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1.
Can J Cardiol ; 2024 Apr 24.
Article En | MEDLINE | ID: mdl-38670457

BACKGROUND: Intravascular lithotripsy is effective and safe for managing coronary calcification; however, available devices are limited, and complex lesions have been excluded in previous studies. This study aimed to investigate the effectiveness and safety of a novel intravascular lithotripsy system for severe calcification in a population with complex lesions. METHODS: CALCI-CRACK (ChiCTR2100052058) is a prospective, single-arm, multicenter study. The primary endpoint was the procedural success rate. Major safety endpoints included major adverse cardiovascular events (MACE) and target lesion failure (TLF) at 30 days and 6 months, and severe angiographic complications. Calcification morphology was assessed in the optical coherence tomography (OCT) subgroup. RESULTS: In total, 242 patients from 15 high-volume Chinese centers were enrolled, including 26.45% of patients with true bifurcation lesions, 3.31% with severely tortuous vessels, and 2.48% with chronic total occlusion, respectively. The procedural success rate was 95.04% (95% confidence interval 91.50-97.41%), exceeding the pre-specified performance goal of 83.4% (p<0.001). The 30-day and 6-month MACE rates were 4.13% and 4.55%, respectively. TLF rates at these time-points were 1.24% and 1.65%, respectively. Severe angiographic complications occurred in 0.42% of patients. In the OCT subgroup (n=93), 93.55% of calcified lesions were fractured, and minimal lumen area increased from 1.55 ± 0.55 mm2 to 4.91 ± 1.22 mm2 after stent implantation, with acute gain rate of 245 ± 102%. CONCLUSIONS: The novel intravascular lithotripsy system is effective and safe for managing severely calcified coronary lesions in a cohort that included true bifurcation lesions, severely tortuous vessels, and chronic total occlusion. (ChiCTR2100052058).

2.
BMC Cardiovasc Disord ; 21(1): 605, 2021 12 18.
Article En | MEDLINE | ID: mdl-34922437

BACKGROUND: Ventricular septal rupture (VSR) is a rare but severe complication of acute myocardial infarction (AMI). For such cases, surgical repair is recommended by major guidelines, but not always possible for such cases. CASE PRESENTATION: A 72-year-old man presented to the emergency room. ECG showed the ST-segment was elevated by 2-3 mm in lead II, III, and aVF, with Q-waves. Coronary angiography (CAG) showed multi-vessel disease with a total occlusion of the right coronary artery (RCA) and severe stenosis of the left anterior descending artery (LAD). A diagnosis of acute inferior myocardial infarction was made. VSR occurred immediately after percutaneous coronary intervention (a 2.5 × 20 mm drug-eluting stent implanted in RCA), and the patient developed cardiogenic shock. An intra-aortic balloon pump (IABP) was used to stabilize the hemodynamics. Transthoracic echocardiography (TTE) revealed an 11.4-mm left-to-right shunt in the interventricular septum. An attempt was made to reduce the IABP augmentation ratio for weaning on day 12 but failed. Transcatheter closure was conducted using a 24-mm double-umbrella occluder on day 28. The patient was weaned from IABP on day 31 and underwent secondary PCI for LAD lesions on day 35. The patient was discharged on day 41. Upon the last follow-up 6 years later, CAG and TTE revealed no in-stent restenosis, no left-to-right shunt, and 51% left ventricular ejection fraction. CONCLUSIONS: Prolonged implementation of IABP can be a viable option to allow deferred closure of VSR in AMI patients, and transcatheter closure may be considered as a second choice for the selected senior and vulnerable patients, but the risk is still high.


Cardiac Catheterization , Inferior Wall Myocardial Infarction/therapy , Intra-Aortic Balloon Pumping/adverse effects , Percutaneous Coronary Intervention , Shock, Cardiogenic/therapy , Ventricular Septal Rupture/therapy , Aged , Drug-Eluting Stents , Humans , Inferior Wall Myocardial Infarction/complications , Inferior Wall Myocardial Infarction/diagnostic imaging , Inferior Wall Myocardial Infarction/physiopathology , Male , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/instrumentation , Recovery of Function , Shock, Cardiogenic/diagnosis , Shock, Cardiogenic/etiology , Shock, Cardiogenic/physiopathology , Time Factors , Treatment Outcome , Ventricular Septal Rupture/diagnostic imaging , Ventricular Septal Rupture/etiology , Ventricular Septal Rupture/physiopathology
3.
BMC Cardiovasc Disord ; 21(1): 488, 2021 10 10.
Article En | MEDLINE | ID: mdl-34629058

BACKGROUND: Primary percutaneous coronary intervention is the treatment of choice in ST-segment elevation myocardial infarction and no-reflow phenomenon is still an unsolved problem. METHODS: We searched PubMed, EmBase, and Cochrane Central Register of Controlled Trials for relevant randomized controlled trials. The primary endpoint was the incidence of major adverse cardiac events and the secondary endpoint was the incidences of no-reflow phenomenon and complete resolution of ST-segment elevation. RESULTS: Eighteen randomized controlled trials were enrolled. Nicorandil significantly reduced the incidence of no-reflow phenomenon (OR, 0.46; 95% CI, 0.36-0.59; P < 0.001; I2 = 0%) and major adverse cardiac events (OR, 0.42; 95% CI, 0.27-0.64; P < 0.001; I2 = 52%). For every single outcome of major adverse cardiac events, only heart failure and ventricular arrhythmia were significantly improved with no heterogeneity (OR, 0.36; 95% CI, 0.23-0.57, P < 0.001; OR, 0.43; 95% CI, 0.31-0.60, P < 0.001 respectively). A combination of intracoronary and intravenous nicorandil administration significantly reduced the incidence of major adverse cardiac events with no heterogeneity (OR, 0.24; 95% CI, 0.13-0.43, P < 0.001; I2 = 0%), while a single intravenous administration could not (OR, 0.66; 95% CI, 0.40-1.06, P = 0.09; I2 = 52%). CONCLUSIONS: Nicorandil can significantly improve no-reflow phenomenon and major adverse cardiac events in patients undergoing primary percutaneous coronary intervention. The beneficial effects on major adverse cardiac events might be driven by the improvements of heart failure and ventricular arrhythmia. A combination of intracoronary and intravenous administration might be an optimal usage of nicorandil.


