Urgent Target Vessel Revascularization Research Articles

Long-term clinical outcomes in patients with non-ST-segment Elevation Acute Coronary Syndrome and ST-segment elevation myocardial infarction with thrombolysis in myocardial infarction 0 flow.

Thrombolysis in Myocardial Infarction (TIMI) 0 flow often characterizes ST-segment Elevation Myocardial Infarction (STEMI) patients, but may also feature in non-ST-segment Elevation Acute Coronary Syndrome (NSTE-ACS). Since recanalization usually occurs later in NSTE-ACS patients, the aim of this study was to assess whether patients presenting with NSTE-ACS and TIMI 0 flow have worse clinical outcomes as compared to patients presenting with STEMI and TIMI 0 flow. A single-center retrospective cohort study was conducted with patients treated for NSTE-ACS and STEMI with TIMI 0 flow at diagnostic angiogram between January 2015 and December 2019. The two patient groups were 1:1 matched using a propensity score logistic regression model. The primary outcome was Major Adverse Cardiac Events (MACE), a composite of all-cause mortality, any myocardial infarction, coronary artery bypass graft, urgent target vessel revascularization or stroke during long term follow-up. The total population consisted of 1255 ACS patients, of which 249 NSTE-ACS and 1006 STEMI patients. After propensity score matching, 234 NSTE-ACS patients were matched with 234 STEMI patients. In this matched population, the mean age was 62.6 (±12.4) years and 75.2% of the patients was male. The median follow-up time was 3.2years. MACE rates during follow-up were similar between the two matched groups (HR=0.84 [95% CI 0.60 - 1.12] with p=0.33) with cumulative event-free survival of 63.3% in the NSTE-ACS group vs 59.3% in the STEMI group at 6year follow-up. In this retrospective study, a culprit lesion with TIMI 0 flow has similar clinical outcome in NSTE-ACS and STEMI patients. Further research is warranted to determine optimal the timing of PCI in NSTE-ACS patients with TIMI 0 flow.

Rationale and design of the PARTHENOPE trial: A two-by-two factorial comparison of polymer-free vs biodegradable-polymer drug-eluting stents and personalized vs standard duration of dual antiplatelet therapy in all-comers undergoing PCI

BackgroundOver the past few decades, percutaneous coronary intervention (PCI) has undergone significant advancements as a result of the combination of device-based and drug-based therapies. These iterations have led to the development of polymer-free drug-eluting stents. However, there is a scarcity of data regarding their clinical performance. Furthermore, while various risk scores have been proposed to determine the optimal duration of dual antiplatelet therapy (DAPT), none of them have undergone prospective validation within the context of randomized trials. DesignThe PARTHENOPE trial is a phase IV, prospective, randomized, multicenter, investigator-initiated, assessor-blind study being conducted at 14 centers in Italy (NCT04135989). It includes 2,107 all-comers patients with minimal exclusion criteria, randomly assigned in a 2-by-2 design to receive either the Cre8 amphilimus-eluting stent or the SYNERGY everolimus-eluting stent, along with either a personalized or standard duration of DAPT. Personalized DAPT duration is determined by the DAPT score, which accounts for both bleeding and ischemic risks. Patients with a DAPT score <2 (indicating higher bleeding than ischemic risk) receive DAPT for 3 or 6 months for chronic or acute coronary syndrome, respectively, while patients with a DAPT score ≥2 (indicating higher ischemic than bleeding risk) receive DAPT for 24 months. Patients in the standard DAPT group receive DAPT for 12 months. The trial aims to establish the noninferiority between stents with respect to a device-oriented composite end point of cardiovascular death, target-vessel myocardial infarction, or clinically-driven target-lesion revascularization at 12 months after PCI. Additionally, the trial aims to demonstrate the superiority of personalized DAPT compared to a standard approach with respect to a net clinical composite of all-cause death, any myocardial infarction, stroke, urgent target-vessel revascularization, or type 2 to 5 bleeding according to the Bleeding Academic Research Consortium criteria at 24-months after PCI. SummaryThe PARTHENOPE trial is the largest randomized trial investigating the efficacy and safety of a polymer-free DES with a reservoir technology for drug-release and the first trial evaluating a personalized duration of DAPT based on the DAPT score. The study results will provide novel insights into the optimizing the use of drug-eluting stents and DAPT in patients undergoing PCI.

