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Primary Percutaneous Coronary Intervention with High-Bolus Dose Tirofiban: The FASTER (Favorite Approach to Safe and Effective Treatment for Early Reperfusion) Multicenter Registry

Primary Percutaneous Coronary Intervention with High-Bolus Dose Tirofiban: The FASTER (Favorite... Hindawi Journal of Interventional Cardiology Volume 2022, Article ID 9609970, 5 pages https://doi.org/10.1155/2022/9609970 Research Article Primary Percutaneous Coronary Intervention with High-Bolus Dose Tirofiban: The FASTER (Favorite Approach to Safe and Effective Treatment for Early Reperfusion) Multicenter Registry 1 2 3 2 Stefano Rigattieri , Corrado Lettieri, Gianluca Tiberti, Michele Romano, 4 5 6 7 8 Marco Ferlini, Luca Testa, Simona Pierini, Federica Ettori, Enrico Passamonti, 9 10 11 12 Alfredo Marchese, Giuseppe Musumeci, Giovanni Esposito, and Giuseppe Tarantini Interventional Cardiology, Sant’Andrea Hospital, Sapienza University, Rome, Italy Cardiology Department, Carlo Poma Hospital, Mantua, ASST Mantova, Italy Cardiovascular Department, Alessandro Manzoni Hospital, Lecco, ASST Lecco, Italy Cardiology Department, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy Department of Cardiology, IRCCS Policlinico San Donato, Milan, Italy Ospedale Bassini, Cinisello Balsamo, Italy Cardiology Unit, ASST Degli Spedali Civili di Brescia, Brescia, Italy Ospedale di Cremona, Struttura Complessa di Cardiologia, Cremona, Italy Interventional Cardiology, Santa Maria Hospital, Bari, Italy Cardiology Department, A. O. Ordine Mauriziano di Torino, Turin, Italy Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy Department of Cardiac, 2oracic, Vascular Sciences and Public Health, University of Padua Medical School, Padua, Italy Correspondence should be addressed to Stefano Rigattieri; stefanorigattieri@yahoo.it Received 4 January 2022; Revised 4 March 2022; Accepted 10 March 2022; Published 29 March 2022 Academic Editor: Shenghua Zhou Copyright © 2022 Stefano Rigattieri et al. &is is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Objectives. To investigate the safety and clinical efficacy of tirofiban during primary percutaneous coronary interventions (pPCI). Background. Gp IIb/IIIa inhibitors (GPI) use during pPCI has declined over years, mainly for the increased hemorrhagic risk associated to their use and for the availability of potent, fast-acting oral antiplatelet drugs. However, several pharmacodynamic studies showed suboptimal platelet inhibition with P2Y12-blockers, such as prasugrel or ticagrelor. Methods. Patients with ST- segment elevation myocardial infarction (STEMI) undergoing pPCI were prospectively enrolled in a multicenter registry conducted in high-volume centers in Italy. All patients received intraprocedural tirofiban. &e primary safety endpoint was the occurrence of in-hospital bleedings according to the Bleeding Academic Research Consortium definition. In-hospital major adverse coronary events (MACE, defined as death, reinfarction, stent thrombosis, and target vessel revascularization), final TIMI flow, myocardial blush grade, and ST-segment resolution were also evaluated. Results. A total of 472 patients (mean age 61± 11 years, 83% males) were enrolled in 16 Italian centers from October 2015 to June 2018. Mean basal thrombus grade score was 3.47± 1.25. PCI was performed by transradial approach in 88% of patients. We observed a very low rate of 30 days BARC bleedings (2.1%) and MACE (0.8%). Complete (>70%) ST-segment resolution was observed in 67% of patients.Conclusions. In the FASTER registry, the use of tirofiban during primary PCI, performed with a transradial approach in most cases, in patients with high thrombus burden was associated with high rates of complete ST-segment resolution and low rates of in-hospital bleeding and MACE. 2 Journal of Interventional Cardiology at a rate of 0.15 microgram/Kg/min for up to 18 hours was 1. Introduction strongly suggested, although not mandatory. In case of Patients with ST-segment elevation myocardial infarction severe renal failure (creatinine clearance <30 ml/min), the (STEMI) have high expression of platelet P2Y12 receptors dose of tirofiban was reduced by 50%. &e primary safety [1] and high platelet reactivity [2] that are associated to endpoint was the occurrence of Bleeding Academic Research worse clinical outcome after revascularization with primary Consortium (BARC) bleedings during hospital stay. Sec- percutaneous coronary intervention (pPCI) [3]. Historically, ondary endpoints were major adverse coronary events these patients