Drug-coated balloons for de novo coronary lesions: results from the Valentines II trial

Abstract

The Valentines II trial demonstrates the feasibility of using a second-generation DIOR DCB as adjunct to POBA in de novo coronary lesions. This approach achieved high procedural success with acceptable rates of bail-out stenting and low MACE rates at mid-term follow-up, and offers an attractive alternative for revascularisation of patients who are unsuitable candidates for drug-eluting stents.

Rotational Atherectomy Followed by Drug-Coated Balloon Dilation in Possible Coronary Sequelae of Kawasaki Disease

“…7,8) In contrast, for de novo coronary artery lesions, no definite evidence supporting the superiority of DCB over DES is available, 17,18) while a few registries have shown acceptable results regarding the safety and efficacy of DCB in de novo coronary lesions. 19,20) In the Valentines II, a prospective registry of 109 lesions in 103 patients with stable or unstable angina and/or positive stress test with de novo lesions of > 50% stenosis undergoing plain old balloon angioplasty followed by DCB dilation, the primary endpoint of major adverse cardiac events at 8 months was 8.7% with 1% all-cause death, 1% myocardial infarction, and 2.9% target lesion revascularization (TLR), despite the 11.9% bail-out bare metal stent (BMS) implantation. 19) In part of the SeQuent Please World Wide Registry, a prospective registry of 554 lesions in 496 patients with de novo lesions (small vessels with a mean reference diameter of 2.6 mm) undergoing DCB dilation alone or DCB dilation followed by BMS implantation, the primary endpoint of clinically driven TLR at 9 months was 1.0% in DCB alone and 2.4% in DCB/BMS with 0.7%/0.0% MI and 1.0%/1.2% cardiac death, respectively.…”

“…19,20) In the Valentines II, a prospective registry of 109 lesions in 103 patients with stable or unstable angina and/or positive stress test with de novo lesions of > 50% stenosis undergoing plain old balloon angioplasty followed by DCB dilation, the primary endpoint of major adverse cardiac events at 8 months was 8.7% with 1% all-cause death, 1% myocardial infarction, and 2.9% target lesion revascularization (TLR), despite the 11.9% bail-out bare metal stent (BMS) implantation. 19) In part of the SeQuent Please World Wide Registry, a prospective registry of 554 lesions in 496 patients with de novo lesions (small vessels with a mean reference diameter of 2.6 mm) undergoing DCB dilation alone or DCB dilation followed by BMS implantation, the primary endpoint of clinically driven TLR at 9 months was 1.0% in DCB alone and 2.4% in DCB/BMS with 0.7%/0.0% MI and 1.0%/1.2% cardiac death, respectively. 20) Although the role of DCB in de novo coronary artery lesions including post-rotational atherectomy lesions remains unclear, it is reasonable to propose that DCB-based PCI could be an alternative revascularization therapy of choice among patients with de novo coronary lesions who are inappropriate candidates for DES implantation.…”

Percutaneous Coronary Interventions with Drug-eluting Balloons: Croatian Experience.

“…DEB je korišten u 28 bolesnika (11,3% svih indikacija) na krvnoj žili >2,8 mm. Pregledom literature, do sada je objavljeno jedno istraživanje na de novo lezijama ≥2,5 mm, bez ograničenja maskimalnoga promjera krvne žile u uključnim kriterijima -The Valentines II trial 10 . Rezultati na 103 bolesnika su pokazali da je postupak siguran (2% smrti i infarkta miokarda) te efikasan (6,9% revaskularizacije ciljne lezije i ciljne krvne žile) tijekom 227 ± 40 dana praćenja.…”

“…DEB was used on 28 patients (11.3% of all indications) on a blood vessel >2.8 mm. by reviewing the literature, up-to-date there has been one research conducted on de novo lesions ≥2.5 mm, without the limit on the maximum diameter of the blood vessel in the crucial criteria -The Valentines II trial 10 . The results on 103 patients have shown that the procedure is safe (2% of deaths and myocardial infarctions) and efficient (6.9% target lesion and target blood vessel revascularization) over the span of 227 ± 40 days of observation.…”

Assessment of a Drug-Eluting Balloon for the Treatment of de novo Coronary Lesions Guided by Optical Coherence Tomography: Study Protocol for a Randomized Controlled Trial

“…However, clinical information on the efficacy and safety in de novo coronary lesions is limited. Moreover, several studies and trials have produced conflicting results in patients with a stable coronary artery disease [8,9,10,11,12,13]. Therefore, we hypothesize that DEB may also be safe for the treatment of non-small coronary artery lesions.…”