Publications by authors named "Adnan Kastrati"

737 Publications

Cis-epistasis at the LPA locus and risk of cardiovascular diseases.

Cardiovasc Res 2021 Apr 20. Epub 2021 Apr 20.

Estonian Genome Center, Institute of Genomics, University of Tartu, 51010, Tartu, Estonia.

Aims: Coronary artery disease (CAD) has a strong genetic predisposition. However, despite substantial discoveries made by genome-wide association studies (GWAS), a large proportion of heritability awaits identification. Non-additive genetic-effects might be responsible for part of the unaccounted genetic variance. Here we attempted a proof-of-concept study to identify non-additive genetic effects, namely epistatic interactions, associated with CAD.

Methods And Results: We tested for epistatic interactions in ten CAD case-control studies and UK Biobank with focus on 8,068 SNPs at 56 loci with known associations with CAD risk. We identified a SNP pair located in cis at the LPA locus, rs1800769 and rs9458001, to be jointly associated with risk for CAD (odds ratio [OR]=1.37, p = 1.07 × 10-11), peripheral arterial disease (OR = 1.22, p = 2.32 × 10-4), aortic stenosis (OR = 1.47, p = 6.95 × 10-7), hepatic lipoprotein(a) (Lp(a)) transcript levels (beta = 0.39, p = 1.41 × 10-8), and Lp(a) serum levels (beta = 0.58, p = 8.7 × 10-32), while individual SNPs displayed no association. Further exploration of the LPA locus revealed a strong dependency of these associations on a rare variant, rs140570886, that was previously associated with Lp(a) levels. We confirmed increased CAD risk for heterozygous (relative OR = 1.46, p = 9.97 × 10-32) and individuals homozygous for the minor allele (relative OR = 1.77, p = 0.09) of rs140570886. Using forward model selection, we also show that epistatic interactions between rs140570886, rs9458001, and rs1800769 modulate the effects of the rs140570886 risk allele.

Conclusions: These results demonstrate the feasibility of a large-scale knowledge-based epistasis scan and provide rare evidence of an epistatic interaction in a complex human disease. We were directed to a variant (rs140570886) influencing risk through additive genetic as well as epistatic effects. In summary, this study provides deeper insights into the genetic architecture of a locus important for cardiovascular diseases.

Translational Perspective: Genetic variants identified by GWAS studies explain about a quarter of the heritability of coronary artery disease by additive genetic effects. Our study demonstrates that non-additive effects contribute to the genetic architecture of the disease as well and identifies complex interaction patterns at the LPA locus, which affect LPA expression, Lp(a) plasma levels and risk of atherosclerosis. This proof-of-concept study encourages systematic searches for epistatic interactions in further studies to shed new light on the aetiology of the disease.
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http://dx.doi.org/10.1093/cvr/cvab136DOI Listing
April 2021

Association between duration of drug-coated balloon inflation and efficacy in patients with drug-eluting stent restenosis.

Coron Artery Dis 2021 Apr 19. Epub 2021 Apr 19.

Deutsches Herzzentrum München, an der Technische Universität München Herzzentrum der Segeberger Kliniken Erste medizinisch Klinik, Bad Segeberg, Klinikum rechts der Isar, Technische Universität München DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich Universitäts-Herzzentrum Freiburg-Bad Krozingen, Germany.

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http://dx.doi.org/10.1097/MCA.0000000000001045DOI Listing
April 2021

Efficacy and Safety of Ticagrelor Versus Prasugrel in Women and Men with Acute Coronary Syndrome: A Pre-specified, Sex-Specific Analysis of the ISAR-REACT 5 Trial.

J Atheroscler Thromb 2021 Apr 16. Epub 2021 Apr 16.

Deutsches Herzzentrum München, Cardiology, and Technische Universität München.

Aim: Sex-specific analyses of direct head-to-head comparisons between newer P2Y inhibitors are limited. This study was conducted to assess the efficacy and safety of ticagrelor versus prasugrel in women and men with acute coronary syndromes (ACS) planned for an invasive strategy.

Methods: This pre-specified analysis of the ISAR-REACT 5 trial included 956 women and 3,062 men with ACS randomly assigned to either ticagrelor or prasugrel. The primary endpoint was the 12-month incidence of death, myocardial infarction, or stroke; the safety endpoint was the 12-month incidence of bleeding (type 3-5 according to the Bleeding Academic Research Consortium [BARC]).

Results: The primary endpoint occurred in 42 women (8.9%) in the ticagrelor group and 39 women (8.3%) in the prasugrel group (hazard ratio [HR]=1.10, 95% confidence interval [CI] 0.71-1.70, P=0.657) and in 142 men (9.4%) in the ticagrelor group and 98 men (6.5%) in the prasugrel group (HR=1.47 [1.13-1.90], P=0.004; P for interaction [P]=0.275). BARC type 3-5 bleeding occurred in 36 women (9.7%) in the ticagrelor group and 34 women (9.7%) in the prasugrel group (HR=1.04 [0.65-1.67], P=0.856) and in 59 men in the ticagrelor group (4.4%) and 46 men (3.6%) in the prasugrel group (HR=1.24 [0.85-1.83], P=0.266; P=0.571).

Conclusions: Although there was no significant interaction between sex and treatment effect of study drugs, the superior efficacy of prasugrel was more evident among men. No difference in bleeding between the two study groups was seen for both women and men.
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http://dx.doi.org/10.5551/jat.62776DOI Listing
April 2021

Guided P2Y inhibitor therapy after percutaneous coronary intervention.

Lancet 2021 Apr;397(10283):1423-1425

German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Germany; Deutsches Herzzentrum München, Department of Cardiology, Technische Universität München, Munich 80636, Germany.

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http://dx.doi.org/10.1016/S0140-6736(21)00728-5DOI Listing
April 2021

A proteomic atlas of the neointima identifies novel druggable targets for preventive therapy.

Eur Heart J 2021 May;42(18):1773-1785

Department of Cardiology, German Heart Centre Munich, Technical University of Munich, Munich, Germany.

Aims : In-stent restenosis is a complication after coronary stenting associated with morbidity and mortality. Here, we sought to investigate the molecular processes underlying neointima formation and to identify new treatment and prevention targets.

