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Early use of PCSK9 inhibitor therapy after heart transplantation from a hepatitis C virus positive donor

Fanous, Matthew M; Gianos, Eugenia; Sperling, Laurence S; Mintz, Guy L; Majure, David T; Hirsh, Benjamin J
Although statin therapy is a primary treatment to prevent cardiac allograft vasculopathy (CAV), its use may be delayed due to pharmacologic interactions in the early post-transplant period among heart transplant (HT) recipients with hepatitis C virus positive (HCV+) donors. Further examination of the possible benefits of early, nonstatin lipid-lowering therapies (LLT), such as PCSK9 inhibitors (PCSK9i), among this specific subset of transplant recipients is therefore becoming increasingly important. We report a 60-year-old man who received a HT from a HCV+ donor for end-stage ischemic cardiomyopathy. In the early post-transplant period, there was concern for drug-drug interactions between statin, immunosuppressant, and direct acting antiviral (DAA) therapy. In addition, prior to transplant, he reported statin-associated muscle symptoms in response to multiple statins, which persisted despite attempts to re-challenge and use an every-other-day dosing strategy. Therefore, the patient was started on PCSK9i therapy after transplantation and while receiving curative DAA therapy for HCV. As the number of HT recipients of HCV+ donors continue to rise, investigation into the safety and benefits of early use of PCSK9i for the reduction of CAV and improved cardiovascular and mortality outcomes should be pursued.
PMID: 34120877
ISSN: 1933-2874
CID: 4911222

Managing cardiometabolic risk factors across a woman's lifespan: A lipidologist's perspective

Gianos, Eugenia; Karalis, Dean G; Gaballa, Dianna; Paparodis, Rodis; Mintz, Guy L; Balakrishnan, Maya; Myerson, Merle; Brinton, Eliot A; Wild, Robert A
A recent rise in atherosclerotic cardiovascular disease (ASCVD) mortality in women warrants a heightened focus on the cardiometabolic risk factors that are closely tied to increasing trends in obesity and suboptimal lifestyle. Polycystic ovarian syndrome (PCOS), adverse pregnancy outcomes (APOs) and nonalcoholic fatty liver disease (NAFLD) are often manifestations of cardiometabolic disease that convey cardiovascular risk requiring recognition foremost, as well as a targeted approach to treatment. Similarly, menopause is a time to reflect on a woman's cardiovascular risk as multiple cardiometabolic changes occur during this time. Contraceptives and menopausal replacement therapy (MRT) should be considered along with a woman's individual thrombotic and cardiovascular risk. Clinicians should be attuned to cardiometabolic risk factors throughout a woman's lifespan and familiar with strategies to reduce cardiovascular risk.
PMID: 33836983
ISSN: 1933-2874
CID: 4845412

Usefulness of Minimum Stent Cross Sectional Area as a Predictor of Angiographic Restenosis After Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction (from the HORIZONS-AMI Trial IVUS Substudy)

Choi SY; Maehara A; Cristea E; Witzenbichler B; Guagliumi G; Brodie B; Kellett MA Jr; Dressler O; Lansky AJ; Parise H; Mehran R; Mintz GS; Stone GW
HORIZONS-AMI was a prospective dual-arm randomized trial of different antithrombotic regimens and stent types in patients with ST-segment elevation myocardial infarction. A formal intravascular ultrasound (IVUS) substudy enrolled 464 patients with baseline and 13-month follow-up at 36 centers. Of them, 318 patients with 355 lesions were evaluated for this study. Angiographic restenosis occurred in 45 of 355 lesions (12.7%). Bare-metal stent use (45.5% vs 21.2%, p <0.001) and diabetes mellitus (29.5% vs 10.9%, p <0.001) were more prevalent in patients with versus without restenosis. Postprocedure IVUS minimum lumen area (5.6 mm(2), 5.0 to 6.1, vs 6.7 mm(2), 6.5 to 6.9, p <0.001), minimum stent area (5.7 mm(2), 5.1 to 6.3, vs 6.9 mm(2), 6.6 to 7.1, p <0.001), and reference average lumen area (7.7 mm(2), 6.8 to 8.6, vs 9.7 mm(2), 9.3 to 10.1, p <0.001) were smaller in restenotic versus nonrestenotic lesions. By multivariable analysis, minimum stent area was an independent predictor of angiographic restenosis (odds ratio 0.75, 95% confidence interval 0.61 to 0.93, p = 0.009) in addition to diabetes, bare-metal stent use, and longer stent length. Attenuated plaque behind the stent struts had a trend to predict less binary restenosis (p = 0.07). In conclusion, a smaller IVUS minimum stent area was an independent predictor of angiographic restenosis after primary percutaneous intervention in patients with ST-segment elevation myocardial infarction, similar to patients with stable coronary artery disease
PMID: 22118823
ISSN: 1879-1913
CID: 147224

