Simple, Five-Item Risk Score May Predict Early Post-PCI Bleeding Risk

Patrice Wendling

March 13, 2017

BERN, SWITZERLAND — The newly developed PRECISE-DAPT score could help clinicians predict the risk of out-of-hospital bleeding after PCI and guide in selecting the duration of dual antiplatelet therapy (DAPT), a new study suggests[1].

The bedside risk scoring tool was devised using patient-level data pooled from 14,963 patients on DAPT with aspirin and a P2Y12 inhibitor after coronary stenting in eight randomized trials.

The researchers identified five predictors of out-of-hospital TIMI major or minor bleeding occurring at least 7 days after stenting and assigned points to each factor. A nomogram to calculate the score is available online and a mobile app is expected to follow.

The primary outcome occurred in 218 patients over a median follow-up of 552 days (1-year incidence 12.5/1000 patients), with previous spontaneous bleeding emerging as the strongest predictor of TIMI bleeding in the score.

Out-of-Hospital TIMI Bleeding Risk Predictors*

Risk Hazard Ratio (95% CI) P
Previous bleeding 4.14 (1.22–14.02) 0.023
Age (per 10-year increase) 1.34 (1.11–1.48) 0.005
White blood cell count (per increase of 103 cells/μL) 1.06 (0.99–1.13) 0.078
Baseline hemoglobin (per increase of 1 g/dL) 0.67 (0.53–0.84) 0.001
Creatinine clearance (per increase of 10 mL/min) 0.90 (0.82–0.99) 0.004
*Multivariable analysis

Several bleeding and ischemic risk scores have been proposed to predict in- or out-of-hospital events after PCI. "However, most failed to be implemented in everyday clinical practice largely because their use did not affect treatment decisions," senior author Dr Francesco Costa (Bern University Hospital, Switzerland) and colleagues write in the study, published in the March 11, 2017 issue of the Lancet.

He added, "The novel score showed reasonable discrimination and calibration in two independent validation cohorts of patients with contemporary use of all three oral P2Y12 inhibitors and has potential to inform decision making on DAPT duration."

Recent guidelines, including the US 2016 focused update on DAPT, recommend a more individualized approach to DAPT duration, recognizing the delicate balance to be achieved between ischemic and bleeding risks. Shortening the commonly used 12-month DAPT duration to 6 or even 3 months has been shown to significantly reduce bleeding in patients with drug-eluting stents. On the other hand, prolonging treatment in select patients who've tolerated the first year of DAPT without bleeding events can reduce ischemic events.

The difficulty for physicians, the researchers note, is that "no standardized algorithm is available for defining optimal DAPT duration at the time of coronary stent implantation."

In an accompanying editorial[2], Dr Davide Capodanno (University of Catania, Italy) and Dr Dominick Angiolillo (University of Florida, Jacksonville) describe PRECISE-DAPT as a "parsimonious prognostic index" and suggest it has important implications beyond the mere determination of DAPT duration.

"This kind of early risk assessment might be a timely factor in decision making for other bleeding-avoidance strategies such as selection of vascular access, stent, or drugs."

They also point out that most (88%) patients in the derivation cohort received DAPT consisting of aspirin and clopidogrel, but that the more potent antiplatelet agents prasugrel (Effient, Daiichi-Sankyo/Lilly) and ticagrelor (Brilinta/Brilique, AstraZeneca) are currently recommended for acute coronary syndrome.

As such, adaptability of the PRECISE-DAPT score to "disparate and overlapping clinical scenarios," including ACS patients on contemporary antiplatelet regimens, "is a desirable future that warrants confirmation in independent prospective validation studies."

In the derivation cohort, the PRECISE-DAPT score showed a c-index of 0.73 (95% CI 0.61–0.85) for out-of-hospital TIMI major or minor bleeding and 0.71 (95% CI 0.57–0.85) for TIMI major bleeding within 12 months.

The researchers note that the score discrimination was consistent regardless of clinical presentation at the time of PCI or treatment with clopidogrel or ticagrelor but was lower for patients treated with prasugrel and higher for those treated with proton-pump inhibitors.

When the novel risk tool was validated in 8595 patients treated with PCI from the PLATO trial and 6172 participants from the Bern PCI registry, the c-indices were 0.70 and 0.66, respectively.

Finally, the investigators assessed PRECISE-DAPT in 10,081 patients on different DAPT durations in five of the eight randomized trials. They found a significant increase in bleeding with a long (12–24 month) rather than short (3–6 month) duration of DAPT only in patients at high bleeding risk, identified by a PRECISE-DAPT score >25 (absolute risk difference 2.59%; NNT=38).

Conversely, longer DAPT duration reduced the composite ischemic end point of MI, definite stent thrombosis, stroke, or target vessel revascularization only in patients not at high bleeding risk (absolute risk difference -1.53%, NNT=65).

"The resulting net effect on bleeding and ischemia suggested a favorable outcome with 12- to 24-month DAPT in patient at non–high bleeding risk, but not in those at high PRECISE-DAPT risk," Costa and colleagues write.

The editorialists point out that "categorizing a patient as having high bleeding risk is challenged by the notion that the risk for bleeding is dynamic and might change over time, a process that cannot necessarily be accounted for when limited to in-hospital criteria.

"As such, clinicians must remain aware and vigilant that risk scores, like PRECISE-DAPT, although useful to improve the accuracy of the prognostic assumptions affecting clinical decisions, cannot be considered a clear-cut decision rule or substitute for case-by-case critical judgment."

Costa reports no relevant financial relationships. Disclosures for the coauthors are listed in the paper. Capodanno reports receiving payments for consulting fee or honorarium from AstraZeneca, Bayer, Daiichi Sankyo, Eli Lilly, and the Medicines Company. Angiolillo reports receiving payments for consulting or honoraria from Abbott Vascular, Amgen, AstraZeneca, Bayer, Chiesi, Daiichi Sankyo, Eli Lilly, Merck, Pfizer, PLx Pharma, Sanofi, and the Medicines Company; participation in review articles from Johnson & Johnson and St Jude Medical; and institutional payments for grants from Amgen, AstraZeneca, CSL Behring, Daiichi Sankyo, Eli Lilly, Gilead, GlaxoSmithKline, Janssen, Novartis, Osprey Medical, and the Medicines Company.

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