Single‐Antiplatelet Treatment After Coronary Angioplasty With Drug‐Coated Balloon

In the past decade, many efforts have been made to understand the correct length of dual antiplatelet treatment (DAPT) in patients at high bleeding risk (HBR) after coronary stenting. With many of the current‐generation drug‐eluting stents, reduced (1–3 months) DAPT can be pursued in case of clinical need. In Onyx ONE (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy [DAPT] for High‐Bleeding Risk Patients), patients with an HBR treated with permanent polymer or no‐polimer stents received 1‐month DAPT, and, despite the treatment allocation, the whole population had a 1‐year target‐vessel failure of 18% and 2 to 5 Bleeding Academic Research Consortium (BARC) bleedings of 15%. Notably, 65% of the thrombotic events occurred during the first 30 days. ¹

Drug‐coated balloons (DCBs) have been shown to be an alternative to drug‐eluting stents in some cases of de novo lesions or in patients with HBR. ² , ³ Usually a minimum of 30 days of DAPT has always been applied with this technology, without any scientific evidence. DAPT, initially with ticlopidine, and thereafter with clopidogrel, ticagrelor, or prasugrel on top of aspirin, was tested and introduced to reduce the risk of stent thrombosis; however, from a pharmacological standpoint, its role in reducing the risk of vessel closure after balloon angioplasty is debatable. ⁴ On the other hand, DAPT should be considered for the reduction of recurrent events after acute coronary syndromes (ACS).

We retrospectively analyzed our database of patients who underwent percutaneous coronary intervention with DCBs for de novo coronary lesions from 2012 to 2021. After exclusion of patients treated with drug‐eluting stents in other lesions, we identified a group of 107 patients treated with single‐antiplatelet treatment (SAP) because of HBR or active bleeding (Table). We thus analyzed the outcome of this cohort of patients at 1‐year follow up and compared it with the entire cohort of patients with DCBs. A multivariate logistic regression model was used to estimate odds ratios and 95% CIs to assess the association between baseline characteristics and the outcome, adjusting for potential confounding factors derived from univariate analysis. All tests were 2‐tailed and a P value <0.05 was considered significant. The investigation was reviewed by the institutional review board, and all patients gave informed consent relative to this study. The data that support the findings of this study are available from the corresponding author upon reasonable request.

Table .

Clinical Characteristics and Outcome According to Antiplatelet Treatment

	DCB cohort (n=1110)	DCB with SAP (n=107)	OR (95% CI)	P value
Age, median (IQR), y	69 (57–78)	71 (59–82)	…	0.71
Age ≥75 y	36	39	0.99 (0.65–1.49)	0.89
Women	39	36	1.01 (0.67–1.50)	0.87
Use of anticoagulants	27	48	2.80 (1.91–4.26)	0.03
Diabetes	44	42	0.88 (0.59–1.32)	0.91
Hypertension	77	79	1.38 (0.85–2.23)	0.89
Anemia	29	78	8.03 (5.07–12.74)	<0.001
Bleeding diathesis	23	83	13.29 (8.14–21.68)	<0.001
Atrial fibrillation/flutter	24	43	2.34 (1.55–3.53)	0.03
History of heart failure	29	34	1.49 (0.93–2.15)	0.74
Prior MI	28	33	1.46 (0.96–2.23)	0.89
Prior PCI	22	18	0.86 (0.52–1.41)	0.81
Prior stroke/TIA	4	3	1.40 (0.58–3.37)	0.94
Severe renal disease, CrCl <30 mL/min	23	42	2.70 (1.80–4.05)	0.03
Active malignancy	11	21	2.26 (1.38–3.70)	0.02
Hemoglobin at admittance, median (IQR), g/dL	12 (9.3–14.2)	9.9 (8.1–11.3)	…	0.002
Acute coronary syndrome	45	13	0.20 (0.12–0.35)	0.02
Stable CAD	55	87	4.50 (2.64–7.65)	0.04
LVEF, mean±SD	50.3±9.1	50.9±8.6	…	0.87
Chronic total occlusion	11	9	0.79 (0.41–1.51)	0.90
RVD, mm	2.76	2.68	…	0.64
Type A, B dissection left	38	47	1.44 (0.96–2.14)	0.10
Bailout stenting, culprit lesion	8	0	…	0.02
Procedural success	97	96	0.53 (0.23–1.22)	0.98
Aspirin at discharge	89	35	0.11 (0.07–0.17)	<0.001
Clopidogrel at discharge	40	65	2.45 (1.62–3.70)	0.01
In‐hospital mortality	1	1	0.86 (0.11–6.70)	0.96
In‐hospital bleeding	6.5	5.9	1.04 (0.46–2.32)	0.89
Aspirin, follow‐up	65	18	0.14 (0.08–0.23)	<0.001
Clopidogrel, follow‐up	27	77	8.41 (5.30–13.34)	<0.001
All‐cause mortality	4.5	7	1.97 (0.97–4.00)	0.56
Cardiac death	2	2	1.36 (0.40–4.61)	0.96
Any MI	8	7	1.04 (0.50–2.12)	0.91
TLR	3.5	4	1.58 (0.65–3.83)	0.87
Vessel thrombosis/abrupt occlusion	0	0	…	1
MACE	10	9 (8.1 in clopidogrel, 9.2 in aspirin)	1.03 (0.53–1.98)	0.84
BARC bleedings 2–5	9	6	0.80 (0.38–0.98)	0.04
BARC bleedings 3–5	2	2	1.42 (0.41–4.84)	0.94

Values are expressed as percentages unless otherwise indicated. BARC indicates Bleeding Academic Research Consortium; CAD, coronary artery disease; CrCl, creatinine clearance; DCB, drug‐coated balloon; IQR, interquartile range; LVEF, left ventricular ejection fraction; MACE, major adverse cardiac events; MI, myocardial infarction; OR, odds ratio; PCI, percutaneous coronary intervention; RVD, reference vessel diameter; SAP, single‐antiplatelet treatment; TIA, transient ischemic attack; and TLR, target lesion revascularization.

Patients with SAP had lower initial levels of hemoglobin and fewer acute coronary syndromes at presentation. Procedural success was not statistically different, as well as in‐hospital outcome. At discharge, 35% of patients taking SAP were treated with aspirin and 65% with clopidogrel for decision of the operator. The group treated with SAP and the one treated with DAPT (median time, 198±67 days) differed for several clinical and procedural characteristics (Table), but procedural success and in‐hospital outcome did not differ. After 1 year, the primary end point of major adverse cardiac events (and its components cardiac death, myocardial infarction, target lesion revascularization) was not significantly different between the 2 groups (10% versus 9%, P=0.78), but a reduction in the cumulative rate of 2 to 5 BARC bleedings was observed in the SAP group (9% versus 6%, P=0.04). After adjusting for confounding factors through multivariate analysis bleeding diathesis, DAPT and anticoagulant use were predictors of BARC bleedings, whereas bleeding diathesis and acute coronary syndromes were predictors of major adverse cardiac events.

The results of this study, while hypothesis‐generating, may have important clinical implications. Considerable uncertainty remains, but, in our data, thrombotic event rates were not significantly different comparing a SAP regimen after DCB with standard antiplatelet regimen, and BARC bleedings were found to be lower after 12 months. Current‐generation metallic platforms are safer than the previous ones but are still associated with a high risk of thrombotic events in patients with HBR.

In this article, we report some hypothesis‐generating results of an observational study, which show how in a fragile patient population with native coronary artery disease, a DCB strategy with SAP should be considered.

Sources of Funding

None.

Disclosures

None.