Methods And Results : Neointima formation was induced by wire injury in mouse femoral arteries. High-accuracy proteomic measurement of single femoral arteries to a depth of about 5000 proteins revealed massive proteome remodelling, with more than half of all proteins exhibiting expression differences between injured and non-injured vessels. We observed major changes in the composition of the extracellular matrix and cell migration processes. Among the latter, we identified the classical transient receptor potential channel 6 (TRPC6) to drive neointima formation. While Trpc6-/- mice presented reduced neointima formation compared to wild-type mice (1.44 ± 0.39 vs. 2.16 ± 0.48, P = 0.01), activating or repressing TRPC6 in human vascular smooth muscle cells resulted in increased [vehicle 156.9 ± 15.8 vs. 1-oleoyl-2-acetyl-sn-glycerol 179.1 ± 8.07 (103 pixels), P = 0.01] or decreased migratory capacity [vehicle 130.0 ± 26.1 vs. SAR7334 111.4 ± 38.0 (103 pixels), P = 0.04], respectively. In a cohort of individuals with angiographic follow-up (n = 3068, males: 69.9%, age: 59 ± 11 years, follow-up 217.1 ± 156.4 days), homozygous carriers of a common genetic variant associated with elevated TRPC6 expression were at increased risk of restenosis after coronary stenting (adjusted odds ratio 1.49, 95% confidence interval 1.08-2.05; P = 0.01).

Conclusions : Our study provides a proteomic atlas of the healthy and injured arterial wall that can be used to define novel factors for therapeutic targeting. We present TRPC6 as an actionable target to prevent neointima formation secondary to vascular injury and stent implantation.
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http://dx.doi.org/10.1093/eurheartj/ehab140DOI Listing
May 2021

Ticagrelor or aspirin after coronary artery bypass in patients with chronic kidney disease.

Ann Thorac Surg 2021 Apr 2. Epub 2021 Apr 2.

Deutsches Herzzentrum Mu¨nchen, Technische Universität Mu¨nchen, Germany; German Center for Cardiovascular Research (DZHK), Munich Heart Alliance, Germany.

Background: The optimal antiplatelet therapy for patients with chronic kidney disease (CKD) undergoing coronary artery bypass grafting (CABG) remains unknown.

Methods: This post hoc analysis of the Ticagrelor in Coronary Artery Bypass (TiCAB) trial examined the efficacy and safety of ticagrelor versus aspirin in patients with or without CKD. Primary endpoint was the composite of cardiovascular death, stroke, myocardial infarction or revascularization (MACCE) at 1 year after CABG. Secondary endpoints included individual components of the primary endpoint, all-cause death, and major bleeding.

Results: CKD was present in 276 of 1,843 randomized patients (15.0%). Patients with CKD versus those without CKD had higher 1-year rates of MACCE (13.0% vs. 8.3%, HR 1.63, 95% CI 1.12-2.39, P=0.01) and major bleeding (5.6% vs. 3.1%, HR 1.84, 95% CI 1.03-3.28, P=0.04). The 1-year rate of MACCE was increased with ticagrelor versus aspirin in patients with CKD (18.2% vs. 8.9%, HR 2.15, 95% CI 1.08-4.30, P=0.03), but not in patients without CKD (8.5% vs. 8.1%, HR 1.05, 95% CI 0.74-1.49, P=0.79) (P=0.067). There was no difference in the 1-year rate of major bleeding with ticagrelor versus aspirin in patients with CKD (6.6% vs. 4.7%, HR 1.44, 95% CI 0.52-3.97, P=0.48) and without CKD (3.3% vs. 2.9%, HR 1.14, 95% CI 0.64-2.01, P=0.65).

Conclusions: In patients with CKD and CABG, those who received ticagrelor had a higher incidence of MACCE but a similar incidence of major bleeding compared to those who received aspirin.
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http://dx.doi.org/10.1016/j.athoracsur.2021.03.061DOI Listing
April 2021

Efficacy and Safety of Revacept, a Novel Lesion-Directed Competitive Antagonist to Platelet Glycoprotein VI, in Patients Undergoing Elective Percutaneous Coronary Intervention for Stable Ischemic Heart Disease: The Randomized, Double-blind, Placebo-Controlled ISAR-PLASTER Phase 2 Trial.

JAMA Cardiol 2021 Mar 31. Epub 2021 Mar 31.

Department of Cardiology, Medizinische Klinik und Poliklinik I, Munich University Clinic, Ludwig-Maximilian University of Munich, Munich, Germany.

Importance: The assessment of new antithrombotic agents with a favorable safety profile is clinically relevant.

Objective: To test the efficacy and safety of revacept, a novel, lesion-directed antithrombotic drug, acting as a competitive antagonist to platelet glycoprotein VI.

Design, Setting, And Participants: A phase 2 randomized clinical trial; patients were enrolled from 9 centers in Germany from November 20, 2017, to February 27, 2020; follow-up ended on March 27, 2020. The study included patients with stable ischemic heart disease (SIHD) undergoing elective percutaneous coronary intervention (PCI).

Interventions: Single intravenous infusion of revacept, 160 mg, revacept, 80 mg, or placebo prior to the start of PCI on top of standard antithrombotic therapy.

Main Outcomes And Measures: The primary end point was the composite of death or myocardial injury, defined as an increase in high-sensitivity cardiac troponin to at least 5 times the upper limit of normal within 48 hours from randomization. The safety end point was bleeding type 2 to 5 according to the Bleeding Academic Research Consortium criteria at 30 days.

