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PRAGUE 14: Perioperative ischemia versus perioperative bleeding in consecutive cardiac patients undergoing non-cardiac surgery

Acute Coronary Syndromes (ACS)


 Presenter abstract  Discussant report

All the Scientific resources on ESC Congress 365

Presentation

By Petr Widimsky
Zuzana Moťovská, Lukáš Havlůj, Tomáš Balík, Radek Bartoška, Lukáš Bittner, Valér Džupa, Robert Grill, Pavel Haninec, Jiří Knot, Martin Krbec, Libor Mencl, Martina Ondráková, Jan Pachl, Petr Waldauf, Robert Gürlich
Background:
Modern therapy of most cardiac diseases includes some form of antithrombotic therapy. Surgeons usually recommend to stop all antithrombotic medication one week before surgery to prevent perioperative bleeding. This strategy may increase the risk of perioperative ischemic or thrombotic complications. This study was designed to collect data from all consecutive patients with heart disesase undergoing non-cardiac surgery in order to analyze the bleeding / ischemic risk balance.
Methods and patients:
All departments performing major non-cardiac surgery in a large tertiary university hospital participated: abdominal surgery, vascular surgery, oncologic surgery, trauma surgery, orthopedic surgery, urology, neurosurgery and anesthesiology. The study was designed and coordinated by the department of cardiology in the same hospital. All 1005 consecutive patients undergoing non-cardiac surgery while having a cardiovascular disease have been enrolled. The cardiovascular diagnosis included at least one of the following: coronary artery disease (68% pts.), atrial fibrillation (32%), valvular disease (14,5%), prior stroke (10%), prior pulmonary embolism (7%), prosthetic valve (2,5%), heart failure (4%), cardiomyopathy (2%).
These 1005 cardiac patients formed 4,7% of all patients undergoind non-cardiac surgery in this hospital during the study period of 2,5 years (2011 – 2013)
The baseline characteristics included: (mean) age 74 ± 11 years, male sex in 58%, diabetes in 29%, hypertension in 76%, history of chronic kidney disease in 11%, chronic liver disease in 5%, chronic pulmonary disease in 13%, current tumor in 16%.
The following data were recorded: medication (prior, during and after surgery), blood count, INR, type of surgery, type of anesthesia, perioperative bleeding, perioperative thrombotic and ischemic complications, cause of death.
Results: Chronic medication included aspirin in 58%, thienopyridine in 5%, warfarin in 24% and dabigatran in 0,3%. Medication was stopped median 7 (aspirin), 4 (thienopyridine) and 8 (warfarin) days prior to surgery. Perioperative bleeding greater then usual occurred in 10% of patients (serious bleeding in 2%), blood transfusions were used in 13%. Perioperative ischemic / thrombotic complications occurred in 4,6% and acute (or worsening) heart failure in 3,4%. In-hospital mortality of cardiac patients was 3% (versus 0,5% mortality of remaining patients without heart disease). In-hospital mortality of cardiac patients with perioperative ischemic or thrombotic complication was 24%. The most frequent cause of death was heart failure (n = 16), followed by pulmonary embolism (n = 4). Only one patient died as a direct result of bleeding.
There were no significant differences in mean duration of chronic aspirin/warfarin (antithrombotic) therapy interruption between the groups with perioperative bleeding (aspirin 4,2 days and warfarin 6,5 days) versus perioperative ischemia (aspirin 3,8 days and warfarin 4,3 days). Interestingly, the mean time without antithrombotic therapy was significantly shorter (aspirin 3,8 days and warfarin 4,3 days) among patients who developed perioperative ischemia versus those without ischemia (aspirin 7 days, p < 0,001 and warfarin 8 days, p < 0,013). Preoperative dual antiplatelet therapy was used only in 24 patients, this small number did not allow statistical analysis of this subgroup.

Conclusions:
Delayed (or no) interruption of antithrombotic therapy with aspirin or warfarin before major non-cardiac surgery in cardiac patients does not prevent perioperative ischemic or thrombotic complications, while such strategy increases the risk of bleeding complications. The ischemic or thrombotic complications in this high risk elderly population are surprisingly rare. Thus, the traditional strategy of one week interruption of antithrombotic drugs should not be changed.

Discussant Report

Kurt Huber

Introduction
Recommendations in guidelines on how to behave in patients under antithrombotic therapy due to cardiovascular diseases date back to 2009 (Guidelines for pre-operative cardiac risk assessment and perioperative cardiac management in non-cardiac surgery. Eur Heart J 2009;30:2769-812). They are clear with respect to patients receiving anticoagulants and dual antiplatelet therapy (I B), but give relatively weak recommendations with respect to antiplatelet therapy with aspirin (IIa B) and leave it up to the operator not to perform surgery, for example, under aspirin and stop the drug 3.5 days before surgery. Accordingly, the perioperative strategies differ in many centers.

Study Outcomes
The important PRAGUE-14 registry in “real-life” patients (n=1211) with known coronary artery disease undergoing major non-cardiac surgery (most of them under chronic antithrombotic therapy) showed an early increase in cardiovascular events and bleedings in the first 2 days, mainly driven by the fact that 37% of all patients were operated acutely and there was no time to pre-operatively stratify for perioperative cardiovascular or bleeding risk. Moreover, these patients had surgery while on active antithrombotic therapy.
Although cardiovascular events were reported only half as often as bleeding events (7.6% vs. 13.3%), death from cardiovascular events was 10-times higher compared to death from bleeding events (3.0 vs. 0.3%), thus supporting recent knowledge that bleeding is not as dangerous as frequently believed. Indeed, only 10% of the patients who bled needed a surgical re-do, and only 2 bleedings (out of 159 in total) were fatal. Most importantly, patients who underwent elective non-cardiac surgery exhibited a dramatic increase in cardiovascular events on day 6 after stopping aspirin (Figure 1).

Figure 1: Complication risk vs. ASA interruption length before elective surgery


 

Interpretation of results
Given that the majority of patients had ischemic heart disease and were on secondary prevention with low-dose aspirin, this finding in elective surgery supports the recommendations that aspirin should not be stopped in most cases of elective major non-cardiac surgery (Patrono et al. Eur Heart J 2011;32:2922-32; and Korte et al. Thromb Haemost 2011;105:743-49) in order to reduce cardiovascular events few days after surgery.

References


Session Title: PRAGUE 14: Perioperative ischemia versus perioperative bleeding in consecutive cardiac patients undergoing non-cardiac surgery - 707

The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.