Cardiology Trials

N Engl J Med 2003;349:733-742 Background: In patients with ST elevation myocardial infarction, treatment with balloon angioplasty improved outcomes compared to fibrinolysis, as seen in the Primary Angioplasty in Myocardial Infarction Study Group trial . Other trials showed similar findings. However, these trials were relatively small in size and mainly conducted at hospitals with high experience i...

N Engl J Med 1993;328:673-679 Background: Previous trials established that thrombolysis improves mortality in patients with acute myocardial infarction, as seen in the GISSI-1 and ISIS-2 trials. However, thrombolysis has limitations, including an increased risk of bleeding and the inability to achieve arterial patency in approximately 20% of the cases. As a result, there was a growing interest in...

THE LANCET 2011;377:1409-1420 Background: When patients undergo coronary angiography, a hollow tube called a sheath is inserted into an artery. The primary function for the sheath is to provide a stable entry point into the artery, allowing for the safe navigation of instruments to the coronary arteries. Traditionally these sheaths were inserted into the femoral artery. One of the common complicat...

N Engl J Med 2009;360:213-24 Lancet 2015;386:1853-60 Background: Fractional flow reserve (FFR) is a measure of the physiologic significance of a coronary stenosis that is defined as the ratio of maximal blood flow in a stenotic artery to normal maximal flow. It is measured during coronary angiography by calculating the ratio of distal coronary pressure measured with a coronary pressure guidewire t...

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N Engl J Med 2016;375:1242-1252 Background: The first drug-eluting stent (DES) was approved by the FDA in 2003 following the publication of the RAVEL trial . Since then, newer generations of DES were developed and were tested in clinical trials. The majority of trials comparing DES to bare-metal stents (BMS) showed reduction in repeat revascularization with DES but no significant reduction in deat...

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Our initial review of the PLATO trial , published in April 2024, was based on the data available to us at that time. We have since became aware of new information that reduces our confidence in the PLATO results. This new information has major implications for clinical practice. Cardiology Trial’s Substack is a reader-supported publication. To receive new posts and support our work, consider becom...

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N Engl J Med 2010;362:1663-74. Background: The RAVEL and TAXUS-IV trials compared the sirolimus- and paclitaxel-eluting 2nd generation stents to 1st generation bare metal stents. Both trials reported improvements in surrogate endpoints - “in-stent luminal loss” was the primary endpoint of RAVEL and “ischemia-driven target-vessel revascularization” was the primary endpoint of TAXUS-IV . Neither tri...

N Engl J Med 2004;350:221-31 Background: For the past year we have been posting reviews of seminal trials in cardiovascular medicine. It is our anticipation that these will ultimately be published in a textbook format that will be indexed by major subject headings and the reviews will be presented in chronological order. However, in curating postings for Substack we have had to jump around in orde...

N Engl J Med 2002;346:1773-1780 Background: Percutaneous revascularization of the coronary arteries is frequently performed for patients with stable and unstable angina. By the late 1990s and early 2000s, most percutaneous coronary interventions (PCI) were performed with intracoronary stent placement rather than balloon angioplasty alone given lower rates of angiographic detected restenosis with s...

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The Lancet Volume 403, Issue 10438 p1753-1765May 04, 2024 Background Cardiologist have long been taught that acute plaque rupture leading to myocardial infarction is more likely to come from non-flow-limiting lipid-rich atherosclerotic plaques. The concept of the vulnerable plaque is surely one of the reasons that revascularization of high-grade stable coronary artery disease does not reduce myoca...

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N Engl J Med 2009;360:2503-2515 Background: Type 2 diabetes increases the risk of cardiovascular events and death. Previous trials comparing revascularization versus medical therapy included patients with diabetes, however, a large-scale trial specifically focusing on patients with type 2 diabetes was lacking. Cardiology Trial’s Substack is a reader-supported publication. To receive new posts and...

N Engl J Med 2022;386:128-137 Background: Patients with three-vessel coronary artery disease have better outcomes when revascularization is performed using coronary artery bypass grafting (CABG) compared to percutaneous coronary intervention (PCI), as seen in the SYNTAX and FREEDOM trials. Fractional flow reserve (FFR) was not required and was not routinely performed in these trials. Cardiology Tr...

N Engl J Med 2016;375:2223-2235 Background: Smaller randomized trials have shown that outcomes are not significantly different when patients with left main disease are treated with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). In the subgroup of patients with left main disease in the SYNTAX trial , outcomes were similar between PCI and CABG in patients with lo...

Lancet 2016;388:2743-52 Background: PCI was commonly used for the management of patients with left main coronary artery disease and favorable pathology (i.e., absence of complex lesions). This was recommended by the guidelines at the time and based mainly on the prespecified subgroup of 705 patients with left main disease in the SYNTAX trial . The NOBLE trial sought to more rigorously test the hyp...

N Engl J Med 2012;367:2375-2384 Background: The first large trial to compare PCI vs CABG was SYNTAX . In the subgroup of patients with diabetes, which made up approximately 25% of the trial population, PCI was associated with a higher rate of adverse events compared to CABG, primarily driven by higher rates of repeat revascularization in the PCI group. The Future Revascularization Evaluation in Pa...

N Engl J Med 2009;360:961-972 Background: After its introduction in 1968, the use of coronary artery bypass grafting (CABG) in patients with coronary artery disease grew rapidly. Although early trial results were mixed (see the Veterans Administration Cooperative study , the European Coronary Surgery Study and the CASS study ), advancements in surgical techniques and the use of arterial conduits i...

N Engl J Med 2023;389:2319-2330 Background: Percutaneous coronary intervention (PCI) does not reduce mortality or myocardial infarction as seen in COURAGE , FAME 2 , ISCHEMIA and ISCHEMIA-CKD . However, unblinded studies have indicated that revascularization may improve symptoms, which is a key factor in driving PCI decisions for many patients. ORBITA was the first blinded, placebo-controlled tria...

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N Engl J Med 2022;387:1351-1360 Background: Systolic heart failure and obstructive coronary artery disease often coexist. Some patients show improvement in left ventricular systolic function after revascularization, which led to the development of the concept of myocardial hibernation. In this state, areas of the heart that are exposed to repetitive ischemia reduce their contractility to help faci...

The Lancet Volume 391, Issue 10115, 6–12 January 2018, Pages 31-40 Background:   For decades, cardiologists commonly used percutaneous coronary intervention (PCI) for the relief of angina. It made sense because PCI resulted in near complete resolution of blood flow through a stenosed vessel. The problem facing evidence-based clinicians was that no previous trial had compared PCI to a placebo (sham...