Results: Of 334 participants (median age, 67.4 years; interquartile range, 60-75.1 years; 253 men [75.7%]; and 330 White participants [98.8%]), 120 were allocated to receive the 160-mg dose of revacept, 121 were allocated to receive the 80-mg dose, and 93 received placebo. The primary end point showed no significant differences between the revacept and placebo groups: 24.4%, 25.0%, and 23.3% in the revacept, 160 mg, revacept, 80 mg, and placebo groups, respectively (P = .98). The high dose of revacept was associated with a small but significant reduction of high-concentration collagen-induced platelet aggregation, with a median 26.5 AU × min (interquartile range, 0.5-62.2 AU × min) in the revacept, 160 mg, group; 43.5 AU × min (interquartile range, 22.8-99.5 AU × min) in the revacept, 80 mg, group; and 41.0 AU × min (interquartile range, 31.2-101.0 AU × min) in the placebo group (P = .02), while adenosine 5'-diphosphate-induced aggregation was not affected. Revacept did not increase Bleeding Academic Research Consortium type 2 or higher bleeding at 30 days compared with placebo: 5.0%, 5.9%, and 8.6% in the revacept, 160 mg, revacept, 80 mg, and placebo groups, respectively (P = .36).

Conclusions And Relevance: Revacept did not reduce myocardial injury in patients with stable ischemic heart disease undergoing percutaneous coronary intervention. There were few bleeding events and no significant differences between treatment arms.

Trial Registration: ClinicalTrials.gov Identifier: NCT03312855.
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http://dx.doi.org/10.1001/jamacardio.2021.0475DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8014195PMC
March 2021

Antithrombotic treatment in primary percutaneous coronary intervention.

Expert Rev Cardiovasc Ther 2021 Apr 25;19(4):313-324. Epub 2021 Mar 25.

Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.

Introduction: Despite a timely mechanical reperfusion with primary percutaneous coronary intervention (pPCI) patients presenting with ST-elevation myocardial infarction (STEMI) display an increased risk of adverse cardiovascular events. Several studies have demonstrated that guideline-directed antithrombotic therapy is effective to reduce this risk. However, there is still much to be accomplished to improve antithrombotic therapies in this clinical setting.

Areas Covered: This paper reviews current data on antithrombotic therapy in STEMI patients undergoing pPCI.

Expert Opinion: Antithrombotic therapy for STEMI patients undergoing pPCI should take into account the variability of thrombotic and bleeding risk in the short and long term. Patients with STEMI profit from the administration of early onset antiplatelet agents and anticoagulation to achieve sufficient and predictable antithrombotic effect at the time of pPCI. Thereafter, antithrombotic therapies should be tailored to individual risk of recurrence over the long term, to avoid excess bleeding, while ensuring adequate secondary ischemic prevention.
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http://dx.doi.org/10.1080/14779072.2021.1902807DOI Listing
April 2021

Clinical and angiographic outcomes of crossing techniques for coronary chronic total occlusions - The ISAR-CTO Registry.

EuroIntervention 2021 Mar 2. Epub 2021 Mar 2.

Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.

Background: Clinical and angiographic outcomes following recanalization of coronary chronic total occlusions (CTO) through contemporary dissection and reentry techniques (DART) as opposed to intraplaque techniques remain controversial.

Aims: To compare clinical and angiographic outcomes following subintimal and intraplaque CTO recanalization.

Methods: 453 consecutive patients undergoing successful CTO recanalization (473 vessels) were included. Intraplaque techniques were used in 403 (85.2%) and DART in 70 (14.8%) vessels. Surveillance angiography was scheduled at 6-9 months and clinical follow-up was performed up to 12 months.

Results: No significant differences in terms of cumulative incidence of MACE (P=0.862) or binary restenosis (P=0.320) were present between the two groups. There was no independent correlation between recanalization technique and MACE occurrence or in-segment binary restenosis. Target lesion revascularization (TLR) was performed in 60 (15.5%) and 12 (17.9%) (P=0.678) lesions respectively. The occurrence of occlusive restenosis was low [7 (2.3%) vs. 1 (1.6%); P=0.824] and comparable between groups.

Conclusions: Contemporary DART are associated with similar mid-term clinical and angiographic outcomes compared to intraplaque recanalization. Rate of occlusive restenosis was low and comparable in both groups. Regardless of recanalization technique, overall incidence of binary restenosis and TLR following CTO recanalization remain higher than those reported for non-CTO PCI.
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http://dx.doi.org/10.4244/EIJ-D-20-01248DOI Listing
March 2021

Design and rationale of a randomized trial of COBRA PzF stenting to REDUCE duration of triple therapy (COBRA-REDUCE).

Cardiovasc Revasc Med 2021 Jan 22. Epub 2021 Jan 22.

Cardiovascular Research Institute Dublin, Mater Private Hospital, Dublin, Ireland; School of Pharmacy and Biomolecular Sciences, Royal College of Surgeons University of Medicine and Health Sciences, Dublin, Ireland. Electronic address:

Background/purpose: A coronary stent with thromboresistant and pro-healing properties such as the polymer polyzene F-coated (COBRA PzF) stent might safely allow for a very short duration of triple therapy in patients taking oral anticoagulation (OAC) who undergo coronary stenting.

Methods: The COBRA-REDUCE trial is a prospective, multinational, randomized, open-label, assessor-blinded trial. A total of 996 patients at high bleeding risk because of requirement for OAC (with a vitamin K antagonist or non-vitamin K antagonist for any indication) will be randomized at sites in the United States and Europe to treatment with the COBRA-PzF stent followed by very short duration (14 days) DAPT or a Food and Drug Administration (FDA)-approved new generation drug-eluting stent followed by guideline-recommended DAPT duration (3 or 6 months). Two co-primary endpoints will be tested at 6 months: a bleeding co-primary endpoint (bleeding academic research consortium [BARC] ≥2 bleeding beyond 14 days or after hospital discharge, whichever is later [superiority hypothesis]) and a thrombo-embolic co-primary endpoint (the composite of all-cause death, myocardial infarction, definite/probable stent thrombosis or ischaemic stroke [non-inferiority hypothesis]). The trial is registered at clinicaltrials.gov (NCT02594501).

Conclusion: The COBRA-REDUCE trial will determine whether coronary stenting with the COBRA PzF stent followed by 14 days of clopidogrel will reduce bleeding without increasing thrombo-embolic events compared with FDA-approved DES followed by 3-6 months clopidogrel in patients taking OAC and aspirin.
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http://dx.doi.org/10.1016/j.carrev.2021.01.022DOI Listing
January 2021

Creatine kinase and bleeding in patients with acute coronary syndromes.

Eur J Clin Invest 2021 Feb 11:e13514. Epub 2021 Feb 11.