have been routinely treated with glycoprotein (MACE) defined as all-cause death, reinfarction, stent IIb/IIIa receptor inhibitors (GPI), based on their potent and thrombosis (according to Academic Research Consortium fast-acting antiplatelet effect, which has been shown to re- definition), and target vessel revascularization (TVR) during duce mortality in patients at high risk of thrombotic hospital stay. Reinfarction was defined as the occurrence of complications [4]. More recently, the results of some ran- new symptoms and ECG signs associated with >20% in- domized controlled trials [5, 6], the growing awareness of the crease in cardiac troponin I; stent thrombosis was de- increased hemorrhagic risk associated with these drugs [7], fined according to Academic Research Consortium and the availability of potent, fast-acting oral antiplatelet definition; TVR was defined as unplanned revasculari- agents [8, 9] questioned and reduced their use in clinical zation, either by PCI or CABG, of the vessel treated at the practice [10]. Nevertheless, optimal levels of platelet inhi- index PCI. &e occurrence of both primary and sec- bition during pPCI are unfrequently achieved after loading ondary endpoints was also assessed at 30 days after PCI, dose of either prasugrel or ticagrelor [11, 12], whereas the either by phone interview or ambulatory visit. Data use of high-dose tirofiban on top of a loading dose of 600 mg about TIMI flow and myocardial blush grade after PCI clopidogrel was associated with improved myocardial were collected. ST-segment resolution was assessed by reperfusion in the absence of increased bleedings in the On- comparing the sum of ST-segment elevation (􏽐ST) be- TIME 2 trial [13]. Furthermore, transradial compared to tween ECG at presentation and 60 minutes after PCI; transfemoral approach in patients with acute coronary complete ST-segment resolution was defined as >70% syndrome undergoing PCI significantly reduced bleeding reduction of ST. and improved survival [14]. We designed this prospective, multicenter registry in order to investigate the role of high-dose tirofiban on top of 2.1.StatisticalAnalysis. Given the observational, descriptive contemporary pharmacological therapy in a recent setting of nature of the study, no formal assessment of sample size was STEMI patients undergoing pPCI. performed. Descriptive statistics (mean, median, interquartile range, minimum and maximum, and standard deviation) were calculated for continuous variables. Abso- 2. Materials and Methods lute frequencies and percentages were obtained for quali- tative variables. P values less than 0.05 (2 sides) were &e Favorite Approach to Safe and Effective Treatment for considered statistically significant. Early Reperfusion (FASTER) Registry is a multicenter ob- servational registry promoted by the Italian Society of Interventional Cardiology (SICI-GISE) aiming to investigate 3. Results safety and efficacy outcomes in patients with ST-elevation myocardial infarction and high thrombus burden under- A total of 472 patients (mean age 61± 11 years, 83% males) going primary PCI with high-bolus dose tirofiban. &e study were enrolled in 16 Italian centers from October 2015 to June was supported by an unrestricted educational grant issued 2018. Clinical characteristics and blood test results at pre- by Correvio International (Geneve, Switzerland). An ex- sentation are given in Table 2. STEMI was anterior in 46% of ternal Clinical Research Organization (Clirest S.R.L., Fer- cases; the majority of patients were in Killip class 1 or 2. rara, Italy) was responsible for data capture and Procedural characteristics are given in Table 3. Most patients management. &e study was conducted in full conformity were treated within 6 hours from symptoms onset; radial with the Declaration of Helsinki and Good Clinical Practice access was largely prevalent (88%); a high thrombus burden guidelines; the study protocol was approved by institutional was found in the majority of patients (mean TIMI thrombus review boards of participating centers, and written informed grade score 3.47± 1.25). &rombus aspiration was per- consent was obtained by each patient. &e inclusion and formed in about one-third of patients, balloon predilatation exclusion criteria are given in Table 1. Coronary thrombus was performed in 71%, and at least 1 drug-eluting stent was burden was visually assessed by the operator and graded implanted in 92% of patients. As far as antithrombotic from 0 (no angiographically visible thrombus) to 5 therapy is concerned, 86% of patients were given aspirin and (thrombus