Key Points Dedicated CHIP training can improve access and outcomes for high-risk patients needing revascularization. Given the variability in current CHIP training programs, uniformity in institutional training standards and case matrix may be an important step to achieve proficiency in all key CHIP skill domains and ensure a smooth transition to practice. Though CHIP procedures carry higher costs, overall contribution margins remain positive.
Chronic total occlusion (CTO) remains a technical challenge for the interventional cardiologists. The application of the retrograde approach has dramatically improved success rates of CTO PCI. However, retrograde wire externalization could be very difficult especially when the antegrade guiding catheter cannot sit into the coronary ostium stably. We report a novel technique to facilitate retrograde wire externalization in aorto-ostial chronic total occlusion intervention without using snare.
Objectives The FUTURE-I study aimed to assess preliminary safety and effectiveness with the long-term clinical and imaging follow-up for the Firesorb (MicroPort, Shanghai, China), a thinner-strut sirolimus-eluting bioresorbable scaffold (BRS). Background First-generation BRS has been associated with unexpected device-related adverse outcomes at long-term follow-up. Methods In this prospective, open-label, first-in-man study, patients with single de novo lesions in native coronary arteries were randomized 2:1 into two cohorts after successful Firesorb implantation: cohort 1 (n = 30) underwent multimodality imaging assessment at 6 and 24 months; and cohort 2 (n = 15) at 12 and 36 months. All patients underwent clinical follow-up at 1, 6, and 12 months and annually up to 5 years. Results Between January and March 2016, 45 patients were enrolled. At 3-year follow-up, one patient had experienced target lesion failure and none scaffold thrombosis. In-scaffold minimal lumen diameter decreased significantly from 6-month to 2-year (2.53 +/- 0.24 mm vs. 2.27 +/- 0.37 mm, p = .0003), and only numerically from 1-year to 3-year follow-up (2.48 +/- 0.28 mm vs. 2.22 +/- 0.13 mm, p = .08). By optical coherence tomography, neointimal strut coverage at 3-year follow-up was 99.8%, and very low rate of late scaffold discontinuity was observed, only in one patient on two cross sections with three malapposed struts. Conclusions At 3-year follow-up of the FUTURE-I study, implantation of the thinner-strut Firesorb BRS appeared preliminary feasible and effective in the treatment of patients with noncomplex coronary lesions.
Objectives To determine whether gamma-glutamyl transferase (GGT) to albumin ratio (GAR) independently predicts mortality and bleeding events in coronary artery disease (CAD) patients who undergo percutaneous coronary intervention (PCI). Background Serum GGT and albumin levels have been associated with CAD risk and mortality. However, more analysis is needed to determine their predictive relationship with adverse outcomes. Methods In total, 5,638 patients from a large retrospective cohort study were enrolled from January 2008 to December 2016 and divided into two groups (GAR <0.62, n = 2,712 and GAR >= 0.62, n = 2,926). The average follow-up time was 35.9 +/- 22.6 months. Multivariate Cox regression analyses were performed to determine the risk of all-cause mortality and bleeding events associated with GAR. Results The low-GAR group had a significantly higher number of all-cause mortality (p = .016) and bleeding events (p = .010) than the high-GAR group. Multivariate Cox regression analyses showed that the risk of all-cause death and bleeding events decreased by 23.8% (hazard risk [HR] = 0.762 95% confidence interval [CI]: 0.601-0.966, p = .025) and 39.4% (HR = 00.616, 95% CI: 0.446-0.852, p = .003), respectively, in the high-GAR group. In patients with acute coronary syndrome, the risk of bleeding events decreased by 57.3% in the high-GAR group (HR = 0.427, 95% CI: 0.234-0.781, p = .006). In patients with stable coronary heart disease, the risk of all-cause death decreased 28.6% (HR = 0.714, 95% CI: 0.540-0.944, p = .018) in the high-GAR group. Conclusion GAR was an independent and novel predictor of mortality and bleeding events in CAD patients who underwent PCI.
