; 95% CI: 1.19-7.32, p = 0.019). The addition of SII significantly improved the reclassification beyond the baseline model with traditional risk factors (MACCE: NRI, 0.115; p = 0.0001; all-cause death: NRI, 0.369; p = 0.0001). Reclassification with the addition of SII also demonstrated an IDI of 0.0022 (p = 0.006) in MACCE and 0.0033 (p = 0.014) in all-cause death. Conclusion: In TVD patients after revascularization, increased SII is an independent prognostic factor for long-term outcomes of MACCE and death. Compared to traditional risk factors, SII improved the risk prediction of major cardiovascular events in TVD patients who underwent revascularization.

Gender-Based Long-Term Outcomes After Revascularization for Three-Vessel Coronary Disease: A Propensity Score-Matched Analysis of a Large Cohort.

Objective: To investigate the impact of gender on long-term outcomes after revascularization in patients with three-vessel disease (TVD), a severe and challenging subtype of coronary artery disease. Methods: This was a single center retrospective cohort study. A total of 3776 patients with TVD who underwent revascularization between 2013 and 2018 were analyzed and were divided into the female group (n = 1039, 27.5%) and the male group (n = 2737, 72.5%). We performed a 1:2 propensity score matching (PSM) to balance the baseline characteristics, and a total of 1506 (504 matched pairs) patients were created after undertaking PSM. The primary outcome was the frequency of major adverse cardiac and cerebrovascular events (MACCE) including all-cause death, myocardial infarction, repeat revascularization, stroke, and readmission for angina pectoris or heart failure. The secondary outcome was the incidence of all-cause death. Results: Through 2.4-year follow-up, no significant differences in MACCE (25.8% vs 27.5%, p = 0.279) and all-cause death (2.1% vs 2.2%, p = 0.888) were observed between the two cohorts. Similar results as with the early detection were obtained in propensity-matched patients. Multivariable analysis revealed that female gender (hazard ratio 0.99, 95% confidence interval 0.88-1.17, p = 0.820) was not an independent predictor of MACCE but percutaneous coronary intervention (compared with coronary artery bypass graft surgery), hypertension, diabetes mellitus, atrial fibrillation, left main trunk involvement and left ventricular ejection fraction ≤40% were independently associated with a higher MACCE rate in these patients. Conclusion: For patients with TVD after coronary revascularization, there were no gender-based differences in the long-term outcomes and female gender was not an independent predictor of MACCE.

Predictors of Adverse Events Among Chronic Total Occlusion Patients Undergoing Successful Percutaneous Coronary Intervention and Medical Therapy.

OBJECTIVE: Limited data are available on the predictors of major adverse cardiac events (MACE) after a successful coronary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) and medical therapy. This study aimed to identify predictors of MACE in CTO patients undergoing successful recanalization and medical therapy. METHODS: A total of 2015 patients with CTOs were enrolled. About 718 patients underwent successful CTO recanalization, and 1297 patients received medical therapy. The primary outcome was the frequency of MACE, defined as a composite of cardiac death, myocardial infarction, and target-vessel revascularization. Multivariate models were used to determine predictors of MACE. RESULTS: In successful CTO recanalization group, MACE occurred in 123 (17.1%) patients. In multivariate analysis, heart failure (hazard ratio [HR] 1.77, 95% confidence interval [CI]: 1.04-3.04, p = 0.036) was identified as independent predictors for MACE in successful CTO recanalization. Additionally, in medical therapy group, the significant predictors of MACE were male gender (HR 1.53, 95% CI: 1.13-2.05, p = 0.005), diabetes mellitus (HR 1.39, 95% CI: 1.11-1.74, p = 0.003), heart failure (HR 1.44, 95% CI: 1.10-1.87, p = 0.007), J-CTO score (HR 1.17, 95% CI: 1.07-1.28, p = 0.001) and multivessel disease (HR 2.20, 95% CI: 1.42-3.39, p < 0.001). CONCLUSION: Heart failure was predictor for composite cardiovascular events in patients with CTO after successful recanalization. Male gender, diabetes mellitus, heart failure, J-CTO score and multivessel disease were predictors of MACE in CTO patients with medical therapy.

Serum alkaline phosphatase levels are associated with coronary artery calcification patterns and plaque vulnerability.