Distal Target Vessel Quality and Outcomes of Chronic Total Occlusion Percutaneous Coronary Intervention

BackgroundDistal vessel quality is a key parameter in the global chronic total occlusion (CTO) crossing algorithm. ObjectivesThe study sought to evaluate the association of distal vessel quality with the outcomes of CTO percutaneous coronary intervention. MethodsWe examined the clinical and angiographic characteristics and procedural outcomes of 10,028 CTO percutaneous coronary interventions performed at 39 U.S. and non-U.S. centers between 2012 and 2022. A poor-quality distal vessel was defined as <2 mm diameter or with significant diffuse atherosclerotic disease. In-hospital major adverse cardiac events (MACE) included death, myocardial infarction, urgent repeat target vessel revascularization, tamponade requiring pericardiocentesis or surgery, and stroke. ResultsA total of 33% of all CTO lesions had poor-quality distal vessel. When compared with good-quality distal vessels, CTO lesions with a poor-quality distal vessel had higher J-CTO (Japanese chronic total occlusion) scores (2.7 ± 1.1 vs 2.2 ± 1.3; P < 0.01), lower technical (79.9% vs 86.9%; P < 0.01) and procedural (78.0% vs 86.8%; P < 0.01) success, and higher incidence of MACE (2.5% vs 1.7%; P < 0.01) and perforation (6.4% vs 3.7%; P < 0.01). A poor-quality distal vessel was independently associated with technical failure and MACE. Poor-quality distal vessels were associated with higher use of the retrograde approach (25.2% vs 14.9%; P < 0.01) and higher air kerma radiation dose (2.4 [IQR: 1.3-4.0] Gy vs 2.0 [IQR: 1.1-3.5] Gy; P < 0.01). ConclusionsA poor-quality distal vessel in CTO lesions is associated with higher lesion complexity, higher need for retrograde crossing, lower technical and procedural success, higher incidence of MACE and coronary perforation, and higher radiation dose.

Comparison of Ischemic and Bleeding Events Between Short-Duration Versus Long-Duration Tirofiban Regimens in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention.

Tirofiban has been used historically as a bridge to platelet inhibition with clopidogrel in ST-segment myocardial infarction (STEMI) during percutaneous coronary intervention (PCI) to prevent stent thrombosis. However, ticagrelor and prasugrel reach similar levels of platelet inhibition at 30 minutes to that of clopidogrel at 6 hours, challenging the need for long-duration tirofiban. This 1-year, retrospective cohort study compared ischemic and bleeding outcomes of short-duration versus long-duration tirofiban regimens in patients with STEMI who received ticagrelor or prasugrel at the time of PCI. The primary outcome was major adverse cardiovascular events (MACEs) including cardiovascular mortality, recurrent myocardial infarction, urgent target vessel revascularization, or stroke. Secondary outcomes included individual MACE, all-cause mortality, bleeding events defined by the International Society on Thrombosis and Hemostasis, thirty-day readmissions for MACE and bleeding, and tirofiban pharmacy cost. A total of 283 charts were reviewed and 177 included (short duration n = 57; long duration n = 120). MACE rates were similar between short-duration and long-duration groups (0 [0%] vs. 5 [4.2%]; P = 0.18), including 4 cardiovascular deaths and 1 recurrent myocardial infarction. Bleeding event rates were also similar in short-duration versus long-duration groups including major bleeds (2 [3.5%] vs. 2 [1.7%]; P = 0.60) and clinically relevant nonmajor bleeds (3 [5.3%] vs. 9 [7.5%]; P = 0.75). Cost analysis indicated lower pharmacy cost with the short-duration group. In this cohort of patients with STEMI receiving a fast-acting P2Y12 inhibitor, the length of tirofiban infusion did not affect ischemic or bleeding outcomes, yet short-duration regimens were lower cost.

Bivalirudin in patients undergoing percutaneous coronary intervention and independent predictors of postoperative adverse events in these patients: A real world retrospective study.

