Timing and Type of Events Post-PCI Have Implications for Prognosis—and Honest Discussions With Patients
About one in eight patients who undergo successful PCI with DES will suffer a clinically relevant bleeding event, MI, or stent thrombosis within 2 years, according to an analysis of the ADAPT-DES registry. The fallout from each of these events in terms of mortality varies by timing, with early stent thrombosis carrying the highest risk.
While physicians are good at telling their patients to take their medications, they are not explicitly laying out the risk of adverse events, lead author Sorin Brener, MD (New York Methodist Hospital, Brooklyn, NY), told TCTMD. “We very much emphasize that the stent may clot, but it’s not just the stent that may be the problem,” he said, adding that clinicians “don’t necessarily need to frighten people” but do need to be a bit more realistic.
“There is this idea that the stent cures or the bypass surgery cures, and neither is true,” Brener continued. “They don’t cure anything. It’s just an alleviation of one problem but not all the problems.”
Results for the new analysis were published online June 29, 2016, ahead of print in JACC: Cardiovascular Interventions.
Timing Is Everything?
The researchers looked at 8,582 patients who were enrolled in ADAPT-DES and had successful PCI with DES. Over 2 years, 12.4% had an event, including 8.1% who had clinically relevant bleeding, 3.4% who suffered an MI not related to stent thrombosis, and 0.9% who developed stent thrombosis.
All-cause (and cardiovascular) death rates were higher for patients with stent thrombosis (27.2%) than for patients with MI or bleeding (both P < 0.0001 for trend). Patients without an event had the lowest mortality rate (2.7%).
Timing of events relative to the index PCI appeared to play a role in mortality risk, with 38.5% of the patients who developed early stent thrombosis (≤ 30 days) dying within 30 days of the event versus 15.3% of those whose events occurred late (30-365 days) and 20.0% of those whose events occurred very late (beyond 365 days).
For those experiencing MI, the risk of mortality within 30 days of the event followed the opposite pattern: rising from 0.8% to 5.1% to 7.5% when MI occurred early versus late versus very late. For clinically relevant bleeding, the rates were 1.6%, 7.3%, and 4.2%, respectively, for the three time periods.
On multivariate analysis, early stent thrombosis (HR 11.37; 95% CI 7.61-16.98), MI without stent thrombosis (HR 1.84; 95% CI 1.24-2.72), and clinically relevant bleeding (HR 2.43; 95% CI 1.86-3.18) were all independent predictors of death within 2 years of PCI.
A Need for Honesty
Brener said to the best of his knowledge this study is the first to separate out MI from stent thrombosis events. This design, as well as the fact that they were able to include all events early and late, allowed the researchers to produce more granular results that more or less confirm what has been established before, he explained.
One potential explanation for why early stent thrombosis leads to more death than do later events “is probably because it occurs more suddenly,” Brener said. “Late stent thrombosis is usually the consequence of new atherosclerosis, so it’s less of a sudden event, and patients have symptoms prior to their presentation. Many of them will actually have unstable angina, and they may have the opportunity to present to the doctor.”
In an accompanying editorial, Donald Cutlip, MD (Beth Israel Deaconess Medical Center, Boston, MA), cautioned that just because early stent thrombosis seems to be the more dangerous type, physicians should not be “lulled into complacency about the serious consequences of late and very late [stent thrombosis].” He pointed out that the 30-day mortality risk of very late stent thrombosis was “still nearly threefold higher than spontaneous MI or [clinically relevant bleeding] at any time.”
Brener said there are a few take-home messages for clinicians from this study. First, honesty is key. When talking with patients immediately after PCI, “it’s fair to say that there is a one in eight chance that over the next 2 years they will have some sort of an event, meaning that they are not really scot-free,” he commented.
That also means “you need to stay in touch,” Brener said. Because the early period is the “most vulnerable, . . . that’s the one we need to watch the most,” he continued. “That means follow-up needs to be gradual and decreasing in intensity.”
Lastly, Brener posited that “it’s possible that we overemphasize the importance of bleeding and potentially underemphasize the importance of myocardial infarction.” Specifically, he noted the spontaneous myocardial infarctions that tend to occur later on. This means “we need to intensify secondary prevention,” Brener observed.
Note: Three of the study authors are faculty members of the Cardiovascular Research Foundation, which owns and operates TCTMD.
- DES Patients Who Bleed After Hospital Discharge Face Higher Mortality Risk
- Post-discharge Bleeding Common, Predictive of Mortality After PCI
- Spontaneous Bleeding After PCI Tied to Worse Long-term Mortality
Brener SJ, Kirtane AJ, Stuckey TD, et al. The impact of timing of ischemic and hemorrhagic events on mortality after percutaneous coronary intervention: the ADAPT-DES study. J Am Coll Cardiol Interv. 2016;Epub ahead of print.
- Brener reports no relevant conflicts of interest.
- Cutlip reports receiving institutional funding from Medtronic, Boston Scientific, and Celonova.