which totally occludes the vessel) according to 73% a potent P2Y12 inhibitor (prasugrel or ticagrelor) be- the TIMI group classification [15]. Vascular access site, oral fore PCI; intravenous heparin was the only anticoagulant antiplatelet therapy, and parenteral anticoagulant therapy used (mean dose 5560± 2152 IU); no patient received were left to the discretion of the operator. A tirofiban bolus bivalirudin or cangrelor. All patients received a periproce- of 25 microgram/Kg given over a 3-minute period was dural high-dose bolus of tirofiban, which was followed by up administered to all patients, either pre-PCI or during PCI at to 18 hours infusion in 65% of them. &e length of infusion operator’s discretion; after the bolus, a continuous infusion was variable: 0–2 hours in 7% of patients, 2–6 hours in 11%, Journal of Interventional Cardiology 3 Table 1: Inclusion and exclusion criteria Inclusion criteria Exclusion criteria Age 18–85 years Contraindications to use of tirofiban STEMI within 12 hours from symptoms onset with high Patients with left bundle branch block thrombus burden ST-segment elevation >1 mm in 2 adjacent ECG leads &erapy resistant cardiogenic shock Patients eligible for primary PCI within 120 minutes after first Persistent severe hypertension (systolic BP>180 mmHg or diastolic BP medical contact >110 mmHg) Contraindication to anticoagulation Pregnant or breastfeeding women Table 2: Clinical characteristics. Table 3: Procedural characteristics. n 472 Time from symptom onset to PCI Age (years) 61.5 ± 11.2 0–3 hours (n, %) 306 (65) Male gender (n, %) 391 (83) 3–6 hours (n, %) 113 (24) Weight (Kg) 78.8 ± 14.6 6–12 hours (n, %) 52 (11) History of smoking (n, %) 287 (61) Radial access (n, %) 414 (88) Diabetes mellitus (n, %) 79 (17) Basal TIMI flow (n, %) Hypertension (n, %) 247 (53) 0 342 (72.5) Dyslipidemia (n, %) 208 (45) 1 70 (14.8) Previous myocardial infarction (n, %) 48 (10) 2 38 (8.1) Previous TIA/stroke (n, %) 18 (4) 3 22 (4.7) Previous PCI (n, %) 57 (12) TIMI thrombus grade score 3.47 ± 1.25 Previous CABG (n, %) 12 (3) Pretreatment with prasugrel or ticagrelor (n, %) 344 (73) STEMI location (n, %) Tirofiban (n, %) Anterior 217 (46) Planned pre-PCI 374 (79) Nonanterior 253 (54) Intraprocedural 98 (21) Killip class 3-4 12 (2.5) Bolus-only 164 (35) Heart rate (bpm) 77± 18 Bolus + infusion 308 (65) Systolic blood pressure (mmHg) 134± 27 &rombus aspiration Hemoglobin (g/dl) 14.5± 2.5 No 300 (64) Hematocrit (%) 42.5± 5.8 Manual 158 (33) GFR (ml/min) 82.1± 23.5 Rheolytic 14 (3) Predilatation (n, %) 335 (71) DES (n, %) 433 (92) Final TIMI flow 6–12 hours in 25%, and 12–18 hours in 22% (Figure 1). Final 0 3 (0.6) grade 3 TIMI flow and complete (>70%) ST-segment res- 1 5 (1.1) olution were obtained in 90.5% and 67% of patients, re- 2 37 (7.8) spectively; pretreatment with either prasugrel or ticagrelor 3 427 (90.5) did not affect ST-segment resolution at univariate analysis Final TIMI myocardial blush grade (OR 1.01, 95% CI 0.67–1.51). Data about final myocardial 0 41 (17.2) blush were available in 239 patients, with grade 3 being 1 23 (9.6) reported in 49% of them. At discharge, 97% of patients 2 58 (24.3) received ASA, 8% clopidogrel, 30% prasugrel, and 62% 3 117 (49.0) ticagrelor. ST-segment resolution (n, %) &e rate of in-hospital and 30-day adverse events is given <30% 28 (6) 30–70% 127 (27) in Table 4. In-hospital BARC bleedings were observed in 8 >70% 317 (67) patients (1.7%) and major bleeding (BARC 3–5) in 4 (0.8%). As far as in-hospital MACEs are concerned, one patient died from refractory cardiogenic shock and 3 patients had def- inite stent thrombosis/reinfarction treated by new PCI. were relatively young, mostly in Killip class I or 2, and on average, they presented with normal hemoglobin levels and 4. Discussion renal function. Moreover, most of them were treated within 3 hours from symptoms onset, and pPCI was largely per- In this multicenter, observational registry, the use of high- bolus dose tirofiban in STEMI patients with high thrombus formed with transradial approach in high-volume centers. According to contemporary guidelines, most patients were burden undergoing primary PCI was associated to a very low discharged with double antiplatelet therapy with aspirin and incidence of both major bleedings and MACE at 30 days. prasugrel or ticagrelor, although pretreatment with these &ese results may be first related to the low clinical and P2Y12 inhibitors was not associated with improved ST- procedural risk of the population enrolled. Indeed, patients 4 Journal of Interventional Cardiology Modalities of