Deutsches Herzzentrum München, Technische Universität, Munich, Germany.

Background: The association between elevated creatine kinase (CK) and bleeding in patients with acute coronary syndrome (ACS) remains incompletely investigated. We undertook this study to assess whether there is an association between elevated CK activity and the risk for bleeding in contemporary patients with ACS.

Materials And Methods: This post hoc analysis of a randomized trial included 3368 patients with ACS undergoing percutaneous coronary intervention. CK was measured serially in all patients until hospital discharge. The main outcome was 30-day incidence of major bleeding (type 3 to 5 bleeding according to the Bleeding Academic Research Consortium criteria).

Results: Patients were categorized in groups according to the peak CK tertiles: 1st tertile (CK ≤259 U/L; n = 1127 patients), 2nd tertile (CK ≥260 to 990 U/L; n = 1119 patients), and 3rd tertile (CK ≥ 991 U/L; n = 1122 patients). Peak CK activity was higher in patients with bleeding than those without bleeding (771 [316-1845] U/L vs. 496 [190-1357] U/L; P <.001). Bleeding occurred in 26 patients (2.3%) with peak CK within 1st tertile, 39 patients (3.5%) with peak CK within 2nd tertile, and 54 patients (4.8%) with peak CK within 3rd tertile (univariable hazard ratio [HR]=1.39, 95% confidence interval [CI] 1.08 to 1.81, P =.012, per tertile increment in CK values). After adjustment, peak CK activity remained significantly associated with the 30-day bleeding (HR = 1.67 [1.16-2.41]; P =.006 per unit increment in logarithmic CK values). The C statistic of the multivariable model with CK activity was 0.807 [0.770-0.842].

Conclusions: In patients with ACS, peak CK activity was independently associated with increased 30-day incidence of bleeding.
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http://dx.doi.org/10.1111/eci.13514DOI Listing
February 2021

Letter by Kessler et al Regarding Article, "Comparative Efficacy and Safety of Oral P2Y12 Inhibitors in Acute Coronary Syndrome: Network Meta-Analysis of 52 816 Patients From 12 Randomized Trials".

Circulation 2021 Feb 8;143(6):e230-e231. Epub 2021 Feb 8.

Department of Cardiology, German Heart Centre Munich, Technical University of Munich (T.K., S.C., A.K.).

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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.049650DOI Listing
February 2021

Antiplatelet therapy in patients with myocardial infarction without obstructive coronary artery disease.

Heart 2021 Jan 27. Epub 2021 Jan 27.

Population Health Research Institute (PHRI), Hamilton, Ontario, Canada

Objective: Approximately 10% of patients with myocardial infarction (MI) have no obstructive coronary artery disease. The prognosis and role of intensified antiplatelet therapy in those patients were evaluated.

Methods: We analysed data from the Clopidogrel and Aspirin Optimal Dose Usage to Reduce Recurrent Events-Seventh Organisation to Assess Strategies in Ischaemic Symptoms trial randomising patients with ACS referred for early intervention to receive either double-dose (600 mg, day 1; 150 mg, days 2-7; then 75 mg/day) or standard-dose (300 mg, day 1; then 75 mg/day) clopidogrel. Outcomes in patients with myocardial infarction with non-obstructive coronary arteries (MINOCA) versus those with obstructive coronary artery disease (CAD) and their relation to standard-dose versus double-dose clopidogrel were evaluated. The primary outcome was cardiovascular (CV) death, MI or stroke at 30 days.

Results: We included 23 783 patients with MI and 1599 (6.7%) with MINOCA. Patients with MINOCA were younger, presented more frequently with non-ST-segment elevation MI and had fewer comorbidities. All-cause mortality (0.6% vs 2.3%, p=0.005), CV mortality (0.6% vs 2.2%, p=0.006), repeat MI (0.5% vs 2.3%, p=0.001) and major bleeding (0.6% vs 2.4%, p<0.0001) were lower among patients with MINOCA than among those with obstructive CAD. Among patients with MINOCA, 2.1% of patients in the double-dose clopidogrel group and 0.6% in the standard-dose group experienced a primary outcome (HR 3.57, 95% CI 1.31 to 9.76), whereas in those with obstructive CAD, rates were 4.3% and 4.7%, respectively (HR 0.91, 95% CI 0.80 to 1.03; p value for interaction=0.011).

Conclusions: Patients with MINOCA are at lower risk of recurrent CV events compared with patients with MI with obstructive CAD. Compared with a standard clopidogrel-based dual antiplatelet therapy (DAPT) regimen, an intensified dosing strategy appears to offer no additional benefit with a signal of possible harm. Further randomised trials evaluating the effects of potent DAPT in patients with MINOCA are warranted.

Trial Registration Number: NCT00335452.
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http://dx.doi.org/10.1136/heartjnl-2020-318045DOI Listing
January 2021

Impact of calcified lesion complexity on the success of percutaneous coronary intervention with upfront high-speed rotational atherectomy or modified balloons - A subgroup-analysis from the randomized PREPARE-CALC trial.

Cardiovasc Revasc Med 2021 Jan 7. Epub 2021 Jan 7.

Heart Center Bad Segeberg, Segeberger Kliniken GmbH, Bad Segeberg, Germany. Electronic address:

Background/purpose: In the randomized PREPARE-CALC trial, lesion preparation of calcified lesions with upfront rotational atherectomy (RA) prior to drug-eluting stent (DES) implantation resulted in higher acute success as compared to a provisional modified balloon (MB) strategy. We aimed to investigate the impact of calcified lesion complexity on the treatment effect with either MB or RA.

Methods/materials: Two hundred patients were randomized to lesion preparation with either MB or RA. The study population was stratified according to lesion complexity into at least one type-C lesion or into exclusively non-type-C lesions. Endpoints were strategy success, need for bail-out RA, acute lumen gain, and late lumen loss (LLL) at 9 months.

