Benefit-risk profile of extended dual antiplatelet therapy beyond 1 year in patients with high risk of ischemic or bleeding events after PCI.

The benefits and harms of dual antiplatelet therapy (DAPT) continuation with aspirin and clopidogrel beyond 1 year after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation for high ischemic or bleeding risk patients remain unclear. All consecutive patients undergoing PCI were prospectively included in the Fuwai PCI Registry from January 2013 to December 2013. We evaluated 7521 patients who were at high risk for thrombotic or hemorrhagic complications and were events free at 1 year after the index procedure. "TWILIGHT-like" patients with high risk of bleeding or ischemic events were defined by clinical and angiographic criteria. The primary ischemic outcome was major adverse cardiac and cerebrovascular events [MACCE] (a composite of all-cause death, myocardial infarction, or stroke). Median follow-up duration was 2.4 years. The risk of MACCE was significantly lower in DAPT>1-year group (n = 5252) than DAPT≤1-year group (n = 2269) (1.5% vs. 3.8%; hazard ratio [HR]: 0.37; 95% confidence interval [CI]: 0.27-0.50; P < .001). This difference was largely driven by a lower risk of all-cause death. In contrast, the risk of Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding was statistically similar between the two groups (1.0% vs. 1.1%; HR: 0.80; 95% CI: 0.50-1.28; P = .346). Results were consistent after multivariable regression and propensity-score matching. Prolonged DAPT beyond 1 year after DES implantation resulted in a significantly lower rate of atherothrombotic events, including a mortality benefit, with no higher risk of clinically relevant bleeding in "TWILIGHT-like" patients who were at high-risk for ischemic or bleeding events.

Association of lipoprotein(a) with platelet aggregation and thrombogenicity in patients undergoing percutaneous coronary intervention.

This study aimed to evaluate the association of lipoprotein(a) levels with platelet aggregation and thrombogenicity in patients undergoing percutaneous coronary intervention (PCI), and to investigate the ischemic outcome on this population. Lipoprotein(a) and modified thrombelastography were measured in 6601 consecutive patients underwent PCI on dual antiplatelet therapy. Cox proportional regression analysis was applied to illustrate the ischemic events in a 2-year follow up. The mean levels of lipoprotein(a) were 29.0 mg/dl. Patients with higher lipoprotein(a) levels had significantly accelerated fibrin generation (lower K time and bigger α angle) and greater clot strength (higher maximum amplitude (MA)) than patients with lower lipoprotein(a) levels (P < .001). Moreover, the higher lipoprotein(a) group also exhibited significantly higher adenosine diphosphate (ADP) induced platelet aggregation (MAADP) by thrombelastography platelet mapping assay than lower lipoprotein(a) group. Cox regression analyzes revealed that patients with higher lipoprotein(a) levels had a 16% higher risk of major adverse cardiovascular and cerebrovascular events (HR 1.159, 95%CI: 1.005-1.337, P = .042) compared with patients with lower lipoprotein(a) levels. This association persisted after adjustment for a broad spectrum of risk factors (HR 1.174, 95%CI: 1.017-1.355, P = .028). High plasma lipoprotein(a) levels were associated with increased platelet aggregation and ischemic events in patients underwent PCI. Lipoprotein(a) might indicate the need for prolonged antiplatelet therapy.

Percutaneous Coronary Intervention Complexity and Risk of Adverse Events in relation to High Bleeding Risk among Patients Receiving Drug-Eluting Stents: Insights from a Large Single-Center Cohort Study.

Background/Aim: The relation between complex percutaneous coronary intervention (PCI), high bleeding risk (HBR), and adverse events after coronary artery implantation of drug-eluting stents has been incompletely characterized. This study sought to investigate the ischemic and bleeding events after complex PCI including stratification according to HBR estimated by PARIS bleeding risk score. Methods: Between January 2013 and December 2013, 10,167 consecutive patients undergoing PCI were prospectively enrolled in Fuwai PCI Registry. Complex PCI was defined when having at least one of the following characteristics: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, treatment of chronic total occlusion, unprotected left main PCI, in-stent restenosis target lesion, and severely calcified lesion. The primary ischemic endpoint was major adverse cardiovascular events (MACE) (composite of cardiac death, myocardial infarction, definite/probable stent thrombosis, and target lesion revascularization), and primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. Results: The median duration of follow-up was 29 months. In adjusted Cox regression analysis, patients having complex PCI procedures experienced higher risks of MACE (hazard ratio (HR): 1.63, 95% confidence interval (CI): 1.38-1.92; P < 0.001), compared with noncomplex PCI. In contrast, the risk of clinically relevant bleeding was statistically similar between the 2 groups (HR: 0.86 [0.66-1.11]; P = 0.238). There was no statistical interaction between HBR (PARIS bleeding score ≥8 or <8) and complex PCI in regard to MACE (adjusted P interaction = 0.388) and clinically relevant bleeding (adjusted P interaction = 0.279). Conclusions: Patients who had undergone complex PCI resulted in substantially more ischemic events, without an increase in clinically relevant bleeding risk, and these associations did not seem to be modified by HBR status. More intensified antiplatelet therapy may be beneficial for patients with complex percutaneous coronary revascularization procedures.