Impact of intravascular ultrasound imaging on early and late clinical outcomes following percutaneous coronary intervention with drug-eluting stents

Claessen, Bimmer E; Mehran, Roxana; Mintz, Gary S; Weisz, Giora; Leon, Martin B; Dogan, Ozgen; de Ribamar Costa, Jose Jr; Stone, Gregg W; Apostolidou, Irene; Morales, Andy; Chantziara, Vasiliki; Syros, George; Sanidas, Elias; Xu, Ke; Tijssen, Jan G P; Henriques, Jose P S; Piek, Jan J; Moses, Jeffrey W; Maehara, Akiko; Dangas, George D
OBJECTIVES: This study sought to assess the impact of intravascular ultrasound (IVUS)-guided versus angiography-guided drug-eluting stent (DES) implantation. BACKGROUND: There are limited data on IVUS guidance in the DES era. Therefore, we investigated the impact of IVUS guidance on clinical outcomes in the MATRIX (Comprehensive Assessment of Sirolimus-Eluting Stents in Complex Lesions) registry. METHODS: The MATRIX registry prospectively enrolled consecutive, unselected patients treated with sirolimus-eluting stents (SES) (n = 1,504); 631 patients (42%) underwent IVUS-guided stenting, and 873 (58%) had only angiographic guidance. We assessed 30-day, 1-year, and 2-year rates of death/myocardial infarction (MI), major adverse cardiac events (cardiac death, MI, or target vessel revascularization), and definite/probable stent thrombosis in 548 propensity-score matched patient pairs. RESULTS: After matching, baseline and angiographic characteristics were similar in IVUS and no-IVUS groups. Patients in the IVUS group had significantly less death/MI at 30 days (1.5% vs. 4.6%, p < 0.01), 1 year (3.3% vs. 6.5%, p < 0.01), and 2 years (5.0% vs. 8.8%, p < 0.01). Patients in the IVUS group had significantly less major adverse cardiac events at 30 days (2.2% vs. 4.8%, p = 0.04) and numerically less major adverse cardiac events at 1 year (9.1% vs. 13.5%, p = 0.07) and 2 years (12.9% vs. 16.7%, p = 0.18). Rates of MI were significantly lower in the IVUS group at 30 days (1.5% vs. 4.0%, p < 0.01), 1 year (1.8% vs. 4.8%, p < 0.01), and 2 years (2.1% vs. 5.7%, p < 0.01). CONCLUSIONS: IVUS-guided stent implantation appears to be associated with a reduction in both early and long-term clinical events. Further investigation in randomized controlled trials is warranted
PMID: 21939937
ISSN: 1876-7605
CID: 147230

Intravascular ultrasound findings of early stent thrombosis after primary percutaneous intervention in acute myocardial infarction: a Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) substudy

Choi, So-Yeon; Witzenbichler, Bernhard; Maehara, Akiko; Lansky, Alexandra J; Guagliumi, Giulio; Brodie, Bruce; Kellett, Mirle A Jr; Dressler, Ovidiu; Parise, Helen; Mehran, Roxana; Dangas, George D; Mintz, Gary S; Stone, Gregg W
BACKGROUND: Small stent area and residual inflow/outflow disease have been reported as the strongest intravascular ultrasound (IVUS) predictors of early stent thrombosis (ST) in patients with stable angina. IVUS predictors of early ST in patients with acute myocardial infarction have not been studied. METHODS AND RESULTS: In the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) study, a formal substudy included poststent and 13-month follow-up IVUS at 36 centers. Twelve patients with baseline IVUS who had definite/probable early ST </=30 days after enrollment were compared with 389 patients without early ST. Significant residual stenosis was a lumen area <4.0 mm(2) with >/=70% plaque burden </=10 mm from each stent edge. Significant edge dissection was more than medial dissection with lumen area <4 mm(2) or dissection angle >/=60 degrees . Randomization to bivalirudin (P=0.29) or paclitaxel-eluting stent (P=0.74) was not related to early ST. Minimum lumen area was smaller in patients with versus without early ST (4.4 mm(2) [3.6, 6.9] versus 6.7 mm(2) [5.3, 8.0], respectively, P=0.014). Minimum lumen area <5 mm(2), significant residual stenosis, significant stent edge dissection, and significant tissue (plaque/thrombus) protrusion (more than the median that narrowed the lumen to <4 mm(2)) were more prevalent in patients with early ST, but significant acute malapposition (more than the median) was not. Overall, 100% of patients with early ST had at least 1 of these significant features: minimum lumen area <5 mm(2), edge dissection, residual stenosis, or tissue protrusion versus 23% in patients without early ST (P<0.01). CONCLUSIONS: Smaller final lumen area and inflow/outflow disease (residual stenosis or dissection) but not acute malapposition were related to early ST after acute myocardial infarction intervention. CLINICAL TRIAL REGISTRATION: URL: Unique identifier: NCT00433966
PMID: 21586693
ISSN: 1941-7632
CID: 147246