Objectives This study evaluated quantitative flow ratio (QFR) to predict microvascular dysfunction (MVD) in patients with ST-segment elevation myocardial infarction (STEMI). Background QFR is a novel approach for the rapid computation of fractional flow reserve based on three-dimensional quantitative coronary angiography. We hypothesized that QFR computation could be used to predict MVD after STEMI. Methods Indexes such as contrast-flow QFR (cQFR), fixed-flow QFR (fQFR), and hyperemic flow velocity (HFV) were calculated in 130 STEMI patients with culprit lesion with >= 50% diameter stenosis and TIMI flow grade 2/3 in the spontaneously recanalized culprit artery on initial angiography. MVD was defined as microvascular obstruction determined by contrast-enhanced cardiac magnetic resonance at a median of 5 days after percutaneous coronary intervention. Results Patients were divided into the MVD group (76/130, 58.5%) and non-MVD group (54/130, 41.5%). Patients with MVD had higher cQFR-fQFR value (0.080 +/- 0.058 vs. 0.038 +/- 0.039, p < .001) and lower modeled HFV (0.096 +/- 0.044 vs. 0.144 +/- 0.041 m/s, p < .001). Receiver operator characteristic curve analysis revealed that both the cQFR-fQFR value (area under the curve, AUC = 0.716, p < .001) and modeled HFV (AUC = 0.805, p < .001) had high specificity and positive predictive value to predict MVD. In multivariable logistic analysis, cQFR-fQFR was identified as an independent predictor of MVD (odds ratio = 9.800, p < .001). Conclusions This proof-of-concept study suggested that QFR computation may be a useful tool to predict MVD after STEMI (Trial Registration:NCT03780335).
Objective This study aimed to evaluate the usefulness of the admission risk index (RI) to predict short-term and long-term outcomes in a broad population with ST-elevation myocardial infarction (STEMI) using data from the Chinese Acute Myocardial Infarction Registry. Background The RI was developed as a simple tool to predict risk of death in STEMI patients. The performance in predicting short-term and long-term risk of death in Chinese patients receiving percutaneous coronary intervention and conservative treatment for STEMI remains unclear. Methods Age, heart rate (HR), and systolic blood pressure (SBP) were used to calculate RI using (HRx[age/10](2))/SBP. We used the prediction tool to predict mortality over 12 months. Results The C-index of the admission RI for predicting in-hospital, 1-, 6-, and 12-months mortality were 0.78, 0.78, 0.78, and 0.77, respectively, compared with 0.75 of the Global Registry in Acute Coronary Events score. Based on the receiver operating characteristic curve analysis, the RI was categorized into quintiles for convenient clinical use, and it revealed a nearly 15-fold gradient of increasing mortality from 2.29 to 32.5% (p < .0001) while RI >34 had the highest mortality. By categorizing into five different risk groups, the short-term and long-term mortality of patients receiving different treatments could be distinguished. Conclusions RI based on three routine variables and easily calculated by any medical practitioner is useful for predicting in-hospital and long-term mortality in patients with STEMI at the initial consultation with clinicians.
Objectives This study aimed to evaluate the safety and efficiency of percutaneous transluminal angioplasty (PTA) with selective stenting treating Chinese patients with renal artery stenosis (RAS) due to fibromuscular dysplasia (FMD). Background Endovascular data of patients with RAS caused by FMD are scarce in China. Methods Clinical data of 105 hypertensive patients with RAS caused by FMD underwent endovascular therapy at a single-site between June 2001 and October 2018 were analyzed retrospectively. Baseline blood pressure, use of antihypertensive medications, renal function, and adverse events at a 1-year follow-up were evaluated. Results The patients were aged between 10 and 64 years (mean age 26.7 +/- 8.2 years) and 52 (49.5%) were female. In total, 105 patients undergoing endovascular therapy involving 124 RASs. Thirty (24.2%), sixty-four (51.6%), and thirty (24.2%) RASs were multifocal, unifocal, and tubular types, respectively. Ninety-four (89.5%) and eleven (10.5%) patients underwent PTA alone and PTA plus stenting, respectively. The technical success rate for endovascular therapy was 95.2% (100/105) without severe complications. During 1-year follow-up (n = 100), the mean systolic and diastolic blood pressure decreased from 157.6 +/- 17.5 and 102.3 +/- 14.2 to 129.6 +/- 12.3 and 81.3 +/- 11.1 mmHg, respectively, and the number of antihypertensive medications reduced from 2.2 +/- 1.2 to 0.8 +/- 1.0 (all p < .001). The cure rate and improved rate of blood pressure was 49.0 and 40.0%, respectively. The serum creatinine levels remained stable. The primary and secondary restenosis rate was 13.4 and 5.8%, respectively. Conclusion Endovascular therapy for treating RAS caused by FMD was technically safe and effective for reducing blood pressure in Chinese patients.
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.
