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Elective stenting in small coronary arteries: results of the Italian prospective multicenter registry MICROSCOPE
Flavio Airoldi1, Carlo Di Mario, Patrizia Presbitero
1Interventional Cardiology Unit, San Raffaele Hospital, Milan.
Background:
The role of stent implantation in small coronary arteries is still controversial. The MICROSCOPE study (Ministenting in small coronary arteries, a prospective evaluation) is a multicenter registry addressed to prospectively evaluate the immediate and mid-term clinical and angiographic results of elective stenting of lesions located in coronary arteries with an angiographic reference diameter < or = 2.75 mm.
Methods:
A total of 146 patients (160 lesions) were included in the study. The percentage of complex lesions (B2 and C lesions) was 49.3%. The clinical indications for stent implantation were: stable angina (55.0%), unstable angina (24.6%), and clinical evidence of myocardial ischemia in asymptomatic patients (20.4%); 60% of patients had multivessel disease. Stent deployment could be performed in 96.2% of lesions. The baseline reference diameter was 2.12 +/- 0.36 mm. In all cases the Ministent (Cordis, a J&J Company, Miami, FL, USA), specifically designed for small coronary arteries, was employed. The stent was pre-mounted on low profile balloons available in three different diameters (2.25, 2.50 and 2.75 mm) and three different lengths (11, 15 e 26 mm).
Results:
The primary endpoint of successful stent-assisted angioplasty in all study vessels without major adverse cardiac events was achieved in 95.8% of the patients. The minimal lumen diameter increased from 0.64 +/- 0.24 to 2.02 +/- 0.43 mm and the dimensions of the stenosis (expressed as a percentage of the diameter of the coronary vessel) decreased from 68.6 +/- 10.8 to 16.2 +/- 10.7% (< 30% standard deviation in all cases). After the procedure all the patients received double antiplatelet therapy for 4 weeks. Post-procedural complications were limited to 2 patients (1.3%) who had a non-Q wave myocardial infarction at 6 months of follow-up; 13 patients (11%) required target lesion revascularization. No patient died following the procedure. Angiographic control was performed in 44% of lesions. The minimal lumen diameter decreased to 1.12 +/- 0.47 mm and the percent stenosis increased to 45.9 +/- 23.2%. The incidence of binary restenosis (stenosis > or = 50%) was 41%.
Conclusions:
Elective stenting of small coronary arteries with the Ministent can be safely performed and is associated with a low incidence of acute or subacute stent thrombosis. The mid-term results indicate a high rate of angiographic restenosis but a low need of target vessel revascularization. These data suggest that stenting cannot be considered the treatment of choice for unselected lesions located in coronary arteries with a small reference diameter, but represents a safe solution if unsatisfactory results are obtained with balloon angioplasty alone.
Insights
Stenting small coronary arteries using the Ministent device is safe, with low acute thrombosis. However, high restenosis rates suggest it
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Device Technology
Background:
- The efficacy of stent implantation in small coronary arteries (< or = 2.75 mm) remains a subject of debate.
- The MICROSCOPE study (Ministenting in small coronary arteries, a prospective evaluation) was designed to assess elective stenting outcomes in these vessels.
Purpose of the Study:
- To prospectively evaluate the immediate and mid-term clinical and angiographic results of elective stenting in small coronary arteries.
- To assess the safety and efficacy of the Ministent device in treating lesions in coronary arteries with a reference diameter <= 2.75 mm.
Main Methods:
- A multicenter registry included 146 patients (160 lesions) with small coronary arteries.
- Patients presented with stable angina, unstable angina, or asymptomatic myocardial ischemia; 60% had multivessel disease.
- The Ministent device was used for stent implantation in 96.2% of lesions, with a mean reference diameter of 2.12 +/- 0.36 mm.
Main Results:
- Successful stent-assisted angioplasty was achieved in 95.8% of patients, with significant improvement in minimal lumen diameter and reduction in stenosis.
- Post-procedural complications were low (1.3%), with no deaths.
- At mid-term follow-up, 41% of lesions showed binary restenosis (> or = 50% stenosis), and 11% required target lesion revascularization.
Conclusions:
- Elective stenting of small coronary arteries with the Ministent is safe, with low acute stent thrombosis.
- Mid-term outcomes show a high rate of angiographic restenosis but a low need for target vessel revascularization.
- Stenting may not be the first choice for unselected small vessel lesions but is a safe option for unsatisfactory results after balloon angioplasty.