tirofiban administration comparison with prasugrel or ticagrelor is available [20]. Moreover, in a recent pharmacodynamic study in STEMI patients undergoing primary PCI, cangrelor yielded sig- 30 nificantly inferior inhibition of platelet aggregation as compared to tirofiban, although both parenteral drugs were more effective than prasugrel, either administered as integral pills or chewed pills [21]. &e latter study further supports a strategy of use of parenteral drugs (possibly GPI) to achieve immediate inhibition of platelet aggregation and to bridge 5 the initial gap typical of orally administered drugs. Besides the antiplatelet effect, GPI was also shown to improve mi- crovascular perfusion [22], whereas no data are available for cangrelor in this regard. Our study presents several limitations. First of all, it is an observational study without a comparator arm. Sec- ond, despite the presence of high thrombotic burden at Figure 1: Patterns of administration of tirofiban in study patients. angiography, the population enrolled was at low risk, especially for bleeding; this may explain the low rate of MACE and bleeding events at 30-day follow-up which, in Table 4: In-hospital and 30 days adverse events. turn, precluded the possibility of subgroup analyses In- Discharge to 30 aiming to assess, if any, clinical and angiographic pre- Overall hospital days dictors of enhanced benefit of tirofiban on top of standard treatment. &ird, most patients were treated by trans- All BARC (n, %) 8 (1.7) 2 (0.4) 10 (2.1) BARC 3–5 (n,%) 4 (0.8) 1 (0.2) 5 (1) radial approach, which is consistently associated with a Death (n, %) 1 (0.2) 0 (0) 1 (0.2) striking reduction in access-related bleeding as compared TVR (n, %) 1 (0.2) 0 (0) 1 (0.2) to transfemoral approach in primary PCI [23], especially Stent thrombosis (n, when GPI is used [24]. Fourth, pharmacodynamic 3 (0.6) 0 (0) 3 (0.6) %) evaluation of platelet aggregation was not performed. IMA (n, %) 3 (0.6) 0 (0) 3 (0.6) Finally, relevant angiographic data, such as number of diseased vessels, lesion length, and number of stents, are missing. segment resolution, similar to the findings of the AT- LANTIC randomized trial [16]. As far as tirofiban is con- cerned, it is interesting to observe that a bolus-only strategy 5. Conclusion was adopted in about one-third of patients. Although no comparison can be made in our cohort between the bolus- &is study suggests that in STEMI patients undergoing only group and the bolus plus infusion group, given the low transradial pPCI with high thrombus burden and low risk of number of events, a bolus-only strategy coupled with early bleeding, a strategy of bolus-only or bolus followed by short administration of potent oral P2Y12 inhibitors could rep- infusion of tirofiban on top of oral loading with potent resent an effective way to provide optimal platelet inhibition P2Y12 inhibitors is associated with high rates of complete during pPCI, bridging the delay in the onset of antiplatelet ST-segment resolution and low rates of both ischemic and activity of oral drugs and, at the same time, reducing the risk hemorrhagic complications at 30 days. Adequately powered of bleeding complications associated with long-lasting GPI randomized controlled trials with clinical endpoints are infusion. &is strategy has been evaluated in the FABOLUS- needed in order to evaluate the safety and efficacy of the PRO trial, a pharmacodynamic study which showed that the association of potent parenteral and potent oral antiplatelet association of 60 mg loading dose of prasugrel with high- drugs in STEMI patients undergoing pPCI. dose bolus of tirofiban achieved higher and consistent antiplatelet activity obviating the need of postbolus tirofiban infusion [17]. &e possible benefit of this strategy was also Data Availability assessed in an observational study showing that a bolus-only eptifibatide regimen was associated with similar infarct size &e dataset used to support the findings of this study is but with significantly reduced major bleedings in STEMI available at the Contract Research Organization who fol- patients undergoing pPCI as compared to conventional lowed the study: Clirest S.R.L. Via Valdicuore, 17, 44124 bolus and infusion treatment [18]. Another possible strategy Ferrara, Italy. to bridge the initial onset delay of oral P2Y12 inhibitors could be the administration of cangrelor, which is the only parenteral P2Y12 inhibitor and is characterized by a very fast Conflicts of Interest onset of action [19]. However, data in STEMI patients from the CHAMPION program are limited, and no randomized &e authors declare that there are no conflicts of interest. (%) bolus-only bolus + 0-2 h infusion bolus + 2-6 h infusion bolus + 6-12 h infusion bolus + 12-18 h infusion Journal of Interventional Cardiology 5 Lancet, vol. 372, pp. 537–546, 2008, https://pubmed.ncbi.nlm. References nih.gov/18707985/. [1] E. Liverani, L. Kilpatrick, A. Tsygankov, and S. Kunapuli, “&e [14] M. Valgimigli, A. Gagnor, P. 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Primary Percutaneous Coronary Intervention with High-Bolus Dose Tirofiban: The FASTER (Favorite Approach to Safe and Effective Treatment for Early Reperfusion) Multicenter Registry