Coronary Circulation/drug effects , Nicorandil/administration & dosage , No-Reflow Phenomenon/prevention & control , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction/therapy , Vasodilator Agents/administration & dosage , Administration, Intravenous , Aged , Female , Humans , Male , Middle Aged , Nicorandil/adverse effects , No-Reflow Phenomenon/diagnosis , No-Reflow Phenomenon/etiology , Percutaneous Coronary Intervention/adverse effects , Randomized Controlled Trials as Topic , Risk Assessment , Risk Factors , ST Elevation Myocardial Infarction/diagnosis , ST Elevation Myocardial Infarction/physiopathology , Treatment Outcome , Vasodilator Agents/adverse effects
4.
JMIR Med Inform ; 9(1): e22753, 2021 Jan 19.
Article En | MEDLINE | ID: mdl-33436354

BACKGROUND: Chest examination by auscultation is essential in patients with COVID-19, especially those with poor respiratory conditions, such as severe pneumonia and respiratory dysfunction, and intensive cases who are intubated and whose breathing is assisted with a ventilator. However, proper auscultation of these patients is difficult when medical workers wear personal protective equipment and when it is necessary to minimize contact with patients. OBJECTIVE: The objective of our study was to design and develop a low-cost electronic stethoscope enabling ear-contactless auscultation and digital storage of data for further analysis. The clinical feasibility of our device was assessed in comparison to a standard electronic stethoscope. METHODS: We developed a prototype of the ear-contactless electronic stethoscope, called Auscul Pi, powered by Raspberry Pi and Python. Our device enables real-time capture of auscultation sounds with a microspeaker instead of an earpiece, and it can store data files for later analysis. We assessed the feasibility of using this stethoscope by detecting abnormal heart and respiratory sounds from 8 patients with heart failure or structural heart diseases and from 2 healthy volunteers and by comparing the results with those from a 3M Littmann electronic stethoscope. RESULTS: We were able to conveniently operate Auscul Pi and precisely record the patients' auscultation sounds. Auscul Pi showed similar real-time recording and playback performance to the Littmann stethoscope. The phonocardiograms of data obtained with the two stethoscopes were consistent and could be aligned with the cardiac cycles of the corresponding electrocardiograms. Pearson correlation analysis of amplitude data from the two types of phonocardiograms showed that Auscul Pi was correlated with the Littmann stethoscope with coefficients of 0.3245-0.5570 for healthy participants (P<.001) and of 0.3449-0.5138 among 4 patients (P<.001). CONCLUSIONS: Auscul Pi can be used for auscultation in clinical practice by applying real-time ear-contactless playback followed by quantitative analysis. Auscul Pi may allow accurate auscultation when medical workers are wearing protective suits and have difficulties in examining patients with COVID-19. TRIAL REGISTRATION: ChiCTR.org.cn ChiCTR2000033830; http://www.chictr.org.cn/showproj.aspx?proj=54971.

5.
Coron Artery Dis ; 32(6): 526-533, 2021 Sep 01.
Article En | MEDLINE | ID: mdl-33229940

BACKGROUND: Treatment of coronary in-stent restenosis (ISR) remains challenging in contemporary clinical applications. Drug-coated balloon (DCB) angioplasty offers an effective treatment for ISR. Shenqi is a novel iopromide-based paclitaxel-coated balloon and its clinical safety, effectiveness and angiographic efficacy in patients with ISR have not been investigated. METHODS: A total of 216 subjects with the first occurrence of ISR at 11 investigational sites in China were randomly allocated in a 1:1 fashion to treatment with DCB SeQuent Please or Shenqi. Clinical follow-up was planned at 1, 6, 9 and 12 months, and angiographic follow-up was planned at 9 months. The study was powered for the primary endpoint of 9-month in-segment late loss. RESULTS: At 9-month follow-up, the in-segment late loss was 0.29 ± 0.43 mm with Shenqi versus 0.30 ± 0.46 mm with SeQuent Please, and the one-sided 97.5% upper confidence limit of the difference was 0.14 mm, achieving noninferiority of Shenqi compared with SeQuent Please (P = 0.002). In total, 12 patients developed target lesion failure (TLF) in the Shenqi group compared with 16 patients in the SeQuent Please group (10.91% versus 15.09%; P = 0.42) within 1 year. TLF was mainly driven by target lesion revascularization (9.09%) followed by target vessel-related myocardial infarction (1.82%) and cardiovascular death (0.91%) in the Shenqi group. CONCLUSIONS: Shenqi DCB was noninferior to SeQuent Please DCB for the primary endpoint of 9-month in-segment late loss. Shenqi DCB may become an attractive alternative treatment for patients with coronary ISR, withholding the need for additional stent implantation.


