Percutaneous Coronary Intervention Population Research Articles

Impact of Chronic Kidney Disease on Chronic Total Occlusion Revascularization Outcomes: A Meta-Analysis.

Objectives: To examine the impact of revascularization and associated clinical outcomes of chronic kidney disease (CKD) chronic total occlusion (CTO) and non-CKD CTO groups. Background: The influence of CKD on clinical outcomes after percutaneous coronary intervention (PCI) for CTO lesions is unknown, and there is no systemic review of this topic to date. Methods: We searched the PubMed, Embase, ProQuest, ScienceDirect, Cochrane Library, ClinicalKey, Web of Science, and ClinicalTrials Databases for articles published between 1 January 2010 and 31 March 2020. CKD was defined as estimated glomerular filtration rate of <60 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease formula. Data included demographics, lesion distributions, incidence of contrast-induced nephropathy (CIN), acute kidney injury (AKI), procedural success rate, mortality, and target lesion revascularization (TLR)/target vessel revascularization (TVR). Results: Six studies were ultimately included in this systematic review. A high prevalence (25.5%; range, 19.6–37.9%) of CKD was noted in the CTO population. In the non-CKD group, outcomes were better: less incidence of CIN or AKI (odds ratio (OR), 2.860; 95% confidence interval (CI), 1.775–4.608), higher procedural success rate (OR, 1.382; 95% CI, 1.036–1.843), and lower long-term mortality (OR, 4.502; 95% CI, 3.561–5.693). The incidence of TLR/TVR (OR, 1.118; 95% CI, 0.888–1.407) did not differ between groups. Conclusions: In the CKD CTO PCI population, a lower procedural success rate, a higher incidence of CIN or AKI, and higher in-hospital and long-term mortality rate were noted due to more complex lesions and more comorbidities. However, the incidence of TLR/TVR did not differ between groups.

Impact of High-Density Lipoprotein Levels on Cardiovascular Outcomes of Patients Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents

Low levels of high-density lipoprotein (HDL) have been associated with adverse cardiovascular events in epidemiologic studies. Evidence regarding its role in patients who underwent percutaneous coronary intervention (PCI) is scarce. We evaluated consecutive patients who underwent PCI with drug-eluting stents from 2012 to 2017, excluding those with unavailable baseline HDL, age <18 years, presentation with ST-segment elevation myocardial infarction (MI) or shock, and coexisting neoplastic disease. The final population was stratified according to baseline HDL levels into reduced and nonreduced HDL cohorts, with cut-off value 40 mg/dl in males and 50 mg/dl in females. The primary end point was 1-year major adverse cardiovascular events (MACE), defined as the composite of death, MI, or target vessel revascularization (TVR). Among 10,843 patients included, 6,511 (60%) had reduced HDL, and 4,332 (40%) nonreduced HDL. The rate of 1-year MACE was similar between the 2 groups (7.5% vs 6.6%; p = 0.14). Although mortality and MI rates were comparable, reduced HDL was associated with significantly higher TVR 5.2% vs 4.0%; p = 0.02, a finding that attenuated after multivariable adjustment (adjusted hazard ratio 1.18, p = 0.14). Sex subgroup analysis included 7,718 (71.2%) males and 3,125 (28.8%) females. Among men, there was a trend toward higher MACE in those with reduced HDL (7.4% vs 6.0%; p = 0.08) mostly driven by TVR (5.4% vs 3.7%; p = 0.005). No association between HDL and 1-year outcomes was evident in females. Assessment for interaction between sex and reduced HDL did not reach statistical significance. In conclusion, reduced baseline HDL was not associated with increased risk of MACE in a contemporary PCI population.

One-year outcomes of patients undergoing complex percutaneous coronary intervention with three contemporary drug-eluting stents.

