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Effect of Short Procedural Duration with Bivalirudin

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Effect of Short Procedural Duration with Bivalirudin Research JAMA Cardiology | Brief Report Effect of Short Procedural Duration With Bivalirudin on Increased Risk of Acute Stent Thrombosis in Patients With STEMI A Secondary Analysis of the HORIZONS-AMI Randomized Clinical Trial Hector Tamez, MD, MPH; Duane S. Pinto, MD, MPH; Ajay J. Kirtane, MD, SM; Claire Litherland, MS; Robert W. Yeh, MD, MSc; George D. Dangas, MD; Roxana Mehran, MD; Efthymios N. Deliargyris, MD; Guillermo Ortiz, MD; C. Michael Gibson, MS, MD; Gregg W. Stone, MD Supplemental content IMPORTANCE Bivalirudin has been associated with reduced bleeding and mortality during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI). However, increased rates of acute stent thrombosis (AST) have been noted when bivalirudin is discontinued at the end of the procedure, which is perhaps related to this medication’s short half-life. OBJECTIVES To evaluate the clinical effect of procedure duration on AST when either bivalirudin or heparin plus glycoprotein IIb/IIIa receptor inhibitor (GPI) is used. DESIGN, SETTING, AND PARTICIPANTS An ad hoc analysis of the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) clinical trial was performed between March 1, 2015, and April 30, 2016, on patients who underwent primary percutaneous coronary intervention with stents and were randomized 1:1 to bivalirudin or heparin plus GPI. Defined as the difference between the patient’s arrival at the catheterization laboratory and the patient’s final angiogram. Participants included 3602 patients with STEMI, aged 18 years or older, who were undergoing primary percutaneous coronary intervention and presenting less than 12 hours from symptom onset. MAIN OUTCOMES AND MEASURES Clinical events committee–adjudicated definite AST (occurring Յ24 hours after percutaneous coronary intervention). RESULTS Among patients included in this analysis, procedure time was identified in 1286 receiving bivalirudin and 1412 receiving heparin plus GPI. Shorter procedures were defined as the lowest quartile of duration (<45 minutes). Patients undergoing shorter procedures were younger and less likely to be hypertensive and smokers. Shorter procedures were less complicated with fewer stents implanted, less multivessel stenting, less thrombus, and less Author Affiliations: Division of Cardiology, Beth Israel Deaconess no-reflow. An increased risk of definite AST was associated with shorter than with longer Medical Center, Boston, procedures with bivalirudin (7 [2.1%] vs 7 [0.7%]; relative risk, 2.87; 95% CI, 1.01-8.17; P = .04) Massachusetts (Tamez, Pinto, Yeh, but not with heparin plus GPI (0 vs 3 [0.3%]; P = .30). Ortiz, Gibson); Columbia University Medical Center/New York- Presbyterian Hospital and the CONCLUSIONS AND RELEVANCE Despite less procedural complexity, shorter primary Cardiovascular Research Foundation, percutaneous coronary intervention time was associated with an increased risk of AST in New York, New York (Kirtane, patients treated with bivalirudin but not patients treated with heparin plus GPI, possibly Litherland, Stone); Associate Editor, JAMA Cardiology (Kirtane); Mount because of the rapid offset of bivalirudin’s antithrombotic effect during a window of limited Sinai Medical Center, New York, oral antiplatelet action. New York (Dangas, Mehran); The Medicines Company, Parsippany, TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00433966 New Jersey (Deliargyris). Corresponding Author: Duane S. Pinto, MD, MPH, Department of Cardiology, Beth Israel Deaconess Medical Center, 1 Deaconess Rd, JAMA Cardiol. 2017;2(6):673-677. doi:10.1001/jamacardio.2016.5669 Palmer 415, Boston, MA 02215 Published online March 1, 2017. ([email protected]). (Reprinted) 673 © 2017 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 10/02/2021 Research Brief Report Effect of Short Procedures With Bivalirudin on Acute Stent Thrombosis Risk n the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) ran- Key Points domized clinical trial, bivalirudin, compared with heparin I Question Do “fast” procedures (<45 minutes) have a higher risk of and glycoprotein IIb/IIIa receptor inhibitor (GPI), had similar acute stent thrombosis? rates of ischemic complications and reduced bleeding and mor- Findings In this ad hoc analysis of the Harmonizing Outcomes tality after primary percutaneous coronary intervention (PPCI) with Revascularization and Stents in Acute Myocardial Infarction for ST-segment elevation myocardial infarction (STEMI).1 Defi- (HORIZONS-AMI) clinical trial, patients who were randomized to 2-4 nite stent thrombosis was more common with bivalirudin. bivalirudin, underwent stent