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.