OBJECTIVES: This study aimed to investigate the association of serum alkaline phosphatase (ALP) with calcification patterns and plaque morphology detected by intravascular ultrasound (IVUS) in acute coronary syndrome (ACS) patients. BACKGROUND: ALP has been shown to predict vascular calcification and long-term cardiovascular events. However, the relationship between ALP and vascular calcification patterns or plaque morphology remains unclear. METHODS: In total, 328 ACS patients who underwent IVUS examinations were screened from January 2017 to December 2018; among them, 234 eligible participants were grouped according to the tertiles of ALP levels (<68, 68-80, and >80 IU/L). Demographic data and IVUS parameters were documented and analyzed. RESULTS: After adjusting for potential confounders, independent associations were observed between ALP and the presence of coronary calcification, spotty calcification, minimum lumen area (MLA) ≤ 4.0 mm2 , and plaque burden (PB) > 70%. Compared with the lowest ALP tertile group, the highest ALP group had higher risks of calcification (odds ratio [OR], 2.85; 95% confidence interval [95%CI], 1.38-5.90; p = .005), spotty calcification (OR, 1.86; 95%CI, 1.09-3.84; p = .012), MLA≤4.0 mm2 (OR, 3.32; 95%CI, 1.51-7.28; p = .003), and PB > 70% (OR, 4.59; 95%CI, 1.83-11.50; p = .001). Similar results were found when ALP was analyzed as a continuous variable or a category variate according to the cut-off value determined by the receiver operating characteristic curve analysis. Furthermore, the model including clinical factors and ALP significantly improved the predictive power for coronary calcification, spotty calcification, MLA≤4.0 mm2 , and PB > 70%. CONCLUSION: Our findings suggest that ALP may be a potential predictive biomarker for calcification and plaque vulnerability.

Corrigendum: Long-Term Outcomes of Successful Revascularization for Patients With Coronary Chronic Total Occlusions: A Report of 1,655 Patients.

[This corrects the article DOI: 10.3389/fcvm.2020.00116.].

Impact of Renal Function on Long-Term Clinical Outcomes in Patients With Coronary Chronic Total Occlusions: Results From an Observational Single-Center Cohort Study During the Last 12 Years.

Background: The number of coronary chronic total occlusion (CTO) patients with renal insufficiency is huge, and limited data are available on the impact of renal insufficiency on long-term clinical outcomes in CTO patients. We aimed to investigate clinical outcomes of CTO percutaneous coronary intervention (PCI) vs. medical therapy (MT) in CTO patients according to baseline renal function. Methods: In the study population of 2,497, 1,220 patients underwent CTO PCI and 1,277 patients received MT. Patients were divided into four groups based on renal function: group 1 [estimated glomerular filtration rate (eGFR) ≥ 90 ml/min/1.73 m2], group 2 (60 ≤ eGFR <90 ml/min/1.73 m2), group 3 (30 ≤ eGFR <60 ml/min/1.73 m2), and group 4 (eGFR <30 ml/min/1.73 m2). Major adverse cardiac event (MACE) was the primary end point. Results: Median follow-up was 2.6 years. With the decline in renal function, MACE (p < 0.001) and cardiac death (p < 0.001) were increased. In group 1 and group 2, MACE occurred less frequently in patients with CTO PCI, as compared to patients in the MT group (15.6% vs. 22.8%, p < 0.001; 15.6% vs. 26.5%, p < 0.001; respectively). However, there was no significant difference in terms of MACE between CTO PCI and MT in group 3 (21.1% vs. 28.7%, p = 0.211) and group 4 (28.6% vs. 50.0%, p = 0.289). MACE was significantly reduced for patients who received successful CTO PCI compared to patients with MT (16.7% vs. 22.8%, p = 0.006; 16.3% vs. 26.5%, p = 0.003, respectively) in group 1 and group 2. eGFR < 30 ml/min/1.73 m2, age, male gender, diabetes mellitus, heart failure, multivessel disease, and MT were identified as independent predictors for MACE in patients with CTOs. Conclusions: Renal impairment is associated with MACE in patients with CTOs. For treatment of CTO, compared with MT alone, CTO PCI may reduce the risk of MACE in patients without chronic kidney disease (CKD). However, reduced MACE from CTO PCI among patients with CKD was not observed. Similar beneficial effects were observed in patients without CKD who underwent successful CTO procedures.