Angioplasty, Balloon, Coronary , Coronary Restenosis/drug therapy , Drug-Eluting Stents , Drugs, Chinese Herbal/therapeutic use , Iohexol/analogs & derivatives , Paclitaxel/therapeutic use , China , Coated Materials, Biocompatible , Coronary Angiography , Female , Humans , Iohexol/therapeutic use , Male , Middle Aged
6.
Catheter Cardiovasc Interv ; 95 Suppl 1: 587-597, 2020 02.
Article En | MEDLINE | ID: mdl-31943693

OBJECTIVES: To report the clinical outcomes of the RESTORE drug-coated balloon (DCB; Cardionovum, Bonn, Germany) for treatment of de novo small vessel disease (SVD) beyond 1 year. BACKGROUND: Previous reports have demonstrated the noninferiority of the RESTORE DCB to the RESOLUTE Integrity drug-eluting stent (DES; Medtronic, Minneapolis, Minnesota) in terms of 9-month in-segment percent diameter stenosis. METHODS: In the prospective, multicenter, noninferiority RESTORE SVD China trial, 230 patients with visually-estimated reference vessel diameter (RVD) ≥2.25 and ≤2.75 mm were randomized to DCB or DES in a 1:1 ratio stratified by diabetes and number of lesions treated. Furthermore, 32 patients with RVD ≥2.00 and <2.25 mm were enrolled in a nested very small vessel (VSV) registry. Clinical follow-up were performed at 2 years to evaluate target lesion failure (TLF) in both groups and the VSV cohort. RESULTS: Overall, 256 (97.7%) patients (115 and 109 in the DCB and DES groups, respectively, and 32 in the VSV cohort) completed 2 years of follow-up. There was no significant difference in TLF between the DCB and DES groups (5.2 vs. 3.7%, p = .75). Target lesion revascularization was acceptable at 1 month, 1 year, and 2 years, and did not differ significantly with DCB from that in the DES group (0.9 vs. 0%, p = 1.0, 4.4 vs. 2.6%, p = .72, 5.2 vs. 2.8%, p = .50, respectively). CONCLUSIONS: Compared to the second-generation DES, the RESTORE DCB did not increase the risk of clinical outcomes. Late catch-up phenomen requiring revascularization was not significant in this study.


Angioplasty, Balloon, Coronary/instrumentation , Cardiac Catheters , Coated Materials, Biocompatible , Coronary Artery Disease/therapy , Drug-Eluting Stents , Aged , Angioplasty, Balloon, Coronary/adverse effects , China , Coronary Artery Disease/diagnostic imaging , Female , Humans , Male , Middle Aged , Registries , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome
7.
BMC Cardiovasc Disord ; 19(1): 175, 2019 07 24.
Article En | MEDLINE | ID: mdl-31340761

BACKGROUND: In-stent restenosis remains an unresolved issue. Inflammation plays a pivotal role in the process of in-stent restenosis. Significant and positive associations were found between red blood cell distribution width (RDW) and inflammation. But whether there is a close relationship between higher RDW and in-stent restenosis is still not clarified. METHODS: This retrospective observational study investigated 214 consecutive patients with unstable angina pectoris who underwent successful percutaneous coronary interventions with drug-eluting stents. Patients were divided into three groups according to baseline RDW before percutaneous coronary interventions (low RDW group:≤12.5%; intermediate RDW group:> 12.5% and ≤ 13.5%; high RDW group:> 13.5%). The follow-up angiographies were routinely performed 9-12 months after the initial percutaneous coronary interventions. The multivariate logistic regression analysis was employed to determine the independent predictors of in-stent restenosis. RESULTS: The in-stent restenosis rate was significantly higher in group with higher baseline RDW value (12.3, 19.7, 47.7% in low, intermediate, and high RDW groups respectively, P < 0.001). The baseline RDWs were significantly higher in patients with in-stent restenosis compared with those in patients without in-stent restenosis (13.7 ± 0.8% vs. 13.0 ± 0.8%, P < 0.001). For prediction of in-stent restenosis, the ROC (receiver operating characteristic) curve analysis demonstrated the optimal RDW cutoff value was 13.37 (sensitivity: 65.5%, specificity: 73.6%); the diagnosis cutoff value was 13.89 (sensitivity: 40.0%, specificity: 91.8%); the screening cutoff value was 12.99 (sensitivity: 83.6%, specificity: 49.1%). By multivariate logistic analysis, higher baseline RDW (odds ratio [OR], 5.179; 95% confidence interval [CI], 2.568 to 10.446; P<0.001) together with lower baseline indirect bilirubin (OR, 0.413; 95% CI, 0.305 to 0.559; P<0.001) and diabetes (OR, 4.077; 95% CI, 1.654 to 10.054; P = 0.002) were closely associated with in-stent restenosis at followup (11.1 ± 5.8 months). CONCLUSIONS: The baseline RDW was closely associated with in-stent restenosis at follow-up. The patients with higher baseline RDW might have more chances to develop in-stent restenosis at followup.


