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Predicting long-term bleeding after percutaneous coronary intervention.

ABSTRACT: To construct a model to predict long-term bleeding events following percutaneous coronary intervention (PCI).Treatment with dual antiplatelet therapy following PCI involves balancing the benefits of preventing ischemic events with the risks of bleeding. There are no models to predict long-term bleeding events after PCI.We analyzed 1-year bleeding outcomes from 3,128 PCI procedures in the Patient Risk Information Services Manager (PRISM) observational study. Patient-reported bleeding events were categorized according to Bleeding Academic Research Consortium (BARC) definitions. Logistic regression analysis was used to develop a model predicting BARC???1 bleeding.BARC 0, 1, 2 or 3 bleeding was observed in 574 (18.4%); 2382 (76.2%); 114 (3.6%); and 58 (1.8%) patients, respectively. Compared to patients who had no bleeding, patients with BARC???1 bleeding were more often female (30 vs. 23%), Caucasian (94 vs. 83%), had a higher incidence of drug eluting stent (DES) implantation (83 vs. 76%) and warfarin therapy (7.4 vs. 3.9%), and a lower incidence of diabetes (31 vs. 45%; P-value <0.01 for all comparisons). A 27-variable model had moderate discrimination (c-statistic of 0.674), and good calibration, as did a parsimonious model with 10 variables (c-statistic?=?0.667). This model performed well in predicting BARC???2 bleeding events as well (c-statistic?=?0.653).Bleeding is common in the first year after PCI, and can be predicted by pre-procedural patient characteristics and use of DES. Objective estimates of bleeding risk may help support shared decision-making with respect to stent selection and duration of antiplatelet therapy following PCI. © 2016 Wiley Periodicals, Inc.

SUBMITTER: Sharma PK

PROVIDER: S-EPMC5813282 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature

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Predicting long-term bleeding after percutaneous coronary intervention.

Sharma Praneet K PK Chhatriwalla Adnan K AK Cohen David J DJ Jang Jae-Sik JS Baweja Paramdeep P Gosch Kensey K Jones Philip P Bach Richard G RG Arnold Suzanne V SV Spertus John A JA

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions 20160401 2

<h4>Objectives</h4>To construct a model to predict long-term bleeding events following percutaneous coronary intervention (PCI).<h4>Background</h4>Treatment with dual antiplatelet therapy following PCI involves balancing the benefits of preventing ischemic events with the risks of bleeding. There are no models to predict long-term bleeding events after PCI.<h4>Methods</h4>We analyzed 1-year bleeding outcomes from 3,128 PCI procedures in the Patient Risk Information Services Manager (PRISM) obser ...[more]

PMID: 27037854

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Project description:The authors sought to describe the association between post-procedural bleeding and long-term recurrent bleeding, major adverse cardiac events (MACE), and mortality among older patients undergoing percutaneous coronary intervention (PCI).Bleeding complications after PCI are associated with an increased risk for acute morbidity and long-term mortality, but the association of these bleeding complications with other events is unknown.Patients entered into the National Cardiovascular Data Registry (NCDR) CathPCI Registry (n = 461,311; 946 sites) from January 2004 to December 2008 were linked with claims from the Centers for Medicare & Medicaid Services and grouped according to in-hospital post-PCI bleeding. The association between post-PCI bleeding and 1-, 12-, and 30-month readmission for bleeding, MACE, and all-cause mortality was examined with Cox regression that included patient and procedural characteristics using no bleeding as the reference.Overall, 3.1% (n = 14,107) of patients experienced post-PCI bleeding. Patients who bled were older, more often female, had more medical comorbidities, less often received bivalirudin, and more often underwent PCI via the femoral approach. After adjustment, bleeding after the index procedure was significantly associated with readmission for bleeding (adjusted hazard ratios [95% confidence interval]: 1 month, 1.54 [1.42 to 1.67]; 12 months, 1.52 [1.40 to 1.66]; 30 months, 1.29 [1.11 to 1.50]), MACE (1 month, 1.11 [1.07 to 1.15]; 12 months, 1.17 [1.13 to 1.21]; 30 months, 1.12 [1.06 to 1.19]) and all-cause mortality (1 month, 1.32 [1.26 to 1.38]; 12 months, 1.33 [1.27 to 1.40]); 30 months, 1.22 [1.15 to 1.30]).Post-PCI bleeding complications are associated with an increased risk for short- and long-term recurrent bleeding, MACE, and all-cause mortality. These data underscore the prognostic importance of periprocedural bleeding and the need for identifying strategies to reduce long-term bleeding risk among patients undergoing PCI.

