Impact of Clopidogrel Pretreatment on Ischemic Complications of PCI among Bivalirudin-Treated Patients: Results from the EVENT Registry

Computational Infrastructure and Informatics Poster SessionBackground: Although clopidogrel (CLO) pretreatment benefits PCI patients with acute coronary syndromes, these benefits are less well-established among elective PCI patients—particularly when treated with the direct thrombin inhibitor (DTI), bivalirudin. The effect of timing of CLO pretreatment on ischemic complications in these patients is also unknown. Methods: We used data from the multicenter EVENT registry to assess the association of clopidogrel pretreatment (600 mg 2 hr pre-PCI, 300 mg 6 hrs pre-PCI, or 75 mg/d for 1 week) with PCI-related complications in patients undergoing elective PCI with a DTI as planned antithrombotic. The primary endpoint was the composite of in-hospital death or MI (peak CKMB > 3 x ULN). Results: Between 01/05 and 12/07, 3568 pts underwent elective PCI and 1913 (54%) received DTI as planned anticoagulant (37% diabetics, age 65±10 y). Clopidogrel pre-treatment was used in 923 (48%). There were no differences in in-hospital or 1 year ischemic or bleeding events in relation to clopidogrel pretreatment in both unadjusted and adjusted analyses (see Table). There was a trend toward lower rates of death or MI with earlier pretreatment, however [Odds ratios vs. no pretreatment: >1 week 0.48 (95% CI 0.08 - 2.73); > 6 h OR 0.69 (95% CI 0.11 - 4.45) and 2-6 h OR 0.77 (95% CI 0.18 - 3.31)]. Conclusion: Among unselected patients undergoing elective PCI with DTI as the planned anticoagulant, clopidogrel pretreatment was common, but was not associated with a reduced risk of ischemic complications

A randomized, double-blind, placebo-controlled trial of Ad5FGF-4 gene therapy and its effect on myocardial perfusion in patients with stable angina

AbstractObjectivesThe primary objective of this study was to determine whether intracoronary administration of the adenoviral gene for fibroblast growth factor (Ad5FGF-4) can improve myocardial perfusion compared with placebo.BackgroundAnimal studies and observational clinical studies have shown improvement in perfusion of the ischemic myocardium using genes encoding angiogenic growth factors; however, randomized, double-blind data in humans are lacking.MethodsWe performed a randomized, double-blind, placebo-controlled trial of intracoronary injection of 1010adenoviral particles containing a gene encoding fibroblast growth factor (Ad5FGF-4) to determine the effect on myocardial perfusion. Fifty-two patients with stable angina and reversible ischemia comprising >9% of the left ventricle on adenosine single-photon emission computed tomography (SPECT) imaging were randomized to gene therapy (n = 35) or placebo (n = 17). Clinical follow-up was performed, and 51 (98%) patients underwent a second adenosine SPECT scan after 8 weeks.ResultsOverall (n = 52), the mean total perfusion defect size at baseline was 32.4% of the left ventricle, with 20% reversible ischemia and 12.5% scar. At eight weeks, Ad5FGF-4 injection resulted in a significant reduction of ischemic defect size (4.2% absolute, 21% relative; p < 0.001) and placebo-treated patients had no improvement (p = 0.32). Although the change in reversible perfusion defect size between Ad5FGF-4 and placebo was not significant (4.2% vs. 1.6%, p = 0.14), when a single outlier was excluded a significant difference was observed (4.2% vs. 0.8%, p < 0.05). Ad5FGF-4 was well tolerated and did not result in any permanent adverse sequelae.ConclusionsIntracoronary injection of Ad5FGF-4 showed an encouraging trend for improved myocardial perfusion; however, further studies of therapeutic angiogenesis with Ad5FGF-4 will be necessary

Evidence for Prevention of Death and Myocardial Infarction With Platelet Membrane Glycoprotein IIb/IIIa Receptor Blockade by Abciximab (c7E3 Fab) Among Patients With Unstable Angina Undergoing Percutaneous Coronary Revascularization fn1fn1This study was supported by Centocor, Inc., Malvern, Pennsylvania.