Angina, Unstable/therapy , Coronary Restenosis/etiology , Drug-Eluting Stents , Erythrocyte Indices , Erythrocytes , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/instrumentation , Aged , Angina, Unstable/blood , Angina, Unstable/diagnostic imaging , Coronary Restenosis/blood , Coronary Restenosis/diagnostic imaging , Female , Humans , Male , Middle Aged , Predictive Value of Tests , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome
8.
JACC Cardiovasc Interv ; 11(23): 2381-2392, 2018 12 10.
Article En | MEDLINE | ID: mdl-30522667

OBJECTIVES: The aim of this study was to evaluate the angiographic efficacy and clinical outcomes of the Restore paclitaxel-coated balloon in a randomized trial designed to enable its approval with an indication for small-vessel disease (SVD). BACKGROUND: Higher rates of restenosis and stent thrombosis limit the effectiveness of drug-eluting stent (DES) treatment of SVD. Whether a drug-coated balloon (DCB)-only strategy is effective in de novo SVD is not yet established. METHODS: In the noninferiority RESTORE SVD China trial, eligible patients with reference vessel diameter ≥2.25 and ≤2.75 mm were randomized to the Restore DCB or the RESOLUTE Integrity DES in a 1:1 ratio stratified by diabetes and number of lesions treated. Patients with RVD ≥2.00 and <2.25 mm were enrolled in a nested very small vessel registry. Angiographic and clinical follow-up were planned at 9 months and 1 year, respectively, in all patients. The study was powered for the primary endpoint of 9-month in-segment percentage diameter stenosis. RESULTS: Between August 2016 and June 2017, a total of 230 subjects at 12 sites were randomized to the DCB group (n = 116) or DES group (n = 114); 32 patients were treated with the DCB in the very small vessel cohort. Nine-month in-segment percentage diameter stenosis was 29.6 ± 2.0% with the DCB versus 24.1 ± 2.0% with the DES; the 1-sided 97.5% upper confidence limit of the difference was 10.9%, achieving noninferiority of the DCB compared with the DES (p for noninferiority < 0.001). The DCB and DES had comparable 1-year rates of target lesion failure (4.4% vs. 2.6%, p = 0.72). CONCLUSIONS: In this multicenter randomized trial, the Restore DCB was noninferior to the RESOLUTE DES for 9-month in-segment percentage diameter stenosis. (Assess the Efficacy and Safety of RESTORE Paclitaxel Eluting Balloon Versus RESOLUTE Zotarolimus Eluting Stent for the Treatment of Small Coronary Vessel Disease; NCT02946307).


Angioplasty, Balloon, Coronary/instrumentation , Cardiac Catheters , Cardiovascular Agents/administration & dosage , Coated Materials, Biocompatible , Coronary Stenosis/therapy , Drug-Eluting Stents , Sirolimus/analogs & derivatives , Aged , Angioplasty, Balloon, Coronary/adverse effects , Cardiovascular Agents/adverse effects , China , Coronary Restenosis/etiology , Coronary Stenosis/diagnostic imaging , Coronary Thrombosis/etiology , Female , Humans , Male , Middle Aged , Prosthesis Design , Registries , Risk Factors , Sirolimus/administration & dosage , Sirolimus/adverse effects , Time Factors , Treatment Outcome
9.
J Geriatr Cardiol ; 15(7): 469-475, 2018 Jul.
Article En | MEDLINE | ID: mdl-30364848

OBJECTIVE: Small coronary vessel disease (disease affecting coronary vessels with main branch diameters of ≤ 2.75 mm) is a common and intractable problem in percutaneous coronary intervention (PCI). This study was designed to test the theory that the effectiveness and safety of drug-eluting balloons for the treatment of de novo lesions in small coronary vessels are non-inferior to those of drug-eluting stents. METHODS: We designed a prospective, multicenter, randomized, controlled clinical trial aiming to assess the effectiveness and safety of the RESTORE® (Cardionovum, Bonn, Germany) drug-eluting balloon (DEB) versus the RESOLUTE® (Medtronic, USA) drug-eluting stent (DES) in the treatment of small coronary vessel disease. This trial started in August 2016. A total of 230 patients with a reference vessel diameter (RVD) ≥ 2.25 mm and ≤ 2.75 mm were randomly assigned to treatment with a DEB or a DES at a 1:1 ratio. The study was also designed to enroll 30 patients with an RVD ≥ 2.00 mm and ≤ 2.25 mm in the tiny vessel cohort. RESULTS: The key baseline data include demographic characteristics, relative medical history, baseline angiographic values and baseline procedural characteristics. The primary endpoint is in-segment diameter stenosis at nine months after the index procedure. Secondary endpoints include acute success, all-cause death, myocardial infarction, target vessel revascularization, target lesion revascularization and stent thrombosis. CONCLUSIONS: The study will evaluate the clinical efficacy, angiographic outcomes, and safety of DEBs compared to DESs in the treatment of de novo coronary artery lesions in small vessels.

