Coronary Stent Trials Research Articles

Ethnic minorities treated with new-generation drug-eluting coronary stents in two European randomised clinical trials.

Several ethnic minorities have an increased risk of cardiovascular events, but previous European trials that investigated clinical outcome after coronary stenting did not assess the patients' ethnic background. To compare ethnic minority and Western European trial participants in terms of both cardiovascular risk profile and 1‑year clinical outcome after percutaneous coronary intervention. In the BIO-RESORT and BIONYX randomised trials, which assessed new-generation drug-eluting stents, information on patients' self-reported ethnic background was prospectively collected. Pooled patient-level data of 5803 patients, enrolled in the Netherlands and Belgium, were analysed in this prespecified analysis. The main endpoint was target vessel failure after 1year. Patients were classified as belonging to an ethnic minority (n = 293, 5%) or of Western European origin (n = 5510, 95%). Follow-up data were available in 5772 of 5803 (99.5%) patients. Ethnic minority patients were younger, less often female, more often current smokers, more often medically treated for diabetes, and more often had apositive family history of coronary artery disease. The main endpoint target vessel failure did not differ between ethnic minority and Western European patients (3.5% vs 4.9%, hazard ratio 0.71, 95% confidence interval 0.38-1.33; p = 0.28). There was also no difference in mortality, myocardial infarction, and repeat revascularisation rates. Despite the unfavourable cardiovascular risk profile of ethnic minority patients, short-term clinical outcome after treatment with contemporary drug-eluting stents was highly similar to that in Western European patients. Further efforts should be made to ensure the enrolment of more ethnic minority patients in future coronary stent trials.

Drug-eluting stents for coronary artery disease in the perspective of bibliometric analysis.

Drug-eluting stents (DES) play a crucial role in treating coronary artery disease (CAD) by preventing restenosis. These stents are coated with drug carriers that release antiproliferative drugs within the vessel. Over the past two decades, DES have been employed in clinical practice using various materials, polymers, and drug types. Despite optimizations in their design and materials to enhance biocompatibility and antithrombotic properties, evaluating their long-term efficacy and safety necessitates improved clinical follow-up and monitoring. To delineate future research directions, this study employs a bibliometric analysis approach. We comprehensively surveyed two decades' worth of literature on DES for CAD using the Web of Science Core Collection (WOSCC). Out of 5,778 articles, we meticulously screened them based on predefined inclusion and exclusion criteria. Subsequently, we conducted an in-depth analysis encompassing annual publication trends, authorship affiliations, journal affiliations, keywords, and more. Employing tools such as Excel 2021, CiteSpace 6.2R3, VOSviewer 1.6.19, and Pajek 5.17, we harnessed bibliometric methods to derive insights from this corpus. Analysis of annual publication data indicates a recent stabilisation or even a downward trend in research output in this area. The United States emerged as the leading contributor, with Columbia University and CRF at the forefront in both publication output and citation impact. The most cited document pertained to standardized definitions for clinical endpoints in coronary stent trials. Our author analysis identifies Patrick W. Serruys as the most prolific contributor, underscoring a dynamic exchange of knowledge within the field.Moreover, the dual chart overlay illustrates a close interrelation between journals in the "Medicine," "Medical," and "Clinical" domains and those in "Health," "Nursing," and "Medicine." Frequently recurring keywords in this research landscape include DES coronary artery disease, percutaneous coronary intervention, implantation, and restenosis. This study presents a comprehensive panorama encompassing countries, research institutions, journals, keyword distributions, and contributions within the realm of DES therapy for CAD. By highlighting keywords exhibiting recent surges in frequency, we elucidate current research hotspots and frontiers, thereby furnishing novel insights to guide future researchers in this evolving field.

Clinical outcome up to 2 years after percutaneous coronary intervention in all-comers with concomitant symptomatic peripheral arterial disease: a pooled analysis in 9,204 randomized trial participants