Results: In total, 143 patients were graded as type-C (45% patients were allocated to MB), whereas 57 patients were graded as non-type-C (61% patients were allocated to MB). In patients with at least one type-C lesion, strategy success with RA was higher than with MB (97% vs 72%, p < 0.001), but superiority of RA was not observed in patients with non-type-C lesions (100% vs 97%, p = 1.00; p = 0.001). The need for bail-out RA was higher in patients with type-C lesions (n = 15) as compared with non-type-C lesions (n = 1). Acute lumen gain, LLL, and target lesion revascularization at 9 months were not dependent on lesion complexity and upfront lesion preparation strategy.

Conclusions: In patients with calcified non-type-C lesions, the treatment strategy with RA or MB before DES implantation results in comparable success rates, whereas in type-C lesions upfront RA appears to be the superior upfront strategy.
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http://dx.doi.org/10.1016/j.carrev.2021.01.002DOI Listing
January 2021

SARS-CoV-2 Infection in Asymptomatic Patients Hospitalized for Cardiac Emergencies: Implications for Patient Management.

Front Cardiovasc Med 2020 18;7:599299. Epub 2020 Dec 18.

Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) e.V., Partner Site Munich Heart Alliance, Munich, Germany.

The coronavirus disease (COVID-19) pandemic imposed diverse challenges on the health care system. Morbidity and mortality of non-COVID-19 emergencies might also have changed because hospitals may not be able to provide optimal care due to restructured resources and uncertainties how to deal with potentially infected patients. It has been recommended to stratify treatment of cardiovascular emergencies according to cardiovascular risk. However, data on the prevalence of asymptomatic SARS-CoV-2 infection in patients presenting with cardiac emergencies remain scarce. We retrospectively analyzed patients' data from a tertiary cardiology department between April 15 and May 31, 2020. All patients were screened on admission for COVID-19 symptoms using a questionnaire and body temperature measurements. All hospitalized patients were routinely screened using nasopharyngeal swab testing. In total, we counted 710 urgent and emergency admissions. Nasopharyngeal swab tests were available in 689 (97%) patients, 409 and 280 of which presented as urgent and emergency admissions, respectively. Among 280 emergency admissions, none tested positive for SARS-CoV-2. In cardiac emergency patients which were screened negative for COVID-19 symptoms, the prevalence of SARS-CoV-2 infection in regions with a modest overall prevalence is low. This finding might be helpful to better determine timing of emergency procedures and reasonable usage of protective equipment during the COVID-19 crisis and the future.
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http://dx.doi.org/10.3389/fcvm.2020.599299DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7793638PMC
December 2020

Impact of oral anticoagulation on clinical outcomes of COVID-19: a nationwide cohort study of hospitalized patients in Germany.

Clin Res Cardiol 2021 Jan 8. Epub 2021 Jan 8.

AOK Research Institute (WIdO), Berlin, Germany.

Objectives: The aim of this study was to investigate the impact of concomitant long-term medication-with a focus on ACE inhibitors and oral anticoagulation-on clinical outcomes in patients hospitalized with coronavirus disease 2019.

Methods: This is a retrospective cohort study using claims data of the biggest German health insurance company AOK, covering 26.9 million people all over Germany. In particular, patient-related characteristics and co-medication were evaluated. A multivariable logistic regression model was adopted to identify independent predictors for the primary outcome measure of all-cause mortality or need for invasive or non-invasive ventilation or extracorporeal membrane oxygenation.

Results: 6637 patients in 853 German hospitals were included. The primary outcome occurred in 1826 patients (27.5%). 1372 patients (20.7%) died, 886 patients (13.3%) needed respiratory support, and 53 patients (0.8%) received extracorporeal membrane oxygenation. 34 of these patients survived (64.2%). The multivariable model demonstrated that pre-existing oral anticoagulation therapy with either vitamin-K antagonists OR 0.57 (95% CI 0.40-0.83, p = 0.003) or direct oral anticoagulants OR 0.71 (95% CI 0.56-0.91, p = 0.007)-but not with antiplatelet therapy alone OR 1.10 (95% CI 0.88-1.23, p = 0.66)-was associated with a lower event rate. This finding was confirmed in a propensity match analysis.

Conclusions: In a multivariable analysis, a therapy with both direct oral anticoagulants or vitamin-K antagonists-but not with antiplatelet therapy-was associated with improved clinical outcomes. ACE inhibitors did not impact outcomes. Prospective randomized trials are needed to verify this hypothesis.
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http://dx.doi.org/10.1007/s00392-020-01783-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7791911PMC
January 2021

Early Aspirin Discontinuation After Coronary Stenting: A Systematic Review and Meta-Analysis.

J Am Heart Assoc 2021 Jan 7;10(2):e018304. Epub 2021 Jan 7.

Klinik für Herz- und Kreislauferkrankungen Deutsches Herzzentrum MünchenTechnische Universität München Munich Germany.

Background The clinical impact of early aspirin discontinuation compared with dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention with stenting remains poorly studied. We investigated the clinical outcomes of patients assigned to either early aspirin discontinuation or DAPT after percutaneous coronary intervention with stenting. Methods and Results We performed a meta-analysis of aggregate data from randomized clinical trials enrolling participants receiving a percutaneous coronary intervention with stenting and assigned to either early aspirin discontinuation or DAPT. Scientific databases were searched from inception through March 30, 2020. Trial-level hazard ratios (HRs) and 95% CIs were pooled using a random effects model with inverse variance weighting. The primary outcome was all-cause death. Secondary outcomes were myocardial infarction, stent thrombosis, stroke, and major bleeding. Overall, 36 206 participants were allocated to either early aspirin discontinuation (experimental therapy, n=18 088) or DAPT (control therapy, n=18 118) in 7 trials. Median follow-up was 12 months. All-cause death occurred in 2.5% of patients assigned to experimental and 2.9% of patients assigned control therapy (hazard ratio [HR], 0.91, 95% CI, 0.75-1.11; =0.37). Overall, patients treated with experimental versus control therapy showed no significant difference in terms of myocardial infarction (HR, 1.02 [0.85-1.22], =0.81), stent thrombosis (HR, 1.02 [0.87-1.20], =0.83), or stroke (HR, 1.01 [0.68-1.49], =0.96). However, the risk for major bleeding (HR, 0.58 [0.43-0.77], <0.01) was significantly reduced by experimental as compared with control therapy. Conclusions In patients treated with percutaneous coronary intervention and stenting, assigned to a strategy of early aspirin discontinuation versus DAPT, the risk of death and ischemic events is not significantly different but the risk of bleeding is lower.
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http://dx.doi.org/10.1161/JAHA.120.018304DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7955304PMC
January 2021

Antithrombotic therapy with or without clopidogrel after transcatheter aortic valve replacement. A meta-analysis of randomized controlled trials.

