The Real-World CONSEQUENT ALL COMERS Study: Predictors for Target Lesion Revascularization and Mortality in an
Ralf Langhoff1,2, Jawed Arjumand3, Matthias Waliszewski4,5
1Department of Angiology, 155840Sankt-Gertrauden-Krankenhaus, Berlin, Germany.
Insights
This study shows a resveratrol-paclitaxel-coated balloon catheter is safe and effective for peripheral artery disease. It achieved low target lesion revascularization rates in a large patient group.
Area of Science:
- Vascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- Peripheral artery disease (PAD) affects millions globally, necessitating effective endovascular treatments.
- Drug-coated balloons (DCBs) offer a promising alternative to traditional angioplasty, potentially reducing restenosis rates.
Purpose of the Study:
- To evaluate the safety and efficacy of a novel resveratrol-paclitaxel-coated peripheral balloon catheter.
- To assess 12-month outcomes in an all-comer patient cohort with above- and below-the-knee PAD.
Main Methods:
- Prospective, single-arm, multicenter observational study (CONSEQUENT ALL COMERS).
- 879 lesions in 784 patients with claudication or critical limb ischemia (CLI) were analyzed.
- Primary endpoint: 12-month target lesion revascularization (TLR) rate; Secondary endpoints: patency, revascularization, mortality.
Main Results:
- High technical success rate (99.6%) with the drug-coated balloon (DCB).
- 12-month TLR rates were 6.3% for CLI and 9.6% for claudicants.
- Primary patency rates were 89.9% (CLI) and 87.1% (claudicants); all-cause mortality was 4.3%.
Conclusions:
- The resveratrol-paclitaxel-coated DCB demonstrates favorable safety and efficacy in an all-comer PAD population.
- Predictors of TLR included female gender, baseline in-stent restenosis, and lesion length.
- This DCB represents a viable option for endovascular PAD treatment.
Abstract:
We evaluated the safety and efficacy of a resveratrol-paclitaxel-coated peripheral balloon catheter in an all-comer patient cohort undergoing endovascular treatment of above-the-knee and below-the-knee peripheral artery disease. CONSEQUENT ALL COMERS (Clinical Post-Market Clinical Follow-up [PMCF] on Peripheral Arteries treated with SeQuent Please OTW [Over-the Wire]) is a prospective, single-arm, multicenter observational study (ClinicalTrials Identifier: NCT02460042). The primary end point was the 12-month target lesion revascularization (TLR) rate. Secondary end points included vessel patency, target vessel revascularization, and all-cause mortality. A total of 879 lesions in 784 consecutive patients (71.3 ± 10.4 years old, 57.7% male) were analyzed; 53.3% had claudication, whereas the remaining 46.7% exhibited critical limb ischemia (CLI). Substantial comorbidities were present, including diabetes mellitus (41.2%), smoking (66.1%), and coronary artery disease (33.9%). Lesion length (879 lesions) was 12.0 ± 9.3 cm and 31.8% were Transatlantic Inter-Society Consensus II C/D lesions. The overall technical success rate of the 1269 drug-coated balloon (DCB)'s used was 99.6% (1.60 ± 0.79 DCB's/patient). At 12 months, the TLR rates were 6.3% in patients with CLI and 9.6% in claudicants, with a primary patency rate of 89.9% and 87.1%, respectively. All-cause mortality was 4.3% (28/658). The most important predictors for TLR were female gender, in-stent restenosis at baseline and lesion length.
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