Other Trials of Potential Interest

In Progress

ISCHEMIA EXTEND

ISCHEMIA-Heart Failure Planning Study

ISCHEMIA-2 Beta Blocker Trial (ISCHEMIA-2 BB)

Proposed/Planning

CABG-PCI-SHOCK


ISCHEMIA EXTEND

The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) and the ISCHEMIA-Chronic Kidney Disease (CKD) trial EXTENDed Follow-up (EXTEND) is the proposed long-term follow-up of randomized, surviving participants in the ISCHEMIA and ISCHEMIA-CKD trials. The long-term follow-up will assess whether an initial invasive strategy—cardiac catheterization and revascularization when feasible plus optimal medical therapy (OMT)—reduces long-term all-cause mortality as compared with an initial conservative strategy of OMT for stable ischemic heart disease patients with moderate or severe ischemia.

We are in a transition phase that will allow us to conduct long-term vital status follow-up of the ISCHEMIA and ISCHEMIA-CKD trials’ participants in ISCHEMIA-EXTEND. As noted, these trials did not demonstrate a reduction in their primary endpoints with an initial invasive strategy.  All-cause mortality was similar over 5 years. There was an early excess of peri-procedural MI and a late reduction in spontaneous MI in both trials, with the spontaneous MI curves separating after one year. Prior evidence demonstrates that spontaneous MI has a larger impact on subsequent death than peri-procedural MI. Therefore, based on the observed reduction in spontaneous MI, it is imperative to assess long-term all-cause mortality to provide patients and clinicians with robust evidence regarding whether an initial invasive strategy reduces death over the long-term (~10 years).

Furthermore, understanding the impact of nonfatal events on subsequent mortality among patients with stable ischemic heart disease (SIHD) will influence clinical practice and the design of cardiovascular clinical trials for years to come. With the ever-increasing sensitivity of biomarker assays for MI, it is of paramount importance to understand the relationship between MI and future death. The ISCHEMIA and ISCHEMIA-CKD datasets thus afford a unique opportunity to inform patients, physicians and researchers about multiple aspects of the care of patients with SIHD.


ISCHEMIA-Heart Failure Planning Study

ISCHEMIA-Heart Failure Planning Study UPDATE

The ISCHEMIA-Heart Failure Planning Study funded by NHLBI (R34 HL141621-01A1),  is designed to explore the feasibility of conducting a future multisite prospective pragmatic randomized trial to compare the effects of revascularization with coronary bypass graft surgery (CABG) vs. percutaneous coronary intervention (PCI) on risk of all-cause mortality and heart failure hospitalization in symptomatic heart failure patients with reduced left ventricular ejection fraction and obstructive coronary disease of suitable anatomy.

Over 200 ISCHEMIA sites responded to the survey sent in November 2019. The survey results indicate that approximately 90% of the responding sites have adequate procedural volumes and numbers of patients with heart failure to support future study recruitment. We will continue to provide updates as new data become available.

The ISCHEMIA Clinical Coordinating Center at NYU is currently planning for a new study! Drs. Stuart Katz, Judith Hochman, and Sripal Bangalore are pleased to introduce the ISCHEMIA-Heart Failure planning study funded by NHLBI (R34 HL141621-01A1). This study will explore the feasibility of conducting a future randomized clinical trial to evaluate revascularization strategies in patients with ischemic cardiomyopathy and reduced left ventricular ejection fraction.

Who will be asked to participate? ISCHEMIA sites that have reported onsite PCI and CABG capabilities. Are opportunities available to contribute to the proposed trial? Pilot data are currently being collected through various methods, such as interviews and surveys, and from a variety of sources, including industry experts, ISCHEMIA sites, and patients. We may reach out to your site to participate in the collection of pilot data as these opportunities arise. How will we use the pilot data? All pilot data collected will be used to optimize study design for a future international multisite clinical trial to compare the effects of myocardial revascularization with coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) on clinical outcomes in patients with ischemic cardiomyopathy with reduced ejection fraction. Interested in learning more? Please contact us at ISCHEMIA-HF@nyulangone.org to learn more about this exciting pilot study.


ISCHEMIA-2 Beta Blocker Trial (ISCHEMIA-2 BB)

The primary objective is to determine whether β-blockers (continuation or initiation) provide incremental benefit in reducing the incidence of the primary endpoint (composite of death; myocardial infarction; stroke; or hospitalization for resuscitated cardiac arrest, unstable angina requiring urgent revascularization, or heart failure) when compared with no β-blockers (discontinuation or no initiation), in patients with stable coronary artery disease and preserved left ventricular systolic function treated with guideline-directed medical therapy.


CABG-PCI-SHOCK

Myocardial infarction (MI) complicated by cardiogenic shock is associated with high mortality and is the main reason patients die with MI. The 35-45% 30-day mortality rate with PCI has persisted for decades despite advances in anti-thrombotic pharmacology, use of left ventricular support, and PCI techniques. Multi-vessel PCI in patients with MI and cardiogenic shock results in higher mortality compared with PCI of the culprit lesion only. Non-randomized studies, including SHOCK trial data, suggest potential benefit from complete revascularization and cardioprotective measures employed with CABG in patients with multi-vessel CAD and cardiogenic shock. We are planning a multicenter, randomized trial of initial infarct-only PCI for rapid reperfusion versus multi-vessel CABG immediately after cardiac catheterization with/without percutaneous infarct-related artery (IRA) reperfusion (such as balloon angioplasty and/or mechanical thrombectomy) in patients with MI, multi-vessel CAD, and cardiogenic shock. Participants in both groups may undergo placement of a LV support device of choice, and those randomly assigned to initial infarct-only PCI may have staged non-IRA PCI at a later date. For trial planning purposes we would appreciate your participation in a brief 5-minute internet-based survey (http://is.gd/CABG_SHOCK) to determine contemporary management of cardiogenic shock and to assess the feasibility of the proposed multi-center trial. Participation in the survey is voluntary. Your responses to the questions will help guide study design and may be considered during site selection for trial participation. Click on the link to participate: http://is.gd/CABG_SHOCK