Noncoronary vascular surgery in high-CV-risk patients: Add PCI or CABG?
April 20, 2007
Washington, DC - Perioperative PCI or CABG makes little clinical impact in high-cardiovascular-risk patients with ischemic heart disease who undergo major noncoronary vascular surgery, suggests a randomized but inconclusive study [1].
Designed to clarify feasibility and safety considerations for any future larger, definitive exploration of the strategy, the study wasn't statistically strong enough to show whether adding perioperative coronary revascularization makes a clinical difference, caution the authors, led by Dr Don Poldermans (Erasmus Medical Center, Rotterdam, the Netherlands).
But having set the stage for a larger trial, according to the group as well as an accompanying editorial [2], the pilot study raises questions about CV screening before noncardiac surgery and the clinical importance of any discovered coronary stenoses that would be targeted by perioperative revascularization as compared with, for example, vulnerable plaques that are angiographically invisible.
The trial's neutral findings may relate to histopathologic evidence "that the pathophysiology surrounding fatal MI in the perioperative period after noncardiac surgery often includes unstable plaque and plaque disruption," write the editorialists, Drs Mauro Moscucci and Noah Jones (University of Michigan, Ann Arbor). "Thus, it is possible that revascularization of stable coronary artery stenosis might not add significantly to the effect of optimal medical therapy, similar to what has been shown for other low-risk patients with stable coronary artery disease."
The findings from the fifth Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography (DECREASE-5) pilot study and its accompanying editorial are published online April 13, 2007 by the Journal of the American College of Cardiology. They follow similar results from the Coronary Artery Revascularization Prophylaxis (CARP) trial, published in 2004 and reported by heartwire at the time, that compared the invasive and conservative perioperative strategies in a lower-risk CAD population [3].
Conducted in four European countries and Brazil over five years ending in 2005, DECREASE-5 randomized 101 patients with CAD who were scheduled for open abdominal aortic or infrainguinal arterial surgeries to receive either perioperative PCI or CABG (32 and 17 patients, respectively) or medical therapy (52 patients). Patients had been required to have at least three major cardiac risk factors (eg, angina, evidence of prior MI or neurologic events, heart failure, diabetes, or renal dysfunction) as well as stress-test-documented myocardial ischemia. Beta blockers were initiated for any patient not already on them.
In the PCI/CABG group, two patients died from ruptured aortic aneurysms prior to their noncoronary surgical procedures, "consistent with the fact that urgent or emergency vascular surgery in unstable patients should not be delayed by revascularization," Moscucci and Jones caution.
Rates of the primary end point, a 30-day composite of all-cause mortality and nonfatal MI, were 43% and 33%, respectively (p=0.30). Even out to one year, the rates were similar, at 49% and 44%, respectively (p=0.48). Incidences of the primary-end-point components did not differ between the groups. None in the medical-management group required coronary revascularization within a year of the noncoronary vascular surgery.
As none of the conservatively managed patients underwent diagnostic catheterization, yet their outcomes were similar to those managed with PCI or CABG, write the editorialists, "effective beta blockade and medical therapy might be sufficient, raising the question of whether stable patients scheduled for major vascular surgery should even be screened with stress testing."
However, they conclude, "the debate on screening and revascularization for patients with peripheral arterial disease and scheduled for major vascular surgery continues to be far from settled." DECREASE-5 provided safety and sample-size information needed for a larger exploration of the issue, they write. "It is now time to move forward with such a trial."
Moscucci reports receiving consulting fees from Pfizer and Boston Scientific, lecture fees from Pfizer, and grant support from Cordis
Sources
1. Poldermans D, Schouten O, Vidakovic R, et al. A clinical randomized trial to evaluate the safety of a noninvasive approach in high-risk patients undergoing major vascular surgery: The DECREASE-V pilot study. J Am Coll Cardiol 2007; DOI:10.1016/j.jacc.2006.11.052. Available at: http://www.theheart.org/viewDocument.do?document=http%3A%2F%2Fcontent.onlinejacc.org.
2. Moscucci M, Jones N. Coronary revascularization before noncardiac vascular surgery: One more step forward in understanding its role. J Am Coll Cardiol 2007; DOI:10.1016/j.jacc.2007.01.068 . Available at: http://www.theheart.org/viewDocument.do?document=http%3A%2F%2Fcontent.onlinejacc.org.
3. McFalls EO, Ward HB, Moritz TE, et al. Coronary-artery revascularization before elective major vascular surgery. N Eng J Med 2004; 351:2795-2804.
Related links
Risk for death, stroke increased with combined CABG and CEA [Other News > Medscape Medical News; Jan 16, 2007]
Higher risk of stroke and death in patients undergoing combined CEA-CABG surgery vs CABG alone [HeartWire > Other News; Apr 25, 2005]
No benefit from revascularization before vascular surgery: CARP published [HeartWire > Other News; Dec 29, 2004]
April 20, 2007
Washington, DC - Perioperative PCI or CABG makes little clinical impact in high-cardiovascular-risk patients with ischemic heart disease who undergo major noncoronary vascular surgery, suggests a randomized but inconclusive study [1].