Abstract Background An increasing number of patients with coronary artery disease, who undergo percutaneous coronary intervention, also have symptomatic peripheral arterial disease. These patients have a worse long-term prognosis, but it is unclear whether the inferior outcome can be seen as early as during the first 2 years from coronary stenting. Purpose The aim of this study in all-comers was to evaluate the impact of symptomatic peripheral arterial disease on 1- and 2-year clinical outcome after coronary stenting. Methods Patient-level data from four large-scale randomised coronary drug-eluting stent trials in all-comers (TWENTE (clinicaltrials.gov: NCT01066650), DUTCH PEERS (NCT01331707), BIO-RESORT (NCT01674803), and BIONYX (NCT02508714)) were pooled to evaluate the impact of symptomatic peripheral arterial disease on clinical outcome after coronary stenting. Peripheral arterial disease was defined as a history (by anamnesis or medical record) of an obstructive arterial lesion, resulting from atherosclerosis in peripheral locations including the lower and upper extremities, carotid or vertebral arteries, and mesenteric or renal arteries. Main clinical endpoint was target vessel failure, a composite of cardiac death, target vessel related myocardial infarction, or clinically indicated target vessel revascularisation. Results Of all 9,204 trial participants, 695 (7.6%) had symptomatic peripheral arterial disease. These patients were older and had a higher cardiovascular risk profile, including a higher prevalence of diabetes, renal failure, hypertension, hypercholesterolemia, and prior stroke. At 1-year follow-up, patients with peripheral arterial disease showed significantly higher event rates of some endpoints. At 2-year follow-up, patients with peripheral arterial disease showed significantly higher rates of various clinical endpoints, including mortality (7.1% vs. 3.0%, p<0.001), myocardial infarction (4.8% vs. 3.4%, p0.04), repeated revascularisation (6.7% vs 4.5%, p<0.04), and major adverse cardiac events (14.6% vs. 8.3%, p<0.001, Figure 1). After multivariate adjustment for confounders, symptomatic peripheral arterial disease was found to be independently associated with the 2-year risks of target vessel and lesion failure, major adverse cardiac events, and all-cause death (p<0.02, for all, Table 1). Conclusion Obstructive coronary artery disease with concomitant symptomatic peripheral arterial disease resulted in higher cardiovascular risk profiles and higher rates of all-cause mortality and various composite clinical endpoints during the first two years of follow-up after coronary stenting. Knowledge of these findings allows to identify patients with an increased short- and medium-term adverse event risk after percutaneous coronary intervention, which is useful for both Heart Team and informed consent discussions. Funding Acknowledgement Type of funding sources: Other. Main funding source(s): The original trials were funded by Abbott Vascular, Medtronic, Boston Scientific and Biotronik.

Consequences of Inaccurate Assumptions in Coronary Stent Noninferiority Trials

The outcome and interpretation of noninferiority trials depend on the magnitude of the noninferiority margin and whether a relative or absolute noninferiority margin is used and may be affected by imprecision in event rate estimation. To assess the consequence of imprecise event rate estimations on interpretation of peer-reviewed randomized clinical trials. PubMed/MEDLINE was searched for articles published between January 1, 2015, and April 30, 2021. Noninferiority randomized clinical trials of coronary stents published in selected journals with clinical events as the primary end point. Two reviewers (M.S. and F.V.) independently extracted data on trial characteristics, noninferiority assumptions, primary end point clinical outcomes, and study conclusions. Overestimation or underestimation of the control event rate was evaluated by dividing the assumed control event rate by the observed control event rate. For noninferiority end points with absolute margins, the assumed corresponding relative margin was defined as the ratio of the absolute margin and the assumed event rate, and the observed corresponding relative margin as the ratio between the absolute margin and the observed event rate in the control arm. Noninferiority comparisons with absolute margins were reanalyzed using the assumed corresponding relative margin and the Farrington-Manning score test for relative risk. Overestimation or underestimation, assumed and observed corresponding relative margins, and relative reanalysis of the primary end points of trials with absolute margins. A total of 106 989 patients from 58 trials were included. The event rate in the control arms was overestimated by a median (IQR) of 28% (2%-74%). Most noninferiority trials used absolute rather than relative margins (55 of 58 trials [94.8%]). Owing to overestimation, absolute noninferiority margins became more permissive than originally assumed (median [IQR] of observed relative noninferiority margin, 1.62 [1.50-1.80] vs assumed relative noninferiority margin, 1.47 [1.39-1.55]; P < .001). Among trial comparisons that met noninferiority with an absolute noninferiority margin, 17 of 50 trials (34.0%) would not have met noninferiority with a corresponding assumed relative noninferiority margin. In this systematic review and meta-analysis, assumed event rates were often overestimated in noninferiority coronary stent trials. Because most of these trials use absolute margins to define noninferiority, such overestimation results in excessively permissive relative noninferiority margins.

