Faculty Bibliography

OBJECTIVES:To evaluate the safety and efficacy of switching to bivalirudin during primary percutaneous coronary intervention (PCI) for patients who received preprocedure unfractionated heparin (UFH). BACKGROUND:Current guidelines favor bivalirudin for primary PCI in patients at high risk of bleeding, particularly when femoral access is used. However, patients with ST-segment elevation myocardial infarction frequently receive UFH before arrival in the catheterization laboratory. METHODS:Scientific databases and websites were searched for randomized controlled trials. Patients were divided into those who received heparin with or without glycoprotein IIb/IIIa inhibitors (heparin group); those switched to bivalirudin during primary PCI from preprocedure UFH (switch group); and those who received bivalirudin without preprocedure UFH (Biv-alone group). Both traditional pairwise meta-analyses using moderator analyses and network meta-analyses using mixed-treatment comparison models were performed. RESULTS:Data from five trials including13,547 patients were analyzed. In mixed-comparison models, switching to bivalirudin during primary PCI was associated with lower rates for all-cause mortality and major adverse cardiovascular events (MACEs) compared to the other strategies. Rates for all-cause mortality, MACEs, and net adverse clinical events (NACEs) were similar for the heparin and Biv-alone groups. Switching strategies was also associated with lower major bleeding rates compared to heparin alone. Similarly, in a standard pairwise model, both the switch and Biv-alone groups were associated with decreased bleeding risk compared to the heparin group. However, only the switch strategy was associated with decreased all-cause mortality (RR, 0.47; 95% CI, 0.30-0.75; P = 0.001), MACE (RR, 0.67; 95% CI, 0.49-0.91; P = 0.012), and NACE (RR, 0.61; 95% CI, 0.41-0.92; P = 0.019) compared with heparin alone. CONCLUSIONS:During primary PCI, use of bivalirudin for those receiving preprocedure UFH was associated decreased rates for major bleeding, NACEs, MACEs, and all-cause mortality compared to heparin +/- GPI. This strategy was also associated with decreased rates for MACEs and all-cause mortality compared to bivalirudin alone without preprocedure UFH.

Importance:Following negative randomized clinical trials, US guidelines downgraded support for routine manual aspiration thrombectomy (AT) during primary percutaneous coronary intervention (pPCI) for ST-segment elevation myocardial infarction (STEMI). However, some PCI operators continue to endorse a clinical benefit with AT use despite the lack of supportive data. Objective:To examine temporal trends and comparative outcomes of AT use during pPCI for STEMI. Design, Setting, and Participants:Retrospective cohort study of the National Cardiovascular Data Registry (NCDR) CathPCI Registry from July 1, 2009, to June 30, 2016, to assess temporal trends and in-hospital outcomes associated with AT use. To evaluate outcomes through 180 days, a subanalysis was conducted among Centers for Medicare and Medicaid Services-linked patients from July 1, 2009, through December 31, 2014. The comparative effectiveness analysis was performed using instrumental variable analyses to account for treatment selection bias. The instrumental variable was operator's preference to use AT during pPCI. Data were analyzed between February 1, 2017, and April 1, 2018. Exposures:Aspiration thrombectomy use during pPCI for STEMI. Main Outcomes and Measures:Primary outcomes included in-hospital stroke and death. Secondary outcomes included heart failure, stroke, all-cause rehospitalization, and death through 180 days of follow-up. Results:Among all pPCIs performed (683 584), the mean (SD) age of patients was 61.7 (12.8) years, 489 257 were male (71.6%), and 596 384 were white (87.2%). Among patients undergoing pPCI, AT use increased from 2009 through 2011, with peak use of 13.8%. This was followed by a decline of more than 9%, reaching 4.7% by mid-2016. Overall, AT was used in 10.8% of pPCIs (lowest operator group median, 0%; highest operator group median, 33.8%). After instrumental variable analysis, AT use was associated with no difference in in-hospital death (adjusted absolute risk difference, -0.18%; 95% CI, -0.53% to 0.16%; P = .29) and a small increase in in-hospital stroke (adjusted RD, 0.14%; 95% CI, 0.01%-0.30%; P = .03). Among Centers for Medicare and Medicaid Services-linked patients, AT use was not associated with differences in death, heart failure, stroke, or rehospitalization at 180 days. Conclusions and Relevance:In this large, nationwide analysis, AT use during STEMI pPCI declined by more than 50% since 2011, with use as of mid-2016 at less than 5%. Selective AT use was associated with a small excess risk of in-hospital stroke and no difference in other outcomes through 180 days of follow-up.