Long-Term Outcomes of Successful Revascularization for Patients With Coronary Chronic Total Occlusions: A Report of 1,655 Patients.

Background: To date, the benefit of successful revascularization of chronic total occlusions (CTOs) on prognosis remains uncertain, and there is a paucity of data on the impact of successful revascularization for CTO patients on long-term cardiovascular survival. This study aimed to investigate the long-term cardiovascular survival for patients with successful and unsuccessful CTO revascularization in a large cohort of patients. Methods: There were 1,655 consecutive patients with at least one CTO included and were grouped into successful revascularization (n = 591) and unsuccessful revascularization (n = 1,064). Propensity score matching (PSM) was carried out to balance the clinical and the angiographic characteristics. Cardiac mortality was defined as the primary endpoint. Major adverse cardiac event (MACE) was assessed as a "secondary endpoint." Results: After 3.6 years of follow-up, there was no significant difference between the successful and the unsuccessful revascularization groups in the rate of cardiac mortality [adjusted hazard ratio (HR) 0.96, 95% confidence interval (CI) 0.59-1.58, p = 0.865]. After the PSM analysis (371 pairs) between the two groups, the cardiac mortality rate values (HR 0.51, 95% CI 0.23-1.15, p = 0.104) were equivalent, whereas the adjusted risk of MACE (HR 0.43, 95% CI 0.32-0.58, p = 0.001) and target-vessel revascularization (HR 0.41, 95% CI 0.29-0.58, p < 0.001) were significantly higher in patients with unsuccessful revascularization. Conclusion: For the treatment of CTO patients, successful revascularization was not associated with a lesser risk for cardiac mortality as compared with unsuccessful revascularization. However, successful revascularization reduced MACE and target-vessel revascularization.

Long-term outcomes of medical therapy versus successful recanalisation for coronary chronic total occlusions in patients with and without type 2 diabetes mellitus.

BACKGROUND: In this study, we compared the outcomes of medical therapy (MT) with successful percutaneous coronary intervention (PCI) in chronic total occlusions (CTO) patients with and without type 2 diabetes mellitus. METHODS: A total of 2015 patients with CTOs were stratified. Diabetic patients (n = 755, 37.5%) and non-diabetic patients (n = 1260, 62.5%) were subjected to medical therapy or successful CTO-PCI. We performed a propensity score matching (PSM) to balance the baseline characteristics. A comparison of the major adverse cardiac events (MACE) was done to evaluate long-term outcomes. RESULTS: The median follow-up duration was 2.6 years. Through multivariate analysis, the incidence of MACE was significantly higher among diabetic patients compared to the non-diabetic patients (adjusted hazard ratio [HR] 1.32, 95% confidence interval [CI] 1.09-1.61, p = 0.005). Among the diabetic group, the rate of MACE (adjusted HR 0.61, 95% CI 0.42-0.87, p = 0.006) was significantly lower in the successful CTO-PCI group than in the MT group. Besides, in the non-diabetic group, the prevalence of MACE (adjusted HR 0.85, 95% CI 0.64-1.15, p = 0.294) and cardiac death (adjusted HR 0.94, 95% CI 0.51-1.70, p = 0.825) were comparable between the two groups. Similar results as with the early detection were obtained in propensity-matched diabetic and non-diabetic patients. Notably, there was a significant interaction between diabetic or non-diabetic with the therapeutic strategy on MACE (p for interaction = 0.036). CONCLUSIONS: For treatment of CTO, successful CTO-PCI highly reduces the risk of MACE in diabetic patients when compared with medical therapy. However, this does not apply to non-diabetic patients.

Three-year follow up of biodegradable polymer cobalt-chromium sirolimus-eluting stent (EXCROSSAL) in treating de novo coronary artery disease: Pooled analysis of CREDIT II and CREDIT III trials.

