Applied Clinical Research, Clinical Trials and Regulatory Affairs

Author(s): Gohar Jamil, Mohammed N. Elnour, Mujgan Jamil, Faisal Aziz, Hanaa M. Mohammed and Abbas Ahmed

DOI: 10.2174/2213476X03666160720124208

Bioresorbable Vascular Scaffold: Our Initial Experience

Page: [101 - 106] Pages: 6

  • * (Excluding Mailing and Handling)

Abstract

Background: Drug eluting stents (DES) are the most frequently used devices during coronary interventions. Bioresorbable vascular scaffold (BVS) were developed to circumvent some of the limitations of DES. Worldwide, there is very limited experience with this device. The aim of our study was to see the initial challenges encountered by a single center while using this new device.

Methods: We implanted a total of 24 BVS in 17 patients. These patients were followed for a two-year period. All patients received similar, standard of care adjunctive medical therapy. Clinical conditions that necessitated BVS usage were ST elevation myocardial infarction (STEMI), Non STEMI and acute coronary syndromes (ACS).

Results: We encountered a high complication rate. Acute and late scaffold thrombosis was seen in four patients. Death or major bleeding was not seen. Patients with and without complications were compared for their coronary artery disease (CAD) risk factors, angiographic characteristics and laboratory data. No difference was detected in their CAD risk factors or metabolic investigations. In all patients post dilation after scaffold deployment was not performed as per industry recommendation at that time.

Conclusion: This small study gives insights into potential challenges that centers may face adapting this new technology. Larger randomized trials with long-term follow-up are needed.

Keywords: Bioresorbable scaffold, drug eluting stents, coronary angiography.

Graphical Abstract