AbstractObjectives. We sought to evaluate whether patients with unstable angina undergoing coronary intervention derive particular clinical benefit from potent platelet inhibition.Background. Plaque rupture and platelet aggregation are pathogenetic processes common to unstable angina and ischemic complications of percutaneous coronary intervention.Methods. Of the 2,099 patients undergoing a coronary intervention in the Evaluation of 7E3 in Preventing Ischemic Complications (EPIC) trial, 489 were enrolled with the diagnosis of unstable angina and randomized to receive placebo, an abciximab (c7E3) bolus immediately before the intervention or an abciximab bolus followed by a 12-h infusion. The primary end point was a composite of death, myocardial infarction (MI) or urgent repeat revascularization within 30 days of randomization. The occurrence of death, MI or any revascularization within 6 months was also assessed.Results. Compared with placebo, the bolus and infusion of abciximab resulted in a 62% reduction in the rate of the primary end point (12.8% vs. 4.8%, p = 0.012) among patients with unstable angina, due primarily to a reduction in the incidences of death (3.2% vs. 1.2%, p = 0.164) and MI (9% vs. 1.8%, p = 0.004). By 6 months, cumulative death and MI were further reduced by abciximab (6.6% vs. 1.8%, p = 0.018 and 11.1% vs. 2.4%, p = 0.002, respectively). The magnitude of the risk reduction with abciximab was greater among the patients with unstable angina than among other patients in the EPIC trial without unstable angina for the end points of death (interaction: p = 0.008 at 30 days, p = 0.002 at 6 months) and MI (interaction: p = 0.004 at 30 days, p = 0.003 at 6 months).Conclusions. The syndrome of unstable angina identifies patients who will experience particularly marked reductions in the risk of death and MI with abciximab during coronary intervention.(J Am Coll Cardiol 1997;30:149–56

Effect of increasing age on percutaneous coronary intervention vs coronary artery bypass grafting in older adults with unprotected left main coronary artery disease: A meta-analysis and meta-regression

Background: Older adults (≥70-year-old) are under-represented in the published data pertaining to unprotected left main coronary artery disease (ULMCAD).Hypothesis: Percutaneous coronary intervention (PCI) might be comparable to coronary artery bypass grafting (CABG) for revascularization of ULMCAD.Methods: We compared PCI versus CABG in older adults with ULMCAD with an aggregate data meta-analyses (4880 patients) of clinical outcomes [all-cause mortality, myocardial infarction (MI), repeat revascularization, stroke and major adverse cardiac and cerebrovascular events(MACCE)] at 30 days, 12-24 months & ≥36 months in patients with mean age ≥70 years and ULMCAD. A meta-regression analysis evaluated the effect of age on mortality after PCI. Odds ratios (OR) and 95% confidence intervals (CI) were estimated using random-effects model.Results: All-cause mortality between PCI and CABG was comparable at 30-days (OR0.77, 95% CI 0.42- 1.41) and 12-24-months (OR 1.22, 95% CI 0.78-1.93). PCI was associated with a markedly lower rate of stroke at 30-day follow-up in octogenarians (OR 0.14, 95% CI 0.02-0.76) but an overall higher rate of repeat revascularization. At ≥36-months, MACCE (OR 1.26,95% CI 0.99-1.60) and all-cause mortality (OR 1.39, 95% CI 1.00-1.93) showed a trend favoring CABG but did not reach statistical significance. On meta-regression, PCI was associated with a higher mortality with advancing age (coefficient=0.1033, p=0.042).Conclusions: PCI was associated with a markedly lower rate of early stroke in octogenarians as compared to CABG. All-cause mortality was comparable between the two arms with a trend favoring CABG at ≥36-months.PCI was however associated with increasing mortality with advancing age as compared to CABG

Clinical impact of baseline chronic kidney disease in patients undergoing transcatheter or surgical aortic valve replacement