10.
Medicine (Baltimore) ; 97(29): e11416, 2018 Jul.
Article En | MEDLINE | ID: mdl-30024512

BACKGROUND: PGE1 has been studied for prevention of CI-AKI in several RCTs and significant heterogeneous results exist. METHODS: We searched PubMed, EMBase, and Cochrane Central Register of Controlled Trials up to December 26, 2017 for RCTs comparing PGE1 with placebo or other active medications for the prevention of CI-AKI in patients. Odds ratio and 95% confidence interval (CI) were used for pooling dichotomous data, while mean difference and 95% confidence interval for pooling continuous data. RESULTS: Seven RCTs involving 1760 patients were included in this meta-analysis. All these 7 trials reported the incidence of CI-AKI and compared with placebo or other treatment options, PGE1 was associated with a reduced risk of CI-AKI (OR: 0.38, 95% CI: 0.28-0.53; P < .001) and only a trend for lower post procedure serum creatinine (Scr) levels compared with control groups at 48 hours (MD: -0.03 mg/dL, 95% CI: -0.08 to 0.02 mg/dL; P = .25; 6 trials combined). But the postprocedure Scr levels were significantly reduced in PGE1 groups compared with control groups at 72 hours (MD: -0.07 mg/dL, 95% CI: -0.11 to -0.04 mg/dL; P < .001; 4 trials combined). We also meta-analyzed the postprocedure cystatin C (CysC) at 24 and 48 hours with 2 trials. There were lower postprocedure CysC levels in PGE1 groups than those in control groups (MD: -0.18 mg/L, 95% CI: -0.33 to -0.03 mg/L; P = .02 at 24 hours and MD: -0.14 mg/L, 95% CI: -0.23 to -0.06 mg/L; P = .001 at 48 hours). CONCLUSIONS: PGE1 provides effective nephroprotection against CI-AKI and may act as a part of effective prophylactic pharmacological regimens.


Acute Kidney Injury/prevention & control , Alprostadil/therapeutic use , Contrast Media/adverse effects , Acute Kidney Injury/epidemiology , Acute Kidney Injury/etiology , Creatinine/blood , Female , Humans , Incidence , Male , Randomized Controlled Trials as Topic , Treatment Outcome
11.
EuroIntervention ; 13(10): 1210-1217, 2017 Nov 20.
Article En | MEDLINE | ID: mdl-28741576

AIMS: The EVOLVE China randomised study sought to evaluate the clinical safety and effectiveness of the SYNERGY bioabsorbable polymer-coated everolimus-eluting stent (EES) for the treatment of patients with coronary heart disease in China. METHODS AND RESULTS: Eligible patients with de novo native coronary artery lesions were randomised (1:1) to receive the SYNERGY or PROMUS Element Plus stent. The primary endpoint was in-stent late loss at nine months. Secondary endpoints included death, MI, revascularisation, and stent thrombosis up to 12 months. A total of 412 subjects were randomised (205 SYNERGY; 207 PROMUS Element Plus) at 14 sites in China from October 2013 to July 2014. SYNERGY was non-inferior to PROMUS Element Plus for the primary endpoint of nine-month in-stent late loss: SYNERGY 0.20±0.33 mm vs. PROMUS Element Plus 0.17±0.38 mm with an upper one-sided 97.5% confidence interval of the difference (0.10 mm), significantly less than the non-inferiority margin (0.15 mm; p<0.0008). Clinical adverse event rates were low and not significantly different between groups at nine and 12 months (all p>0.05). CONCLUSIONS: In the EVOLVE China trial, the SYNERGY bioabsorbable polymer-coated EES was noninferior to the PROMUS Element Plus permanent polymer-coated EES for the primary endpoint of late loss at nine months.


Drug-Eluting Stents , Everolimus/therapeutic use , Percutaneous Coronary Intervention , Adolescent , Adult , Aged , China , Chromium , Coronary Artery Disease/therapy , Female , Humans , Male , Middle Aged , Myocardial Infarction/etiology , Myocardial Infarction/therapy , Percutaneous Coronary Intervention/methods , Platinum , Polymers/adverse effects , Sirolimus/therapeutic use , Treatment Outcome , Young Adult
12.
Circ Cardiovasc Interv ; 9(2): e003145, 2016 Feb.
Article En | MEDLINE | ID: mdl-26858080

BACKGROUND: There are no reports on a large-scale randomized trial exploring optimal dual antiplatelet therapy (DAPT) duration after biodegradable polymer sirolimus-eluting stent implantation. We sought to report the outcomes of a randomized substudy of the prospective Evaluate Safety and Effectiveness of the Tivoli DES and the Firebird DES for Treatment of Coronary Revascularization (I-LOVE-IT 2) trial. METHODS AND RESULTS: In the prospective noninferiority randomized I-LOVE-IT 2 trial, 1829 patients allocated to the biodegradable polymer sirolimus-eluting stent group were also randomized to receive either 6-month (n=909) or 12-month DAPT (n=920). The primary end points of this noninferiority substudy were 12-month target lesion failure (composite of cardiac death, target vessel myocardial infarction or clinically indicated target lesion revascularization), and the major secondary end points were 12-month net adverse clinical and cerebral events (composite of all-cause death, all myocardial infarction, stroke, or major bleeding [Bleeding Academic Research Consortium type ≥3]). The 12-month target lesion failure in 6-month DAPT group was comparable with the 12-month DAPT group (6.8% versus 5.9%; difference and 95% confidence interval, 0.87% [-1.37% to 3.11%], P for noninferiority=0.0065). Further follow-up at 18 months showed that incidence of target lesion failure and net adverse clinical and cerebral events were similar between the 2 groups (7.5% versus 6.3%, log-rank P=0.32; 7.8% versus 7.3%, log-rank P=0.60; respectively), as well as their individual end point components. CONCLUSIONS: This study indicated noninferiority in safety and efficacy of 6-month versus 12-month DAPT after implantation of a novel biodegradable polymer sirolimus-eluting stent. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01681381.