Two-Year Outcomes after Left Main Coronary Artery Percutaneous Coronary Intervention in Patients Presenting with Acute Coronary Syndrome.

OBJECTIVES: We aim to evaluate long-term outcomes after left main coronary artery (LMCA) percutaneous coronary intervention (PCI) in patients presenting with acute coronary syndrome (ACS). BACKGROUND: PCI of the LMCA has been an acceptable revascularization strategy in stable coronary artery disease. However, limited studies on long-term clinical outcomes of LMCA PCI in ACS patients are available. METHODS: A total of 6429 consecutive patients with ACS undergoing PCI in Fuwai Hospital in 2013 were enrolled. Patients are divided into LMCA group and Non-LMCA group according to whether the target lesion was located in LMCA. Prognosis impact on 2-year major adverse cardiovascular and cerebrovascular events (MACCE) is analyzed. RESULTS: 155 (2.4%) patients had target lesion in LMCA, while 6274 (97.6%) patients belong to the non-LMCA group. Compared with non-LMCA patients, LMCA patients have generally more comorbidities and worse baseline conditions. Two-year follow-up reveals that LMCA patients have significantly higher rate of cardiac death (2.6% vs. 0.7%, p = 0.034), myocardial infarction (7.1% vs. 1.8%, p < 0.001), in-stent thrombosis (4.5% vs. 0.8%, p < 0.001), and stroke (7.1% vs. 6.4%, p = 0.025). After adjusting for confounding factors, LMCA remains independently associated with higher 2-year myocardial infarction rate (HR = 2.585, 95% CI = 1.243-5.347, p = 0.011). CONCLUSION: LMCA-targeted PCI is an independent risk factor for 2-year myocardial infarction in ACS patients.

Apolipoprotein B/A-I Ratio Predicts Lesion Severity and Clinical Outcomes in Diabetic Patients With Acute Coronary Syndrome.

BACKGROUND: Dyslipidemia plays a crucial role in acute coronary syndrome (ACS). Paucity of data is available concerning the effect of apolipoprotein (apo) B/A-I ratio on the severity and outcomes in diabetic patients with ACS. This study investigated these associations in a Chinese cohort undergoing percutaneous coronary intervention.Methods and Results:In 2013, a total of 2,563 diabetic patients concomitant with ACS were included. Patients were divided into 2 groups based on the apoB/apoA-I ratio on admission: <0.63 (n=1,279, 49.9%) and ≥0.63 (n=1,284, 50.1%). Angiographic complexity and severity were determined by SYNTAX score (SS). A higher apo ratio was significantly associated with higher proportions of acute myocardial infarction (MI) and intermediate-high SS. Multivariable logistic regression analysis showed that the apo ratio was an independent factor of complicated lesions (OR 1.341, 95% confidence interval 1.039-1.730, P=0.024). Moreover, consistent results were found in the subgroups of normal concentrations of conventional lipid parameters. During a median follow-up period of 878 days, significant differences were found in periprocedural MI (1.0% vs. 2.2%, P=0.019) and total events of MI (2.0% vs. 3.3%, P=0.028). After adjusting for confounders, a high apo ratio remained independently predictive of MI, the risk of which was doubled during the periprocedural period and in the long term. CONCLUSIONS: The ApoB/apoA-I ratio is an independent predictor for complicated lesions and future MI in patients with diabetes and ACS.

Benefit-Risk Profile of DAPT Continuation Beyond 1 Year after PCI in Patients with High Thrombotic Risk Features as Endorsed by 2018 ESC/EACTS Myocardial Revascularization Guideline.