The efficacy and safety of bivalirudin in percutaneous coronary intervention (PCI) has always been a hot topic in perioperative antithrombotic therapy, but there are still some controversies. So studies are needed to provide more evidence, especially the real world study which includes patients excluded from previous RCT studys. Our study aimed to investigate these information and analyze the independent predictors of postoperative adverse events.A retrospective study enrolled 1416 patients underwent PCI in Tianjin Chest Hospital from May 2016 to October 2017. The incidence of stent-thrombosis and net clinical adverse events, including all-cause death, myocardial infarction, stroke, urgent target-vessel revascularization and bleeding, were followed up for 30 days and 1 year. Logistic regression and COX regression were respectively used to analyze independent predictors of bleeding events within 30-days, and independent predictors of Major adverse cardiovascular and cerebrovascular events (MACCE) in patients with stent implantation within 1-year.Seven hundred six patients were treated with bivalirudin while 710 with unfractionated heparin (UFH). The proportions of diabetes, hypertension, anemia, myocardial-infarction history, PCI history, moderate-to-severe renal-impairment, gastrointestinal-bleeding history in the bivalirudin group were significantly higher (P < .05). Women, anemia were independent risk factors for bleeding within 30-days (P < .05). Among 682 patients with stent implantation in bivalirudin group, anemia, Body Mass Index (BMI) >25 kg/m2, KILLIP ≥2, ejection fraction (EF) <45%, eGFR <60 ml/minutes were independent risk factors for MACCE, while Statins, proton pump inhibitor (PPI) were independent protective factors for MACCE with-in 1-year (P < .05).Bivalirudin have good anticoagulant effect and lower bleeding risk during PCI, especially in patients with higher bleeding risk. In patients treated with bivalirudin, female, anemia were independent predictors of bleeding within 30-days, BMI >25 kg/m2, anemia, KILLIP ≥2, EF <45%, eGFR <60 ml/minutes were independent risk factors and Statins, PPI were independent protective factors of MACCE within 1-year.

Cardiac Catheterizations in Patients With Prior Coronary Bypass Surgery: Impact of Access Strategy on Short-Term Safety and Long-Term Efficacy Outcomes.

Little data are available on access strategy outcomes for cardiac catheterizations in patients with prior coronary artery bypass graft surgery (CABG). We investigated the effect of transradial access (TRA) and transfemoral access (TFA) on short-term major vascular complications (MVC) and long-term major adverse cardiovascular events (MACE). In this single-center, retrospective cohort study, 1084 patients met our inclusion criteria (TRA = 469; TFA = 615). The cumulative incidence for the primary safety endpoint MVC at 30 days (a composite of major bleeding, retroperitoneal hematoma, dissection, pseudoaneurysm, and arteriovenous fistula) was lower with TRA (0.7% vs 3.0%, P < .01) and this difference remained significant after propensity score adjustment (odds ratio: 0.24; 95% CI, 0.07-0.83; P = .024). The cumulative incidence for the primary efficacy endpoint MACE at 36 months (a composite of all-cause mortality, myocardial infarction, stroke, and urgent target vessel revascularization) was 28.6% with TRA and 27.6% with TFA, respectively. Kaplan-Meier curves showed no difference for the primary efficacy endpoint (P = .65). Contrast use (mL) was significantly lower with TRA (130 [100-180] vs 150 [100-213], P < .01). In conclusion, in patients with prior CABG, TRA was associated with significantly fewer short-term MVC and contrast use, but not with a difference in long-term MACE, compared with TFA.

Prognostic impact of FFR/contrast FFR discordance

BackgroundContrast fractional flow reserve (cFFR) is a relatively new tool for the assessment of intermediate coronary artery stenosis and represents a reliable surrogate of FFR with the advantage of potentially simplifying functional evaluation. We aimed to compare the incidence of major adverse cardiac events (MACE) in patients undergoing functional evaluation with both FFR and cFFR based on the results of the two indexes. Method and ResultWe retrospectively analyzed outcomes in 488 patients who underwent functional evaluation with FFR and cFFR. Patients were divided into four groups using the cutoff values of 0.80 for FFR and 0.85 for cFFR: −/− (n = 298), +/+ (n = 134), −/+(n = 31) and +/− (n = 25). All patients were treated according to FFR value. MACE rate was assessed in each group, including death, myocardial infarction and urgent target vessel revascularization (TVR). Mean follow-up time was 22 ± 15 months. Incidence of MACE at follow-up was 8.3% in FFR−/cFFR−, 14.0% in FFR+/cFFR+, 16.0% in FFR−/cFFR+ and 8.0% in FFR+/cFFR− without a significant difference amongst the 4 groups (p = 0.2). Nevertheless, a significant difference in the rate of TVR comparing FFR−/cFFR− (n = 17) and FFR−/cFFR+ (n = 5) was found at 24 months (5.7% vs 16.0%; p = 0.027). ConclusioncFFR is accurate in predicting FFR and consequently reliable in guiding coronary revascularization. In the rare case of discordance, while FFR+/cFFR- patients show a prognosis similar to FFR-/cFFR- patients, FFR-/cFFR+ patients show a prognosis similar to FFR+/cFFR+ patients.

