Author + information
- Damiano Regazzoli1,
- Azeem Latib2,
- Babu Ezhumalai3,
- Akihito Tanaka2,
- Pier Pasquale Leone4,
- Marco Ancona5,
- Antonio Mangieri2,
- Francesco Giannini2,
- Satoru Mitomo6,
- Ashok Seth7 and
- Antonio Colombo8
- 1San Raffaele Scientific Institute, Milano, Milan, Italy
- 2Interventional Cardiology Institute San Raffaele Hospital, Milan, Milan, Italy
- 3MIOT International, Chennai, Tamil Nadu, India
- 4San Raffaele Hospital, Milan, Milan, Italy
- 5San Raffaele Hospital, Milan, Italy, Milano, Milan, Italy
- 6IRCCS San Raffaele Scientific Institute, Milan, Milan, Italy
- 7Fortis Escorts Heart Institute, New Delhi, Delhi, India
- 8Interventional Cardiology Institute San Raffaele Hospital - Stamford Hospital - Columbia University - Centro Cuore Columbus, Milan, Milan, Italy
Incidence of late BVS thrombosis is of concern. Clinical experiences have shown that ‘dedicated implantation technique' is a key to decrease ST. The aim of this study was to evaluate the use of ‘dedicated implantation technique' in the outcome of BRS.
We retrospectively analyzed consecutive patients that underwent BVS implantation in three high-volume centers before December 2014, in order to have long clinical follow-up. A total of 492 patients were identified for a total of 763 lesions implanted with BRS using a dedicated implantation strategy from the beginning.
Mean age was 60±11 (male sex 90%), 35% of patients were diabetics, left ventricular systolic function (54±8%) and renal function (eGFR 90±25 ml/min) were preserved. The coronary anatomy was predominantly complex, with type B2 or C lesions in 75%, CTOs in 5.6%, bifurcations in 31% and severely calcific lesions in 13%. The dedicated implantation technique included good lesion preparation and debulking (when necessary): predilatation was performed in 99% of cases (cutting balloon 3.5%, scoring balloon 8%, rotational atherectomy 5%). OCT and IVUS were used in 15% and 37% of cases, respectively. Mean scaffold length was 31±16 mm, with a 1:1 high-pressure (21±4atm) postdilatation rate of 99.9%. Angiographic success was achieved in 99.9% of cases. All patients were discharged with dual antiplatelet therapy. Median follow-up was 954 (IQR 760-1130) days and was obtained for 98.8% of patients. Definite or probable scaffold thrombosis occurred in 0.6% (3 pts) of patients ay 1 year and remained stable at 2 and 3 year. Rate of target lesion failure (cardiovascular death, target vessel MI, TLR) was 3.8%, 6.1% and 7.1% at 1, 2 and 3 years follow-up respectively. All the patients were in dual antiplatelet therapy at 1 year and 51% of patients did not discontinue DAPT at last contact.
This large multicenter registry enrolled patients with high prevalence of complex disease and showed good outcomes. The use of a dedicated implantation technique seems to be a mandatory aspect in order to achieve good long term results when implanting BVS. The role of long term DAPT in this setting must be furtherly addressed.
CORONARY: Bioresorbable Vascular Scaffolds