Stent thrombosis relationship to discontinuation of antiplatelet therapy

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Incidence of premature discontinuation of antiplatelet therapy

In a prospective study analyzing 1622 patients who received at least one DES, 14.4% discontinued at least 1 antiplatelet drug, predominantly clopidogrel with an incidence of 11.8% for at least five consecutive days during the first year post-implantation.

Predictors of premature discontinuation of antiplatelet therapy

According to a prospective study analyzing 1622 patients, the following observations were made as the reason for discontinuation of one or both antiplatelet therapy:

• Bleeding events or invasive procedures:
  • Nearly 50% patients had interventions or minor bleeding that did not require discontinuation.
  • In patients who discontinued due to bleeding events/invasive procedures, predictors included renal impairment, prior major hemorrhage, or peripheral artery disease

• Medical decisions: 32% patients were either undergoing procedures in a private hospital or did not receive instructions in whom medical decision was the cause.

• Patient decision: 18% patients stopped antiplatelet therapy on their own accord or were on psychotropic drugs.

According to the results evaluated in the PREMIER registry of MI patients, predictors of premature thienopyridine discontinuation included:

• Older age,
• Lower level of education,
• Avoidance of healthcare because of cost,
• Unmarried,
• Anemia,
• Preexisting cardiovascular disease,
• Absence of discharge instructions about the medication, and
• Lack of referral to a cardiac rehabilitation program.

Risk associated with premature discontinuation of antiplatelet therapy

In patients with DES , the most important risk factor for late ST (>30days to 1year) was premature cessation (less than 6 months) of antiplatelet therapy.

• In a prospective observational cohort study followed for 18 months analyzing 3021 patients, thienopyridine was discontinued during the first six months which was the major determinant of ST (hazard ratio 13.7). However there is insufficient information available on the benefit of continuing thienopyridine beyond 6 months.

• From a total cohort of 2974 consecutive patients treated with DES, 38 patients presented with angiographic evidence of ST. Acute ST occurred in 5 patients, subacute ST in 25 patients and late ST in 8 patients. Individuals who discontinued clopidogrel more likely had late ST (36.8% versus 10.7% percent in those without stent thrombosis). The mean duration between cessation of clopidogrel and stent thrombosis was 153 days.

• Drug-eluting stents significantly reduce restenosis, but require 3 to 6 months of thienopyridine therapy to prevent stent thrombosis. The rate and consequences of prematurely discontinuing thienopyridine therapy were also evaluated in the PREMIER registry of MI patients. Almost 14% MI patients treated with DES discontinued thienopyridine therapy at 30 days. Those who discontinued medication were more likely to die during the next 11 months (7.5% versus 0.7%).

The above studies suggest that dual antiplatelet therapy with thienopyridine plus aspirin for at least six months, reduces the likelihood of ST during the first year after DES placement.

However, there is insufficient information available about the optimal time to stop thienopyridine.

Risk associated with late discontinuation of antiplatelet therapy

Stent thrombosis (ST) has been documented in patients who have received dual antiplatelet therapy for 1year or more and then had thienopyridine or both drugs discontinued.

In a study of 2,006 patients with DES, 8 late ST developed in 7 patients. Three cases were related to complete cessation of antiplatelet therapy, two cases occurred while patients were on aspirin therapy within one month of cessation of clopidogrel, and three cases occurred at a time when patients were apparently clinically stable on aspirin monotherapy.

There are few studies which indicate that even if Aspirin therapy if used alone there is partial protection against late ST.

• In a study of 1,236 patients hospitalized for acute coronary syndrome, 20% of ST developed after discontinuation of aspirin with mean delay between aspirin withdrawal and the acute coronary event being 10 +/- 1.9 days. This suggests that aspirin withdrawal in coronary patients may represent a real risk for the occurrence of a new coronary event.

• In an observational study in Japan, 2-year outcomes were assessed in 10,778 patients undergoing SES implantation. It was concluded that discontinuation of both thienopyridine and aspirin, but not discontinuation of thienopyridine therapy only, was associated with an increased risk of stent thrombosis.

Therefore aspirin should be continued indefinitely in patients with coronary artery disease.

Failure of therapy

Premature discontinuation of dual antiplatelet therapy (DAT)is a risk factor for ST, however it is important to note that administration of dual antiplatelet therapy does not prevent the occurrence of ST and many patients are on DAT at the time of the event.

An observational study in Japan analyzed 10778 patients undergoing sirolimus-eluting stent placement.

• Incidences of definite ST were 0.34% at 30 days, 0.54% at 1 year, and 0.77% at 2 years.

• Patients who discontinued both thienopyridine and aspirin had a significantly higher rate of ST than those who continued both (1.76% versus 0.1% at an interval of 31 to 180 days; 0.72% versus 0.07% at an interval of 181 to 365 days; 2.1% versus 0.14% at an interval of 366 to 548 days).

Discontinuation of both thienopyridine and aspirin, but not discontinuation of thienopyridine therapy only, was associated with an increased risk of stent thrombosis.

There was no apparent clinical benefit observed with thienopyridine use beyond 6 months after sirolimus-eluting stent implantation.