Propensity Score-adjusted Regression Analysis Research Articles

Intravenous antiplatelet therapy with cangrelor vs. tirofiban in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention

Abstract Background Intravenous antiplatelet drugs provide rapid and sustained inhibition of platelet aggregation and can mitigate the ischemic risk of patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI). However, there are few real-world studies comparing cangrelor to tirofiban in this patient population. Purpose The aim of this study was to evaluate the effectiveness and the safety of cangrelor compared to tirofiban in a real-world population of STEMI patients undergoing pPCI. Methods This was a prospective, multicenter, observational study including consecutive STEMI patients who received either cangrelor or tirofiban during pPCI at six Italian high-volume pPCI centers from January 2020 to January 2022. The study population was divided into two groups according the antiplatelet treatment received (cangrelor or tirofiban). The primary study outcome was impaired myocardial revascularization assessed by post-procedural Thrombolysis in Myocardial Infarction (TIMI) flow grade <3. The secondary outcome measures were major bleeding, defined as Bleeding Academic Research Consortium (BARC) type 3 or 5, and all-cause mortality during the hospitalization. Results A total of 478 STEMI patients received intravenous antiplatelet therapy during pPCI. Of them, 16 patients were excluded since they received both cangrelor and tirofiban as bailout strategy. Thus, the final study population included 462 patients (mean age 63.9±11.8 years; 79.7% males): 223 patients received cangrelor (48.3%), and 239 tirofiban (51.7%). Patients treated with tirofiban had higher prevalence of prior myocardial infarction (p=0.016) and prior PCI (p=0.048) than patients receiving cangrelor (Table 1); also, they showed higher SYNTAX score (p=0.038) than patients receiving cangrelor, and a higher proportion of stent thrombosis as culprit lesion (p=0.047; Table 2). Conversely, patients treated with cangrelor had worse Killip class (p<0.001), and underwent more frequently pPCI via femoral access. Post-procedural TIMI flow<3 was reported in 114 (24.7%) patients. At propensity score adjusted regression analysis, the use of cangrelor was associated with a lower probability of post-procedural TIMI flow<3 (aOR: 0.530; 95% CI: 0.313–0.900; p=0.019) than tirofiban. Major bleeding and all-cause death occurred in 28 (6.1%) and 19 (4.1%) patients. There was no difference in the risk of major bleeding (aOR: 1.626; 95% CI: 0.618–4.279; p=0.324) and death (aOR: 2.724; 95% CI: 0.719–10.318; p=0.140) between groups. Conclusions In this real-world population of STEMI patients undergoing pPCI, periprocedural use of cangrelor was associated with improved myocardial reperfusion compared to tirofiban, but with no differences in terms of major bleeding or death during the hospitalization. Funding Acknowledgement Type of funding sources: None.

Percutaneous Treatment and Outcomes of Small Coronary Vessels: A SCAAR Report

ObjectivesThe aim of this study was to investigate the outcomes of patients with de novo lesions in small coronary vessels undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCBs) or newer-generation drug-eluting stents (n-DES). BackgroundNotwithstanding the available evidence from a few randomized clinical trials and meta-analyses, the best device for PCI in patients with small-vessel coronary artery disease is not yet established. MethodsThe study included all consecutive patients with de novo lesions in small coronary vessels undergoing PCI in Sweden from April 2009 to July 2017. A small coronary vessel was defined by a device diameter ≤2.5 mm. The primary outcomes were restenosis and definite target lesion thrombosis at 3-year follow-up. The secondary outcomes were the occurrence of all-cause death and myocardial infarction. ResultsThe study population included 14,788 patients: 1,154 treated with DCBs and 13,634 with n-DES. Overall, 35,541 PCIs were performed using 2,503 DCBs and 33,038 n-DES. The propensity score–adjusted regression analysis showed a significantly higher risk for restenosis in the DCB group compared with the n-DES group (adjusted hazard ratio [HR]: 2.027; 95% confidence interval [CI]: 1.537 to 2.674). Conversely, no difference in the risk for target lesion thrombosis (adjusted HR: 0.741; 95% CI: 0.412 to 1.331) was detected. The risk for all-cause death (adjusted HR: 1.178; 95% CI: 0.992 to 1.399) and myocardial infarction (adjusted HR: 1.251; 95% CI: 0.960 to 1.629) was comparable between groups. ConclusionsBecause of the significantly higher risk for restenosis up to 3 years, this research suggests that DCBs are not an equally effective alternative to n-DES for percutaneous treatment of small coronary vessels.

Risk of pulmonary toxicity of bleomycin and filgrastim.

To estimate the relative risk of pulmonary toxicity in patients exposed to a bleomycin-based chemotherapy including filgrastim compared to a similar chemotherapy without filgrastim. We conducted a nested case-control study of patients treated with BEP (bleomycin, etoposide and cisplatin) for germ cell cancer or with ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) for Hodgkin's lymphoma at the Hôtel-Dieu de Lévis Hospital between 31 October 2000 and 30 June 2016. The relative risk was estimated by an adjusted odds ratio (aOR) using a propensity score-adjusted regression analysis. Thirteen cases of pulmonary toxicity, representing 14.7% of the 88 patients included in the study, were matched with 65 controls. A higher proportion of women (31.8%) than men (11.3%) developed pulmonary toxicity although the difference was not statistically significant (P = 0.08). Within the cohort, two deaths related to lung toxicity were observed among cases where no filgrastim was used. The risk of pulmonary toxicity associated with the addition of filgrastim was not statistically significant (aOR = 2.48 95% CI = 0.50 to 12.19). The results add further evidence that the concomitant use of filgrastim might not increase the risk of pulmonary toxicity of bleomycin. It also suggests that female patients might be more likely to develop this adverse effect. A clinical trial would be needed to confirm this result.