Objectives We evaluated the safety and usefulness of preparatory anatomical reshaping with a geometric hourglass-shaped balloon to optimize transcatheter aortic valve replacement (TAVR) outcomes in bicuspid aortic valve (BAV) stenosis. Background TAVR has been increasingly performed for BAV stenosis; however, technical challenges remain. Procedural results are suboptimal given unfavorable valvular anatomies. Methods Eligible patients with BAV stenosis were enrolled to undergo aortic valve predilatation with the hourglass-shaped TAV8 balloon before TAVR using the self-expandable Venus A-Valve. Procedural details and outcomes were compared to a sequential group of patients with BAV who underwent TAVR with the same device following preparatory dilatation using a cylindrical balloon. Results A total of 22 patients were enrolled in the TAV8 group and 53 were included in the control group. Valve downsizing was less common in the TAV8 group (36.4 vs. 67.9%; p = .012). Stable valve release and optimal implant depth were consistently achieved in the TAV8 group with no requirement for a second valve (0 vs. 17.0%; p = .039) and with higher device success rates (100.0 vs 77.4%; p = .014). Residual aortic regurgitation graded as >= mild was less common in the TAV8 group (13.6 vs 45.3%; p = .009). Mortality was similar (0 vs. 3.8%; p = 1); no major/disabling stroke or conversion to open-heart surgery was seen in either group within 30 days. Conclusions Compared with standard cylindrical balloon valvuloplasty, preparatory reshaping with the hourglass-shaped balloon before self-expandable TAVR in BAV was associated with significantly better procedural results and may encourage more promising outcomes.
Background The Coronary Artery Tree description and Lesion EvaluaTion (CatLet) score accommodating the variability in coronary anatomy is a recently developed and comprehensive angiographic scoring system aimed at assisting in risk-stratification of patients with coronary artery disease. However, a validation of this angiographic scoring system is lacking. Methods The CatLet score was calculated retrospectively in 308 consecutively enrolled patients with acute myocardial infarction (AMI) undergoing primary percutaneous coronary intervention. The primary endpoint, major adverse cardiac or cerebrovascular events (MACCEs), was stratified according to CatLet tertiles: CatLetlow <= 14 (n = 124), CatLetmid 15-21 (n = 82) and CatLettop >= 22 (n = 102). Results The CatLet score alone or after adjusting for a broad spectrum of risk factors, significantly predicted clinical outcomes at a median 4.3-year follow-up. Multivariable-adjusted hazard ratios (95%CI)/unit higher score were 1.05 (1.04-1.07) for MACCE, 1.06 (1.04-1.07) for cardiac death, and 1.05 (1.04-1.07) for all-cause death. When compared to the SYNTAX score, improved discrimination and better calibration of this CatLet score resulted in a significantly refined risk stratification. The overall category-free net reclassification improvement afforded by this CatLet score was as follows: 37.2% (p = .008) for MACCEs, 35.5% (p = .0249) for cardiac death, and 31.8% (p = .0316) for all-cause death. Conclusions The ability to integrate the variability in coronary anatomy into angiographic scoring makes the CatLet score a more specific tool for outcome predictions in AMI. (http://. Unique identifiers: ChiCTR-POC-17013536).
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.
Objectives To evaluate the impact of extended dual antiplatelet therapy (DAPT) beyond 12 months in acute coronary syndrome (ACS) patients with intermediate-risk to high-risk of developing ischemia according to the Global Acute Coronary Event Registration (GRACE) score. Background The duration of optimal DAPT remains controversial in patients at higher risk of developing ischemia. Methods Overall, 9,309 ACS patients in the Optimal antiPlatelet Therapy for Chinese patients with Coronary Artery Disease (OPT-CAD) study were stratified as low-risk (n = 5,112) or intermediate-risk to high-risk (n = 4,197) according to the GRACE score on hospital discharge. Clinical outcomes at 12-24 months in patients with intermediate-to-high risk who completed 1-year DAPT without any adverse events were analyzed. The primary endpoint was 24-month net adverse clinical events (NACEs). Results Patients at intermediate-to-high-risk had significantly higher incidence of NACE (10.2 vs. 4.9%, p < .01) and ischemic events (8.3 vs. 3.8%, p < .01) than low-risk patients at 24 months. For patients at intermediate-to-high-risk, extended DAPT beyond 12 months was associated with lower risk of NACE (3.0 vs. 5.1%, p = .012), all-cause death (1.1 vs. 2.6%, p = .01), and cardiac death (0.6 vs. 1.8%, p = .01), without excessive risk of major bleeding events (0.3 vs. 0.5%, p = .47). Clinical outcomes in the propensity-matched cohort were consistent. Conclusions ACS patients with intermediate-risk or high-ischemic risk may benefit from extended DAPT beyond 1 year, an outcome than requires further confirmation in large-scale randomized trials.