PURPOSE: The ischemic/bleeding trade-off of continuing dual antiplatelet therapy (DAPT) beyond 1 year after PCI for patients with high thrombotic risk (HTR) as endorsed by 2018 ESC/EACTS myocardial revascularization guidelines remain unknown. METHODS: Patients undergoing coronary stenting between January 2013 and December 2013 from the prospective Fuwai registry were defined as HTR if they met at least 1 ESC/EACTS guideline-endorsed HTR criteria. A total of 4578 patients who were at HTR and were events free at 1 year after the index procedure were evaluated. The primary efficacy outcome was major adverse cardiac and cerebrovascular events (MACCE) (composite of all-cause death, myocardial infarction, or stroke). RESULTS: Median follow-up period was 2.4 years. > 1-year DAPT with clopidogrel and aspirin significantly reduced the risk of MACCE compared with ≤ 1-year DAPT (1.9% vs. 4.6%; hazard ratio (HR): 0.38; 95% confidence interval (CI): 0.27-0.54; P < 0.001), driven by a reduction in all-cause death (0.2% vs. 3.0%; HR, 0.07; 95% CI, 0.03-0.15). Cardiac death and definite/probable stent thrombosis also occurred less frequently in prolonged DAPT group. Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding occurred similarly between both groups (1.1% vs. 0.9%; HR, 1.11; 95% CI, 0.58-2.13; P = 0.763). Similar results were found using multivariable Cox model, propensity score-matched, and inverse probability of treatment weighting analysis. CONCLUSIONS: Among patients with ESC-endorsed HTR who were free from major ischemic or bleeding events 1 year after coronary stenting, continued DAPT beyond 1 year might offer better effectiveness in terms of atherothrombotic events and comparable safety in terms of clinically relevant bleeding compared with ≤ 1-year DAPT. ESC-HTR criteria is an important parameter to take into account in tailoring DAPT prolongation.

Contribution of ESC DAPT guideline-endorsed high thrombotic risk features to long-term clinical outcomes among patients with and without high bleeding risk after PCI.

BACKGROUND: Whether the underlying risk of high bleeding risk (HBR) influences the relationship of high thrombotic risk (HTR) features with adverse events after drug-eluting stent implantation remains unclear. The purpose of this study was to evaluate (1) the prognostic effect of ESC guideline-endorsed HTR features on long-term clinical outcomes and (2) whether the outcomes of HTR versus non-HTR features vary by HBR status. METHODS: Ten thousand one hundred sixty-seven consecutive patients who underwent percutaneous coronary intervention between January 2013 and December 2013 were prospectively enrolled in Fuwai PCI Registry. Patients who are at HTR were defined as: diffuse multivessel disease in diabetic patients, chronic kidney disease, at least three stents implanted, at least three stents lesions treated, bifurcation with two stents implanted, total stent length > 60 mm, or treatment of chronic total occlusion. The definition of HBR was based on the Academic Research Consortium for HBR criteria. The primary ischemic outcome was major adverse cardiac event (MACE), a composite of cardiac death, myocardial infarction, target vessel revascularization and stent thrombosis. The primary bleeding outcome was clinically relevant bleeding, defined according to Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding. RESULTS: With a 2.4-year median follow-up, 4430 patients (43.6%) having HTR experienced a significantly higher risk of MACE (hazard ratio [HR] adjust: 1.56, 95% confidence interval [CI]: 1.34-1.82; P < 0.001) and device-oriented composite endpoint (composite of cardiac death, target-vessel MI, and target lesion revascularization) (HRadjust: 1.52 [1.27-1.83]; P < 0.001), compared to those having non-HTR. The risk of clinically relevant bleeding did not differ between groups (HRadjust: 0.85 [0.66-1.08]; P = 0.174). Associations between HTR and adverse events were similar in HBR and non-HBR groups, without evidence of interaction (all Pinteraction > 0.05); however, adverse event rates were highest among subjects with both HTR and HBR. CONCLUSIONS: ESC guideline-endorsed HTR was associated with significantly increased risk of MACE without any significant differences in clinically relevant bleeding. The presence of HBR does not emerge as a modifier of cardiovascular risk for patients at HTR, suggesting more potent and longer antiplatelet therapy may be beneficial for this patient population.

Lipoprotein(a) levels are associated with coronary severity but not with outcomes in Chinese patients underwent percutaneous coronary intervention.