Clin Res Cardiol 2020 Dec 23. Epub 2020 Dec 23.

Klinik Für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse, 36, Munich, Germany.

Aims: To investigate the clinical outcomes associated with an antithrombotic therapy with or without clopidogrel after transcatheter aortic valve replacement (TAVR).

Methods And Results: This is a study-level meta-analysis including all randomized trials investigating antithrombotic regimens after TAVR. The protocol was registered with PROSPERO (CRD42020191036). We searched electronic scientific databases for eligible studies. The primary outcome was all-cause death. Main secondary outcome was major bleeding. Other outcomes were life-threatening (or disabling) bleeding, myocardial infarction (MI) and stroke. Six eligible trials randomly allocated 3056 TAVR patients to aspirin or oral anticoagulation (OAC) with clopidogrel (n = 1525) versus aspirin and/or OAC without clopidogrel (n = 1531). In the overall estimates, an antithrombotic therapy with clopidogrel versus without displayed a comparable risk of all-cause death [Risk Ratio-RR = 0.83, 95% Confidence intervals-CI (0.57-1.20); P = 0.25] and major bleeding [RR = 1.33, 95% CI (0.61-2.92); P = 0.39]. However, the combination of aspirin or OAC with clopidogrel doubled the risk of major bleeding as compared to aspirin or OAC without clopidogrel [RR = 2.08, 95% CI (1.27-3.42); P = 0.015, P for interaction = 0.021]. Treatment strategies did not differ with respect to the risk of life-threatening bleeding, MI and stroke.

Conclusions: In patients receiving TAVR, a therapeutic strategy of aspirin or OAC with clopidogrel significantly increases the risk of major bleeding without impact on mortality and ischemic outcomes compared to aspirin or OAC without clopidogrel. The performance of different antithrombotic regimens in terms of long-term clinical outcomes and bioprosthesis valve function requires further investigation. Forest plots from pairwise and network meta-analyses associated with an antithrombotic therapy with or without clopidogrel Risk ratio for all outcomes of interest calculated with the pairwise meta-analysis (left side) and for main outcomes calculated with the network meta-analysis (right side) in patients allocated to an antithrombotic therapy with clopidogrel or without. The diamonds indicate the point estimate and the left and the right ends of the lines the [95% CI]. CI: Confidence intervals; OAC; oral anticoagulation.
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http://dx.doi.org/10.1007/s00392-020-01791-xDOI Listing
December 2020

Comparison of latest generation supra-annular and intra-annular self-expanding transcatheter heart valves.

J Thorac Dis 2020 Nov;12(11):6769-6779

Klinik für Herz-und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.

Background: This study compares two latest-generation self-expanding transcatheter heart valves (THV), the supra-annular ACURATE neo (Boston Scientific) and the intra-annular Centera THV (Edwards Lifesciences).

Methods: In this single center observational cohort trial 317 patients treated with the ACURATE neo and 78 patients treated with the Centera TVH were included. The main endpoints were device success and the early safety endpoint at 30 days.

Results: Besides higher incidence of diabetes mellitus and higher body mass index in patients treated with the ACURATE neo THV, there were no baseline differences between the groups. Device success was similar in both groups (neo: 91.8% Centera: 93.6%; P=0.598), with numerically higher rates of moderate to severe paravalvular leakage in the ACURATE neo group (4.7% 1.3%; P=0.214). At 30 days all-cause mortality rates were low in both groups (0.3% 0%; P=0.620) and no difference occurred in the early safety at 30 days (19.3% 16.7%; P=0.599). However, all-cause stroke rates were significantly higher in patients treated with the Centera THV (6.4 1.6%; P=0.015).

Conclusions: The ACURATE neo and the Centera THV show low mortality rates as well as comparable, favorable hemodynamics. The finding of higher stroke rates at 30 days with the repositionable Centera SE-THV needs further assessment.
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http://dx.doi.org/10.21037/jtd-20-1700DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7711404PMC
November 2020

Super High-Pressure Balloon versus Scoring Balloon to Prepare Severely Calcified Coronary Lesions: The ISAR-CALC Randomized Trial.

EuroIntervention 2020 Dec 1. Epub 2020 Dec 1.

Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Munich, Germany.

Aims: The comparative efficacy of balloon-based techniques to prepare severely calcified coronary lesions before stenting remains poorly studied. We sought to compare stent expansion following preparation of severely calcified coronary lesions with either super high-pressure balloon or scoring balloon.

Methods And Results: In this randomized, open-label trial 74 patients with severely calcified coronary lesions were enrolled at 5 centers in Germany and Switzerland. After unsuccessful lesion preparation with standard non-compliant balloon (<30% reduction of baseline diameter stenosis), participants were randomized to pre-dilation with either super high-pressure balloon or scoring balloon before drug-eluting stent (DES) implantation. The primary endpoint of the study was stent expansion index as assessed by optical coherence tomography (OCT). The key secondary endpoints included angiographic, strategy and procedural success. OCT data after DES implantation was available for 70 patients (94.6%). Lesion preparation with super high-pressure balloon versus scoring balloon led to comparable stent expansion index (0.72±0.12 versus 0.68±0.13; p=0.22). Compared with scoring balloon, super high-pressure balloon increased minimum lumen diameter (2.83±0.34 mm versus 2.65±0.36 mm; p=0.03) and reduced diameter stenosis (11.6±4.8% versus 14.4±5.6%; p=0.02) without difference in terms of angiographic success (100% versus 97.3%; p>0.99). Strategy success (91.9% versus 83.8%; p=0.48) and procedural success (100% versus 89.2%; p=0.12) were numerically more frequent with super high-pressure balloon versus scoring balloon.