We aimed to evaluate the 1-year outcomes of three everolimus-eluting stents (EES) for complex percutaneous coronary intervention (PCI). It is controversial whether contemporary bioresorbable-polymer drug-eluting stents (BP-DES) are associated with better outcomes compared with durable-polymer DES (DP-DES). Patients undergoing PCI with cobalt-chromium (CoCr)-DP-EES (Xience), platinum-chromium (PtCr)-DP-EES (Promus), or PtCr-BP-EES (Synergy) at one high-volume institution between 2015 and 2017 were included. The primary endpoint was 1-year major adverse cardiac events (MACE), a composite of death, myocardial infarction, and target-vessel revascularization. Associations were also examined in patients undergoing complex PCI. Multivariable analysis was conducted to adjust for baseline differences across groups. We included n= 5,446 patients (CoCr-DP-EES, n= 3,177; PtCr-DP-EES, n= 1,555; PtCr-BP-EES, n= 714). Patients treated with PtCr-BP-EES had higher comorbidity burden and procedural complexity. At 1 year, MACE rates were 8.9% for CoCr-DP-EES versus 8.9% for PtCr-DP-EES versus 8.6% for PtCr-BP-EES (p= .97). The incidence of definite/probable stent thrombosis (ST) was also similar (0.6 vs. 0.4 vs. 0.3%, p= .69). Complex PCI was performed in n= 2,894/5,446 (53.1%). At 1 year, MACE rates were 11.5 versus 10.7 versus 10.3%, respectively (p= .83). The incidence of definite/probable ST was also similar (0.9 vs. 0.3 vs. 0.3%, p= .22). On multivariable analysis, stent type was not an independent predictor of MACE either in the overall or in the complex PCI population. We observed comparable 1-year rates of MACE and definite/probable ST in patients undergoing PCI with CoCr-DP-EES, PtCr-DP-EES, and PtCr-BP-EES. Results were unchanged among patients undergoing complex PCI. Future multicenter randomized studies should confirm and extend our findings.

DAPT Score and the Impact of Ticagrelor Monotherapy During the Second Year After PCI

ObjectivesThis study assessed the ability of the dual-antiplatelet therapy (DAPT) score in stratifying ischemic and bleeding risk in a contemporary percutaneous coronary intervention (PCI) population. BackgroundThe DAPT score is recommended by guidelines as a tool to stratify ischemic and bleeding risk. Its utility in contemporary PCI is unknown. MethodsThe study studied patients in GLOBAL LEADERS (A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation) who were free of major ischemic and bleeding events and adhered to antiplatelet strategy during the first year after PCI. The primary ischemic endpoint was the composite of myocardial infarction or stent thrombosis. The primary bleeding endpoint was Bleeding Academic Research Consortium type 3 or 5. Outcomes from 12 to 24 months after PCI were compared according to the DAPT score. ResultsOf 11,289 patients that were event-free after the first year, 6,882 and 4,407 patients had low (<2) and high (≥2) DAPT scores, respectively. Compared with a low DAPT score, patients with a high DAPT score had a higher rate of the composites of myocardial infarction or stent thrombosis (0.70% vs. 1.55%; p < 0.0001). The rate of Bleeding Academic Research Consortium type 3 or 5 bleeding was 0.54% and 0.30% in the low and high DAPT score groups, respectively (p = 0.058). The effect of ticagrelor versus aspirin monotherapy on primary ischemic and bleeding endpoints during the second year were no different among the 2 groups. ConclusionsThe DAPT score can stratify ischemic but not bleeding risk in a contemporary PCI population during the second year. The score did not provide additional value for selection of antiplatelet strategy beyond the first year.

Validation of Predictive Value of Patterns of Nonadherence to Antiplatelet Regimen in Stented Patients Thrombotic Risk Score in Chinese Population Undergoing Percutaneous Coronary Intervention: A Prospective Observational Study.