Lower Glucose Target Is Associated With Improved 30-Day Mortality in Cardiac and Cardiothoracic Patients

Practice guidelines recommend against intensive insulin therapy in patients who are critically ill based on trials that had high rates of severe hypoglycemia. Intermountain Healthcare uses a computerized IV insulin protocol that allows choice of blood glucose (BG) targets (80-110 vs90-140mg/dL) and has low rates of severe hypoglycemia. We sought to study the effects of BG target on mortality in adult patients in cardiac ICUs that have very low rates of severe hypoglycemia. Critically ill patients receiving IV insulin were treated with either of two BG targets (80-110 vs90-140mg/dL). We created a propensity score for BG target using factors thought to have influenced clinicians' choice, and then we performed a propensity score-adjusted regression analysis for 30-day mortality. There were 1,809 patients who met inclusion criteria. Baseline patient characteristics were similar. Median glucose was lower in the 80-110mg/dL group (104 vs122mg/dL, P< .001). Severe hypoglycemia occurred at very low rates in both groups (1.16% vs 0.35%,P= .051). Unadjusted 30-day mortality was lower in the 80-110mg/dL group (4.3%vs9.2%, P< .001). This remained after propensity score-adjusted regression (OR, 0.65; 95%CI, 0.43-0.98; P= .04). Tight glucose control can be achieved with low rates of severe hypoglycemia and is associated with decreased 30-day mortality in a cohort of largely patients in cardiac ICUs. Although such findings should not be used to guide clinical practice at present, the use of tight glucose control should be reexamined using a protocol that has low rates of severe hypoglycemia.

Comparison of outcomes of patients with inpatient or outpatient onset ischemic stroke

BackgroundReperfusion times for ischemic stroke occurring in the outpatient setting have improved significantly in recent years. However, quality improvement efforts have largely ignored ischemic stroke occurring in patients hospitalized for...

Management of High-Risk Patients With Aortic Stenosis and Coronary Artery Disease

Aortic valve replacement with coronary artery bypass graft surgery is currently the standard therapy for patients with aortic stenosis and concomitant coronary artery disease. We sought to determine whether transcatheter aortic valve implantation combined with percutaneous coronary intervention might be an equivalent strategy. A total of 243 high-risk patients (Society of Thoracic Surgeons [STS] score >10% and/or European System for Cardiac Operative Risk Evaluation [EuroSCORE] >15%) presenting with aortic stenosis with concomitant coronary artery disease were studied. Patients were treated either by surgical aortic valve replacement combined with coronary artery bypass graft (group 1, n = 184) or by percutaneous coronary intervention within 12 months before transapical or transfemoral transcatheter aortic valve implantation (group 2, n = 59). A propensity score adjusted regression analysis was used to compare 30-day mortality as the primary study endpoint between the groups. Group 1 mean age (75 ± 6 years), EuroSCORE (18.1% ± 13.8%), and STS score (13.1% ± 8.7%) were significantly different from group 2 (mean age 80 ± 6 years, EuroSCORE 27.5% ± 16.3%, and STS score 16.7% ± 10.5%; p < 0.001). Thirty-day mortality was 12.5% in group 1 compared with 11.9% in group 2 (odds ratio 0.94, 95% confidence interval: 0.38 to 2.32, p = 0.89). Univariate analysis revealed left ventricular ejection fraction, pulmonary hypertension, renal insufficiency, STS score, EuroSCORE, and previous cardiac surgery as predictors for 30-day mortality (p < 0.05). Risk-adjusted multivariate regression analysis showed only left ventricular ejection fraction to be strongly associated with 30-day mortality and confirmed no significant difference between the groups (p = 0.44). To further control for study bias, a 10-layer propensity score model based on the univariate analysis again indicated equivalence regarding the primary endpoint (p = 0.33). The present study demonstrates that transcatheter aortic valve implantation in combination with prior percutaneous coronary intervention within 12 months produces similar results in a propensity score matched high-risk patient population.

Enteric-Coated Mycophenolate Sodium Versus Mycophenolate Mofetil Maintenance Immunosuppression: Outcomes Analysis of the United Network for Organ Sharing/Organ Procurement and Transplantation Network Database

A large, retrospective database analysis was conducted to evaluate the long-term outcomes of patients who received enteric-coated mycophenolate sodium (EC-MPS) versus mycophenolate mofetil (MMF) maintenance immunosuppression at the time of discharge. All primary kidney transplant patients who received either EC-MPS or MMF at time of discharge in the United Network for Organ Sharing/Organ Procurement and Transplantation Network database from 2004 to 2007 were included. Patients were excluded if they had received a previous kidney transplant, multiple organs, or combination therapy with everolimus at the time of discharge. Outcomes included graft failure, death-censored graft failure, and death with functioning graft, biopsy-proven acute rejection (BPAR), new-onset diabetes mellitus, and renal function. The propensity score method was used to adjust for nonrandomized treatment selection. A total of 48,458 patients were included in the analysis. At time of discharge, 10.4% of patients received EC-MPS (n=5057) and 89.6% received MMF (n=43,401). Propensity score-adjusted regression analysis showed that patients who received EC-MPS were at increased risk of BPAR (hazards ratio, 1.167; 95% confidence interval, 1.056-1.129; P=0.002). The adjusted BPAR rate difference at 3 years posttransplantation was less than 2% (13.6% vs. 11.7%); statistically significant because of the large number of patients included in the analysis, but a difference that may not be clinically meaningful. No differences in graft survival, new-onset diabetes mellitus, or renal function were observed between the treatment groups.