OBJECTIVES: To analyze the 3-year outcomes of the biodegradable polymer cobalt-chromium sirolimus-eluting stent (EXCROSSAL) in CREDIT II AND III TRIALS. BACKGROUND: Though approved by CFDA, the long-term safety and efficacy of EXCROSSAL is still unknown. METHODS: CREDIT II was a randomized trial comparing the EXCROSSAL versus EXCEL stents in patients with up to two de novo coronary lesions, and CREDIT III was a prospective, single-arm study evaluating the efficacy and safety of EXCROSSAL in broad types of de novo coronary artery lesions. We pooled the 3-year follow-up data of the EXCROSSAL arm of the CREDIT II and CREDIT III Trials. The primary outcome was 3-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (CI-TLR). The patient-oriented composite endpoint (PoCE) (all-cause death, all MI, or any revascularization) and stent thrombosis (ST) were also analyzed. RESULTS: A total of 833 patients were included in this study. The incidence of TLF and PoCE in the 3-year follow-up were 7.6% and 12.5%, respectively. ST occurred in 0.6% of patients. In the subgroup analyses, TLF was significantly higher in small target vessels, multi-lesion PCI, and multi-vessel disease. CONCLUSIONS: The 3-year follow-up analysis confirmed low rates of TLF and ST in EXCROSSAL, which is similar to the most widely used new generation durable polymer drug-eluting stent.

Corrigendum: Impact of Renal Function on Long-Term Clinical Outcomes in Patients With Coronary Chronic Total Occlusions: Results From an Observational Single-Center Cohort Study During the Last 12 Years.

[This corrects the article DOI: 10.3389/fcvm.2020.550428.].

Two-year clinical outcomes of medical therapy vs. revascularization for patients with coronary chronic total occlusion.

OBJECTIVES: There are little data on the long-term clinical outcomes of medical therapy (MT) compared with revascularization in patients with chronic total occlusions (CTOs). METHODS: Between January 2007 and December 2016, a total of 1655 patients with ≥1 CTO were enrolled in our center and were divided into the MT group (n = 800) and revascularization group (n = 855) according to the initial treatment strategy. Propensity score matching was also performed to adjust for baseline characteristics. The primary outcome was cardiac death. RESULTS: After 2 years of follow-up, there was no significant difference between the two groups with regard to the prevalence of cardiac death (MT vs. revascularization: 6.6% vs. 4.2%, adjusted hazard ratio [HR] 0.95, 95% confidence interval [CI] 0.60-1.49, p = 0.820). In the propensity-matched population (406 pairs), there were no significant differences in the prevalence of cardiac death (MT vs. revascularization: 5.4% vs. 4.7%, HR 0.88, 95% CI 0.48-1.63, p = 0.694), except for target vessel revascularization (TVR) (0.44, 0.31-0.63, <0.001) and major adverse cardiovascular events (MACE) (0.51, 0.38-0.68, <0.001), between the two groups. There were also no significant differences in the prevalence of cardiac death (MT vs. successful CTO-PCI: 6.6% vs. 4.0%, HR 0.94, 95% CI 0.41-2.15, p = 0.881) between the MT and successful CTO-PCI groups. CONCLUSION: As an initial management strategy in patients with CTOs, revascularization did not reduce the risk of cardiac death compared with treatment with medical therapy alone. However, revascularization was associated with reduction in the prevalence of TVR and MACE. Furthermore, successful CTO-PCI was also not associated with improved long-term survival compared with MT alone.

Successful recanalisation of coronary chronic total occlusions is not associated with improved cardiovascular survival compared with initial medical therapy.

Objective. To compare the clinical outcomes associated with successful percutaneous coronary intervention (PCI) versus initial medical therapy (MT) in patients with coronary chronic total occlusions (CTOs). Methods. Between January 2007 and December 2016, a total of 1702 patients with ≥1 CTO were enrolled. Patients who had a failed CTO-PCI were excluded. After exclusion, 1294 patients with 1520 CTOs were divided into the MT group initially (did not undergo a CTO-PCI attempt) (n = 800) and successful PCI group (n = 494). Propensity-score matching was also performed to adjust for baseline characteristics. The primary outcome was cardiac death. Results. The median overall follow-up duration was 3.6 (IQR, 2.1-5.0) years, there was no significant difference between the two groups with respect to the prevalence of cardiac death (MT vs. successful PCI: 6.6 vs. 3.8%, adjusted hazard ratio [HR] 0.93, 95% confidence interval [CI] 0.41-2.14, p = .867). In the propensity-matched population (286 pairs), there were no significant differences in the prevalence of cardiac death (MT vs. successful PCI: 5.9% vs. 3.1%, HR 0.51, 95% CI 0.23-1.15, p = .104) and major adverse cardiovascular events (MACE) (HR 0.76, 95% CI 0.53-1.09, p = .130) between the two groups. Conclusion. In the treatment of patients with CTOs, successful PCI is not associated with improved long-term cardiovascular survival or reduced the risk of MACE compared with MT alone initially.

