Health Evidence Review Commission's Value-based Benefits Subcommittee

Balloon angioplasty and Intravascular Stenting
Issue: During the 2016 CPT code review of intra-arterial mechanical thrombectomy, similar
procedures were identified that are currently being covered and which appear to have limited
evidence of effectiveness. 61630 (Balloon angioplasty, intracranial (eg, atherosclerotic
stenosis), percutaneous) and 61635 (Transcatheter placement of intravascular stent(s),
intracranial (eg, atherosclerotic stenosis), including balloon angioplasty, if performed) were
new CPT codes for 2006 and do not appear to have been reviewed extensively at the time of
their placement on the Prioritized List. At some point between 2006 and present, 61635 was
placed on the non-covered list.
Current Placement
61630 Balloon angioplasty, intracranial (eg, atherosclerotic stenosis), percutaneous: line 200
SUBARACHNOID AND INTRACEREBRAL HEMORRHAGE/HEMATOMA; CEREBRAL ANEURYSM;
COMPRESSION OF BRAIN.
61635 Transcatheter placement of intravascular stent(s), intracranial (eg, atherosclerotic
stenosis), including balloon angioplasty, if performed: Services Recommended for Non-
Coverage Table
Evidence
1) NICE 2012 Endovascular stent insertion for intracranial atherosclerotic disease
a. Current evidence on the efficacy of endovascular stent insertion for intracranial
atherosclerotic disease shows no substantial differences in clinical outcomes
compared with medical treatment after 1–2 years. Evidence on its safety shows
that there is a significant risk of periprocedural stroke and death. Therefore, this
procedure should only be used in the context of research.
2) VISSIT; RCT of balloon angioplasty/stent vs medical management for intracranial
stenosis http://jama.jamanetwork.com/article.aspx?articleid=2208809
a. Zaidat 2015, VISSIT
i. N=112 patients randomized to medical management alone vs medical
management plus balloon-expandable stent placement
1. Enrollment stopped early due to early analysis finding negative
outcomes
ii. RESULTS The 30-day primary safety end point occurred in more patients
in the stent group (14/58; 24.1%[95%CI, 13.9%-37.2%]) vs the medical
group (5/53; 9.4%[95%CI, 3.1%-20.7%]) (P = .05). Intracranial hemorrhage
within 30 days occurred in more patients in the stent group (5/58;
8.6%[95%CI, 2.9%-19.0%]) vs none in the medical group (95%CI, 0%-5.5%)
(P = .06). The 1-year primary outcome of stroke or hard TIA occurred in
more patients in the stent group (21/58; 36.2%[95%CI, 24.0-49.9]) vs the
medical group (8/53; 15.1% [95%CI, 6.7-27.6]) (P = .02).Worsening of
baseline disability score (modified Rankin Scale) occurred in more
patients in the stent group (14/58; 24.1%[95%CI, 13.9%-37.2%]) vs the
medical group (6/53; 11.3%[95%CI, 4.3%-23.0%]) (P = .09).The EuroQol-