The relationship between attenuated plaque identified by intravascular ultrasound and no-reflow after stenting in acute myocardial infarction: the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial

Wu, Xiaofan; Mintz, Gary S; Xu, Kai; Lansky, Alexandra J; Witzenbichler, Bernhard; Guagliumi, Giulio; Brodie, Bruce; Kellett, Mirle A Jr; Dressler, Ovidiu; Parise, Helen; Mehran, Roxana; Stone, Gregg W; Maehara, Akiko
OBJECTIVES: The aim of this study was to understand the impact of attenuated plaque on distal embolization during stent implantation in patients with acute myocardial infarction (AMI). BACKGROUND: Attenuated plaques identified by grayscale intravascular ultrasound (IVUS) might predict transient deterioration in coronary flow and/or no-reflow during percutaneous coronary intervention (PCI). METHODS: We analyzed clinical, angiographic, and IVUS data from 364 patients (n = 364 infarct-related arteries) enrolled in the randomized HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial. No-reflow was final Thrombolysis In Myocardial Infarction (TIMI) flow grade </=2 in the absence of mechanical obstruction. Attenuated plaque was hypoechoic or mixed atheroma with ultrasound attenuation without calcification. A mean attenuation score was created by measuring the angle of attenuation each 1 mm, scoring the angle as 1 to 4 (corresponding to <90 degrees , 90 degrees to 180 degrees , 180 degrees to 270 degrees , or 270 degrees to 360 degrees , respectively), summing the scores, and normalizing for analysis length. RESULTS: Overall, 284 (78.0%) patients had attenuated plaques; no-reflow occurred in 37 (10.2%). Patients with no-reflow had a higher mean attenuation score (median [interquartile range] 2.2 [0.0 to 2.8] vs. 1.3 [0.7 to 1.8], p < 0.001), lower baseline left ventricular ejection fraction (52.8% [43.2% to 61.5%] vs. 61.4% [52.2% to 68.1%], p = 0.002), and more baseline angiographic thrombus (89.2% vs. 74.1%, p = 0.043) with no differences in post-PCI stent expansion versus patients without no-reflow. Multivariate analysis indicated that mean attenuation score was the strongest predictor of no-reflow. The mean attenuation score that best predicted no-reflow was >/=2 points (90 degrees to 180 degrees , sensitivity of 81.5%, and specificity of 80.5%). CONCLUSIONS: Attenuated plaque was present in three-quarters of patients with AMI. The amount of attenuated plaque strongly correlated with no-reflow; the larger the attenuated plaque, the greater the likelihood of no-reflow. (Dual Arm Factorial Randomized Trial in Patients w/ST Segment Elevation AMI to Compare the Results of Using Anticoagulation With Either Unfractionated Heparin + Routine GP IIb/IIIa Inhibition or Bivalirudin + Bail-out GP IIb/IIIa Inhibition; and Primary Angioplasty with stent implantation with Either a Slow Rate-release Paclitaxel-eluting Stent [TAXUS] or Uncoated Bare Metal Stent [EXPRESS2]; NCT00433966)
PMID: 21596321
ISSN: 1876-7605
CID: 147245

Two-year safety and effectiveness of sirolimus-eluting stents (from a prospective registry)