Same day discharge after chronic total occlusion interventions: A single center experience.

To assess the feasibility and safety of same day discharge (SDD) after chronic total occlusion (CTO) percutaneous coronary intervention (PCI). CTO PCI has been associated with higher complication rates and procedural and hospitalization costs. Shortening post-PCI hospitalization length not only increases the patients' comfort but at the same time it consists an important part of cost reduction policies. We retrospectively compared the 30-day outcomes of patients who underwent CTO PCI at the Red Cross Hospital, Greece between January 2016 and June 2019 and underwent SDD versus non-SDD. Major adverse cardiovascular events (MACE) were defined as the composite of death, myocardial infarction, urgent repeat target vessel revascularization, tamponade, and stroke. A total of 173 patients (mean age 63.7 ± 8.9 years) were included, of whom 51 (30%) underwent SDD. SDD patients were less likely to have diabetes mellitus (51 vs. 31%, p=.015), arterial hypertension (89 vs. 67%, p < .001), and acute coronary syndrome presentation (39.7 vs. 21.6%, p=.022), compared with non-SDD patients. Forearm access was used in all SDD patients and in 83% of the non-SDD patients. The 30-day incidence of MACE was 0% in the SDD group and 1.6% in the non-SDD group. Multivariable analysis showed that diabetes mellitus and longer procedural time were associated with lower probability of SDD (OR: 0.34, 95% CI: 0.15, 0.73 and OR: 0.29, 95% CI: 0.12, 0.71, respectively). SDD appears to be feasible and safe in selected patients undergoing an uncomplicated CTO PCI through forearm approach.

Ticagrelor alone or conventional dual antiplatelet therapy in patients with stable or acute coronary syndromes.

The aim of this study was to investigate the effect of ticagrelor monotherapy after one-month dual antiplatelet therapy (DAPT) or conventional DAPT in patients with or without acute coronary syndrome (ACS) in the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY). Risk estimates were expressed as rate ratios (RR) with 95% confidence intervals (CI). A total of 3,840 ACS and 3,745 stable ischaemic heart disease (SIHD) patients were included. At two years, rates of the co-primary efficacy endpoint, a composite of death, myocardial infarction, stroke or urgent target vessel revascularisation, were 7.94% in the experimental and 9.68% in the control group (RR 0.82, 95% CI: 0.66-1.01) among ACS patients and 6.31% in the experimental and 7.14% in the control group (RR 0.89, 95% CI: 0.69-1.13) among SIHD patients (pint=0.63). Trends for lower and higher risk of BARC 3 or 5 bleeding with the experimental strategy in ACS (2.27% vs 3.00%, RR 0.76, 95% CI: 0.51-1.12) and SIHD (2.70% vs 1.96%, RR 1.39, 95% CI: 0.91-2.12) patients, respectively, were observed with significant interaction testing (pint=0.039). A net clinical benefit endpoint, the composite of both co-primary study endpoints, favoured the experimental treatment among ACS patients only. Ticagrelor monotherapy after one-month DAPT provided consistent treatment effects on ischaemic endpoints in patients with or without ACS but only the former experienced a net clinical benefit. ClinicalTrials.gov identifier: NCT03231059.

Percutaneous Coronary Intervention With an Initial Bolus of Low-Dose Heparin in Biomarker-Negative Patients

ObjectivesThe safety and efficacy of an initial intravenous bolus of low-dose heparin (40 IU/kg) was evaluated in biomarker negative patients undergoing percutaneous coronary intervention (PCI). BackgroundA bolus of 70–100 IU/kg of heparin is currently recommended for patients undergoing PCI. However, the ideal dose of heparin has not been evaluated in a randomized trial. The higher dose of 100 IU/kg may increase the risk of bleeding. An initial bolus of low-dose heparin may be advantageous to avoid supratherapeutic activating clotting times (ACT) while still allowing for the administration of additional heparin if the ACT is subtherapeutic. MethodsFrom January 2008 to February 2020, 904 patients undergoing elective transfemoral PCI received an initial bolus of 40 IU/kg of heparin. Patients who underwent transradial PCI were not included. Patients were routinely pretreated with dual antiplatelet therapy. The primary end point was the composite of cardiac death, myocardial infarction (MI), urgent target vessel revascularization (TVR) for ischemia, or major bleeding within 30 days after PCI. ResultsThe initial mean activating clotting time was 235.4 ± 26.6 s. The clinical event rates were low: the primary end point occurred in 5.3%, cardiac death in 1.0%, MI in 3.1%, urgent TVR in 0.7% and major bleeding in 1.9%. Stent thrombosis was uncommon (0.2%). No patients developed profound thrombocytopenia. Three patients (0.3%) had acute limb ischemia that required revascularization. ConclusionAn initial strategy of low-dose heparin is associated with low ischemic and bleeding complications in biomarker negative patients who undergo transfemoral PCI.