Abstract 8887: Impact of Event Rate Assumptions on the Conclusions of Non-Inferiority Coronary Stent Trials

Background: Non-inferiority trials are increasingly common in assessing novel therapies. The outcome and interpretation of non-inferiority trials depends on the magnitude of the non-inferiority margin, whether a relative or absolute non-inferiority margin is used, and may be affected by imprecision in event rate estimation. Methods: We performed a systematic review of randomized non-inferiority coronary stent trials published within the past 5 years as a case study. For non-inferiority endpoints with absolute margins, the assumed corresponding relative margin was defined as the ratio of the absolute margin and the assumed event rate, and the observed corresponding relative margin as the ratio between the absolute margin and the observed event rate in the control arm. Results: A total of 58 trials, encompassing 106,989 patients, were identified and analyzed. The event rate in the control arms were overestimated by a median of 28% [2%-74%]. The majority of non-inferiority trials used absolute rather than relative margins (55/58; 94.8%). Due to overestimation, absolute non-inferiority margins became more permissive than originally assumed (observed relative non-inferiority margin 1.62 [1.50-1.80] versus assumed relative non-inferiority margin 1.47 [1.39-1.55], p&lt;0.001). Among trial comparisons that met non-inferiority with an absolute non-inferiority margin, 17/50 (34%) would not have met non-inferiority with a corresponding assumed relative non-inferiority margin. Conclusions: Assumed event rates are often overestimated in non-inferiority coronary stent trials. Because most of these trials use absolute margins to define non-inferiority, such overestimation results in excessively permissive non-inferiority margins.

Prognostic Impact of Race in Patients Undergoing PCI: Analysis From 10 Randomized Coronary Stent Trials

ObjectivesThe aim of this study was to assess race-based differences in patients undergoing percutaneous coronary intervention from a large pooled database of randomized controlled trials. BackgroundData on race-based outcomes after percutaneous coronary intervention are limited, deriving mainly from registries and single-center studies. MethodsBaseline characteristics and outcomes at 30 days, 1 year, and 5 years were assessed across different races, from an individual patient data pooled analysis from 10 randomized trials. Endpoints of interest included death, myocardial infarction, and major adverse cardiac events (defined as cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization). Multivariate Cox proportional hazards regression was performed to assess associations between race and outcomes, controlling for differences in 12 baseline covariates. ResultsAmong 22,638 patients, 20,585 (90.9%) were white, 918 (4.1%) were black, 404 (1.8%) were Asian, and 473 (2.1%) were Hispanic. Baseline and angiographic characteristics differed among groups. Five-year major adverse cardiac event rates were 18.8% in white patients (reference group), compared with 23.9% in black patients (p = 0.0009), 11.2% in Asian patients (p = 0.0007), and 21.5% in Hispanic patients (p = 0.07). Multivariate analysis demonstrated an independent association between black race and 5-year risk for major adverse cardiac events (hazard ratio: 1.28; 95% confidence interval: 1.05 to 1.57; p = 0.01). ConclusionsIn the present large-scale individual patient data pooled analysis, comorbidities were significantly more frequent in minority-group patients than in white patients enrolled in coronary stent randomized controlled trials. After accounting for these differences, black race was an independent predictor of worse outcomes, whereas Hispanic ethnicity and Asian race were not. Further research examining race-based outcomes after percutaneous coronary intervention is warranted to understand these differences.

Long-Term Outcomes After Revascularization for Stable Ischemic Heart Disease: An Individual Patient-Level Pooled Analysis of 19 Randomized Coronary Stent Trials.

Whether revascularization improves prognosis in stable ischemic heart disease is controversial. Individual patient-level data from 19 prospective, randomized stent trials were pooled. Rates of 5-year major adverse cardiovascular events (MACE; a composite of cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization) were assessed and compared after percutaneous coronary intervention with bare-metal stents (BMS) and first-generation and second-generation drug-eluting stents (DES1 and DES2, respectively). Poisson multivariable regression analysis was performed to identify predictors of adverse events. Among 10 987 patients treated with percutaneous coronary intervention for stable ischemic heart disease, 1550, 2776, and 6661 received BMS, DES1, and DES2, respectively. The 5-year rates of MACE progressively declined with evolution in stent technology (BMS: 24.1% versus DES1: 17.9% versus DES2: 13.4%, P<0.0001). However, MACE rates between 1 and 5 years increased from BMS to DES1, then declined with DES2 (BMS: 7.4% versus DES1: 10.2%, DES2: 8.5%, P=0.02). Patients with stable ischemic heart disease remain at substantial risk for long-term MACE after revascularization with percutaneous coronary intervention, even with contemporary DES. New approaches to reduce the ongoing risk of MACE beyond 1 year after stent implantation are necessary.