Aspirin/administration & dosage , Percutaneous Coronary Intervention/instrumentation , Platelet Aggregation Inhibitors/administration & dosage , Ticlopidine/analogs & derivatives , Absorbable Implants , Aged , Antibiotics, Antineoplastic/administration & dosage , Clopidogrel , Drug-Eluting Stents , Female , Humans , Male , Middle Aged , Prospective Studies , Sirolimus/administration & dosage , Ticlopidine/administration & dosage
13.
Int J Cardiol ; 172(2): 326-31, 2014 Mar 15.
Article En | MEDLINE | ID: mdl-24525155

BACKGROUND: It is necessary to develop a new thrombolytic agent which can be used by a single bolus at first aid sites to decrease the time to reperfusion in clinical practice. HTUPA, a genetically engineered new thrombolytic with a longer half-life, is well qualified. We aim to compare the thrombolytic efficacy and safety of human tissue urokinase type plasminogen activator (HTUPA) to recombinant tissue plasminogen activator (rt-PA) in Chinese patients with acute myocardial infarction (AMI). METHODS: AMI patients (n=221) were randomized to rt-PA (a standard protocol) or HTUPA (25 mg bolus) treatment groups. All patients also received oral aspirin and intravenous heparin. Coronary angiography was performed 90 min after therapy initiation to determine infarct-related coronary artery (IRA) patency. Clinical outcomes and changes of clotting variables, heart rate, blood pressure, left ventricular ejection fraction (LVEF), and electrocardiogram were evaluated. RESULTS: Patent IRA [thrombolysis in myocardial infarction (TIMI) grade 2 or 3] was observed in 77% of HTUPA-treated patients, compared to 76% of rt-PA-treated patients (P=0.76). TIMI grade 3 patency rates were 52% and 44% in the HTUPA and rt-PA groups, respectively (P=0.37). The total patency rate was 77% (86/111 patients) in the HTUPA group and 73% (80/110 patients) in the rt-PA group (P=0.41). Adverse events were infrequent in both groups, and no significant differences were detected in mortality, re-occlusion rate, revascularization rate, adverse effects, clotting index, LVEF, or electrocardiogram between the two groups. CONCLUSIONS: Intravenous HTUPA had a safe and efficacious profile as good as rt-PA in patients with AMI.


Fibrinolytic Agents/therapeutic use , Myocardial Infarction/drug therapy , Urokinase-Type Plasminogen Activator/therapeutic use , Adult , Aged , Anticoagulants/therapeutic use , Aspirin/therapeutic use , Blood Pressure/physiology , China , Coronary Angiography , Electrocardiography , Female , Heart Rate/physiology , Heparin/therapeutic use , Humans , Male , Middle Aged , Myocardial Infarction/diagnostic imaging , Myocardial Infarction/physiopathology , Stroke Volume/physiology , Treatment Outcome , Vascular Patency
14.
Med Princ Pract ; 19(1): 22-7, 2010.
Article En | MEDLINE | ID: mdl-19996615

OBJECTIVE: The objective of the study was to estimate the prevalence of hypertension and associated factors among older rural adults in Liaoning Province, China. SUBJECTS AND METHODS: The study was conducted in 2004-2006, using a multistage, stratified clustering sampling scheme to select a representative sample. A total of 10,065 adults aged 60 years or older were examined. A survey of blood pressure and associated factors was carried out. All data analyses were conducted using SPSS 11.5 statistical software package. RESULTS: Overall, the prevalence rates of hypertension are 57, 64.4 and 64.9% for the age groups 60-69, 70-79 and >or=80 years, respectively. The prevalence of hypertension was positively correlated with age, female gender, Mongolian ethnicity, overweight and obesity, smoking and drinking, whereas income level was a protective factor for hypertension. The rates of awareness, treatment and control among older rural adults were very low (overall 35.2, 28.7 and 1.0%, respectively). CONCLUSION: Hypertension was highly prevalent among older rural adults in Liaoning Province, and it was associated with many factors. The percentages of hypertensives who were aware, treated, and controlled were very low. These data underscore the urgent need to strengthen the public health education and blood pressure monitoring system to better manage hypertension among older adults in rural China.


Hypertension/epidemiology , Rural Population , Age Distribution , Aged , Aged, 80 and over , Alcohol Drinking/adverse effects , Alcohol Drinking/epidemiology , China/epidemiology , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Obesity/complications , Obesity/epidemiology , Prevalence , Sex Distribution , Smoking/adverse effects , Smoking/epidemiology , Social Class
15.
Int J Cardiol ; 137(3): 276-81, 2009 Nov 12.
Article En | MEDLINE | ID: mdl-19211161

BACKGROUND: Multislice computed tomography (MSCT) has been used extensively for coronary artery imaging. To understand the relationship between coronary artery and coronary sinus (CS) anatomy in patients undergoing electrophysiological study, conventional invasive angiography is typically performed. The purpose of this study was to image the coronary artery and CS and its tributaries using MSCT, in comparison with invasive angiography. METHODS AND RESULTS: The study consisted of 141 patients (83 men, 58 women; age 52+/-10 years) who underwent 64-slice MSCT and 3D reconstruction and invasive coronary artery and CS angiography before radiofrequency catheter ablation. The cardiac venous system and coronary artery were visualized in all patients by MSCT and invasive angiography. All data of angiography and MSCT were measured via the same projection (right or left anterior oblique). Angiography and MSCT result revealed coronary arteries of all patients with a vessel diameter over 1 mm. The CS and the middle cardiac vein (MCV) were observed in all patients. MSCT provided high accuracy for the MCV to the CS ostium (CSO), the posterior interventricular vein (PIV) to CSO, and the mean diameter of MCV, PIV and CS ostia, compared with invasive angiography (p<0.001). CONCLUSIONS: MSCT was a reliable tool to visualize the relationship between the coronary artery and CS and its tributaries. MSCT may improve the procedural success rate and reduce the complication rate in patients undergoing electrophysiological study.