The Ulnar Artery as a Favorable Primary or Alternative Access Site for Coronary Angiography and Interventions.

The transulnar approach (TUA) has been considered both as primary access and as a secondary access site after transradial access (TRA) failure for coronary invasive procedures. However, there is little evidence supporting the use of the TUA as the first approach to diagnostic coronary angiography (CAG) or interventions. Patients (n = 587) who underwent CAG and/or angioplasty (292 patients via TRA, 295 patients via TUA) were included. The primary end points of the study were major adverse cardiac events and major vascular events (hematoma, vascular occlusion, vasospasm), and secondary end points included angiographic success, crossover rate, and angiographic procedural times. The mean age was 60 ± 21 years. The composite primary end points occurred in 34 (11.6%) patients in the TRA and 22 (7.4%) patients in the TUA arm (P < .001). More arterial occlusion and more arterial spasm than in the TUA and similar urgent target vessel revascularization were observed in the TRA group in 48 hours. Based on previous studies and our clinical experience, we speculated that the TUA performed by an experienced operator has equal status with the TRA for coronary catheterization, especially in patients with a palpable ulnar pulse.

Ticagrelor Alone Versus Dual Antiplatelet Therapy From 1 Month After Drug-Eluting Coronary Stenting

BackgroundThe GLOBAL LEADERS (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation) study randomly assigned 15,991 patients undergoing percutaneous coronary intervention to 1-month dual antiplatelet therapy (DAPT) followed by 23-month ticagrelor monotherapy or conventional 12-month DAPT followed by 12-month aspirin. Apart from Q-wave myocardial infarction (MI), all study endpoints were analyzed as investigator reported. ObjectivesThis was a pre-specified ancillary study assessing whether experimental therapy is noninferior, and if met, superior, to conventional treatment for the coprimary efficacy endpoint of all-cause death, nonfatal MI, nonfatal stroke, or urgent target vessel revascularization and superior in preventing BARC 3 (Bleeding Academic Research Consortium) or 5 bleeding (coprimary safety endpoint) at 2 years with a 0.025 significance level to preserve nominal 5% alpha error. MethodsAn independent clinical event committee adjudicated investigator-reported and eventually unreported events of 7,585 patients from the 20 top-enrolling participating sites. ResultsThe 2-year coprimary efficacy endpoint occurred in 271 (7.14%) and in 319 (8.41%) patients in the experimental and conventional groups, respectively (rate ratio [RR]: 0.85; 95% confidence interval [CI]: 0.72 to 0.99), fulfilling noninferiority (p noninferiority <0.001), but not superiority (p superiority = 0.0465). The rates of BARC 3 or 5 bleeding did not differ (RR: 1.00; 95% CI: 0.75 to 1.33; p = 0.986). A time-dependent treatment effect was observed with the experimental strategy being associated with a lower risk of MI (RR: 0.54; 95% CI: 0.33 to 0.88; p interaction = 0.062) and definite stent thrombosis (RR: 0.14; 95% CI: 0.03 to 0.63; p interaction = 0.007) after 1-year post-percutaneous coronary intervention. ConclusionsTicagrelor monotherapy after 1-month DAPT was noninferior, but not superior, to conventional treatment in the prevention of ischemic events, and it did not decrease major bleeding risk as compared with conventional treatment. (GLOBAL LEADERS Adjudication Sub-Study [GLASSY]; NCT03231059).

Dual antiplatelet therapy following percutaneous coronary intervention: protocol for a systematic review

IntroductionDual antiplatelet therapy (DAPT) is routinely given to patients after percutaneous coronary intervention (PCI) with stenting; however, there is ongoing debate about the optimal duration, especially in specific patient groups....

