Papers

The Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease (FREEDOM) study enrolled 1,900 patients over a 5-year period from 2005 through 2010.

Contemporary PCI and CABG techniques and currently recommended ancillary medical therapies were examined to determine whether CABG or PCI with drug-eluting stents are the superior approach to revascularization in patients with diabetes and multivessel coronary artery disease.

In 1995 Topol[1] first described what vascular surgeons have known for many years:

The pressure drop in a fluid flowing through a long cylindrical pipe such as a stenotic artery becomes functionally significant when the obstruction exceeds 70%, first described in the Poiseuille law in 1846[2].

As was stated in Topol's paper: “Accordingly, before the residual stenosis in an infarct vessel is addressed, there should be demonstration of either spontaneous or provocable signs of ischemia… clinicians and investigators rely excessively on angiography for clinical decision-making… Procedures should not be performed solely to improve the luminal appearance—so-called coronary “cosmetology".

This principle was tested with the PCI Fractional Flow Reserve FAME 1[3]&2[4] trials:

In the SYNTAX trial 1800 patients with previously untreated left-main or three-vessel disease were randomized to CABG or PCI.

As expected, differences in long-term outcomes of Coronary Artery Bypass Grafting vs. PCI, already present after year one, have continued to become more obvious during the next four years:

SYNTAX five-year results for patients with three-vessel disease:

In a large comparative study, interventions for CAD were compared. From 1999-2007 more than 150000 interventions were performed in Washington State. During that period, the volume of PCI procedures increased by 71%, while simultaneously, CABG diminished by almost 40%. In final analysis, PCI was almost five times more likely to happen than CABG.

SYNTAX was an 1800-patient trial randomizing patients with left main coronary disease and/or three-vessel disease to either CABG or PCI using the Taxus drug-eluting stent (DES).

Findings

In patients with severe, multi-vessel coronary disease, coronary artery bypass grafting (CABG) continues as the standard of care of revascularization. Death and MI rates did become significantly greater in the PCI group after four years:

Carcinoma of the esophagus is a relatively rare but very lethal disease. 50% of all patients diagnosed will have adeno carcinoma, which has been associated with a very poor long term survival.

A subset of patients with diabetes and 3VD was examined in a 2nd paper in 2010.

MASS II [i] is a small, single-center study designed to compare the long term effects of Medical Therapy (MT), Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG) among patients with stable angina, multivessel CAD and preserved ventricular function. Patients selected were appropriate candidates for all 3 therapies.

Optimal Medical Therapy with or without PCI for Stable Coronary Disease

William E. Boden, M.D.,and others, NEJM april 12, 2007.

This study was performed to evaluate and compare optimal medical therapy with percutaneous coronary intervention (PCI).

In all likelihood this article has only been read by cardiac surgeons. It provides "new" (actually old) information about what constitutes current and optimal therapy for CAD, and especially what long term outcomes can be expected. For this reason the article was printed in its entirety:

Comments: If there is any area where primary PCI is of particular value, it is in STEMI. No other procedure promises better and/or quicker myocardial reperfusion, and this discussion illustrates this very well {From: Primary PCI for Myocardial Infarction with ST-Segment Elevation by Ellen C. Keeley, M.D., and L. David Hillis, M.D. (NEJM: Volume 356:47-54 January 4, 2007)}:

A 58-year-old man has chest pain at 9:30 a.m.; 3 hours later, he calls for an ambulance.

… Published the results of survival of patients with diabetes and MVD after surgical or percutaneous coronary revascularization. Their results showed that in 2766 risk matched diabetics PCI increased five-year mortality by 1.5–3.9 times...

In 2,766 patients with diabetes undergoing their first coronary revascularization procedure, improved survival with CABG was the initial revascularization demonstrated. The analysis supported that bypass surgery is preferable to coronary angioplasty for the revascularization of patients with diabetes with both 2VD- and 3VD:

In a paper, published in JAMA in 2010, the association of different amounts of physical activity with long-term weight changes among women consuming a usual diet was examined.

The BARI 2D Study Group. A randomized trial of therapies for type 2 diabetes and coronary artery disease.

In this study, the authors report the findings of the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial, involving 2368 patients with both diabetes and coronary disease.