Background:The patterns of nonadherence to antiplatelet regimen in stented patients (PARIS) thrombotic risk score are a novel score for predicting the risk of coronary thrombotic events (CTEs) after percutaneous coronary intervention (PCI) with drug-eluting stents. However, the prognostic value of this score has not been fully evaluated in non-Euro-American PCI populations.Methods:We performed a prospective, observational study of 10,724 patients who underwent PCI in Fuwai hospital, China and evaluated the PARIS thrombotic risk score's predictive value of CTEs in the PCI population. The area under the receiver operating characteristic curve (AUROC) was used to assess the predictive value of the PARIS score for CTE.Results:Among 9782 patients without in-hospital events, a total of 95 CTEs occurred during the 2-year follow-up. The PARIS score was significantly higher in patients with CTEs (3.38 ± 2.04) compared with patients without events (2.53 ± 1.70, P < 0.001). According to the risk stratification of the PARIS thrombotic score, the risk of CTEs in the high-risk group was 3.14 times higher than that in the low-risk group (hazard ratio [HR], 3.14; 95% confidence interval [CI], 1.92–5.13; P < 0.001). However, the risk of CTEs in the intermediate-risk and low-risk groups was not significant (HR, 1.39; 95% CI, [0.86–2.24]; P = 0.184). The PARIS score showed prognostic value in evaluating CTEs in the overall population (AUROC, 0.621; 95% CI, 0.561–0.681), the acute coronary syndrome (ACS) population (AUROC, 0.617; 95% CI, 0.534–0.700; P = 0.003), and the non-ACS population (AUROC, 0.647; 95% CI, 0.558–0.736; P = 0.001).Conclusions:In a real-world Chinese population, the PARIS thrombotic risk score shows a modest prognostic value for CTEs in patients after PCI. This score also has a predictive value for CTEs in the ACS and non-ACS subgroup populations.

PREVENTION OF LEFT VENTRICULAR THROMBUS FORMATION AND SYSTEMIC EMBOLISM AFTER ANTERIOR MYOCARDIAL INFARCTION: A SYSTEMATIC LITERATURE REVIEW

Anterior myocardial infarction (MI) with apical dysfunction is associated with left ventricular thrombus (LVT) formation and an increased risk of systemic embolism (SE). However, the role for prophylactic anticoagulation in current practice is a matter of debate. We therefore propsed a systematic review of peer-reviewed data regarding the efficacy and safety of adding anticoagulation to standard therapy following anterior myocardial infarction for the prevention LVT/SE. We conducted a systematic review of full peer-reviewed original articles involving human clinical subjects in either English or French by searching PubMed, Ovid/MEDLINE/Embase, the Cochrane Library, and Google Scholar. An initial search returned 7,380 records. However, only 14 were ultimately retained for quantitative analysis according to our selection criteria. Nine articles addressed anticoagulation for patients not treated with percutaneous coronary intervention (PCI). Another five included at least some patients treated with PCI. Only one study specifically addressed prophylaxis in an exclusively primary PCI population. Some studies showed a benefit for adding anticoagulation to standard therapy in patients not treated with PCI, but results were inconsistent. No evidence of benefit was found when PCI patients were included and one study found a signal for net harm. No studies included a significant number of patients treated with the newer P2Y12-inhibitors. Also, there was no data on the use of non-vitamin K antagonist oral anticoagulants for the sole purpose of LVT/SE prevention in the setting of LV apical dysfunction. There was important inter-study heterogeneity in terms of the therapies studied, Background therapy, revascularization therapy, and study design that precluded formal meta-analysis. All studies were likely individually underpowered. Studies of LVT/SE prevention following MI to date have generally lacked statistical power and there is significant heterogeneity in terms of the treatments evaluated, revascularization METHODS, Background optimal medical therapy, and study design. We conclude that there is no compelling evidence thus far either for or against adding anticoagulation to standard therapy following MI for patients with apical dysfunction.

Comparison of radial access versus femoral access with the use of a vascular closure device for the prevention of vascular complications and mortality after percutaneous coronary intervention

Background: Radial access (RA) and vascular closure devices (VCD) have been shown to be superior to transfemoral access (TFA) with regard to the prevention of vascular complications after percutaneous coronary intervention (PCI).Objective: The present study evaluates whether RA is associated with less vascular complications and a lower mortality than VCD.Methods: A total of 6999 consecutive PCI patients were studied through a single-centre prospective registry from January 2011 to August 2015. RA was applied in 1385 patients (20%), VCDs with Angio-Seal were implanted in 2145 patients (30%) and manual compression of TFA was performed in 3468 patients (50%).Results: RA and VCD patients had comparable baseline risk profiles. The overall vascular complication rate was 2.0% (n = 137) and was composed of false aneurysms (n = 85), clinically relevant haematomas (n = 27), arteriovenous fistulas (n = 12), arterial occlusions (n = 11) and local infections (n = 2). Vascular complications occurred in 0.6% of RA patients, 1.8% of VCD patients and 2.6% of TFA patients (p < .01). In-hospital mortality was 0.8% in RA patients, 0.8% in VCD patients and 3.8% in TFA patients (p < .01). In a multivariate logistic regression model, RA, compared to VCD, was found to be independently associated with a lower rate of vascular complications (OR: 0.34, 95% CI: 0.16–0.75), but not with lower mortality rates (OR: 1.20, 95% CI: 0.51–2.85).Conclusion: In this large all-comers PCI population, the radial approach, compared to the femoral approach with VCD use (Angio-Seal), was independently associated with a reduction of vascular complications, but not with lower mortality rates.