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Hindawi Journal of Interventional Cardiology Volume 2022, Article ID 9609970, 5 pages https://doi.org/10.1155/2022/9609970 Research Article Primary Percutaneous Coronary Intervention with High-Bolus Dose Tirofiban: The FASTER (Favorite Approach to Safe and Effective Treatment for Early Reperfusion) Multicenter Registry 1 2 3 2 Stefano Rigattieri , Corrado Lettieri, Gianluca Tiberti, Michele Romano, 4 5 6 7 8 Marco Ferlini, Luca Testa, Simona Pierini, Federica Ettori, Enrico Passamonti, 9 10 11 12 Alfredo Marchese, Giuseppe Musumeci, Giovanni Esposito, and Giuseppe Tarantini Interventional Cardiology, Sant’Andrea Hospital, Sapienza University, Rome, Italy Cardiology Department, Carlo Poma Hospital, Mantua, ASST Mantova, Italy Cardiovascular Department, Alessandro Manzoni Hospital, Lecco, ASST Lecco, Italy Cardiology Department, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy Department of Cardiology, IRCCS Policlinico San Donato, Milan, Italy Ospedale Bassini, Cinisello Balsamo, Italy Cardiology Unit, ASST Degli Spedali Civili di Brescia, Brescia, Italy Ospedale di Cremona, Struttura Complessa di Cardiologia, Cremona, Italy Interventional Cardiology, Santa Maria Hospital, Bari, Italy Cardiology Department, A. O. Ordine Mauriziano di Torino, Turin, Italy Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy Department of Cardiac, 2oracic, Vascular Sciences and Public Health, University of Padua Medical School, Padua, Italy Correspondence should be addressed to Stefano Rigattieri; stefanorigattieri@yahoo.it Received 4 January 2022; Revised 4 March 2022; Accepted 10 March 2022; Published 29 March 2022 Academic Editor: Shenghua Zhou Copyright © 2022 Stefano Rigattieri et al. &is is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Objectives. To investigate the safety and clinical efficacy of tirofiban during primary percutaneous coronary interventions (pPCI). Background. Gp IIb/IIIa inhibitors (GPI) use during pPCI has declined over years, mainly for the increased hemorrhagic risk associated to their use and for the availability of potent, fast-acting oral antiplatelet drugs. However, several pharmacodynamic studies showed suboptimal platelet inhibition with P2Y12-blockers, such as prasugrel or ticagrelor. Methods. Patients with ST- segment elevation myocardial infarction (STEMI) undergoing pPCI were prospectively enrolled in a multicenter registry conducted in high-volume centers in Italy. All patients received intraprocedural tirofiban. &e primary safety endpoint was the occurrence of in-hospital bleedings according to the Bleeding Academic Research Consortium definition. In-hospital major adverse coronary events (MACE, defined as death, reinfarction, stent thrombosis, and target vessel revascularization), final TIMI flow, myocardial blush grade, and ST-segment resolution were also evaluated. Results. A total of 472 patients (mean age 61± 11 years, 83% males) were enrolled in 16 Italian centers from October 2015 to June 2018. Mean basal thrombus grade score was 3.47± 1.25. PCI was performed by transradial approach in 88% of patients. We observed a very low rate of 30 days BARC bleedings (2.1%) and MACE (0.8%). Complete (>70%) ST-segment resolution was observed in 67% of patients.Conclusions. In the FASTER registry, the use of tirofiban during primary PCI, performed with a transradial approach in most cases, in patients with high thrombus burden was associated with high rates of complete ST-segment resolution and low rates of in-hospital bleeding and MACE. 2 Journal of Interventional Cardiology at a rate of 0.15 microgram/Kg/min for up to 18 hours was 1. Introduction strongly suggested, although not mandatory. In case of Patients with ST-segment elevation myocardial infarction severe renal failure (creatinine clearance <30 ml/min), the (STEMI) have high expression of platelet P2Y12 receptors dose of tirofiban was reduced by 50%. &e primary safety [1] and high platelet reactivity [2] that are associated to endpoint was the occurrence of Bleeding Academic Research worse clinical outcome after revascularization with primary Consortium (BARC) bleedings during hospital stay. Sec- percutaneous coronary intervention (pPCI) [3]. Historically, ondary endpoints were major adverse coronary events these patients have been routinely treated with glycoprotein (MACE) defined as all-cause death, reinfarction, stent IIb/IIIa receptor inhibitors (GPI), based on their potent and thrombosis (according to Academic Research Consortium fast-acting antiplatelet effect, which has been shown to re- definition), and target vessel revascularization (TVR) during duce mortality in patients at high risk of thrombotic hospital stay. Reinfarction was defined as the occurrence of complications [4]. More recently, the results of some ran- new symptoms and ECG signs associated with >20% in- domized controlled trials [5, 6], the growing awareness of the crease in cardiac troponin I; stent thrombosis was de- increased hemorrhagic risk associated with these drugs [7], fined according to Academic Research Consortium and the availability of potent, fast-acting oral antiplatelet definition; TVR was defined as unplanned revasculari- agents [8, 9] questioned and reduced their use in clinical zation, either by PCI or CABG, of the vessel treated at the practice [10]. Nevertheless, optimal levels of platelet inhi- index PCI. &e occurrence of both primary and sec- bition during pPCI are unfrequently achieved after loading ondary endpoints was also assessed at 30 days after PCI, dose of either prasugrel or ticagrelor [11, 12], whereas the either by phone interview or ambulatory visit. Data use of high-dose tirofiban on top of a loading dose of 600 mg about TIMI flow and myocardial blush grade after PCI clopidogrel was associated with improved myocardial were collected. ST-segment resolution was assessed by reperfusion in the absence of increased bleedings in the On- comparing the sum of ST-segment elevation (􏽐ST) be- TIME 2 trial [13]. Furthermore, transradial compared to tween ECG at presentation and 60 minutes after PCI; transfemoral approach in patients with acute coronary complete ST-segment resolution was defined as >70% syndrome undergoing PCI significantly reduced bleeding reduction of ST. and improved survival [14]. We designed this prospective, multicenter registry in order to investigate the role of high-dose tirofiban on top of 2.1.StatisticalAnalysis. Given the observational, descriptive contemporary pharmacological therapy in a recent setting of nature of the study, no formal assessment of sample size was STEMI patients undergoing pPCI. performed. Descriptive statistics (mean, median, interquartile range, minimum and maximum, and standard deviation) were calculated for continuous variables. Abso- 2. Materials and Methods lute frequencies and percentages were obtained for quali- tative variables. P values less than 0.05 (2 sides) were &e Favorite Approach to Safe and Effective Treatment for considered statistically significant. Early Reperfusion (FASTER) Registry is a multicenter ob- servational registry promoted by the Italian Society of Interventional Cardiology (SICI-GISE) aiming to investigate 3. Results safety and efficacy outcomes in patients with ST-elevation myocardial infarction and high thrombus burden under- A total of 472 patients (mean age 61± 11 years, 83% males) going primary PCI with high-bolus dose tirofiban. &e study were enrolled in 16 Italian centers from October 2015 to June was supported by an unrestricted educational grant issued 2018. Clinical characteristics and blood test results at pre- by Correvio International (Geneve, Switzerland). An ex- sentation are given in Table 2. STEMI was anterior in 46% of ternal Clinical Research Organization (Clirest S.R.L., Fer- cases; the majority of patients were in Killip class 1 or 2. rara, Italy) was responsible for data capture and Procedural characteristics are given in Table 3. Most patients management. &e study was conducted in full conformity were treated within 6 hours from symptoms onset; radial with the Declaration of Helsinki and Good Clinical Practice access was largely prevalent (88%); a high thrombus burden guidelines; the study protocol was approved by institutional was found in the majority of patients (mean TIMI thrombus review boards of participating centers, and written informed grade score 3.47± 1.25). &rombus aspiration was per- consent was obtained by each patient. &e inclusion and formed in about one-third of patients, balloon