Shuzheng Lv

Comparison of Double Kissing Crush Versus Culotte Stenting for Unprotected Distal Left Main Bifurcation Lesions Results From a Multicenter, Randomized, Prospective DKCRUSH-III Study

OBJECTIVES The study aimed to investigate the difference in major adverse cardiac event (MACE) at 1-year after double kissing (DK) crush versus Culotte stenting for unprotected left main coronary artery (UPLMCA) distal bifurcation lesions. BACKGROUND DK crush and Culotte stenting were reported to be effective for treatment of coronary bifurcation lesions. However, their comparative performance in UPLMCA bifurcation lesions is not known. METHODS A total of 419 patients with UPLMCA bifurcation lesions were randomly assigned to DK (n = 210) or Culotte (n = 209) treatment. The primary endpoint was the occurrence of a MACE at 1 year, including cardiac death, myocardial infarction, and target vessel revascularization (TVR). In-stent restenosis (ISR) at 8 months was secondary endpoint, and stent thrombosis (ST) served as a safety endpoint. Patients were stratified by SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) and NERS (New Risk Stratification) scores. RESULTS Patients in the Culotte group had significant higher 1-year MACE rate (16.3%), mainly driven by increased TVR (11.0%), compared with the DK group (6.2% and 4.3%, respectively; all p < 0.05). ISR rate in side branch was 12.6% in the Culotte group and 6.8% in the DK group (p = 0.037). Definite ST rate was 1.0% in the Culotte group and 0% in the DK group (p = 0.248). Among patients with bifurcation angle ≥70°, NERS score ≥20, and SYNTAX score ≥23, the 1-year MACE rate in the DK group (3.8%, 9.2%, and 7.1%, respectively) was significantly different to those in the Culotte group(16.5%, 20.4%, and 18.9%, respectively; all p < 0.05). CONCLUSIONS Culotte stenting for UPLMCA bifurcation lesions was associated with significantly increased MACEs, mainly due to the increased TVR. (Double Kissing [DK] Crush Versus Culotte Stenting for the Treatment of Unprotected Distal Left Main Bifurcation Lesions: DKCRUSH-III, a Multicenter Randomized Study Comparing Double-Stent Techniques; ChiCTR-TRC-00000151).

Comparison of long-term (4-year) outcomes of patients with unprotected left main coronary artery narrowing treated with drug-eluting stents versus coronary-artery bypass grafting.

Percutaneous coronary intervention with drug-eluting stents (DES) may achieve midterm outcomes comparable to coronary artery bypass grafting (CABG) for unprotected left main coronary artery disease, but few real-world, long-term studies have been reported. In this study, 376 patients with unprotected left main coronary artery disease who underwent DES implantation (n = 131) or CABG (n = 245) were evaluated, and outcomes were compared using propensity analyses to adjust for baseline differences. Overall, 367 patients (98%) had complete clinical follow-up for a median of 4.0 years (interquartile range 3.2 to 4.7). Although the overall sample size was limited, there was a trend toward lower mortality with DES versus CABG in unadjusted (hazard ratio [HR] 0.50, 95% confidence interval [CI] 0.20 to 1.22, p = 0.13), multivariate-adjusted (HR 0.37, 95% CI 0.13 to 1.09, p = 0.07), and propensity score-adjusted (HR 0.34, 95% CI 0.12 to 1.03, p = 0.06) analyses. Treatment with DES was associated with a higher rate of target-vessel revascularization (TVR; 18% vs 9%, p = 0.02). However, ischemic TVR was not significantly different between the 2 groups (25% vs 39%, p = 0.15) in patients who received angiographic follow-up. No differences were detected in the occurrence of composite major adverse cardiac and cerebrovascular events between DES and CABG (27% vs 22%, p = 0.42). In conclusion, during 4-year follow-up, overall composite major adverse cardiac and cerebrovascular events were similar after DES and CABG treatment of unprotected left main coronary artery disease, with a trend toward lower mortality after percutaneous coronary intervention with DES. DES were associated with a higher rate of TVR compared to CABG, but ischemic TVR was not significantly different between the 2 groups.

Clinical Outcome After DK Crush Versus Culotte Stenting of Distal Left Main Bifurcation Lesions: The 3-Year Follow-Up Results of the DKCRUSH-III Study.