Project description:BackgroundAlthough many studies show an inverse association between operator procedural volume and short-term adverse outcomes after percutaneous coronary intervention (PCI), the association between procedural volume and longer-term outcomes is unknown.MethodsUsing the National Cardiovascular Data Registry CathPCI registry data linked with Medicare claims data, we examined the association between operator PCI volume and long-term outcomes among patients ≥65 years of age. Operators were stratified by average annual PCI volume (counting PCIs performed in patients of all ages): low- (<50 PCIs), intermediate- (50-100), and high- (>100) volume operators. One-year unadjusted rates of death and major adverse coronary events (MACEs; defined as death, readmission for myocardial infarction, or unplanned coronary revascularization) were calculated with Kaplan-Meier methods. The proportional hazards assumption was not met, and risk-adjusted associations between operator volume and outcomes were calculated separately from the time of PCI to hospital discharge and from hospital discharge to 1-year follow-up.ResultsBetween July 1, 2009, and December 31, 2014, 723 644 PCI procedures were performed by 8936 operators: 2553 high-, 2878 intermediate-, and 3505 low-volume operators. Compared with high- and intermediate-volume operators, low-volume operators more often performed emergency PCI, and their patients had fewer cardiovascular comorbidities. Over 1-year follow-up, 15.9% of patients treated by low-volume operators had a MACE compared with 16.9% of patients treated by high-volume operators ( P=0.004). After multivariable adjustment, intermediate- and high-volume operators had a significantly lower rate of in-hospital death than low-volume operators (odds ratio, 0.91; 95% CI, 0.86-0.96 for intermediate versus low; odds ratio, 0.79; 95% CI, 0.75-0.83 for high versus low). There were no significant differences in rates of MACEs, death, myocardial infarction, or unplanned revascularization between operator cohorts from hospital discharge to 1-year follow-up (adjusted hazard ratio for MACEs, 0.99; 95% CI, 0.96-1.01 for intermediate versus low; hazard ratio, 1.01; 95% CI, 0.99-1.04 for high versus low).ConclusionsUnadjusted 1-year outcomes after PCI were worse for older adults treated by operators with higher annual volume; however, patients treated by these operators had more cardiovascular comorbidities. After risk adjustment, higher operator volume was associated with lower in-hospital mortality and no difference in postdischarge MACEs.

Project description:ObjectivesThe purpose of this study was to evaluate ischemic and bleeding outcomes of unselected cancer patients undergoing percutaneous coronary intervention (PCI).BackgroundThe number of cancer patients undergoing PCI is increasing despite concerns regarding ischemic and bleeding risks.MethodsBetween 2009 and 2017, consecutive patients undergoing PCI were prospectively included in the Bern PCI Registry. Cancer-specific data including type, date of initial diagnosis, and health status at index PCI were collected. We performed propensity score matching to adjust for baseline differences between patients with and without cancer. The primary ischemic endpoint was the device-oriented composite endpoint (cardiac death, target vessel myocardial infarction, target lesion revascularization) at 1 year, and the primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) 2 to 5 at 1 year.ResultsAmong 13,647 patients, 1,368 (10.0%) had an established diagnosis of cancer. The 3 leading cancer types were prostate (n = 294), gastrointestinal tract (n = 188), and hematopoietic (n = 177). At index PCI, 179 (13.1%) patients were receiving active cancer treatment. In matched analysis, there was no significant difference in device-oriented composite endpoint (11.5% vs. 10.2%; p = 0.251), whereas cardiac death and BARC 2 to 5 bleeding occurred more frequently among patients with cancer compared with those without cancer (6.8% vs. 4.5%; p = 0.010 and 8.0% vs. 6.0%; p = 0.026, respectively). Cancer diagnosis within 1 year before PCI emerged as an independent predictor for cardiac death and BARC 2 to 5 bleeding at 1 year.ConclusionsCancer patients carry an increased risk of cardiac mortality that was not associated with stent-related ischemic events among patients undergoing PCI in routine clinical practice. Higher risk of bleeding in cancer patients undergoing PCI deserves particular attention. (CARDIOBASE Bern PCI Registry; NCT02241291).