Conclusions: In patients with severely calcified coronary artery lesions, preparation with super high-pressure balloon versus scoring balloon was associated with comparable stent expansion on intravascular imaging and a signal toward improved angiographic performance.
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http://dx.doi.org/10.4244/EIJ-D-20-01000DOI Listing
December 2020

Antiplatelet strategies in acute coronary syndromes: design and methodology of an international collaborative network meta-analysis of randomized controlled trials.

Minerva Cardioangiol 2020 Dec 1. Epub 2020 Dec 1.

Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA -

Introduction: The optimal choice of oral P2Y12 receptor inhibitors has the potential to significantly influence outcomes. We seek to compare the safety and efficacy of the three most commonly used oral P2Y12 receptor inhibitors (clopidogrel, prasugrel, and ticagrelor) in acute coronary syndromes (ACS) via a comprehensive systematic review and network meta-analysis.

Evidence Acquisition: We will perform a comprehensive search for randomized clinical trials which compared cardiovascular and hemorrhagic outcomes after use of at least two of the distinct oral P2Y12 receptor inhibitors (i.e. clopidogrel, prasugrel, and ticagrelor). In addition, key inclusion criteria will be trial size of at least 100 patients and at least 1 month of follow-up time. Several pre-specified subgroups will be explored, including Asian patients, patients presenting with ST-elevation myocardial infarction, patients of advanced age, and others.

Evidence Synthesis: Exploratory frequentist pairwise meta-analyses will be based primarily on a random-effects method, relying on relative risks (RR) for short-term endpoints and incidence rate ratios (IRR) for long-term endpoints. Inferential frequentist network meta-analysis will be based primarily on a random-effects method, relying on RR and IRR as specified above. Results will be reported as point summary of effect, 95% CI, and p-values for effect, and graphically represented using forest plots.

Conclusions: An international collaborative network meta-analysis has begun to comprehensively analyze the safety and efficacy of prasugrel, ticagrelor and clopidogrel, each on a background of aspirin, for management of patients with ACS. It is our hope that the rigor and breadth of the undertaking described herein will provide novel insights that will inform optimal patient care for patients with ACS treated conservatively, or undergoing revascularization.
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http://dx.doi.org/10.23736/S0026-4725.20.05353-0DOI Listing
December 2020

Outcomes of endovascular treatment for infrapopliteal peripheral artery disease based on the updated TASC II classification.

Vasc Med 2021 Feb 1;26(1):18-25. Epub 2020 Dec 1.

Klinikum rechts der Isar, Klinik und Poliklinik für Innere Medizin I., Technische Universität München, Munich, Germany.

We retrospectively analyzed all endovascular procedures of infrapopliteal arterial lesions ( = 383) performed in 270 patients at our institution between December 2008 and January 2018. The overall technical success rate was 97% and yielded 98% for stenoses ( = 214) and 95% for occlusions ( = 169). Trans-Atlantic Inter-Society Consensus (TASC II) classification had no impact on success rates (TASC A + B vs C + D; 96.5% vs 96.9%, = 0.837). Freedom from clinically driven target lesion revascularization (TLR) after 6 and 12 months was 88.3% and 77.2%. TLR was comparable for TASC A to C lesions and no difference was observed comparing groups of moderately complex TASC A/B lesions and more complex TASC C/D lesions (TASC A + B vs C + D; 78.5% vs 74.2%, = 0.457). Freedom from TLR was significantly lower in very complex TASC D lesions (TASC A + B + C vs D; 79.7% vs 42.5%, < 0.001). Multivariate analysis identified TASC D lesions (hazard ratio D/A: 1.5; overall = 0.002), Fontaine class III and IV (hazard ratio III or IV/IIa or IIb: 2.4; = 0.041), and occlusive lesions (hazard ratio occlusion/stenosis: 2.4; = 0.026) as predictors for TLR. In conclusion, endovascular therapy for infrapopliteal artery disease was safe and accompanied with a promising long-term outcome.
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http://dx.doi.org/10.1177/1358863X20967091DOI Listing
February 2021

Anatomic and Flow Characteristics of Left Anterior Descending Coronary Artery Angiographic Stenoses Predisposing to Myocardial Infarction.

Am J Cardiol 2021 02 19;141:7-15. Epub 2020 Nov 19.

Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.

The impact of the anatomic characteristics of coronary stenoses on the development of future coronary thrombosis has been controversial. This study aimed at identifying the anatomic and flow characteristics of left anterior descending (LAD) coronary artery stenoses that predispose to myocardial infarction, by examining angiograms obtained before the index event. We identified 90 patients with anterior ST-elevation myocardial infarction (STEMI) for whom coronary angiograms and their reconstruction in the three-dimensional space were available at 6 to 12 months before the STEMI, and at the revascularization procedure. The majority of culprit lesions responsible for STEMI occurred between 20 and 40 mm from the LAD ostium, whereas the majority of stable lesions not associated with STEMI were found in distances >60 mm (p < 0.001). Culprit lesions were significantly more stenosed (diameter stenosis 68.6 ± 14.2% vs 44.0 ± 10.4%, p < 0.001), and significantly longer than stable ones (15.3 ± 5.4 mm vs 9.2 ± 2.5 mm, p < 0.001). Bifurcations at culprit lesions were significantly more frequent (88.8%) compared with stable lesions (34.4%, p < 0.001). Computational fluid dynamics simulations demonstrated that hemodynamic conditions in the vicinity of culprit lesions promote coronary thrombosis due to flow recirculation. A multiple logistic regression model with diameter stenosis, lesion length, distance from the LAD ostium, distance from bifurcation, and lesion symmetry, showed excellent accuracy in predicting the development of a culprit lesion (AUC: 0.993 [95% CI: 0.969 to 1.000], p < 0.0001). In conclusion, specific anatomic and hemodynamic characteristics of LAD stenoses identified on coronary angiograms may assist risk stratification of patients by predicting sites of future myocardial infarction.
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http://dx.doi.org/10.1016/j.amjcard.2020.11.012DOI Listing
February 2021

Ticagrelor or Prasugrel in Patients With Non-ST-Segment Elevation Acute Coronary Syndromes.

J Am Coll Cardiol 2020 11;76(21):2436-2446

Deutsches Herzzentrum München, Cardiology, and Technische Universität München, Munich, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Munich, Germany.