Long-term outcomes after percutaneous coronary interventions in cancer survivors.

Cancer patients are mostly excluded from percutaneous coronary intervention (PCI) clinical trials and oncologic history is lacking from most PCI registries. Thus, little is known about the clinical outcomes following PCI among cancer survivors. Our aim was to examine the prevalence and long-term outcome of cancer survivors among a large PCI patient cohort. We retrospectively integrated and analyzed cardiovascular and oncologic data of 12 785 consecutive patients who underwent PCI between April 2004 and October 2014. Cancer survivors were compared with pair-matched cancer-naive patients. Cancer survivors constituted 7.8% (1005) of the patients. The mean cancer diagnosis-to-PCI interval was 3.6±3.4 years and the mean post-PCI follow-up was 6.4±5.9 years. Postmatching baseline characteristics were similar between the groups. Cancer survivors were referred to the catheterization laboratory because of acute coronary syndrome and were treated with bare-metal stents more often than cancer-naive patients. Cancer survivors to cancer-naive patients' hazard ratio and 95% confidence interval were 1.46 (1.24-1.72), P value less than 0.001 for all-cause mortality and 1.41 (1.23-1.63), P value less than 0.001 for the composite of death, nonfatal myocardial infarction, target vessel revascularization, and coronary bypass surgery. Cardiac death was the leading cause of mortality in our hospital during follow-up in both groups, although more cancer survivors died of malignancy (25 vs. 5%, P<0.001). Cancer survivors constitute a high proportion of the PCI population (one in every 13 patients) and have an ∼40% increased risk for cardiovascular morbidity and death. Cardiac disease was a leading cause of in-hospital mortality among these patients.

Ticagrelor with aspirin or alone in high-risk patients after coronary intervention: Rationale and design of the TWILIGHT study

Dual antiplatelet therapy (DAPT) is necessary to prevent thrombosis yet increases bleeding after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Antiplatelet monotherapy with a potent P2Y12 receptor antagonist may reduce bleeding while maintaining anti thrombotic efficacy compared with conventional DAPT. TWILIGHT is a randomized, double-blind placebo-controlled trial evaluating the comparative efficacy and safety of antiplatelet monotherapy versus DAPT in up to 9000 high-risk patients undergoing PCI with DES. Upon enrollment after successful PCI, all patients will be treated with open label low-dose aspirin (81-100 mg daily) plus ticagrelor (90 mg twice daily) for 3 months. Event-free patients will then be randomized in a double-blind fashion to low-dose aspirin versus matching placebo with continuation of open-label ticagrelor for an additional 12 months. The primary hypothesis is that a strategy of ticagrelor monotherapy will be superior with respect to the primary endpoint of bleeding academic research consortium type 2, 3 or 5, while maintaining non-inferiority for ischemic events compared with ticagrelor plus ASA. TWILIGHT is the largest study to date that is specifically designed and powered to demonstrate reductions in bleeding with ticagrelor monotherapy versus ticagrelor plus ASA beyond 3 months post-procedure in a high-risk PCI population treated with DES. The trial will provide novel insights with respect to the potential role of ticagrelor monotherapy as an alternative for long-term platelet inhibition in a broad population of patients undergoing PCI with DES.

Short- and long-term outcomes in Middle Eastern diabetic patients after percutaneous coronary intervention: results from The First Jordanian PCI Registry (JoPCR1).