OBJECTIVES The present study aimed to investigate the difference in major adverse cardiac events (MACE) at 3 years after double-kissing (DK) crush versus culotte stenting for unprotected left main distal bifurcation lesions (LMDBLs). BACKGROUND The multicenter and randomized DKCRUSH-III (Comparison of double kissing crush versus culotte stenting for unprotected distal left main bifurcation lesions: results from a multicenter, randomized, prospective study) showed that DK crush stenting was associated with fewer MACE at 1-year follow-up in patients with LMDBLs compared with culotte stenting. Here, we report the 3-year clinical outcome of the DKCRUSH-III study. METHODS A total of 419 patients with LMDBLs who were randomly assigned to either the DK crush or culotte group in the DKCRUSH-III study were followed for 3 year. The primary endpoint was the occurrence of a MACE at 3 years. Stent thrombosis (ST) was the safety endpoint. Patients were classified by simple and complex LMDBLs according to the DEFINITION (Definition and Impact of Complex Bifurcation Lesions on Clinical Outcomes After Percutaneous Coronary Intervention Using Drug-Eluting Stents) study criteria. RESULTS At 3 years, MACE occurred in 49 patients the culotte group and in 17 patients in the DK crush group (cumulative event rates of 23.7% and 8.2%, respectively; p < 0.001), mainly driven by increased myocardial infarction (8.2% vs. 3.4%, respectively; p = 0.037) and target-vessel revascularization (18.8% vs. 5.8%, respectively; p < 0.001) between groups. Definite ST rate was 3.4% in the culotte group and 0% in the DK crush group (p = 0.007). Complex LMDBLs were associated with a higher rate of MACE (35.3%) at 3 years compared with a rate of 8.1% in patients with simple LMDBLs (p < 0.001), with an extremely higher rate in the culotte group (51.5% vs. 15.1%, p < 0.001). CONCLUSIONS Culotte stenting for LMDBLs was associated with significantly increased rates of MACE and ST. (Double Kissing [DK] Crush Versus Culotte Stenting for the Treatment of Unprotected Distal Left Main Bifurcation Lesions: DKCRUSH-III, a Multicenter Randomized Study Comparing Double-Stent Techniques; ChiCTR-TRC-11001877).

Fractional flow reserve versus angiography for guiding percutaneous coronary intervention: a meta-analysis

Objectives The purpose of this study was to investigate whether fractional flow reserve (FFR) should be performed for patients with coronary artery disease (CAD) to guide the percutaneous coronary intervention (PCI) strategy. Background PCI is the most effective method to improve the outcomes of CAD. However, the proper usage of PCI has not been achieved in clinical practice. Methods A meta-analysis was performed on angiography-guided PCI and FFR-guided PCI strategies. Prospective and retrospective studies were included when research subjects were patients with CAD undergoing PCI. The primary endpoint was the rate of major adverse cardiac events (MACE) or major adverse cardiac and cerebrovascular events (MACCE). Secondary endpoints included death, myocardial infarction (MI), repeat revascularisation and death or MI. Results Four prospective and three retrospective studies involving 49 517 patients were included. Absolute risks of MACE/MACCE, death, MI, revascularisation and death or MI for angiography-guided PCI and FFR-guided PCI were 34.8% vs 22.5%, 15.3% vs 7.6%, 8.1% vs 4.2%, 20.4% vs 14.8%, and 21.9% vs 11.8%, respectively. The meta-analysis demonstrated that FFR-guided PCI was associated with lower MACE/MACCE (OR: 1.71, 95% CI 1.31 to 2.23), death (OR: 1.64, 95% CI 1.37 to 1.96), MI (OR: 2.05, 95% CI 1.61 to 2.60), repeat revascularisation (OR: 1.25, 95% CI 1.09 to 1.44), and death or MI (OR: 1.84, 95% CI 1.58 to 2.15) than angiography-guided PCI strategy. Conclusions This meta-analysis supports current guidelines advising the FFR-guided PCI strategy for CAD. PCI should only be performed when haemodynamic significance is found.

Hospital Quality Improvement Initiative for Patients With Acute Coronary Syndromes in China A Cluster Randomized, Controlled Trial

Background—Substantial evidence-practice gaps exist in the management of acute coronary syndromes (ACS) in China. Clinical pathways are tools for improving ACS quality of care but have not been rigorously evaluated. Methods and Results—Between October 2007 and August 2010, a quality improvement program was conducted in 75 hospitals throughout China with mixed methods evaluation in a cluster randomized, controlled trial. Eligible hospitals were level 2 or level 3 centers routinely admitting >100 patients with ACS per year. Hospitals were assigned immediate implementation of the American Heart Association/American College of Cardiology guideline based clinical pathways or commencement of the intervention 12 months later. Outcomes were several key performance indicators reflecting the management of ACS. The key performance indicators were measured 12 months after commencement in intervention hospitals and compared with baseline data in control hospitals, using data collected from 50 consecutive patients in each hospital. Pathway implementation was associated with an increased proportion of patients discharged on appropriate medical therapy, with nonsignificant improvements or absence of effects on other key performance indicators. Conclusions—Among hospitals in China, the use of a clinical pathway for the treatment of ACS compared with usual care improved secondary prevention treatments, but effectiveness was otherwise limited. An accompanying process evaluation identified several health system barriers to more successful implementation. Clinical Trial Registration—URL: http://www.anzctr.org.au/default.aspx. Unique identifier: ACTRN12609000491268.