Background: Current guidelines recommend intensified platelet inhibition by prasugrel or ticagrelor in patients with unstable angina (UA) or non-ST-segment elevation (NSTE) myocardial infarction (MI).

Objectives: This study sought to investigate the benefits and risks of ticagrelor as compared with prasugrel in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) and planned invasive management.

Methods: This post hoc analysis combines the pre-specified subgroups of UA and NSTEMI of the randomized ISAR-REACT 5 trial. It included 1,179 patients assigned to ticagrelor and 1,186 assigned to prasugrel. Ticagrelor was started immediately after randomization and prasugrel after coronary angiography. The primary endpoint was a composite of death, MI, or stroke during 1-year follow-up, and the safety endpoint was Bleeding Academic Research Consortium class 3-5.

Results: The primary endpoint was reached in 101 (8.7%) patients in the ticagrelor and in 73 (6.3%) patients in the prasugrel group (hazard ratio [HR]: 1.41; 95% confidence interval [CI]: 1.04 to 1.90). The HR for all-cause death was 1.43 (95% CI: 0.93 to 2.21) and that for MI 1.43 (95% CI: 0.94 to 2.19). The safety endpoint occurred in 49 (5.2%) patients in the ticagrelor and in 41 (4.7%) patients in the prasugrel group (HR: 1.09; 95% CI: 0.72 to 1.65). Landmark analysis revealed persistence of the efficacy advantage with prasugrel after the first month.

Conclusions: In patients with NSTE-ACS, we found that prasugrel was superior to ticagrelor in reducing the combined 1-year risk of death, MI, and stroke without increasing the risk of bleeding. Due to the post hoc nature of the analysis, these findings need confirmation by further studies. (Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome; NCT01944800).
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http://dx.doi.org/10.1016/j.jacc.2020.09.584DOI Listing
November 2020

Evaluation of a Low-Dose Radiation Protocol During Transcatheter Aortic Valve Implantation.

Am J Cardiol 2021 01 24;139:71-78. Epub 2020 Oct 24.

German Heart Centre Munich, Technical University Munich, Munich, Germany; Department of Cardiology, University Heart Centre, University Hospital Zurich, Zurich, Switzerland. Electronic address:

We aimed to evaluate the efficacy and safety of a low-dose imaging protocol to reduce intraprocedural radiation during transcatheter aortic valve implantation (TAVI). Observational analysis: 802 transfemoral TAVI patients receiving balloon-expandable devices ≥23 mm at a high-volume centre. After propensity score matching, a standard-dose group (SD, n = 333) treated between January 2014 and February 2016 was compared with a low-dose group (LD, n = 333) treated between August 2017 and March 2019 after departmental uptake of a low-dose imaging protocol (reduced field size, high table height, use of "fluoro save," 3.75 frames/second acquisition, increased filtering). Primary end point was dose-area product (DAP). Secondary safety end points were VARC-2 device success and a composite of in-hospital complications. The LD protocol was associated with lower DAP (4.64 [2.93, 8.42] vs 22.73 [12.31, 34.58] Gy⋅cm, p <0.001) and fluoroscopy time (10.4 [8.1, 13.9] vs 11.5 [9.1, 15.3] minutes, p = 0.001). Contrast use was higher in the LD group (LD 110 [94, 130] vs SD 100 [80, 135] milliliters, p = 0.042). Device success (LD 88.3% vs SD 91.3%, p = 0.25), and the composite end point (LD 8.1% vs SD 11.4%, p = 0.19) were similar. In multivariate analysis, the low-dose protocol was associated with a 19.8 Gy⋅cm reduction in procedural DAP (p <0.001). In conclusion, compared with standard imaging, a low-dose protocol for TAVI significantly reduced radiation dose without compromising outcomes.
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http://dx.doi.org/10.1016/j.amjcard.2020.10.035DOI Listing
January 2021

Clinical outcomes of complete versus incomplete revascularization in patients treated with coronary artery bypass grafting: insights from the TiCAB trial.

Eur J Cardiothorac Surg 2020 Nov 14. Epub 2020 Nov 14.

Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.

Objectives: In this post hoc analysis of the Ticagrelor in coronary artery bypass grafting (CABG) trial, we aimed to analyse patients treated with CABG receiving either complete revascularization (CR) or incomplete revascularization (ICR) independent from random allocation to either ticagrelor or aspirin.

Methods: Of 1859 patients enrolled in the Ticagrelor in CABG trial, 1550 patients (83.4%) received CR and 309 patients (16.6%) ICR. Outcomes were evaluated regarding all-cause mortality, cardiovascular death, myocardial infarction (MI), repeat revascularization, stroke and bleeding within 12 months after CABG.

Results: Baseline parameters revealed significant differences regarding clinical presentation (stable angina pectoris: CR 68.9% vs ICR 71.2%, instable angina pectoris: 14.1% vs 7.8%, non-ST elevation MI: 17.0% vs 21.0%, P ˂ 0.01), lesion characteristics (chronic total occlusion: CR 91.3% vs ICR 96.8%, P ˂ 0.01), operative technique [off-pump coronary artery bypass surgery (OPCAB): CR 3.0% vs ICR 6.1%, P ˂ 0.01] and number of utilized grafts (total number of grafts: 2.69/patient vs 2.49/patient, P ˂ 0.001). ICR patients displayed a significantly increased risk of repeat revascularization [hazard ratio (HR) 1.91, 95% confidence interval (CI) 1.16-3.16; P < 0.01] and percutaneous coronary intervention (HR 1.95, 95% CI 1.13-3.35; P < 0.05) within 12 months after CABG. Higher risk for repeat revascularization in ICR patients was independent from random allocation to either ticagrelor or aspirin and persisted after adjustment for baseline imbalances.

Conclusions: Patients with ICR presented more stable at the time of admission, but received less grafts, highly likely due to a higher rate of chronic total occlusion lesions and performed OPCAB. Although mortality presented no difference between groups, our results suggest that patients benefit from CR with regard to prevention of repeat revascularization.
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http://dx.doi.org/10.1093/ejcts/ezaa330DOI Listing
November 2020