predilatation exclusion criteria are given in Table 1. Coronary thrombus was performed in 71%, and at least 1 drug-eluting stent was burden was visually assessed by the operator and graded implanted in 92% of patients. As far as antithrombotic from 0 (no angiographically visible thrombus) to 5 therapy is concerned, 86% of patients were given aspirin and (thrombus which totally occludes the vessel) according to 73% a potent P2Y12 inhibitor (prasugrel or ticagrelor) be- the TIMI group classification [15]. Vascular access site, oral fore PCI; intravenous heparin was the only anticoagulant antiplatelet therapy, and parenteral anticoagulant therapy used (mean dose 5560± 2152 IU); no patient received were left to the discretion of the operator. A tirofiban bolus bivalirudin or cangrelor. All patients received a periproce- of 25 microgram/Kg given over a 3-minute period was dural high-dose bolus of tirofiban, which was followed by up administered to all patients, either pre-PCI or during PCI at to 18 hours infusion in 65% of them. &e length of infusion operator’s discretion; after the bolus, a continuous infusion was variable: 0–2 hours in 7% of patients, 2–6 hours in 11%, Journal of Interventional Cardiology 3 Table 1: Inclusion and exclusion criteria Inclusion criteria Exclusion criteria Age 18–85 years Contraindications to use of tirofiban STEMI within 12 hours from symptoms onset with high Patients with left bundle branch block thrombus burden ST-segment elevation >1 mm in 2 adjacent ECG leads &erapy resistant cardiogenic shock Patients eligible for primary PCI within 120 minutes after first Persistent severe hypertension (systolic BP>180 mmHg or diastolic BP medical contact >110 mmHg) Contraindication to anticoagulation Pregnant or breastfeeding women Table 2: Clinical characteristics. Table 3: Procedural characteristics. n 472 Time from symptom onset to PCI Age (years) 61.5 ± 11.2 0–3 hours (n, %) 306 (65) Male gender (n, %) 391 (83) 3–6 hours (n, %) 113 (24) Weight (Kg) 78.8 ± 14.6 6–12 hours (n, %) 52 (11) History of smoking (n, %) 287 (61) Radial access (n, %) 414 (88) Diabetes mellitus (n, %) 79 (17) Basal TIMI flow (n, %) Hypertension (n, %) 247 (53) 0 342 (72.5) Dyslipidemia (n, %) 208 (45) 1 70 (14.8) Previous myocardial infarction (n, %) 48 (10) 2 38 (8.1) Previous TIA/stroke (n, %) 18 (4) 3 22 (4.7) Previous PCI (n, %) 57 (12) TIMI thrombus grade score 3.47 ± 1.25 Previous CABG (n, %) 12 (3) Pretreatment with prasugrel or ticagrelor (n, %) 344 (73) STEMI location (n, %) Tirofiban (n, %) Anterior 217 (46) Planned pre-PCI 374 (79) Nonanterior 253 (54) Intraprocedural 98 (21) Killip class 3-4 12 (2.5) Bolus-only 164 (35) Heart rate (bpm) 77± 18 Bolus + infusion 308 (65) Systolic blood pressure (mmHg) 134± 27 &rombus aspiration Hemoglobin (g/dl) 14.5± 2.5 No 300 (64) Hematocrit (%) 42.5± 5.8 Manual 158 (33) GFR (ml/min) 82.1± 23.5 Rheolytic 14 (3) Predilatation (n, %) 335 (71) DES (n, %) 433 (92) Final TIMI flow 6–12 hours in 25%, and 12–18 hours in 22% (Figure 1). Final 0 3 (0.6) grade 3 TIMI flow and complete (>70%) ST-segment res- 1 5 (1.1) olution were obtained in 90.5% and 67% of patients, re- 2 37 (7.8) spectively; pretreatment with either prasugrel or ticagrelor 3 427 (90.5) did not affect ST-segment resolution at univariate analysis Final TIMI myocardial blush grade (OR 1.01, 95% CI 0.67–1.51). Data about final myocardial 0 41 (17.2) blush were available in 239 patients, with grade 3 being 1 23 (9.6) reported in 49% of them. At discharge, 97% of patients 2 58 (24.3) received ASA, 8% clopidogrel, 30% prasugrel, and 62% 3 117 (49.0) ticagrelor. ST-segment resolution (n, %) &e rate of in-hospital and 30-day adverse events is given <30% 28 (6) 30–70% 127 (27) in Table 4. In-hospital BARC bleedings were observed in 8 >70% 317 (67) patients (1.7%) and major bleeding (BARC 3–5) in 4 (0.8%). As far as in-hospital MACEs are concerned, one patient died from refractory cardiogenic shock and 3 patients had def- inite stent thrombosis/reinfarction treated by new PCI. were relatively young, mostly in Killip class I or 2, and on average, they presented with normal hemoglobin levels and 4. Discussion renal function. Moreover, most of them were treated within 3 hours from symptoms onset, and pPCI was largely per- In this multicenter, observational registry, the use of high- bolus dose tirofiban in STEMI patients with high thrombus formed with transradial approach in high-volume centers. According to contemporary guidelines, most patients were burden undergoing primary PCI was associated to a very low discharged with double antiplatelet therapy