BACKGROUND AND AIMS: The association between lipoprotein(a) [Lp(a)] levels and the risk of cardiovascular disease is of great interest but still controversial. This study sought to investigate the impact of Lp(a) on coronary severity and long-term outcomes of patients who undergo percutaneous coronary intervention (PCI). METHODS AND RESULTS: A total of 6714 consecutive patients who received PCI were enrolled to analyze the association between Lp(a) and coronary severity and major adverse cardiovascular and cerebrovascular events (MACCE). Patients were divided into tertiles according to Lp(a) levels on admission. Coronary severity was evaluated by SYNTAX scoring system. The MACCE included recurrent myocardial infarction, unplanned target vessel revascularization, stent thrombosis, ischemic stroke and all-cause mortality. Significantly, Lp(a) levels were positively associated with coronary severity (p < 0.001). Multivariate logistic regression analyses showed Lp(a) was an independent predictor of intermediate to high SYNTAX score. During an average of 874 days follow-up, 755 patients presented with MACCE (11.25%) were reported. The incidence rates of MACCE, all-cause mortality, cardiac death, target vessel revascularization, recurrent myocardial infarction, stent thrombosis, stroke and bleeding were not statistically different among the Lp(a) tertile groups. Furthermore, both Kaplan-Meier and Cox regression analyses found no relationship between Lp(a) and cardiovascular outcomes (p > 0.05). CONCLUSION: Lp(a) is an independent predictor of the prevalence of more complex coronary artery lesions (SYNTAX score ≥ 23) in patients with PCI. In addition, our study has shown that Lp(a) has no relationship with long-term cardiovascular outcomes in Chinese patients with PCI.

Effect of prior stroke on long-term outcomes of percutaneous coronary interventions in Chinese patients: A large single-center study.

OBJECTIVES: To evaluate the effect of prior stroke on long-term outcomes in patients undergoing percutaneous coronary interventions (PCI). BACKGROUND: Patients with coronary heart disease (CHD) and prior stroke history have more serious clinical and angiographic conditions, which make the choice of treatment strategy complex. METHODS: A total of 10,724 consecutive patients who underwent PCI from January 2013 to December 2013 were enrolled. 2-Year clinical outcomes between patients with prior stroke (n = 1150) and those with no prior stroke (n =9574) were compared. RESULTS: The proportion of patients with prior stroke was 10.72%. These patients had higher clinical risks (age, sex, and cardiovascular risk factors) and more extensive coronary disease (higher pre-PCI and residual SYNTAX scores). During the 2-year follow-up, patients with prior stroke had a higher incidence of major adverse cardiac and cerebrovascular events (MACCE), all-cause death, stent thrombosis and stroke than those without prior stroke (14.3% vs. 11.8%, p = 0.02; 2.3% vs. 1.1%, p < 0.01; 1.6% vs. 0.8%, p < 0.01; 3.3% vs. 1.1%, p < 0.01, respectively). Multivariable regression analyses identified a positive association between prior stroke and risk of stroke (HR = 2.07, 95%CI: 1.35-3.19, p < 0.01). Propensity score matched analyses (962 pairs) indicated that the only primary end point that differed in incidence between the groups was stroke and prior stroke was the only independent predictor of stroke (HR = 2.31, 95%CI: 1.20-4.45, p = 0.01). CONCLUSIONS: Prior stroke history was the only predictor of risk of post-PCI stroke. The noncerebrovascular adverse events were not increased after adjusted analyses of baseline characteristics and propensity analyses.

Platelet reactivity in patients with chronic kidney disease undergoing percutaneous coronary intervention.

This study aimed to evaluate the platelet reactivity in real-world patients with different chronic kidney disease (CKD) stages after percutaneous coronary intervention (PCI), and to examine whether high residual platelet reactivity (HRPR) is associated with higher incidence of adverse cardiovascular events in a 2-year follow up. A total of 10 724 consecutive patients receiving DAPT with aspirin and clopidogrel after PCI throughout 2013 were enrolled. We applied modified thromboelastography (mTEG) in 6745 patients. Kaplan-Meier analysis and Cox proportional regression analysis were applied to illustrate end points for patients. The prevalence of HRPR for adenosine diphosphate (ADP) was higher in patients with CKD3-5 than patients with CKD1-2 (47.0% vs. 37.3%, p = 0.002), but not for arachidonic acid (AA). No significant difference was observed for MACCE between patients with or without HRPR for ADP (HR 1.004, 95%CI: 0.864-1.167, p = 0.954). Patients with HRPR for ADP was associated with less bleeding events than patients without HRPR for ADP (HR 0.795, 95%CI: 0.643-0.982, p = 0.034). In this large cohort of real-world patients after PCI, the deterioration of renal function was linked to HRPR for ADP. HRPR was not associated with MACCE in patients with CKD in a 2-year follow up. Bleeding risks were significantly lower in PCI patients with versus without HRPR for ADP.