Claessen, Bimmer E; Mehran, Roxana; Leon, Martin B; Heller, Eric A; Weisz, Giora; Syros, George; Mintz, Gary S; Franklin-Bond, Theresa; Apostolidou, Irene; Henriques, Jose P S; Stone, Gregg W; Moses, Jeffrey W; Dangas, George D
Uncertainty exists about the long-term safety and efficacy outcomes of sirolimus-eluting stents (SESs) in unselected patients. The present study was performed to evaluate the safety and efficacy of the SES in treatment of patients with coronary artery disease in an unselected population. Over a 2-year period, 1,504 consecutive patients undergoing percutaneous coronary intervention with >/=1 SES were enrolled. The primary end point was the occurrence of target vessel failure (TVF; a composite of cardiac death, myocardial infarction, or clinically driven target vessel revascularization). An independent clinical event committee adjudicated all adverse events up to 2-year follow-up. Dual antiplatelet therapy was recommended for >/=1 year throughout the study period. Mean age was 65 +/- 11 years; 75% were men, and 34% were diabetics. SESs were implanted for off-label indications in 86% of cases. TVF rates were 3.3%, 6.9%, 11.5%, and 15.5% at 30-day, 6-month, 1-year, and 2-year follow-ups, respectively. The 2-year cumulative rate of definite/probable stent thrombosis was 0.9%; 0.2% was very late thrombosis, occurring from 1 year to 2 years. Patients off dual antiplatelet therapy at 6 months had a significantly increased rate of subsequent death from noncardiac causes. Patients off dual antiplatelet therapy at 1 year had a significantly decreased rate of subsequent clinically driven target lesion revascularization. In conclusion, use of SESs in unselected patients with coronary artery disease was associated with a low TVF rate at 2 years with an acceptable incidence of stent thrombosis
PMID: 21195378
ISSN: 1879-1913
CID: 147254

Strut coverage and late malapposition with paclitaxel-eluting stents compared with bare metal stents in acute myocardial infarction: optical coherence tomography substudy of the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) Trial

Guagliumi, Giulio; Costa, Marco A; Sirbu, Vasile; Musumeci, Giuseppe; Bezerra, Hiram G; Suzuki, Nobuaki; Matiashvili, Aleksandre; Lortkipanidze, Nikoloz; Mihalcsik, Laurian; Trivisonno, Antonio; Valsecchi, Orazio; Mintz, Gary S; Dressler, Ovidiu; Parise, Helen; Maehara, Akiko; Cristea, Ecaterina; Lansky, Alexandra J; Mehran, Roxana; Stone, Gregg W
BACKGROUND: The safety of drug-eluting stents in ST-segment elevation myocardial infarction (STEMI) continues to be debated. Pathological studies have demonstrated an association between uncovered struts and subsequent stent thrombosis. Optical coherence tomography can detect stent strut coverage in vivo on a micron-scale level. We therefore used optical coherence tomography to examine strut coverage in patients with STEMI treated with paclitaxel-eluting stents (PES) and bare metal stents (BMS). METHODS AND RESULTS: In the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, patients with STEMI were randomized 3:1 to PES or BMS implantation. In a formal substudy, optical coherence tomography at 13 months was performed in 118 consecutive randomized patients (89 PES, 29 BMS) in whom 188 stents were assessed (146 PES and 42 BMS). A total of 44 139 stent struts were analyzed by an independent core laboratory blinded to stent assignment. The primary prespecified end point, the percentage of uncovered stent struts per lesion at follow-up, was 1.1 +/- 2.5% in BMS lesions versus 5.7 +/- 7.0% in PES lesions (P < 0.0001). Malapposed struts were observed in 0.1 +/- 0.2% of BMS lesions versus 0.9 +/- 2.1% of PES lesions (P = 0.0003). Percentage net volume obstruction was 36.0 +/- 15.4% with BMS and 19.2 +/- 11.3% with PES (P < 0.0001). CONCLUSIONS: In patients with STEMI undergoing primary percutaneous coronary intervention, implantation of PES as compared with BMS significantly reduces neointimal hyperplasia but results in higher rates of uncovered and malapposed stent struts as assessed by optical coherence tomography at 13-month follow-up. Further studies are required to determine the clinical significance of these findings. CLINICAL TRIAL REGISTRATION: URL: Unique identifier: NCT00433966
PMID: 21220730
ISSN: 1524-4539
CID: 147253