Safety and Efficacy of Periprocedural Heparin Plus a Short-Term Infusion of Tirofiban Versus Bivalirudin Monotherapy in Patients Who Underwent Percutaneous Coronary Intervention (from the Intermountain Heart Institute STAIR Observational Registry)

Glycoprotein IIb/IIIa inhibitors, used as a standard intravenous bolus followed by a prolonged infusion for 12 to 18 hours, reduces ischemic complications during percutaneous coronary interventions (PCI) but often at a cost of increased bleeding. Today, when dual oral antiplatelet therapy is routine, heparin use plus short-term (bolus alone or with a <6 hours infusion) glycoprotein IIb/IIIa inhibitors, or bivalirudin monotherapy, have been proposed as potentially superior alternatives. This observational study evaluated the safety and efficacy of heparin plus short-term tirofiban versus bivalirudin monotherapy during PCI. Patients with successful PCI and no cardiogenic shock who were anticoagulated with either of the above regimens were followed for 30-day major bleeding and major adverse cardiovascular events (death, nonfatal myocardial infarction, and urgent target vessel revascularization) at 30 days, 1 year, and long term. A total of 727 patients receiving tirofiban (age = 63 ± 13 years, males = 76%, ACS presentation = 75%, radial access = 51%) and 459 patients receiving bivalirudin, (age = 65 ± 13 years, males = 71%, ACS presentation = 78%, radial access = 18%) were included. Thirty-day major bleeding was 0.7% and 4.1% for tirofiban and bivalirudin, respectively (adjusted odds ratio = 0.17 [0.06, 0.46], p = 0.001). During 30-day, 1-year, and long-term (1.7 ± 0.9 years) follow-up, major adverse cardiovascular events risk did not differ significantly between tirofiban and bivalirudin. However, long-term death was significantly lower in those receiving tirofiban (adjusted hazard ratio = 0.58 [0.34, 1.00], p = 0.05). In conclusion, in this observational study, PCI patients receiving heparin plus short-term tirofiban experienced significantly lower 30-day major bleeding, and improved long-term survival, than those receiving bivalirudin monotherapy.

Post-Procedural Bivalirudin Infusion at Full or Low Regimen in Patients With Acute Coronary Syndrome

BackgroundThe value of prolonged bivalirudin infusion after percutaneous coronary intervention (PCI) in acute coronary syndrome (ACS) patients with or without ST-segment elevation remains unclear. ObjectivesThe purpose of this study was to assess efficacy and safety of a full or low post-PCI bivalirudin regimen in ACS patients with or without ST-segment elevation. MethodsThe MATRIX program assigned bivalirudin to patients without or with a post-PCI infusion at either a full (1.75 mg/kg/h for ≤4 h) or reduced (0.25 mg/kg/h for ≤6 h) regimen at the operator’s discretion. The primary endpoint was the 30-day composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (composite of all-cause death, myocardial infarction, or stroke, or major bleeding). ResultsAmong 3,610 patients assigned to bivalirudin, 1,799 were randomized to receive and 1,811 not to receive a post-PCI bivalirudin infusion. Post-PCI full bivalirudin was administered in 612 (ST-segment elevation myocardial infarction [STEMI], n = 399; non–ST-segment elevation acute coronary syndromes [NSTE-ACS], n = 213), whereas the low-dose regimen was administered in 1,068 (STEMI, n = 519; NSTE-ACS, n = 549) patients. The primary outcome did not differ in STEMI or NSTE-ACS patients who received or did not receive post-PCI bivalirudin. However, full compared with low bivalirudin regimen remained associated with a significant reduction of the primary endpoint after multivariable (rate ratio: 0.21; 95% CI: 0.12 to 0.35; p < 0.001) or propensity score (rate ratio: 0.16; 95% CI: 0.09 to 0.26; p < 0.001) adjustment. Full post-PCI bivalirudin was associated with improved outcomes consistently across ACS types compared with the no post-PCI infusion or heparin groups. ConclusionsIn ACS patients with or without ST-segment elevation, the primary endpoint did not differ with or without post-PCI bivalirudin infusion but a post-PCI full dose was associated with improved outcomes when compared with no or low-dose post-PCI infusion or heparin (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX [MATRIX]; NCT01433627).

Clinical impact of routine angiographic follow-up after percutaneous coronary interventions on unprotected left main.

Patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stent (DES) on unprotected left main (ULM) represent a complex subset. The role of routine coronary angiography at follow up in this subset remains debated. At the documented center, all patients undergoing successful PCI on ULM lesions performing angiographic follow-up is suggested, but adherence to such a recommendation is inhomogeneous. Consecutive patients undergoing DES PCI on ULM were enrolled and experienced no adverse events during the first 6 months. Patients were then allocated to two groups: those undergoing routine control angiography (CA) and those undergoing clinical follow-up (CF). Primary endpoint was major adverse cardiac events (MACE) defined as cardiac death, myocardial infarction and urgent repeat target vessel revascularization. A total of 190 patients underwent successful DES implantation on ULM and the study population was without early events. CA was performed at 6 months after the index procedure in 91 (48%) patients. After 35 ± 21 months, MACE rates were significantly more common in the CF group as compared with the CA group (16.2% vs. 4.3%, p = 0.009). At multivariable analysis, CA was associated with reduced MACE risk (HR 0.13, 95% CI 0.1-0.7, p = 0.028). Of note, this was mainly driven by higher cardiac death rate in those undergoing CF than in those undergoing CA (p = 0.01). CA after complex PCI, such as ULM PCI, is associated with reduced MACE. Such an observation calls for appropriately designed randomized trials.

Radial versus femoral access and bivalirudin versus unfractionated heparin in invasively managed patients with acute coronary syndrome (MATRIX): final 1-year results of a multicentre, randomised controlled trial

The Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox (MATRIX) programme was designed to assess the comparative safety and effectiveness of radial versus femoral access and of bivalirudin versus unfractionated heparin with optional glycoprotein IIb/IIIa inhibitors in patients with the whole spectrum of acute coronary syndrome undergoing invasive management. Here we describe the prespecified final 1-year outcomes of the entire programme. MATRIX was a programme of three nested, randomised, multicentre, open-label, superiority trials in patients with acute coronary syndrome in 78 hospitals in Italy, the Netherlands, Spain, and Sweden. Patients with ST-elevation myocardial infarction were simultaneously randomly assigned (1:1) before coronary angiography to radial or femoral access and to bivalirudin, with or without post-percutaneous coronary intervention infusion or unfractionated heparin (one-step inclusion). Patients with non-ST-elevation acute coronary syndrome were randomly assigned (1:1) before coronary angiography to radial or femoral access and, only if deemed eligible to percutaneous coronary intervention after angiography (two-step inclusion), entered the antithrombin type and treatment duration programmes. Randomisation sequences were computer generated, blocked, and stratified by intended new or current use of P2Y12 inhibitor (clopidogrel vs ticagrelor or prasugrel), and acute coronary syndrome type (ST-elevation myocardial infarction, troponin-positive, or troponin-negative non-ST-elevation acute coronary syndrome). Bivalirudin was given as a bolus of 0·75 mg/kg, followed immediately by an infusion of 1·75 mg/kg per h until completion of percutaneous coronary intervention. Heparin was given at 70-100 units per kg in patients not receiving glycoprotein IIb/IIIa inhibitors, and at 50-70 units per kg in patients receiving glycoprotein IIb/IIIa inhibitors. Clinical follow-up was done at 30 days and 1 year. Co-primary outcomes for MATRIX access and MATRIX antithrombin type were major adverse cardiovascular events, defined as the composite of all-cause mortality, myocardial infarction, or stroke up to 30 days; and net adverse clinical events, defined as the composite of non-coronary artery bypass graft-related major bleeding, or major adverse cardiovascular events up to 30 days. The primary outcome for MATRIX treatment duration was the composite of urgent target vessel revascularisation, definite stent thrombosis, or net adverse clinical events up to 30 days. Analyses were done according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01433627. Between Oct 11, 2011, and Nov 7, 2014, we randomly assigned 8404 patients to receive radial (4197 patients) or femoral (4207 patients) access. Of these 8404 patients, 7213 were included in the MATRIX antithrombin type study and were randomly assigned to bivalirudin (3610 patients) or heparin (3603 patients). Patients assigned to bivalirudin were included in the MATRIX treatment duration study, and were randomly assigned to post-procedure infusion (1799 patients) or no post-procedure infusion (1811 patients). At 1 year, major adverse cardiovascular events did not differ between patients assigned to radial access compared with those assigned to femoral access (14·2% vs 15·7%; rate ratio 0·89, 95% CI 0·80-1·00; p=0·0526), but net adverse clinical events were fewer with radial than with femoral access (15·2% vs 17·2%; 0·87, 0·78-0·97; p=0·0128). Compared with heparin, bivalirudin was not associated with fewer major adverse cardiovascular (15·8% vs 16·8%; 0·94, 0·83-1·05; p=0·28) or net adverse clinical events (17·0% vs 18·4%; 0·91, 0·81-1·02; p=0·10). The composite of urgent target vessel revascularisation, stent thrombosis, or net adverse clinical events did not differ with or without post-procedure bivalirudin infusion (17·4% vs 17·4%; 0·99, 0·84-1·16; p=0·90). In patients with acute coronary syndrome, radial access was associated with lower rates of net adverse clinical events compared with femoral access, but not major adverse cardiovascular events at 1 year. Bivalirudin with or without post-procedure infusion was not associated with lower rates of major adverse cardiovascular events or net adverse clinical events. Radial access should become the default approach in acute coronary syndrome patients undergoing invasive management. Italian Society of Invasive Cardiology, The Medicines Company, Terumo, amd Canada Research Chairs Programme.