Guideline for [Clinical Guidelines Constitution/Amendment] in China.

QUALITY PROBLEM OR ISSUE: Chinese medical institutions need clinical guidelines to improve healthcare quality. Unfamiliarity with clinical methodology and procedures leads to poor quality. INITIAL ASSESSMENT: This study examined 327 clinical guidelines made in China during the period of 2006-10 and found these clinical guidelines have many problems in terms of guideline making procedures-compliant process, conflicts of interest disclosure. CHOICE OF SOLUTION: Chinese Medical Association organized a working group in 2014 to make a national [Guideline for Clinical Guidelines Constitution/Amendment] and invited multidiscipline experts to prove its possibility. IMPLEMENTATION: Experts investigated and reviewed numerous domestic and foreign published literature within the past 2 years, concluded that a clinical guideline should have following seven components: I. Objective; II. General Principle; III. Procedure and Methodology; IV. Confirmation, Publication and Dissemination; V. Update and Amendment; VI. Implementation and Outcome Validation; VII. Reference. EVALUATION: The [Guideline for Clinical Guidelines Constitution/Amendment] will improve the quality of Chinese clinical guidelines and regulate applications, as well as outcome evaluations of clinical guidelines in China. LESSONS LEARNED: Standardized methodology and procedures are important for constituting high-quality clinical guidelines.

Biodegradable polymer drug-eluting stents versus second-generation drug-eluting stents in patients with and without diabetes mellitus: a single-center study.

BACKGROUND: To improve outcomes in patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention remain an unmet clinical need. The study aimed to evaluate the efficacy and safety of G2-DESs and BP-DESs in patients with and without DM in a single center in China. METHODS: A total of 7666 consecutive patients who exclusively had G2-DES or BP-DES implantation throughout 2013 in our center were studied. The primary efficacy endpoint was any target lesion revascularization (TLR), whereas the primary safety endpoint was a composite of death or myocardial infarction (MI) at 2-year follow-up. RESULTS: G2-DESs had a similar occurrence of death, non-fatal MI, TLR, stroke, and stent thrombosis compared with BP-DESs in patients with DM (all P > 0.05). The incidence of TVR and TLR was lower for G2-DESs than for BP-DESs in patients without DM (3.2% vs. 5.1%, P = 0.002; 2.2% vs. 4.5%, P < 0.001, respectively). Kaplan-Meier analysis also showed better TVR- and TLR-free survival rates for G2-DESs than for BP-DESs in patients without DM. Multivariate analysis showed that a BP-DES was an independent risk factor for TLR (hazard ratio 1.963, 95% confidence interval 1.390-2.772, P < 0.001) in patients without DM, which was not predictive of other components of major adverse cardiac events (P > 0.05). CONCLUSIONS: G2-DESs have better efficacy, represented by a reduced risk of TLR, and similar safety compared with BP-DESs in patients without DM. G2-DESs have similar efficacy and safety compared with BP-DESs in patients with DM at 2-year follow-up.

Clinical outcomes and influencing factors of in-stent restenosis after stenting for symptomatic stenosis of the vertebral V1 segment.