Treatment of OSA Reduces the Risk of Repeat Revascularization After Percutaneous Coronary Intervention

BACKGROUND The impact of OSA treatment with CPAP on percutaneous coronary intervention (PCI) outcomes remains largely unknown. METHODS Between 2002 and 2012, we identified 390 patients with OSA who had undergone PCI. OSA was diagnosed through in-laboratory sleep studies and defined by an apnea-hypopnea index ≥ 5 events/h. The cohort was divided into three groups: (1) moderate-severe OSA successfully treated with CPAP (n = 128), (2) untreated moderate-severe OSA (n = 167), and (3) untreated mild OSA (n = 95). Main outcomes included repeat revascularization, major adverse cardiac events (MACEs) (ie, death, nonfatal myocardial infarction, repeat revascularization), and major adverse cardiac or cerebrovascular events (MACCEs). The median follow-up period was 4.8 years (interquartile range, 3.0-7.1). RESULTS The untreated moderate-severe OSA group had a higher incidence of repeat revascularization than the treated moderate-severe OSA group (25.1% vs 14.1%, P = .019). There were no differences in mortality (P = .64), MACE (P = .33), and MACCE (P = .76) among the groups. In multivariate analysis adjusted for potential confounders, untreated moderate-severe OSA was associated with increased risk of repeat revascularization (hazard ratio, 2.13; 95% CI, 1.19-3.81; P = .011). CONCLUSIONS Untreated moderate-severe OSA was independently associated with a significant increased risk of repeat revascularization after PCI. CPAP treatment reduced this risk.

Culprit Vessel Only versus Multivessel Percutaneous Coronary Intervention in Patients Presenting with ST-Segment Elevation Myocardial Infarction and Multivessel Disease

Background The best strategy for ST-segment elevation myocardial infarction (STEMI) patients with multivessel disease (MVD), who underwent primary percutaneous coronary intervention (PCI) in the acute phase, is not well established. Objectives Our goal was to conduct a meta-analysis comparing culprit vessel only percutaneous coronary intervention (culprit PCI) with multivessel percutaneous coronary intervention (MV-PCI) for treatment of patients with STEMI and MVD. Methods Pubmed, Elsevier, Embase, and China National Knowledge Infrastructure (CNKI) databases were systematically searched for randomized and nonrandomized studies comparing culprit PCI and MV-PCI strategies during the index procedure. A meta-analysis was performed using Review Manager 5.1 (Cochrane Center, Denmark). Results Four randomized and fourteen nonrandomized studies involving 39,390 patients were included. MV-PCI strategy is associated with an increased short-term mortality (OR: 0.50, 95% CI: 0.32 to 0.77, p = 0.002), long-term mortality (OR: 0.52, 95% CI: 0.36 to 0.74, p<0.001), and risk of renal dysfunction (OR: 0.77, 95% CI: 0.61 to 0.97, p = 0.03) compared with culprit PCI strategy, while it reduced the incidence of revascularization (OR: 2.65, 95% CI: 1.80 to 3.90, p<0.001). Conclusions This meta-analysis supports current guidelines which indicate that the non-culprit vessel should not be treated during the index procedure.

Relationship of depression, stress and endothelial function in stable angina patients.

Endothelial dysfunction has been considered as one of potential mechanisms by which depression and stress might contribute to the development of coronary artery disease (CAD). Recent studies suggest that circulating endothelial progenitor cells (EPCs) and brachial artery flow-mediated dilation (FMD) are related to endothelial function and progression of CAD. We investigated the relationships between the level of circulating CD34/KDR(+) EPCs and CD133/KDR(+) EPCs, brachial FMD, and scores of depression and stress measured with the Depression Anxiety Stress Scales in 288 stable angina patients without major psychiatric disorders. As defined by the ≥75th percentile, 100 (35%) subjects had high depression score (≥8), and 84 (29%) subjects had high stress score (≥10). Subjects with high depression or stress score had significantly lower FMD (1.86±0.14 vs. 3.63±0.17%, p<0.001; 2.05±0.18 vs. 3.48±0.17%, p<0.001) and percentage of circulating CD34/KDR(+) EPCs (0.97±0.11 vs. 1.94±0.17%, p<0.001; 1.09±0.13 vs. 1.68±0.16%, p=0.005), but not CD133/KDR(+) EPCs (0.52±0.04 vs. 0.66±0.06%, p=0.057; 0.61±0.05 vs. 0.59±0.05%, p=0.833), as compared with subjects with normal depression or stress score. Multivariate regression analysis indicated that high depression score (OR 1.09, 95% CI: 1.04-1.15, p<0.001), but not stress score or percentage of circulating EPCs, independently predicted impaired brachial FMD. In conclusions, our results demonstrated that in stable angina patients without major psychiatric disorders, a high depression or stress score was related to attenuated brachial FMD and depletion of circulating EPCs. However, only the depression score, but not the stress score or the level of EPCs, was an independent predictor for decreased brachial FMD.