ObjectivesTo assess the treatment effect of TAVR versus SAVR on clinical outcomes to 3 years in patients stratified by chronic kidney disease (CKD) by retrospectively studying patients randomized to TAVR or SAVR.BackgroundThe impact of CKD on mid‐term outcomes of patients undergoing TAVR versus SAVR is unclear.MethodsPatients randomized to TAVR or SAVR in the CoreValve US Pivotal High Risk Trial were retrospectively stratified by eGFR: none/mild or moderate/severe CKD. To evaluate the impact of baseline CKD in TAVR patients only, all patients undergoing an attempted TAVR implant in the US Pivotal Trial and CAS were stratified by baseline eGFR into none/mild, moderate, and severe CKD. The primary endpoint was major adverse cardiovascular and renal events (MACRE), a composite of all‐cause mortality, myocardial infarction, stroke/TIA, and new requirement of dialysis.ResultsModerate/severe CKD was present in 62.7% and 60.7% of high‐risk patients randomized to TAVR or SAVR, respectively. Baseline characteristics were similar between TAVR and SAVR patients in both CKD subgroups, except for higher rates of diabetes and higher serum creatinine in SAVR patients. Among high‐risk patients with moderate/severe CKD, TAVR provided a lower 3‐year MACRE rate compared with SAVR: 42.1% vs. 51.0, P = .04. Of 3,733 extreme‐ and high‐risk TAVR patients, 39.9% had none/mild, 53.8% moderate, and 6.4% severe CKD. Worsening baseline CKD was associated with increased 3‐year MACRE rates [none/mild 51.5%, moderate 54.5%, severe 63.1%, P = .001].ConclusionsTAVR results in lower 3‐year MACRE versus SAVR in high‐risk patients with moderate/severe CKD. In patients undergoing TAVR, worsening CKD increases mid‐term mortality and MACRE. Randomized trials of TAVR vs. SAVR in patients with moderate‐severe CKD would help elucidate the best treatment for these complex patients.Trial RegistrationCoreValve US Pivotal Trial: NCT01240902.CoreValve Continued Access Study: NCT01531374.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/148361/1/ccd27928_am.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/148361/2/ccd27928.pd

Transcatheter and Doppler waveform correlation in transcatheter aortic valve replacement

Transcatheter aortic valve replacement (TAVR) has become the preferred therapy for treatment of severe aortic stenosis in patients at intermediate to high risk of perioperative mortality following surgical aortic valve replacement. Haemodynamic assessment is an integral part of the procedure, and it is crucial for the operator to have an in-depth understanding of the haemodynamic alterations that occur during balloon aortic valvuloplasty and transcatheter valve deployment. Comprehension of the haemodynamic tracings is also pivotal for early recognition of periprocedural complications. With expanding indications for TAVR, it is imperative for members of the structural heart team to have an in-depth, nuanced understanding of transcatheter haemodynamic waveforms and their correlation with echocardiographic Doppler waveforms that are obtained periprocedurally during TAVR. This review provides a collection of transcatheter haemodynamic tracings and their corresponding Doppler echocardiography correlates that are demonstrative of physiological alterations and pathological lesions (complications) that occur during TAVR

Triage Considerations for Patients Referred for Structural Heart Disease Intervention During the Coronavirus Disease 2019 (COVID-19) Pandemic: An ACC /SCAI Consensus Statement

The COVID-19 pandemic has strained health care resources around the world causing many institutions to curtail or stop elective procedures. This has resulted in the inability to care for patients valvular and structural heart disease (SHD) in a timely fashion potentially placing these patients at increased risk for adverse cardiovascular complications including congestive heart failure and death. The effective triage of these patients has become challenging in the current environment as clinicians have had to weigh the risk of bringing susceptible patients into the hospital environment during the COVID-19 pandemic versus the risk of delaying a needed procedure. In this document, we suggest guidelines as to how to triage patients in need of SHD interventions and provide a framework of how to decide when it may be appropriate to proceed with intervention despite the ongoing pandemic. In particular, we address the triage of patients in need of trans-catheter aortic valve replacement and percutaneous mitral valve repair. We also address procedural issues and considerations for the function of structural heart disease teams during the COVID-19 pandemic

Triage Considerations for Patients Referred for Structural Heart Disease Intervention During the COVID-19 Pandemic: An ACC/SCAI Position Statement

The coronavirus disease-2019 (COVID-19) pandemic has strained health care resources around the world, causing many institutions to curtail or stop elective procedures. This has resulted in an inability to care for patients with valvular and structural heart disease in a timely fashion, potentially placing these patients at increased risk for adverse cardiovascular complications, including CHF and death. The effective triage of these patients has become challenging in the current environment as clinicians have had to weigh the risk of bringing susceptible patients into the hospital environment during the COVID-19 pandemic against the risk of delaying a needed procedure. In this document, the authors suggest guidelines for how to triage patients in need of structural heart disease interventions and provide a framework for how to decide when it may be appropriate to proceed with intervention despite the ongoing pandemic. In particular, the authors address the triage of patients in need of transcatheter aortic valve replacement and percutaneous mitral valve repair. The authors also address procedural issues and considerations for the function of structural heart disease teams during the COVID-19 pandemic