Association Between Maximal Activated Clotting Time and Major Bleeding Complications During Transradial and Transfemoral Percutaneous Coronary Intervention

ObjectivesThis study sought to determine whether higher maximal activated clotting time (ACT) during transradial (TR) percutaneous coronary intervention (PCI) is associated with greater bleeding risk. BackgroundHigher maximal ACT during transfemoral (TF) PCI has been associated with a greater bleeding risk. It is unclear whether this relationship exists in the setting of TR PCI. MethodsAmong 14,637 patients undergoing TR or TF PCI with unfractionated heparin monotherapy, the study related maximal ACT to the risk of major bleeding. In secondary analyses, the study related maximal ACT to composites of in-hospital death, myocardial infarction (MI), or stroke and in-hospital death, MI, or urgent target vessel revascularization. Multivariable logistic regression was employed to compare outcomes in the third with the first and second maximal ACT tertiles. ResultsMore major bleeding occurred at ACT >290 s versus ≤290 s following TF (7.7% vs. 5.8%; p = 0.006) but not TR PCI (1.7% vs. 2.4%; p = 0.18). After adjustment, major bleeding risk remained significantly higher at ACT >290 s versus ACT ≤290 s among TF (odds ratio: 1.28; 95% confidence interval: 1.02 to 1.62; p = 0.036) but not TR PCI (odds ratio: 0.72; 95% confidence interval: 0.42 to 1.22; p = 0.22). Maximal ACT was not related to the incidence of composite death, MI, or stroke or death, MI, or urgent target vessel revascularization following TF or TR PCI. ConclusionsHigher maximal ACT is associated with a greater risk of major bleeding following TF PCI than TR PCI.

6- Versus 24-Month Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents in Patients Nonresistant to Aspirin: Final Results of the ITALIC Trial (Is There a Life for DES After Discontinuation of Clopidogrel)

ObjectivesThe aim of this study was to test the hypothesis that 6-month dual antiplatelet therapy (DAPT) is noninferior to 24-month DAPT in aspirin-sensitive patients. BackgroundThe ITALIC (Is There a Life for DES After Discontinuation of Clopidogrel) trial showed that rates of bleeding and thrombotic events at 1 year were much the same with 6 versus 12 months of DAPT after percutaneous coronary intervention with second-generation drug-eluting stents. In this report, 2-year follow-up is presented. MethodsIn a multicenter randomized study, patients with confirmed nonresistance to aspirin undergoing drug-eluting stent implantation were allocated to 6 or 24 months of DAPT. The primary endpoint was a composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding at 12 months post–percutaneous coronary intervention. The secondary endpoints comprised the same composite endpoint at 24 months and each individual component. ResultsOverall, 2,031 patients from 70 centers were screened; 926 were randomized to 6-month and 924 to 24-month DAPT. Noninferiority was demonstrated for 6- versus 12-month DAPT, with an absolute risk difference of 0.11% (95% confidence interval: −1.04% to 1.26%; p = 0.0002). At 2 years, the composite endpoint was unchanged, at 3.5% for 6 months and 3.7% for 24 months (p = 0.79), and rates of myocardial infarction (1.3% vs. 1.0%; p = 0.51), stroke (0.6% vs. 0.8%; p = 0.77), and target vessel revascularization (1.0% vs. 0.3%; p = 0.09) were likewise similar. There was a trend toward higher mortality with longer DAPT (2.2% vs. 1.2%; p = 0.11). Four patients (0.4%) in the 24-month group and none in the 6-month group had major bleeding. ConclusionsTwo-year outcomes in the ITALIC trial confirmed the 1-year results and showed that patients receiving 6-month DAPT after percutaneous coronary intervention with second-generation drug-eluting stent have similar outcomes to those receiving 24-month DAPT.

Optimal duration of dual antiplatelet therapy following percutaneous coronary intervention: protocol for an umbrella review

IntroductionAlthough dual antiplatelet therapy (DAPT) is routinely given to patients after percutaneous coronary intervention (PCI) with stenting, the optimal duration is unknown. Recent evidence indicates there may be benefits in...