Endpoint selection for noninferiority percutaneous coronary intervention trials: a methodological description.

Background:The objective of this review is to provide a practical update on endpoint selection for noninferiority (NI) studies in percutaneous coronary intervention studies.Methods:A PubMed search was conducted for predefined terms to explore the use of NI designs and intrapatient comparisons to determine their current importance. Sample size calculations for the most frequently used endpoints with NI hypotheses were done to increase statistical awareness.Results:Reported NI trials, with the most frequently chosen clinical endpoint of major adverse cardiac events (MACE), had NI margins ranging from 1.66% to 5.00%, resulting in patient populations of 400–1500 per treatment group. Clinical study endpoints comprising of MACE complemented with rates of bleeding complications and stent thrombosis (ST) are suggested to conduct a statistically and clinically meaningful NI trial. Study designs with surrogate endpoints amenable to intrapatient randomizations, are a very attractive option to reduce the number of necessary patients by about half. Comparative clinical endpoint studies with MACE and ST/bleeding rates to study a shortened dual antiplatelet therapy (DAPT) in coronary stent trials are feasible, whereas ST as the sole primary endpoint is not useful.Conclusions:Expanded composite clinical endpoints (MACE complemented by ST and bleeding rates and intrapatient randomization for selected surrogate endpoints) may be suitable tools to meet future needs in device approval, recertification and reimbursement.

Impact of Periprocedural Myocardial Biomarker Elevation on Mortality Following Elective Percutaneous Coronary Intervention

ObjectivesThis study sought to explore the association between biomarker elevation, with creatine kinase–myocardial band (CK-MB) or cardiac troponin (cTn), following percutaneous coronary intervention (PCI) and mortality in patients undergoing PCI for stable angina with normal baseline values. BackgroundSeveral studies have shown a strong association between post-PCI CK-MB elevation and subsequent mortality. However, the prognostic significance of troponin elevation following coronary intervention is still debated. MethodsPatient-level data from 5 contemporary coronary stent trials and 1 large registry were pooled. Mortality of patients with stable angina, with normal baseline biomarkers, was compared between patients with and those without different cutoff values of cTn and CK-MB. ResultsA total of 13,452 patients were included in this pooled analysis. The overall percentage of patients with elevated biomarkers following PCI was 23.9% for CK-MB and 68.4% for cTn. In the patient cohort for whom both assays were available (n = 8,859), 2.4% had both CK-MB ≥5 × the upper limit of normal (ULN) and cTn ≥35 × ULN, while 92% had both CK-MB <5 × ULN and cTn <35 × ULN. Among patients with CK-MB ≥5 × ULN (n = 315), 212 (67.3%) also had cTn ≥35 × ULN. Conversely, 390 of patients (64.8%) who had cTn ≥35 × ULN did not have CK-MB ≥5 × ULN. A total of 259 patients (1.9%) died at 1 year; 20 (7.7%) had CK-MB ≥5 × ULN, and 23 (8.8%) had cTn ≥35 × ULN. In the Cox multivariate analysis, in which the CK-MB and cTn ratios post-procedure were forced into the model, age, prior myocardial infarction, lesion complexity, hyperlipidemia, and CK-MB ratio (≥10) post-procedure were associated with increased 1-year mortality. ConclusionsFollowing elective PCI in patients in stable condition treated with second-generation drug-eluting stent, CK-MB and cTn elevations remain common. After multivariate adjustment, there was an increased mortality rate with elevation of CK-MB after PCI, whereas cTn elevation was not independently associated with mortality at 1 year.