OBJECTIVE: The objective of this study was to evaluate 30-day and long-term clinical outcomes and influencing factors of in-stent restenosis (ISR) after stenting for symptomatic stenosis of the vertebral V1 segment. METHODS: The clinical and follow-up data of 301 consecutive patients (mean age, 64 ± 8 years; 252 men) with symptomatic V1 stenosis who underwent stenting at the Fuwai Hospital between January 2010 and June 2016 were collected retrospectively. The 30-day and long-term follow-up of stroke and death after stenting and the recurrence of symptoms, ISR, and repeated revascularization were assessed. RESULTS: Technical success was 100%. The mean stenosis of lesions was reduced from 82.8% ± 7.6% to 4.4% ± 4.0% immediately after 312 stents (165 bare-metal stents [BMSs] and 147 drug-eluting stents) were implanted. The overall risk of combined any stroke and death was 1.0% (3/301) within 30 days after stenting. The rates of freedom from any stroke and death were 98.2%, 96.8%, and 91.4% at 1 year, 3 years, and 5 years, respectively. After a mean follow-up of 2.9 ± 1.5 years, 46 (15.8%) patients developed ISR, of whom 19 (6.5%) were symptomatic. Twenty-two (7.6%) patients with ISR underwent repeated revascularization. The primary and assisted patency rates were 90.0% and 95.4%, 82.6% and 90.3%, and 80.3% and 87.9% at 1 year, 3 years, and 5 years, respectively. BMS (hazard ratio, 2.02; 95% confidence interval, 1.01-4.06; P < .05) and diabetes (hazard ratio, 1.87; 95% confidence interval, 1.04-3.37; P = .04) were independently associated with an increased risk of ISR. CONCLUSIONS: Percutaneous stent placement for symptomatic V1 stenosis is safe and associated with a good long-term patency rate. BMS and diabetes are independent predictive factors of ISR.

Predictive value of neutrophil to lymphocyte ratio in long-term outcomes of left main and/or three-vessel disease in patients with acute myocardial infarction.

OBJECTIVES: We sought to evaluate the independent predictive value of left main disease (LMD) and/or three-vessel disease (LMD/3VD) in acute myocardial infarction (AMI) patients. BACKGROUND: Patients with acute coronary syndrome resulting from LMD and/or three-vessel disease (LMD/3VD) are at the highest risk of adverse cardiovascular events. Neutrophil to lymphocyte ratio (NLR) has been proposed as a marker of cardiovascular risk, but the prognostic value of NLR in patients with LMD/3VD who underwent percutaneous coronary intervention (PCI) is not clearly defined. METHODS: Patients (n = 806) admitted with LMD/3VD who underwent PCI between January 2013 and December 2013 were followed up for 2 years. Admission NLR was divided into two sub-groups based on an optimal cut off value predicting 2-year all-cause mortality. The primary end point was all-cause death. The secondary end point was long-term major adverse cardiovascular and cerebrovascular events (MACCE). RESULTS: During follow-up, the high NLR group was associated with a significantly higher rate of long-term all-cause mortality (6.7 vs. 0.9%, P < .001), and MACCE (24.7 vs. 15.8%, P = .002) compared to the low NLR group. In multivariate analysis, after adjusting for risk factors, NLR ≥ 3.39 was determined to be an independent predictor of 2-year all-cause mortality (hazard ratio[HR] 3.08, 95% confidence interval [CI] 1.06 to 8.97, P = .039) and MACCE (hazard ratio 1.44, 95% CI 1.01 to 2.05, P = .046) for LMD/3VD. CONCLUSIONS: The admission NLR as relatively inexpensive marker of inflammation may aid in the risk stratification and prognosis of patients diagnosed with LMD/3VD.

Dual antiplatelet therapy after coronary drug-eluting stent implantation in China: A large single center study.

OBJECTIVE: To investigate the actual dual antiplatelet therapy (DAPT) duration after drug-eluting stent (DES) treatment in China. BACKGROUND: Currently, less is known about actual DAPT duration after drug-eluting stent (DES) treatment in China. Here, we performed a study in the largest cardiovascular center in China to investigate DAPT duration and identify associated factors after DES implantation. METHODS: A total of 9,919 consecutive patients with DES implantation from January 2013 to December 2013 were enrolled. DAPT cessation was observed, and factors associated with different DAPT durations were analyzed. RESULTS: The median follow-up time was 882 days. The proportion of patients with DAPT coverage at 1-year of follow-up was 97.3%, and it decreased to 30.1% for 2 years. The distribution of DAPT duration was not significantly different among patients with acute myocardial infarction (AMI) versus non-AMI (P = 0.41) and with new-generation DES versus first-generation DES (P = 0.54). The multivariable analysis indicated some independent predictors prolonging DAPT duration, including target vessel revascularization (OR 2.50, 95% CI 2.04-3.06, P < 0.001), stent numbers (OR 1.10, 95% CI 1.05-1.15, P < 0.001), and previous coronary artery bypass grafting (OR 0.76, 95% CI 0.61-0.96, P = 0.02). Other clinical factors, such as the increased risk of bleeding and high ischemic risk, were not associated with DAPT duration. CONCLUSIONS: The 1-year DAPT after DES was applied to 97.3% of Chinese patients in the studied clinical center. However, the DAPT duration after 1 year was not adjusted according to the patients' bleeding situation and ischemic risks.