Nine-month angiographic and 2-year clinical follow-up of the NOYA biodegradable polymer sirolimus-eluting stent in the treatment of patients with de novo native coronary artery lesions: the NOYA I trial

AIMS This study sought to evaluate the safety and efficacy of the NOYA stent which is a cobalt chromium-based sirolimus-eluting stent (SES) with DL-polylactide biodegradable polymer (Medfavour Medical, Beijing, China) in treating de novo coronary artery lesions. METHODS AND RESULTS The NOYA I trial was designed to compare the NOYA stent with the FIREBIRD2™ stent, a durable polymer SES widely used in China (MicroPort Medical, Shanghai, China); the trial was a non-inferiority trial with a primary angiographic endpoint of the in-stent late lumen loss (LLL) at nine-month follow-up. The secondary endpoints were binary restenosis rates within nine months, major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction (MI) or target lesion revascularisation (TLR), and definite/probable stent thrombosis (ST) at 24-month follow-up. A total of 300 patients (n=150 in each group) were enrolled in the study from 16 Chinese centres. The LLL in the NOYA group at nine-month follow-up was similar to the FIREBIRD2 group (0.11±0.18 mm vs. 0.14±0.23 mm, p=0.16; non-inferiority p<0.001). The rates of MACE, death, MI and TLR at 24-month follow-up were comparable between these two devices (p>0.05, respectively). CONCLUSIONS The biodegradable polymer NOYA stent was non-inferior to the FIREBIRD2 durable polymer stent with respect to the primary non-inferiority endpoint of in-stent LLL at nine-month follow-up. Clinical outcomes at 24-month follow-up were comparable between the two stents. (ClinicalTrials.gov number, NCT01226355).

Impact of diabetes mellitus on patients with unprotected left main coronary artery lesion disease treated with either percutaneous coronary intervention or coronary-artery bypass grafting.

ObjectiveThis study was conducted to evaluate the impact of diabetes on patients with unprotected left main coronary artery (LMCA) disease treated with either percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG). BackgroundThe optimal coronary revascularization strategy in diabetic patients with unprotected LMCA disease remains uncertain. MethodsA total of 823 consecutive patients having unprotected LMCA disease, who received drug-eluting stent (DES) (n=331) implantation or underwent CABG (n=492), were retrospectively analyzed. We compared the effects of these two treatments on clinical outcomes [death, cardiac death, myocardial infarction (MI), stroke, target vessel revascularization, and the composite of death, MI, or stroke], according to the patients’ diabetic status. ResultsAfter multivariable adjustment, the risk of death [hazard ratio (HR): 1.096, 95% confidence interval (CI): 0.541–2.222; P=0.799] and that of the composite of death, MI, or stroke (HR: 0.769, 95% CI: 0.446–1.328; P=0.346) were similar in the DES and CABG groups. However, the rate of target vessel revascularization was significantly higher in the DES group (HR: 0.169, 95% CI: 0.079–0.358; P<0.001). Incidence of MI (HR: 1.314, 95% CI: 0.238–7.254; P=0.754) and that of the composite of death, MI, or stroke (HR: 1.497, 95% CI: 0.682–3.289; P=0.315) were similar between DES and CABG in the nondiabetic group; however, in the diabetic population incidence of the composite of death, MI, or stroke (HR: 0.31, 95% CI: 0.126–0.761; P=0.011) was significantly higher in the DES compared with the CABG group, driven mainly by the significantly higher rate of MI in the DES group (HR: 0.114, 95% CI: 0.022–0.593; P=0.01). Rate of repeat revascularization was higher with DES compared with CABG in both diabetic and nondiabetic groups. ConclusionThere was a prognostic impact of diabetes mellitus on treatment effects in patients with unprotected LMCA lesions who underwent DES or CABG. For patients with unprotected LMCA lesions, PCI with DES was an acceptable alternative to CABG at risk for higher repeat revascularization in the nondiabetic cohort, whereas in the diabetic cohort PCI with DES was inferior to CABG in terms of both safety and efficacy.