Designed to clarify feasibility and safety considerations for any future larger, definitive exploration of the strategy, the study wasn't statistically strong enough to show whether adding perioperative coronary revascularization makes a clinical difference, caution the authors, led by Dr Don Poldermans (Erasmus Medical Center, Rotterdam, the Netherlands).
But having set the stage for a larger trial, according to the group as well as an accompanying editorial [2], the pilot study raises questions about CV screening before noncardiac surgery and the clinical importance of any discovered coronary stenoses that would be targeted by perioperative revascularization as compared with, for example, vulnerable plaques that are angiographically invisible.
The trial's neutral findings may relate to histopathologic evidence "that the pathophysiology surrounding fatal MI in the perioperative period after noncardiac surgery often includes unstable plaque and plaque disruption," write the editorialists, Drs Mauro Moscucci and Noah Jones (University of Michigan, Ann Arbor). "Thus, it is possible that revascularization of stable coronary artery stenosis might not add significantly to the effect of optimal medical therapy, similar to what has been shown for other low-risk patients with stable coronary artery disease."
The findings from the fifth Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography (DECREASE-5) pilot study and its accompanying editorial are published online April 13, 2007 by the Journal of the American College of Cardiology. They follow similar results from the Coronary Artery Revascularization Prophylaxis (CARP) trial, published in 2004 and reported by heartwire at the time, that compared the invasive and conservative perioperative strategies in a lower-risk CAD population [3].
Conducted in four European countries and Brazil over five years ending in 2005, DECREASE-5 randomized 101 patients with CAD who were scheduled for open abdominal aortic or infrainguinal arterial surgeries to receive either perioperative PCI or CABG (32 and 17 patients, respectively) or medical therapy (52 patients). Patients had been required to have at least three major cardiac risk factors (eg, angina, evidence of prior MI or neurologic events, heart failure, diabetes, or renal dysfunction) as well as stress-test-documented myocardial ischemia. Beta blockers were initiated for any patient not already on them.
In the PCI/CABG group, two patients died from ruptured aortic aneurysms prior to their noncoronary surgical procedures, "consistent with the fact that urgent or emergency vascular surgery in unstable patients should not be delayed by revascularization," Moscucci and Jones caution.
Rates of the primary end point, a 30-day composite of all-cause mortality and nonfatal MI, were 43% and 33%, respectively (p=0.30). Even out to one year, the rates were similar, at 49% and 44%, respectively (p=0.48). Incidences of the primary-end-point components did not differ between the groups. None in the medical-management group required coronary revascularization within a year of the noncoronary vascular surgery.
As none of the conservatively managed patients underwent diagnostic catheterization, yet their outcomes were similar to those managed with PCI or CABG, write the editorialists, "effective beta blockade and medical therapy might be sufficient, raising the question of whether stable patients scheduled for major vascular surgery should even be screened with stress testing."
However, they conclude, "the debate on screening and revascularization for patients with peripheral arterial disease and scheduled for major vascular surgery continues to be far from settled." DECREASE-5 provided safety and sample-size information needed for a larger exploration of the issue, they write. "It is now time to move forward with such a trial."
Moscucci reports receiving consulting fees from Pfizer and Boston Scientific, lecture fees from Pfizer, and grant support from Cordis
Sources
1. Poldermans D, Schouten O, Vidakovic R, et al. A clinical randomized trial to evaluate the safety of a noninvasive approach in high-risk patients undergoing major vascular surgery: The DECREASE-V pilot study. J Am Coll Cardiol 2007; DOI:10.1016/j.jacc.2006.11.052. Available at: http://www.theheart.org/viewDocument.do?document=http%3A%2F%2Fcontent.onlinejacc.org.
2. Moscucci M, Jones N. Coronary revascularization before noncardiac vascular surgery: One more step forward in understanding its role. J Am Coll Cardiol 2007; DOI:10.1016/j.jacc.2007.01.068 . Available at: http://www.theheart.org/viewDocument.do?document=http%3A%2F%2Fcontent.onlinejacc.org.
3. McFalls EO, Ward HB, Moritz TE, et al. Coronary-artery revascularization before elective major vascular surgery. N Eng J Med 2004; 351:2795-2804.
Related links
Risk for death, stroke increased with combined CABG and CEA [Other News > Medscape Medical News; Jan 16, 2007]
Higher risk of stroke and death in patients undergoing combined CEA-CABG surgery vs CABG alone [HeartWire > Other News; Apr 25, 2005]
No benefit from revascularization before vascular surgery: CARP published [HeartWire > Other News; Dec 29, 2004]
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