Background Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor has become the standard of care to reduce thrombotic events in patients with acute coronary syndrome or after percutaneous coronary intervention (PCI). The role of routine platelet function testing (PFT) in patients treated with DAPT after PCI remains controversial and evidence of PFT-guided antiplatelet therapy for patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI is limited. Methods We analyzed 1,353 consecutive STEMI patients undergoing primary PCI. PFT was performed 72 hr postprocedure using a vasodilator-stimulated phosphoprotein assay. The primary endpoint of major adverse cardio-cerebral events (MACCEs) was defined as a composite of all-cause death, cardiac death, nonfatal myocardial infarction, target vessel revascularization, and ischemic stroke. Patients with high platelet reactivity (HPR) were randomized to receive an intensified antiplatelet strategy by switching from clopidogrel to ticagrelor (HPR switch group) or to continue on clopidogrel (HPR nonswitch group). One-year clinical outcomes were compared among the groups. Results The baseline clinical characteristics were comparable across all groups (all p > .05). At the 1-year clinical follow-up, the primary endpoint of MACCE was significantly higher in the HPR nonswitch group than in the non-HPR and HPR switch groups (19.49% vs. 10.20% or 8.57%, p < .05), which was mainly caused by higher mortality (14.87% vs. 4.51% or 5.71%, p < .05). Major bleeding events were comparable across the groups. Conclusions In STEMI patients with HPR, identified by vasodilator stimulated phosphoprotein (VASP)-determined PFT, switching clopidogrel to ticagrelor could significantly improve 1-year clinical outcomes without increasing the risk of bleeding.
Objectives We aimed to evaluate the safety and efficacy of Nano+(TM) (Lepu Medical, Beijing, China) stent implantation in all-comer patients at the 1-year follow-up. Background The Nano+(TM) stent is a novel polymer-free sirolimus-eluting stent polymer that employs nanoporous stent surface technology to control drug-delivery. The Nano+(TM) stent is one of the most widely used drug-eluting stent (DES) in China. Methods A total of 2,481 consecutive patients were included in the multicenter and prospective NANO registry. In this study, the primary endpoint was target lesion failure (TLF) at 1-year follow-up, defined as a composite of cardiac death, target vessel nonfatal myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR). The safety endpoint was the occurrence of definite or probable stent thrombosis (ST). Results Up to 40.2% of patients presented with acute myocardial infarction (AMI). A total of 63.9% of the 2,904 lesions were American College of Cardiology/American Heart Association (ACC/AHA) type B2 or C lesions. One-year follow-up data were available for 98.4% of patients. The 1-year rate of TLF was 3.1% with rates of 1.3, 1.8, and 0.4% for clinically driven TLR, cardiac death, and TV-MI, respectively. ST occurred in 0.4% of patients. Diabetes mellitus, AMI, left ventricular ejection fraction <40% and long lesions (>40 mm) were independent predictors of 1-year TLF. Conclusions The 1-year clinical outcomes were excellent for Nano+(TM) polymer-free SES implantation in an all-comer patient population. Follow-up will be extended up to 5 years, to further elucidate the potential long-term clinical benefits. Clinical Trial Registration URL: . Unique identifier: NCT02929030.
Purpose To assess the safety, feasibility and effectiveness of balloon-expandable bare metal stents (BMS) as bridge stents during thoracic endovascular aortic repair (TEVAR). Materials and Methods Retrospective analysis was conducted on 103 consecutive patients who underwent TEVAR procedures from December 2015 to March 2018. Thirty-one patients fulfilled requirements for inclusion and exclusion in the analysis. Thirty-three in situ fenestration (ISF) procedures (single fenestration [n = 29]; dual fenestration [n = 2]) were performed in the 31 patients (67.7% men; median age, 61.5 year) who underwent TEVAR for thoracic lesions (aortic dissection [n = 23], aortic aneurysm [n = 3], aortic ulcer [n = 5]) with 34 stents (33 balloon-expandable BMS, 1 covered stents) implanted in supraaortic arteries. The success rate of overall intervention, fenestration, and implantation of BMS was recorded. The therapeutic effects and complications during admission and follow-up (median 29.7 months, range 18-45 months) were the primary outcomes. Results The technical success rate was 90.3% (28/31). All thoracic lesions were totally excluded. Major complications (6.5%) were one dissection in the left subclavian artery (n = 1) and thrombus formation (n = 1). Minor complications (12.9%) were hematoma (n = 1), and type III endoleak (n = 3). During follow-up, no endoleak developed and all fenestrated branch arteries were patent, except for one left subclavian artery dissection and occlusion. Conclusions Use of balloon-expandable BMS in ISF is safe and effective in reconstruction of supraarotic arteries during TEVAR.