Stromal Cell-Derived Factor-1 Plasmid Treatment for Patients With Peripheral Artery Disease (STOP-PAD) Trial: Six-Month Results.

To present the 6-month results of the tromal Cell-Derived Factor-1 Plasmid reatment fr atients with eripheral rtery isease (STOP-PAD) trial. The trial was an attempt to alter the course of chronic limb-threatening ischemia (CLTI) with a biological agent vs placebo after successful arterial revascularization at or below the knee. The multicenter, randomized, double-blinded, placebo-controlled, phase 2B STOP-PAD trial ( identifier NCT02544204) randomized 109 patients (mean age 71 years; 68 men) with Rutherford category 5 or 6 CLTI and evidence of persistent impaired forefoot perfusion following recent successful revascularization to 8- (n=34) or 16-mg (n=36) intramuscular injections of a non-viral DNA plasmid-based treatment vs placebo (n=34).

SDF-1 plasmid treatment for patients with peripheral artery disease (STOP-PAD): Randomized, double-blind, placebo-controlled clinical trial.

The efficacy of biologic therapies in critical limb ischemia (CLI) remains elusive, in part, due to limitations in trial design and patient selection. Using a novel design, we examined the impact of complementing revascularization therapy with intramuscular JVS-100 - a non-viral gene therapy that activates endogenous regenerative repair pathways. In this double-blind, placebo-controlled, Phase 2B trial, we randomized 109 patients with CLI (Rutherford class V or VI) to 8 mg or 16 mg intramuscular injections of placebo versus JVS-100.

Clopidogrel: the data, the experience, and the controversies.

Dual antiplatelet therapy with acetylsalicylic acid (aspirin) and clopidogrel is a guideline-recommended standard of care for patients with acute coronary syndromes (ACS) and those who undergo percutaneous coronary intervention (PCI). Despite a large body of clinical evidence obtained from randomized clinical trials and patient registries supporting the efficacy and safety of aspirin plus clopidogrel therapy in these patients, questions concerning the optimal use of dual antiplatelet therapy remain. Widely debated topics pertaining to dual antiplatelet therapy in patients with ACS or undergoing PCI include (i) the appropriate clopidogrel loading dose; (ii) the optimal time to initiate the clopidogrel loading dose; (iii) the optimal duration of dual antiplatelet therapy following ACS or PCI; (iv) impact of variability of platelet response on patient outcomes; and (v) the role of other recommended and emerging P2Y₁₂ antagonists.

Cardiac events after non-cardiac surgery in patients with previous coronary intervention in the drug-eluting stent era.

The peri-operative risk for patients with coronary drug-eluting stents (DES) who subsequently have non-cardiac surgery (NCS) is unclear. We performed this retrospective study of all patients in our institution who had coronary intervention and subsequent NCS from 2003 through December 2008 to evaluate the incidence of major adverse cardiac events (MACE) in patients who received DES compared to those who received bare-metal stents (BMS) or had percutaneous transluminal coronary angioplasty (PTCA) during the same time period. The main outcome measures were 30-day post-operative myocardial infarction, stent thrombosis, target vessel revascularization (TVR) and cardiac death.

Limitation of fractional flow reserve in evaluating coronary artery myocardial bridge.

Symptomatic myocardial bridge is treated with medical therapy, but in refractory cases, percutaneous revascularization has been used. We describe two cases to highlight differences in coronary compression and flow pattern, which make the luminal narrowing associated with a myocardial bridge anatomically and physiologically different from the fixed stenosis of atherosclerotic epicardial disease. Due to these characteristics, evaluating the functional severity of a myocardial bridge using fractional flow reserve as a guide to revascularization may be of limited value.

Early invasive strategy improves outcomes in patients with acute coronary syndrome with previous coronary artery bypass graft surgery: a report from TACTICS-TIMI 18.

Background: Patients with previous coronary artery bypass graft surgery (CABG) have been classified as a high-risk subset of patients who experience non-ST elevation acute coronary syndrome (ACS). Recent studies suggest that an early invasive strategy is beneficial in moderate- and high-risk patients with non-ST elevation ACS. We hypothesized that an early invasive strategy is associated with improved outcomes in patients with non-ST elevation ACS with prior CABG.