Diabetes mellitus (DM) is highly prevalent among Middle Eastern patients admitted with acute coronary syndrome (ACS) or who undergo percutaneous coronary intervention (PCI). This study used data from the First Jordanian PCI Registry (JoPCR1) to determine the short- and long-term outcomes in a subgroup of diabetic patients within a large PCI population. JoPCR1, a prospective, multicenter study of consecutive patients who underwent PCI from January 2013 to February 2014, assessed the incidence of major cardiovascular events (cardiac mortality, stent thrombosis, major bleeding events and coronary revascularization) in diabetic compared with nondiabetic patients from the index hospitalization to 1 year of follow-up. Of 2426 patients enrolled, 1300 (53.6%) were diabetics. Compared with nondiabetic patients, diabetic patients were older, more likely to be female and to have hypertension, hypercholesterolemia and chronic renal disease. Diabetic patients had higher prevalences of multivessel coronary artery disease and PCI than nondiabetic patients. Although both groups had similar proportions of patients undergoing PCI for ACS (76.3 vs. 78.4%; p=0.237), fewer diabetic patients had PCI for ST-segment elevation myocardial infarction than nondiabetics (27.5 vs. 33.7%; p=0.0002). Both groups had similar incidences of stent thrombosis (ST) during hospitalization (0.46 vs. 0.27%; p=0.665) and at 1 year (2.36 vs. 1.53%; p=0.196). Similarly, major bleeding events were not different between diabetic and nondiabetic patients during hospitalization (1.31 vs. 0.53%; p=0.077) and at 1 year (1.47 vs. 0.98%; p=0.377). Compared with nondiabetic patients, diabetic patients had a higher incidence of readmission for ACS and coronary revascularization at 1 year. Diabetic patients had higher incidences of cardiac mortality than nondiabetic patients during the index hospitalization (1.23 vs. 0.27%; p=0.015) and at 1 year (2.58 vs. 0.81%; p=0.002). In multivariate analysis, diabetic patients were four times more likely to die in the hospital compared to nondiabetic patients (odds ratio=4.2; 95% CI 1.2-14.8, p=0.025). Diabetic patients, who accounted for more than half of this Middle Eastern PCI population, had a higher risk of cardiac mortality, readmission for ACS and coronary revascularization at 1 year compared with nondiabetic patients.

Clinical characteristics and in hospital outcomes of heart transplant recipients with allograft vasculopathy undergoing percutaneous coronary intervention: Insights from the National Cardiovascular Data Registry

Cardiac allograft vasculopathy is a major cause of morbidity and mortality following heart transplantation. Large multicenter studies evaluating the clinical characteristics and inhospital outcomes of heart transplant recipients undergoing percutaneous coronary intervention (PCI) are lacking. To evaluate the clinical characteristics, treatment patterns and inhospital outcomes of heart transplant recipients undergoing PCI compared to general population. We analyzed 1,897,328 patients from the National Cardiovascular Data Registry CathPCI registry who underwent PCI of at least 1 native vessel between July 2009 and December 2013 from 1,477 centers, of which 542 patients (0.03%) were heart transplant recipients. Clinical characteristics were evaluated and, after 1:4 propensity matching, inhospital outcomes were compared between 538 heart transplant patients and 2,128 non-transplant patients. Transplant recipients undergoing PCI had a higher prevalence of diabetes, dyslipidemia and peripheral vascular disease; lower prevalence of angina, acute coronary syndrome, abnormal noninvasive functional study, and type C coronary lesions compared to the non-transplant PCI population. After propensity matching, all-cause inhospital mortality was similar between transplant and non-transplant groups (1.3% vs 1.0%; OR, 1.21; 95% CI, 0.54-2.67). This is the largest series to date outlining the characteristics of heart transplant recipients undergoing PCI. Similar inhospital outcomes were noted in heart transplant recipients compared to the general population. Further studies evaluating long-term outcomes are warranted.

Post-PCI Antithrombotic Therapy in Patients Requiring Long-Term Anticoagulation.

The number of patients who undergo percutaneous coronary intervention (PCI) and additionally require chronic anticoagulation for a variety of indications is not insignificant. The choice of antithrombotic therapy after PCI in patients with chronic indications for anticoagulation therapy remains a challenge for interventional cardiologists, as the risk of bleeding must be adequately weighed against the benefit of preventing future ischemic events. While these clinical scenarios are encountered in approximately 10 % of patients undergoing PCI, current practice guidelines do not sufficiently guide physicians as to how to best treat these PCI patients requiring chronic anticoagulation. Notwithstanding the clinical difficulties of treating such patients, there are several recent studies and analyses that have assessed optimal antithrombotic strategies in the PCI population, and there are several others that are currently underway. This review evaluates the currently available data and clinical scenarios commonly encountered by treating physicians.