Project description:BackgroundThe development of the technique has improved the success rate of percutaneous coronary intervention (PCI) for in-stent chronic total occlusion (IS-CTO). However, long-term outcomes remain unclear. The present study sought to investigate long-term outcomes of PCI for IS-CTO.MethodsA total of 474 IS-CTO patients were enrolled at two cardiac centers from 2015 to 2018 retrospectively. These patients were allocated into either successful or failed IS-CTO PCI groups. The primary endpoint (major adverse cardiac events [MACE]) consisted of recurrent angina pectoris (RAP), target-vessel myocardial infarction (MI), heart failure, cardiac death, or ischemia-driven target-vessel revascularization (TVR) at follow-up. Multivariable Cox regression analysis was used to investigate the association between treatment appropriateness and clinical outcomes.ResultsA total of 367 patients were successfully treated with IS-CTO PCI while 107 patients had failed recanalization. After a median follow-up of 30 months (interquartile range: 17-42 months), no significant difference was observed between the two groups for the following parameters: cardiac death (successful PCI vs. failed PCI: 0.9% vs. 2.7%; adjusted hazard ratio [HR]: 1.442; 95% confidence interval [CI]: 0.21-9.887; P = 0.709), RAP (successful PCI vs. failed PCI: 40.8% vs. 40.0%; adjusted HR: 1.025; 95% CI: 0.683-1.538; P = 0.905), heart failure (successful PCI vs. failed PCI: 6.1% vs. 2.7%; adjusted HR: 0.281; 95% CI: 0.065-1.206; P = 0.088), target-vessel related MI (successful PCI vs. failed PCI: 1.5% vs. 2.7%; adjusted HR: 1.150; 95% CI: 0.221-5.995; P = 0.868), MACE (successful PCI vs. failed PCI: 44.2% vs. 45.3%; adjusted HR: 1.052; 95% CI: 0.717-1.543; P = 0.797). More patients were free of angina in the successful IS-CTO PCI group compared with failed PCI in the first (80.4% vs. 60%, P < 0.01) and second years (73.3% vs. 60.0%, P = 0.02) following up. Successful IS-CTO PCI had a lower incidence of MACE in the first and second years (20.2% vs. 40.0%, P < 0.01; 27.9% vs. 41.3%, P = 0.023) compared with failed PCI. After a median follow-up of 30 months, the reocclusion rate was 28.5% and TVR was 26.1% in the successful IS-CTO PCI group. Receiving >18 months of dual antiplatelet therapy (DAPT) was an independent predictor of decreased risk of TVR (HR: 2.682; 95% CI: 1.295-5.578; P = 0.008) or MACE (without TVR) (HR: 1.898; 95% CI: 1.036-3.479; P = 0.038) in successful IS-CTO PCI.ConclusionsAfter a median follow-up of 30 months, the successful IS-CTO PCI group had MACE similar to that of the failed PCI group. However, the successful IS-CTO PCI group had improved angina symptoms and were free from requiring coronary artery bypass grafting in the first or second years. To decrease MACE, DAPT was found to be essential and recommended for at least 18 months for IS-CTO PCI.

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Predicting long-term bleeding after percutaneous coronary intervention.

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Predicting long-term bleeding after percutaneous coronary intervention.

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