Association of elevated B-type natriuretic peptide levels with angiographic findings among patients with unstable angina and non-ST-segment elevation myocardial infarction.

Objectives: We hypothesized that elevated B-type natriuretic peptide (BNP) levels would be associated with a greater severity of angiographic disease and a greater extent of myocardium at risk.

Background: Elevations of BNP have been associated with increased risk of adverse outcomes in patients with unstable angina and non-ST-segment elevation myocardial infarction (UA/NSTEMI).

Methods: Of the 2,220 patients with UA/NSTEMI enrolled in the Treat Angina with Aggrastat and Determine Cost of Therapy with an Invasive or Conservative Strategy-Thrombolysis In Myocardial Infarction-18 (TACTICS-TIMI-18) trial, 276 randomized to the invasive arm had both baseline BNP levels and angiographic core laboratory data.

A risk score to estimate the likelihood of coronary artery bypass surgery during the index hospitalization among patients with unstable angina and non-ST-segment elevation myocardial infarction.

Objectives: A simple risk score on admission to estimate the likelihood of in-hospital coronary artery bypass graft surgery (CABG) might be useful in selecting patients for early clopidogrel therapy.

Background: Routine early use of clopidogrel in patients with unstable angina (UA) and non-ST-segment elevation myocardial infarction (NSTEMI) is associated with increased risk of bleeding in patients who undergo early CABG.

Methods: The test cohort utilized to derive the score was the 2,220 patients with UA/NSTEMI enrolled in the Treat Angina with Aggrastat and Determine Cost of Therapy with an Invasive or Conservative Strategy-Thrombolysis in Myocardial Infarction-18 (TACTICS-TIMI-18) trial.

Incidence and time course of thrombocytopenia with abciximab and eptifibatide in patients undergoing percutaneous coronary intervention.

Thrombocytopenia is recognized as a potential adverse effect in patients treated with glycoprotein IIb/IIIa inhibitors. We monitored platelet counts at baseline and at 10 minutes and at 1, 8, and 24 hours after initiation of therapy with either abciximab (n = 74) or eptifibatide (n = 26) in a series of 100 consecutive patients who underwent percutaneous coronary intervention. Thrombocytopenia (platelet count <100,000 m(3) occurred in 11 patients treated with abciximab (15%) and in none of those treated with eptifibatide.

Clinical and angiographic characteristics of patients with combined anterior and inferior ST-segment elevation on the initial electrocardiogram during acute myocardial infarction.

Objective: We evaluated the significance of combined anterior and inferior ST-segment elevation on the initial electrocardiogram (EKG) in patients with acute myocardial infarction (AMI) and correlated it with AMI size and left ventricular (LV) function.

Methods: We analyzed admission EKGs of 2996 patients with AMI from the GUSTO-I angiographic substudy and the GUSTO-IIb angioplasty substudy who underwent immediate angiography. In all, we identified 1046 patients with anterior ST elevation (ST-segment elevation in > or =2 of leads V1-V4) and divided them into 3 groups: Group 1, anterior + inferior ST elevation (ST elevation in > or =2 of leads II, III, aVF, n =179); Group 2, anterior ST elevation only (<2 of leads II, III, aVF with ST elevation or depression, n = 447); Group 3, anterior ST elevation + superior ST elevation (ST depression in > or =2 of leads II, III, aVF, n = 420).

Primary PCI for ST-segment elevation myocardial infarction in a patient treated with subcutaneous enoxaparin utilizing point-of-care Enox test.

The superiority of enoxaparin compared with unfractionated heparin in the medical management of patients with non-ST elevation acute coronary syndromes (NSTE ACS) has been demonstrated in clinical trials. Further, enoxaparin has been shown to be safe and effective during PCI, including in combination with glycoprotein IIb/IIIa inhibitors. Whether enoxaparin is superior to unfractionated heparin in patients with NSTE ACS under-going early invasive strategy is currently being tested in a large clinical trial.