Ethnic Differences in Coronary Artery Revascularisation in New Zealand: Does the Inverse Care Law Still Apply?

In 2002 striking differences in cardiac revascularisation rates were reported between New Zealand Māori, Pacific and European ethnicities. This paper examines whether this inequity still exists, taking into account ethnic differences in need. Age-standardised time trends in intervention rates for coronary artery bypass grafts (CABG), percutaneous coronary intervention (PCI) and ST elevation myocardial infarction (STEMI) were calculated by ethnicity. Ethnic-specific trends were also calculated in the ratio of observed to expected CABG and PCI interventions based on the rate of hospitalisation with a diagnosis of STEMI. On a per capita basis, standardised CABG intervention rates were significantly higher for Pacific (both sexes) and female Māori than Other throughout 2000-2012, and were significantly higher for Māori males than Other in 2009-12. Population based PCI rates were significantly lower for male Māori from 2000-2012, while for female Māori they were significantly lower in 2000-2004 but significantly higher in 2009-12. However, and despite some improvement since 2000-2004, Māori and Pacific intervention numbers for PCI in 2009-2012 were still 22%-32% lower than expected for the rate of STEMI hospitalisation they experience. Overall revascularisation ratios were significantly lower than expected for Māori (both sexes) and Pacific females. Large increases in the PCI population intervention rates in Māori and Pacific over the period 2000-2012 have not been sufficient to eliminate inequalities in relation to need, except perhaps for Pacific men.

Individualising dual antiplatelet therapy after percutaneous coronary intervention: the IDEAL-PCI registry

ObjectiveTo evaluate the clinical utility of individualising dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in an all-comers population, including ST-elevation myocardial infarction (STEMI) patients.SettingTertiary care single centre registry.Participants1008...

Cost-effectiveness of contemporary vascular closure devices for the prevention of vascular complications after percutaneous coronary interventions in an all-comers PCI population.

The present observational case-control study assessed the cost-effectiveness of contemporary vascular closure devices (VCDs) for the prevention of vascular complications in an all-comers transfemoral percutaneous coronary intervention (PCI) population. A total of 8,292 consecutive PCI patients were enrolled from a single-centre prospective registry from January 2005 to December 2010. VCDs were available from July 2007 and, from that time point, VCDs were implanted in 1,780 of the 5,394 patients (33%). Vascular complications occurred in 221 (2.7%) patients. The use of VCDs was independently associated with a 53% risk reduction (OR 0.47, 95% CI: 0.3-0.7) in vascular complications (3.0% vs. 1.5%) and with a 65% risk reduction (IRR 0.37, 95% CI: 0.32-0.43) in the post-PCI length of hospital stay (LOS) (mean 2.8 vs. 1.5 days). Mainly due to the reduced LOS, the patients with VCDs accrued vascular direct medical costs (VCD, diagnosis and treatment of vascular complications, post-PCI LOS) that were on average 498€ less than those accrued by the non-VCD patients. The cost-effectiveness was present across all vascular risk profiles. In this large, all-comers transfemoral PCI population, the use of VCDs was independently associated with a reduction in the rate of vascular complications and the post-PCI length of hospital stay and proved to be cost-saving across all vascular risk profiles.