A risk score to predict postdischarge bleeding among acute coronary syndrome patients undergoing percutaneous coronary intervention: BRIC-ACS study.

BACKGROUND: Dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) prevents ischemic events while increasing bleeding risk. Real-world-based metrics to accurately predict postdischarge bleeding (PDB) occurrence and its potential impact on postdischarge major cardiovascular event (MACE) remain undefined. This study sought to evaluate the impact of PDB on MACE occurrence, and to develop a score to predict PDB risk among Chinese acute coronary syndrome (ACS) patients after PCI. METHODS AND RESULTS: From May 2014 to January 2016, 2496 ACS patients who underwent PCI were recruited consecutively from 29 nationally representative Chinese tertiary hospitals. Among 2,381 patients (95.4%, 2,381/2,496) who completed 1-year follow-up, the cumulative incidence of PDB (bleeding academic research consortium type [BARC] ≥2) and postdischarge MACE (a composite of all-cause death, nonfatal myocardial infarction, ischemic stroke, or urgent revascularization) was 4.9% (n = 117) and 3.3% (n = 79), respectively. The association between PDB and MACE during 1-year follow-up, as well as the impact of DAPT with ticagrelor or clopidogrel on PDB were evaluated. PDB was associated with higher risk of postdischarge MACE (7.7 vs. 3.1%; adjusted hazard ratio: 2.59 [95% confidence interval: 1.17-5.74]; p = .02). For ticagrelor versus clopidogrel, PDB risk was higher (8.0 vs. 4.4%; 2.05 [1.17-3.60]; p = .01), while MACE risk was similar (2.0 vs. 3.4%; 0.70 [0.25-1.93]; p = .49). Based on identified PDB predictors, the constructed bleeding risk in real world Chinese acute coronary syndrome patients (BRIC-ACS) score for PDB was established. C-statistic for the score for PDB was 0.67 (95% CI: 0.62-0.73) in the overall cohort, and >0.70 in subgroups with non-ST- and ST-segment elevation myocardial infarction, diabetes and receiving more than two drug eluting stents. CONCLUSIONS: In Chinese ACS patients, PDB with BARC ≥2 was associated with higher risk for MACE after PCI. The constructed BRIC-ACS risk score provides a useful tool for PDB discrimination, particularly among high ischemic and bleeding risk patients.

A randomised comparison of healing response between the BuMA Supreme stent and the XIENCE stent at one-month and two-month follow-up: PIONEER-II OCT randomised controlled trial.

AIMS: The aim of this study was to compare the strut coverage of the XIENCE stent with that of the BuMA Supreme sirolimus-eluting cobalt-chromium stent, which has a shorter drug elution, on optical coherence tomography (OCT) one or two months after implantation. METHODS AND RESULTS: The PIONEER-II OCT trial was a multicentre, two-arm randomised trial, which comprised two cohorts: cohort-1 underwent an OCT imaging one month after coronary intervention (BuMA: 16 patients with 18 lesions, XIENCE: 15 patients with 17 lesions), whereas cohort-2 underwent OCT at two months (BuMA: 21 patients with 21 lesions, XIENCE: 23 patients with 28 lesions). The primary hypotheses were non-inferiority of the BuMA stent to the XIENCE stent in percent strut coverage at one month (cohort-1) or two months (cohort-2). In cohort-1, the BuMA stent was non-inferior to the XIENCE stent in terms of the strut coverage (83.8±10.4% for BuMA vs. 73.0±17.5% for XIENCE, pfor noninferiority <0.001), and was also significantly higher than the XIENCE (pfor superiority 0.037). In cohort-2, the BuMA stent was non-inferior to the XIENCE stent in OCT strut coverage (80.3±18.3% vs. 73.3±21.3%, pfor noninferiority 0.006, pfor superiority 0.24). Healing scores showed better healing in the BuMA stent in cohort-1 (32.36±21.59 vs. 54.88±34.65, p=0.027), whereas there was comparable healing between the BuMA and XIENCE stents in cohort-2 (39.86±37.77 vs. 53.75±42.84, p=0.25). CONCLUSIONS: The BuMA Supreme had a faster coverage than the XIENCE at one month, presumably due to faster and shorter sirolimus elution. The difference in tissue coverage became less evident at two months.