TCT-795 Prognostic Impact of Race in Patients Undergoing PCI: Analysis of 22,638 Patients from 10 Randomized Coronary Stent Trials

TCT-795 Prognostic Impact of Race in Patients Undergoing PCI: Analysis of 22,638 Patients from 10 Randomized Coronary Stent Trials

Impact of Outcome Measure and Duration of Follow-up on the Reliability of Clinical Trials Assessing the Efficacy and Safety of Coronary Artery Stents

Aim: Advances in coronary stent design have reduced rates of coronary restenosis and the need for further revascularisation. However, compared with second-generation(2ndGen) drug-eluting stents(DES), first-generation(1stGen) DES and bioresorbable coronary scaffolds(BVS) have an increased risk of stent thrombosis which may not be adequately assessed in individual studies. A meta-analysis was undertaken to evaluate the best choice of endpoint and follow-up duration to detect any increased risk of stent or scaffold thrombosis(ST). Methods: Medline, Embase and Central were searched for randomised coronary stent trials involving ≥100 patients and reporting clinical outcomes for ≥12months. Meta-analyses compared 1stGenDES with bare metal stents(BMS), 2ndGenDES with BMS, 2ndGenDES with 1stGenDES, 2ndGenDES with BVS. Landmark analysis evaluated clinical outcomes ≤1 year and >1 year. Results: 75 trials were analysed involving 78,491 patients. Compared with BMS, 1stGenDES decreased revascularisation[OR0.36(95%CI 0.25,0.53)] and myocardial infarction(MI)[OR0.65(95%CI 0.52,0.82)] ≤1 year, but increased ST[OR1.66(95%CI 1.21,2.29)] and MI[OR1.41(95%CI 1.07,1.87)] >1 year. 2ndGenDES vs BMS decreased revascularisation[OR0.51(95%CI 0.44,0.58)], MI[OR0.70(95%CI 0.58,0.85)], and ST[OR0.48(95%CI 0.31,0.72)], at ≤1 year with little impact on other and later end-points. Compared with 1stGenDES and BVS, 2ndGenDES reduced ST and MI at >1 year. Coronary revascularisation, and composite endpoints including death and revascularisation, did not reliably identify ST-related risk. Conclusion: Revascularisation rates ≤12 months can evaluate the efficacy of stents on reducing restenosis. Long-term safety can only be assessed in large study populations followed for several years, with the best endpoint a combination of MI and ST. A two-phased approach is required to evaluate the next generation of coronary stents and scaffolds.

Coronary bifurcation lesions treated with simple or complex stenting: 5-year survival from patient-level pooled analysis of the Nordic Bifurcation Study and the British Bifurcation Coronary Study.

Randomized trials of coronary bifurcation stenting have shown better outcomes from a simple (provisional) strategy rather than a complex (planned two-stent) strategy in terms of short-term efficacy and safety. Here, we report the 5-year all-cause mortality based on pooled patient-level data from two large bifurcation coronary stenting trials with similar methodology: the Nordic Bifurcation Study (NORDIC I) and the British Bifurcation Coronary Study: old, new, and evolving strategies (BBC ONE). Both multicentre randomized trials compared simple (provisional T-stenting) vs. complex (culotte, crush, and T-stenting) techniques, using drug-eluting stents. We analysed all-cause death at 5 years. Data were collected from phone follow-up, hospital records, and national mortality tracking. Follow-up was complete for 890 out of 913 patients (97%). Both Simple and Complex groups were similar in terms of patient and lesion characteristics. Five-year mortality was lower among patients who underwent a simple strategy rather than a complex strategy [17 patients (3.8%) vs. 31 patients (7.0%); P = 0.04]. For coronary bifurcation lesions, a provisional single-stent approach appears to be associated with lower long-term mortality than a systematic dual stenting technique.

Validity of SYNTAX score II for risk stratification of percutaneous coronary interventions: A patient-level pooled analysis of 5433 patients enrolled in contemporary coronary stent trials

ObjectivesTo assess the clinical profile and long-term mortality in SYNTAX score II based strata of patients who received percutaneous coronary interventions (PCI) in contemporary randomized trials. BackgroundThe SYNTAX score II was developed in the randomized, all-comers' SYNTAX trial population and is composed by 2 anatomical and 6 clinical variables. The interaction of these variables with the treatment provides individual long-term mortality predictions if a patient undergoes coronary artery bypass grafting (CABG) or PCI. MethodsPatient-level (n=5433) data from 7 contemporary coronary drug-eluting stent (DES) trials were pooled. The mortality for CABG or PCI was estimated for every patient. The difference in mortality estimates for these two revascularization strategies was used to divide the patients into three groups of theoretical treatment recommendations: PCI, CABG or PCI/CABG (the latter means equipoise between CABG and PCI for long term mortality). ResultsThe three groups had marked differences in their baseline characteristics. According to the predicted risk differences, 5115 patients could be treated either by PCI or CABG, 271 should be treated only by PCI and, rarely, CABG (n=47) was recommended. At 3-year follow-up, according to the SYNTAX score II recommendations, patients recommended for CABG had higher mortality compared to the PCI and PCI/CABG groups (17.4%; 6.1% and 5.3%, respectively; P<0.01). ConclusionsThe SYNTAX score II demonstrated capability to help in stratifying PCI procedures.