Sex-based differences in bleeding and long-term adverse events after percutaneous coronary intervention in older patients with coronary artery disease.

OBJECTIVES: Differences in outcomes for women and men after percutaneous coronary intervention (PCI) in older patients remain controversial. Herein, we compared 2-year outcomes by sex in Chinese older patients undergoing PCI. METHODS: A total of 4926 consecutive patients (33.6% women, age ≥60 years, mean age 67.4 ± 5.7 years) who underwent PCI at a single center in China from January 2013 to December 2013 were included in this study. The primary endpoint was 2-year risk of bleeding according to the Bleeding Academic Research Consortium definitions. The secondary endpoints included 2-year risk of major adverse cardiovascular and cerebrovascular events (MACCE). Hazard ratios were generated using multivariable Cox regression. RESULTS: Compared with men, women had significantly higher rates of in-hospital all-cause mortality (0.8% vs 0.2%, P = 0.001), cardiac death (0.5% vs 0.1%, P = 0.006), MACCE (2.4% vs 1.5%, P = 0.017), and bleeding (0.4% vs 0.1%, P = 0.015). At 2-year follow up, there were no differences between men and women for all-cause mortality (1.9% vs 1.8%, P = 0.839) and 2-year MACCE (13.1% vs 11.8%, P = 0.216). However, women had a higher risk of 2-year bleeding (9.2% vs 6.2%, P < 0.001), which persisted after adjusting for baseline differences and treatment characteristics (hazard ratio 1.35, 95% confidence interval 1.06-1.71; P = 0.014). CONCLUSION: We found that older women undergoing PCI were at increased risk of 2-year bleeding compared with men. Further dedicated studies are needed to confirm these findings.

Effect of sex difference in clinical presentation (stable coronary artery disease vs unstable angina pectoris or non-ST-elevation myocardial infarction vs ST-elevation myocardial infarction) on 2-year outcomes in patients undergoing percutaneous coronary intervention.

OBJECTIVE: To determine whether there is a difference in 2-year prognosis among patients across the spectrum of coronary artery disease undergoing percutaneous coronary intervention (PCI). METHODS: We analyzed all consecutive patients undergoing PCI at a single center from 1/1-12/31/2013. Clinical presentations were compared between sexes according to baseline clinical, angiographic, and procedural characteristics and 2-year (mean 730 ± 30-day) outcomes. RESULTS: We grouped 10 724 consecutive patients based on sex and clinical presentation. Among patients with ST-elevation myocardial infarction (STEMI), rates of all-cause death (6.7% vs 1.4%) and cardiac death (3.8% vs 1.1%) were significantly higher in women than in men (P < 0.05), but these rates did not differ between men and women with stable coronary artery disease (SCAD) and non-ST-elevation acute coronary syndrome ((NSTE-ACS). Incidence of major bleeding was greater than in men only in those women presenting with ACS. After multivariable adjustment, female sex was not an independent predictor of outcomes in STEMI (hazard ratio [HR] for all-cause death: 1.33, 95% confidence interval [CI]:0.52-3.38; P = 0.55; HR for cardiac death: 0.69, 95%CI: 0.23-2.09, P = 0.51], but was still an independent predictor of bleeding in STEMI (HR: 3.53, 95%CI: 1.26-9.91, P = 0.017). CONCLUSION: Among STEMI patients, women had worse 2-year mortality after PCI therapy, but female sex was not an independent predictor of mortality after adjustment for baseline characteristics. In STEMI patients, women were at higher bleeding risk than men after PCI, even after multivariable adjustment.

Association of CDKN2B-AS1 Polymorphisms with Premature Triple-vessel Coronary Disease and Their Sex Specificity in the Chinese Population.