Coronary Angiography/methods , Coronary Sinus/diagnostic imaging , Coronary Vessels/anatomy & histology , Tomography, Spiral Computed/methods , Catheter Ablation , Contrast Media , Coronary Disease/diagnostic imaging , Coronary Disease/surgery , Female , Humans , Imaging, Three-Dimensional , Iohexol/analogs & derivatives , Male , Middle Aged
16.
Zhonghua Xin Xue Guan Bing Za Zhi ; 36(6): 514-6, 2008 Jun.
Article Zh | MEDLINE | ID: mdl-19100064

OBJECTIVE: To evaluate the value of measuring ankle brachial index (ABI) for diagnosing peripheral arterial disease(PAD) compared with conventional digital subtraction angiography (DSA) as the reference standard. METHODS: A total of 383 consecutive inpatients (245 male, mean age 64.1 +/- 11.7 years) underwent both conventional DSA and ABI measurements. RESULTS: The rate of statin intervention was 90.9%, ACEI 69.2%, antiplatelet 96.6% and beta-blockers 67.9%. The intravascular stenosis was classified into six degrees: normal, < 30%, 30% - 49%, 50% - 69%, 70% - 89% and > or = 90%. Compared to the traditional gold standard (DSA) in diagnosis PDA, the ABI value decreased in proportion to the severity of PAD (the ABI value was 1.08 +/- 0.11, 1.05 +/- 0.16, 0.99 +/- 0.17, 0.66 +/- 0.24, 0.55 +/- 0.28 and 0.54 +/- 0.00 respectively in the six ranks). There was a significant correlation between DSA and ABI in diagnosis PAD. CONCLUSION: ABI measurement is an accurate and reliable non-invasive alternative to conventional DSA in the assessment of lower extremity arteries in patients with peripheral arterial disease.


Angiography, Digital Subtraction , Ankle Brachial Index , Brachial Artery/diagnostic imaging , Peripheral Vascular Diseases/diagnosis , Aged , Ankle/blood supply , Female , Humans , Male , Middle Aged , Predictive Value of Tests , Risk Assessment
17.
Intern Med ; 47(10): 893-7, 2008.
Article En | MEDLINE | ID: mdl-18480572

BACKGROUND: To evaluate the status of overweight and obesity in a Chinese rural adult population and describe relationships between body mass index (BMI) and blood pressure according to JNC-7. METHODS: The study was conducted in 2004-2006, used a multistage cluster sampling method to select a representative sample. A total of 45,925 adults, age 35 years or older, were examined. Height, weight and blood pressure were obtained by trained doctors. Overweight and obesity were defined according to the World Health Organization classification and Chinese definition. RESULTS: The prevalence of overweight and obesity were 16.3% and 1.3% in males, and 24.4% and 2.7% in females (p for gender differences <0.05) according to the World Health Organization classification; The prevalence of overweight and obesity were 29.5% and 5.3% according to the Chinese definition.The prevalence of elevated blood pressure (prehypertension and hypertension) and mean levels of systolic and diastolic blood pressure increased as BMI increased. Multivariate logistic regression revealed that overweight and obesity were risk factors for prehypertension and hypertension whether in males or females. CONCLUSIONS: Overweight and obesity has become very prevalent in the Chinese rural adult population. It is a great health problem. Our study quantifies the strong associations of BMI and elevated blood pressure. It is time to pay more attention to overweight and obese in the county of China.


Blood Pressure , Hypertension/epidemiology , Obesity/epidemiology , Adult , Aged , Body Mass Index , China/epidemiology , Cluster Analysis , Female , Humans , Hypertension/complications , Male , Middle Aged , Obesity/complications , Odds Ratio , Overweight/complications , Overweight/epidemiology , Prevalence , Rural Population
18.
Circ J ; 72(4): 605-10, 2008 Apr.
Article En | MEDLINE | ID: mdl-18362433

BACKGROUND: The aim of the present study was to prospectively evaluate the sensitivity, specificity, positive and negative likelihood ratios (LR+, LR-) of the ankle - brachial index (ABI), using conventional digital subtraction angiography (DSA) as the reference standard, in the assessment of lower extremity arteries, and to research the threshold value of the ABI in diagnosing periphery arterial disease (PAD), as well as the relationship between the ABI value and stenosis in the artery of the lower extremity in Chinese high-risk cardiovascular patients. METHODS AND RESULTS: A total of 298 consecutive patients (199 men, 99 women, 64.9+/-11.3 years old) underwent conventional DSA and ABI measurement. Receiver operator characteristics (ROC) analysis was performed to assess possible threshold values that predict PAD in these patients. The greater the stenosis in the artery of the lower extremity, the lower the measured ABI value. DSA was used as the gold standard in defining lesions >or=30%, >or=50%, and >or=70% and the respective areas under the ROC curve were 0.786 (95% confidence interval (CI) 0.712, 0.860), 0.927 (95% CI 0.869, 0.984), and 0.963 (95% CI 0.927, 0.999). Conventional DSA was the gold standard in defining >or=50% luminal stenosis for the diagnosis of lower extremity PAD. The 0.95 is the overall cutoff of the ABI that was associated with 91% sensitivity, 86% specificity, 6.5 LR+ and 0.1 LR- for detection of hemodynamically significant stenosis (lesions >or=50%) in all 298 subjects (p<0.001). CONCLUSION: The ABI value shows a decreasing tendency with increasing severity of stenosis in patients with PAD. ABI measurement is an accurate and reliable noninvasive alternative to conventional DSA in the assessment of lower extremity arteries and the cut-off of 0.95 is the threshold ABI value for detecting PAD in Chinese patients.