Impact of antithrombotic treatment on short-term outcomes after percutaneous coronary intervention for left main disease: a pooled analysis from REPLACE-2, ACUITY, and HORIZONS-AMI trials

Percutaneous coronary intervention (PCI)-related risks are increased among patients with left main disease (LMD). The aim was to evaluate the impact of antithrombotic therapy on outcomes after LMD PCI in a predominantly ACS population. One hundred and seventy-seven patients undergoing LMD PCI were identified in a pooled dataset of 14,326 patients from three large randomised trials comparing treatment with heparin plus glycoprotein IIb/IIIa inhibitors (GPI) or bivalirudin alone, including the REPLACE-2, ACUITY and HORIZONS-AMI trials. Overall, net adverse clinical events (NACE) and non-CABG major bleedings at 30 days occurred more frequently in patients undergoing LMD PCI compared to the overall non-LMD PCI population (NACE: 19.8% vs. 10.6%, p≤0.001, major bleeding: 9.6% vs. 4.6%, p≤0.001). In the LMD group, bivalirudin was associated with significantly less non-CABG related major bleeding compared to heparin+GPI (4.5% versus 14.6%, relative risk [RR] 0.27, 95% CI: 0.09-0.83; p=0.013), while the composite ischaemic endpoint (death/MI/TVR) at 30 days was similar in the two groups (11.4% vs. 12.4%, p=0.513) resulting in a benefit on NACE for bivalirudin over heparin+GPI (14.8% vs. 24.7%; RR 0.53; p=0.039). Among patients undergoing LMD PCI, the use of bivalirudin instead of heparin+GPI resulted in significantly less major bleeding and improved short-term net clinical outcome. Bivalirudin may be the preferred anticoagulation strategy in LMD PCI patients.

Comparison of Clinical Efficacy and Safety of Clopidogrel Resinate With Clopidogrel Bisulfate in Patients Undergoing Percutaneous Coronary Intervention

A new polymeric salt form of clopidogrel, clopidogrel resinate (CR), is a resinate complex of the (+)-clopidogrel optical isomer wherein the (+)-clopidogrel isomer binds to a water-soluble cation exchange resin via sulfonic acid groups. CR was approved for marketing by the Korean Food and Drug Administration based on a Phase I bioequivalence study. However, no data are available regarding its impact on adverse clinical outcomes in patients undergoing percutaneous coronary intervention (PCI). Clopidogrel bisulfate (CB) was used exclusively from January 2004 through April 2010, after which CR was exclusively administered from May 2010 through September 2011, in 8 centers. We categorized the overall population (N = 10,487) into two groups according to the prescribed clopidogrel type: CB (n = 9,127) or CR (n = 1,360). To minimize the covariate imbalance and confounding in comparing CB and CR, we used a multivariable Cox proportional hazard regression model and the propensity score (PS) method to identify a 1:1 matched cohort (n = 2,470). We compared cumulative adverse outcomes during a 1-year follow-up after PCI in the overall population and in the PS-matched cohort. In the overall population, there is no difference in the 1-year cumulative event rates between the two groups (CB : CR) : composite of any death, nonfatal myocardial infarction or stroke (6.0 % vs. 6.0 %, adjusted HR, 0.82; 95 % CI, 0.61-1.11, p = 0.57), stent thrombosis (0.4 % vs. 0.2 %; adjusted HR, 0.40; 95 % CI, 0.09-1.72, p = 0.31), and bleeding (0.9 % vs. 0.6 %; adjusted HR, 0.67; 95 % CI, 0.28-1.58, p = 0.22). In the PS-matched cohort, the overall findings were consistent. In this large real-world PCI population, CR was as effective and as safe as CB in preventing adverse clinical outcomes.

Antiplatelet Drug Resistance and Variability in Response: The Role of Antiplatelet Therapy Monitoring

Dual antiplatelet therapy of clopidogrel added aspirin is an established treatment strategy to prevent recurrent ischemic event occurrence in coronary artery disease patients. Generally, a one size fits all nonselective strategy is used without an assessment of pharmacodynamic efficacy of clopidogrel therapy. However, pharmacodynamic studies revealed various limitations of clopidogrel metabolism and numerous factors such as genetic and, drug-drug interactions influence the antiplatelet response to clopidogrel therapy. Translational platelet function investigations performed in the percutaneous coronary intervention (PCI)-treated population receiving clopidogrel have identified high platelet reactivity (HPR) to adenosine diphosphate as a major risk factor for both acute as well as long-term ischemic event occurrence, including stent thrombosis. Recent studies have highlighted the relation of single nucleotide polymorphisms of genes involved in clopidogrel absorption and metabolism to reduced pharmacokinetic and pharmacodynamic responses to clopidogrel. Cytochrome (CYP) 2C19 loss-of-function (LoF) allele carriage has been associated with increased thrombotic risk in the PCI population. However, clopidogrel is pharmacodynamically effective in about two thirds of patients undergoing PCI; these patients do not have HPR. Therefore, selectively treating two thirds of patients with generic clopidogrel may provide significant cost savings. Unselected therapy with the new P2Y12 receptor blockers is associated with increased bleeding. The introduction of generic clopidogrel holds the strong possibility of inducing a change in practice whereby genetic and platelet function testing are performed more frequently in patients receiving a stent.

