Updated June 08, 2015.
By DrRich
In an article due to be published on December 19 in the Journal of the American College of Cardiology (but released from embargo today due to the wide general interest in this topic), investigators from the BASKET-LATE trial add important new observations to the ongoing question of late coronary artery occlusion with drug-eluting stents (DES).
DES were developed in the attempt to reduce the incidence of restenosis seen with bare metal stents.
They have been quite successful at doing this. However, for a year or more, concerns have been raised that DES may have an increased propensity to suddenly and completely occlude, due to the sudden formation of blood clots, many months or even years after the stents have been placed. Because these occlusions can be quite sudden, they apparently often manifest as sudden death or a large heart attack. The risk of such occlusions can be limited with the prolonged use of clopidogrel (Plavix) and aspirin. However, Plavix is quite expensive, and can cause significant bleeding problems. Nobody knows at this point the optimal length of time a patient should take Plavix after a DES has been placed.
In the BASKET-LATE study, long-term follow-up was initiated in order to examine the question of late stent occlusion in patients who had already been randomized to receive either DES or bare metal stents (BMS). These patients were treated with Plavix and aspirin for 6 months after stent placement, at which time Plavix was stopped.
The investigators report today that, over the following 12 months, patients with DES had a reduced need for additional revascularization procedures as compared to those receiving BMS (which was exactly what DES were designed to do). However, patients with DES during that 12-month interval had twice the risk of death or a heart attack as those with BMS (2.6% vs. 1.3%).
In an accompanying editorial, Drs. Harrington and Califf from Duke university suggest that patients with DES should be kept on Plavix and aspirin more-or-less indefinitely if at all possible, at least until future studies demonstrate the safety of stopping these drugs.
DrRich Comments:
DES clearly and significantly reduce the risk of early restenosis after stent placement.This early restenosis often leads to recurrent symptoms, arrhythmias, and even heart attacks, and reducing its incidence is a good thing. As we now know, however, there is a price to pay for this success. There is a small but appreciable and statistically significant increase in the risk of sudden, late stent occlusion with DES. To reduce this risk, doctors will be increasingly committing their DES patients to prolonged, potentially life-long therapy with Plavix.
For many patients, the increased late risk associated with DES will be more than made up for by the reduced risk of earlier restenosis, and the use of DES will, for this reason, often be appropriate. However, doctors should now feel deeply obligated to discuss with their patients and their families - before a DES is used - all the implications of choosing a DES over a BMS. These implications include the need for taking Plavix every day for a long, long time, and the increased risk of death or heart attack that may ensue if the Plavix is stopped before it is shown to be safe to do so.
Sources:
Pfisterrer M, Brunner-La Rocca HP, Buser PT, Rickenbacher P, Hunziker P, Mueller C, Jeger R, Bader F, Osswald S, Kaiser C. Late clinical events after clopidogrel discontinuation may limit the benefits of drug-eluting stents. J Am Coll Cardiol 2006;48:2584.
Harrington RA, Califf RM. Late ischemic events after clopidogrel cessation following drug-eluting stenting. Should we be worried? J Am Coll Cardiol 2006;48:2592.
By DrRich
In an article due to be published on December 19 in the Journal of the American College of Cardiology (but released from embargo today due to the wide general interest in this topic), investigators from the BASKET-LATE trial add important new observations to the ongoing question of late coronary artery occlusion with drug-eluting stents (DES).
DES were developed in the attempt to reduce the incidence of restenosis seen with bare metal stents.
They have been quite successful at doing this. However, for a year or more, concerns have been raised that DES may have an increased propensity to suddenly and completely occlude, due to the sudden formation of blood clots, many months or even years after the stents have been placed. Because these occlusions can be quite sudden, they apparently often manifest as sudden death or a large heart attack. The risk of such occlusions can be limited with the prolonged use of clopidogrel (Plavix) and aspirin. However, Plavix is quite expensive, and can cause significant bleeding problems. Nobody knows at this point the optimal length of time a patient should take Plavix after a DES has been placed.
In the BASKET-LATE study, long-term follow-up was initiated in order to examine the question of late stent occlusion in patients who had already been randomized to receive either DES or bare metal stents (BMS). These patients were treated with Plavix and aspirin for 6 months after stent placement, at which time Plavix was stopped.
The investigators report today that, over the following 12 months, patients with DES had a reduced need for additional revascularization procedures as compared to those receiving BMS (which was exactly what DES were designed to do). However, patients with DES during that 12-month interval had twice the risk of death or a heart attack as those with BMS (2.6% vs. 1.3%).
In an accompanying editorial, Drs. Harrington and Califf from Duke university suggest that patients with DES should be kept on Plavix and aspirin more-or-less indefinitely if at all possible, at least until future studies demonstrate the safety of stopping these drugs.
DrRich Comments:
DES clearly and significantly reduce the risk of early restenosis after stent placement.This early restenosis often leads to recurrent symptoms, arrhythmias, and even heart attacks, and reducing its incidence is a good thing. As we now know, however, there is a price to pay for this success. There is a small but appreciable and statistically significant increase in the risk of sudden, late stent occlusion with DES. To reduce this risk, doctors will be increasingly committing their DES patients to prolonged, potentially life-long therapy with Plavix.
For many patients, the increased late risk associated with DES will be more than made up for by the reduced risk of earlier restenosis, and the use of DES will, for this reason, often be appropriate. However, doctors should now feel deeply obligated to discuss with their patients and their families - before a DES is used - all the implications of choosing a DES over a BMS. These implications include the need for taking Plavix every day for a long, long time, and the increased risk of death or heart attack that may ensue if the Plavix is stopped before it is shown to be safe to do so.
Sources:
Pfisterrer M, Brunner-La Rocca HP, Buser PT, Rickenbacher P, Hunziker P, Mueller C, Jeger R, Bader F, Osswald S, Kaiser C. Late clinical events after clopidogrel discontinuation may limit the benefits of drug-eluting stents. J Am Coll Cardiol 2006;48:2584.
Harrington RA, Califf RM. Late ischemic events after clopidogrel cessation following drug-eluting stenting. Should we be worried? J Am Coll Cardiol 2006;48:2592.