Peripheral Vascular Diseases/diagnostic imaging , Peripheral Vascular Diseases/diagnosis , Aged , Angiography, Digital Subtraction , Ankle/blood supply , Arterial Occlusive Diseases/diagnosis , Arterial Occlusive Diseases/diagnostic imaging , Arterial Occlusive Diseases/physiopathology , Brachial Artery/physiopathology , Constriction, Pathologic/diagnosis , Constriction, Pathologic/diagnostic imaging , Female , Humans , Leg , Male , Middle Aged , Peripheral Vascular Diseases/physiopathology , Predictive Value of Tests , Prospective Studies , ROC Curve , Sensitivity and Specificity
19.
Zhonghua Yi Xue Za Zhi ; 86(22): 1553-7, 2006 Jun 13.
Article Zh | MEDLINE | ID: mdl-16854283

OBJECTIVE: To investigate the distribution of the single nucleotide polymorphism (SNP) sites in TBX1 gene and the distribution of related haplotypes in the patients with conotruncal defects (CTD) and normal people. METHODS: The genotypes of the 3 selected SNPs: G2857C (rs737868), G2963A (rs28649236), and A6571T (rs28939675) in TBX1 gene were analyzed by PCR-RFLP among 130 patients with CTD and 200 normal people. Contingency table was applied to analyze the frequencies of these SNP genotypes and related alleles. PHASE software was used to construct the haplotypes and analyze the haplotype frequencies in these 2 groups. RESULTS: There were no significant differences in the allele frequency and genotype rates of the SNPs G2587C and A6571T between the CTD patients and normal controls (all P > 0.05). However, the allele frequency and genotype rates of the SNP G2963A were significant different between he CTD patients and normal controls: the G allele frequency in the CTD patients was 53.8%, significantly higher than that in the normal controls (42.5%, chi(2) = 8.14, P < 0.005); and the AA genotype rate of the CTD patients was 21.6%, significantly lower than that of the controls (38.0%), and the GA genotype rate in the CTD patients was 49.2%, significantly higher than that in the controls (39.0%) (both chi(2) = 9.9, P < 0.05). The haplotype frequencies of G2587/G2963/A6571 and G2587/A2963/T6571 of the CTD patients were 49.2% and 14.6% respectively, both significantly higher than those of the normal controls (36.3% and 9.5% respectively), and the haplotype frequencies of G2587/G2963/T6571 and G2587/A2963/A6571 in the CTD patients were 34.6% and 3% respectively, both significantly lower than those in the normal controls (48.3% and 18% respectively) (chi(2) = 22.39, P < 0.005). CONCLUSION: The SNP site G2963A located in the coding-region of TBX1 gene is associated with CTD. The persons with G2963 have higher risk of CTD than those with A2963. The haplotypes constructed with these 3 SNP sites may be linked with the susceptibility gene of CTD.


Haploidy , Heart Defects, Congenital/genetics , Polymorphism, Single Nucleotide/genetics , T-Box Domain Proteins/genetics , Adolescent , Adult , Case-Control Studies , Child , Child, Preschool , Humans , Infant
20.
Zhonghua Xin Xue Guan Bing Za Zhi ; 34(1): 19-22, 2006 Jan.
Article Zh | MEDLINE | ID: mdl-16626543

OBJECTIVE: To obtain the coronary artery and coronary sinus (CS) and its tributaries imaging with multislice computed tomography (MSCT), measure the distance between coronary artery and CS and its tributaries and analyze their spatial relationships. METHODS: The MSCT scans of 117 patients (67 men, 50 women, age 56 +/- 10 years) were obtained, 3D image reconstructed and the vessels courses evaluated. The concomitant distances and spatial relationships of the vessels were determined. RESULTS: Right coronary artery domination was found in 107 cases (91.4%), left coronary artery domination in 7 cases (6.0%), and co-domination in 3 cases (2.6%). Left circumflex artery (LCX) was concomitant with CS or the great cardiac vein (GCV) in 81 cases (69.2%), intersected with left posterior vein in 62 cases (53.0%) and with middle cardiac vein (MCV) in 5 cases (4.3%), respectively. The dominant coronary artery branched out into the posterior descending artery (PDA) and the left posterior artery (LPA) in 112 cases (95.7%). PDA was concomitant with MCV in 93 cases (79.5%) and intersected with MCV in 44 cases (37.6%). LPA was intersected with MCV in 106 cases (90.6%), and concomitant with CS in 50 cases (42.7%). CONCLUSIONS: MSCT is a reliable tool to visualize the relationship between coronary artery and CS and its tributaries. Owing to the multiple possibilities inherent to this technique, MSCT has broad potential for more clinical use.


Coronary Angiography , Coronary Sinus/diagnostic imaging , Coronary Vessels/anatomy & histology , Tomography, Spiral Computed , Adult , Aged , Aged, 80 and over , Coronary Sinus/anatomy & histology , Female , Humans , Male , Middle Aged
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