OBJECTIVE: The aim of this study is to establish whether cyclin-dependent kinase inhibitor 2B antisense RNA 1 (CDKN2B-AS1) gene polymorphisms are associated with premature triple-vessel disease (PTVD). METHODS: Nine single-nucleotide polymorphisms (rs1063192, rs10757274, rs1333042, rs1333049, rs2285327, rs3217986, rs3217992, rs4977574, and rs9632884) were genotyped in 884 PTVD patients and 907 control subjects (males ⪕ 50 years old and females ⪕ 60 years old) using the improved multiplex ligase detection reaction method. RESULTS: The allele frequencies of rs10757274 G, rs1333049 C, rs4977574 G (all P < 0.001), and rs3217986 G (P = 0.040) were significantly higher in the PTVD group than in the control group, but those of rs1063192 A, rs1333042 G, and rs9632884 C (all P < 0.001) were significantly lower in the former than in the latter. Logistic regression analysis revealed that homozygote AA of rs1333042 is associated with decreased risk for PTVD (OR = 0.42, 95% CI: 0.22-0.82, P = 0.011). In addition, the allele frequencies observed differed between genders. The G allele of rs3217986 was associated with increased risk for PTVD in male patients only (OR = 2.94, 95% CI: 1.27-6.80, P = 0.012) in the dominant model, and no positively mutated allele was found in female patients. CONCLUSION: Polymorphisms of the CDKN2B-AS1 gene are associated with the incidence of PTVD in the Chinese population. Furthermore, the frequencies of mutated alleles differed between genders.

Prognostic Value of NT-proBNP in Stable Coronary Artery Disease in Chinese Patients after Percutaneous Coronary Intervention in the Drug-eluting Stent Era.

OBJECTIVE: The predictive value of N-terminal pro-brain natriuretic peptide (NT-proBNP) in patients with stable coronary artery disease (SCAD) in the drug-eluting stent era is not yet clear. We aimed to evaluate the prognostic value of NT-proBNP in SCAD patients after percutaneous coronary intervention (PCI). METHODS: We examined 4,293 consecutive SCAD patients who underwent PCI between January 2013 and December 2013 in Fuwai Hospital, China. The primary endpoint was all-cause death. NT-proBNP levels were measured before PCI using Elisa kits (Biomedica, Austria). The indication for PCI was based on the degree of coronary stenosis and evidence of ischemia. RESULTS: Among 3,187 SCAD patients with NT-proBNP data, after a 2-year follow-up, NT-proBNP levels were predictive for all-cause death in the SCAD population [area under the receiver operating characteristic curve, 0.768; 95% confidence interval (CI), 0.687-0.849; P < 0.001]. At the optimum cutoff point of 732 pg/mL, the sensitivity and specificity of death was 75.0% and 72.3%, respectively. In a multivariable Cox regression model, the death hazard ratio was 6.43 (95% CI, 2.99-13.82; P < 0.001) for patients with NT-proBNP levels ⪖ 732 pg/mL, compared with < 732 pg/mL. CONCLUSION: NT-proBNP is a strong predictor of 2-year death with SCAD after PCI in the drug-eluting stent era.

Effect of coronary dominance on 2-year outcomes after percutaneous coronary intervention in patients with acute coronary syndrome.

OBJECTIVES: This retrospective, single-center, observational analysis from prospectively collected database evaluated whether left dominance affected the long-term outcomes of acute coronary syndrome patients undergoing percutaneous coronary intervention, and whether the effect was independent of SYNTAX score. BACKGROUND: Left dominance is believed to be associated with worse prognoses. The anatomical SYNTAX score is a scoring system based on the complexity and severity of coronary lesions and is thought to be a prognostic tool to predict short- and long-term outcomes. There are few studies about whether the effect of left dominance is independent of SYNTAX score. METHODS: Between January 2013 and December 2013, 6255 consecutive acute coronary syndrome patients who were admitted to Fuwai hospital and underwent percutaneous coronary intervention (PCI) were enrolled in this study. Based on coronary dominance and the calculation methods of the SYNTAX score, patients were divided into a left-dominant group (LD group; 390 patients) and a right-dominant or co-dominant group (RD + Co group, 5865 patients). RESULT: The 2-year mortality rate was significantly higher in the LD group than in the RD + Co group (2.58% vs. 1.23%, P = 0.024). In multivariate Cox analysis, the independent predictors of mortality were coronary dominance, IABP support, age, baseline SYNTAX score, and ejection fraction. CONCLUSIONS: LD was an independent predictor of long-term mortality in ACS patients undergoing PCI. The effect of LD still existed after adjustment for several important variables and was independent of SYNTAX score. © 2017 Wiley Periodicals, Inc.