Interventional cardiology: Outcomes in coronary stent trials--1 year is not enough.

The medical literature contains a huge number of studies on the safety and performance of novel stent platforms, with primary outcomes usually assessed at 6 months or 1 year. The 5-year analysis from SORT OUT III demonstrates that, when assessing clinical outcomes in stent trials, 1-year follow-up is not enough.

Impact of the Angiographic Mechanisms Underlying Periprocedural Myocardial Infarction After Drug-Eluting Stent Implantation

Periprocedural myocardial infarction (MI) can be induced by several angiographic mechanisms. However, there are limited data on whether these mechanisms differentially affect clinical outcomes. The purpose of our study was to investigate the impact of periprocedural MI on mortality according to the underlying angiographic mechanisms after drug-eluting stent (DES) implantation. We pooled the databases from 7 coronary stent trials using DES. Periprocedural MI was classified according to its underlying angiographic mechanisms as type 1 (due to side-branch occlusion), type 2 (due to other angiographic complications), or type 3 (without angiographically identifiable causes). Among 10,889 patients treated with DES, 768 (7.1%) experienced periprocedural MI; 463 cases (60.3%) were driven by type 1 cause, 138 (18.0%) by type 2 cause, and 167 (21.7%) by type 3 cause. Mortality rates at 2 years were higher in patients with periprocedural MI than in those without (3.5% vs 2.1%, respectively). Significant differences in mortality were observed according to the angiographic mechanisms of MI (type 1: 2.8% vs type 2: 6.1% vs type 3: 3.1%). After multivariable adjustment, type 2 MI was significantly associated with an increased risk of mortality (hazard ratio 2.65, 95% confidence interval 1.77 to 3.96), whereas type 1 and type 3 MI were not related with increased mortality. In conclusion, among patients receiving DES implantation, periprocedural MI was associated with increased mortality, and there were differential associations with mortality according to the underlying angiographic mechanisms.

Association Between Intraprocedural Thrombotic Events and Adverse Outcomes After Primary Percutaneous Coronary Intervention for ST-Segment Elevation Myocardial Infarction (a Harmonizing Outcomes With RevasculariZatiON and Stents in Acute Myocardial Infarction [HORIZONS-AMI] Substudy)

The present study sought to determine the extent to which adverse angiographic events encountered during percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI) are associated with adverse clinical outcomes. Patients with STEMI represent a cohort at particularly high risk of intraprocedural thrombotic events (IPTEs). The overall frequency and implications of IPTEs occurring in patients with STEMI have not been systematically quantified in previous studies. A total of 3,163 patients undergoing primary percutaneous coronary intervention with stent implantation for STEMI in the Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial underwent detailed frame-by-frame core laboratory angiographic analysis to assess IPTEs. The clinical outcomes at 30 days were compared between the patients with and without IPTEs. IPTEs, defined as the development of new or increasing thrombus, abrupt vessel closure, no reflow, slow reflow, and distal embolization at any point during the procedure, occurred in 386 patients (12.2%). The independent predictors of IPTE were thrombus at baseline, lesion length, and randomization to bivalirudin; the patients with IPTEs were also more likely to receive bailout glycoprotein IIb/IIIa inhibitors and unplanned thrombectomy. Compared with patients without IPTEs, the patients with IPTEs had higher 30-day rates of composite major adverse cardiovascular events (death, myocardial infarction, ischemic target vessel revascularization, and stroke; 7.8% vs 4.2%, p = 0.002), major bleeding not related to coronary artery bypass grafting (11.8% vs 6.5%, p <0.001), and all-cause death (4.2% vs 1.8%, p = 0.002). On multivariate analysis, IPTEs were independently associated with 30-day major adverse cardiovascular events, major bleeding, and death. In conclusion, the development of IPTEs in patients undergoing primary percutaneous coronary intervention for STEMI was associated with subsequent adverse outcomes, including major adverse cardiovascular events, major bleeding, and death. Additional studies of strategies to decrease the occurrence of IPTEs are warranted.