Platelet Function Testing and Genotyping Improve Outcome in Patients Treated With Antithrombotic Agents

The only reason P2Y12 inhibitors are administered in addition to aspirin is to improve the prevention of thrombosis. The clinical efficacy of adding clopidogrel to aspirin as a secondary prevention strategy in patients with high-risk coronary artery disease is well established.1 There are no effects of clopidogrel on any receptor other than P2Y12 to explain the magnitude of the clinical benefit. All of the established clinical effects are attributed to reduced platelet responsiveness to ADP.2 Therefore, the patient with inadequate P2Y12 inhibition determined by ex vivo testing logically has an increased risk for thrombosis. Persistent ischemic event occurrence and the irrefutable demonstration of clopidogrel antiplatelet response variability are 2 potent arguments against the widely practiced nonselective or one-size-fits-all strategy of administering clopidogrel therapy. Observational studies conducted in thousands of patients have led to an international consensus that high on-treatment platelet reactivity (HPR) to ADP is a major risk factor for post–percutaneous coronary intervention (PCI) ischemic event occurrence.3,4 Moreover, the recent 2011 American and European guidelines have given a Class IIb recommendation for platelet function testing or genotyping if the results of testing may alter management.5–7 Furthermore, the Society of Thoracic Surgeons gave a Class IIb recommendation for platelet function testing to determine the timing of surgery in patients on clopidogrel therapy (Level of Evidence C).8 These recommendations for personalizing antiplatelet therapy are unprecedented and acknowledge that a large body of data has accrued demonstrating the relation of HPR to ischemic risk in the PCI-treated patient. Finally, the evidence of diminished effectiveness of clopidogrel in poor metabolizers (those having 2 loss-of-function [LoF] cytochrome P450 [ CYP ] 2C19 alleles) has been recognized by the Food and Drug Administration (FDA) boxed warning about treatment with clopidogrel.9 Response by Krishna …

Procedural Factors Associated With Percutaneous Coronary Intervention-Related Ischemic Stroke

This study sought to determine whether procedural factors during percutaneous coronary intervention (PCI) are associated with the occurrence of ischemic stroke or transient ischemic attack (PCI-stroke). Stroke is a devastating complication of PCI. Demographic predictors are nonmodifiable. Whether PCI-stroke is associated with procedural factors, which may be modifiable, is unknown. We performed a single-center retrospective study of 21,497 PCI hospitalizations between 1994 and 2008. We compared procedural factors from patients who suffered an ischemic stroke or transient ischemic attack related to PCI (n=79) and a control group (n=158), and matched them 2:1 based on a predicted probability of stroke developed from a logistic regression model. PCI-stroke procedures involved the use of more catheters (median: 3 [quarter (Q) 1, Q3: 3, 4] vs. 3 [Q1, Q3: 2, 3], p<0.001), greater contrast volumes (250 ml vs. 218 ml, p=0.006), and larger guide caliber (median: 7-F [Q1, Q3: 6, 8] vs. 6-F [Q1, Q3: 6, 8], p<0.001). The number of lesions attempted (1.7±0.8 vs. 1.5±0.8, p=0.14) and stents placed (1.4±1.2 vs. 1.2±1.1, p=0.35) were similar between groups, but PCI-stroke patients were more likely to have undergone rotational atherectomy (10% vs. 3%, p=0.029). Overall procedural success was lower in the PCI-stroke group compared with controls (71% vs. 85%, p=0.017). Evaluation of the entire PCI population revealed no difference in the rate of PCI-stroke between radial and femoral approaches (0.4% vs. 0.4%, p=0.78). Ischemic stroke related to PCI is associated with potentially modifiable technical parameters. Careful procedural planning is warranted, particularly in patients at increased risk.