A prospective natural-history study of coronary atherosclerosis

Stone, Gregg W; Maehara, Akiko; Lansky, Alexandra J; de Bruyne, Bernard; Cristea, Ecaterina; Mintz, Gary S; Mehran, Roxana; McPherson, John; Farhat, Naim; Marso, Steven P; Parise, Helen; Templin, Barry; White, Roseann; Zhang, Zhen; Serruys, Patrick W
BACKGROUND: Atherosclerotic plaques that lead to acute coronary syndromes often occur at sites of angiographically mild coronary-artery stenosis. Lesion-related risk factors for such events are poorly understood. METHODS: In a prospective study, 697 patients with acute coronary syndromes underwent three-vessel coronary angiography and gray-scale and radiofrequency intravascular ultrasonographic imaging after percutaneous coronary intervention. Subsequent major adverse cardiovascular events (death from cardiac causes, cardiac arrest, myocardial infarction, or rehospitalization due to unstable or progressive angina) were adjudicated to be related to either originally treated (culprit) lesions or untreated (nonculprit) lesions. The median follow-up period was 3.4 years. RESULTS: The 3-year cumulative rate of major adverse cardiovascular events was 20.4%. Events were adjudicated to be related to culprit lesions in 12.9% of patients and to nonculprit lesions in 11.6%. Most nonculprit lesions responsible for follow-up events were angiographically mild at baseline (mean [+/-SD] diameter stenosis, 32.3+/-20.6%). However, on multivariate analysis, nonculprit lesions associated with recurrent events were more likely than those not associated with recurrent events to be characterized by a plaque burden of 70% or greater (hazard ratio, 5.03; 95% confidence interval [CI], 2.51 to 10.11; P<0.001) or a minimal luminal area of 4.0 mm(2) or less (hazard ratio, 3.21; 95% CI, 1.61 to 6.42; P=0.001) or to be classified on the basis of radiofrequency intravascular ultrasonography as thin-cap fibroatheromas (hazard ratio, 3.35; 95% CI, 1.77 to 6.36; P<0.001). CONCLUSIONS: In patients who presented with an acute coronary syndrome and underwent percutaneous coronary intervention, major adverse cardiovascular events occurring during follow-up were equally attributable to recurrence at the site of culprit lesions and to nonculprit lesions. Although nonculprit lesions that were responsible for unanticipated events were frequently angiographically mild, most were thin-cap fibroatheromas or were characterized by a large plaque burden, a small luminal area, or some combination of these characteristics, as determined by gray-scale and radiofrequency intravascular ultrasonography. (Funded by Abbott Vascular and Volcano; number, NCT00180466.)
PMID: 21247313
ISSN: 1533-4406
CID: 147252

Near infrared spectroscopic assessment of lipid core plaque changes after coronary artery stenting [Meeting Abstract]

Hakim D.A.; Maehara A.; Mintz G.S.; Banerjee S.; Abdel-Karim A.-R.R.; Yakushiji T.; Sum S.T.; Madden S.P.; Stone G.W.; Muller J.E.; Brilakis E.S.
Background: Intravascular near-infrared spectroscopy (NIRS) has been validated for assessment of confluent lipid core plaque (LCP) while virtual histology intravascular ultrasound (VH-IVUS) classifies plaque as necrotic core (NC), fibrofatty, fibrotic, or dense calcium. Methods: We performed both NIRS and VH-IVUS pre- and post-intervention in a cohort of 30 pts to evaluate LCP changes after coronary artery stenting. Based on the NIRS block chemogram(a metric of the probability of LCP in a 2mm-long NIRS chemogram segment),we excluded 5 lesions without any LCP (no yellow blocks,the highest probability of LCP). We divided the other 25 pts into 2 groups: A - lesions with a >=2 block reduction in the number of yellow or tan blocks (2 highest probabilities of LCP, n=17) in the post-stent block chemogram and B - lesions with little or no change post-stenting (n=8).VH-IVUS assessment of the worst 10mm-long lumen-compromised segment included quantitative measures of the 4 plaque components and the presence of a VH thin cap or thick-cap fibroatheroma(TCFA or ThCFA) Results: 51% of pts presented with acute coronary syndrome. The average stent size (2.9+/-0.3mm) and total stent length (22.3+/-6.6mm) were comparable between the 2 groups. Pre-intervention lipid core burden index (LCBI) was similar in both groups, but was significantly reduced post-stenting in Group A.Pre-intervention VH-IVUS showed that Group A had a smaller minimum lumen area(MLA) with a greater plaque burden at the MLA site, and a trend toward longer VH-TCFA, but shorter ThCFA (Table). (Table Presented) Conclusion: more than half (56.6%) of lesions have a decrease in LCP (NIRS) after coronary stent implantation. The presence of a longer superficial NC (VH-TCFA) predicted the plaques that would have a reduced lipid core after stenting
ISSN: 0735-1097
CID: 141791