Antiplatelet therapy after coronary stenting: for how long?

Dual antiplatelet therapy (DAPT) with aspirin and an oral P2Y12 receptor blocker is the standard regimen to prevent atherothrombotic events in patients after percutaneous coronary stenting. 1 Wijns W Kolh P Danchin N et al. Guidelines on myocardial revascularization. Eur Heart J. 2010; 31: 2501-2555 Crossref PubMed Scopus (26) Google Scholar Although the prevalence is low in terms of numbers, the consequences of stent thrombosis are severe with a 64% rate of death or myocardial infarction and a mortality rate of 9–45%. 2 Iakovou I Schmidt T Bonizzoni E et al. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA. 2005; 293: 2126-2130 Crossref PubMed Scopus (2924) Google Scholar , 3 Cutlip DE Baim DS Ho KK et al. Stent thrombosis in the modern era: a pooled analysis of multicenter coronary stent clinical trials. Circulation. 2001; 103: 1967-1971 Crossref PubMed Scopus (821) Google Scholar The risk of stent thrombosis is difficult to assess in patients who need to cease treatment with DAPT, and the possibility of stent thrombosis causes much anxiety in patients awaiting DAPT. Cessation of dual antiplatelet treatment and cardiac events after percutaneous coronary intervention (PARIS): 2 year results from a prospective observational studyIn a real-world setting, for patients undergoing PCI and discharged on DAPT, cardiac events after DAPT cessation depend on the clinical circumstance and reason for cessation and attenuates over time. While most events after PCI occur in patients on DAPT, early risk for events due to disruption is substantial irrespective of stent type. Full-Text PDF

Critical role of systemic inflammation in patients with ST-segment elevation myocardial infarction complicated with renal dysfunction

side branch stent for the treatment of bifurcation lesions: a two center registry analysis. Catheter Cardiovasc Interv 2011;77(6):798–806. [7] Grundeken MJ, Asgedom S, Damman P, et al. Six-month and one-year clinical outcomes after placement of a dedicated coronary bifurcation stent: a patient-level pooled analysis of eight registry studies. EuroIntervention 2013;9(2):195–203. [8] Cutlip DE,Windecker S,Mehran R, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115(17):2344–51. [9] Editors Of The Heart Group Journals. Statement on matching language to the type of evidence used in describing outcomes data. Int J Cardiol 2013;166(1):1.

Combined anatomical and clinical factors for the long-term risk stratification of patients undergoing percutaneous coronary intervention: the Logistic Clinical SYNTAX score

The SYNTAX score (SXscore), an anatomical-based scoring tool reflecting the complexity of coronary anatomy, has established itself as an important long-term prognostic factor in patients undergoing percutaneous coronary intervention (PCI). The incorporation of clinical factors may further augment the utility of the SXscore to longer-term risk stratify the individual patient for clinical outcomes. Patient-level merged data from >6000 patients in seven contemporary coronary stent trials was used to develop a logistic regression model-the Logistic Clinical SXscore-to predict 1-year risk for all-cause death and major adverse cardiac events (MACE). A core model (composed of the SXscore, age, creatinine clearance, and left ventricular ejection fraction) and an extended model [incorporating the core model and six additional (best performing) clinical variables] were developed and validated in a cross-validation procedure. The core model demonstrated a substantial improvement in predictive ability for 1-year all-cause death compared with the SXscore in isolation [area under the receiver operator curve (AUC): core model: 0.753, SXscore: 0.660]. A minor incremental benefit of the extended model was shown (AUC: 0.791). Consequently the core model alone was retained in the final the Logistic Clinical SXscore model. Validation plots confirmed the model predictions to be well calibrated. For 1-year MACE, the addition of clinical variables did not improve the predictive ability of the SXscore, secondary to the SXscore being the predominant determinant of all-cause revascularization. The Logistic Clinical SXscore substantially enhances the prediction of 1-year mortality after PCI compared with the SXscore, and allows for an accurate personalized assessment of patient risk.

Different cardiac biomarkers to detect peri-procedural myocardial infarction in contemporary coronary stent trials: impact on outcome reporting

ObjectiveTo assess the differential implications of cardiac biomarker type on peri-procedural myocardial infarction (PMI) reporting.SettingThe Resolute ‘All-Comers’ stent trial.InterventionsBlood samples for creatine kinase (CK), CK-myoband (CK-MB) mass or cardiac troponin...