placement, and had shorter (<45 Preprocedural heparin and high-dose clopidogrel therapy re- minutes) procedures were at statistically higher risk of acute stent duced subacute stent thrombosis but not acute stent throm- thrombosis than patients who underwent longer procedures. bosis (AST).2 It was postulated that (1) in shorter procedures sup- Meaning Short-acting medications, such as bivalirudin, may not ported by procedural bivalirudin, AST rates would be higher allow for adequate antithrombotic effect of oral antiplatelets in than in longer procedures because the therapeutic antiplate- fast procedures; additional studies are needed to evaluate let effect was not achieved before antithrombin inhibition re- antithrombotic therapies with different pharmacokinetics. solves, and (2) this phenomenon would not be observed with heparin plus GPI because of longer antithrombin and more potent antiplatelet effect.1,2 Results Methods Baseline Characteristics Median (interquartile range [IQR]) procedure time was 55 (49- The HORIZONS-AMI randomized clinical trial, conducted be- 77) minutes and was similar in the bivalirudin group and the tween March 25, 2005, and May 7, 2007, was a prospective, heparin-plus-GPI group (median [IQR], 58 [45-76] minutes; open-label, multicenter trial that included 3602 patients with P = .35). Median (IQR) procedure time was 38 (32-42) min- STEMI, aged 18 years or older, who were undergoing PPCI and utes in the shorter procedure quartile, while the other quar- presenting fewer than 12 hours from symptom onset. The study tiles had a pooled median (IQR) of 68 (56-85) minutes. Base- design and primary results of this trial have been published.1 line clinical characteristics are shown in Table 1. Patients who The trial was approved by the institutional review board or eth- underwent shorter procedures were younger and less likely to ics committee at each participating site, and all participants be hypertensive and smokers. provided written informed consent prior to participation. Pa- tients were randomized 1:1 to bivalirudin or heparin plus GPI Procedural Characteristics and then 3:1 to the TAXUS-Express paclitaxel-eluting stent (Bos- Shorter procedures in both treatment groups were associated ton Scientific Corporation) or identical bare metal stents. Clini- with shorter door-to-balloon times, less frequent use of ra- cal follow-up occurred at 30 days, 6 months, 1 year, 2 years, dial access, and more frequent use of a 600-mg (rather than and 3 years. This ad hoc analysis was conceived and prepared 300-mg) clopidogrel loading dose (Table 2). Rates of prepro- between March 1, 2015, and April 30, 2016. cedure heparin administration were similar for shorter and lon- ger procedures. Shorter procedural times were associated with Study Design and Patient Population less complex procedures and less multivessel PPCI. There were Procedure time, defined as the difference between the patient’s no substantial differences between pre-PCI and post-PCI arrival at the catheterization laboratory and the patient’s final thrombolysis in myocardial infarction flow or peak activated angiogram, was identified in all patients (bivalirudin, n = 1286; clotting time measurements according to procedure time. Bail- heparin plus GPI, n = 1412) (eFigure in the Supplement). Total out use of GPI in patients treated with bivalirudin was more procedure time was divided into shorter (shortest procedure frequent among patients with longer procedures (Table 2). The quartile) and longer (other 3 quartiles) procedures. Patients were most common indications for bailout use of GPI were sus- excluded for bivalirudin or heparin infusion postprocedure tained no-reflow (47 [32.1%]) and giant thrombus (39 [26.7%]). (n = 185) (eFigure in the Supplement), missing procedure times (n = 16), or no stent implantation (n = 703). Stent Thrombosis Among patients treated with bivalirudin, definite AST was more Primary Outcome frequent after shorter procedures than after longer proce- The primary outcome was clinical events committee– dures (7 [2.1%] vs 7 [0.7%]; 95% CI, 1.01-8.17; P =.04)(Table 3). adjudicated definite AST (occurring ≤24 hours after percuta- All stent thromboses occurred postprocedure. The median neous coronary intervention), according to Academic (IQR) procedure time for bivalirudin-treated patients with AST Research Consortium criteria.5 Core laboratory angiographic was 49 (30-67) minutes and for bivalirudin-treated patients analysis confirming stent thrombosis was performed. Pro- without AST was 60 (45-79) minutes (P = .04). Most AST oc- pensity score matching (eTable in the Supplement) was curred among patients treated with bivalirudin, with proce- employed to address known confounding factors and to dure times faster than
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