with aspirin and incidence of both major bleedings and MACE at 30 days. prasugrel or ticagrelor, although pretreatment with these &ese results may be first related to the low clinical and P2Y12 inhibitors was not associated with improved ST- procedural risk of the population enrolled. Indeed, patients 4 Journal of Interventional Cardiology Modalities of tirofiban administration comparison with prasugrel or ticagrelor is available [20]. Moreover, in a recent pharmacodynamic study in STEMI patients undergoing primary PCI, cangrelor yielded sig- 30 nificantly inferior inhibition of platelet aggregation as compared to tirofiban, although both parenteral drugs were more effective than prasugrel, either administered as integral pills or chewed pills [21]. &e latter study further supports a strategy of use of parenteral drugs (possibly GPI) to achieve immediate inhibition of platelet aggregation and to bridge 5 the initial gap typical of orally administered drugs. Besides the antiplatelet effect, GPI was also shown to improve mi- crovascular perfusion [22], whereas no data are available for cangrelor in this regard. Our study presents several limitations. First of all, it is an observational study without a comparator arm. Sec- ond, despite the presence of high thrombotic burden at Figure 1: Patterns of administration of tirofiban in study patients. angiography, the population enrolled was at low risk, especially for bleeding; this may explain the low rate of MACE and bleeding events at 30-day follow-up which, in Table 4: In-hospital and 30 days adverse events. turn, precluded the possibility of subgroup analyses In- Discharge to 30 aiming to assess, if any, clinical and angiographic pre- Overall hospital days dictors of enhanced benefit of tirofiban on top of standard treatment. &ird, most patients were treated by trans- All BARC (n, %) 8 (1.7) 2 (0.4) 10 (2.1) BARC 3–5 (n,%) 4 (0.8) 1 (0.2) 5 (1) radial approach, which is consistently associated with a Death (n, %) 1 (0.2) 0 (0) 1 (0.2) striking reduction in access-related bleeding as compared TVR (n, %) 1 (0.2) 0 (0) 1 (0.2) to transfemoral approach in primary PCI [23], especially Stent thrombosis (n, when GPI is used [24]. Fourth, pharmacodynamic 3 (0.6) 0 (0) 3 (0.6) %) evaluation of platelet aggregation was not performed. IMA (n, %) 3 (0.6) 0 (0) 3 (0.6) Finally, relevant angiographic data, such as number of diseased vessels, lesion length, and number of stents, are missing. segment resolution, similar to the findings of the AT- LANTIC randomized trial [16]. As far as tirofiban is con- cerned, it is interesting to observe that a bolus-only strategy 5. Conclusion was adopted in about one-third of patients. Although no comparison can be made in our cohort between the bolus- &is study suggests that in STEMI patients undergoing only group and the bolus plus infusion group, given the low transradial pPCI with high thrombus burden and low risk of number of events, a bolus-only strategy coupled with early bleeding, a strategy of bolus-only or bolus followed by short administration of potent oral P2Y12 inhibitors could rep- infusion of tirofiban on top of oral loading with potent resent an effective way to provide optimal platelet inhibition P2Y12 inhibitors is associated with high rates of complete during pPCI, bridging the delay in the onset of antiplatelet ST-segment resolution and low rates of both ischemic and activity of oral drugs and, at the same time, reducing the risk hemorrhagic complications at 30 days. Adequately powered of bleeding complications associated with long-lasting GPI randomized controlled trials with clinical endpoints are infusion. &is strategy has been evaluated in the FABOLUS- needed in order to evaluate the safety and efficacy of the PRO trial, a pharmacodynamic study which showed that the association of potent parenteral and potent oral antiplatelet association of 60 mg loading dose of prasugrel with high- drugs in STEMI patients undergoing pPCI. dose bolus of tirofiban achieved higher and consistent antiplatelet activity obviating the need of postbolus tirofiban infusion [17]. &e possible benefit of this strategy was also Data Availability assessed in an observational study showing that a bolus-only eptifibatide regimen was associated with similar infarct size &e dataset used to support the findings of this study is but with significantly reduced major bleedings in STEMI available at the Contract Research Organization who fol- patients undergoing pPCI as compared to conventional lowed the study: Clirest S.R.L. 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